Jcistd Lab 2010

2nd Edition
JOINT COMMISSION INTERNATIONAL

ACCREDITATION STANDARDS FOR
CliniCAl lAborAtoriEs
Effective
1 April 2010
2nd Edition
JOINT COMMISSION INTERNATIONAL
ACCREDITATION STANDARDS FOR
CliniCAl lAborAtoriEs
Effective
1 April 2010
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Joint Commission International
A division of Joint Commission Resources, Inc.
The mission of Joint Commission International (JCI) is to improve the safety and quality of care in the inter-
national community through the provision of education, publications, consultation, and evaluation services.
Joint Commission Resources educational programs and publications support, but are separate from, the
accreditation activities of Joint Commission International. Attendees at Joint Commission Resources educa-
tional programs and purchasers of Joint Commission Resources publications receive no special consideration
or treatment in, or confidential information about, the accreditation process.
2010 Joint Commission International
All rights reserved. No part of this publication may be reproduced in any form or by any means without writ-
ten permission from the publisher.
Printed in the U.S.A. 5 4 3 2 1
Requests for permission to make copies of any part of this work should be mailed to
Permissions Editor
Department of Publications
Joint Commission Resources
One Renaissance Boulevard
Oakbrook Terrace, Illinois 60181 U.S.A.
permissions@jcrinc.com
ISBN: 978-1-59940-385-4
Library of Congress Control Number: 2009937081
For more information about Joint Commission Resources, please visit http://www.jcrinc.com.
For more information about Joint Commission International, please visit
http://www.jointcomissioninternational.org.
JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR CLINICAL LABORATORIES, SECOND EDITION
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Contents
Foreword..........................................................................................................................v
Joint Commission International Standards Subcommittee ................................................vii
Introduction ....................................................................................................................1
Joint Commission International Accreditation Policies and Procedures ................................7
International Patient Safety Goals (IPSG) ..............................................................29
Management and Leadership (MGT)......................................................................33
Development and Control of Policies and Procedures (DCP) ................................57
Resource Management and Laboratory Environment (RSM) ................................67
Quality Control Processes (QCP) ..........................................................................89
Glossary ......................................................................................................................145
Index ..........................................................................................................................157
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Foreword
Joint Commission International (JCI) is very pleased to present this second edition of the International
Standards for Clinical Laboratories. JCI was created in 1998 as the international arm of The Joint
Commission (United States), and this new edition of the standards reaffirms JCIs mission to improve
the safety and quality of patient care around the world.
JCI standards are truly international in their development and revision. The process of developing stan-
dards is actively overseen by an expert international task force, whose members are drawn from each of
the worlds populated continents. In addition, the standards were evaluated by individuals around the
world via an Internet-based field review, as well as considered by JCI Regional Advisory Councils in Asia
Pacific, Europe, and the Middle East, and other experts from various health care fields. This new edition
of the clinical laboratory standards joins the suite of JCI international standards related to Hospitals,
Ambulatory Care, the Care Continuum, Medical Transport, and Primary Care, and those for the certifi-
cation of Disease-Condition-Service programs. JCI standards are the basis for accreditation and certification
of individual health care facilities and programs around the world. In addition, JCI standards have been
used to develop and establish accreditation programs in many countries and by public agencies, health
ministries, and others seeking to evaluate and improve the safety and quality of patient care.
This second edition reflects the dynamic changes occurring around the globe in health care. The treat-
ment of infectious diseases such as HIV/AIDS, tuberculosis, and malaria requires accessible and accurate
clinical laboratory support available around the world. In addition, health care workers are faced with
exposure to biological and other hazards as infectious agents spread rapidly across the globe. Patient-safe
health care relies on accurate testing and reporting of laboratory results. This new edition of the clinical
laboratory standards addresses these and other issues with new and revised standards, including a new
chapter focused on the International Patient Safety Goals, new accreditation decision rules, and revised
accreditation policies. Many of these changes are identified in the table found on pages 4 and 5.
As with all JCI standards, this edition contains the complete set of standards, a statement of intent for
each standard, and measurable elements for assessing compliance with each standard. This structure will
permit readers to identify and understand the specific requirements embodied in the standards.
For further information on the clinical laboratory and other accreditation and certification programs of
JCI, the International Patient Safety Goals, and other JCI initiatives, or assistance in developing a country-
specific accreditation program, please contact us at
Joint Commission International Accreditation Program
1515 West 22nd Street, Suite 1300W
Oak Brook, IL 60523 USA
01-630-268-7400
JCIAccreditation@jcrinc.com
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JCI well understands that standards are continually a work in progress. In that spirit, we welcome
comments and suggestions for improvement.
Karen H. Timmons
President and CEO
Joint Commission International and Joint Commission Resources
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Joint Commission
International Standards
Subcommittee
Joint Commission International Standards Subcommittee
Lee Chien Earn, M.D.
Singapore
Paul B. Hofmann, Dr.P.H., F.A.C.H.E.
Moraga, California, USA
William L. Holzemer, R.N., Ph.D., F.A.A.N.
San Francisco, California, USA
Stanley S. Kent, M.S., R.Ph., F.A.S.H.P.
Evanston, Illinois, USA
Mary Ann Kliethermes, B.S., Pharm.D.
Downers Grove, Illinois, USA
Beth Lilja, M.D.
Copenhagen, Denmark
Suet Wun Lim, M.D. (Chair)
Singapore
David Marx, M.D.
Prague, Czech Republic
Jose Noronha, M.D.
Rio de Janeiro, Brazil
Yazid A. Ohaly, M.D.
Riyadh, Saudi Arabia
Hua Wang, M.D.
Wuhan, Peoples Republic of China
Stuart Whittaker, M.D.
Pinelands, Republic of South Africa
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In"od#c"ion
This second edition of the Joint Commission International Accreditation Standards for Clinical Laboratories
contains all the standards, intent statements, and measurable elements of standards; accreditation policies
and procedures; a glossary of key terms; and an index. This Introduction is designed to provide you with
information on the following topics:
The benefits of accreditation
Joint Commission International (JCI) and its relationship to The Joint Commission (USA)
The international accreditation initiatives of JCI
The origin of the standards and how they are organized
How to use this standards manual
Special features of this manual
If, after reading this publication, you have questions about the standards or the accreditation process, please
contact JCI. Contact information is located in the Foreword (page v).
Common Q#e!"ion! and An!%e! Regading JCI
Accedi"a"ion, Clinical Laboa"oie!, and The!e
S"andad!
Wha" i! accedi"a"ion?
Accreditation is a process in which an entity, separate and distinct from the health care organization, usually
nongovernmental, assesses the health care organization to determine if it meets a set of requirements (stan-
dards) designed to improve the safety and quality of care. Accreditation is usually voluntary. Accreditation
standards are usually regarded as optimal and achievable. Accreditation provides a visible commitment by an
organization to improve the safety and quality of patient care, ensure a safe care environment, and continu-
ally work to reduce risks to patients and staff. Accreditation has gained worldwide attention as an effective
quality evaluation and management tool.
Wha" ae "he benefi"! of accedi"a"ion?
The accreditation process is designed to create a culture of safety and quality within an organization that
strives to continually improve patient care processes and results. In doing so, organizations
improve public trust that patient safety and the quality of care are priorities for the organization;
provide a safe and efficient work environment that contributes to worker satisfaction;
negotiate with sources of payment for care with data on the quality of care;
listen to patients and their families, respect their rights, and involve them in the care process as part-
ners;
create a culture that is open to learning from the timely reporting of adverse events and safety con-
cerns; and
1
01 JCIIL09 - Inrod!cion - 4h Pages:La"o! 1 9/17/2009 5:07 PM Page 1
establish collaborative leadership that sets priorities for and provides continuous leadership for quality
and patient safety at all levels.
Wha" i! JCI*! ela"ion!hip "o The Join" Commi!!ion?
JCI is the international arm of The Joint Commission (US); JCIs mission is to improve the quality and safe-
ty of health care in the international community.
For more than 75 years, The Joint Commission and its predecessor organization have been dedicated to
improving the quality and safety of health care services. Today, The Joint Commission is the largest accredi-
tor of health care organizations in the United Statesit surveys nearly 16,000 health care programs through
a voluntary accreditation process. The Joint Commission and JCI are both nongovernmental, not-for-profit
USA corporations.
Wha" ae "he p#po!e and "he goal of JCI accedi"a"ion ini"ia"i$e!?
JCI accreditation is a variety of initiatives designed to respond to a growing demand around the world for
standards-based evaluation in health care. The purpose is to offer the international community standards-
based, objective processes for evaluating health care organizations. The goal of the program is to stimulate
demonstration of continuous, sustained improvement in health care organizations by applying international
consensus standards, International Patient Safety Goals, and indicator measurement support. In addition to
the standards for clinical laboatories contained in this second edition, JCI has developed standards and
accreditation programs for the following:
Hospitals
Ambulatory care
Primary care centers
The care continuum (home care, assisted living, long term care, hospice care)
Medical transport organizations
JCI also offers certification of programs that provide Disease-Condition-Service care such as programs for
stroke care or cardiac care. JCI accreditation programs are based on an international framework of standards
adaptable to local needs. The programs are characterized by the following:
International consensus standards, developed and maintained by an international task force and
approved by an international board, are the basis of the accreditation program.
The underlying philosophy of the standards is based on principles of quality management and con-
tinuous quality improvement.
The accreditation process is designed to accommodate the legal, religious, and/or cultural factors
within a country. Although the standards set uniform, high expectations for the safety and quality of
patient care, country-specific considerations related to compliance with those expectations are part of
the accreditation process.
The on-site survey team and agenda will vary depending on the organizations size and type of servic-
es provided. For example, a large multispecialty clinical laboratories may require a four-day survey by
a physician, a nurse, and an administrator, whereas a smaller dental center or diagnostic center may
only require a two-day survey by a smaller team.
JCI accreditation is designed to be valid, reliable, and objective. Based on the analysis of the survey
findings, final accreditation decisions are made by an international accreditation committee.
Ho% %ee "he !"andad! ini"iall& de$eloped and efined fo "hi! !econd
edi"ion?
A 12-member International Standards Subcommittee, composed of experienced physicians, nurses, adminis-
trators, and public policy experts, guides the development and revision process of the JCI international
2
3
INTRODUCTION
accreditation standards. The subcommittee consists of members from six major world regions: Latin America
and the Caribbean, Asia and the Pacific Rim, the Middle East, Central and Eastern Europe, Western
Europe, and Africa. The work of the subcommittee is refined based on an international field review of the
standards and the input from experts and others with unique content knowledge.
All international standards are reviewed and approved by the JCI Accreditation Committee, also an interna-
tional group.
Ho% ae "he !"andad! ogani'ed?
The standards are organized around the important functions common to all health care organizations. The
functional organization of standards is now the most widely used around the world and has been validated
by scientific study, testing, and application.
The standards are grouped by those functions related to providing patient care and those related to provid-
ing a safe, effective, and well-managed organization. These functions apply to the entire organization as well
as to each department, unit, or service within the organization. The survey process gathers standards compli-
ance information throughout the entire organization, and the accreditation decision is based on the overall
level of compliance found throughout the entire organization.
Ae "he !"andad! a$ailable fo "he in"ena"ional comm#ni"& "o #!e?
Yes. These standards are available in the international public domain for use by individual health care organ-
izations and by public agencies in improving the quality of patient care. The standards alone can be down-
loaded at no cost from the JCI Web site for adapting them to the needs of individual countries. The transla-
tion and use of the standards as published by JCI require permission.
When "hee ae na"ional o local la%! ela"ed "o a !"andad, %hich applie!?
When standard compliance is related to a law or regulation, whichever sets the higher or stricter requirement
applies.
Ho% do I #!e "hi! !"andad! man#al?
This international standards manual can be used to
guide the efficient and effective management of a health care organization;
guide the organization and delivery of patient care services, and efforts to improve the quality and
efficiency of those services;
review the important functions of a health care organization;
become aware of those standards that all organizations must meet to be accredited by JCI;
review the compliance expectations of standards and the additional requirements found in associated
intent statements;
become aware of the accreditation policies and procedures and the accreditation process; and
become familiar with the terminology used in the manual.
Wha" ae "he (mea!#able elemen"!) of a !"andad?
The measurable elements of a standard are those requirements of the standard and its intent statement that
will be reviewed and assigned a score during the accreditation survey process. The measurable elements simply
list what is required to be in full compliance with the standard. Each element is already reflected in the stan-
dard or intent statement. Listing the measurable elements is intended to provide greater clarity to the stan-
dards and to help organizations educate staff about the standards and prepare for the accreditation survey.
Wha" i! "he S"a"egic Impo$emen" Plan (SIP)?
A Strategic Improvement Plan (SIP) is a required written Plan of Action that the organization develops in
response to not met findings identified in the Official Accreditation Findings Report. The written SIP is
expected to
establish the strategies/approach that the organization will implement to address each not met finding;
describe specific actions the organization will use to achieve compliance with the not met stan-
dards/measurable elements cited;
describe methodology to prevent reoccurrence and sustain improvement over time; and
identify the indicators that will be used to evaluate the effectiveness of the improvement plan (sub-
mission of data to occur over the subsequent three years).
The SIP must demonstrate that the organizations actions lead to full compliance with the standards and
measurable elements. The SIP must be approved by the JCI Central Office staff before the Accreditation
Certification Letter and Gold Seal will be awarded.
Ho% feq#en"l& %ill "he !"andad! be #pda"ed?
Information and experience related to the standards will be gathered on an ongoing basis. If a standard no
longer reflects contemporary health care practice, commonly available technology, quality management prac-
tices, and so forth, it will be revised or deleted. It is currently anticipated that the standards will be revised
and published at least every three years.
Wha" doe! "he (effec"i$e) da"e on "he co$e of "hi! !econd edi"ion of "he
!"andad! man#al mean?
The effective date found on the cover means one of two things:
1. For clinical laboratories already accredited under the first edition of the standards, this is the date by
which they now must be in full compliance with all the standards in the second edition. Standards
are published at least six months in advance of the effective date to provide time for organizations
to come into full compliance with the revised standards.
2. For clinical laboratories seeking accreditation for the first time, the effective date indicates the date
after which all surveys and accreditation decisions will be based on the standards of the second edi-
tion. Any survey and accreditation decisions before the effective date of the second edition will be
based on the first edition standards.
Wha" i! ne% in "hi! !econd edi"ion of "he man#al?
There have been many substantial changes to this second edition of the clinical laboratories manual. A thor-
ough review is strongly recommended. Some of the most significant changes are the following:
A new chapter contains the International Patient Safety Goals.
The format and grouping of the standards were changed to remove the extensive redundancy that
resulted when the format of the ISO 15189 lab standards was used for the first edition.
All the standards related to management and leadership were combined into one chapter. In the first
edition, these requirements were spread over several chapters.
All laboratory quality control processes were placed into one chapter, and a quality control for molec-
ular testing was added.
Standards related to development and control of policies and procedures were added and placed in
one chapter.
Resource management and management of the laboratory environment were combined into one
chapter.
4
5
INTRODUCTION
The requirements from the chapter titled Planning, Development, and Provision of Laboratory
Services (PDP) were divided into other chapters, with related requirements.
The Glossary has been updated and expanded.
The Index has been expanded significantly to facilitate navigation between related standards and topics.
6
J&!%+ C&$$!**!&%
I%+e)%a+!&%a#
Acc)ed!+a+!&% P&#!c!e*
a%d P)&ced,)e*
Tab#e &f P&#!c!e* a%d P)&ced,)e*
General ......................................................................................................................................9
General Eligibility Requirements for Survey ..................................................................................9
Purpose of an Accreditation Survey ................................................................................................9
Scope of Accreditation Surveys ......................................................................................................9
Outcomes of Accreditation Surveys ................................................................................................9
Accredited or Accreditation Denied ......................................................................................9
Accreditation Awards ....................................................................................................................9
Length of Accreditation Awards ..................................................................................................10
Accreditation Process Time Line ..................................................................................................10
Presurvey ..................................................................................................................................11
How to Apply for Accreditation ..................................................................................................11
Scheduling the Survey and Planning the Survey Agenda ..............................................................11
Information Accuracy and Truthfulness Policy ..............................................................................11
Purpose ............................................................................................................................11
Policy................................................................................................................................12
Postponement Policy....................................................................................................................13
Accepted Reasons for Postponement ....................................................................................13
Cancellation Policy ....................................................................................................................13
JCI Accreditation Fee Structure Policy..........................................................................................13
Initial and Triennial Accreditation Fee ..............................................................................13
Focused Survey Fee ............................................................................................................14
Postponement Fee ..............................................................................................................14
Cancellation Fee................................................................................................................14
Travel Costs Related to the Accreditation Survey or Focused Survey ......................................14
Payment Schedule of Survey Fees ........................................................................................14
On-Site Survey Process ..............................................................................................................15
General Information ..................................................................................................................15
Observation of the On-Site Survey Process....................................................................................16
Surveyor Training During the On-Site Survey Process ..................................................................16
JCI Focused Survey Policy ..........................................................................................................16
Purpose ............................................................................................................................16
Policy................................................................................................................................16
Follow-up Focused Surveys ................................................................................................16
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02 JCIIL09 - Policies - 4th Pages:Laout 1 9/23/2009 10:43 AM Page 7
For-Cause Focused Surveys ................................................................................................16
Procedure ..........................................................................................................................16
Extension Survey ........................................................................................................................17
Policy................................................................................................................................18
Procedure ..........................................................................................................................18
Validation Survey ......................................................................................................................18
Purpose ............................................................................................................................18
Process ..............................................................................................................................18
Threat to Health and Safety Policy ..............................................................................................18
Purpose ............................................................................................................................18
Policies ..............................................................................................................................18
Responsibilities ..................................................................................................................18
Procedure ..........................................................................................................................19
Confidentiality ..........................................................................................................................19
At Risk for Denial of Accreditation Policy ....................................................................................20
Purpose ............................................................................................................................20
Policies ..............................................................................................................................20
Responsibilities ..................................................................................................................20
Procedure ..........................................................................................................................20
Postsurvey..................................................................................................................................21
Revision of the Official Accreditation Findings Report ..................................................................21
The Accreditation Decision (Decision Rules) ................................................................................21
Accredited or Denial of Accreditation..................................................................................21
The Accreditation Decision Appeal Policy ....................................................................................21
Notification to the Organization of Areas of Noncompliance with JCI Standards or
Conditions Related to Threat to Life ........................................................................................21
Consideration of the Organizations Response................................................................................21
Action by the JCI Accreditation Committee..................................................................................21
Information on Accreditation Status Available to the Public..........................................................22
Accreditation Award Display and Use..........................................................................................22
Maintaining Accreditation........................................................................................................22
Reporting Requirements Between Surveys ....................................................................................22
JCI Sentinel Event Policy ............................................................................................................23
Sentinel Events ..................................................................................................................23
Goals of the Sentinel Event Policy ......................................................................................23
Standards Relating to Sentinel Events ................................................................................23
Definition of a Sentinel Event ............................................................................................23
Expectations for an Organizations Response to a Sentinel Event ..........................................24
How JCI Becomes Aware of a Sentinel Event ......................................................................24
Reasons for Reporting a Sentinel Event to JCI ....................................................................24
Reviewable Sentinel Events ................................................................................................25
Implementing the Sentinel Event Policy ..............................................................................25
Complaint Management/Quality Monitoring ..............................................................................26
Responding to a Complaint About a JCIAccredited Organization ......................................26
Accreditation Renewal Process......................................................................................................27
8
9
JOINT COMMISSION INTERNATIONAL ACCREDITATION POLICIES AND PROCEDURES
P*'&&"- a)! P,*"!/,"-
Health care organizations wishing to be accredited by Joint Commission International (JCI) must meet the
following requirements.
Ge%e)a#
Ge%e)a# E#!g!b!#!+0 Re(,!)e$e%+* f&) S,)-e0
Any health care organization may apply for JCI accreditation if it meets the following requirements:
The organization is currently in operation as a health care provider in the country and is licensed (if
required).
The organization assumes, or is willing to assume, responsibility for improving the quality of its care
and services.
The organization provides services addressed by JCI standards.
P,)'&*e &f a% Acc)ed!+a+!&% S,)-e0
An accreditation survey assesses an organizations compliance with JCI standards and their intent statements.
The survey evaluates the organizations compliance based on
interviews with staff and patients and other verbal information;
on-site observations of patient care processes by the surveyors;
policies, procedures, and other documents provided by the organization; and
results of self-assessments when part of the accreditation process.
The on-site survey process, as well as continued self-assessment, helps the organization identify and correct
problems and improve the quality of care and services. In addition to evaluating compliance with standards,
their intent statements, and the International Patient Safety Goals, surveyors spend time providing education
in support of the organizations quality improvement activities.
Sc&'e &f Acc)ed!+a+!&% S,)-e0*
The scope of the JCI survey includes all standards-related functions of an applicant organization and all
patient care settings. Applicable standards are selected by JCI from this manual based on the scope of services
provided by an organization applying for survey.
The on-site survey will consider specific cultural and/or legal factors that may influence or shape decisions
regarding the provision of care and/or policies and procedures in an organization.
O,+c&$e* &f Acc)ed!+a+!&% S,)-e0*
The Accreditation Committee of JCI makes accreditation decisions based on the findings of the survey. An
organization can receive one of the following two accreditation decisions:
A,"!&."! *, A,"!&.a.&*) D")&"!. These accreditation decisions are based on whether or not the
organization meets the decision rules. For a description of the decision rules, please refer to the Survey Process
Guide or access the rules on the JCI Web site.
Acc)ed!+a+!&% A.a)d*
To gain accreditation, organizations must demonstrate acceptable compliance with all standards and achieve a
minimal numerical score on these standards as identified in the decision rules. Accredited organizations receive an
Official Accreditation Findings Report and award certificate. The report indicates the level of compliance with JCI
standards achieved by the organization.
Le%g+ &f Acc)ed!+a+!&% A.a)d*
An accreditation award is valid for three years unless revoked by JCI. The award is retroactively effective on
the first day after JCI completes the organizations survey or, when follow-up is required, completes any
required focused surveys.
At the end of the organizations three-year accreditation cycle, the organization must be reevaluated to be eli-
gible for renewal of its accreditation award.
If, during the period of accreditation, the organization undergoes changes in its structure, ownership, or ser-
vices, it must notify JCI. JCI will then determine the need to re-survey the organization and/or render a new
accreditation decision.
Acc)ed!+a+!&% P)&ce** T!$e L!%e
The following is a typical time line for organizations for JCI accreditation, from application to Accreditation
Decision and Official Accreditation Findings Report and beyond.
10
11
P)e*,)-e0
H&. +& A''#0 f&) Acc)ed!+a+!&%
A health care organization that wishes to be accredited begins the accreditation process by completing and
submitting the application for survey. This document provides the essential information about the health care
organization, including ownership, demographics, and types and volume of services provided either directly,
under contract, or through some other arrangement. The application for survey
describes the organization seeking accreditation;
requires the organization to provide JCI with all official records and reports of relevant licensing, regu-
latory, or other governmental bodies;
authorizes JCI to obtain any records and reports about the organization not possessed by the organization;
and
when finalized and accepted by JCI and the applicant, establishes the terms of the relationship between
the organization and JCI.
The health care organization may apply in electronic format by downloading an application form at
http://www.jointcommissioninternational.org and returning the completed form by facsimile (fax) or e-mail to
Joint Commission International Accreditation Program
Fax: +1 630.268.2921
E-mail: jciaccreditation@jcrinc.com
The organization must inform JCI about any changes to the information contained in its application for sur-
vey from the time the application is submitted until the survey is conducted.
Sced,#!%g +e S,)-e0 a%d P#a%%!%g +e S,)-e0 Age%da
JCI and the organization select the survey date (see Accreditation Process Time Line on page 10) and pre-
pare the survey agenda together to meet the organizations needs and the requirements for an efficient survey.
To reduce surveyor travel costs, JCI will make every effort to coordinate the scheduling of surveys of related
or independent organizations in a specific country or region.
JCI will assign each organization an accreditation service specialist, who will serve as the primary contact
between the organization and JCI. This individual will coordinate survey planning and will be available to the
organization to answer any questions about policies, procedures, or accreditation issues.
The accreditation service specialist will work with the organization to prepare a survey agenda based on the
size, type, and complexity of the health care organization. The agenda specifies the sites in the organization to
be visited, the type of interviews to be conducted, the personnel to be interviewed, and the documents to be
provided to the surveyors.
Highly qualified international surveyors will perform the survey. JCI will make every effort to provide survey-
ors fluent in the language(s) used at the organization. If JCI surveyors with the appropriate language capabili-
ties are not available, JCI will work with the organization to identify qualified interpreters.
Circumstances may arise when the organization or JCI must postpone the scheduled survey or may wish to
cancel the scheduled survey. See Cancellation Fee on page 14 for more details.
I%f&)$a+!&% Acc,)ac0 a%d T),+f,#%e** P&#!c0
P/,+*-". To ensure the consistent understanding of the expectations associated with the provision of infor-
mation by organizations participating in the JCI accreditation process and timeliness of organizations
response to requests by the JCI Accreditation Program.
P*'&3
a) The organization must provide accurate and truthful information at all times in the accreditation
process. Falsification is defined as fabrication, in whole or in part, of any information provided by an
applicant or accredited organization to the JCI Accreditation Program.
b) If the organization falsifies information relevant to the accreditation, either by commission or omis-
sion, its accreditation award will immediately be terminated, or in the case of a new applicant, the
organization will be ineligible for reevaluation for one year. Examples of fabrication can include alter-
ing the content of documents through redrafting, reformatting, or deleting content; knowingly submit-
ting false information; or hiding or removing evidence during a survey.
c) Once the organization has submitted an application form, the JCI Accreditation Program must be
notified within 30 days of any change or at least 30 days before the scheduled survey date, if there is a
change in the organization that modifies the information reported in the survey application.
d) During the three years between surveys, the organization must notify the JCI Accreditation Program
within 30 days when there are changes, including the following:
1) A change in the organizations name and/or ownership
2) A change in a significant number of management and clinical staff or operating policies and procedures
3) A change in the contact person(s) that the organization has designated for all accreditation-related
communications
4) A significant increase or decrease in the volume of services
5) The addition of a new health service or acquisition of a health service organization
6) The deletion of an existing health service
7) A significant alteration to the organizations buildings/physical plant
e) To ensure the efficient and accurate transfer of information between the JCI Accreditation Program
and the organization, it is recommended that JCIs contact at the organization is a full-time employee
with a long-term commitment to the continuous improvement of quality and patient safety in the
organization. Part-time, short-term, or contracted individuals should not be delegated this critical
long-term communication role.
f ) The JCI Accreditation Program will restrict most accreditation-related communication to only the fol-
lowing three primary JCI Accreditation Program contacts listed in the application form: chief executive
officer (or equivalent), JCI accreditation survey coordinator, and billing contact. The following com-
munication requirements will apply to the individuals listed as the three primary contacts:
1) The JCI Accreditation Program primary contacts need to establish a communication mechanism to
ensure that all JCI Accreditation Program communications directed to them are responded to with-
in the required time frame.
2) The JCI Accreditation Program will not respond to accreditation-related communications from the
organizations staff outside of the JCI Accreditation Program primary contacts unless directed to do
so by the primary contacts.
3) The organization is required to submit an updated Organization Contact Information form within
30 days of any change in contact information or personnel for the JCI Accreditation Program pri-
mary contacts. The form can be downloaded from the JCI Resource Center for Accredited
Organizations on the JCI Web site (http://www.jointcommissioninternational.org).
4) The accredited organization is required to submit the completed Organization Contact Information
form within the first week of every year.
g) If the JCI Accreditation Program learns that the organization fails to meet one or more of the above
requirements, the organization will initially be contacted to discuss the situation and the JCI accredita-
tion requirements. During the discussion, the Central Office staff will remind the leaders that their
lack of compliance with the policy could place them in the administrative classification of At Risk for
Denial of Accreditation. If the organization continues to not meet the requirement(s), staff will place
12
13
the organization in the At Risk for Denial of Accreditation category, and their accreditation decision
will be reviewed by the Accreditation Committee to determine the outcome.
P&*+'&%e$e%+ P&#!c0
An organization may postpone scheduled surveys when one or more accepted reasons for postponement
occur.
A"+."! R"a-*)- #*, P*-.+*)"(").
A natural disaster or another major unforeseen event occurs that totally or substantially disrupts opera-
tions.
The organization is involved in a major strike, has ceased accepting patients, and is transferring
patients to other facilities.
Patients, the organization, or both are being moved to another building during the scheduled survey.
JCI reserves the right to conduct an on-site survey if the organization continues to provide patient care servic-
es under such circumstances.
Ca%ce##a+!&% P&#!c0
A survey may be canceled by either party without penalty or damages when the following events make it
impossible, illegal, or unreasonable to go forward, including
acts of God;
war;
terrorism;
government regulation;
disaster;
strikes;
civil disorders; and/or
other emergencies of a similar nature.
Cancellation due to any of the reasons cited above must be communicated in writing as soon as practically
possible. Further, JCI may follow the advice of relevant ministries concerned with evaluating political and
military circumstances with regard to scheduling surveys.
JCI Acc)ed!+a+!&% Fee S+),c+,)e P&#!c0
The accreditation survey fee is based on several factors, including the volume and type of services provided by
the organization, the number of locations or care settings included in the survey, and the number of surveyors
and survey days required to conduct the evaluation of compliance with JCI standards. Surveyor time for
report preparation is included in the calculated survey days. The organization is not charged for the cost of a
validation survey. The organization is charged for any required focused survey (see page 14).
I)&.&a' a)! T,&"))&a' A,"!&.a.&*) F"". For most organizations, a three-member survey team
conducting a three-day survey will be needed to efficiently conduct a comprehensive evaluation. For larger or
smaller organizations, the fees will be adjusted upward or downward as appropriate. Included in the fees are:
Survey Process Guide;
custom survey agenda;
all supporting information and assistance regarding the on-site survey process and interpretation of the
standards;
an internationally experienced survey team consisting of one or more of the following individuals
depending on the services provided and standards to be surveyed:
physician;
nurse;
administrator; and
someone with special expertise such as laboratories, medical transport provider;
all preliminary and final reports; and
an accreditation certificate.
F*/-"! S/,0"3 F"". Focused surveys are conducted when JCI becomes aware of potentially serious
standards compliance, patient care, or safety issues, or when JCI has other valid reasons for surveying an
accredited organization. The focused survey reviews only the standards and/or International Patient Safety
Goal requirements in noncompliance at the time of survey or addressed in an incident report. In most cases, a
focused survey is conducted by one surveyor during one day. However, JCI reserves the right to assign more
than one surveyor or to schedule more than one day when indicated by the number of standards to be sur-
veyed or the variety of survey activities.
P*-.+*)"("). F"". In rare circumstances, JCI may, at its discretion, approve a request to postpone a
survey for an organization not meeting any of the criteria described previously (see Postponement Policy on
page 13). In such cases, the organization may be charged a fee to defray costs.
Ca)"''a.&*) F""
Organization-Initiated Cancellation. If the organization cancels the survey thirty (30) or fewer days prior to
the first date of the survey for any reason or for reasons other than those previously stated (see Cancellation
Policy on page 13) the JCI Accreditation Program may require payment of one half of the survey fees to
recover costs the JCI Accreditation Program will incur.
JCIInitiated Cancellation. In the event that JCI cancels the survey for any reason or reasons other than
those previously stated, the organization will not be charged.
T,a0"' C*-.- R"'a."! .* .%" A,"!&.a.&*) S/,0"3 *, F*/-"! S/,0"3. In addition to survey
fees, the organization is responsible for paying all travel costs for the surveyors. These include transportation (air-
fare, train, and car) and reasonable accommodations, including a set daily rate for meals and incidental expenses.
This rate will not exceed the current rates set forth by the U.S. Department of State for international travel.
Pa3("). S%"!/'" *# S/,0"3 F""-. JCI accreditation fees can be billed using one of the two
options. Organizations are asked to identify their preferred option by selecting and signing for the desired
option on the last page of their contract.
Option I. Upon acceptance of this agreement, the organization will receive an invoice for 100% of the survey
fees, (in US dollars), at least 45 days before the start date of the survey. Payment is expected by wire transfer
21 days or more before the start date of the survey. At the conclusion of the survey, if the organization
achieves accreditation, the JCI accreditation certificates will be sent immediately to the organization, along
with the Official Accreditation Findings Report. JCI will then bill the organization for the surveyor(s) expens-
es related to travel and maintenance within 30 days of the conclusion of the survey. The surveyor(s) expenses
must be paid upon receipt of the invoice.
By selecting Option I, JCI expects the organization will pay the surveyor(s) expenses on a timely basis as
billed. If the organization does not pay the surveyor(s) expenses on a timely basis, JCI will recommend to the
JCI Accreditation Committee that the organizations accreditation certificate be returned to JCI and the
accreditation status of the organization be removed.
OR
14
15
Option II. Survey fees will be paid via two separate invoices; a third invoice will be sent to the organization
for the surveyor(s) expense for travel and maintenance.
a) Upon acceptance of this agreement, the organization will receive an invoice for the first half of the accredi-
tation survey fee. This invoice for the first 50% of the survey fees will be billed 45 days before the survey,
with payment expected by wire transfer within 21 days before the start date of the survey. Payment of the
first half of the accreditation survey fee must be received by the JCI Finance Department at least three
weeks before the survey begins. If the first half of the accreditation survey fee is not received four weeks
before the designated survey start date, JCI may reschedule the survey to another available date.
b) At the conclusion of the survey, the second invoice for the remaining 50% of the survey fees will be billed
to the organization. In addition, the surveyor(s) expenses for travel and maintenance will be billed within
30 days following the survey. All payments for fees and expenses must be paid upon receipt of the invoice.
Once the accreditation decision is rendered and JCI has received payment for all the survey fees, the
Official Accreditation Findings Report and accreditation certificate for the organization will be mailed.
Please Note: It is important to keep payments up-to-date, as JCI policy requires payment for one phase of
work before beginning new phases. Delay in submitting payment of the first half of the accreditation fee may
result in greater cost to the organization for the surveyors travel expenses due to the tendency for airlines to
charge a higher ticket fee when travel arrangements are made closer to the actual date of travel.
Payment in full is due upon receipt by your institution of JCI invoices. After 30 days, penalty charges may be
added to the invoice.
O%-S!+e S,)-e0 P)&ce**
Ge%e)a# I%f&)$a+!&%
The surveyors will visit the organization during the dates established and according to the prepared agenda.
The surveyors may ask to interview any personnel during the survey, ask to visit any other unit or location of
the organization not on the agenda, or request additional information. The organization must cooperate with
the surveyors to provide accurate information about the organization and its compliance with the standards.
Delays in providing the required information will be considered noncooperation, which may result in prema-
ture termination of the accreditation process.
The tracer methodology is the foundation of the JCI on-site survey. (See your Survey Process Guide for full
explanation.) The tracer methodology
incorporates the use of information provided in the accreditation survey application;
follows the experience of care for a number of patients through the organizations entire health care process;
and
allows the surveyor(s) to identify performance issues in one or more steps of the patient care process,
or in the interfaces between processes.
The surveyors will confer with the organizations chief executive officer and other leaders at a leadership con-
ference at the end of each survey. During this conference, the surveyors will provide preliminary information
about their findings. This information is strictly preliminary and should not be considered final until review
by the JCI Central Office has been completed.
If, during the survey, the surveyors identify any condition they believe poses a serious threat to public or
patient safety, they will notify the JCI Central Office. JCI will decide whether to issue an expedited Denial of
Accreditation decision and inform relevant public authorities.
For detailed information, see the relevant Survey Process Guide.
Ob*e)-a+!&% &f +e O%-S!+e S,)-e0 P)&ce**
JCI management and supervisory personnel may observe an accreditation survey. The organization or JCI
may request that one or more other individuals observe the survey process. The requesting party must obtain
the express written consent of the other party in order to facilitate the observance. This written consent
should be obtained at least five days prior to survey. Observers, which include consultants or advisors hired by
the organization and employees of another organization, will not have an interactive role in the survey
process. As such, they will not participate in the discussions, interviews, or other activities conducted during
the survey. Costs associated with the observation will be borne by the requesting party.
S,)-e0&) T)a!%!%g D,)!%g +e O%-S!+e S,)-e0 P)&ce**
JCI reserves the right to assign one or more surveyors-in-training to accompany the designated survey team.
This individual(s) may participate in the survey process under the direct supervision and guidance of the sur-
vey team. All costs associated with this training activity will be borne by JCI.
JCI F&c,*ed S,)-e0 P&#!c0
P/,+*-". A focused survey is an on-site survey that is limited in scope, content, and length and designed to
gather information on a specific issue(s) or limited number of standards or measurable elements.
P*'&3. JCI may conduct a focused survey
as follow-up to a full survey (initial of triennial);
when it becomes aware of potentially serious standards compliance or patient care or safety issues;
when it has other valid reasons for surveying an accredited/certified organization; or
when it classifies the organization as At Risk for Denial of Accreditation to an organization (see At
Risk for Denial of Accreditation Policy on page 20).
In most cases, a focused survey is conducted by one surveyor during one day. However, the JCI Accreditation
Program reserves the right to require more than one surveyor or more than one day when indicated by the
number of standards to be surveyed or the variety of survey activities.
An organization is charged for a focused survey regardless of the outcome. An organization can determine the
cost of such a survey by contacting the JCI Accreditation Program.
There are two types of focused surveys used to evaluate an organization: follow-up and for-cause. The specific
reasons for each of these types of focused surveys are described below.
F*''*1-/+ F*/-"! S/,0"3-. The need for surveyor observation, staff or patient interviews, or the
inspection of the physical facility to confirm that an organization has taken sufficient action to achieve accept-
able compliance with any JCI standards and/or International Patient Safety Goal(s) identified as not met or
partially met at the time of initial or triennial full survey.
F*,-Ca/-" F*/-"! S/,0"3-. The receipt of information regarding the occurrence of any event or
series of events in an accredited/certified organization that creates either of the following significant situations:
Concern of a continuing and/or immediate threat to patient/public/staff health and safety within the
organization
To confirm/investigate an applicable condition(s) that resulted in the organization being classified as
At Risk for Denial of Accreditation and not covered by a follow-up focused survey or the Threat to
Health and Safety Protocol
P,*"!/,". Procedure for follow-up and for-cause focused surveys is as follows:
1. JCI will notify the organizations CEO within ten (10) days at the close of an initial or triennial full
survey of any requirement for a follow-up focused survey to reevaluate all the measurable elements
16
17
found to be not met. This follow-up focused survey will be performed within 90 days after the
Official Accreditation Findings Report is sent to the organization. The composition of the survey team
will be determined by the accreditation office based on the number and type of findings and number
of measurable elements to be reevaluated.
2. JCI will notify the organizations CEO of the need for a for-cause focused survey within 45 days when an
organization has been classified as At Risk for Denial of Accreditation. The senior executive director,
accreditation and standards, along with the JCI Accreditation Programs executive director and associate
directors, will evaluate the relevant information regarding an organization and make recommendations to
the JCI president or chair of the Accreditation Committee regarding appropriate actions for at risk
organizations.
3. The recommendation for a for-cause focused survey to the JCI president by the senior executive direc-
tor, accreditation and standards, and the accreditation program executive director may support that the
focused survey be unannounced when one or more of the following conditions is perceived to exist:
The risk to the health and safety of patients, the public, and staff is ongoing, immediate, and
significant.
The risk situation is best evaluated outside of normal schedules and procedures at the organization.
The organizations senior leaders do not need to be present for the appropriate evaluation of the risks.
The organization has the potential to orchestrate situations and conditions that make a thorough
risk analysis difficult or not possible.
JCI surveyors are in the region or area of the organization, and visas or other administrative barriers
are not an issue.
4. When an organization is considered at risk for a potential threat to health and safety, the JCI Threat
to Health and Safety Protocol is immediately put into effect.
5. Upon completion of the for-cause focused survey, the senior executive director, accreditation and stan-
dards, accreditation program executive director, and associate directors will evaluate the relevant infor-
mation regarding an organization and make recommendations to the JCI president and Accreditation
Committee. As appropriate, the recommendations state whether the organization should be awarded
initial accreditation/certification, denied accreditation/certification, allowed to maintain current
accreditation/certification status, or to revoke the current accreditation/certification.
6. The JCI Accreditation Committee will review follow-up focused survey reports in the following situations:
The Committee will review all reports of organizations that fail to meet the accreditation decision
rules, and staff recommend Denial of Accreditation, including following a focused survey con-
ducted as a follow-up, for-cause or extension survey.
The Committee will review the reports of any organization for which staff believe there are special
or unusual compliance issues, including being designated as an organization that is At Risk for
Denial of Accreditation.
The Committee reviews the report of any organization that challenges or disputes the findings con-
tained in the Official Accreditation Findings Report. Appeal of accreditation decisions will follow
the approved policy, the Accreditation Decision Appeal Policy (see page 21).
7. The JCI Accreditation Committee will consider the JCI staff recommendation at its next scheduled
meeting and determine the final accreditation/certification decision.
8. The organization is advised of the accreditation/certification decision within 60 days of the completion
of the focused survey and 10 days following Accreditation Committee action. Staff take appropriate
follow-up actions.
E/+e%*!&% S,)-e0
P*'&3. JCI may conduct an extension survey when an organizational evaluation is determined to be neces-
sary by any of the following factors:
A change in organization ownership
A significantly altered building/physical plant; or an organization has offered at least 25% of its servic-
es at a new location or in a significantly altered physical plant.
A significant increase or decrease in the volume of services
An organization has expanded its capacity to provide services by 25% or greater, as measured by
patient volume or other relevant measures.
The addition of a new type of health service
The deletion of an existing health service
An organization has merged with, consolidated with, or acquired an unaccredited site, service, or pro-
gram for which there are applicable JCI standards.
P,*"!/,". The organization must notify JCI of any significant changes that occur between surveys, as
required by JCIs policy on Reporting Requirements Between Surveys (see page 22). Information submitted
will be reviewed by JCI Central Office staff to determine if a full or focused accreditation survey is necessary
to evaluate the changes described by the organization.
Va#!da+!&% S,)-e0
P/,+*-". The purpose of the validation survey is to evaluate the effectiveness of the JCI survey process in
assessing international standards compliance in health care organizations, as part of JCI Accreditations inter-
nal quality improvement efforts. Organizations that volunteer for a validation survey will not be invoiced.
P,*"--. Organizations that have achieved JCI accreditation will be invited to volunteer for a validation
survey immediately following the initial or triennial re-survey. Validation surveys will be conducted within 60
to 180 days following initial surveys or triennial re-surveys. The length and components of the survey will
replicate the organizations most recent initial or triennial survey process. The surveyors assigned to conduct
the validation survey will have no information about the results of the organizations most recent survey, and
the organization will be requested not to share that information with them in any way.
The participating organizations accreditation decision will not be affected by the findings of a validation sur-
vey in accordance with the decision rules applicable to an initial survey or triennial re-survey. However, if any
condition is identified during survey and believed to pose a serious threat to public or patient health or safety,
the JCI Central Office will be notified and the JCI Threat to Health and Safety Policy will be implemented.
At the completion of the survey, the surveyors will orally report their observations to organization leadership.
A written report will not be left on site.
Organizations that volunteer for a validation survey will be requested not to divulge the results of the valida-
tion survey to any person or organization outside of their own. Similarly, JCI will not release any information
about this survey to the public. Organizations that volunteer for a validation survey will not incur any cost.
T)ea+ +& Hea#+ a%d Safe+0 P&#!c0
P/,+*-". To provide JCI surveyors with a process to respond to a situation that they believe poses a serious
threat to public or patient health or safety in an organization that they are surveying.
P*'&&"-. The JCI Accreditation Program may consider for accreditation purposes a surveyors findings, a
complaint to the organization or JCI, or other information received by JCI as relevant in deciding whether
some aspect of an organizations operation may result in or is likely to result in serious injury, harm, impair-
ment, or death to a patient, staff, or the public and that immediate action must be taken.
R"-+*)-&b&'&.&"-. JCI surveyors are responsible for reporting all situations in which they believe there is a
potential of serious injury, harm, impairment, or death to a patient, staff, or the public at an organization that
they are surveying.
18
19
P,*"!/,". The procedure for threat to health and safety is as follows:
1. The surveyor will notify the JCI Central Office immediately if any condition is identified and believed
to pose such a serious threat to public or patient health or safety.
2. The JCI executive director may request the survey team leader, if a survey is in progress, to coordinate
a conference call from the Central Office to the organization to discuss the findings with the organiza-
tions senior leadership.
3. The survey shall continue, and all subsequent findings are immediately reported to the Central Office.
4. JCIs senior executive director, accreditation and standards, will make a recommendation to the presi-
dent of JCI regarding whether a threat to health or safety status should be declared.
5. The President, or the Chair of the Accreditation Committee if the president is not available, after con-
sultation with the senior executive director of accreditation and standards, can then issue a decision
disclosable to the public that any existing accreditation status is no longer effective, pending subse-
quent review by the JCI Accreditation Committee.
6. The president, or the chair of the JCI Accreditation Committee, can then issue an expedited Denial of
Accreditation decision.
7. The senior executive director of accreditation and standards promptly informs the organizations CEO (and
appropriate governmental authorities if applicable) of this decision and the findings that led to this action.
8. The JCI Accreditation Committee confirms or reverses the decision at its next meeting, or a special
meeting can be convened at the request of the president or senior executive director, accreditation and
standards, based on the level of threat to health or safety. The JCI Accreditation Committee will con-
sider information received from the accredited organization and then decide whether to immediately
deny accreditation or take whatever action it deems appropriate. The Accreditation Committee may
take into consideration an organizations corrective actions or responses to a serious threat situation.
The organization can provide information to demonstrate that the serious threat-to-health-and-safety
situation has been corrected prior to the Accreditation Committees consideration of the Denial of
Accreditation decision.
In these situations, the corrective action is considered when a single issue leads to the adverse finding, and the
organization demonstrates that it
took immediate action to completely remedy the situation;
prepared a thorough and credible root cause analysis;
adopted systems changes to prevent a future recurrences of the problem; and
had a scheduled focused survey that verified the implementation of each of the above corrective actions.
C&%f!de%+!a#!+0
The JCI Accreditation Program keeps confidential the following information received or developed during the
accreditation process:
The Official Accreditation Findings Report, unless the organization wishes to use its accreditation to
fulfill government requirements (for example, for licensure). JCI will release additional information, up
to and including the Official Accreditation Findings Report, to the relevant government agency with
the accredited organizations authorization.
Information learned from the organization before, during, or following the accreditation survey, that
is used to determine compliance with specific accreditation standards
An organizations root cause analysis or action plan prepared in response to a sentinel event or in
response to other circumstances specified by JCI
All other material that may contribute to the accreditation decision (for example, surveyor notes)
Written staff analyses and Accreditation Committee minutes and agenda materials
The identity of any individual who files a complaint about an accredited organization, unless JCI has
the express permission of the submitter, or unless required by law
JCI will provide to the public
an accredited organizations status; that is, whether the organization is accredited or was denied accredi-
tation; and
upon request, the number of complaints an organization has had that met the JCI criteria for review.
JCI will provide to the individual submitting a complaint that met the criteria for review
the applicable standards reviewed;
any standards for which recommendations for improvement were issued as a result of the review; and
when applicable, any change in the organizations accreditation status.
The accredited organization may release more detailed information, up to and including its Official
Accreditation Findings Report, to whomever it wishes. However, when an organization disseminates inaccu-
rate information about its accreditation, JCI reserves the right to clarify information that would otherwise be
considered confidential.
A+ R!*" f&) De%!a# &f Acc)ed!+a+!&% P&#!c0
P/,+*-". The policy allows the JCI Accreditation Program staff to identify specific conditions that, if pres-
ent in an accredited organization, could individually or together demonstrate the need for additional oversight
to ensure that its quality and patient safety program is not in jeopardy.
P*'&3. At Risk for Denial of Accreditation is an administrative classification that results when the JCI
Accreditation Program staff determine that one or more of the following conditions are present:
An immediate threat to patient/public health or staff safety exists within the organization.
An individual who does not possess a license, registration, or certification is providing or has provided health
care services in the organization that would, under applicable law or regulation, require such a license, regis-
tration, or certification and which placed the organizations patients at risk for a serious adverse outcome.
JCI is reasonably persuaded that the organization submitted falsified documents or misrepresented
information in seeking to achieve or retain accreditation, as required by the Information Accuracy and
Truthfulness Policy (see page 11).
The organization does not possess a license, certificate, and/or permit, as, or when, required by appli-
cable law and regulation, to provide the health care services for which the organization is seeking
accreditation.
The organization has not met the accreditation policy for Reporting Requirements Between Surveys
(see page 22).
The organization fails to submit an acceptable Strategic Improvement Plan (SIP) within 120 days of
the organizations survey.
R"-+*)-&b&'&.&"-. Accreditation office staff and surveyors may identify the conditions during an on-site
survey, the review of a survey report or postsurvey follow-up activity, as well as from a complaint submitted
against the organization. Accreditation surveyors will confirm/investigate the applicable condition either while
on site conducting a survey or as part of a focused survey. Recommendations of the accreditation office staff
will be reviewed by the Accreditation Committee.
P,*"!/,". When one or more of the seven conditions listed above is identified, the JCI Accreditation
Program staff notify the senior executive director, accreditation and standards, and the executive director, JCI
Accreditation Program, to review the situation. Based on the outcome of the review, the JCI president and
CEO may be notified depending on the risk(s) identified.
A determination will be made as to the next steps, such as asking the organization for clarifying information,
scheduling a follow-up/for-cause focused survey, or other appropriate activity.
20
21
When the surveyors find the condition has been substantiated and not resolved, Denial of Accreditation will
be recommended to the Accreditation Committee. The organization has the right to appeal this decision as
described in The Accreditation Decision Appeal Policy (see next section).
P&*+*,)-e0
Re-!*!&% &f +e Off!c!a# Acc)ed!+a+!&% F!%d!%g* Re'&)+
The organization has 30 days from receipt of its Official Accreditation Findings Report to request, in writing
or by e-mail, revision of the report related to survey findings. This revision request must be accompanied by
appropriate data and information to support the request. The Accreditation Committee considers this request
for revision and makes the final decision.
Te Acc)ed!+a+!&% Dec!*!&% (Dec!*!&% R,#e*)
The Accreditation Committee of JCI makes accreditation decisions based on the findings of the survey. An
organization can receive one of the following two accreditation decisions.
A,"!&."! *, D")&a' *# A,"!&.a.&*). These accreditation decisions are based on whether or not
the organization meets the decision rules. For a description of the decision rules, please see the Survey Process
Guide or access the rules on the JCI Web site.
Te Acc)ed!+a+!&% Dec!*!&% A''ea# P&#!c0
If, based on a full, focused, or other survey activity, or a threat-to-life situation, there is a decision to deny or with-
draw accreditation, an organization has 20 calendar days from receipt of its Official Accreditation Findings Report
or notice of accreditation withdrawal to notify JCI, in writing or by e-mail, of its intent to appeal the decision.
An organization then has an additional 60 days to submit to JCI, in writing or by e-mail, acceptable data and
information to support its appeal. If, after JCI review of any submitted materials, the decision to deny or with-
draw accreditation is confirmed, an organization may, at its own expense, appear before the JCI Accreditation
Committee to support its appeal. The following sections outline the review and appeal procedure.
N*.&#&a.&*) .* .%" O,$a)&4a.&*) *# A,"a- *# N*)*(+'&a)" 1&.% JCI S.a)!a,!-
*, C*)!&.&*)- R"'a."! .* T%,"a. .* L&#". If JCI staff, based on survey findings, survey documents,
and any other relevant materials or information received from any source, determine, in accordance with deci-
sion rules approved by the JCI Accreditation Committee, to recommend to the JCI Accreditation Committee
that the organization be denied accreditation or have its accreditation withdrawn, staff will outline their find-
ings and determination. The organization may then
a) accept the findings and determination; or
b) submit to JCI evidence of its compliance with the cited JCI standards at the time of survey that is not
reflected in the Official Accreditation Findings Report, along with an explanation of why such infor-
mation was not available at the time of survey; or
c) submit to JCI evidence related to the findings of a threat-to-life situation.
C*)-&!",a.&*) *# .%" O,$a)&4a.&*)6- R"-+*)-". JCI will review the submissions and, in accor-
dance with the decision rules approved by the JCI Accreditation Committee, do the following:
a) Recommend to the JCI Accreditation Committee that the organization be accredited; or
b) Recommend that the organization be denied accreditation
A.&*) b3 .%" JCI A,"!&.a.&*) C*((&.."". The JCI Accreditation Committee may
a) accredit the organization;
b) deny accreditation to the organization;
c) defer consideration while additional information regarding the organizations compliance status or the
threat to-life situation is gathered and reviewed by JCI accreditation staff; or
d) order a re-survey or focused survey of the organization and an evaluation of the results to the extent
deemed appropriate by the JCI Accreditation Program staff.
If an organization withdraws from the accreditation process after the survey has taken place, the JCI
Accreditation Committee will make its decision based on the full accreditation survey findings and follow-up
and will render the decision to the organization.
I%f&)$a+!&% &% Acc)ed!+a+!&% S+a+,* A-a!#ab#e +& +e P,b#!c
JCI is committed to making relevant and accurate information about surveyed organizations available to the
public. Information about an organizations performance not only helps providers to improve their services,
but also helps educate users of the organization. Such information may also help patients and payers make
informed choices in selecting health care providers.
However, it is important that confidentiality be maintained for certain information to encourage openness in
the accreditation process. This openness facilitates improvement of the quality of health care to benefit the
public. Please refer to the section on confidentiality on page 19 for specific information on this issue.
Acc)ed!+a+!&% A.a)d D!*'#a0 a%d U*e
JCI provides each organization with a certificate of accreditation at the time of initial accreditation and at the
time of accreditation renewal. There is no charge for the certificate. Additional copies of certificates may be
purchased by contacting JCI. The certificate and all copies remain JCIs property. They must be returned if
the organization is issued a new certificate reflecting a name change; or
the organizations accreditation is withdrawn or denied for any reason.
An organization accredited by JCI must be accurate in describing to the public the nature and meaning of its
accreditation award. Therefore, an organization must not misrepresent its accreditation status or the facilities
and services to which the accreditation award applies. JCI will supply each organization receiving accredita-
tion with appropriate guidelines for announcing the accreditation award.
Ma!%+a!%!%g Acc)ed!+a+!&%
JCI will continue to monitor accredited organizations and certified programs for compliance with all of the
International Patient Safety Goals and relevant JCI standards on an ongoing basis throughout the three-year
accreditation or certification cycle.
Re'&)+!%g Re(,!)e$e%+* Be+.ee% S,)-e0*
Accreditation is neither automatically transferred nor continued if significant changes occur within the organi-
zation. Such changes may necessitate a full or focused accreditation survey if the organization has
instituted a new service or program for which JCI has standards; including any additions or deletions
of type of health service(s);
made a change in organization name and/or ownership, including any significant number of changes
in the management and clinical staff or operating policies and procedures;
made a change in the contact person(s) that the organization has designated for all accreditation-relat-
ed communications;
made a change in the organizations leadership and/or any personnel designated as JCI primary contacts;
offered at least 25% of its services at a new location or in a significantly altered building/physical facility;
22
23
a significant increase in the volume of services, such as the organization has expanded its capacity to
provide services, or use of its services, by 25% or more as measured by beds, patient visits, pieces of
equipment, or other relevant measures;
a significant decrease in the volume of services, such as the organization has reduced its capacity to
provide services, or use of its services, by 25% or more as measured by beds, patient visits, pieces of
equipment, or other relevant measures;
developed a more intensive level of service (for example, from outpatient cardiac rehabilitation to inpa-
tient invasive diagnostic cardiology); and/or
merged with, consolidated with, or acquired an unaccredited site, service, or program for which there
are applicable JCI standards.
When any of these changes occur, the organization must notify JCI in writing not more than 30 days after
such a change occurs. An organization that fails to provide timely notification to JCI of these changes will be
classified as At Risk for Denial Accreditation, as stated in the policy.
If an accredited organization is purchased by another organization or is physically or organizationally merged
with another organization, JCI may decide that the organization responsible for providing the clinical services
must be re-surveyed or initially surveyed, if not previously accredited. Barring exceptional circumstances, JCI
continues accreditation of the organization undergoing the kind of changes described above until it deter-
mines whether a full or focused accreditation survey is necessary.
JCI Se%+!%e# E-e%+ P&#!c0
S").&)"' E0").-. In support of its mission to improve the safety and quality of health care provided to
the international community, JCI reviews organization activities in response to sentinel events in its accredita-
tion process. This includes all initial accreditation surveys, triennial accreditation surveys, and as appropriate,
focused surveys. The following apply:
A sentinel event is an unanticipated occurrence involving death or major permanent loss of function
unrelated to the natural course of the patients illness or underlying condition.
A sentinel event may occur due to wrong-site, wrong-procedure, wrong-patient surgery.
Such events are called sentinel because they signal a need for immediate investigation and response.
The terms sentinel event and medical error are not synonymous; not all sentinel events occur because of
an error, and not all errors result in sentinel events.
G*a'- *# .%" S").&)"' E0"). P*'&3. The policy has four goals:
1. To have a positive impact in improving patient care, treatment, and services and preventing sentinel
events.
2. To focus the attention of an organization that has experienced a sentinel event on understanding the
causes that underlie the event and on changing the organizations systems and processes to reduce the
probability of such an event in the future.
3. To increase general knowledge about sentinel events, their causes, and strategies for prevention.
4. To maintain the confidence of the public and internationally accredited organizations in the accredita-
tion process.
S.a)!a,!- R"'a.&)$ .* S").&)"' E0").-. The standards related to quality and safety in this publi-
cation contain requirements that specifically relate to the management of sentinel events.
D"#&)&.&*) *# a S").&)"' E0").. The standards in this publication related to quality and safety require
every accredited organization to establish which unanticipated events are significant and the process for their
intense analysis. While the determination of what constitutes a significant event must be consistent with the
general definition of sentinel event as described in this policy, accredited organizations have some latitude in
setting more specific parameters to define unanticipated and major permanent loss of function. At a minimum,
an organization must include the following events as subject to review:
Unanticipated death unrelated to the natural course of the patients illness or underlying condition
Major permanent loss of function unrelated to the natural course of the patients illness or underlying
condition
Wrong-site, wrong-procedure, wrong-patient surgery
E2+".a.&*)- #*, a) O,$a)&4a.&*)6- R"-+*)-" .* a S").&)"' E0").. Accredited organizations
are expected to identify and respond appropriately to all sentinel events (as established by the organization in
accordance with the previous paragraph) occurring in the organization or associated with services that the organi-
zation provides, or provides for. Appropriate response includes conducting a timely, thorough, and credible root
cause analysis; developing an action plan designed to implement improvements to reduce risk; implementing the
improvements; and monitoring the effectiveness of those improvements.
Root Cause Analysis. Root cause analysis is a process for identifying the basis or causal factors that bring
about variation in performance, including the occurrence, or possible occurrence, of a sentinel event. A root
cause analysis focuses primarily on systems and processes, not on individual performance.
Action Plan. The product of the root cause analysis is an action plan that the organization intends to imple-
ment in order to reduce the risk of similar events occurring in the future. The plan should address responsibil-
ity for implementation, oversight, pilot testing as appropriate, time lines, and strategies for measuring the
effectiveness of the actions.
Survey Process. When conducting an accreditation survey, JCI seeks to evaluate the organizations compli-
ance with the applicable standards and to score those standards based on performance throughout the organi-
zation over time (for example, the preceding 12 months for a triennial re-survey or the preceding 4 months
for an initial survey). If, in the course of conducting the usual survey activities a sentinel event is identified,
the surveyor will take the following steps:
Inform the CEO that the event has been identified.
Inform the CEO that the event will be reported to the JCI Central Office for further review and fol-
low-up under the provisions of the Sentinel Event Policy.
During the on-site survey, the surveyor(s) will assess the organizations compliance with sentinel eventrelated
standards in the following ways:
Review the organizations process for responding to a sentinel event.
Interview the organizations leaders and staff about their expectations and responsibilities for identify-
ing, reporting, and responding to sentinel events.
Ask for an example of a root cause analysis that has been conducted in the past year to assess the ade-
quacy of the organizations process for responding to a sentinel event.
Review additional examples, if needed, to more fully assess the organizations understanding of and
ability to conduct root cause analyses. In selecting an example, the organization may choose a closed
case to demonstrate its process for responding to a sentinel event.
H*1 JCI B"*("- A1a," *# a S").&)"' E0").. Each organization is encouraged, but not
required, to report to JCI any sentinel event meeting the previously stated criteria for reviewable sentinel
events. Alternatively, JCI may become aware of a sentinel event by some other means such as communication
from a patient, a family member, an employee of the organization, a surveyor, or through the media.
R"a-*)- #*, R"+*,.&)$ a S").&)"' E0"). .* JCI. Although self-reporting a sentinel event is not
required, and there is no difference in the expected response, time frames, or review procedures whether the
24
25
organization voluntarily reports the event or JCI becomes aware of the event by some other means, there are
two major advantages to the organization that self-reports a sentinel event:
Early reporting provides an opportunity for consultation with JCI Central Office staff during the
development of the root cause analysis and action plan.
The organizations message to the public that it is doing everything possible to ensure that such an
event will not happen again is strengthened by its acknowledgement and collaboration with JCI to
understand how the event happened and what can be done to reduce the risk of such an event occur-
ing in the future.
R"0&"1ab'" S").&)"' E0").-. The definition of a reviewable sentinel event takes into account a wide
array of occurrences applicable to a wide variety of health care organizations. These occurrences may apply to
a particular organization. Thus, one of the following occurrences may apply to your particular organization.
The following sentinel events are subject to review by JCI and include any occurrence that meets the follow-
ing criteria:
The event has resulted in an unanticipated death or major permanent loss of function; or
The event resulted from wrong-site, wrong-patient, wrong-procedure surgery.
Required Response to a Reviewable Sentinel Event. If JCI becomes aware (either through voluntary self-
reporting or otherwise) of a sentinel event that meets the above criteria, and the event has occurred in an
accredited organization, the organization is expected to do the following:
Prepare a thorough and credible action plan within 45 calendar days of the event or of becoming aware
of the event.
Submit to JCI its root cause analysis and action plan, or otherwise provide for JCI evaluation of its
response to the sentinel event.
Review of Root Cause Analysis and Action Plan. A root cause analysis will be considered acceptable if it
has the following characteristics:
The analysis focuses primarily on systems and processes, not individual performance.
The analysis progresses from specific causes in the clinical care process to common causes in the orga-
nizational process.
The analysis repeatedly digs deeper.
The analysis identifies changes that could be made in systems and processes (either through redesign or
development of new systems or processes) that would reduce the risk of such events occurring in the
future.
All root cause analyses and action plans will be considered and treated as confidential by JCI.
Follow-up Activities. After JCI has determined that an organization has conducted an acceptable root cause
analysis and developed an acceptable action plan, JCI will notify the organization that the root cause analysis
and action plan are acceptable and will assign a follow-up activity, if appropriate.
I(+'"(").&)$ .%" S").&)"' E0"). P*'&3. If an organization wishes to report an occurrence in the
subset to sentinel events that are subject to review by JCI, the organization can submit the report to the JCI
Central Office by mail, electronic transmission, or facsimile transmission. If JCI becomes aware of a sentinel
event subject to review under the Sentinel Event Policy that was not reported to JCI by the organization, the
CEO of the organization is contacted, and a preliminary assessment of the sentinel event is made. An event
that occurred more that one year before the date JCI became aware of the event will not, in most cases, be
reviewed under the Sentinel Event Policy. In such a case a written response will be requested from the organi-
zation, including a summary of the processes in place to prevent similar occurrences.
Based on available factual information received about the event, JCI staff will apply the previously stated definition to
determine that an event is reviewable under the Sentinel Event Policy. Challenges to a determination that an event is
reviewable will be resolved through consultation with the JCI executive director and JCI chief medical officer.
Initial On-Site Review of a Sentinel Event. An initial on-site review of a sentinel event will usually not be
conducted unless it is determined that there is a potential ongoing immediate threat to patient health and
safety or potential significant noncompliance with JCI standards. Immediate threat-to-life incidents include
situations in which the organizations noncompliance with one or more standards has caused, or is likely to
cause, major permanent loss of function, impairment, or death to a patient and is likely to continue.
Complaints are assigned this priority if the information indicates immediate corrective action is necessary. All
are immediately referred to JCI executive leadership for authorization to conduct a focused survey. If a
focused survey is conducted, the organization will be billed an appropriate amount based on the established
fee schedule to cover the cost of conducting such a survey.
Disclosable Information. If JCI receives an inquiry about the accreditation decision of an organization that
has experienced a reviewable sentinel event, the organizations accreditation decision will be reported in the
usual manner without making reference to the sentinel event. If the inquirer specifically references the specific
sentinel event, JCI will acknowledge that it is aware of the event and is currently working or has worked with
the organization through the sentinel event review process.
C&$'#a!%+ Ma%age$e%+/Q,a#!+0 M&%!+&)!%g
R"-+*)!&)$ .* a C*(+'a&). Ab*/. a JCI5A,"!&."! O,$a)&4a.&*). The JCI Office of
Quality and Safety Monitoring triages and reviews complaints, concerns, and inquiries related to accredited
health care organizations, as received from a variety of sources. These complaints may be submitted by
patients, families, and health care providers; by governmental agencies in the form of reports; or through
information from the media. The term complaint therefore covers a broad spectrum of information received
by the JCI Accreditation Program.
Upon the JCI Accreditation Programs review of a complaint, a number of actions may result. These include
recording the information for trending purposes and possible action in the future, obtaining the involved
health care organizations response to the complaint, and conducting a for-cause focused survey. If the JCI
Accreditation Program determines that the organization should respond to the complaint, the organization
will be so notified. The request for a response will be e-mailed to the organizations CEO and posted to the
organizations secure, password-protected JCI Resource Center Web site. The organizations response to the
complaint also takes place through its protected area of the Web site.
The complaint information posted on the protected area of the Web site may be either of the following:
The complaint itself
A summary of the complaint, if the complainant requested anonymity
If a health care organization is required to respond to the complaint, it is required to do so usually within 30
days of being notified. For more serious issues, the organization may be required to respond to the complaint
within 7 days of being notified, or sooner. When a response in a short time frame is required, the organiza-
tion will be so notified.
Once a response is received, it is evaluated for compliance with JCI accreditation standards, as applicable. If
additional information is required, the organization will be notified.
When the organizations response is complete and has been accepted, a letter indicating acceptance is e-mailed
to the CEO, and the case is considered closed.
26
27
The JCI Accreditation Program requires that the accredited organization communicate to employees, visitors,
and patients that when complaints are not resolved to their satisfaction, individuals may choose to report their
complaint to the JCI Accreditation Program.
The JCI Accreditation Programs policies prohibit organizations from taking retaliatory action against employ-
ees who submit a complaint to the JCI Accreditation Program and prohibit the JCI Accreditation Program
from disclosing to a complainant whether a complaint is substantiated.
Acc)ed!+a+!&% Re%e.a# P)&ce**
The JCI Accreditation Program sends the organization a Request to Resurvey before the organizations trienni-
al accreditation due date. The organization is responsible for completing and returning the Request for
Resurvey to JCI by a specified date. JCI then schedules the survey. Every effort is made to schedule the trien-
nial survey to occur at the approximate conclusion of the previous three-year accreditation cycle. JCI will
work with the organization and other organizations in the country or region that are also due for surveys to
schedule the appropriate survey date(s). An organizations previous accreditation status may remain in effect
up to two months after the subsequent full accreditation survey to accomplish any required follow-up. If, dur-
ing the period of accreditation, JCI receives information that the organization is substantially out of compli-
ance with current accreditation standards, JCI will determine the need to resurvey the organization and/or
render a new accreditation decision. (See JCI Focused Survey Policy, page 16.)
28
International Patient Safety
Goals (IPSG)
Goals
The following is a list of all goals. They are presented here for your convenience without their requirements,
intent statements, or measurable elements. For more information about these goals, please see the next section
in this chapter, Goals, Standards, Intents, and Measurable Elements.
IPSG.1 Identify Patients Correctly
IPSG.2 Improve Effective Communication
IPSG.3 Not applicable for laboratories
IPSG.4 Ensure Correct-Site, Correct-Procedure, Correct-Patient Surgery
IPSG.5 Reduce the Risk of Health CareAssociated Infections
IPSG.6 Not applicable for laboratories
29
03 JCIIL09 - IPSG - 4th Pages:Layout 1 9/17/2009 5:16 PM Page 29
Goals, Standards, Intents, and Measurable Elements
G"al 1: Ide!&if) Pa&ie!&% C"$$ec&l)
S&a!da$d IPSG.1
The organization develops an approach to improve accuracy of patient identifications.
Intent of IPSG.1
Wrong-patient errors occur in virtually all aspects of diagnosis and treatment. Patients may be sedated, disori-
ented, or not fully alert; may change beds, rooms, or locations within the organization; may have sensory dis-
abilities; or may be subject to other situations that may lead to errors in identification. The intent of this goal
is twofold: first, to reliably identify the patient as the person for whom the service or treatment is intended;
second, to match the service or treatment to that individual patient.
Policies and/or procedures are collaboratively developed to improve identification processesin particular, the
processes used to identify a patient when giving medications, blood, or blood products; taking blood or other
specimens for clinical testing; or providing any other treatments or procedures. The policies and/or procedures
require at least two ways to identify a patient, such as the patients name, identification number, birth date, or
other ways. The patients room number or location cannot be used for identification. The policies and/or pro-
cedures clarify the use of two different identifiers in different locations within the organization, such as in
ambulatory care or other outpatient services, the emergency department, or operating theatre. Identification
of the comatose patient with no identification is also included. A collaborative process is used to develop the
policies and/or procedures to ensure that they address all possible identification situations.
Measurable Elements of IPSG.1
J 1. A collaborative process is used to develop policies and/or procedures that address the accuracy of
patient identification.
J 2. The policies and/or procedures require the use of two patient identifiers, not including the use of the
patients room number or location.
J 3. Patients are identified before administering medications, blood, or blood products.
J 4. Patients are identified before taking blood and other specimens for clinical testing.
J 5. Patients are identified before providing treatments and procedures.
G"al 2: I#$"(e Effec&i(e C"'!ica&i"!
S&a!da$d IPSG.2
The organization develops an approach to improve the effectiveness of communication among caregivers.
Intent of IPSG.2
Effective communicationwhich is timely, accurate, complete, unambiguous, and understood by the recipient
reduces errors and results in improved patient safety. Communication can be electronic, verbal, or written. The
most error-prone communications are patient care orders given verbally and those given over the telephone, when
permitted under local laws or regulations. Another error-prone communication is the reporting back of critical test
results, such as the clinical laboratory telephoning the organization to report the results of a critical lab value.
30
31
INTERNATIONAL PATIENT SAFETY GOALS (IPSG)
The organization collaboratively develops a policy and/or procedure for verbal and telephone orders that
includes the writing down, legibly (or entering into a computer), the complete order or test result by the
receiver of the information; the receiver reading back the order or test result; and the confirmation that what
has been written down and read back is accurate. The policy and/or procedure identifies permissible alterna-
tives when the read-back process may not always be possible, such as in the operating theatre or in emergency
situations in the emergency department or intensive care unit.
J 1. A collaborative process is used to develop policies and/or procedures that address the accuracy of ver-
bal and telephone communications.
J 2. The complete verbal and telephone order or test result is written down legibly and signed by the
receiver of the order or test result.
J 3. The complete verbal and telephone order or test result is read back by the receiver of the order or test
result.
J 4. The order or test result is confirmed by the individual who gave the order or test result.
G"al 4: E!%'$e C"$$ec&-Si&e, C"$$ec&-P$"ced'$e, C"$$ec&-
Pa&ie!& S'$ge$)
S&a!da$d IPSG.4
The organization develops an approach to ensuring correct-site, correct-procedure, and correct-patient surgery.
Intent of IPSG.4
Wrong-site, wrong-procedure, wrong-patient surgery is a disturbingly common occurrence in health care
organizations. These errors are the result of ineffective or inadequate communication between members of the
surgical team, lack of patient involvement in site marking, and lack of procedures for verifying the operative
site. In addition, inadequate patient assessment, inadequate medical record review, a culture that does not
support open communication among surgical team members, problems related to illegible handwriting, and
the use of abbreviations are frequent contributing factors.
Organizations need to collaboratively develop a policy and/or procedure that is effective in eliminating this
disturbing problem. Evidence-based practices, such as those described in The Joint Commissions Universal
Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery should be adopted.
The essential processes found in the Universal Protocol are
marking the surgical site;
a preoperative verification process; and
a time-out that is held immediately before the start of a procedure.
Marking the surgical site involves the patient and is done with an unambiguous mark. The mark should be
consistent throughout the organization; should be made by the person performing the procedure; should take
place with the patient awake and aware, if possible; and must be visible after the patient is prepped and
draped. The surgical site is marked in all cases involving laterality, multiple structures (fingers, toes, lesions),
or multiple levels (spine).
The purpose of the preoperative verification process is to
verify the correct site, procedure, and patient;
ensure that all relevant documents, images, and studies are available, properly labeled, and displayed; and
verify that any required special equipment and/or implants are present.
The time-out permits any unanswered questions or confusion to be resolved. The procedure should not be
initiated in the absence of such resolution. The time-out is conducted in the location where the procedure
will be done, just before starting the procedure, and involves the entire operative team. The organization
determines how the process is to be briefly documented, such as in a checklist.
J 1. A collaborative process is used to develop policies and/or procedures that will establish uniform
processes to ensure the correct site, correct procedure, and correct patient, including procedures done
in settings other than the operating theatre.
J 2. The organization uses a clearly understood mark for surgical site identification and involves the
patient in the marking process.
J 3. The organization uses a process to verify that all documents and equipment needed are on hand, cor-
rect, and functional.
J 4. The organization uses a checklist and time-out procedure just before starting a surgical procedure.
G"al 5: Red'ce &he Ri%k "f Heal&h Ca$e*A%%"cia&ed
I!fec&i"!%
S&a!da$d IPSG.5
The organization develops an approach to reduce the risk of health careassociated infections.
Intent of IPSG.5
Infection prevention and control are challenging in most health care settings, and rising rates of health
careassociated infections are a major concern for patients and health care professionals (also see Glossary).
Infections common to many health care settings include catheter-associated urinary tract infections, blood-
stream infections, and pneumonia (often associated with mechanical ventilation).
Central to the elimination of these and other infections is proper hand hygiene. Internationally acceptable
hand hygiene guidelines are available from the World Health Organization (WHO), the US Centers for
Disease Control and Prevention (US CDC), and various other national and international organizations.
The organization has a collaborative process to develop policies and/or procedures that adapt or adopt cur-
rently published and generally accepted hand hygiene guidelines and for the implementation of those guide-
lines within the organization.
J 1. A collaborative process is used to develop policies and/or procedures that address reducing the risk of
health careassociated infections.
J 2. The organization has adopted or adapted currently published and generally accepted hand hygiene
guidelines.
J 3. The organization implements an effective hand hygiene program.
32
Managemen" and
Leade!hip (MGT)
S"andad!
The following is a list of all standards. They are presented here for your convenience without their require-
ments, intent statements, or measurable elements. For more information about these standards, please see the
next section in this chapter, Standards, Intents, and Measurable Elements.
Planning
MGT.1 The leaders are responsible for laboratory planning.
MGT.1.1 The leaders plan the type and scope of services to be provided after communicating
with customers regarding their needs.
Contract and Reference Laborator Services
MGT.1.2 The laboratory director and other leaders define the process for selecting and approving contract
and reference laboratory services, including services that provide blood and blood products.
Contract Laborator Services
MGT.1.2.1 The laboratory director is responsible for assuring the consistent per-
formance of contract laboratory services.
Reference Laborator Services
MGT.1.2.2 The laboratory director is responsible for assuring the consistent per-
formance of reference laboratory services.
Resource Planning
MGT.1.3 The leaders are responsible for providing adequate resources for the provision of
planned laboratory services.
Re!pon!ibili"& and A#"hoi"&
MGT.2 Responsibilities for administrative direction and clinical direction of the laboratory are defined in
writing. In addition, other leadership roles are also defined.
MGT.2.1 The directorship of the laboratory is effective.
MGT.2.2 The laboratory director is responsible for requiring practices that respect the needs of
patients and other customers.
33
04 JCIIL09 - MGT - 4th Pages:Layout 1 9/17/2009 5:16 PM Page 33
Comm#nica"ion and Coodina"ion
MGT.3 Laboratory leaders provide for communication and coordination throughout the laboratory and
with outside customers.
MGT.3.1 Leaders communicate to laboratory staff the priority of meeting the needs of clinicians,
patients, and other users of laboratory services.
MGT.3.2 Necessary policies are developed for communicating with clinicians who order tests.
Q#ali"& Managemen" and Impo$emen" Poce!!
Planning and Coordination of the Qualit Management and Improvement Program
MGT.4 Laboratory leaders are responsible for planning, documenting, implementing, and monitoring a
quality management and improvement program.
MGT.4.1 The laboratorys program for process design and quality measurement, analysis, and
improvement is systematic and addresses
the goals of the quality management and improvement system;
all of the quality management and improvement systems components;
the methodology used to measure and improve processes and services; and
the systems used for quality control of laboratory testing and other services.
MGT.4.1.1 Laboratory leaders ensure that the program is coordinated and an appro-
priate individual(s) is appointed to implement and manage the process.
MGT.4.1.2 The leaders assign adequate resources to quality management and
improvement activities.
MGT.4.1.3 Leaders communicate the key elements of the quality management and
improvement program to employees.
MGT.4.1.4 The leaders define performance and quality control activities used to
monitor the laboratorys processes and the systems used to ensure proper
operation and control of these processes.
Design of New Processes
MGT.4.1.5 The laboratory designs new and redesigns existing systems and processes
according to quality improvement principles.
MGT.4.1.6 The leaders prioritize which processes are to be measured and which
improvement activities will be implemented.
Data Collection for Qualit Measurement
MGT.4.2 The laboratorys leaders identify key measures (indicators) to measure clinical and man-
agerial structures, processes, and outcomes.
MGT.4.2.1 Quality measurement includes those aspects of the following that are
selected by leaders:
a) The laboratorys safety and infection control programs
b) The laboratorys quality control programs
c) Preanalytic processes, including
patient preparation;
specimen quality processes (collection, labeling, preservation,
transportation, and rejection); and
completeness of requisitions.
34
35
MANAGEMENT AND LEADERSHIP (MGT)
d) Postanalytic processes, including
efficient transfer of information;
timeliness of reporting test results;
adequacy of documentation; and
accuracy of reports.
MGT.4.2.2 Managerial measurement includes aspects of the following that are select-
ed by leaders:
a) The needs, expectations, and satisfaction of individuals and organi-
zations served
b) The appropriateness of tests offered
c) Key aspects of the procurement of routinely required supplies and
equipment essential to provide laboratory services
d) Those aspects of laboratory employee expectations and satisfaction
selected by the leaders
e) Those aspects of financial management selected by the leaders
f ) Those aspects of the prevention and control of events that jeopard-
ize the safety of patients, families, and staff selected by the leaders,
including the International Patient Safety Goals
Analsis of Measurement Data
MGT.4.3 Individuals with appropriate experience, knowledge, and skills systematically aggregate
and analyze data in the laboratory.
MGT.4.4 The frequency of data analysis is appropriate to the process being studied and meets
laboratory requirements.
MGT.4.5 The analysis process includes comparisons internally, with other laboratories when avail-
able, and with published scientific standards and desirable practices.
MGT.4.6 Data are analyzed when undesirable trends and variation are evident from the data.
Improvement
MGT.4.7 Improvement in quality and safety is achieved and sustained.
MGT.4.8 Improvement and safety activities are undertaken for the priority areas identified by the
laboratorys leaders.
MGT.4.9 An ongoing program of identifying and reducing unanticipated adverse events and safe-
ty risks to patients and staff is defined and implemented.
Qualit Management and Improvement Program Review
MGT.4.10 Leaders manage the quality and improvement process and periodically review the effec-
tiveness, adequacy, and relevance of the monitoring and improvement activities.
36
37
S"andad!, In"en"!, and Mea!#able Elemen"!
Pa""i"g
S'a"da%d MGT.1
The leaders are responsible for laboratory planning.
I"'e"' #f MGT.1
Laboratory leaders engage in activities for laboratory planning. This includes defining the laboratorys mission,
values, and goals. The planning process includes establishing timely, clearly defined goals and creating the
plans and policies needed to meet the goals and fulfill the mission. Leaders arise from many sources. The lab-
oratory director, those providing governance, and the owners, if different from the medical director, are
responsible for managing the laboratory and are, therefore, the formal leaders. In addition, managers and
supervisors have leadership roles in the laboratory. Other leaders may be informally recognized for their sen-
iority, stature, or contribution to the laboratory. Whenever possible, it is important to recognize all leaders
and bring them into the process of defining the laboratorys mission and goals.
Mea&(%abe Ee!e"'& #f MGT.1
J 1. The laboratorys mission, values, and goals are defined by laboratory leaders.
J 2. The mission, values and goals are delineated in a written document.
J 3. When possible, all leaders are included in the process of defining the mission and goals.
S'a"da%d MGT.1.1
The leaders plan the type and scope of services to be provided after communicating with customers regarding
their needs.
I"'e"' #f MGT.1.1
To be successful, laboratory services are planned and designed to respond to the needs of clinicians and the
patient population using the laboratorys services. The planning process is continued throughout the life the
laboratory, based on the changing needs of these customers, as well as changes and innovations in laboratory
tests. The laboratory uses results of discussions with customers and/or other means of determining needs
when planning for
a) the laboratory testing to be performed within the laboratory;
b) tests to be referred to other laboratories;
c) turnaround time and testing frequency requirements; and
d) the degree of clinical consultation required by clinicians.
After results and the resources of the laboratory are assessed, the type and scope of services provided are defined in a
written policy. Over time, the plan for services is reviewed and modified, as the laboratory services evolve and change.
Mea&(%abe Ee!e"'& #f MGT.1.1
J 1. Laboratory and other organization leaders plan for the type and scope of services to be provided.
J 2. Part of the planning process includes discussing the needs of clinicians and other customers in deter-
mining the service dimensions listed in elements a) through d) in the intent.
38
J 3. The planning process is ongoing, based on changing customer needs and changes and innovations in
laboratory testing processes.
J 4. The type and scope of laboratory services provided are defined in a written policy.
J 5. The plan for services is periodically reviewed and modified as the requirements for services evolve
and change.
Con"ac" and Refeence Laboa"o& Se$ice!
S'a"da%d MGT.1.2
The laboratory director and other leaders define the process for selecting and approving contract and reference
laboratory services, including services that provide blood and blood products.*
I"'e"' #f MGT.1.2
The laboratory director is accountable for providing services according to the laboratorys plan for services. When
contract or reference services are used, the director retains overall responsibility and authority for ensuring the con-
sistent performance of these services. Therefore, the laboratory has defined how these services are selected.
Input from the clinical staff regarding reference and contract services is sought and used to determine their
acceptability. All such services meet applicable laws and regulations.
J 1. The laboratory director defines in writing the criteria used to select and approve contract laboratory services.
J 2. The laboratory director defines in writing the criteria used to select and approve reference laboratory services.
J 3. The laboratory seeks and uses input from clinicians who use these services regarding their acceptability.
J 4. This input is documented.
J 5. All contract laboratory services meet applicable law and regulation.
J 6. All reference laboratory services meet applicable law and regulation.
Con"ac" Laboa"o& Se$ice!
S'a"da%d MGT.1.2.1
The laboratory director is responsible for assuring the consistent performance of contract laboratory services.
I"'e"' #f MGT.1.2.1
The laboratory director and other leaders are responsible for choosing and monitoring contract laboratory
services, including consultants. Therefore, the leaders have defined in writing the means used to monitor the
accuracy, availability, appropriateness, and effectiveness of these services.
The laboratory maintains records of contract laboratories used, along with evidence of any required licensure,
certification, or other regulatory requirements. There is periodic review of these services to determine whether
clinicians and other users are satisfied with services rendered and whether laboratory leaders remain satisfied
*CLSI publication GP9-A, Selecting and Evaluating a Referral Laboratory; Approved Guideline, is one resource that may be
used as a guideline if assistance is needed.
39
with their performance. Laboratory leaders consult with users, when appropriate, about preferences for, and
satisfaction with, outside services used.
As part of the periodic review of contract and/or consultant services, laboratory leaders examine the following
issues:
a) Are specimen collection protocols provided by the contract laboratory?
b) Are the specimen collection protocols clearly written and adequate?
c) Are specimen transport services adequate?
d) Are clinicians and other laboratory clients satisfied with the reliability of results?
e) Are clinicians and other laboratory clients satisfied with turnaround times for test results?
f ) Is there effective communication among the referring laboratory, the contract laboratory, the clinician,
and the patient?
g) Do contract consultants provide accurate and timely reports to the laboratory?
Mea&(%abe Ee!e"'& #f MGT.1.2.1
J 1. The laboratory director defines in writing the means used to monitor the accuracy, availability,
appropriateness, and effectiveness of contract laboratory services.
J 2. There is documented evidence that the quality of contract laboratory services, including consultants,
is monitored on a periodic basis for quality and adequacy of service.
J 3. There is documented evidence that the review includes results of monitoring, as well as examination
of specific issues, including those in elements a) through g) in the intent, as appropriate.
J 4. There is documented evidence that the contract laboratory maintains a quality control program.
J 5. Records are maintained for contract laboratory services used, including evidence of required licen-
sure, certification, or other regulatory requirements.
Refeence Laboa"o& Se$ice!
S'a"da%d MGT.1.2.2
The laboratory director is responsible for assuring the consistent performance of reference laboratory services.
I"'e"' #f MGT.1.2.2
The laboratory director and other leaders are responsible for choosing and monitoring reference laboratory
services. Therefore, the leaders have defined in writing the means used to monitor the accuracy, ready avail-
ability, appropriateness, and effectiveness of these services.
The laboratory maintains records of reference laboratories used, along with evidence of any required licensure,
certification, or other regulatory requirements. There is periodic review of these services to determine whether
clinicians and other users are satisfied with services rendered and whether laboratory leaders remain satisfied
with their performance. Laboratory leaders consult with users, when appropriate, about preferences for, and
satisfaction with, outside services used.
As part of the periodic review of reference and/or consultant services, laboratory leaders examine the following
issues:
a) Are specimen collection protocols provided by the reference laboratory?
b) Are the specimen collection protocols clearly written and adequate?
c) Are specimen transport services adequate?
d) Are clinicians and other laboratory clients satisfied with the reliability of results?
e) Are clinicians and other laboratory clients satisfied with turnaround times for test results?
f ) Is there adequately open communication among the referring laboratory, the reference laboratory, the
clinician, and the patient?
J 1. The laboratory director defines in writing the means used to monitor the accuracy, availability,
appropriateness, and effectiveness of reference laboratory services.
J 2. There is documented evidence that the quality of reference laboratory services is monitored on a
periodic basis for quality and adequacy of service.
J 3. There is documented evidence that the review includes results of monitoring, as well as examination
of specific issues, including those in elements a) through f ) in the intent.
J 4. Records are maintained for reference and laboratory services used, including evidence of required
licensure, certification, or other regulatory requirements.
Re!o#ce Planning
S'a"da%d MGT.1.3
The leaders are responsible for providing adequate resources for the provision of planned laboratory services.
I"'e"' #f MGT.1.3
The planning process includes defining the necessary resources for providing services. Planning addresses
a) providing a budget and fiscal resources to operate the laboratory;
b) required personnel in numbers and qualifications to meet the mission of the laboratory;
c) physical structure and spaces in the laboratory to facilitate efficient and effective delivery of laboratory
services;
d) necessary equipment;
e) accessibility of services and provisions for specimen collection, storage, and transport;
f ) requirements for clinical consultation and other communications; and
g) safe use, maintenance, and supervision of space, equipment, and other environmental elements, such
as required utilities.
J 1. Leadership planning includes providing a budget and fiscal resources to operate the laboratory.
J 2. Leadership planning includes defining necessary resources, as required in elements b) through d) in
the intent.
J 3. Leadership planning includes providing for processes to provide the requirements of elements e) and
f ) in the intent.
J 4. Leadership planning includes providing measures for the management of equipment by the physical
plant, as defined in element g) in the intent.
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Re&$#"&ibii'* a"d A('h#%i'*
S'a"da%d MGT.2
Responsibilities for administrative direction and clinical direction of the laboratory are defined in writing. In
addition, other leadership roles are also defined.
I"'e"' #f MGT.2
Responsibilities and authorities for the laboratory are defined in writing. If there is more than one director,
the responsibilities of each are clearly delineated. Responsibilities for other leadership roles are also defined.
Responsibilities and authorities are communicated to all laboratory staff members. The organizational struc-
ture of the laboratory is defined in writing and/or by diagram.
J 1. Laboratory directors responsibilities are clearly defined in writing.
J 2. Other leaders responsibilities are clearly defined in writing.
J 3. Responsibilities and authorities of leadership positions are communicated to all laboratory staff.
J 4. The organizational structure of the laboratory is defined in writing and/or by diagram.
S'a"da%d MGT.2.1
The directorship of the laboratory is effective.
I"'e"' #f MGT.2.1
Directors are ultimately responsible for administration of the laboratory. The best evidence of effective leader-
ship is a laboratory that operates effectively and efficiently. Laboratory services are organized, directed, and
staffed in keeping with the scope of services offered.
The director is not required to personally perform all the following functions but is responsible for assuring
that they are carried out:
a) Providing consultation to requesters about the choice of tests, the use of the laboratory service, and the
interpretation of laboratory test results
b) Developing plans, managing processes, and setting priorities to measure, assess, and improve the quali-
ty of laboratory services in implementing the quality management and improvement system
c) Developing, implementing, and maintaining policies and procedures that guide and support the provi-
sion of services
d) Providing oversight for any point-of-care testing performed
e) Defining and maintaining necessary quality control programs
f ) Providing an adequate number of qualified competent staff
g) Determining the qualifications and competence of laboratory staff
h) Orienting new employees and providing ongoing in-service training and continuing education
i) Determining space and other resources required for services
j) Establishing and monitoring processes to ensure the efficient provision of services
k) Preparing, implementing, and managing appropriate operating and capital budgets
J 1. The director provides for the type of consultation delineated in element a) in the intent, as required.
J 2. The director provides leadership for the quality management and improvement program, as
described in element b) in the intent.
J 3. The director ensures that the responsibilities of elements c), d), and e) in the intent are met.
J 4. The director ensures that the responsibilities for personnel, as delineated in elements f ), g), and h) in
the intent, are met.
J 5. The director ensures that adequate resources are provided for the laboratory services offered, as
described in element i) in the intent.
J 6. The director is responsible for establishing and managing appropriate operating and capital budgets,
and for the efficient provision of services, as described in elements j) and k) in the intent.
S'a"da%d MGT.2.2
The laboratory director is responsible for requiring practices that respect the needs of patients and other
customers.
I"'e"' #f MGT.2.2
The laboratory director requires practices that respect and support patients rights. This includes defining and
implementing policies that support patients rights to
a) privacy;
b) security;
c) confidentiality;
d) ask questions or express complaints about their care or services; and
e) effective communication.
J 1. Patients privacy and security are provided and supported by policies and practice.
J 2. The patients right to voice complaints about care or services and to have those complaints
reviewedand, when possible, resolvedis respected and supported by a written policy, and the pol-
icy is implemented.
J 3. The patients right to effective communication is supported by a written policy, and the policy is
implemented.
J 4. Confidentiality regarding patients and their information is required of all employees in a written pol-
icy, and the policy is implemented.
C#!!("ica'i#" a"d C##%di"a'i#"
S'a"da%d MGT.3
Laboratory leaders provide for communication and coordination throughout the laboratory and with outside
customers.
I"'e"' #f MGT.3
To coordinate and integrate laboratory services, the leaders develop a culture that emphasizes cooperation and
communication. The leaders develop methods for promoting communication within the laboratory.
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Depending on the size and complexity of the laboratory, communication processes may be formal, such as a
standing committee or in-service presentations, or less formal methods, such as newsletters and posters. Most
laboratories use a combination of formal and informal communication processes.
The leaders also develop relationships and processes to communicate with clinicians and other outside cus-
tomers. These communication processes are effectively used to ensure optimal care for patients.
J 1. There is evidence that leaders have developed and implemented methods and processes for promot-
ing communication within the laboratory.
J 2. There is evidence that leaders have developed and implemented processes for communicating with
clinicians and other customers.
S'a"da%d MGT.3.1
Leaders communicate to laboratory staff the priority of meeting the needs of clinicians, patients, and other
users of laboratory services.
I"'e"' #f MGT.3.1
Leaders communicate to laboratory staff and employees the priority of meeting the needs of clinicians,
patients, and other users of laboratory services by requiring written procedures to
a) address complaints from clinicians who order tests;
b) address complaints or questions from patients; and
c) respect patients rights, as outlined in MGT.2.2.
Staff education regarding these procedures is documented. Violations of the defined procedures are docu-
mented, as well as remedial training for the staff member.
J 1. Leaders require procedures to meet the requirements of elements a) through c) in the intent.
J 2. The procedures are defined in writing.
J 3. Employee education regarding these procedures is documented.
J 4. Employees follow the requirements of the procedures.
J 5. Remedial training and, when necessary, disciplinary action are documented for staff members who
violate the requirements of the procedures.
S'a"da%d MGT.3.2
Necessary policies are developed for communicating with clinicians who order tests.
I"'e"' #f MGT.3.2
There are certain policies and practices that are required to provide high-quality laboratory services. These
include effective and immediate communication with clinicians when clinicians require emergency tests or
when results indicate the need for such communication. The laboratory has defined policies and implemented
practices for these communication processes, which include the following:
a) There is a protocol for critical test results that indicate an immediate threat to the patients condition.
The protocol defines the laboratorys critical values, and it defines the process to follow when a test
result is critical. It also requires critical results to be reported immediately and directly to either the
responsible clinician or an authorized intermediary. It requires documentation of reporting, including
the name of the individual notified, the time and date of direct notification, and documentation that
the result was correctly read back.
And the following, when appropriate:
b) Providing guidelines to practitioners for requesting and receiving test results on an emergency or STAT
basis
c) A process for notifying clinicians and others responsible for the patients care when incorrect test results
have been reported and for correcting the results
J 1. There are policies addressing communications with clinicians that include element a) above and,
when appropriate, elements b) and c) in the intent.
J 2. The policies are consistently followed.
Q(ai'* Ma"age!e"' a"d I!$%#)e!e"' P%#ce&&
Laboratory leaders are responsible for planning, implementing, and reviewing a strategy to measure, analyze,
and improve the processes of the laboratory. This section describes a comprehensive approach to quality man-
agement and improvement for clinical laboratories.
The program for this approach is comprehensive and includes requiring processes for
monitoring quality control and equipment performance testing data;
monitoring laboratory processes by collecting data using indicators and criteria; and
taking actions and initiating changes when monitoring indicates the need for such action.
This approach includes
planning and implementing a quality management and improvement program;
designing new clinical and managerial processes well;
monitoring how well processes work by using indicators to collect data;
analyzing the data; and
implementing and sustaining changes that result in improvement.
These processes provide the framework for the laboratory and its leaders to achieve a commitment to provide
high-quality laboratory services in a safe, well-managed environment.
This approach is rooted in the daily work of individual laboratory professionals and other staff. They can
apply the standards in this section to their daily work to understand how processes can be more efficient and
resources used more wisely.
These standards emphasize that continuously monitoring, analyzing, and improving clinical and managerial
processes must be well organized and have clear leadership to achieve maximum benefit.
The framework presented in these standards is suitable for a wide variety of structured programs and less for-
mal approaches to quality management and improvement. This framework can also incorporate traditional
monitoring programs such as those related to unexpected events (risk management) and resource use (utiliza-
tion management).
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Over time, laboratories following this framework will
develop greater leadership support for a laboratorywide program;
train and involve more staff in monitoring and improvement activities;
set clearer priorities for what to monitor and what to improve;
use indicator data to assist in making decisions; and
make improvements based on comparisons to other organizations, nationally and internationally.
The laboratory uses the information from data analysis to identify potential improvements or reduce (or prevent)
adverse events. Improvement activities are undertaken for the priority areas identified by the laboratorys leaders.
The laboratory uses appropriate resources and involves those individuals and laboratory areas closest to the
processes or activities to be improved. Laboratory leaders have the responsibility for planning, implementing,
and directing the quality management and improvement activities.
Planning and Coodina"ion of "he Q#ali"& Managemen"
and Impo$emen" Pogam
S'a"da%d MGT.4
Laboratory leaders are responsible for planning, documenting, implementing, and monitoring a quality
management and improvement program.
S'a"da%d MGT.4.1
The laboratorys program for process design and quality measurement, analysis, and improvement is systemat-
ic and addresses
the goals of the quality management and improvement system;
all of the quality management and improvement systems components;
the methodology used to measure and improve processes and services; and
the systems used for quality control of laboratory testing and other services.
I"'e"' #f MGT.4 a"d MGT.4.1
To initiate and maintain a laboratory quality management and improvement process, leadership and planning
are essential. The laboratory director and governing leader(s) (if other than the director) are included in the
planning process, and other laboratory management and supervisory staff are included when possible. Each
identified leader participates in creating and implementing the laboratorys approach to quality management
and improvement. This includes clearly communicating the leaders commitment to the program, as well as
the expectation that laboratory employees will be involved, to the extent appropriate to their jobs. The leaders
determine the approach used for the program and direct the operation of the program. The leaders, through
their vision and support, shape the quality culture of the laboratory.
Quality management and improvement programs are most effective when they are planned and systematic
across the laboratory. The leaders plan the structure for the quality management and improvement system.
This structure is provided in a written plan for the program. The plan also describes the goals of the quality
management and improvement system. The program includes all areas of the laboratory and all quality activi-
ties, including
a) quality measurement and improvement;
b) quality control; and
c) equipment performance testing.
The plan defines the methodology to be used to measure and improve the quality and efficiency of laboratory
services provided. There is a description of how the laboratory prioritizes which activities are to be monitored
and improved.
J 1. The laboratory leaders participate in planning a program for process design and quality management
and improvement.
J 2. Laboratory leaders are involved in defining the program in writing.
J 3. Laboratory leaders are involved in implementing the program.
J 4. Laboratory leaders are actively involved in monitoring the program.
J 1. The quality management and improvement plan is implemented systematically throughout the laboratory.
J 2. The plan defines the structure, goals, and components of the program.
J 3. The plan describes the methodology used to measure and improve processes and services.
J 4. The program includes all areas of the laboratory and all quality activities, including those described
in elements a) through c) in the intent.
J 5. The director of the laboratory is responsible for the quality of the program.
S'a"da%d MGT.4.1.1
Laboratory leaders ensure that the program is coordinated and an appropriate individual(s) is appointed to
implement and manage the process.
I"'e"' #f MGT.4.1.1
The quality management and improvement program shall be centrally coordinated to best use available
resources. This coordination may be provided through
a steering group or committee; or
an individual who provides effective administration of quality management and improvement activities
throughout the laboratory.
Included in the responsibilities of this group or individual is communication of information about the pro-
gram to leadership and staff on a regular basis. In addition, this group or individual is provided with training,
if necessary, to obtain the expertise needed to administer the program.
J 1. The quality management and improvement activities are centrally coordinated through laboratory leadership.
J 2. A steering committee or an individual is appointed to administer the quality management and
improvement program.
J 3. The steering committee or individual is provided with adequate training to administer the program.
J 4. Quality management and improvement findings, actions, and other information are regularly com-
municated to leadership and staff.
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S'a"da%d MGT.4.1.2
The leaders assign adequate resources to quality management and improvement activities.
I"'e"' #f MGT.4.1.2
Laboratory leaders are responsible for providing adequate resources, including personnel, information systems,
and data management processes, to meet the goals of the quality management program. Participation in data
collection and analysis, and planning and implementation of quality improvements, require knowledge and
skills that most staff do not have. Thus, when asked to participate in the program, staff members receive
training consistent with roles in the planned activity. The laboratory identifies or provides a knowledgeable
trainer for the education. Personnel are permitted to attend training as part of their assigned duties. Assigned
personnel are also allotted adequate time to perform the data collection, assessment, and other activities
required for a successful program. Other required resources such as information systems and data manage-
ment processes are also provided.
J 1. Adequate resources are provided for the quality management and improvement program.
J 2. Personnel are provided adequate knowledge-based training consistent with their roles in the program.
J 3. Assigned personnel are allotted adequate amounts of time to fulfill their duties for the program.
J 4. Information systems and data management processes provided are adequate to facilitate the processes
required.
S'a"da%d MGT.4.1.3
Leaders communicate the key elements of the quality management and improvement program to employees.
I"'e"' #f MGT.4.1.3
To ensure better understanding and cooperation, laboratory leaders communicate the key elements of the
quality management program to employees. This helps facilitate total laboratory involvement. The communi-
cation includes
a) the mission and goals of the laboratory;
b) the quality management processes used to measure and improve services;
c) the quality measures for which data are being collected;
d) results of quality measurement and assessment activities; and
e) actions taken and changes made to improve the quality of laboratory services.
J 1. There is evidence that elements a) and b) in the intent have been communicated to employees.
J 2. There is evidence that laboratory employees have been notified of relevant quality measures and crite-
ria for which data are being collected.
J 3. There is evidence that information about elements d) and e) in the intent is communicated to employees.
S'a"da%d MGT.4.1.4
The leaders define performance and quality control activities used to monitor the laboratorys processes and
the systems used to ensure proper operation and control of these processes.
I"'e"' #f MGT.4.1.4
The laboratory director, or other leaders authorized by the director, defines the laboratorys performance crite-
ria for test methodologies and equipment, quality control (internal), proficiency testing (external quality con-
trol), specimen quality, and reporting of results. In addition, criteria and methods are defined for measuring
and assessing the quality and stability of processes throughout the laboratory. When new processes are
designed and implemented, performance expectations are established, measured, and evaluated for acceptabili-
ty of the process. For existing tests and processes, the director evaluates quality control and other data to
determine whether existing criteria are either too stringent or not stringent enough and makes necessary
changes.
J 1. The laboratory director requires and approves written quality criteria for test method and equipment
performance.
J 2. The laboratory director requires and approves written criteria for internal quality control and external
quality control (proficiency testing) performance.
J 3. The laboratory director requires and approves written criteria for specimen quality.
J 4. The laboratory director requires and approves written criteria for reporting results and documenting
all verbal reporting of results.
J 5. The laboratory director and other leaders evaluate quality control and other data to determine the
acceptability and relevance of existing criteria and make changes, if indicated.
De!ign of Ne% Poce!!e!
S'a"da%d MGT.4.1.5
The laboratory designs new and redesigns existing systems and processes according to quality improvement
principles.
I"'e"' #f MGT.4.1.5
Laboratories frequently have the opportunity to design new processes or have a need to modify existing
processes. The new or modified process uses design elements from authoritative sources, including laws and
regulations, as applicable. Such authoritative sources include standards of practice, national standards and
norms, and other sources of information.
The design of new or modified processes may also be guided by the experiences of others considered to be
best/better/good practices. Such practices are evaluated by the laboratory, and relevant practices may be used
and tested.
When processes or services are designed well, they draw on a variety of information sources. Good process
design
a) is consistent with the laboratorys mission and plans;
b) meets the needs of patients, families, staff, and others;
c) uses current practice guidelines, clinical standards, scientific literature, and other relevant evidence-
based information on clinical practice design;
d) is consistent with sound business practices;
e) considers relevant risk management information;
f ) builds on available knowledge and skills in the laboratory;
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49
g) builds on the best/better/good practices of other laboratories;
h) uses information from related improvement activities; and
i) integrates and connects processes and systems.
When a laboratory designs new processes, it selects suitable measures (indicators) for the process. When a lab-
oratory implements a new process, it collects data to see if the process is actually operating as expected.
J 1. Quality improvement principles and tools are applied to the design of new or modified processes.
J 2. Design elements a) through i) are considered, when relevant to the process being designed or
modified.
J 3. Indicators are selected to measure how well the newly designed or redesigned process operates.
J 4. Indicator data are used to evaluate the ongoing operation of the process.
S'a"da%d MGT.4.1.6
The leaders prioritize which processes are to be measured and which improvement activities will be implemented.
I"'e"' #f MGT.4.1.6
A primary responsibility of leaders is to set priorities. Laboratories may find more opportunities for quality
monitoring and improvement than can be accomplished with available staff and other resources. Therefore,
the leaders provide focus for the quality measurement and improvement activities. The leaders prioritize those
critical, high-risk, problem-prone, primary processes that most directly relate to the quality of laboratory ser-
vices provided and the safety of patients and the environment. The priorities include the implementation and
monitoring of the International Patient Safety Goals (see pages 2932). The leaders use available data and
information to identify priority areas.
J 1. The leaders set priorities for measurement activities.
J 2. The leaders set priorities for improvement and patient safety activities.
J 3. The priorities include the implementation of the International Patient Safety Goals.
Da"a Collec"ion fo Q#ali"& Mea!#emen"
S'a"da%d MGT.4.2
The laboratorys leaders identify key measures (indicators) to measure clinical and managerial structures,
processes, and outcomes.
(Note: The areas noted in MGT.4.2.1 through MGT.4.2.2 are included in the laboratorys quality monitoring
process.)
S'a"da%d MGT.4.2.1
Quality measurement includes those aspects of the following that are selected by leaders:
a) The laboratorys safety and infection control programs
b) The laboratorys quality control programs
c) Preanalytic processes, including
patient preparation;
specimen quality processes (collection, labeling, preservation, transportation, and rejection); and
completeness of requisitions.
d) Postanalytic processes, including
efficient transfer of information;
timeliness of reporting test results;
adequacy of documentation; and
accuracy of reports.
S'a"da%d MGT.4.2.2
Managerial measurement includes aspects of the following that are selected by leaders:
a) The needs, expectations, and satisfaction of individuals and organizations served
b) The appropriateness of tests offered
c) Key aspects of the procurement of routinely required supplies and equipment essential to providing
laboratory services
d) Those aspects of laboratory employee expectations and satisfaction selected by the leaders
e) Those aspects of financial management selected by the leaders
f ) Those aspects of the prevention and control of events that jeopardize the safety of patients, families,
and staff selected by the leaders, including the International Patient Safety Goals
I"'e"' #f MGT.4.2 Th%#(gh MGT.4.2.2
Quality management and improvement are data driven. Because most laboratories have limited resources,
they cannot collect data to measure everything they want. Thus, each laboratory must choose which quality
and managerial processes and outcomes are most important to monitor, based on its mission, patient needs,
and services. Monitoring often focuses on those processes that are high risk to patients, are provided in high
volume, or are problem prone.
A laboratorys leaders are responsible for making the final selection of the key measures to be included in the
laboratorys monitoring activities. The measures selected relate to the important quality and managerial areas
identified in standards MGT.4.2 through MGT.4.2.2. For each of these areas, leaders decide
the process, procedure, or outcome to be measured;
the availability of science or evidence supporting the measure;
how measurement will be accomplished;
how the measures fit into the laboratorys overall plan for quality monitoring and patient safety; and
the frequency of measurement.
Identifying the process, procedure, or outcome to be measured is clearly the most important step. The mea-
sure needs to focus on, for example, risk points in processes, procedures that frequently present problems or
are performed in high volume, and outcomes that can be clearly defined and are under the laboratorys con-
trol. For example, a laboratory may choose to measure the processes for maintaining the identity of specimens
and blood components used in transfusion. In addition, the laboratory may wish to measure the process used
to monitor the quality of reference laboratories or contract services used. Frequency of data collection is asso-
ciated with how often the particular process is used or procedure performed. Sufficient data from all cases or a
sample of cases are needed to support conclusions and recommendations.
The measurements used may be changed when the data for a particular process are no longer useful or the
process being measured is no longer a problem. In addition, new measures are selected to monitor new
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51
processes or processes that have become problematic. Thus, a laboratory must have a track record of continu-
ous monitoring in the area identified; however, the actual monitors may change.
To monitor processes, the laboratory needs to determine how to organize the measurement activities, how
often to collect data, and how to incorporate data collection into daily work processes. The measures are also
helpful in better understanding or more intensively assessing the areas under study. Likewise, the analysis of
the measurement data may result in strategies for improvement in the area being monitored. The measure
then is helpful in understanding the effectiveness of the improvement strategy.
Collected data may help the laboratory evaluate outcomes or determine the performance of a function,
process, or testing activity. When data collection is systematic, it can be used to
establish a performance baseline;
describe process performance or stability;
identify areas for more focused data collection; and
sustain improvement.
The laboratorys leaders are responsible for making the final selection of the key measures to be included in
the laboratorys measurement activities. The measures selected relate to the important areas identified in stan-
dards MGT.4.2 through MGT.4.2.2 For each of these areas, the leaders decide
the process, procedure, or outcome to be measured;
how measurement will be accomplished; and
the frequency of measurement.
The detail and frequency of data collection are determined, as appropriate, for monitoring ongoing perfor-
mance. Data are collected at the frequency and with the detail identified by laboratory leaders. When possi-
ble, data collection is incorporated into day-to-day activities rather than as a separate activity.
J 1. The leaders identify key measures to monitor quality areas.
J 2. The leaders identify key measures to monitor managerial areas.
J 3. The leaders base measures on scientific evidence or standards of practice, when they are available and
relevant.
J 4. The scope, method, and frequency are identified for each measure.
J 5. The monitoring is part of the quality management and improvement program.
J 6. The results of monitoring are communicated to the person or group that administers the quality
management process and periodically to the leaders and governance structure of the laboratory.
J 1. Quality monitoring includes the areas identified in the standard.
J 2. Quality monitoring data are used to study areas targeted for improvement.
J 3. Quality monitoring data are used to monitor and evaluate the effectiveness of improvements.
J 1. Managerial monitoring includes the areas identified in the standard.
J 2. Managerial monitoring data are used to study areas targeted for improvement.
J 3. Managerial monitoring data are used to monitor and evaluate the effectiveness of improvements.
Anal&!i! of Mea!#emen" Da"a
S'a"da%d MGT.4.3
Individuals with appropriate experience, knowledge, and skills systematically aggregate and analyze data in the laboratory.
I"'e"' #f MGT.4.3
To reach conclusions and make decisions, data must be aggregated, analyzed, and transformed into useful
information. Data analysis involves individuals who understand information management, have skills in data
aggregation methods, and know how to use various statistical tools. Data analysis involves the individuals
responsible for the process or outcome being measured. These individuals may be clinical, managerial, or a
combination. Thus, data analysis provides continuous feedback of quality management information to help
those individuals make decisions and continuously improve clinical and managerial processes.
Understanding statistical techniques is helpful in data analysis, particularly in interpreting variation and decid-
ing where improvement needs to occur. Run charts, control charts, and histograms are examples of statistical
tools useful in understanding trends and unacceptable variance in providing laboratory services.
J 1. Data obtained from the monitoring of processes are aggregated, analyzed, and transformed into use-
ful information.
J 2. Individuals with appropriate quality or managerial experience, knowledge, and skills participate in
the process.
J 3. Statistical tools and techniques are used in the analysis process when appropriate.
S'a"da%d MGT.4.4
The frequency of data analysis is appropriate to the process being studied and meets laboratory requirements.
I"'e"' #f MGT.4.4
Laboratory leaders determine how often data are aggregated and analyzed. The frequency depends on the activity
or area being measured, the frequency of measurement, and the laboratorys priorities. For example, clinical labo-
ratory quality control data may be analyzed weekly to meet local regulations, and specimen rejection data may be
analyzed monthly or quarterly. Thus, aggregation of data at points in time enables the laboratory to judge a partic-
ular processs stability or a particular outcomes predictability in relation to expectations.
J 1. The frequency of data analysis is appropriate to the process under study.
J 2. The frequency of data analysis meets laboratory requirements.
S'a"da%d MGT.4.5
The analysis process includes comparisons internally, with other laboratories when available, and with pub-
lished scientific standards and desirable practices.
I"'e"' #f MGT.4.5
The goal of data analysis is to be able to compare a laboratory in four ways:
1. With itself over time, such as month to month, or one year to the next
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53
2. With other similar laboratories, using such sources as reference databases
3. With standards, such as those set by accrediting and professional bodies or those set by law or regulation
4. With recognized desirable practices identified in the literature as best or better practices, or practice
guidelines
These comparisons help the laboratory understand the source and nature of undesirable change and help to
focus improvement efforts.
J 1. Comparisons are made over time within the laboratory.
J 2. Comparisons are made with similar laboratories, when possible.
J 3. Comparisons are made with standards, when appropriate.
J 4. Comparisons are made with known desirable practices.
S'a"da%d MGT.4.6
Data are analyzed when undesirable trends and variation are evident from the data.
I"'e"' #f MGT.4.6
When the laboratory detects or suspects undesirable change from what is expected, it initiates intense analysis
to determine where best to focus improvement. In particular, intense analysis is initiated when levels, patterns,
or trends vary significantly and undesirably from
what was expected;
those of other laboratories; or
recognized standards.
Analyses are conducted for
all confirmed transfusion reactions, if applicable to the laboratory; and
other events, such as infectious disease outbreaks.
J 1. Intense analysis of data takes place when adverse levels, patterns, or trends occur.
J 2. All confirmed transfusion reactions, if applicable to the laboratory, are analyzed.
J 3 Other events defined by the laboratory are analyzed.
Impo$emen"
S'a"da%d MGT.4.7
Improvement in quality and safety is achieved and sustained.
I"'e"' #f MGT.4.7
The laboratory uses the information from data analysis to identify potential improvements or reduce (or pre-
vent) adverse events. Routine monitoring data, as well as data from intensive assessments, contribute to this
understanding of where improvement will be planned and what priority is to be given to the improvement. In
particular, improvements are planned for the priority data collection areas identified by leaders.
J 1. The laboratory plans and implements improvements using a consistent process selected by the leaders.
J 2. The laboratory documents the improvements achieved and sustained.
S'a"da%d MGT.4.8
Improvement and safety activities are undertaken for the priority areas identified by the laboratorys leaders.
I"'e"' #f MGT.4.8
The laboratory uses appropriate resources and involves those individuals, disciplines, and departments closest
to the processes or activities to be improved. Responsibility for planning and carrying an improvement is
assigned to individuals or a team, any needed training is provided, and information management or other
resources are made available.
When a change is planned, data are collected during a test period to demonstrate that the planned change was
actually an improvement. To ensure that the improvement is sustained, monitoring data are then collected for
ongoing analysis. Effective changes are incorporated into standard operating procedure, and any necessary
staff education is carried out. The laboratory documents those improvements achieved and sustained as part
of its quality management and improvement program.
J 1. The priority areas identified by the laboratorys leaders are included in improvement activities.
J 2. Human and other resources needed to carry out an improvement are assigned or allocated.
J 3. Changes are planned and tested.
J 4. Changes that result in improvements are implemented.
J 5. Data are available to demonstrate that improvements are effective and sustained.
J 6. Policy changes necessary to carry out the plan and sustain the improvements are made.
J 7. Successful improvements are documented.
S'a"da%d MGT.4.9
An ongoing program of identifying and reducing unanticipated adverse events and safety risks to patients and
staff is defined and implemented.
I"'e"' #f MGT.4.9
Laboratories need to adopt a proactive process to evaluate near misses and other high-risk processes for
which a failure would result in a sentinel event. One tool that provides such a proactive analysis of the con-
sequences of an event that could occur in a critical, high-risk process is failure mode and effects analysis. The
laboratory can also identify and use similar tools to identify and reduce risks, such as a hazard vulnerability
analysis.
To use this or similar tools effectively, the laboratorys leaders need to adopt and learn the approach, agree on
a list of high-risk processes in terms of patient and staff safety, and then use the tool on a priority risk process.
Following analysis of the results, the laboratorys leaders take action to redesign the process or similar actions
to reduce the risk in the process. This risk-reduction process is carried out at least once per year and
documented.
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55
J 1. The laboratorys leaders adopt a process by which they identify high-risk areas in terms of patient and
staff safety.
J 2. The laboratorys leaders prioritize patient and staff safety risks at least once annually.
J 3. The laboratory conducts and documents use of a proactive risk-reduction tool at least annually on
one of the priority risk processes.
J 4. The laboratorys leaders take action to redesign high-risk processes based on the analysis.
Q#ali"& Managemen" and Impo$emen" Pogam Re$ie%
S'a"da%d MGT.4.10
Leaders manage the quality and improvement process and periodically review the effectiveness, adequacy, and
relevance of the monitoring and improvement activities.
I"'e"' #f MGT.4.10
Leaders manage the quality process by providing review and guidance, as necessary. The written plan defines
how often the process is to be reviewed. At a minimum there is at least an annual review. The review includes
assessing opportunities for improvement and the need for changes to the quality management and improve-
ment process, including the quality plan and goals.
The review also includes
a) results of data analysis, decisions made, and actions taken;
b) summaries of quality control activities, particularly when problems have required remedial action;
c) summaries of equipment performance, particularly trends of equipment failure;
d) follow-up review of actions recommended from previous review to assess their degree of success; and
e) reports from laboratory leaders.
The leaders document decisions made and actions taken as a result of the review process.
J 1. The leaders provide guidance and review of the quality management process.
J 2. The leaders review the quality management process as often as defined in the written plan, but at
least annually.
J 3. The review includes an assessment of opportunities to improve, including (if there is a need for
changes to the quality management process) the quality plan and goals.
J 4. The review includes elements a) through e) in the intent.
J 5. The review is documented, including decisions made and actions taken as a result of the review.
56
Development and
Control of Policies and
Procedures (DCP)
Standards
The following is a list of all standards. They are presented here for your convenience, without their require-
DCP.1 The requirements for developing and maintaining the laboratorys policies and procedures are
defined in a written protocol.
Preanalytic Policies and Procedures
DCP.2 Procedures for ordering tests are defined in writing.
DCP.2.1 Policies and procedures are developed to provide step-by-step specimen collection pro-
tocols for each type of specimen submitted to the laboratory.
DCP.2.2 Policies and procedures are developed to guide how specimens are accessioned and
processed in the laboratory.
Analytic Policies and Procedures
DCP.3 The laboratory has current written descriptions and instructions for performing test methods and
procedures.
Postanalytic Policies and Procedures
DCP.4 The laboratory develops policies, procedures, and controls for the postexamination processes.
DCP.4.1 The laboratory has defined a process for immediate notification of the responsible clini-
cian when specific critical results indicate that the patients situation is life-threatening.
DCP.4.2 The laboratory has defined the process of measuring turnaround times.
DCP.4.3 The laboratory has a defined process for correcting reported results.
Record and Specimen Retention Requirements
DCP.5 A written protocol defines the storage and maintenance requirements for records, including
retained specimens, slides, tissues, and blocks.
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Standards, Intents, and Measurable Elements
S$anda"d DCP.1
The requirements for developing and maintaining the laboratorys policies and procedures are defined in a
written protocol.
In$en$ of DCP.1
The laboratory defines, in writing, the requirements for policies and procedures. They include at least the
following:
a) Initial review and approval of all policies and procedures is performed and documented by the clinical
director of the laboratory. Policies and procedures are not distributed for use until the approval process
is completed.
b) Periodic review of all policies and procedures is performed and documented at a frequency defined in
the protocol, but at least every two years. This review is performed by the director, an appropriate
supervisor, or another knowledgeable individual.
c) The director or supervisor approves, in writing, all changes in policies and procedures.
d) All policies and procedures are clearly and legibly written.
e) If manufacturers manuals or package inserts are used for technical procedures, they are enhanced to
include specific operational policies (for example, detailed quality control protocols, calibration proce-
dures, other laboratory-specific procedures).
For discontinued policies and procedures, the following are defined and implemented:
f ) The laboratory defines how long discontinued policies and procedures are to be retained. This time of
retention is at least as long as required by applicable law and regulation, or for two years, whichever
requirement is more stringent.
g) The dates of implementation and discontinuance are available for all policies and procedures.
h) Discontinued documents are segregated to prevent accidental use while being retained for reference, if
needed.
Control of policies and procedures includes the following:
i) There is a method to identify and track all policies and procedures in current use, including the dates
of implementation and all changes and review information.
j) There is a process for informing staff about the content of policies and procedures as they are initially
implemented and/or changed.
All policies and procedures, including those required in other chapters of this manual, comply with require-
ments a) through j) in this intent.
Mea#%"able Elemen$# of DCP.1
J 1. There is a defined protocol for policies and procedures that includes the requirements of elements a)
through e) in the intent.
J 2. The protocol addresses discontinued procedures, as required in elements f ) through h) in the intent.
J 3. The protocol defines a method for identifying and tracking all policies and procedures, as required in
element i) of the intent.
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59
DEVELOPMENT AND CONTROL OF POLICIES AND PROCEDURES (DCP)
J 4. The protocol also defines the process for informing staff members about the content and changes in
policies and procedures, as required in element j) of the intent.
J 5. The protocol applies to all policies and procedures throughout this manual.
J 6. The protocol is implemented and, when required, documented.
P"eanal&$ic Policie# and P"oced%"e#
S$anda"d DCP.2
Procedures for ordering tests are defined in writing.
In$en$ of DCP.2
There are procedures defining the process for ordering laboratory tests. These procedures include information
about
a) the use of correct request forms;
b) the process for identifying patients;
c) information required on orders or request forms, to include at least the following:
Patients name
Patients gender
Patients age or date of birth
Authorized requesting individual, including, as applicable, a contact person to enable the reporting
of imminently life-threatening laboratory results
The specimen source, when appropriate
Test(s) or examination(s) requested
Date and, when relevant, time of specimen collection
Additional information required to select appropriate tests and to ensure accurate test interpretation
and reporting of results (for example, race/ethnicity, family history, pedigree)
d) the processes for confirming oral or telephonic requests; and
e) the process for ordering tests on an emergency or STAT basis.
Requests are made by individuals authorized by law or regulation to order tests or receive results.
Policies for ordering tests are implemented and enforced.
J 1. Policies and procedures describe processes that comply with elements a) through c) in the intent.
J 2. The process for confirming oral or telephonic requests is defined in writing.
J 3. There is a written description of the process for ordering tests on an emergency basis.
J 4. Only individuals authorized by law or regulation are allowed to order tests or receive test results.
J 5. Policies and procedures for ordering tests are implemented and enforced.
S$anda"d DCP.2.1
Policies and procedures are developed to provide step-by-step specimen collection protocols for each type of
specimen submitted to the laboratory.
In$en$ of DCP.2.1
Written policies and procedures are developed to guide specimen collection for laboratory testing.
Information provided to those who use the laboratorys services includes
a) a list of available tests provided by the laboratory or its reference laboratories; and
b) any consent forms used.
Specimen collection procedures
c) are comprehensive and current;
d) include instructions for any specimen collection procedure used and all types of specimens sent to the
laboratory;
e) relate to at least the following:
Medical indications for the test
Standard and special methods for preparing patients for specimen collection
Precautions to be taken for special procedures
Storage, preservation, and transportation of specimens
f ) Identification of the patient and the specimen are specifically addressed, including requirements to
use at least two patient identifiers at the time of specimen collection;
the patients room number or physical location is not used as an identifier; and
containers used for laboratory specimens are labeled with the identifiers in the presence of the patient.
g) apply to anyone collecting procedures for laboratory tests;
h) are made available to all individuals collecting specimens;
i) are followed by those who collect specimens;
j) include a means of identifying the individual who collected a specimen; and
k) include instructions for specimens sent to reference or contract laboratories (may be obtained from the
reference laboratory and need not be rewritten).
Mea#%"able Elemen$# of DCP.2.1
J 1. Specimen collection information given to those who use the laboratorys services includes elements a)
and b) in the intent.
J 2. Policies and procedures address the requirements of elements c) through e) in the intent.
J 3. The policy for patient and specimen identification includes the requirements of element f ) in the
intent.
J 4. Specimen collection policies and procedures are readily available and followed, as required in ele-
ments g) through j) in the intent.
J 5. Specimen collection procedures address the requirements of reference or contract laboratories to
which specimens are sent.
J 6. Specimen collection procedures are followed by staff who collect specimens.
S$anda"d DCP.2.2
Policies and procedures are developed to guide how specimens are accessioned and processed in the laboratory.
In$en$ of DCP.2.2
Policies and procedures describe how specimens are received in the laboratory and documented. They define
the record of specimen accession throughout the time it is in the laboratory and also include the system for
maintaining the identity of specimens, aliquots, and records.
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61
The laboratory maintains a record of daily specimen accession that allows convenient and timely retrieval by
date, or patient name or other identifiers, of the following:
a) Patients name and other identifiers of the patient and specimen
b) Patients gender
c) Patients age or date of birth
d) Authorized requesting individual, including, as applicable, a contact person to enable the reporting of
STAT or critical test results
e) The specimen source, when appropriate
f ) Tests or examinations requested and reported
g) Date and, when relevant, time of specimen collections
h) Date and time of specimen receipt by the laboratory
i) Condition of any unsatisfactory specimen
j) Additional information required to select appropriate tests and to ensure accurate test interpretation
and reporting (for example, race/ethnicity, family history, pedigree)
Policies and procedures include directions for specimen processing and defined criteria for specimen rejection.
J 1. Policies and procedures describe how specimens are received by the laboratory, logged in to the labo-
ratorys systems, and processed.
J 2. The policies describe the specimen accessioning process and how records are maintained, including
the system for maintaining the identity of specimens, aliquots, and records throughout the time they
are in the laboratory.
J 3. Records of daily specimen accession meet the requirements of and include elements a) through j) in
the intent.
J 4. Criteria for specimen rejection are defined in writing.
J 5. The policies and procedures are implemented.
Anal&$ic Policie# and P"oced%"e#
S$anda"d DCP.3
The laboratory has current written descriptions and instructions for performing test methods and procedures.*
In$en$ of DCP.3
The laboratory has current descriptions of and instructions for all analytic methods and procedures. Each cur-
rent description includes the following elements:
a) A complete description of reagents and equipment used
b) Any equipment function verification required before testing is performed
c) Specific instructions for verifying method validity through controls or calibrators, including a defini-
tion of acceptable control values and actions to take when control results are not acceptable
d) The reportable range for patient test results
* If assistance is needed in determining a format, an acceptable reference is NCCLS publication GP2-A3, Clinical
Laboratory Technical Procedures Manual,Third Edition, Approved Guideline.
e) Limitations in methodologies, including interfering substances
f ) A step-by-step description of each phase of patient testing
g) Reference ranges, when applicable
h) Instructions for reporting results
i) Literature references
The laboratorys technical procedures are consistently followed.
J 1. The laboratory has a current written procedure for each analytic method performed.
J 2. The procedure includes the requirements of elements a) through i) in the intent.
J 3. The procedures are consistently followed.
Po#$anal&$ic Policie# and P"oced%"e#
S$anda"d DCP.4
The laboratory develops policies, procedures, and controls for the postexamination processes.
In$en$ of DCP.4
The laboratory has developed policies, procedures, and controls to guide the accurate reporting of results.
These include the following:
a) There is a means of identifying each individual who performed tests, as well as the individual who
reviewed and approved results.
b) The report includes the following:
The name and other identifiers of the patient and the specimen
The name of the ordering clinician
The tests performed, test results, and units of measurement
Date and, when relevant, time of specimen collection
The condition of any unsatisfactory specimen
Reference values for the tests performed
Date and time the result is reported
The identity of the laboratory that performed the test
c) The above elements are also included in reports from reference or contract laboratories.
d) Reports from reference or contract laboratories are not modified in any way that would change their meaning.
e) A report includes the identity of the laboratory that performed a test, including reference or contract
laboratories.
f ) When an interpretation of test results is included, the interpretation is validated by the person who
performed it.
J 1. There is a means of identifying the individual(s) who performed a particular laboratory test.
J 2. The defined requirements for the laboratorys reports, including those from reference or contract lab-
oratories, include the elements in b) through d) in the intent, and they are implemented.
J 3. When a report includes a specific interpretation, the interpretation is validated by the individual who
performed it.
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63
S$anda"d DCP.4.1
The laboratory has defined a process for immediate notification of the responsible clinician when specific crit-
ical results indicate that the patients situation is life-threatening.
In$en$ of DCP.4.1
The laboratory leaders have defined the laboratorys critical values for specific tests, which in the critical range
may be life-threatening. These critical results are reported immediately, according to the laboratorys policy, to
the authorized individual responsible for the patient. The defined process includes the means of notifying the
clinician of these critical values. For inpatients, the process might be notifying a responsible nurse who calls
the physician. For outpatients, the response may be to directly notify the physician. The notification is docu-
mented, including time and date called, and the identification of the individual called. This individual should
write down and read back the result to ensure that it has been understood accurately.
J 1. The laboratory has a written policy defining the laboratorys critical values and the process to follow
when a test result is critical.
J 2. Critical results are reported immediately, according to the laboratorys policy.
J 3. Results are directly reported either to the responsible clinician or an authorized intermediary.
J 4. The notification is documented, including
the individual notified;
the time and date of direct notification; and
documentation that the result was read back and was correct.
S$anda"d DCP.4.2
The laboratory has defined the process of measuring turnaround times.
In$en$ of DCP.4.2
The laboratory follows a written process to measure turnaround times for tests. The process includes a means
of ensuring that turnaround times are acceptable. The procedure also includes a process for notifying the
requester when testing is delayed, particularly in those instances when delay might negatively affect the care or
treatment of patients.
J 1. Laboratory leaders have defined acceptable turnaround times for reporting test results.
J 2. Laboratory leaders have defined a means of measuring the turnaround times for tests.
J 3. Turnaround times are routinely measured, according to the policy.
J 4. When turnaround times for one or more tests are unacceptable, laboratory leaders evaluate the data
and, when necessary, the testing process and take action to either modify the testing and reporting
process or set more reasonable turnaround times.
J 5. The procedure includes a process for notifying requesters when testing is delayed and the delay might
negatively affect the care or treatment of patients.
J 6. All elements of the process are implemented.
S$anda"d DCP.4.3
The laboratory has a defined process for correcting reported results.
In$en$ of DCP.4.3
When an incorrect result is reported, the corrected report is generated as promptly as possible. In such cases,
the laboratory communicates directly with the ordering clinician or other authorized qualified individual who
can take action to avert maltreatment of the patient. The process includes maintenance of both the original
and corrected reports, with identification of each on all copies of the report.
J 1. When the laboratory discovers that an incorrect result has been reported, the corrected report is gen-
erated as promptly as possible.
J 2. The laboratory communicates the error directly to the ordering clinician or other authorized individ-
ual.
J 3. The laboratorys policy for correcting erroneous reported results includes the requirement to maintain
both the original and corrected reports, with each identified on all copies of the report, and the poli-
cy is followed.
Reco"d and Secimen Re$en$ion Re!%i"emen$#
S$anda"d DCP.5
A written protocol defines the storage and maintenance requirements for records, including retained speci-
mens, slides, tissues, and blocks.
In$en$ of DCP.5
The following issues are addressed in the protocol for storage and maintenance of specimens and records:
a) Stored records are maintained in an organized condition.
b) Records are chronologically and alphabetically or numerically identified for easy retrieval.
c) Identity and legibility are maintained.
d) Storage is under acceptable environmental conditions to maintain record or specimen integrity.
e) The length of time each type of record or specimen will be stored is specified.
f ) The following records should be stored for at least two years:
Records of quality management and improvement process activities
Records of quality control results, including remedial actions
Patient testing activities and results
Proficiency testing (external quality control) results
Results of equipment performance testing and calibrations
g) Equipment maintenance and repair records are retained for the life of the instrument.
h) Blood bank records, including quality control records for blood banking, are retained for at least five
years.
It is important that records and specimens are retained at least as long as required by applicable law and regu-
lation. The laboratory must comply with storage and maintenance requirements for records, as defined in the
protocol, and practices are monitored for noncompliance. Actions are taken when noncompliance issues are
identified.
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65
J 1. The laboratorys protocol for storage of records meets the requirements of elements a) through d) in
the intent, and the protocol is implemented.
J 2. The protocol defines environmental storage requirements for specimens, slides, tissues, and blocks.
J 3. Lengths of storage time for records and specimens are specified and at a minimum meet the require-
ments of elements e) through h) in the intent.
J 4. The laboratorys protocol complies with the time requirements in the intent or applicable law and
regulation, whichever is more stringent.
J 5. The protocol for storage of records and specimens is implemented, and laboratory practices are mon-
itored for noncompliance with the protocol.
J 6. Actions are taken when noncompliance issues are identified.
66
Re&"(%ce Ma!agee!'
a!d Lab"%a'"%*
E!)i%"!e!' (RSM)
S'a!da%d&
P%")i&i"! "f Re&"(%ce&
RSM.1 The leaders provide sufficient resources to support the ongoing, uninterrupted operation of the
laboratory.
Human Resources
RSM.1.1 Personnel policies and procedures are described in writing and are followed.
Staff Qualifications
RSM.1.2 Pathology and clinical laboratory services are directed by one or more qualified
professionals.
RSM.1.3 Supervisory staff and other leaders have the appropriate training and expertise to per-
form all responsibilities.
RSM.1.4 The director of the laboratory provides an adequate number of qualified staff.
Staff Orientation and Education
RSM.1.5 All new staff members are oriented to the organization and the laboratory area(s) where
they are assigned, as well as to their specific job responsibilities.
RSM.1.6 In-service or other education and training maintain and improve staff competence.
Competence Assessment and Performance Evaluation
RSM.1.7 Following orientation and/or training, and periodically thereafter, the competence of
each staff member to perform assigned tasks is assessed.
D"c(e!'ed Pe%&"!!el I!f"%a'i"!
RSM.2 Documented personnel information is maintained for each staff member.
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06 JCIIL09 - RSM - 4th Pages:Layout 1 9/17/2009 5:17 PM Page 67
I!f%a&'%(c'(%e,Ba&ic Facili'ie&
RSM.3 Laboratory leaders have planned for basic facilities, including adequate space, utilities, and
equipment.
Laborator Space
RSM.3.1 There is sufficient space for all areas under control of the laboratory. The laboratory
leaders have planned and provided for appropriate space for all laboratory areas.
RSM.3.1.1 Spaces for specific laboratory areas are adequate.
Utilities Management
RSM.3.2 A plan for providing and maintaining necessary utilities is defined and implemented.
RSM.3.2.1 There is a system to inspect, test, and maintain critical operating compo-
nents for utility systems and to investigate and correct utility system
problems.
Lab"%a'"%* E$(i#e!' a!d O'he% Ma'e%ial&
RMS.4 Laboratory leaders ensure that analytic and other equipment, as well as other material resources
required for the provision of services, are adequate, appropriate, and available.
RSM.4.1 Laboratory equipment is maintained, tested, and inspected.
RSM.4.1.1 A historical record is maintained for each analytical instrument and piece
of equipment used by the laboratory.
RSM.4.2 Maintenance and inspection ensure that equipment is safe.
RSM.4.3 There are defined processes in place for validating and maintaining computer software
and information, when they are used by the laboratory.
Reagents and Other Supplies
RSM.4.4 The laboratory follows written guidelines for the periodic evaluation of all reagents,
including water, to provide for accuracy and precision of results.
RSM.4.5 Laboratory records include documentation of required information for reagents, and
reagents are completely and accurately labeled.
Safe'* a!d Sec(%i'*
RSM.5 There is a plan to ensure that laboratory services and facilities are secure.
Ha+a%d"(& Ma'e%ial& a!d Wa&'e
RSM.6 The laboratory has a plan for inventory, handling, storage, and use of hazardous materials and the
control and disposal of hazardous waste.
RSM.6.1 The laboratory uses a coordinated process to reduce the risks of infection as a result of
exposure to biohazardous materials and waste.
RSM.6.2 The laboratory follows defined guidelines for handling and disposing of hazardous
chemicals and waste (including chemotherapeutic materials and waste).
RSM.6.3 If radioactive materials are used in the laboratory, there are processes for safe handling
and monitoring of them.
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69
RESOURCE MANAGEMENT AND LABORATORY ENVIRONMENT (RSM)
W"%k E!)i%"!e!',Lab"%a'"%* Safe'*
RSM.7 The laboratory designs a safe, accessible, effective, and efficient environment consistent with its
mission, services, and law and regulation.
RSM.7.1 Laboratory leaders address fire safety.
RSM.7.1.1 The laboratory conducts fire drills regularly.
RSM.7.2 Adequate safety devices and equipment are provided.
RSM.7.3 When a laboratory performs electron microscopy, the laboratory has processes to ensure
safety and quality.
S'a!da%d&, I!'e!'&, a!d Mea&(%able Elee!'&
P(%,)%$ %f Re)%+(ce)
S*a$da(d RSM.1
The leaders provide sufficient resources to support the ongoing, uninterrupted operation of the laboratory.
I$*e$* %f RSM.1
After planning for the services provided, laboratory leaders are responsible for providing an adequate number
of appropriately trained staff and other resources to meet the goals of the laboratory and to meet customer
needs.
The following are provided for the testing activities of the laboratory:
a) Adequately trained, competent staff with appropriate supervision
b) Adequate space, utilities, and other environmental and safety controls
c) Appropriate equipment, analytic testing systems, reagents, controls, and other supplies
d) Appropriate systems to handle information
(Note: These standards are designed to be equally compatible with noncomputerized environments, current com-
puter technology, and future technologies. The principles of good information systems apply to all methods.)
Mea)+(ab"e E"e#e$*) %f RSM.1
J 1. Resources provided include laboratory personnel who meet the requirements of element a) in the
intent.
J 2. Resources provided include an appropriate and adequate physical environment to meet the require-
ments in element b) in the intent.
J 3. Resources include appropriate equipment and testing materials, as required in element c) in the
intent.
J 4. Resources include appropriate systems to handle information.
H(a! Re&"(%ce&
S*a$da(d RSM.1.1
Personnel policies and procedures are described in writing and are followed.
I$*e$* %f RSM.1.1
a) The desired education, skills, knowledge, and other requirements of all staff members have been
described.
b) Each staff members responsibilities are defined in a current job description.
c) A policy describes how all staff members are oriented to the organization and the laboratory.
d) There is a description of the laboratorys process for staff education and training.
e) The processes for ongoing competence assessment and performance evaluation are described.
70
71
Mea)+(ab"e E"e#e$*) %f RSM.1.1
J 1. Elements a) through e) in the intent have been described in written policies and other documents.
J 2. The laboratory follows the requirements of the written documents.
S'aff Q(alifica'i"!&
S*a$da(d RSM.1.2
Pathology and clinical laboratory services are directed by one or more qualified professionals.
I$*e$* %f RSM.1.2
Clinical laboratory services are under the direction of one or more individuals who are qualified by docu-
mented professional education, training, expertise, and experience, including management experience, to
assume professional responsibility for the facilities and services rendered, and whose qualifications satisfy
applicable law and regulation. The director(s) has the management and administrative skills required to pro-
vide effective leadership for the scope and variety of services provided.
J 1. The director(s) of the laboratory has the professional education, training, and expertise for his or her
position.
J 2. The professional education, training, experience, and expertise of the director(s) are documented.
J 3. The director(s) has the management and administrative skills required to provide effective leadership
for the scope and variety of services provided.
J 4. The qualifications of the director(s) meet applicable law and regulation.
S*a$da(d RSM.1.3
Supervisory staff and other leaders have the appropriate training and expertise to perform all responsibilities.
I$*e$* %f RSM.1.3
Nondirector laboratory leaders, such as supervisory and management staff, are qualified by training, expertise,
and experience to perform the necessary review and supervisory requirements of their positions. This training,
expertise, and experience is documented. They also meet regulatory requirements for their positions.
J 1. Supervisor and management staff are qualified to meet the requirements of their positions.
J 2. Supervisor and management staff qualifications are documented.
J 3. Supervisor and management staff qualifications meet requirements of law and regulation.
S*a$da(d RSM.1.4
The director of the laboratory provides an adequate number of qualified staff.
I$*e$* %f RSM.1.4
The number and qualifications of staff, the director, and managers are appropriate to the laboratorys services.
Required qualifications are at least as stringent as applicable law and regulation. An adequate number of tech-
nical and support staff are provided for all required functions.
72
J 1. Defined job qualifications are appropriate to the services provided by the laboratory.
J 2. Required job qualifications are at least as stringent as applicable law and regulation.
J 3. The number of technical and support staff is adequate and appropriate for the services provided by
the laboratory and all required related functions.
S'aff O%ie!'a'i"! a!d Ed(ca'i"!
S*a$da(d RSM.1.5
All new staff members are oriented to the organization and the laboratory area(s) where they are assigned, as
well as to their specific job responsibilities.
I$*e$* %f RSM.1.5
Each employee in the laboratory, regardless of job duties, is oriented to required duties before being allowed
to perform them unsupervised. When the laboratory is part of a larger health care organization, such as a hos-
pital or ambulatory care center, the employee is also oriented to relevant organization policies and practices.
This orientation is documented and includes the following:
a) Policies that pertain to the individuals employment, including the laboratorys mission, organizational
structure, and quality management plan
b) The laboratorys safety program; laboratory safety policies, procedures, and activities; and the employees
safety responsibilities
c) A specific orientation to the laboratory includes
the individuals job description; and
each activity the employee will be expected to perform, including
1. each analytic instrument and other equipment;
2. each technique used; and
3. all related functions, such as specimen collection and identification, quality control and calibra-
tion, reporting of results, and notification of the supervisor when problems arise.
Participation in the orientation program is documented. This includes verification that the individual has
been successfully oriented and is now competent to perform assigned tasks. There is written approval by the
laboratory director or an appropriate supervisor authorizing the employee to perform laboratory tests and
other job duties, and any exceptions to testing authorization are indicated.
J 1. All new employees are provided with orientation, regardless of their job duties.
J 2. Participation and successful completion of the orientation is documented, including approval by the lab-
oratory director or appropriate supervisor that the individual is competent to perform assigned tasks.
J 3. The competence of individuals is confirmed before they are allowed to perform tasks.
J 4. The orientation includes elements a) and b) in the intent.
J 5. The orientation includes specific orientation to the employees specific job duties, as described in ele-
ment c) in the intent.
73
S*a$da(d RSM.1.6
In-service or other education and training maintain and improve staff competence.
I$*e$* %f RSM.1.6
In-service education and on-the-job training are provided to
a) educate staff about new test methods in the laboratory;
b) reeducate one or more staff members regarding existing test methods performed improperly;
c) provide new information to enhance staff members knowledge in their specific area of expertise;
d) provide results of monitoring from the quality management and improvement process and discuss
changes in processes shown to need improvement; and
e) provide staff education or reeducation regarding safety-related and other laboratory environment issues.
J 1. In-service education and on-the-job training are provided for the occasions listed in elements a)
through e) in the intent.
J 2. In-service education and on-the-job training are documented for each staff member.
C"#e'e!ce A&&e&&e!' a!d Pe%f"%a!ce E)al(a'i"!
S*a$da(d RSM.1.7
Following orientation and/or training, and periodically thereafter, the competence of each staff member to
perform assigned tasks is assessed.*
I$*e$* %f RSM.1.7
A laboratory policy must be present that requires all staff members to have an annual performance assessment
of their competence and abilities to perform the duties and tasks assigned to them in their job description.
The policy defines the process and criteria to be used for competence assessment.
Competence may be assessed in the following ways:
a) Directly observing routine patient testing and other job duties, including, as applicable, specimen col-
lection, handling, processing, and testing
b) Monitoring the recording and reporting of results
c) Reviewing test results or worksheets, quality control, proficiency testing (external quality control), and
equipment preventive maintenance and performance testing results
d) Using blind or other samples to assess test performance
e) Assessing of the individuals judgment and problem-solving skills
A competence assessment record indicates how the assessment was performed, and is completed annually for
each employee.
The use of a combination of these approaches is suggested. When there is direct on-site daily supervision, the
supervisor performing the competence assessment may not need to specifically watch an individual go through
all types of tests performed. However, when an employee works alone, without supervision, there may be a need
to visually observe that individual periodically to make sure he or she is conforming to best practices.
* Refer to NCCLS publication GP21-A, Training Verification for Laboratory Personnel; Approved Guideline, for one accept-
able way to assess competence.
J 1. The organization has a laboratory policy that defines the process and criteria for assessing staff competence.
J 2. Staff members performance and competence are assessed annually.
J 3. The review process includes elements defined in the intent.
J 4. The review includes elements identified in the intent.
J 5. A record of the assessment meets the requirements of element e) in the intent.
D%c+#e$*ed Pe()%$$e" I$f%(#a*%$
S*a$da(d RSM.2
Documented personnel information is maintained for each staff member.
I$*e$* %f RSM.2
Documented personnel information is maintained for each staff member, including the following:
a) A summary of education and training relevant to duties when hired
b) History of related work experience, including references from previous employers, if available
c) Primary source verification of certification or licensure, if required by applicable law and regulation
d) Evidence of certification or licensure, if not required by law and regulation, but if required by organi-
zation policy
e) Current job description
f ) Records of initial orientation and any retraining required
g) Records of any additional training for new job responsibilities
h) Records of continuing education and achievement
i) Records of performance evaluations and periodic assessments of competence
j) Records of health status (as related to work), such as immunization status and health status after work-
related accidents
k) Records of radiation exposure and any monitoring for radiation exposure, when relevant
l) Records of monitoring for exposure to hazardous chemicals, when indicated
m) Records of untoward incident or accident reports, such as accidental needlesticks
J 1. There is documented personnel information for each staff member.
J 2. Documented personnel information includes elements a) through m) listed in the intent of this standard.
I$f(a)*(+c*+(e/Ba)c Fac"*e)
S*a$da(d RSM.3
Laboratory leaders have planned for basic facilities, including adequate space, utilities, and equipment.
I$*e$* %f RSM.3
The laboratory can provide consistent test results of acceptable quality only when there is provision of facili-
ties appropriate for the laboratory environment. These include adequate, safe buildings, space within the labo-
ratory with safety features required for the services provided, appropriate utilities, and supplies and equipment
74
75
for performance of laboratory tests. These provisions should be adequate for the efficient and safe perfor-
mance of the work within the laboratory.
In addition, communication systems within the laboratory and between the laboratory and customers are ade-
quate for the size and complexity of the organization and for the efficient transfer of information and messages.
(Note: Requirements for adequate facilities apply to all areas owned and/or under authority of the laboratory,
not just the main laboratory setting. This includes satellite laboratories, specimen collection stations in any
setting, or laboratory testing performed in another health care organization as a contract service.)
J 1. The building in which the laboratory is located is structurally safe and adequate for the services pro-
vided.
J 2. Appropriate safety features (such as fire prevention and control equipment) are provided.
J 3. Laboratory leaders plan for adequate space.
J 4. Laboratory leaders plan for appropriate utilities, supplies, and equipment for the testing performed.
J 5. Leaders plan for adequate communication systems within the laboratory and between the laboratory
and customers.
J 6. These requirements apply to all areas owned and/or under authority of the laboratory.
Lab"%a'"%* S#ace
S*a$da(d RSM.3.1
There is sufficient space for all areas under control of the laboratory. The laboratory leaders have planned and
provided for appropriate space for all laboratory areas.
I$*e$* %f RSM.3.1
The space provided meets the following requirements:
a) There is sufficient space for all areas under control and/or authority of the laboratory.
b) The space is adequate to allow personnel to perform required work with accuracy, precision, efficiency,
timeliness, and safety.
c) The comfort and safety of personnel, patients, and visitors are not compromised because of the design
and organization of the laboratory.
d) There is a system for providing adequate housekeeping for all areas.
e) Adequacy of space is determined by the laboratory director.
J 1. All areas under the control and/or authority of the laboratory have sufficient space, as determined by
the laboratory director.
J 2. The space for each area allows for the performance of work as required in element b) in the intent.
J 3. The laboratorys design and organization meet the requirement of element c) in the intent.
J 4. There is provision for adequate housekeeping for all areas.
S*a$da(d RSM.3.1.1
Spaces for specific laboratory areas are adequate.
I$*e$* %f RSM.3.1.1
Specific laboratory areas have unique requirements that must be met. These areas include the following:
a) The space provided is suitable for all laboratory technical areas. Suitability includes the following ele-
ments:
Bench space is adequate for the testing performed and for personnel to share a work area, if
required.
There is appropriate space for sample preparation, handling, and processing.
Each piece of equipment has enough space for easy access and adequate ventilation so it can func-
tion properly and not be affected by other equipment.
When designing or allocating space for technical areas, leaders consider the need for separation or
segregation of some areas due to the nature of the work performed or the need for uninterrupted
concentration.
b) Spaces for specimen collection areas are adequately designed for their function. This includes the following:
Primary specimen collection facilities are designed to allow respect and accommodation for
patients
1. privacy;
2. confidentiality;
3. security;
4. comfort; and
5. disabilities.
Provision is made for optimal specimen collection conditions and, when relevant, specimen
processing.
c) Storage areas have appropriate and adequate space, which includes the following:
Reagents are stored properly and are not stacked or arranged in an unsafe manner.
Manufacturers guidelines for reagent storage are met.
Special storage requirements are met for flammable liquids, compressed gases, and any other
reagents with special requirements.
Storage for specimens and control materials is adequate and appropriate.
Proper storage is provided for supplies and equipment.
Histology and cytology slides and blocks are stored correctly.
Adequate storage space is provided for records, files, and manuals.
The temperature of storage areas is appropriate, controlled, and monitored, when indicated.
Storage areas are kept clean and well maintained.
d) Adequate, well-designed spaces are available for performing clerical functions, including
providing areas where interruptions are uncommon; and
providing areas where hazardous materials are minimal or eliminated.
Mea)+(ab"e E"e#e$*) %f RSM.3.1.1
J 1. Spaces provided for technical areas meet the requirements of element a) in the intent.
J 2. Spaces provided for specimen collection meet the requirements of element b) in the intent.
J 3. Storage areas meet the requirements for element c) in the intent.
J 4. Spaces provided for clerical functions meet the requirements of element d) in the intent.
76
77
U'ili'ie& Ma!agee!'
S*a$da(d RSM.3.2
A plan for providing and maintaining necessary utilities is defined and implemented.
I$*e$* f%( RSM.3.2
The laboratory leaders promote a safe, controlled, comfortable laboratory environment through the provision
of necessary utilities. The impact of utilities on infection control systems, environmental support systems,
equipment support systems, and communications systems is addressed.
The following are provided and adequate:
a) Humidity and temperature control
b) Appropriate ventilation systems
c) Necessary communications equipment (for example, telephones)
d) Stable electrical power and grounded electrical outlets
The following are provided, as required:
e) Emergency power, when required*
f ) Biological safety cabinets and chemical fume hoods
g) Emergency lighting for the safe evacuation of the laboratory
h) Vacuum breakers (antisiphon devices) on water outlets, where necessary
i) Suction
j) Gas supplies
J 1. The utilities of the laboratory are planned to meet the requirements of laboratory testing and services.
J 2. Elements a) and b) in the intent are provided and adequate.
J 3. Necessary communications equipment, including telephones, is provided.
J 4. Stable electrical power and grounded electrical outlets are provided.
J 5. Emergency power is provided, when required.
J 6. Elements f ) through j) in the intent are provided and adequate, when required for the services provided.
S*a$da(d RSM.3.2.1
There is a system to inspect, test, and maintain critical operating components for utility systems and to inves-
tigate and correct utility system problems.
I$*e$* f%( RSM.3.2.1
There is a defined plan for inspecting, testing, and maintaining critical components for utility systems. This includes
a) periodically testing the emergency generator;
* Emergency power is required to supply electricity to critical areas when the normal power supply is interrupted. Such
areas include blood, bone, and tissue storage units; essential refrigeration and heating; and essential equipment that might
be required for STAT testing in an emergency situation. If emergency electrical power is not provided for these services,
there should be a defined plan for transfer of blood, bone, and tissue, as well as specimens and tests, to another specified
laboratory and an agreement that the receiving laboratory will accept what is sent and perform required testing.
b) at least annually checking for polarity and ground integrity on electrical outlet circuits;
c) periodically checking (at least annually) and maintaining for the biological safety hood;
d) periodically checking (at least annually) on the chemical fume hood;
e) daily monitoring of temperature-controlled spaces; and
f ) monitoring of humidity, where indicated.
When environmental conditions are unacceptable, there are records of the remedial actions taken and the
results of the actions.
Mea)+(ab"e E"e#e$*) %f 3.2.1
J 1. There is a written plan defining the inspection, testing, and maintenance of critical components for
utility systems.
J 2. The plan includes at least elements a) through f ) listed in the intent.
J 3. All inspections, testing results, and maintenance are documented.
J 4. When utilities are unacceptable, remedial actions are taken and documented.
Lab%(a*%(- E'+&#e$* a$d O*he( Ma*e(a")
S*a$da(d RSM.4
Laboratory leaders ensure that analytic and other equipment, as well as other material resources required for
the provision of services, are adequate, appropriate, and available.*
I$*e$* %f RSM.4
Adequate resources must be provided for the laboratory to meet goals and clinician requirements for patients.
The laboratory director is responsible for defining the process for selecting and using equipment, reagents,
and other supplies that affect the quality of services. In addition, there is a process for ensuring the initial and
continued acceptability of reagents and other supplies.
J 1. There are defined processes for selecting and using equipment, reagents, and other supplies.
J 2. These processes are approved by the laboratory director.
J 3. The director has defined performance criteria for test methodologies, equipment, and quality control.
J 4. There are processes for ensuring the initial and continued acceptability of reagents and other supplies.
S*a$da(d RSM.4.1
Laboratory equipment is maintained, tested, and inspected.
I$*e$* %f RSM.4.1
Laboratory leaders provide for a program to regularly monitor and demonstrate proper calibration and func-
tion of instruments, reagents, and analytic systems. The program also includes preventive maintenance at
defined intervals for each piece of equipment. The minimum procedures performed are those recommended
78
* Refer to CLSI publication GP6-A, Inventory Control Systems for Laboratory Supplies, Approved Guideline, for assistance
with inventory control.
79
by the manufacturer or those required by law and regulation. All required verification checks and preventive
maintenance are documented, as are remedial actions when instruments or other equipment do not meet per-
formance specifications.
In addition, equipment is assessed through periodic inspections, performance testing, and maintenance. The
following are performed and documented:
a) Daily monitoring of temperature-controlled spaces and equipment, such as water baths, heating
blocks, refrigerators, and freezers
b) Evaluation of automated and manual volumetric equipment
c) Periodic checking of mechanical timers for accuracy
d) Periodic cleaning, maintenance, and checking of optical alignment for microscopes
e) Checking of thermometers against an appropriately standardized thermometer prior to use
f ) Periodic checking of centrifuges for essential operating characteristics
g) Checking of sterilizers for proper performance
J 1. There is a defined program for regular monitoring of equipment to demonstrate proper calibration
and function.
J 2. There is preventive maintenance at defined intervals for each piece of equipment.
J 3. At the minimum, the laboratory performs procedural checks recommended by the manufacturer or
required by regulation, whichever is more stringent.
J 4. All performed verification checks and preventive maintenance are documented.
J 5. Remedial action is documented when instruments or test methods do not meet performance specifications.
J 6. The laboratory implements the requirements of elements a) through g) in the intent.
(Note: For standards addressing validation of analytic methods and calibration, see the Quality Control
Processes [QCP] chapter in this manual.)
S*a$da(d RSM.4.1.1
A historical record is maintained for each analytic instrument and piece of equipment used by the laboratory.
I$*e$* %f RSM.4.1.1
There is a historical record for each instrument or piece of laboratory equipment. This historical record iden-
tifies the equipment with
a) the name of the manufacturer;
b) equipment type; and
c) a serial number or another unique identifier.
The record includes
d) all validation, performance testing, and maintenance performed;
e) major repairs or modifications made to the equipment;
f ) contact information for any outside individual or organization that maintains or repairs the equipment; and
g) manufacturers instructions or guidelines, when possible.
Records are retained as follows:
h) Detailed records identifying daily, weekly, or monthly performance tests and function checks are retained
for at least two years, unless there are more stringent requirements to meet applicable law and regulation.
i) Records of major repairs, parts replacement, and semiannual or annual calibration checks and preven-
tive maintenance are retained for the life of an instrument.
Each entry is dated (including the date the equipment was obtained and placed into service and the date
retired) and includes the identity of the person who performed work on the equipment.
J 1. There is a historical record for each analytic instrument and piece of equipment.
J 2. The record identifies each instrument or other equipment, using the information required in ele-
ments a) through c) in the intent.
J 3. The record includes elements d) through g) listed in the intent.
J 4. The minimum record retention time meets the requirements of elements h) and i).
J 5. All entries are dated and include the identification of the person who performed work on the equipment.
S*a$da(d RSM.4.2
Maintenance and inspection ensure that equipment is safe.
I$*e$* %f RSM.4.2
a) Equipment is evaluated by an individual(s) who is competent to assess equipment safety.
b) The assessment includes a check for electrical safety and for working emergency stop devices.
c) Manufacturers instructions are followed.
d) Equipment that is unsafe is removed from use until it has been repaired.
e) There is a process for decontaminating equipment prior to service or disposal.
f ) If equipment is repaired on site, appropriate space and personal protective equipment are provided for
this work.
J 1. Safety evaluation of equipment, including checks for electrical safety and for working emergency stop
devices, is performed by an individual(s) who is competent to perform that function.
J 2. When maintaining and inspecting equipment, manufacturers instructions are followed.
J 3. Safety for those who use and/or maintain equipment is considered by meeting the requirements of
elements d) through f ) in the intent.
S*a$da(d RSM.4.3
There are defined processes in place for validating and maintaining computer software and information, when
they are used by the laboratory.
I$*e$* %f RSM.4.3
a) When computers or electronic testing equipment are used for any of the laboratorys processes, there is
validation of the computer software prior to use.
b) The laboratory provides environmental conditions required for the electronic system and the mainte-
nance of data integrity.
c) Procedures are developed for the use of computers and routine maintenance.
d) There are defined procedures to protect data and information against loss, destruction, tampering, and
unauthorized access or use.
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81
e) There is a defined backup procedure to follow a computer is not functioning, so that laboratory results
continue to be reported in a timely manner and data during this time are not lost.
J 1. There is validation of computer software for computers or electronic testing equipment, as required
in element a) of the intent.
J 2. Optimum environmental conditions are provided for computers or electronic testing equipment.
J 3. Written procedures meet the requirements of elements c) through e) in the intent.
Reage!'& a!d O'he% S(##lie&
S*a$da(d RSM.4.4
The laboratory follows written guidelines for the periodic evaluation of all reagents, including water, to pro-
vide for accuracy and precision of results.
I$*e$* %f RSM.4.4
a) The laboratory has and follows written guidelines for the periodic evaluation of all reagents, including
water, to provide for accuracy and precision of results.
b) Reagent performance and adequacy are verified before use.
c) Kits that contain all essential reagents, standards, diluents, and any other reagent water are evaluated
according to an established protocol.
d) Water used in laboratory testing is appropriate for such use.
e) Proper storage requirements are followed for all reagents.
f ) The laboratory does not use materials of substandard reactivity or outdated or deteriorated materials.
J 1. Written guidelines address the requirements of element a) in the intent.
J 2. Reagents, including water, are evaluated according to the requirements of the written guidelines and
elements b) through d) in the intent.
J 3. All reagents are properly stored.
J 4. The laboratory does not use substandard materials, as required in element f ) in the intent.
S*a$da(d RSM.4.5
Laboratory records include documentation of required information for reagents, and reagents are completely
and accurately labeled.
I$*e$* %f RSM.4.5
The laboratory maintains records of reagents, controls, kits, and solutions received or prepared in the labora-
tory. The records include identification of each reagent, the date of receipt or preparation, and the lot num-
ber, if available.
In addition, all reagents are labeled for
a) identity;
b) strength;
c) storage requirements;
d) cautionary and accessory information;
e) date prepared or received; and
f ) expiration date.
J 1. Records for reagents, controls, kits, and solutions include the identity of the reagent, the date of
receipt or preparation, and the lot number, if available.
J 2. All reagents are labeled with the information required in elements a) through f ).
Safe*- a$d Sec+(*-
S*a$da(d RSM.5
There is a plan to ensure that laboratory services and facilities are secure.
I$*e$* %f RSM.5
Laboratory leaders define and implement a plan that
a) controls access to and use of areas affecting the quality of test results;
b) safeguards specimens and resources from unauthorized access;
c) addresses security issues for patients, visitors and other customers, laboratory staff, and property; and
d) provides safeguards for equipment (software and hardware), reference materials, consumables, reagents,
and analytic systems.
J 1. A written plan that describes security measures for laboratory services and facilities is implemented.
J 2. The plan addresses security issues for people, property, and equipment, as required in elements c)
and d) in the intent.
J 3. The plan provides safeguards for specimens, resources, and laboratory spaces against unauthorized
access.
Ha.a(d%+) Ma*e(a") a$d Wa)*e
S*a$da(d RSM.6
The laboratory has a plan for inventory, handling, storage, and use of hazardous materials and the control and
disposal of hazardous waste.*
I$*e$* %f RSM.6
a) The laboratory identifies and safely controls hazardous materials and waste according to a plan.
b) The plan addresses all types of hazardous materials and waste.
c) The plan requires an inventory of hazardous materials and waste.
d) Procedures define processes for
handling, storage, and use of hazardous materials;
82
* Refer to NCCLS publications GP5-A, Clinical Laboratory Waste Management; Approved Guideline, and GP17-A, Clinical
Laboratory Safety, Approved Guideline, if assistance is needed with hazardous materials and waste management.
83
reporting and investigation of spills, exposures, and other incidents;
proper disposal of hazardous waste;
proper protective equipment and procedures during use, spill, or exposure;
documentation, including any permits, licenses, or other regulatory requirements; and
proper labeling of hazardous materials and waste.
e) Safety policies and procedures are defined for the following, if found in laboratory areas:
Biohazardous or infectious materials and waste, including sharps
Hazardous chemicals and waste
Chemotherapeutic materials and waste
Radioactive materials and waste
Hazardous gases and vapors
f ) For areas that use or contain any of these hazardous materials and waste, housekeeping personnel are
provided with adequate training to ensure their safety and security and the safety of the laboratorys
tests and testing equipment.
J 1. The laboratory has written plans for handling hazardous materials and waste, as described in ele-
ments a) and b) in the intent.
J 2. The laboratory identifies hazardous materials and waste and has a current list of all such materials.
J 3. Procedures define processes for the processes identified in element d) of the intent.
J 4. Safety policies and procedures are defined for the types of hazardous materials identified in element
e) of the intent, if found in the laboratory.
J 5. Housekeeping staff are provided with appropriate training when they work in areas that use or con-
tain hazardous materials and waste.
S*a$da(d RSM.6.1
The laboratory uses a coordinated process to reduce the risks of infection as a result of exposure to biohaz-
ardous materials and waste.
I$*e$* %f RSM.6.1
There are policies, procedures, and practices implemented to reduce the hazards of exposure to biohazardous
materials. Infections acquired in the laboratory are reported internally and, when appropriate, to public health
agencies. The following biosafety hazards and practices are addressed in written procedures, and the require-
ments of the procedures are followed:
a) Exposures to aerosols and droplets are controlled (for example, when mixing, sonicating, centrifuging,
and flaming inoculating loops).
b) Exposure to needlestick and puncture by other sharps is controlled.
c) Laboratory coats, gowns, or uniforms are worn to protect street clothes and prevent contamination.
d) Gloves are worn by all personnel who handle potentially infectious specimens, cultures, or tissues.
e) Personnel are given training on the proper use of personal protective equipment (for example, gloves,
gowns, masks, eye protectors).
f ) Biosafety cabinets are used, when required.
g) Rules govern how to handle laboratory exposure to infectious agents, accidental cuts, needlestick
injuries, accidental ingestion, and contact of potentially infectious agents with mucus membranes.
These rules include decontamination procedures, whom to contact for emergency treatment, and the
location and use of safety equipment.
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h) Rules govern handling, decontamination, and disposal of infectious waste.
i) Appropriate immunizations are defined, as required.
j) There are written procedures defining safe collection, transport, and handling of all specimens.
k) As part of the plan, there is a safety procedure prohibiting anyone in laboratory technical areas from
eating, drinking, smoking, applying cosmetics, manipulating contact lenses, and mouth pipetting.
l) When relevant to their jobs, personnel have received training about precautionary measures, modes of
transmission, and prevention of bloodborne pathogens.
m) The laboratory has a plan to control exposure to tuberculosis.
When problems with practice are identified or accidents occur, corrective actions are taken, documented, and
reviewed.
J 1. The laboratory has a defined process for reducing the risks of infection.
J 2. Infections acquired in the laboratory are reported, as defined in the policy and in compliance with
applicable law and regulation.
J 3. The laboratory follows biosafety rules for relevant practices addressed in elements a) through m) in the intent.
J 4. When problems with practice are identified, or accidents occur, corrective actions are taken, docu-
mented, and reviewed.
S*a$da(d RSM.6.2
The laboratory follows defined guidelines for handling and disposing of hazardous chemicals and waste
(including chemotherapeutic materials and waste).
I$*e$* %f RSM.6.2
The program for handling hazardous chemical reagents and waste includes the following:
a) Guidelines describe the processes for selecting, handling, storing, using, and disposing of hazardous
chemicals and waste from receipt or generation through use or final disposal.
b) The program includes evaluating each chemical in the laboratory for carcinogenic potential, reproduc-
tive toxicity, and acute toxicity.
c) Handling criteria are defined for each category of hazardous chemical.
d) Containers of hazardous chemicals are labeled with precautionary information identifying the type and
severity of hazard. Examples of types of hazards include flammable liquids, asphyxiants, corrosives, irri-
tants, and potential carcinogens.
e) Formaldehyde and xylene vapor concentrations are maintained below the maximum concentrations
allowed by law and regulation.*
f ) There is an initiative to reduce the volume of hazardous waste produced.
g) The method used for disposal of all solid and liquid waste is in compliance with applicable law and regulation.
h) Actions taken in response to problems identified in the handling and disposing of hazardous chemicals
and waste are documented and reviewed.
J 1. The program for hazardous chemicals and waste includes the requirements of elements a) and b) in
the intent.
* Where local laws do not define the limits, the threshold limit values (TLV) published by the American Conference of
Government Industrial Hygienists are to be used as a guide. For example, for xylene the 8-hour time-weighted average
(TWA) limit is 100 ppm, and for formaldehyde the TWA is 0.75 ppm.
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J 2. Procedures and containers for handling chemicals meet the requirements described in elements c)
and d) in the intent.
J 3. Formaldehyde and xylene vapor concentrations are maintained below threshold limit values.
J 4. There is an initiative to reduce the volume of hazardous waste produced.
J 5. Disposal of hazardous waste complies with applicable law and regulation.
J 6. When problems are identified, actions are taken and documented, as required in element h) in the
intent.
S*a$da(d RSM.6.3
If radioactive materials are used in the laboratory, there are processes for safe handling and monitoring of them.
I$*e$* %f RSM.6.3
When the laboratory stores, uses or generates radioactive materials and waste, the following policies and pro-
cedures are developed and implemented:
a) There are safety measures for handling radionuclides and radioactive waste.
b) There are procedures for decontamination.
c) The laboratory complies with posting requirements identifying the presence of radioactive materials.
d) There are procedures for monitoring the amount of radiation in the area.
e) All procedures and practices comply with applicable law and regulation.
J 1. When the laboratory stores, uses, or generates radioactive materials and waste, safety measures and
procedures for decontamination are defined and followed, according to elements a) and b) in the
intent.
J 2. The laboratory complies with the requirements of element c) in the intent.
J 3. There are procedures for monitoring the amount of radiation in the area.
J 4. The laboratory complies with element e) in the intent.
W%(! E$,(%$#e$*/Lab%(a*%(- Safe*-
S*a$da(d RSM.7
The laboratory designs a safe, accessible, effective, and efficient environment consistent with its mission, ser-
vices, and law and regulation.
I$*e$* %f RSM.7
The laboratorys safety processes provide a physical environment where hazards are controlled and personnel
activities are managed to reduce the risk of injuries.
Laboratory leaders
a) conduct a risk assessment that proactively evaluates the impact of buildings, grounds, equipment,
occupants, and internal physical systems on patient and personnel safety;
b) examine safety issues identified by appropriate representatives; and
c) report and investigate all incidents of property damage, occupational illness, and patient, personnel, or
visitor injury.
J 1. Laboratory leaders implement a process to evaluate safety issues as required in element a) in the
intent.
J 2. Laboratory leaders examine safety issues identified by appropriate representatives.
J 3. Laboratory leaders implement a process for reporting and investigating incidents as described in ele-
ment c) in the intent.
J 4. Laboratory leaders implement safety processes to ensure a safe physical environment.
S*a$da(d RSM.7.1
Laboratory leaders address fire safety.
I$*e$* %f RSM.7.1
The laboratorys safety processes provide adequate fire detection and prevention policies and equipment, including
a) protecting patients, personnel, visitors, and property from fire, smoke, and other products of
combustion;
b) inspecting, testing, and maintaining all required fire alarm systems;
c) inspecting, testing, and maintaining all required automatic fire-extinguishing systems;
d) managing portable fire extinguishers, including monthly inspection, regular maintenance, and guide-
lines for their identification, placement, and use; and
e) establishing evacuation routes in case of a fire in the laboratory.
J 1. Fire safety processes to protect patients, personnel, visitors, and property are established.
J 2. Processes are implemented to inspect, test, and maintain all required fire alarm and automated and
portable fire-extinguishing systems.
J 3. Evacuation routes are established and posted.
S*a$da(d RSM.7.1.1
The laboratory conducts fire drills regularly.
I$*e$* %f RSM.7.1.1
The development of a fire response plan is an important step toward achieving a fire-safe environment. It is impor-
tant that this plan be regularly evaluated during implementation (using, for example, drill scenarios) for per-
formance of the fire safety equipment and laboratory personnel. A policy defines the process of fire drills, expecta-
tions of employees during drills, and how frequently fire drills will be conducted. At a minimum, fire drills should
be held every six months. If the laboratory is part of a larger organization, such as a hospital, the organizationwide
drills will meet this requirement if the laboratory and its employees are included in the drills. Employee response
and other aspects of the drills are reviewed, and actions are taken to improve fire safety, when appropriate.
J 1. A written policy describes how fire drills are conducted, along with employee roles in drills and how
they will be monitored.
J 2. Fire drills are conducted at least every six months.
J 3. Results of drills are reviewed, and actions are taken to improve the laboratorys performance, when
appropriate.
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S*a$da(d RSM.7.2
Adequate safety devices and equipment are provided.
I$*e$* %f RSM.7.2
As required, safety devices are provided for laboratory staff. These include the following:
a) An emergency eyewash station is available within 10 seconds travel distance from every area in the
Laboratory where hazardous chemicals are used. This should be capable of providing at least a 15- to
20-minute flush of the eyes with safe water or a sterile solution.
b) Puncture-resistant containers are provided for waste sharp disposal.
c) Safety cans are generally used for volumes of flammable liquids larger than 1 liter.
d) Safety cans are used for flammables that are highly volatile (for example, ether or pentane) for volumes
larger than 500 ml. The only exception would be if the purity required mandated glass storage.
e) Bottle carriers are provided for transporting all glass containers containing hazardous chemicals in
amounts larger than 500 ml.
Other safety devices are provided, as required by the reagents and other chemicals used. These include
f ) safety shower;
g) fire blankets;
h) fire extinguishers; and
i) spill kits.
Eyewash stations and safety showers are tested regularly for proper function, and fire extinguishers are checked
periodically for acceptable pressure.
J 1. The laboratory provides the safety equipment listed in elements a) through e), when indicated.
J 2. The laboratory provides the safety equipment listed in elements f ) through i) when indicated.
J 3. Eyewash stations, safety showers, and fire extinguishers are tested and checked periodically for proper
function.
S*a$da(d RSM.7.3
When a laboratory performs electron microscopy, the laboratory has processes to ensure safety and quality.
I$*e$* %f RSM.7.3
The laboratorys policies and practices for electron microscopy address
a) precautions related to radiation and the electrical hazards of electron microscopes;
b) pathologist review of embedded tissue sections to effectively select areas for examination; and
c) reporting of all electron microscopic studies performed for diagnostic purposes in the clinical record.
J 1. The laboratory has defined policies addressing elements a) through c) in the intent.
J 2. The laboratorys practices conform with the policies.
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Q+a"*- C%$*(%"
P(%ce))e) (QCP)
S*a$da(d)
Q+a"*- C%$*(%" C%##%$ *% A"" A(ea) %f Te)*$g
QCP.1 Quality control processes are established for each test method, and data from these processes are
available and used to monitor and ensure the stability of test systems.
QCP.1.1 The laboratory has a program of external graded interlaboratory comparison testing or
proficiency testing for analytes for each specialty and subspecialty for which such testing
is available.
QCP.1.1.1 Proficiency sample testing is performed in the same manner as patient
sample testing.
QCP.1.1.2 The laboratory uses a system for verifying the accuracy and reliability of
test results obtained for those tests not included in the formal proficiency
testing program.
QCP.1.2 The laboratory uses a system to evaluate and correlate the relationship between results for
the same test performed with different methodologies or instruments or at different sites.
QCP.1.3 The laboratory performs initial validation for new instruments and analytical systems to
verify that the method(s) will produce accurate and reliable results.
QCP.1.4 The laboratory validates electronic or internal monitoring systems prior to using them
for routine quality control.
QCP.1.5 Calibration, linearity checks, and other function checks are performed on instruments
and analytic systems used for patient testing.
QCP.1.6 The quality control processes of the laboratory include a coordinated review of patient
results, quality control results, and instrument function checks.
QCP.1.7 The laboratory takes remedial action for deficiencies identified through quality control
measures or authorized inspections and documents such actions.
89
07 JCIIL09 - QCP - 4-# Pa",:La/).- 1 9/17/2009 5:18 PM Pa" 89
S&eca"*- Q+a"*- C%$*(%"
Hi#$oa$holog'
QCP.2 There are quality control processes in place for surgical pathology and autopsy services.
QCP.2.1 The laboratory has implemented processes for ensuring the proper identification,
preservation, and documentation of receipt of surgical specimens sent for analysis.
QCP.2.1.1 When immunohistochemistry is performed, the laboratory has appropri-
ate quality control processes.
QCP.2.2 The laboratory implements quality control and assurance processes for evaluating the
ongoing qualifications of individuals who perform gross analysis of tissue and micro-
scopic analysis of tissue.
QCP.2.3 There are defined processes to document the ongoing proficiency of individuals who
perform microscopic analysis of tissue.
QCP.2.4 The laboratory has implemented processes to ensure access to required patient informa-
tion and to cross-reference such information to assist in providing a complete and prop-
er diagnosis.
C'$oa$holog'
QCP.3 A pathologist or physician qualified in cytology maintains the quality of the cytopathology service
through direct supervision.
QCP.3.1 The cytology laboratory has a process to measure, assess, and improve quality.
C"$ca" Lab%(a*%(- Te)*$g
Clinical Chemi#$"', Hema$olog', and Coag%la$ion
QCP.4 The laboratory leaders have defined quality control processes for all clinical chemistry, hematology,
and coagulation tests.
QCP.4.1 For tests that produce quantitative results (such as many clinical chemistry, hematology,
and coagulation analyses), laboratory quality meets certain requirements. The laborato-
ry defines and follows certain quality control guidelines.
QCP.4.2 The laboratory has quality control processes in place for blood film evaluation and dif-
ferential counts.
Mic"obiolog'
QCP.5 The laboratory has quality control processes when performing bacteriology, mycobacteriology, and mycology.
QCP.5.1 Antimicrobial, antimycobacterial, and antifungal susceptibility testing systems are veri-
fied with approved reference organisms.
QCP.5.2 All stains are tested with appropriate controls.
Molec%la" Mic"obiolog' Te#$ing
QCP.5.3 There are adequate quality control procedures when molecular microbiology testing is
performed.
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QUALITY CONTROL PROCESSES (QCP)
Pa"a#i$olog'
QCP.6 If the laboratory is performing parasitology, appropriate reference materials, equipment, and meth-
ods are used.
Vi"olog'
QCP.7 If the laboratory performs tests for identifying viruses, records detailing the systems used and the
reactions observed are maintained.
QCP.7.1 The laboratory uses controls that will identify erroneous results in tests for identifying
viruses.
U"inal'#i# and Clinical Mic"o#co'
QCP.8 The laboratory ensures the quality of tests performed in urinalysis and clinical microscopy.
Diagno#$ic Imm%nolog' and Se"olog'
QCP.9 The laboratory runs serologic tests on unknown specimens, including those for syphilis, concur-
rently with a positive control serum of known titer and a negative control, or controls of graded
reactivity, to ensure specificity of antigen reactivity.
QCP.9.1 Equipment, glassware, reagents, controls, and techniques for syphilis tests conform to
manufacturers specifications.
Radiobioa##a' and O$he" Te#$# U#ing Radioi#o$oe#
QCP.10 The laboratory uses written quality control procedures that provide diagnostic reliability and
patient and staff safety when it uses in vitro radioisotopes.
QCP.10.1 Any laboratory performing in vivo testing uses an appropriate quality control system for
such testing and equipment performance checks.
B"%%d Ba$! a$d T(a$)f+)%$ Se(,ce)
Di"ec$o" Re#on#ibili$'
QCP.11 The director of the blood bank or transfusion services is responsible for developing policies and
procedures and implementing practices that ensure the safety of patients being transfused.
Dono" Selec$ion and Te#$ing
QCP.11.1 There are defined procedures and practices for blood donor selection and blood collec-
tion. Staff are trained and assessed as competent to perform these procedures.
QCP.11.1.1 A detailed history of a donor is performed prior to selection for blood
donation.
QCP.11.1.2 An adequate physical examination is performed prior to approving the
individual as a blood donor.
QCP.11.1.3 Donor blood is collected safely and aseptically according to a defined
protocol.
QCP.11.1.4 Written guidelines are implemented when autologous blood is collected.
QCP.11.2 Blood and related donor records are properly identified, and the identification is main-
tained from collection through the time the unit is transfused.
QCP.11.3 Donor blood undergoes routine testing before being used for transfusion. In addition,
process controls are used to ensure appropriate tracking and prevent blood from being
released prematurely.
Blood Comonen$ P"ea"a$ion o" Modifica$ion
QCP.11.4 When components are prepared or modified by the organization, there are defined
procedures for their processing and storage, and appropriate quality control measures
are taken.
Whole Blood
QCP.11.4.1 Tests and processes are used to maintain the quality of whole blood. This
includes whole blood from which components and products are to be
processed.
Red Blood Cell#
QCP.11.4.2 Defined processes are implemented to maintain the quality of red blood
cells.
Pla$ele$#
QCP.11.4.3 Defined processes are used to ensure the quality of platelets.
Pla#ma
QCP.11.4.4 Defined processes are used to ensure the quality of plasma.
C"'o"ecii$a$ed AHF
QCP.11.4.5 Defined processes are used to ensure the quality of cryoprecipitated AHF.
B"%%d a$d C%#&%$e$* S*%(age Re'+(e#e$*) (f%( D%$%( Fac"*- a$d B"%%d
T(a$)f+)%$ Se(,ce))
QCP.11.5 The blood bank director ensures that blood and components are stored in a secure and
appropriate fashion in order to prevent damage or deterioration.
QCP.11.5.1 Storage areas used for blood and components are appropriate for the vol-
ume and variety of components stored.
QCP.11.5.2 Storage areas for blood and components are monitored to ensure that
appropriate temperatures are maintained.
QCP.11.6 The laboratory maintains identification and traceability of specimens; reagents; test
results; and blood, blood components, and products.
B"%%d T(a$)f+)%$ Se(,ce)
Te#$ing of Blood P"io" $o T"an#f%#ion
QCP.11.7 The laboratory tests donor blood and recipient blood with potent typing sera and ade-
quately reactive cells of a known type to determine the correct ABO blood group and
Rh type.
QCP.11.7.1 The potency and reliability of reagents used for ABO grouping, Rh typ-
ing, antibody detection, and compatibility determinations are tested for
reactivity.
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QCP.11.8 Before blood is administered, appropriate compatibility testing and antibody testing
(except in an emergency) are performed. In addition, other procedural controls are
implemented.
Selec$ing Blood and Comonen$# fo" T"an#f%#ion
QCP.11.9 Specific procedures are followed when selecting blood and components for transfusion.
Blood I##%ance and T"an#f%#ion
QCP.11.10The director of the blood transfusion services provides policies and procedures to guide
acceptable practices for blood and component transfusion.
QCP.11.10.1 There are defined processes for checking blood out of the blood bank
before transfusion.
QCP.11.10.2 Specific policies and practices are required before and during blood
administration.
Recogni(ing S%#ec$ed T"an#f%#ion Reac$ion#
QCP.11.10.3 The director has defined criteria for recognition of transfusion reactions,
as well as steps to take when symptoms occur.
Blood Dono" and T"an#f%#ion Se"&ice# Reco"d Re!%i"emen$#
QCP.11.11When the laboratory draws donor blood, prepares blood components, stores blood
and/or components, and/or issues blood for transfusion, there are specific records that
must be maintained.
Hi#$ocoma$ibili$' Te#$ing
QCP.12 When performing histocompatibility testing, the laboratory uses appropriate screening techniques
for donors and recipients.
QCP.12.1 The laboratory performs mixed lymphocyte cultures or other recognized methods to
detect cellular-defined antigens according to defined methods.
QCP.12.2 The laboratory performs HLA serologic typing of both donor and recipient, as appro-
priate to the study or individual procedure performed.
QCP.12.3 Before transplantation is performed, the laboratory crossmatches potential recipients
and donors using the most reactive and recent sera, as appropriate to the study or indi-
vidual procedure performed.
QCP.12.4 The laboratory uses reagents and antisera that are specific and verified with appropriate
controls, when available.
QCP.12.5 The laboratory participates in at least one national or regional cell-exchange program, if
available, or develops an exchange system with another laboratory to validate interlabo-
ratory reproducibility.
QCP.12.6 Storage of records and specimens is addressed.
C'$ogene$ic# Te#$ing
QCP.13 Laboratory procedures and practices in cytogenetics provide for accurate results.
QCP.13.1 Laboratory records identify the media used, the reactions observed, and the details of
each step of the identification procedure.
QCP.13.2 The laboratory obtains and includes in the interpretative report all required clinical
information.
QCP.13.3 The laboratory maintains individual sample identification during all phases of testing
and reporting.
Molec%la" Te#$ing
QCP.14 The laboratory follows written policies and procedures for molecular testing.
QCP.14.1 Validation studies include representatives from each specimen type expected to be tested
in the assay and specimens representing the scope of reportable results.
QCP.14.2 The laboratory establishes quality control limits, reference ranges, and reportable ranges.
QCP.14.3 The laboratory verifies each test run of patient samples in molecular pathology, using
quality controls.
QCP.14.4 Molecular testing reports include specific testing information.
Molec%la" Gene$ic#
QCP.14.5 The laboratory follows written policies and procedures for molecular genetic testing.
QCP.14.6 Molecular genetic testing reports include specific testing information.
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S*a$da(d), I$*e$*), a$d Mea)+(ab"e E"e#e$*)
Q(ai'* C#"'%# C#!!#" '# A A%ea& #f Te&'i"g
S'a"da%d QCP.1
Quality control processes are established for each test method, and data from these processes are available and
used to monitor and ensure the stability of test systems.
I"'e"' #f QCP.1
Quality control processes are established for all tests in the laboratory. At a minimum, they include
a) a successful program for external graded interlaboratory comparison testing or proficiency testing, if
available;
b) another means of ensuring accuracy and reliability, when proficiency testing is not available;
c) initial validation of new methods before reporting patient results;
d) a process to evaluate and correlate the relationship between results for the same test performed with
different methodologies or instruments or at different sites;
e) surveillance of results by appropriate personnel; and
f ) documented remedial action when deficiencies are identified through quality control measures or
authorized inspections.
Mea&(%abe Ee!e"'& #f QCP.1
J 1. Laboratory leaders have established quality control programs for all test methods.
J 2. The processes used for all tests include elements a) through f ) in the intent.
J 3. All quality control processes are documented.
S'a"da%d QCP.1.1
The laboratory has a program of external graded interlaboratory comparison testing or proficiency testing for
analytes for each specialty and subspecialty for which such testing is available.
I"'e"' #f QCP.1.1
External interlaboratory comparisons help a laboratory determine how its results compare with those of other
laboratories that use the same methodologies. Such testing can identify performance problems not identified
by internal quality control systems.
The laboratory subscribes to external graded comparison testing for each specialty and subspecialty for which
such testing is available. The subscription should cover the maximum number of analytes performed by the
laboratory and available from the provider, as well as the complexity of the testing processes used.
The laboratory tests proficiency specimens according to a written protocol and submits results back to the
proficiency testing provider within the required time period.
Review of returned results includes the following:
a) When results are graded and returned, the laboratory director or a designated supervisor reviews the
report and documents the review.
b) A more in-depth review and documentation are completed for each individual result exceeding acceptable
limits.
c) Remedial action is documented for any single or multiple challenge(s) of each analyte that does not fall
within acceptable limits.
d) Other problems or potential problems identified during the review are documented, along with correc-
tive actions.
e) The results are used for education, reeducation, or training of one or more employees, when indicated.
Using graded interlaboratory comparison testing or proficiency testing is a formal way to assess the accuracy
of testing unknown samples. By analyzing the specimens in the same way as patient samples and comparing
results with peers who use the same method, laboratory leaders can gain valuable insight about the laborato-
rys performance. An investigation into why samples did not fall within those of their peers can provide a
valuable problem-solving exercise.
In addition, the review may present information that allows preventive action when results are acceptable but
show a significant shift to one side of the mean.
The laboratory consistently analyzes and reports results. Records for test handling, examination, and reporting
results are retained for at least two years.
Mea&(%abe Ee!e"'& #f QCP.1.1
J 1. The laboratory subscribes to an external proficiency testing program for each specialty and subspecialty
for which proficiency programs are available.
J 2. The subscription covers the maximum number of analytes performed by the laboratory and available
from the provider, as well as the complexity of the testing processes used by the laboratory.
J 3. The laboratory is consistent in testing and reporting results within the required time frame.
J 4. Proficiency samples are tested and reported according to a written laboratory protocol that is consis-
tent with the providers instructions.
J 5. Review of returned reports includes the requirements of elements a) through e) in the intent.
J 6. Records of all processes, including testing, reporting, review, conclusions, and actions, are retained
for at least two years.
S'a"da%d QCP.1.1.1
Proficiency sample testing is performed in the same manner as patient sample testing.
I"'e"' #f QCP.1.1.1
The testing of proficiency samples meets the following requirements:
a) Samples are tested along with the laboratorys regular patient testing work load by personnel who rou-
tinely perform the laboratory test(s) using routine methods.
b) Laboratory personnel test the proficiency samples the same number of times that they routinely test
patient samples.
c) Communication between laboratories about the results of proficiency testing occurs only after the date
the laboratory must report results for the testing event to the provider.
d) The laboratory does not send samples to another laboratory for analysis.
Mea&(%abe Ee!e"'& #f QCP.1.1.1
J 1. There is a policy addressing proficiency testing requirements, as described in elements a) through d)
in the intent.
J 2. The policy is implemented and followed.
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S'a"da%d QCP.1.1.2
The laboratory uses a system for verifying the accuracy and reliability of test results obtained for those tests
not included in the formal proficiency testing program.
I"'e"' #f QCP.1.1.2
The laboratory provides a means of verifying accuracy and reliability for tests when there is no proficiency
testing available. This system is used and its results are documented at least semiannually.
Possible ways to meet the intent of the standard include
a) interlaboratory comparisons of quality control results used to verify the continuing reliability of
tests;
b) comparison of results from a specified number of previously tested specimens with a reference laboratory;
c) having the laboratory director or a qualified supervisor retest a random sample of microscopic tests
throughout the year to cover all testing personnel; and
d) duplicate testing by two or more testing personnel for microscopic tests such as urine sediments, crys-
tal identification, and reticulocyte counts.
The laboratory defines how closely results should correlate to be acceptable and reviews results against those
parameters. When results are not within the set acceptable limits, there is documentation of more intense
analysis and remedial action, when indicated.
J 1. There are processes implemented to verify the accuracy and reliability of tests for which there is no
external proficiency testing program available.
J 2. The laboratory uses one or more of the methods described in elements a) through d) in the intent or
some other acceptable method.
J 3. The laboratory defines limits of acceptability for each test.
J 4. This function is performed and documented at least semiannually.
J 5. Results are reviewed by the director or an appropriate supervisor, and when results are outside accept-
able limits, remedial actions are documented.
S'a"da%d QCP.1.2
The laboratory uses a system to evaluate and correlate the relationship between results for the same test per-
formed with different methodologies or instruments or at different sites.
I"'e"' #f QCP.1.2
When the same analyte is tested using different methodologies or instruments or at different locations, the
laboratory has a system to determine the relationship between or among the results. This prevents misinter-
pretation of the results. The laboratory documents the evaluation of the relationship at least semiannually.
When the results of the correlation demonstrate a clinically significant difference, the laboratory director
determines whether both methods should continue to be used. In some instances, this might be due to the
use of a method using whole blood at the point of care, while the main laboratory methods use plasma.
When methods provide results that differ significantly, the laboratory informs ordering practitioners of this
difference. In addition, when results are significantly different, each should be reported with a reference range
unique to that method.
Although an initial correlation study is desired during the validation of a new method, this standard does not
require this six-month evaluation to be a complete correlation study using 20 or more specimens.
For example, an acceptable laboratory policy might define
a. the number of patient specimens to be tested between or among testing systems (for example, 5
patient specimens, preferably with results that are normal and abnormal); and
b. how closely results should correlate in order to be acceptable. This may differ for different tests.
J 1. The correlation between testing methodologies or instruments is checked at least semiannually.
J 2. The laboratory director has defined the number of specimens to be tested and how closely results
should match to be acceptable.
J 3. When there is a significant difference in results, ordering clinicians are notified of the difference, and
each method has its own unique reference range used for the official report.
S'a"da%d QCP.1.3
The laboratory performs initial validation for new instruments and analytic systems to verify that the
method(s) will produce accurate and reliable results.*
I"'e"' #f QCP.1.3
Laboratory instruments and analytic systems are tested upon installation and before use to ensure their capa-
bility of meeting performance expectations. At a minimum, for new analytic methods, the laboratory
a) verifies accuracy;
b) verifies precision;
c) verifies the reportable range; and
d) confirms that the reference range applies to its patient population.
If one of the following is true:
the laboratory has modified the method;
the method is very complex with more than a few steps;
the method has been developed in-house; or
the manufacturer has not performed validations
the laboratory must test the full range of performance specifications, including
e) accuracy;
f ) precision;
g) reportable range;
h) analytic sensitivity;
i) analytic specificity; and
j) determine the reference range for the laboratorys population of patients.
When a new method is replacing an existing method, and if the existing method is still operational, the vali-
dation should include a correlation study between the two testing systems.
98
* Please refer to the following CLSI publications for guidance: EP6-P, Evaluation of the Linearity of Quantitative Analytic
Methods; EP6-A, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline; and EP15-P, User
Demonstration of Performance for Precision and Accuracy.
99
At the time of validation, the laboratory also establishes the number, type, and frequency of quality control
materials to be tested, using the performance specifications verified or established by the laboratory.
All required verification checks are documented, along with remedial action when instruments or test meth-
ods do not meet performance expectations.
J 1. The laboratory performs and documents validation for all new methods.
J 2. The validation is documented, along with remedial actions when instruments or test methods do not
meet performance specifications.
J 3. For all analytic methods, the minimum validation includes elements a) through d) in the intent.
J 4. For methods that are more complex, are modified, are developed in-house, or have not been validat-
ed by the manufacturer, the laboratory tests the full range of performance specifications, as defined in
elements e) through j) in the intent.
J 5. When a new test, method, or instrument replaces an old test, method, or instrument, correlations are
performed between the existing and the new.
(Note: If replacement of the test, method, or instrument is due to poor performance, this correla-
tion should not be performed.)
J 6. The laboratory determines the number, type, and frequency of quality control materials to be tested
for the method being validated.
S'a"da%d QCP.1.4
The laboratory validates electronic or internal monitoring systems prior to using them for routine quality control.
I"'e"' #f QCP.1.4
Advancements in laboratory technology have led to test systems that often include alternative quality control
monitoring systems, such as electronic simulators, internal controls, or procedural controls. These systems can
monitor the entire analytic process or part of the analytic process. They may be used as routine daily quality con-
trol when they have been properly validated and when external quality control is performed on a periodic basis.
When the laboratory uses electronic or internal controls as daily quality controls, the following have been part
of the validation process:
a) The laboratory ensures that the test performed is automated and not highly complex in the number of
steps or manual manipulations.
b) The laboratory has not modified the test from the manufacturers protocol.
c) For each test, the laboratory determines the sources of error and evaluates whether the electronic or
internal controls monitor the entire analytic process or part of the analytic process.
d) The laboratory validates the electronic or internal controls by performing external controls in parallel
with the electronic or internal controls for a statistically valid sample (at least 20 test runs).
e) Through its validation and data analysis activities, the laboratory determines and defines the variety
and frequency of traditional external quality control sufficient to prevent clinically significant errors in
patient test results.
f ) The laboratory performs external quality controls, as defined by the manufacturer and at intervals that meet
manufacturers recommendations, but at least with each new lot number, shipment, or package of reagents.
g) The determination of frequency for external quality control use should be based on whether the elec-
tronic or internal control tests the entire analytic process or only part of the analytic process.
h) There are at least two levels of electronic simulator control performed and documented at the same fre-
quency as required in the specialty or subspecialty sections of this manual, or at the frequency recom-
mended by the manufacturer, whichever is more frequent.
i) If there are two consecutive unacceptable quality control results (internal or external) for the same level
or measurement, either during the validation process or after the laboratory has reduced the frequency
of testing external controls, the laboratory must investigate, identify the cause, and restart the valida-
tion process.
J 1. The laboratory validates electronic or internal monitoring systems prior to using them for routine
quality control.
J 2. Test systems for which electronic or internal controls are used meet the requirements of elements a)
and b) in the intent.
J 3. The validation process includes the requirements of elements c) through e) in the intent.
J 4. Determination of frequency and variety of internal and external quality control performance includes
the requirements of elements f ) through h) in the intent.
J 5. When two consecutive unacceptable quality controls occur, the validation process is reinitiated.
S'a"da%d QCP.1.5
Calibration, linearity checks, and other function checks are performed on instruments and analytic systems
used for patient testing.
I"'e"' #f QCP.1.5
a) The laboratory follows written procedures for calibration, calibration verification (linearity), and other
function checks, which, at a minimum, includes the requirements established by the manufacturer.
b) The laboratory specifies the number, type, concentration, and acceptable limits for materials used in
calibration, as well as the frequency at which it is to be performed.
c) Calibration is performed using materials traced to a recognized reference standard, whenever possible.
d) The laboratory does not use the same lot number of material for quality control testing as it uses for
calibration procedures.
e) Calibration verification (or a check to reconfirm the reportable range of the test) is performed accord-
ing to manufacturers guidelines, but at least every six months.
f ) The laboratory performs and documents calibration and calibration verification procedures according
to the written protocols.
g) Other instrument function checks are performed and documented according to manufacturers recom-
mendations.
J 1. There are written procedures for calibration, calibration verification, and other instrument function checks.
J 2. The procedures for calibration meet the requirements in elements a) through d) in the intent.
J 3. The procedures for calibration verification meet the requirements of element e) in the intent.
J 4. The procedures for calibration, calibration verification, and function checks meet manufacturers
recommendations.
J 5. The laboratory implements and documents the procedures for calibration, calibration verification,
and other instrument function checks.
100
101
S'a"da%d QCP.1.6
The quality control processes of the laboratory include a coordinated review of patient results, quality control
results, and instrument function checks.
I"'e"' #f QCP.1.6
The laboratory has a defined process for monitoring reported results by qualified personnel. The process
includes a coordinated review of patient test results, work records, equipment performance testing records,
and quality control results. In addition, manually transcribed or handwritten reports are screened for clerical
errors. There is documentation of daily review of patient results. Other records are reviewed periodically, as
defined by laboratory policy, but at least monthly. These reviews are also documented. If the laboratory
reports patient test results when quality control results are unacceptable, it reflects inadequate review and
oversight of the reporting process.
J 1. The laboratory has defined the process for reviewing results.
J 2. The process includes a coordinated review of patient test results, work records, equipment perfor-
mance testing records, and quality control results.
J 3. Manually transcribed and handwritten reports are screened for clerical errors.
J 4. There is documentation of daily review of patient results.
J 5. There is documentation that quality control and equipment testing records are reviewed at least
monthly or more often if required by laboratory policy.
S'a"da%d QCP.1.7
The laboratory takes remedial action for deficiencies identified through quality control measures or authorized
inspections and documents such actions.
I"'e"' #f QCP.1.7
Each laboratorys policies and procedures include instructions to follow when problems arise or when control
results are outside acceptable limits. The instructions also include criteria for determining whether a testing
system is acceptable, identifying backup systems, and selecting alternative facilities to be used when timely
correction cannot be made.
Corrective action is documented when the following situations occur:
a) Control results do not meet the laboratorys criteria for acceptability.
b) A testing instrument does not meet function check or performance testing requirements.
c) Incidents of incorrect test results are reported.
d) Other incidents of unsatisfactory specimen collection, testing, or reporting are identified.
The laboratorys remedial action meets the following criteria:
e) It is taken immediately after problem areas have been identified.
f ) It is consistent with defined quality control policies.
g) It is consistent with defined preventive maintenance or performance testing and equipment inspection policies.
h) It includes documentation of repeat patient testing and quality control, when indicated.
i) It documents correction of patient results, when necessary.
j) It supports timely response to inspections or off-site consultation.
k) It is adequate to correct all the deficiencies implied in the problem (for example, if one patients results
are discovered to be incorrect, other patients results from the same testing sequence are evaluated to
ensure correctness).
l) It includes a process to review the adequacy of actions taken.
If review activities are ongoing and in depth, they can enable the laboratory to take preventive action before
major problems arise. The review of appropriate sources of information such as monitoring and assessment
results, proficiency testing results, quality control records, and customer complaints can alert the laboratory to
take steps to prevent major problems from occurring.
J 1. Each laboratory area has instructions to follow when problem arise or when control results are out-
side acceptable limits.
J 2. The instructions include criteria for determining whether a testing system is acceptable.
J 3. The instructions identify backup systems or alternative facilities to be used when timely correction
cannot be made.
J 4. Corrective action is taken and documented for problems identified in elements a) through d) in the intent.
J 5. The laboratorys remedial actions meet the criteria defined in elements e) through l) in the intent.
J 6. The laboratory reviews quality control data sources and customer complaints so that, when indicat-
ed, preventive actions can be taken before a more serious problem arises.
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S'a"da%d QCP.2
There are quality control processes in place for surgical pathology and autopsy services.
I"'e"' #f QCP.2
The laboratory has developed processes for ensuring the quality of diagnoses made from analysis of surgical
and autopsy tissues. These processes include
a) control of specimen receipt, maintenance of specimen identification, and assurance of proper preserva-
tion, processing, and staining of specimens;
b) a means to monitor the ongoing qualifications of individuals who perform
gross analysis of tissues;
microscopic analysis of specimens; and
autopsies.
c) The quality of these services is enhanced by access to pertinent clinical information about the patient
and processes to enable correlation of that information with the morphologic diagnosis.
J 1. The director of surgical pathology and autopsy services has developed processes for quality control.
J 2. These include elements a) through c) in the intent.
102
103
S'a"da%d QCP.2.1
The laboratory has implemented processes for ensuring the proper identification, preservation, and documen-
tation of receipt of surgical specimens sent for analysis.
I"'e"' #f QCP.2.1
The laboratorys processes for receipt of histologic specimens and quality control in the histology laboratory
include
a) ensuring that responsible personnel have properly identified, labeled, and preserved surgical specimens
consistent with written guidelines;
b) documenting receipt of specimens;
c) maintaining specimen, slide, and block identity throughout the processing, slide preparation, and stor-
age, in accordance with written guidelines;
d) labeling specimens, slides, and blocks legibly and in a manner that labels are securely attached; and
e) using controls for all special stains, verifying stain acceptability before reporting results, and maintain-
ing documentation of control reactivity.
J 1. The laboratory has written procedures to ensure that the processes described in elements a) through
e) in the intent are adequate.
J 2. The laboratorys practices are consistent with the written guidelines.
S'a"da%d QCP.2.1.2
When immunohistochemistry is performed, the laboratory has appropriate quality control processes.
I"'e"' #f QCP.2.1.2
When laboratories perform immunohistochemistry, quality control processes are used to ensure accurate
results. These include the following:
a) For each antibody, controls are used to verify reactivity.
b) Control results are documented, is an assessment of the quality of slide preparation on each day of test-
ing.
c) Controls are stored in a way to best preserve antigen reactivity.
d) There is appropriate pH monitoring of buffers used.
e) Each new lot of antibody is evaluated prior to use or concurrently with first use.
J 1. The laboratory has quality control policies that require at least elements a) through e) in the intent.
J 2. Laboratory practices are in conformance with written policies.
S'a"da%d QCP.2.2
The laboratory implements quality control and assurance processes for evaluating the ongoing qualifications
of individuals who perform gross analysis of tissue and microscopic analysis of tissue.
I"'e"' #f QCP.2.2
The laboratory has defined and implemented processes to document the ongoing proficiency of individuals
who perform gross analysis of tissue.
All gross examination of surgical and autopsy tissue is performed by a pathologist or under the supervision of
a qualified pathologist.
If a nonpathologist performs gross analysis of tissue, the following is required:
a) Evidence of the education, training, and experience of the individual performing the analysis
b) Specific delineation, in writing, of the limits of what the individual may or may not perform (for
example, may weigh, measure, and describe these types of tissue, but not section, or may only per-
form gross analysis of skin biopsies)
c) The individuals work must be reviewed, and the review must be documented by a qualified patholo-
gist within 24 hours.
J 1. All gross examination of surgical and autopsy tissue is performed by a pathologist or under the super-
vision of a qualified pathologist.
J 2. If a nonpathologist performs gross analysis of tissue, elements a) and b) in the intent must be met.
J 3. When gross analysis of tissue is performed by a nonpathologist, his or her work must be reviewed as
required in element c) in the intent.
S'a"da%d QCP.2.3
There are defined processes to document the ongoing proficiency of individuals who perform microscopic
analysis of tissue.
I"'e"' #f QCP.2.3
All microscopic examinations of surgical tissue are performed by a qualified pathologist.
All surgical tissue diagnoses are made by a qualified pathologist. To ensure ongoing competence, there are
records of
a) participation in a formal peer educational program in surgical pathology; and/or
b) records of peer review of microscopic slides from surgical pathology performed by a second reading
from another pathologist, along with results.
Participation in one of these programs occurs at defined intervals at least two times per year. When discrepan-
cies are identified, review is documented, and, when appropriate, actions are taken.
All autopsies are performed by or under the supervision of a qualified pathologist.
J 1. All microscopic examinations of surgical tissue and all surgical tissue diagnoses are made by a quali-
fied pathologist.
J 2. All autopsies are performed by or under the supervision of a qualified pathologist.
J 3. There are records of participation in one or both of the programs described in elements a) and b) in
the intent
J 4. Participation in one of these programs occurs at defined intervals at least two times per year.
J 5. When discrepancies are identified, review is documented, and, when appropriate, actions are taken.
104
105
S'a"da%d QCP.2.4
The laboratory has implemented processes to ensure access to required patient information and to cross-
reference such information to assist in providing a complete and proper diagnosis.
I"'e"' #f QCP.2.4
If the laboratory lacks complete information, it may not be able to fully evaluate pathology specimens.
Therefore, every attempt is made to obtain relevant clinical information and to resolve discrepancies among
various results. The following information is to be available to the pathologist when at all possible:
a) A request for examining surgical specimens is to be accompanied by a concise reason statement for the
exam, as well as other pertinent clinical information. This should include, to the degree known, the
preoperative and postoperative diagnoses.
b) When histology and cytology testing have previously been performed on a patients specimens, these
results are reviewed, if they are relevant to the current case.
c) When special studies are performed, their results are compared to the microscopic findings prior to
reporting of results.
d) To ensure accurate results, when frozen section and final diagnosis results are discrepant, there is a
review of findings, and the discrepancy is resolved, along with communication with the responsible
practitioner.
e) Available pertinent clinical information is obtained and reviewed prior to performance of an autopsy.
J 1. Every attempt is made to obtain relevant clinical information and to resolve discrepancies among var-
ious test results and diagnoses.
J 2. Among the information that should be obtained, whenever possible, are the requirements of ele-
ments a) and b) in the intent.
J 3. Results are compared, when possible, as required in elements c) and d) in the intent.
J 4. When performing an autopsy, the requirements of element e) are met.
C-*%&a*h%"%g-
S'a"da%d QCP.3
A pathologist or physician qualified in cytology maintains the quality of the cytopathology service through
direct supervision.
I"'e"' #f QCP.3
The cytopathology services have appropriate direction by a physician qualified in cytology. This individual
ensures that
a) procedures for adequate specimen collection, identification, preservation, and transport are established
and communicated to clinical staff and other clients who collect cytology specimens;
b) criteria are defined for unacceptable specimens that are to be rejected and recollected before evaluation;
(Note: The following list of common criteria can be used to define unacceptable;
The name on the slide or specimen container is different from the name on the requisition.
The slide or container is not labeled with the patients name or other identifier.
The submitted slide is broken or crushed and cannot be repaired for processing.
The specimen is improperly fixed.)
c) criteria are defined by the laboratory director for unsatisfactory specimens that, upon evaluation, do not
allow for a definitive diagnosis;
(Note: In defining criteria for unsatisfactory specimens, the laboratory can include such items as the following:
The cells on the slide are too few in number or obscured, which would make a definitive diagnosis
inaccurate.
Obscuring inflammation
Obscuring red blood cells
Obscuring lubricant
Excessive air drying
Excessive cellular degeneration
Absence of endocervical components
Smears containing too few epithelial cells)
d) stains and staining techniques that provide acceptable quality for proper evaluation are defined. This
includes using a Papanicolaou, modified Papanicolaou, or other approved alternative staining method for
all gynecologic smears; and
e) effective measures are taken to prevent cross-contamination between gynecologic and nongynecologic
specimens during the staining process.
J 1. Cytopathology services are directed by a pathologist or physician qualified in cytology.
J 2. This individual ensures that procedures for specimens are complete and are communicated to those who
collect cytology specimens.
J 3. Criteria are defined for unacceptable specimens that are rejected.
J 4. Criteria are defined for unsatisfactory specimens.
J 5. Stains and staining techniques meet the requirements of element d) in the intent.
J 6. Measures are taken to prevent cross-contamination, as described in element e) in the intent.
S'a"da%d QCP.3.1
The cytology laboratory has a process to measure, assess, and improve quality.
I"'e"' #f QCP.3.1
A written process is in place to measure, assess, and improve the quality of cytology evaluations performed. If
cytotechnologists perform screening, the following requirements are met:
a) The director or other qualified physician or qualified supervisory cytotechnologist reviews all slides of
extragenital origins.
b) The director or other qualified physician or qualified supervisory cytotechnologist also reviews all of the
following:
Suspicious or malignant cells
Dysplasia
Cervical intraepithelial neoplasia (CIN)
Low - and high-grade squamous intraepithelial lesions
Atypical cells of undetermined significance
Smears interpreted as having reactive or reparative changes
At least 10% of the negative gynecological slides, from both low-risk and high-risk individuals
c) This review is completed and documented before patient results are reported for those slides selected for
review.
106
107
d) Work load limits are established for all cytotechnologists who screen slides. They should not exceed
applicable law and regulation and may be lower than this guideline, if warranted by a cytotechnolo-
gists performance, as documented in the above review of slides.
e) Timely follow-up, reeducation, and other appropriate remedial action is taken and documented when
required for cytology personnel whose results are less than acceptable, as defined by the cytopathology
director.
f ) Cytology reports for all results are made in appropriate descriptive nomenclature.
g) When an incorrect result is reported, the corrected report is generated as promptly as possible. In such
cases, the laboratory communicates directly with the ordering clinician or other authorized individual
qualified to follow up with the patient.
h) Clinical information and histopathology reports are compared with cytology reports when information
is available.
J 1. If cytotechnologists perform screening, review by a qualified individual meets the requirements of
elements a) through c) in the intent.
J 2. The results of the review are used in implementing the requirements of d) and e) in the intent.
J 3. Reporting of cytology results meets the requirements of elements f ) through h) in the report.
Ci"ica Lab#%a'#%* Te&'i"g
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S'a"da%d QCP.4
The laboratory leaders have defined quality control processes for all clinical chemistry, hematology, and coag-
ulation tests.
I"'e"' #f QCP.4
There is documentation of the definition and approval of quality control procedures for all clinical chemistry,
hematology, and coagulation tests. The quality control procedures include the following:
a) The number and levels of controls to be tested
b) The frequency of control testing
c) A description of how control ranges are calculated
d) A description of the process to follow when quality controls are not acceptable
J 1. The laboratory leaders have defined, in writing, quality control processes for all clinical chemistry,
hematology, and coagulation tests to meet the requirements of elements a) through d) in the intent.
J 2. The written procedures are implemented.
S'a"da%d QCP.4.1
For tests that produce quantitative results (such as many clinical chemistry, hematology, and coagulation
analyses), laboratory quality meets certain requirements. The laboratory defines and follows certain quality
control guidelines.
I"'e"' #f QCP.4.1
Quality control protocols are at least as rigorous as the protocol required or suggested by the manufacturer.
They are also consistent with current national, regional, or local standards of practice. At a minimum, the lab-
oratory meets the following guidelines for automated tests:
a) For automated clinical chemistry and hematology tests, at least two levels of control are tested for each
day of patient testing.
b) For automated coagulation tests, at least two levels of control are tested for each eight hours of patient
testing.
Laboratory leaders ensure that control upper and lower limits are set according to the following requirements:
c) Control ranges and limits are established using valid statistical measurements* (mean, standard devia-
tion, coefficient of variation) for each lot number of control material.
d) All standard and reference quality control limits are established and made available to staff.
e) Control ranges and limits are narrow enough to promote adequate precision and accuracy for reliable
patient samples.
f ) The laboratory has only one set of quality control criteria in effect for each test at one time. (For
example, if the policy states that two standard deviations are used to determine quality control ranges,
but the laboratory is really using the manufacturers ranges, this practice would not be considered in
compliance with this requirement.)
For manual tests, the following requirements are met:
g) For manual hematology tests, two levels of control are provided with each testing batch.
h) Cell counts performed using a hemocytometer are tested in duplicate.
i) For manual coagulation tests, each individual performing tests analyzes two levels of control before
testing patient samples and each time a change in reagents occurs.
j) For manual coagulation tests, patient and control samples are tested in duplicate.
k) For manual and semiautomated chemistry tests, each individual performing tests runs and documents
at least two levels of control with each run of patient tests.
J 1. Quality control protocols are at least as rigorous as current national, regional, or local standards of practice.
J 2. Quality control protocols for automated tests meet the requirements for elements a) and b) in the intent.
J 3. Quality control ranges and limits meet the requirements of elements c) through e) in the intent.
J 4. The laboratory has only one set of quality control criteria in effect for each test at one time.
J 5. For manual tests, the laboratory meets the requirements of elements f ) through j) in the intent.
S'a"da%d QCP.4.2
The laboratory has quality control processes in place for blood film evaluation and differential counts.
I"'e"' #f QCP.4.2
The laboratory has a defined process to ensure that differential slides are prepared and stained in a proper and
consistent fashion. Manual differential slide analyses include the white cell differential count as well as an
assessment of red cell and platelet morphology.
108
* If assistance is required, consult CLSI publication EP-13-R, Laboratory StatisticsStandard Deviation: A Report, and
C24A2, Statistical Quality Control for Quantitative Measurements: Principles and Definitions, Approved Guideline, second
edition.
109
Laboratory staff define criteria for when slides are to be reviewed by a knowledgeable individual, such as a
pathologist or qualified technologist. All such reviews are documented.
When a laboratory is performing automated differential counts, the method has been properly validated, and
the validation process is documented. There is a defined quality control procedure that specifies the limits of
agreement for white blood cell types between the automated instrument and manual differentials or commer-
cial control material. The laboratory reviews instrument data and/or slides when results are flagged by the dif-
ferential instrument and it documents the review.
Slides are retained for a defined length of time that is reasonable for the patient population served, in order to be
available for reference. The laboratory maintains a file of slides for reference from interesting or unusual cases.
J 1. Differential slide analysis includes the white blood cell differential count and an assessment of red
blood cell and platelet morphology.
J 2. There are criteria that define the types of slides that are to be reviewed by a knowledgeable patholo-
gist or technologist. All such reviews are documented.
J 3. Automated differential analyzers are properly validated, and guidelines define limits of agreement for
white blood cell types between the automated instrument and manual differentials.
J 4. Data and/or slides are reviewed when results are flagged by the differential instrument, and the
review is documented.
J 5. A file of slides for reference from interesting or unusual cases is maintained.
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S'a"da%d QCP.5
The laboratory has quality control processes when performing bacteriology, mycobacteriology, and mycology.*
I"'e"' #f QCP.5
Quality control processes for chemical and biological solutions, reagents, and antisera meet the following requirements:
a) The laboratory tests solutions, reagents, and antisera used for identifying bacteria, mycobacteria, and
fungi, and it inspects them for deterioration.
b) Positive and, as appropriate, negative controls are used.
c) Positive controls of graded reactivity are used, if applicable.
d) Biochemical panels are tested at intervals that meet manufacturers directions, but at least once before
use or concurrently with each new batch, lot number, or shipment.
e) The following time frames are acceptable unless problems are identified and more stringent measures
are required:
Each day of use: DNA probes, beta-lactamase methods other than Cefinase, and camp test.
Each time a new batch, shipment, and lot number are prepared or opened, and every six months
thereafter: bacitracin; optochin; Cefinase; spot indole; ONPG; X, V, and XV factor discs or strips;
germ tube; yeast morphology media; catalase, coagulase plasma; and oxidase.
Typing sera: when prepared or opened and every six months thereafter.
* If assistance is required, the following references are useful for a guideline: CLSI publication M2-A9, Performance
Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard, ninth edition; and NCCLS publication M22-A3,
Quality Assurance for Commercially Prepared Microbiology Culture Media, second edition; Approved Standard.
f ) For identification methods on automated instruments, the laboratory should follow quality control
requirements recommended by the manufacturer.
J 1. The laboratory follows defined quality control requirements for chemical and biological solutions,
reagents, and antisera used for identifying microorganisms.
J 2. The laboratory meets the quality control requirements of elements a) through f ) listed in the intent.
J 3. All quality control and patient results reactions are documented.
S'a"da%d QCP.5.1
Antimicrobial, antimycobacterial, and antifungal susceptibility testing systems are verified with approved
reference organisms.
I"'e"' #f QCP.5.1
The laboratory performs quality control testing for each lot or shipment of antibacterial, antimycobacterial,
and antifungal susceptibility testing agents. Approved reference organisms are used for quality control, when
possible. Antibacterial and antifungal quality control testing occurs each day of use unless the laboratory
demonstrates satisfactory performance, both initially and sustained, that would qualify the laboratory to per-
form quality control testing on a weekly basis.* Antimycobacterial susceptibility quality control is performed
on a weekly basis.
J 1. Each lot or shipment of antibacterial, antimycobacterial, and antifungal susceptibility testing agents
is quality controlled.
J 2. Approved reference organisms are tested each day of patient testing for antibacterial and antifungal
susceptibility unless the laboratory has successfully validated the process described in the footnote.
J 3. If validation is successful, the laboratory may perform the quality control once a week, unless prob-
lems occur with weekly controls.
J 4. Antimycobacterial susceptibility quality control is performed each week of patient testing.
J 5. Susceptibility quality control is documented.
S'a"da%d QCP.5.2
All stains are tested with appropriate controls.
I"'e"' #f QCP.5.2
The laboratory tests staining procedures for intended reactivity by using smears of microorganisms with pre-
dictable staining characteristics.
J 1. All stains are tested for acceptable reactivity.
110
* For each antimicrobial agent/organism combination, the laboratory should document that appropriate control strains
were tested for a minimum of 20 to 30 consecutive test days. No more than 1 out of 20 or 3 out of 30 results for each
antimicrobial agent/organism combination may be outside the acceptable range in order to allow the laboratory to per-
form quality control weekly.
111
J 2. Gram stains (except virology Gram stains) are tested with each new lot number and weekly thereafter.
J 3. For staff who do not routinely perform Gram stains, such as those on call, Gram stain quality control
is performed concurrently with each staining procedure.
J 4. Each day of use, quality control is performed for nonfluorochrome acid-fast stains and special stains
(spore, capsule, flagella).
J 5. Each time of use, quality control is performed for fluorochrome acid-fast and other fluorescent stains.
J 6. Stain quality control results are documented.
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S'a"da%d QCP.5.3
There are adequate quality control procedures when molecular microbiology testing is performed.
I"'e"' #f QCP.5.3
Quality control procedures for molecular microbiology testing include the following:
a) At a minimum, manufacturers guidelines for test performance and quality control are followed,
including selection of control organisms.
b) For quantitative tests, two levels of control are run each day of patient testing.
c) For qualitative tests, a positive and negative control are run daily.
d) If internal, electronic, or procedural controls are used instead of liquid controls, the requirements of
standard QCP.1.4 must be met.
J 1. The laboratory follows manufacturers guidelines and requirements, as described in element a) in the intent.
J 2. Quality control performance meets the requirements of elements b) through d) in the intent.
J 3. All quality controls are documented.
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S'a"da%d QCP.6
If the laboratory is performing parasitology, appropriate reference materials, equipment, and methods are used.
I"'e"' #f QCP.6
Adequate reference materials must be available. These include textbooks with photographs, collections of pre-
viously stained slides, preserved gross specimens of identified parasites, and slides from proficiency tests. Also,
a calibrated measuring device is provided for determining the size of ova or parasites. There are instructions
for calibrating and using the micrometer.
Permanent stains are not required. However, the laboratory verifies permanent stains through quality control
if they are made. Quality control can consist of fecal samples with parasites or added leukocytes to demon-
strate staining characteristics. The frequency of performing quality control on permanent stains is in accor-
dance with the laboratorys policy, but at least each month of use. If stains are used to detect specific parasites,
they are checked with appropriate control organisms each time the stain is used. Both thick and thin films are
used to provide thorough examination when checking for malarial parasites.
J 1. The laboratory has appropriate reference materials for the parasitology performed.
J 2. There is a calibrated measuring device for determining the size of ova or parasites.
J 3. There are instructions for calibrating the micrometer and documentation that it has been checked for
calibration.
J 4. Permanent parasitology stains are checked for intended reactivity at least monthly.
J 5. If stains are used to detect specific parasites, they are checked with appropriate control organisms
each time the stain is used.
J 6. Both thick and thin films are used to provide thorough examination for malarial parasites.
V(%"%g-
S'a"da%d QCP.7
If the laboratory performs tests for identifying viruses, records detailing the systems used and the reactions
observed are maintained.
I"'e"' #f QCP.7
The laboratory maintains records for the host systems used to isolate viruses, the test methods used for virus-
es, and the reactions observed.
J 1. The laboratory maintains records for host systems used to isolate viruses.
J 2. The laboratory maintains records for the test methods used to isolate viruses.
J 3. The laboratory maintains records for the reactions observed.
S'a"da%d QCP.7.1
The laboratory uses controls that will identify erroneous results in tests for identifying viruses.
I"'e"' #f QCP.7.1
The laboratory uses appropriate controls and processes to identify erroneous results in virology testing. If it
performs such tests, the laboratory documents its use of
a) cell controls;
b) control checks of maintenance media;
c) sterility checks;
d) reagent checks for toxicity to cells;
e) controls for neutralization tests;
f ) hemagglutination inhibition tests;
g) immunoassays;
h) daily quality control for virology Gram stain;
i) direct immunofluorescence tests; and
j) indirect immunofluorescence tests.
J 1. The laboratory uses appropriate controls for virology testing performed.
J 2. When applicable, elements a) through j) in the intent are controlled and documented.
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113
U($a"-)) a$d C"$ca" Mc(%)c%&-
S'a"da%d QCP.8
The laboratory ensures the quality of tests performed in urinalysis and clinical microscopy.
I"'e"' #f QCP.8
The quality of a urinalysis is dependent on a fresh or properly preserved specimen, control of reagents used in
testing, and the competency of personnel who perform the testing. Therefore, the laboratory has processes to
ensure that each of these steps in the process is optimum. The following requirements are met:
a) For manual qualitative dipstick biochemical tests, the laboratory defines how often a control that is
positive for each constituent will be tested.
b) If dipstick testing is performed on an instrument, a positive and negative control are tested each day of use.
c) If an automated urine sediment method is used, the method is initially validated against manual
microscopic analysis prior to routine use. Based on the validation, the laboratory specifies criteria for
urine specimens that may give incorrect results and should be checked manually.
d) For the performance of urine microscopic examinations, the laboratory has reference materials, such as
textbooks with photographs, atlases, or photomicrographs.
e) The laboratory documents the reproducibility of microscopic test results among all testing personnel
on a periodic basis.
J 1. Urinalysis tests are performed on fresh (within one or two hours of collection) or properly preserved
specimens.
J 2. If the laboratory suspects that a specimen is not fresh but nevertheless decides to perform the test,
the condition of the specimen is documented in the clinical report.
J 3. Quality control requirements for urine biochemical testing meet the requirements of elements b) and
c) in the intent.
J 4. To assist with quality control on urine microscopics and to test the competence of personnel, ele-
ments d) and e) in the intent are met.
Dag$%)*c I##+$%"%g- a$d Se(%"%g-
S'a"da%d QCP.9
The laboratory runs serologic tests on unknown specimens, including those for syphilis, concurrently with a
positive control serum of known titer and a negative control, or controls of graded reactivity, to ensure speci-
ficity of antigen reactivity.
I"'e"' #f QCP.9
The laboratory runs controls for diagnostic immunologic and serologic testing as follows:
a) Positive and negative controls are run for serologic tests on unknown specimens on each day of use.
b) If the laboratory uses kits with internal positive and negative procedure controls, after initial validation,
external quality control may be performed at least as often as recommended by the manufacturer or
more frequently, if required by laboratory policy.
c) The validation method is based on using liquid quality control initially for each day of patient testing,
until confidence in the method is established.
d) The laboratory tests all test components (for example, PBS, sorbent, buffers, complement, fluorescent
reagents, graded controls) for reactivity, as necessary.
e) The laboratory determines control reactivity patterns for all test components before performing the test.
f ) The laboratory documents all controls.
J 1. The laboratory complies with element a) in the intent when using serologic tests.
J 2. If the laboratory uses kits with internal controls, an initial validation of the method is performed
according to elements b) and c) in the intent.
J 3. The laboratory controls all components for reactivity, as described in element d) in the intent.
J 4. The laboratory complies with element e) in the intent.
J 5. All quality control testing is documented.
S'a"da%d QCP.9.1
Equipment, glassware, reagents, controls, and techniques for syphilis tests conform to manufacturers specifi-
cations.
I"'e"' f#% QCP.9.1
The laboratory performs tests for syphilis serology with equipment, glassware, controls, and techniques that
conform to manufacturers specifications and also to current standards of practice.
J 1. Equipment (including rotators and needles) used for syphilis serology is tested according to manufac-
turers recommendations and current standards of practice.
J 2. Controls used meet manufacturers specifications and also current standards of practice.
J 3. The laboratory follows techniques specified by the manufacturer when performing tests for syphilis.
Rad%b%a))a- a$d O*he( Te)*) U)$g Rad%)%*%&e)
S'a"da%d QCP.10
The laboratory uses written quality control procedures that provide diagnostic reliability and patient and staff
safety when it uses in vitro radioisotopes.
I"'e"' #f QCP.10
For in vitro radioassay procedures, the quality control requirements for clinical chemistry apply.
The laboratory meets additional requirements for radiobioassay, including defined procedures for the follow-
ing, as appropriate:
a) Background counts
b) Equipment calibration
c) Safety measures for decontamination
d) Handling of radionuclides
e) Handling of radioactive waste
f ) Presence of radioactive materials
g) Radiation area monitoring
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115
J 1. The laboratory follows requirements for chemistry quality control when performing in vitro radiobioassay.
J 2. The laboratory meets the requirements, as appropriate, of elements a) through g) in the intent.
J 3. The laboratory documents all quality control and other measures taken, as well as remedial actions
when results are outside acceptable limits.
S'a"da%d QCP.10.1
Any laboratory performing in vivo testing uses an appropriate quality control system for such testing and
equipment performance checks.
I"'e"' #f QCP.10.1
Laboratories performing in vivo radioassay testing
a) maintain records on radionuclides and radiopharmaceuticals from the point of entering the laboratory
to administration and final disposal;
b) provide documentation in the department records, including the identity of any radionuclide, the date
received, the method of receipt, activity, storage, preparation, handling, the identity of recipients and
dates administered, and disposal;
c) identify the radionuclide and dose verification before administration;
d) prepare radiopharmaceuticals according to manufacturers specifications; and
e) standardize equipment performance by using radiation sources having energies equivalent to radio-
nuclides used in patient studies.
When in vivo testing is performed, the laboratory
J 1. uses appropriate quality control systems for such testing;
J 2. has a system for appropriate equipment performance checks;
J 3. implements and documents compliance with elements a) through e) in the intent.
B##d Ba"k a"d T%a"&f(&i#" Se%)ice&
D(ec*%( Re)&%$)b"*-
S'a"da%d QCP.11
The director of the blood bank or transfusion services is responsible for developing policies and procedures
and implementing practices that ensure the safety of patients being transfused.
I"'e"' #f QCP.11
The director of blood bank and/or transfusion services ensures the following:
a) Policies and procedures encompass the scope of services provided and define every process used.
b) Policies, procedures, and practices are based on authoritative standards, regulations, and recognized
guidelines for the services offered.
c) The blood bank and/or transfusion service complies with applicable law and regulation, as well as
recognized standards of practice.
d) Practices are implemented according to the written policies and procedures.
J 1. The director of the blood bank or transfusion services has ensured that policies and procedures are
developed and implemented as described in elements a) and b) in the intent.
J 2. Policies and procedures and practices comply with applicable law and regulation.
J 3. Blood bank and transfusion services practices comply with written policies and procedures.
D%$%( Se"ec*%$ a$d Te)*$g
(Note: These standards address the requirements for facilities that collect, test, process, store, distribute,
and/or infuse blood and blood components.)
S'a"da%d QCP.11.1
There are defined procedures and practices for blood donor selection and blood collection. Staff are trained
and assessed as competent to perform these procedures.
I"'e"' #f QCP.11.1
a) Potential blood donors are screened by knowledgeable blood bank personnel. This screening includes
an adequate history and physical examination.
b) Staff members have been given in-depth training, and their competence has been assessed, prior to per-
forming these procedures.
c) Blood donor screening processes are defined in written procedures and policies that include criteria for
selection and rejection of individual donors.
d) Written policies and procedures are followed by staff, and donor screenings are documented.
J 1. Potential blood donors are screened by trained knowledgeable personnel for suitability through an
adequate history and physical examination.
J 2. This screening process follows defined procedures and is documented.
S'a"da%d QCP.11.1.1
A detailed history of a donor is performed prior to selection for blood donation.
I"'e"' #f QCP.11.1.1
The history performed is adequate to screen out unsuitable donors. It includes providing donors with educa-
tional materials explaining the risks of infectious disease, unusual antibodies, and, as feasible, drugs. When a
donor is identified as not being eligible due to a condition that the donor is not aware of or is currently under
treatment for, and the condition requires further testing and possible treatment, educational materials should
include the advice to seek additional follow-up.
The history of the donor includes the following:
a) Age
b) Time since last donation
c) History of medical illness: heart, liver, or lungs; cancer; or abnormal bleeding tendency
d) History of drug therapy (Potential donors taking medications should be assessed before donating blood
to determine their acceptability.)
e) Risk factors for HIV or other possible transfusion-transmitted agents, such as history of parenteral
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117
drug use; history of infectious disease such as malaria or hepatitis; positive blood test for HBsAg; or,
during the preceding 12 months,
receipt of a transfusion of blood or blood components;
receipt of hepatitis immunoglobulin;
skin penetrations such as tattoos or acupuncture; and/or
history of incarceration for at least 72 hours in a correctional institution.
f ) Risk factors for Creutzfeldt-Jakob disease (CJD)for example,
in countries outside the United Kingdom, donors who spent a total of three months or more in the
UK from the beginning of 1980 through the end of 1996;
in countries other than France, donors who have spent a total of five years or more in France from
1980 to the present;
donors with a family history of CJD;
donors who have been injected with bovine insulin since 1980, unless it is possible to obtain con-
firmation that the product was not manufactured after 1980 from cattle in the UK;
in countries outside the UK, donors who have received any blood or blood component transfusions
in the UK between 1980 and the present;
donors who have received tissue-derived human growth hormone administration or dura mater
transplant.
g) Donor deferrals should include
a. for pregnancy, excluded for six weeks postpartum;
b. after immunization with toxoids or killed vaccines, including rabies vaccination (unless bitten by a
rabid animal), for one year;
c. after inoculation with attenuated vaccines, for two weeks;
d. after rubella or varicella zoster, for four weeks.
J 1. An adequate history is documented for each potential donor.
J 2. The history includes the information listed in elements a) through g) in the intent.
J 3. Potential donors not meeting the blood banks criteria for suitability are rejected.
J 4. During the screening process, educational materials are given to the potential donors, including
materials on the risk of disease, unusual antibodies, and feasible drugs.
J 5. Donors identified as not being suitable are advised to seek additional care.
S'a"da%d QCP.11.1.2
An adequate physical examination is performed prior to approving the individual as a blood donor.
I"'e"' #f QCP.11.1.2
A proper physical examination is necessary to ensure the health of the donor and safety of the blood. The
physical examination is performed by a qualified individual and documented. It should include the following,
with defined criteria for acceptance of the donor:
a) Temperature, blood pressure, and pulse
b) Weight
c) Hemoglobin or hematocrit (the test is quality controlled for accuracy according to the quality control
requirements of the hematology section of this manual; see QCP.4 through QCP4.2 on pages
107109.
d) Arm inspection to ensure the absence of skin punctures or scars indicating injection of narcotics, and
no infectious skin diseases that would become a risk of contamination of the blood
J 1. A physical examination is performed prior to accepting an individual as a donor.
J 2. The examination is performed by a qualified individual and is documented.
J 3. There are defined criteria for acceptance for donation.
J 4. The physical examination includes elements a) through d) in the intent.
S'a"da%d QCP.11.1.3
Donor blood is collected safely and aseptically according to a defined protocol.
I"'e"' #f QCP.11.1.3
Blood is collected in a safe, conducive environment, with consideration for the safety of the donor and the
blood. The following procedures are implemented:
a) There is a blood collection procedure that includes
descriptions of solutions and methods used to prepare the site of phlebotomy;
how identification of the donor and blood are established and maintained;
step-by-step description of how the phlebotomy is performed;
the procedure for identifying and responding to donor reactions;
labeling procedures for blood and components, including safeguards to avoid labeling errors; and
how to accurately measure the quantity of blood removed from the donor.
b) At all times that donor blood is being collected, a qualified physician and emergency facilities are read-
ily available.
c) Either a qualified physician or staff members under his or her supervision perform the phlebotomy.
d) Phlebotomist training includes
in-depth proper aseptic technique (including donor site preparation);
criteria for recognizing donor reactions and actions to take when such a reaction occurs; and
the procedures used to maintain the identity of donors blood units, other specimens, and records.
e) The phlebotomy is performed using proper aseptic technique, including a closed sterile system.
Solutions for skin preparation are stored in sterile containers and are changed frequently. The tech-
nique used for preparing the venipuncture site minimizes the risk of bacterial contamination.
f ) When a donor reaction occurs, phlebotomists and the medical supervisor take appropriate actions, and
the symptoms and actions taken are documented.
J 1. There is a written procedure for phlebotomy that addresses element a) in the intent.
J 2. A qualified physician and emergency facilities are immediately available when donor blood is collected.
J 3. Phlebotomist training includes the requirements of element d) in the intent.
J 4. The technique used to perform the phlebotomy meets the requirements of element e) in the intent.
J 5. Appropriate actions address the needs of the patient when donor reactions occur, and the incident is
documented.
S'a"da%d QCP.11.1.4
Written guidelines are implemented when autologous blood is collected.
I"'e"' #f QCP.11.1.4
If autologous blood is collected, the following requirements are met:
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119
a) Guidelines have been defined by the blood bank director.
b) The procedure is performed only when there is a written request from the patients physician.
c) The unit of blood is labeled with the same information as other blood units.
d) The blood is tested for blood-transmitted diseases according to the requirements of law and regulation.
J 1. The director has defined guidelines for performing autologous blood collection.
J 2. The procedure is performed only when there is a written request from the patients physician.
J 3. The unit of blood is labeled and tested according to elements c) and d) in the intent.
S'a"da%d QCP.11.2
Blood and related donor records are properly identified, and the identification is maintained from collection
through the time the unit is transfused.
I"'e"' #f QCP.11.2
a) Pilot tubes, blood units, and related donor records are all identified with the same numeric identifica-
tion, and there is a process of checking to make sure the identification is consistent.
b) The confidentiality, security, and integrity of donor records are maintained.
c) Records include documentation of all donor histories, physical examinations, and screening test results,
as well as the informed consent signed by the donor.
J 1. Elements a) through c) in the intent are met.
J 2. Identification is maintained from collection through the time of transfusion.
S'a"da%d QCP.11.3
Donor blood undergoes routine testing before being used for transfusion. In addition, process controls are
used to ensure appropriate tracking and prevent blood from being released prematurely.
I"'e"' #f QCP.11.3
Donor blood is routinely tested for ABO group and Rh type as well as communicable diseases prior to being
released for transfusion. Written procedures describe testing and quality control processes. The following
requirements are met:
a) The ABO group is determined by testing the red cells with anti-A and anti-B reagents and the serum
or plasma with A and B red cells.
b) The Rh type is performed using anti-D. Blood testing negative for anti-D is further tested to detect
weak D.
c) For communicable disease testing, the laboratory follows the regimen currently required by law and
regulation, or current standards of practice, whichever is more stringent.
d) At a minimum, blood is tested with a serologic test for
syphilis;
HBsAg, and anti-HBc;
anti-HTLV-I and anti-HTLV-II;
HIV-1-Ag and anti-HIV-2; and
anti-HCV.
e) Results for quality control, standards, and instrument function checks are deemed acceptable before
reporting donor test results. Records for control reactions, instrument function checks, and donor
blood results are maintained.
Process controls are used to track blood and to ensure that blood is not released until appropriate. These
process controls include
f ) a system for tracking samples;
g) a process to ensure that blood is quarantined as required by policy and also for unit disposal;
h) documentation of all steps of storage and release of blood from quarantine;
i) a process to identify previous donations from individuals who now test positive for viral marker tests;
the process includes the method for notifying organizations who have received components from these
previous units;
j) a check of each donors name against a list of unacceptable donors before the blood is released for dis-
tribution;
k) not releasing donor blood that gives abnormal communicable disease test results; and
l) a review of abnormal donor blood testing results by a qualified physician, with donor notification of
these results.
J 1. Written procedures describe testing processes for donor blood.
J 2. Donor blood is tested for ABO group and Rh type, as defined in elements a) and b) in the intent.
J 3. Donor blood is tested for communicable diseases, as defined in elements c) through e) in the intent.
J 4. Process controls are used and documented, as required in elements f ) through k) in the intent.
B"%%d C%#&%$e$* P(e&a(a*%$ %( M%dfca*%$
S'a"da%d QCP.11.4
When components are prepared or modified by the organization, there are defined procedures for their pro-
cessing and storage, and appropriate quality control measures are taken.
I"'e"' #f QCP.11.4
When blood components are prepared or modified, written procedures are followed for their preparation and
storage. These include quality control measures for each component. The protocols also specify requirements
for maintaining sterility and include standardized acceptable processes for filtration of blood and components.
In addition, each component is labeled according to applicable law and regulation or acceptable standards of
practice.
The following quality and safety measures are taken when blood components are prepared or modified in the
organization:
J 1. There are defined procedures for the collection, preparation, and storage of all components prepared
and stored in the organization.
J 2. Protocols define quality control measures for each component prepared or modified in the organization.
J 3. Records indicate that quality control is acceptable, or if quality control requirements are not met,
immediate corrective action is taken and documented.
J 4. Protocols specify the requirements for maintaining sterility, and expiration dates are assigned for all
final components and products.
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121
J 5. Laboratory filtration of blood and blood components is performed using an appropriate method, as
required by law and regulation or according to acceptable standards of practice.
J 6. Labeling of each component meets applicable laws and regulations, or acceptable standards of practice.
Wh%"e B"%%d
S'a"da%d QCP.11.4.1
Tests and processes are used to maintain the quality of whole blood. This includes whole blood from which
components and products are to be processed.
I"'e"' #f QCP.11.4.1
For whole blood, a specimen of blood taken from the donor at the time of collecting the unit and before use
is tested for the following:
a) Serologic test for syphilis: whole blood is used only if it is negative to the serologic test for syphilis.
b) One or more segments are provided with each unit of whole blood or red blood cells when issued or
reissued.
c) Before they are filled, all segments are marked or identified in order to relate them to the donor of that
unit of whole blood.
d) Determination of blood group: each container is classified as to ABO blood group. At least two blood
group tests are made, and the unit is not issued until grouping tests by different methods or with dif-
ferent lots of antisera are in agreement.
e) Determination of the Rh factors: each container is classified as to the Rh type on the basis of tests per-
formed on the sample. If the test using anti-D blood grouping reagent is positive, the container may
be labeled Rh positive. If the test is negative, the results are confirmed by further testing, which
includes tests for the weak D (formerly Du). Blood is labeled Rh negative if further testing is nega-
tive. Units testing positive after additional, more specific testing shall be labeled Rh positive.
f ) Whole blood intended for transfusion is not tested for sterility by a method that entails entering the
final container before the blood is used for transfusion.
g) Whole blood is inspected visually during storage and immediately before issue. If the color or physical
appearance is abnormal or there is any indication or suspicion of microbial contamination, the unit of
whole blood is not issued for transfusion.
h) Whole blood is tested for communicable disease agents according to standard QCP.11.3 or applicable
law and regulation, whichever is more stringent.
J 1. The laboratory uses tests and processes to maintain the quality of whole blood.
J 2. Blood segments are prepared and are identified according to elements b) and c) in the intent.
J 3. Whole blood is tested and inspected according to the requirements of elements d) through h) in the
intent.
Red B"%%d Ce"")
S'a"da%d QCP.11.4.2
Defined processes are implemented to maintain the quality of red blood cells.
I"'e"' #f QCP.11.4.2
The following requirements for red blood cells are implemented:
a) Immediately after processing, the red blood cells are placed in storage and maintained at a temperature
between 1C and 6C.
b) Units of red blood cells are provided with one or more appropriately marked segments, as in the
requirement for whole blood.
c) All segments are filled at the time the blood is collected or at the time the final product is prepared.
d) Red blood cells are prepared either by centrifugation, in a manner that will not tend to increase the
temperature of the blood, or by normal undisturbed sedimentation. This is done within the time frame
specified in the directions for use for the blood collecting, processing, and storage system used. A por-
tion of the plasma sufficient to ensure optimal cell preservation is left with the red cells, except when a
cryoprotective substance or additive solution is added for prolonged use.
e) All surfaces that come in contact with the red cells are sterile and pyrogen free.
f ) The final container used for red blood cells is the original container unless the method of processing
requires a different container.
g) The component is inspected immediately after separation of the plasma, periodically during storage,
and at the time of issue. It is not to be issued if there is any abnormality in color or physical appear-
ance or if there is any indication of microbial contamination.
h) Any cryophylactic substances added to the red cells for extended manufacturers storage at 65C or
colder do not compromise the required standards of safety, purity, and potency for red blood cells, and
the frozen product maintains those properties for the prescribed dating period.
i) If frozen red blood cells are prepared or stored, the materials used and the processing methods result in
a final product that meets required standards of safety, purity, and potency for red blood cells.
j) Frozen red blood cells are frozen within an appropriate time from collection or following rejuvenation.
k) For washed red blood cells, the methods used ensure removal of almost all the plasma.
l) For leukocyte-reduced red blood cells, the method of preparation provides a final component that
meets regulatory or standard-of-practice requirements for the reduced number of leukocytes.
J 1. For all red blood cell components, elements a) through g) in the intent are met.
J 2. For cryopreserved red blood cells, elements h) through j) in the intent are met.
J 3. For washed red blood cells, element k) in the intent is met.
J 4. For leukocyte-reduced red blood cells, element l) in the intent is met.
P"a*e"e*)
S'a"da%d QCP.11.4.3
Defined processes are used to ensure the quality of platelets.
I"'e"' #f QCP.11.4.3
The following requirements for processing platelets are implemented:
a) Testing as required for whole blood is performed on a sample of blood collected at the time of collect-
ing the source blood, and the sample container is labeled with the donors identification before the
container is filled.
b) Separation of plasma and platelets and resuspension of the platelets is in a closed system. Platelets are
not pooled during processing.
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123
c) Immediately after collection, the whole blood or plasma is held in storage between 20C and 24C
unless it must be transported from the collection center to the processing laboratory. During such
transport, all reasonable methods are used to maintain the temperature as close as possible to a range
between 20C and 24C until it arrives at the processing laboratory, where it is held in the same tem-
perature range until the platelets are separated.
d) The platelet concentrate is separated within four hours or within the time frame specified in the direc-
tions for use for the blood collecting, processing, and storage system.
e) The laboratory has demonstrated that the time and speed of centrifugation produces an unclumped
product, without visible hemolysis, that yields a count of at least 5.5 10(10) platelets per unit in at
least 75% of the units tested.
f ) The volume of original plasma used for resuspension of the platelets is to be determined by the main-
tenance of a pH of not less than 6.0 during the storage period. The pH is measured on a sample of
platelets that has been stored for the maximum dating period at the selected storage temperature.
g) Platelet are stored at a continuous temperature of 20C to 24C.
h) Final containers used for platelets are colorless and transparent to permit visual inspection of the con-
tents; any closure maintains a hermetic seal and prevents contamination of the contents. The container
material does not interact with the contents, under the customary conditions of storage and use, in
such a manner as to have an adverse effect upon the safety, purity, potency, or efficacy of the product.
At the time of filling, the final container is marked or identified by number so as to relate it to the
donor.
i) Immediately after resuspension, platelets are placed in storage at 20C to 24C, and a continuous gen-
tle agitation of the platelet concentrate is maintained throughout the storage period.
j) Each month, four units prepared from different donors are quality control tested at the end of the stor-
age period for
platelet count;
pH of not less than 6.2, measured at the storage temperature of the unit; and
measurement of actual plasma volume.
k) If the results of quality control testing indicate that the product does not meet the prescribed require-
ments, immediate corrective action is taken, and a record of actions taken is maintained.
J 1. Testing and labeling of blood used for platelets complies with element a) in the intent.
J 2. The processing of plasma meets the requirements of elements b) through f ) in the intent.
J 3. Platelets are stored according to the requirements of elements g) and i) in the intent.
J 4. Final containers for platelets meet the requirements of element h) in the intent.
J 5. The quality control requirements of elements j) and k) in the intent are met.
P"a)#a
S'a"da%d QCP.11.4.4
Defined processes are used to ensure the quality of plasma.
I"'e"' #f QCP.11.4.4
The following requirements for processing plasma are implemented:
a) When whole blood is intended for plasma, fresh frozen plasma, and liquid plasma, it is maintained at a
temperature between 1C and 6C until the plasma is removed. Whole blood intended for platelet-rich
plasma is maintained between 20C and 24C until the plasma is removed. The red cells are placed in
storage at a temperature between 1C and 6C immediately after the plasma is separated.
b) Plasma is separated from the red blood cells and is stored at 18C or colder within six hours after
transfer to the final container or within the time frame specified in the directions for use for the blood
collecting, processing, and storage system unless the product is to be stored as liquid plasma.
c) Fresh frozen plasma is prepared from blood collected by a single uninterrupted venipuncture with min-
imal damage to and minimal manipulation of the donors tissue. The plasma is separated from the red
blood cells and placed in a freezer within eight hours or within the time frame specified in the direc-
tions for use for the blood collecting, processing, and storage system, and stored at 18C or colder.
d) Fresh frozen plasma is thawed at 30C to 37C. There is protection against water contamination of
outlet ports.
e) Liquid plasma is separated from the red blood cells and is stored at a temperature of 1C to 6C with-
in four hours after filling the container or within the time frame specified in the directions for use for
the blood collecting, processing, and storage system.
f ) Platelet-rich plasma is prepared from blood collected by a single uninterrupted venipuncture with min-
imal damage to and minimal manipulation of the donors tissue. The plasma is separated from the red
blood cells by centrifugation within four hours after completion of the phlebotomy or within the time
frame specified in the directions for use for the blood collecting, processing, and storage system. The
time and speed of the centrifugation are shown to produce a product with at least 250,000 platelets
per microliter. The plasma is stored at a temperature between 20C and 24C immediately after filling
the final container. A gentle and continuous agitation of the product is maintained throughout the
storage period, if stored at a temperature of 20C to 24C.
g) When there is modification by separating platelets and/or cryoprecipitated antihemophilic factor
(AHF) from plasma, the following apply:
Platelets are separated as described in QCP.11.4.3 before the plasma is frozen. The remaining plas-
ma is considered fresh frozen plasma if frozen within six hours after filling the final container or
within the time frame specified in the directions for use for the blood collecting, processing, and
storage system.
Cryoprecipitated AHF is removed as required in QCP.11.4.5 The remaining plasma is labeled
plasma, cryoprecipitate reduced.
h) The final container has no color added to the plastic and is transparent to permit visual inspection of
the contents; any closure maintains a hermetic seal and prevents contamination of the contents.
i) The final container material does not interact with the contents, under the customary conditions of
storage and use, in such a manner as to have an adverse effect on the safety, purity, potency, and effec-
tiveness of the product.
j) Before filling, the final container is identified by number so as to relate it to the donor.
k) The final product is inspected immediately after separation of the plasma and is not issued for transfu-
sion if there is any abnormality in color or physical appearance or any indication of contamination.
l) With the exception of platelet-rich plasma and liquid plasma, the final product is inspected for evi-
dence of thawing or breakage at the time of issuance. However, the containers need not be stored in a
manner that shows evidence of thawing if records of continuous monitoring of the storage temperature
establish that the temperature remained at 18C or colder. If continuous monitoring of the product is
not available, the final product is stored in a manner that will show evidence of thawing and is not to
be issued if there is any evidence of thawing.
m) No preservative is added to the final product.
J 1. Blood drawn, processed, and stored for plasma meets the requirements of elements a) through e) in
the intent.
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125
J 2. Platelet-rich plasma is drawn, processed, and stored according to element f ) in the intent.
J 3. Modified plasma meets the requirements of element g) in the intent.
J 4. The final container meets the requirements of elements h) through j) in the intent.
J 5. The final product is inspected according to elements k) and l) in the intent.
J 6. No preservative is added to the final product.
C(-%&(ec&*a*ed AHF
S'a"da%d QCP.11.4.5
Defined processes are used to ensure the quality of cryoprecipitated AHF.
I"'e"' #f QCP.11.4.5
The following requirements for processing cryoprecipitated AHF are implemented:
a) The plasma is separated from the red blood cells by centrifugation to obtain essentially cell-free plasma.
b) The plasma is placed in a freezer within eight hours after blood collection or within the time frame
specified in the directions for use for the blood collecting, processing, and storage system.
c) A combination of dry ice and organic solvent may be used for freezing, provided that the procedure
has been shown not to cause the solvent to penetrate the container or leach plasticizer from the con-
tainer into the plasma.
d) Immediately after separation and freezing of the plasma, the plasma is stored and maintained at 18C
or colder until thawing of the plasma for further processing to remove the cryoprecipitated AHF.
e) The cryoprecipitated AHF is separated from the plasma using a procedure that has been shown to pro-
duce an average of no less than 80 units of AHF per final container.
f ) No diluent is added to the product by the manufacturer before freezing.
g) The final container used for cryoprecipitated AHF is colorless and transparent to permit visual inspec-
tion of the contents; any closure maintains a hermetic seal and prevents contamination of the contents.
h) The container material does not interact with the contents, under customary conditions of storage and use,
in such a manner as to have an adverse effect on the safety, purity, potency, and effectiveness of the product.
i) At the time of filling, the final container is identified by a number so as to relate it to the donor.
j) Quality control tests for potency of AHF are conducted each month on at least four representative
containers of cryoprecipitated AHF.
k) If the average potency level of AHF in the containers is less than 80 units of AHF per container, cor-
rective actions are taken immediately, and a record of these actions is maintained.
J 1. In the processing and storage of cryoprecipitated AHF, the blood bank meets the requirements of
elements a) through f ) in the intent.
J 2. The final container for cryoprecipitated AHF meets the requirements of elements g) through i) in the
intent.
J 3. The blood bank meets the quality control requirements of elements j) and k) in the intent.
B"%%d a$d C%#&%$e$* S*%(age Re'+(e#e$*) (f%( D%$%( Fac"*- a$d
B"%%d T(a$)f+)%$ Se(,ce))
S'a"da%d QCP.11.5
The blood bank director ensures that blood and components are stored in a secure and appropriate fashion in
order to prevent damage or deterioration.
I"'e"' #f QCP.11.5
The laboratory provides proper storage facilities for blood and blood components. The director of the blood bank
and/or transfusion services ensures that proper storage is provided at the appropriate temperatures, with continuous
monitoring of temperature-controlled spaces. Policies guiding storage are defined in writing and are implemented.
J 1. The director of the blood bank and/or transfusion services has provided written policies that guide
the storage of blood and components.
J 2. The policies are implemented by organization personnel.
S'a"da%d QCP.11.5.1
Storage areas used for blood and components are appropriate for the volume and variety of components stored.
I"'e"' #f QCP.11.5.1
Blood, blood components, and derivatives are stored at temperatures demonstrated to be optimal for function
and safety.
a) Required temperatures for blood and components are as follows:
Storage areas used for blood and components also meet the following requirements:
b) Storage areas are used exclusively for blood, components, and derivatives; donor and recipient blood
specimens; blood banking reagents and supplies; and tissues for transplantation.
126
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W#)& b&))d a(d *ac%d +d c&&, 12C 3 62C
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Rd c&&, !+)0( $( 40% "&/c+)& 1 3652C
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127
c) Storage areas are sufficient in size for blood and components to be arranged by separating blood types
and types of components so that the risk of issuing or releasing the wrong unit is reduced.
J 1. Blood and components are stored at optimal temperatures, as described in element a) in the intent.
J 2. Storage areas for blood, components, and derivatives meet the requirements of element b) in the intent.
J 3. Storage areas for blood and components meet the requirements of element c) in the intent.
S'a"da%d QCP.11.5.2
Storage areas for blood and components are monitored to ensure that appropriate temperatures are maintained.
I"'e"' #f QCP.11.5.2
Requirements for ongoing monitoring of temperatures for blood storage areas include the following:
a) Refrigerators and freezers and other blood storage areas have a system to monitor the temperature con-
tinuously, and it is recorded either by
an automated continuous recording of the temperature; or
manually recording of the temperature at least every four hours.
b) For large storage units, there is evidence that all areas in the unit have been maintained at the proper
temperature.
c) The proper functioning of each refrigerator and freezer is constantly monitored by
an audible alarm system, including remote alarms when no one is in the laboratory;
the system is battery operated or powered by a different circuit than the refrigerator or freezer; and
the alarms are set to sound before blood or components reach unacceptable temperatures.
d) The temperature-recording probe is located in a container of fluid with the same volume as the small-
est units stored and that has heat transfer characteristics similar to those of blood.
e) The laboratory performs and documents periodic function checks of the temperature recording and
alarm systems.
f ) When acceptable storage temperatures have been exceeded, there are procedures to follow, and staff
document remedial actions taken.
J 1. Monitoring systems for blood and components meet the requirements of elements a) through d) in the intent.
J 2. Periodic function checks are conducted of the temperature recording and alarm systems.
J 3. Ongoing temperature monitoring, function checks, and remedial actions when storage temperatures
have been exceeded are documented, and that documentation is maintained for at least five years.
S'a"da%d QCP.11.6
The laboratory maintains identification and traceability of specimens; reagents; test results; and blood, blood
components, and products.
I"'e"' #f QCP.11.6
For the safety of the recipient, all specimens; reagents; test results; and blood, blood components, and prod-
ucts must be labeled correctly. Their identities are carefully maintained throughout the testing of the donor
blood and patient specimen. The following processes are in place:
a) The patient is positively identified by the specimen collector, using two distinct identifiers, before the
specimen is collected.
b) The system for identifying the patient is defined in writing and consistently used.
c) There is a process for identifying patients who are unconscious or unknown.
d) The specimen collector, at the time of collection,
labels the specimen with the recipients full name and a unique identification number or other system;
labels the specimen immediately and in the recipients presence;
notes the collection time; and
documents the specimen collectors identity.
e) There is a system for maintaining positive identification of all patient specimens, specimen types, and
aliquots at all times.
f ) The laboratory maintains records on the receipt and disposition of all blood components and products.
g) Blood and blood components are disposed in an appropriate manner when they have become outdated
according to the expiration date.
h) The laboratory retains blood bank and transfusion records for as long as required by applicable law and
regulation, but at least for five years.
J 1. A defined system for identifying recipient specimens; reagents; test results; and blood, components,
and products is implemented and consistently followed.
J 2. The method for identifying and maintaining the identity of the recipient meets the requirements of
elements a) through e) in the intent.
J 3. Records on the receipt, storage, and disposition of all blood components and products are maintained.
J 4. All blood bank records are retained for at least five years, or longer if required by law and regulation.
J 5. Outdated blood and components are disposed in an appropriate manner.
B##d T%a"&f(&i#" Se%)ice&
Te)*$g %f B"%%d P(%( *% T(a$)f+)%$
S'a"da%d QCP.11.7
The laboratory tests donor blood and recipient blood with potent typing sera and adequately reactive cells of
a known type to determine the correct ABO blood group and Rh type.
I"'e"' #f QCP.11.7
The transfusion service performing the crossmatch confirms the following according to written procedures:
a) The ABO group of all units of whole blood and red blood cell components;
(Note: The laboratory must determine ABO group by concurrently testing unknown red cells with, at
a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown
serum must be tested with known A1 and B red cells.)
b) The Rh type of units labeled as Rh negative;
(Note: The laboratory must determine the D [Rho] type by testing unknown red cells with anti-D
[anti-Rho] blood typing reagent.)
c) The ABO group and Rh type of the recipient;
d) All Rho (D) negative donor cells are tested for the (Du) variant. This test must be performed by the
donor center.
e) Manufacturers instructions for blood typing are followed.
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129
J 1. The laboratory tests donor units, as required in elements a) and b) in the intent.
J 2. The laboratory tests recipient blood, as required in element c) in the intent.
J 3. Donor cells are tested for the (Du) variant, as required in element d) in the intent.
J 4. Manufacturers instructions for blood typing are followed.
S'a"da%d QCP.11.7.1
The potency and reliability of reagents used for ABO grouping, Rh typing, antibody detection, and compati-
bility determinations are tested for reactivity.
I"'e"' #f QCP.11.7.1
a) The laboratory defines criteria for sera, antisera, cells, and reagents in its policies and procedures.
b) Sera used are of a known potency that meets regulatory requirements and/or international standards of
practice.
c) The laboratory defines, in writing, its procedures for reactivity testing or quality control.
d) Each opened vial of antisera, reactive cells, and reagents is tested for reactivity on each day of use and
when a new lot of reagents is first used.
e) The laboratory confirms that each reagent reacts as expected before any testing is reported.
f ) Results are documented.
J 1. The laboratory defines criteria for testing sera, antisera, cells, and reagents in policies and procedures.
J 2. Sera used meet the requirements of element b) in the intent.
J 3. Written procedures and practices for quality control meet the requirements of elements c) through f )
in the intent.
S'a"da%d QCP.11.8
Before blood is administered, appropriate compatibility testing and antibody testing (except in an emergency)
are performed. In addition, other procedural controls are implemented.
I"'e"' #f QCP.11.8
The following are performed by the laboratory before blood is administered:
a) There is confirmation by a knowledgeable staff member that all identifying information on the trans-
fusion requisition matches that on the specimen tube prior to the performance of compatibility testing.
b) There is confirmation by a knowledgeable staff member that ABO and Rh typing on all donor units
has been performed.
c) Tests on recipient blood include
ABO group and Rh type;
screening for unexpected antibodies and antibody identification; and
a major crossmatch between donor red cells and recipient serum.
d) When a direct antiglobulin test is ordered, the test system used is adequate to detect RBC-bound IgG
and complement.
e) When the screen for unexpected antibodies is negative, serologic testing to detect ABO incompatibility
or a validated electronic crossmatch is required.
f ) The laboratory maintains a file on previously tested patients. Before a unit of whole blood or red blood
cell component is released for transfusion, the current results obtained are compared with any previous
patient records as a process control measure to detect a possible error. This comparison includes
a comparison of ABO and Rh typing during the previous 12 months;
a comparison of results for patients with previous immunohematologic or transfusion problems for
the past five years; and
the laboratory investigating and resolving discrepancies for all cases where the ABO and Rh typing
do not agree with the historical record for the patient.
g) If the laboratory performs a computer crossmatch,
the computer and process have been validated in-house;
the ABO group is verified by repeat testing of the same specimen or a different specimen or by per-
forming a historical search of laboratory records;
the laboratory blood bank computer system has a record of the donor unit number, component
type, ABO/Rh type of the component, results of the ABO confirmatory test, and the recipient's
ABO/Rh type; and
if the laboratory does not perform a serologic crossmatch, computer data is verified as being correct
before blood or components are issued, and the computer contains logic to alert the laboratory of
any discrepancies.
J 1. All identifying information on the specimen and request records is reviewed to ensure that they
match prior to the performance of compatibility testing.
J 2. Testing is performed as required in elements a) through e) in the intent.
J 3. Historical files for previously tested patients are maintained and checked, as required in element f ) in
the intent.
J 4. When the laboratory uses a computer crossmatch, the requirements of element g) in the intent are
met.
Se"ec*$g B"%%d a$d C%#&%$e$*) f%( T(a$)f+)%$
S'a"da%d QCP.11.9
Specific procedures are followed when selecting blood and components for transfusion.
I"'e"' #f QCP.11.9
When selecting blood and blood components for transfusion, patient safety is the primary consideration.
Therefore, procedures and practices are used to provide maximum protection for the patient. The procedures
include the following:
a) ABO group-specific whole blood or red cell components to recipients are given.
b) Rh negative whole blood or red cells are given to Rh negative recipients, except in unusual cases when
Rh negative blood is in short supply and the medical director of the blood bank approves giving Rh
positive blood.
c) For patients with significant red cell antibodies or other immunohematologic conditions, appropriately
prepared components are used for transfusion.
d) When pooled blood components with grossly visible red cells are used, the laboratory ensures that plas-
ma alloantibodies are compatible with the red cells.
e) The red cells in granulocyte components are ABO compatible with the recipients plasmaand fresh
frozen plasma is ABO compatible with the recipient's red cells.
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131
f ) Policies and procedures address how to manage life-threatening situations (for example, the use of
uncrossmatched blood or abbreviated testing). In these situations, the practitioner responsible for the
patient determines and documents by signature the need to bypass the usual steps.
J 1. Procedures are implemented to provide maximum safety for the patient when selecting blood and
components for transfusion.
J 2. Procedures used include elements a) through e) in the intent.
J 3. To manage life-threatening situations when there are time limits for testing, written policies and pro-
cedures are implemented according to element f ) in the intent.
B"%%d I))+a$ce a$d T(a$)f+)%$
S'a"da%d QCP.11.10
The director of the blood transfusion services provides policies and procedures to guide acceptable practices
for blood and component transfusion.
I"'e"' #f QCP.11.10
Blood must be administered in accordance with standards of practice and in a consistent manner in order to
ensure the safety of the recipient. Therefore, written policies and procedures describe the process from pro-
curement of blood from the blood bank or blood storage area, through patient identification, blood adminis-
tration, monitoring of the patient, and identification and response to signs of potential transfusion reactions.
The director of blood transfusion services has the education, knowledge, and expertise to oversee this process
and ensures that these procedures are defined and implemented.
The director of blood transfusion services
J 1. has the education and expertise to oversee the transfusion process;
J 2. provides policies and procedures to guide all steps in the transfusion, as described in the intent; and
J 3. has a means to monitor practices to ensure that the guidelines are consistently followed.
S'a"da%d QCP.11.10.1
There are defined processes for checking blood out of the blood bank before transfusion.
I"'e"' #f QCP.11.10.1
Procedures for checking blood out of the blood bank are vital to patient safety. The process of identifying the
unit of blood that has been crossmatched for a specific recipient and verifying that it is the correct recipient
cannot be bypassed. The processes include the following:
a) A clerical verification of blood and blood types of donor and recipient is performed and documented
prior to the issuance of blood.
b) A compatibility tag is securely attached to the unit before issuance. It is to remain attached to the unit
until the transfusion is completed. This tag provides documentation of
the recipients two identifiers;
the interpretation of compatibility tests; and
the donor unit number.
c) Immediately prior to issue, blood and components are inspected for evidence of hemolysis, possible bacterial
contamination, and any other abnormality that might be visually detected, and the inspection is documented.
J 1. Written procedures are implemented to meet the requirements of element a) in the intent.
J 2. The compatibility tag on the blood meets the requirements of element b) in the intent.
J 3. The blood bank and transfusion service meets the requirements of element c) in the intent.
Specific policies and practices are required before and during blood administration.
I"'e"' #f QCP.11.10.2
The processes required before and during blood administration are essential for the protection of the patient.
This is the final set of process controls to safeguard the patient from receiving an incorrect unit of blood and
to provide timely identification of a potential transfusion reaction. These processes should be clearly defined
in written procedures.
The processes used prior to blood administration include
a) a step-by step description of how the identification of the recipient and the unit of blood is performed
and documented at the patients bedside;
b) requiring, when possible, that the identification be performed by two individuals; and
c) defining the length of time allowed from issue until the transfusion is completed.
Processes used during transfusion include
d) requiring the transfusion to be performed under medical direction;
e) instructions for using infusion devices and ancillary equipment, such as blood warming and cell salvage
devices;
(Note: Blood warming is performed with an approved system that has an alarm to warn the user when
the temperature is outside acceptable limits.)
f ) instructions which indicate that, in general, only 0.9% sodium chloride should be added to blood or com-
ponents unless drugs have been approved by regulation for addition to blood or there are records available
demonstrating that the addition of a drug is safe and does not negatively affect a blood component;
g) appropriate training in all aspects of the transfusion process for staff members who transfuse patients; and
h) documentation at least in the patients clinical record of
the name of the transfusionist;
the time of transfusion;
the type and unit number of the blood component transfused;
evidence and results of patient monitoring; and
any adverse effects of the transfusion.
J 1. Processes used prior to initiating a transfusion are defined and implemented, as required in elements
a) through c) in the intent.
J 2. Processes for performing a transfusion are defined and implemented, as required in elements d)
through f ) in the intent.
J 3. Appropriate training for those who transfuse patients is documented according to element g) in the intent.
J 4. The patients record includes the requirements of element h) in the intent.
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133
Rec%g$.$g S+)&ec*ed T(a$)f+)%$ Reac*%$)
The director has defined criteria for recognition of transfusion reactions, as well as steps to take when symp-
toms occur.
I"'e"' #f QCP.11.10.3
The following are defined and implemented:
a) Staff members who monitor transfusions are trained to recognize the symptoms of a potential transfu-
sion reaction.
b) Criteria are defined for recognizing and responding to such reactions.
c) Staff have a written plan of action to follow in the event of a suspected reaction, and they report any such
reaction immediately to the blood transfusion services and the physician responsible for the patient.
d) When symptoms indicate a possible immediate transfusion reaction, the transfusion is interrupted and
investigated.
e) There is provision for timely clinical management of the patient during the investigation.
f ) The laboratory promptly investigates the cause of an adverse reaction, using a defined protocol, includ-
ing determining whether a hemolytic reaction has occurred.
g) Investigation of a suspected reaction includes immediate appraisal of the following:
Identification of the patient and blood unit labels to verify that the correct unit of blood was given
to the patient for whom it was crossmatched
All records at the bedside and in the laboratory to look for possible errors in patient or blood unit
identification
Visual inspection of the recipients postreaction serum or plasma to check for hemolysis. This speci-
men is to be compared to a prereaction specimen from the recipient, if available.
A direct antiglobulin test is to be performed on the postreaction recipients blood specimen.
The laboratory has criteria defining which circumstances require additional testing and what that
testing should be.
h) The director of blood transfusion services interprets the evaluation of test results ordered as part of the
adverse reaction protocol, and the interpretation is made a permanent part of the recipients clinical record.
i) The director is actively involved when a transfusion reaction investigation indicates a system failure,
such as misadministration of a blood component.
j) Donor and recipient blood specimens are stored for retesting in case of symptoms of a suspected trans-
fusion reaction for the period of time required by law and regulation or at least seven days after trans-
fusion, whichever is more stringent.
k) When faulty components have or might have caused a potential adverse reaction, there is a process for
notifying the blood donor service that provided the component and for follow-up for transfusion-
transmitted disease, including a procedure that describes how recipients who have been transfused with
potentially infectious blood or components are to be notified and counseled.
J 1. For staff members to administer and monitor blood transfusions, the organization complies with ele-
ments a) through e) in the intent.
J 2. The investigation and reporting of results for a suspected transfusion reaction include elements f )
through i) in the intent.
J 3. When faulty components are suspected of causing a potential transfusion reaction, the requirements
of element k) are met.
J 4. All steps in this process are followed and documented.
B"%%d D%$%( a$d T(a$)f+)%$ Se(,ce) Rec%(d Re'+(e#e$*)
S'a"da%d QCP.11.11
When the laboratory draws donor blood, prepares blood components, stores blood and/or components,
and/or issues blood for transfusion, there are specific records that must be maintained.
I"'e"' #f QCP.11.11
The following records are maintained as long as required by applicable law and regulation or for at least five
years, whichever is more stringent:
a) The laboratory records the performance of each significant step in the collection, processing, compati-
bility testing, storage, distribution, issuance, transfusion, and/or disposition of each unit of blood and
blood components.
b) The records identify the person performing the work, the date of each entry, test results and interpreta-
tion of results, and the expiration date assigned to each product.
c) Records are adequately detailed to provide a complete history of the work performed.
d) All records are legible and indelible.
e) Records of the blood donor center include
information about all donors drawn;
all results of blood testing, including test results of transfusion-transmitted diseases;
all quality control testing performed;
all temperature records for blood storage units and facilities; and
verification of the disposition of all blood components obtained, including the method of destruc-
tion or transfer of units unsuitable for transfusion.
f ) Records of the transfusing facility include
all results of blood testing;
results of all quality control testing performed;
records of all blood and components received from another facility;
all temperature records for blood storage units and facilities;
information about all steps involved in the release or issuance of all blood and components;
information about the transfusion, including any transfusion-related reaction, and results of the
transfusion reaction workup and the directors interpretation of the workup; and
verification of the disposition of all blood components obtained, including the method of destruc-
tion or transfer of units unsuitable for transfusion.
J 1. Records meet the requirements of elements a) through d) in the intent.
J 2. The blood donor centers records include the requirements of element e) in the intent.
J 3. The transfusing facility and blood banks records include the requirements of element f ) in the
intent.
J 4. All records are retained for the time required by law and regulation or for five years, whichever
requirement is more stringent.
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135
H)*%c%#&a*b"*- Te)*$g
S'a"da%d QCP.12
When performing histocompatibility testing, the laboratory uses appropriate screening techniques for donors
and recipients.
I"'e"' #f QCP.12
When histocompatibility testing is performed, donors and recipients undergo adequate testing and screening
to minimize the risk of incompatibility and rejection. The laboratory performs the following in the screening
and testing processes for HLA testing:
a) Define and follow criteria for
selecting appropriate patient serum samples for crossmatching;
the technique used in crossmatching;
preparing donor lymphocytes for crossmatching; and
reporting crossmatching results.
b) Provide results of final crossmatches available before an organ tissue is transplanted, when appropriate.
c) Make a reasonable attempt to have available serum specimens for all potential transplant recipients at
initial typing, for periodic screening, for transplantation crossmatch, and after sensitizing events, such
as transfusion and transplant loss.
d) The laboratory screens potential transplant recipient sera for preformed HLA-A and -B antibodies with
a suitable lymphocyte panel on sera collected at the time of the recipients initial HLA typing and fol-
lowing sensitizing events, as well as upon request.
e) A suitable cell panel is used for screening patient sera (antibody screen), a screen that contains all the
major HLA specificities and common splits.
f ) The laboratory
HLA types all potential transplant recipients;
types cells from organ donors referred to the laboratory; and
follows criteria defining when antigen redefinition and retyping are required.
J 1. The laboratory has defined criteria for the requirements of element a) in the intent.
J 2. Element b) in the intent is met when appropriate.
J 3. The laboratory performs adequate screening and selection processes for donors and recipients, as
described in elements c) through f ) in the intent.
J 4. The laboratorys screening and donor selection processes are supported by written procedures.
J 5. The laboratory documents all screening and testing processes.
S'a"da%d QCP.12.1
The laboratory performs mixed lymphocyte cultures or other recognized methods to detect cellular-defined
antigens according to defined methods.
I"'e"' #f QCP.12.1
The laboratorys written culture criteria meet the following requirements:
a) Viability of all suspensions exceeds 80% at the start of the culture.
b) Sera used in media must have a demonstrated lack of cytotoxic antibodies.
c) Each mixed lymphocytic culture (MLC) test includes an autologous control as well as unrelated control
responders and stimulators. Stimulator cell suspensions from three or more unrelated control individuals
and a pool of at least three or more unrelated individuals are used for each responder cell tested.
d) Incubating and labeling techniques are adequate to discriminate positive from negative results.
J 1. The laboratory performs mixed lymphocyte cultures or uses other recognized methods to detect cel-
lular-defined antigens in compliance with elements a) through d) in the intent.
J 2. These processes are defined in written procedures.
J 3. All testing is documented.
S'a"da%d QCP.12.2
The laboratory performs HLA serologic typing of both donor and recipient as appropriate to the study or
individual procedure performed.
I"'e"' #f QCP.12.2
The laboratorys written procedures and practices for HLA typing of donors and recipients includes the
following:
a) Reagents used for typing recipients and donors are adequate to define all major and International
Workshop HLA-A, -B, and -DR specificities for which reagents are readily available.
b) Each HLA-A, -B, and -C antigen is defined by at least two or three different antisera, depending on
whether monospecific or multispecific sera are used.
c) Each HLA-DR antigen is defined by at least five antisera or by three antisera that are operationally
monospecific.
d) The laboratory uses a technique that detects HLA-specific antibody with a specificity equivalent or
superior to that of the basic complement-dependent microlymphocytotoxicity assay.
e) The laboratory defines the processes for the preparation of cells or cellular extracts (for example, solu-
bilized antigens and nucleic acids), as applicable to the HLA typing technique(s) performed.
f ) The laboratorys reagent typing sera inventory (when using locally constructed trays) must indicate
source, bleeding date and identification number, and volume remaining.
g) Reagents used for histocompatibility typing are adequate to define HLA-A, -B, and -DR specificities
that are officially recognized by the most recent World Health Organization (WHO) Committee on
Nomenclature for which sera are readily available.
h) The typing trays for disease-associated testing permit characterization of at least those antigens accept-
ed by the WHO for which sera are readily available.
i) The laboratory follows written procedures specifying the histocompatibility testing (that is, HLA typ-
ing, antibody screening, and compatibility testing and crossmatching) to be performed for each type of
cell, tissue, or organ to be transfused or transplanted.
j) The laboratorys procedures include the following:
Testing protocols for cadaver donor, living, living-related, and combined organ and tissue
transplants
Testing protocols for patients at high risk for allograft rejection
The level of testing required to support clinical transplant protocols (for example, antigen or allele level)
J 1. Written procedures describe the HLA serologic typing processes, as required for elements a) through
j) in the intent.
136
137
J 2. Reagents used for typing recipients and donors meet the requirements of elements a) through d) in
the intent.
J 3. Records for reagent typing sera inventory (for locally constructed trays) meet the requirements of ele-
ment f ) in the intent.
J 4. The laboratory complies with elements g) through i) in the intent.
J 5. The laboratorys procedures include the requirements of element j) in the intent.
J 6. All procedures performed are documented.
S'a"da%d QCP.12.3
Before transplantation is performed, the laboratory crossmatches potential recipients and donors using the
most reactive and recent sera, as appropriate to the study or individual procedure performed.
I"'e"' #f QCP.12.3
The laboratory makes every effort to screen out donors who have any incompatibility potential.
a) The laboratory documents that crossmatching
includes methods to enhance sensitivity; and
is performed with the most reactive sample collected within one month of testing.
b) If the recipient has had a sensitizing event, or if the history is uncertain, the crossmatch is done with a
serum sample collected within two days of the transplant.
J 1. The laboratory makes every effort to screen out donors who have any incompatibility potential.
J 2. Processes used include those in elements a) and b) in the intent.
J 3. All testing is performed according to written procedures and is documented.
S'a"da%d QCP.12.4
The laboratory uses reagents and antisera that are specific and verified with appropriate controls when available.
I"'e"' #f QCP.12.4
Reagent and antisera controls include the following:
a) Each typing tray is checked using
positive and negative control sera; and
positive controls for specific cell types, when applicable (that is, T cells, B cells, and monocytes).
b) Each compatibility test (that is, MLCs, homozygous typing cells, or DNA analysis) is checked and
typed for disease-associated antigens, using controls to monitor the test components and each phase of
the test system.
c) If the laboratory uses immunologic reagents (for example, antibodies or complement) to remove con-
taminating cells during the isolation of lymphocytes or lymphocyte subsets, the methods are verified
with appropriate quality control procedures.
d) Control procedures are established to test each new batch of complement and to ensure reactivity of
stored complement.
e) New reagents are checked for appropriate reactivity before being used.
f ) Control results are documented and verified as acceptable before results are reported.
g) When quality control results are unacceptable, remedial action is documented.
J 1. Reagents and antisera are quality controlled, according to the requirements of elements a) through e)
in the intent.
J 2. Control results are verified as acceptable before results are reported or used.
J 3. Remedial action is documented when control results are unacceptable.
J 4. All quality controls are documented, along with remedial action, when indicated.
S'a"da%d QCP.12.5
The laboratory participates in at least one national or regional cell-exchange program, if available, or develops
an exchange system with another laboratory to validate interlaboratory reproducibility.
I"'e"' #f QCP.12.5
The laboratory participates in at least one cell-exchange program to validate interlaboratory reliability. As part
of this program, the following are implemented:
a) The establishment of valid interlaboratory reproducibility criteria
b) Documentation of performance levels
c) Implementation and documentation of remedial action when criteria are not met
d) The retention of a cumulative record of participation in the program for at least two years
e) Timely review and documentation of results by the director or appropriate supervisor
J 1. The laboratory participates in at least one interlaboratory cell-exchange program, as described in the
intent.
J 2. Interlaboratory reproducibility criteria are developed and used.
J 3. Results, along with remedial action, when indicated, are documented and retained for at least two years.
J 4. The director or appropriate supervisor documents review of results in a timely manner.
S'a"da%d QCP.12.6
Storage of records and specimens is addressed.
I"'e"' #f QCP.12.6
Storage and maintenance of specimens and records include the following:
a) Recipient sera are
stored at an acceptable temperature range;
stored in an area that has a temperature alarm system and an emergency plan for alternative storage
if temperature control should fail; and
properly identified and easily retrievable.
b) The laboratory properly labels and stores cells, complement, buffers, dyes, and all other reagents and
specimens.
c) If the laboratory uses frozen panels, it has a suitable storage system.
d) Records of results of all cell typing or crossmatch studies are retained and readily accessible.
e) The organization participates in and maintains records of patient and donor transplant information in
the United Network for Organ Sharing (UNOS) Clinical Transplant Registry or its equivalent.
138
139
J 1. Appropriate storage is provided for specimens and reagents, along with documented monitoring of
temperature and other conditions, if indicated.
J 2. Recipient sera are stored as described in element a) of the intent.
J 3. Record storage meets the requirements of elements d) and e) in the intent.
C-*%ge$e*c) Te)*$g
S'a"da%d QCP.13
Laboratory procedures and practices in cytogenetics provide for accurate results.
I"'e"' #f QCP.13
The cytogenetics laboratorys quality control procedures and practices include the following:
a) Duplicate or independently established cultures for all specimen types
b) Determination of sex, performed by X and Y chromatin counts, based on examination of an adequate
number of cells
c) Confirmatory testing performed for all atypical results
d) Two cells karyotyped for each case
e) Use of the level of band resolution necessary for interpretation purposes
J 1. The laboratory uses the processes defined in elements a) through e) in the intent to ensure the
required accuracy of cytogenetics testing.
J 2. All processes are defined in written procedures, which are followed.
J 3. Test results are not reported unless control processes are acceptable.
S'a"da%d QCP.13.1
Laboratory records identify the media used, the reactions observed, and the details of each step of the identifi-
cation procedure.
I"'e"' #f QCP.13.1
a) The laboratorys records and results accurately and completely reflect all stages of the process and all
results obtained. Records include the
media used;
reactions observed;
number of cells counted;
number of cells karyotyped;
number of chromosomes counted for each metaphase spread; and
quality of the banding.
b) The resolution is appropriate for the type of tissue or specimen and the type of study required, based
on the clinical information provided to the laboratory.
c) An adequate number of karyotypes is prepared for each patient.
d) The laboratory permanently retains slides, negatives, prints, or magnetic media for all abnormal cases.
J 1. Records of the testing include all stages of the process and all the information required in element a)
in the intent.
J 2. The resolution is appropriate, as described in element b) in the intent.
J 3. The number of karyotypes prepared for each patient is adequate and is supported by standards of practice.
J 4. Results are permanently retained, as described in element d) in the intent
S'a"da%d QCP.13.2
The laboratory obtains and includes in the interpretative report all required clinical information.
I"'e"' #f QCP.13.2
The laboratory report includes the following:
a) Correct use of appropriate nomenclature
b) A summary of the observations
c) The number of cells counted and analyzed
d) Documentation of any preliminary report, such as a verbal or telephone report
e) All required clinical information
J 1. The laboratorys results are reported with the correct use of appropriate nomenclature.
J 2. The report includes all requirements listed in elements b) through e) in the intent.
S'a"da%d QCP.13.3
The laboratory maintains individual sample identification during all phases of testing and reporting.
I"'e"' #f QCP.13.3
a) The laboratory uses a system to ensure that individual samples and reports are not misidentified.
b) The laboratory follows written policies and procedures for individual sample identification.
c) Samples are identified in all phases of analysis, including the following:
Specimen collection and accessioning
Cultures
Cell preparations
Photography or other image reproduction technique
Photographic printing and storage
J 1. The laboratory uses a systematic process to identify patient samples and reports.
J 2. The process is implemented according to written policies and procedures.
J 3. Sample identification is maintained through all phases, as described in element c) in the intent.
M%"ec+"a( Te)*$g
I$*(%d+c*%$
Molecular testing is the analysis or the detection of nucleic acids by hybridization, with or without amplification.
140
141
Molecular testing has become an area of rapid growth and change in the laboratory. This is due to the tremen-
dous potential that molecular testing has for improving the prediction, prevention, detection, and treatment of
disease. It promises to be extremely useful in diagnosis, therapy, epidemiologic investigations, and infection con-
trol. While molecular testing shows great promise, like any other medical testing, it also has the potential to
cause great harm if errors occur. Inaccurate results can lead to misdiagnosis or inappropriate treatment or coun-
seling. Therefore, standards are used to sufficiently support the safeguards required for molecular testing.
S'a"da%d QCP.14
The laboratory follows written policies and procedures for molecular testing.
I"'e"' #f QCP.14
The laboratory follows written policies and procedures that describe the following:
a) Appropriateness of testing
(Note: For genetic testing, additional information might be required to select appropriate tests and to
ensure accurate test interpretation and reporting of results.)
b) Prevention of nucleic acid contamination (including in work areas, equipment, personal protective
equipment, and reagents) during specimen preparation and testing
c) Documentation of all nucleic acid reagents, including probes and primers, used in a particular test
d) Quality and quantity of nucleic acid needed for a particular test
e) Investigation and corrective action taken for internal controls that fail to amplify
f ) Competition between target and internal controls (for example, false negatives or presence of a target
signal is strong, with a negative internal control signal)
g) Investigation of discrepant results between different methods
h) Reuse of patient specimens for quality control purposes
J 1. The laboratory follows policies and procedures that address how the appropriateness of testing is ensured.
J 2. The laboratory follows policies and procedures that address the requirements of element b) in the
intent.
J 3. The laboratory follows policies and procedures that address the requirements of elements c) and d) in
the intent.
J 4. The laboratory follows policies and procedures for quality control that address the requirements of
elements e) through h) in the intent.
S'a"da%d QCP.14.1
Validation studies include representatives from each specimen type expected to be tested in the assay and spec-
imens representing the scope of reportable results.
(Note: Other requirements for validating test methods are addressed in standard QCP.1.3)
I"'e"' #f QCP.14.1
The laboratory performs validation studies that include the following:
a) Positive and negative representatives from each specimen type expected to be tested in the assay
b) Specimens representing the scope of reportable results
c) All the requirements of QCP.1.3
d) Documentation of all aspects of the validation
J 1. The laboratory has written guidelines that address the validation studies required in elements a)
through d) in the intent.
J 2. The laboratory implements the requirements of elements a) through d) in the intent.
S'a"da%d QCP.14.2
The laboratory establishes quality control limits, reference ranges, and reportable ranges.
I"'e"' #f QCP.14.2
The laboratory needs to establish reference ranges to ensure that when patient results are reported, they reflect
actual normal and abnormal conditions. In addition, reportable ranges reflecting the limits of the high and low
limits of the test system must be determined, and results are not reported when outside of those limits. For
quantitative tests, control limits are narrow enough to promote the precision and accuracy of patient test results.
J 1. The laboratory has established reference ranges for all tests performed.
J 2. The laboratory has determined the reportable ranges for all tests performed and does not report a
patient result that is outside the reportable range.
J 3. The laboratory has established control limits for each test.
J 4. For quantitative tests, control limits are narrow enough to promote the precision and accuracy of
patient test results.
S'a"da%d QCP.14.3
The laboratory verifies each test run of patient samples in molecular pathology, using quality controls.
I"'e"' #f QCP.14.3
a) The laboratory defines the quality control procedure for each testing system or methodology, including
the frequency of quality control testing.
b) Procedures are consistent with current practice standards for this or similar methodologies and are at
least as rigorous as those required or recommended by the manufacturer.
c) The laboratory documents quality control.
J 1. The laboratory has defined quality control procedures, as required in element a) in the intent.
J 2. Quality control procedures meet the requirements of element b) in the intent.
J 3. All quality control results are documented.
S'a"da%d QCP.14.4
Molecular testing reports include specific testing information.
I"'e"' #f QCP.14.4
The laboratory report includes the following information:
a) Testing methodology used
b) Limitations of the method used
142
143
c) Any interpretation of findings
d) Any recommendations for additional testing
e) For assays developed by the laboratory, a statement that the assay was developed by the laboratory
f ) Reports filed in the patients clinical record that require specific interpretation are authenticated by the
qualified individual making the interpretation.
J 1. Molecular testing reports meet the requirements of elements a) through d) in the intent.
J 2. If the assay was developed by the laboratory, it meets the requirements of element e) in the intent.
J 3. Reports that require specific interpretation meet the requirements of element f ) in the intent.
M%"ec+"a( Ge$e*c)
(Note: These standards are in addition to those presented in the Molecular Testing section above.)
S'a"da%d QCP.14.5
The laboratory follows written policies and procedures for molecular genetic testing.
I"'e"' #f QCP.14.5
a) The laboratory follows written policies and procedures that address recommending referral for genetic
counseling.
b) The laboratory follows written policies and procedures that address reporting of results when addition-
al information necessary for interpreting test results is not received by the laboratory.
J 1. The laboratory meets the requirements of element a) in the intent.
J 2. The laboratory meets the requirements of element b) in the intent.
S'a"da%d QCP.14.6
Molecular genetic testing reports include specific testing information.
I"'e"' #f QCP.14.6
The laboratory reports include the following information:
a) List of mutant genes for alleles tested
b) Any recommendations for referral to a genetic counselor
c) Detection rate of the test
d) Use of standard nomenclature for genes and mutations
e) Clinical implications of mutations detected
J 1. The laboratory reports for molecular genetic testing include the requirements of elements a) through
c) in the intent.
J 2. Results are reported using standard nomenclature for genes and mutations.
J 3. The report includes clinical implications of mutations detected.
144
Glossary
145
a/"!&1a1&,+ Determination by the Joint
Commission International (JCI) accrediting body
that an eligible health care organization complies
with applicable JCI standards.
a/"!&1a1&,+ !"&0&,+0 Categories of accredi-
tation that an organization can achieve based on a
JCI survey. These decision categories are as follows:
A/"!&1"! The organization demonstrates
acceptable compliance with all standards and
International Patient Safety Goals.
D"+&a) ,# A/"!&1a1&,+ The organization
is consistently not in compliance with JCI stan-
dards and International Patient Safety Goals,
when JCI withdraws its accreditation for other
reasons, or when the organization voluntarily
withdraws from the accreditation process.
a/"!&1a1&,+ #/a*"4,/( The structures and
processes in an organization that are necessary for an
accrediting organization to do the following:
Consistently and reliably evaluate applicant
organizations against standards
Recruit and send out trained evaluators
Reach consistent and defensible accreditation
decisions
Carry out related policies and procedures
a/"!&1a1&,+ -/,"00 A continuous process
whereby health care organizations are required to
demonstrate to JCI that they are providing safe,
high-quality care, as determined by compliance with
JCI standards and International Patient Safety Goals
recommendations. The key component of this
process is an on-site evaluation of an organization by
JCI surveyors.
A/"!&1a1&,+ P/,$/a* (JCI) See JCI
Accreditation Program
a/"!&1a1&,+ 02/3"6 An evaluation of an
organization to assess its compliance with applicable
standards and to determine its accreditation status.
Also known as a triennial survey, the JCI accredi-
tation survey includes the following:
Evaluation of documents provided by organi-
zation staff that show compliance
Verbal information about the implementation
of standards or examples of their implementa-
tion that enables compliance to be determined
On-site observations by surveyors
Tracking of patients through the care process
by the tracer methodology
Education about standards compliance and
performance improvement
"51"+0&,+ 02/3"6 An organizational evalua-
tion made necessary by any of the following
factors:
An organization has offered at least 25% of
its services at a new location or in a signifi-
cantly altered physical plan.
An organization has expanded its capacity to
provide services by 25% or greater, as mea-
sured by patient volume or other relevant
measures.
An organization has merged with, consolidat-
ed with, or acquired an unaccredited site,
service, or program for which there are appli-
cable JCI standards.
#,20"! 02/3"6 Narrow, limited evaluation
of an organization subsequent to an initial or
triennial survey, which concentrates solely on
issues deemed noncompliant during the initial
or triennial survey.
#,)),4-2- #,20"! 02/3"6 Evaluation con-
ducted because of the need for surveyor observa-
tion, staff or patient interviews, or the inspection
08 JCIIL09 - Glossar - 4th Pages:Laout 1 9/17/2009 5:18 PM Page 145
of the physical facility to confirm that an orga-
nization has taken sufficient action to achieve
acceptable compliance with any JCI standards
and/or International Patient Safety Goals identi-
fied as not met or partially met at the time
of initial or triennial full survey.
#,/-a20" #,20"! 02/3"6 An organiza-
tional evaluation undertaken when JCI becomes
aware of potentially serious issues involving
standards compliance, patient care, or patient
safety.
&+&1&a) 02/3"6 Evaluation of an organization
that is seeking JCI accreditation for the first
time or has not been unaccredited by JCI dur-
ing the previous six months.
3a)&!a1&,+ 02/3"6 An evaluation of the sur-
vey process subsequent to an organizations ini-
tial or triennial re-survey, assessing standards
compliance in health care organizations, as part
of JCIs internal quality improvement efforts.
Similar in scope to an initial or triennial survey,
the validation survey is voluntary and in no way
affects the results of an organizations initial or
triennial survey.
a!3"/0" "3"+1 An unanticipated, undesirable, or
potentially dangerous occurrence in a health care
organization. Also see sentinel event.
a*b2)a1,/6 a/" Types of health care services
provided to individuals on an outpatient basis.
Ambulatory care services are provided in many set-
tings, ranging from freestanding surgical facilities to
cardiac catheterization centers. Also see outpatient.
a+a)61" The substance or constituent on which
testing is conducted.
a+a)61& 0"+0&1&3&16 The lowest concentration
or amount of an analyte or other substance that can
be measured.
a+a)61& 0-"&#&&16 The extent to which a
method responds only to the analyte or other sub-
stance to be measured.
a+"01%"0&a a+! 0"!a1&,+ The administration
to an individual, in any setting, for any purpose, by
any route, of medication to induce a partial or total
loss of sensation for the purpose of conducting an
operative or other procedure. Definitions of four lev-
els of sedation and anesthesia include the following:
*&+&*a) 0"!a1&,+ (a+5&,)60&0) A drug-
induced state during which patients respond
normally to verbal commands. Although cogni-
tive function and coordination may be
impaired, ventilatory and cardiovascular func-
tions are unaffected.
-/,"!2/a) (,/ *,!"/a1") 0"!a1&,+
(formerly conscious sedation) A drug-induced
depression of consciousness during which
patients respond purposefully to verbal com-
mands, either alone or accompanied by light
tactile stimulation. Reflex withdrawal from a
painful stimulus is not considered a purposeful
response. No interventions are required to
maintain a patent airway, and spontaneous ven-
tilation is adequate. Cardiovascular function is
usually maintained.
!""- 0"!a1&,+/a+a)$"0&a A drug-induced
depression of consciousness during which patients
cannot be easily aroused but respond purposefully
following repeated or painful stimulation. The
ability to independently maintain ventilatory
function may be impaired. Patients may require
assistance in maintaining a patent airway, and
spontaneous ventilation may be inadequate.
Cardiovascular function is usually maintained.
a+"01%"0&a Consists of general anesthesia
and spinal or major regional anesthesia. It does
not include local anesthesia. General anesthesia
is a drug-induced loss of consciousness during
which patients are not arousable, even by
painful stimulation. The ability to independent-
ly maintain ventilatory function is often
impaired. Patients often require assistance in
maintaining a patent airway, and positive pres-
sure ventilation may be required because of
depressed spontaneous ventilation or drug-
induced depression of neuromuscular function.
Cardiovascular function may be impaired.
a+a1,*& -a1%,),$6 Services related to surgical
pathology, autopsy, and cytology.
146
147
GLOSSARY
a--/,-/&a1"+"00 The degree to which the care
and services provided are relevant to an individuals
clinical needs, given the current state of knowledge.
a00"00 To transform data into information by
analyzing it.
a00"00*"+1 For purposes of quality improve-
ment, the systematic collection and review of specif-
ic data.
a21%"+1&a1" To verify that an entry is complete,
accurate, and final.
b"01 -/a1&" A clinical, scientific, or professional
technique, method, or process that is recognized by a
majority of professionals in a particular field as more
effective at delivering a particular outcome than any
other practice. These practices, also sometimes
referred to as good practice or better practice, are
typically evidence based and consensus driven.
b&a0 An influence on results that causes them to
routinely depart from their true value.
b),,! ,*-,+"+1 A fraction of separated whole
blood (for example, red blood cells, plasma,
platelets, granulocytes).
b),,! !"/&3a1&3" A pooled blood product, such
as albumin, gamma globulin, or Rh immune globu-
lin, whose use is considered significantly lower in
risk than that of blood or blood components.
b),,! 1/a+0#20&,+ 0"/3&"0 Services relating
to transfusing and infusing individuals with blood,
blood components, or blood derivatives.
a)&b/a1&,+ *a1"/&a) A solution that has a
known amount of analyte weighed in or has a value
determined by repetitive testing, using a reference or
definitive testing method. Calibration material, also
referred to as standard, may be traceable to a
National Institute for Standards and Technology
(NIST) standard. Also see analyte.
a)&b/a1&,+ 3"/&#&a1&,+ The process used to
verify a laboratorys reportable range of patient test
results, which includes calibration materials with at
least a minimum value, a midpoint value, and a max-
imum value, performance of which is based on man-
ufacturers recommendations or instrument history,
and whenever a major change in the reagents or
equipment or instrument could affect the calibration.
a-&1a) ,01 The cost of investing in the develop-
ment of new or improved facilities, services, or
equipment. Does not include operational costs.
a/" -)a+ See plan of care.
"/1&#&a1&,+
1. The procedure and action by which an authorized
organization evaluates and certifies that an individ-
ual, institution, or program meets requirements,
such as standards. Certification differs from accredi-
tation in that certification can also be applied to
individuals (for example, a medical specialist).
2. The process by which a nongovernment agency or
association certifies that an individual has met pre-
determined qualifications specified by that agency or
association.
)"a+&+$ Removal of all visible dust, soil, and any
other visible material that microorganisms might
find favorable for continued life and growth. This is
usually done by scrubbing with hot water and deter-
gent.
)&+&a) )ab,/a1,/6 A facility that is equipped to
examine material derived from the human body to
provide information for use in the diagnosis, preven-
tion, or treatment of disease; also called medical lab-
oratory.
)&+&a) -a1%,),$6 Services related to solving
clinical problems, particularly using laboratory
methods in clinical diagnosis. Includes clinical
chemistry, bacteriology and mycology, parasitology,
virology, clinical microscopy, hematology, coagula-
tion immunohematology, immunology, serology,
and radiobioassay.
)&+&a) -a1%4a60 An agreed-upon treatment
regime that includes all elements of care.
)&+&a) -/a1&" $2&!")&+"0 Statements that
help practitioners and patients choose appropriate
health care for specific clinical conditions (for exam-
ple, recommendations on the case management of
diarrhea in children under the age of 5 years). The
practitioner is guided through all steps of consulta-
tion (questions to ask, physical signs to look for, lab
exams to prescribe, assessment of the situation, and
treatment to prescribe).
)&+&a) /",/! See patient record/medical
record/clinical record.
)&+&a) 01a## See staff.
)&+&a) 1/&a) Therapy testing in three or some-
times four stages, depending on the purpose, size,
and scope of the test. Phase I trials evaluate the
safety of diagnostic, therapeutic, or prophylactic
drugs, devices, or techniques to determine the safe
dosage range (if appropriate). They involve a small
number of healthy subjects. The trial usually lasts
about one year. Phase II trials are usually con-
trolled to assess the effectiveness and dosage (if
appropriate) of the drugs, devices, or techniques.
These studies involve several hundred volunteers,
including a limited number of patients with the tar-
get disease or disorder. The trial usually lasts about
two years. Phase III trials verify the effectiveness of
the drugs, devices, or techniques determined in
Phase II studies. Phase II patients are monitored to
identify any adverse reactions from long-term use.
These studies involve groups of patients large
enough to identify clinically significant responses.
The trial usually lasts about three years. Phase IV
trials study the drugs, devices, or techniques that
have been approved for general sale. These studies
are often conducted to obtain more data about a
products safety and efficacy.
CLSI Clinical and Laboratory Standards Institute.
,*-"1"+" A determination of an individuals
skills, knowledge, and capability to meet defined expec-
tations, as frequently described in a job description.
,+#&!"+1&a)&16
1. The restricted access to data and information to
individuals who have a need, a reason, and permis-
sion for such access.
2. An individuals right to personal and information-
al privacy, including for his or her health care
records.
,+1a*&+a1&,+ The presence of an infectious
agent on an animate or inanimate surface.
,+1&+2&16 ,# a/" The degree to which the care
of individuals is coordinated among practitioners,
among organizations, and over time.
,+1&+22* ,# a/" Matching the individuals
ongoing needs with the appropriate level and type of
care, treatment, and service within an organization
or across multiple organizations.
,+1/a1"! 0"/3&"0 Services provided through
a written agreement with another organization,
agency, or individual. The agreement specifies the
services or personnel to be provided on behalf of the
applicant organization and the fees to provide these
services or personnel.
/"!"+1&a)&+$ The process of obtaining, verifying,
and assessing the qualifications of a health care practi-
tioner to provide patient care services in or for a health
care organization. The process of periodically checking
staff qualifications is called recredentialing.
/"!"+1&a)0 Evidence of competence, current and
relevant licensure, education, training, and experi-
ence. Other criteria may be added by a health care
organization. Also see competence; credentialing.
!a1a Facts, clinical observations, or measurements
collected during an assessment activity. Data before
they are analyzed are called raw data.
!&0a01"/ See emergency.
!&0%a/$" The point at which an individuals
active involvement with an organization or program
is terminated, and the organization or program no
longer maintains active responsibility for the care of
the individual.
!&0%a/$" 02**a/6 A section of a patient record
that summarizes the reasons for admission, the signifi-
cant findings, the procedures performed, the treatment
rendered, the patients condition on discharge, and any
specific instructions given to the patient or family (for
example, follow-up, medications).
!&0&+#"1&,+ The use of a chemical procedure that
eliminates most disease-producing organisms, but not
all microbial forms.
148
149
GLOSSARY
9!, +,1 20": )&01 A written catalog of abbrevia-
tions, acronyms, and symbols that are not to be used
throughout an organizationwhether handwritten
or entered as free text into a computerdue to their
potentially confusing nature.
"##&&"+6 The relationship between the outcomes
(results of care) and the resources used to deliver
care. For example, when two programs use the same
amount of resources, the one that achieves a higher
immunization coverage rate is the more efficient.
Increasing efficiency involves achieving the same
outputs with fewer resources or more outputs with
the same amount of resources.
"*"/$"+6
1. An unanticipated or sudden occasion, as in emer-
gency surgery needed to prevent death or serious
disability.
2. A natural or man-made event that significantly
disrupts the environment of care (for example, dam-
age to the organizations building[s] and grounds
due to severe winds, storms, or earthquakes); that
significantly disrupts care and treatment (for exam-
ple, loss of utilities such as power, water, or tele-
phones due to floods, civil disturbances, accidents,
or emergencies in the organization or its communi-
ty); or that results in sudden, significantly changed
or increased demands for the organizations services
(for example, bioterrorist attack, building collapse,
or plane crash in the organizations community).
Some emergencies are called disasters or potential
injury-creating events (PICEs).
"+3&/,+*"+1a) *a+a$"*"+1 -)a+(0) The
organizations written document describing the
process it has in place for the following areas of its
operations: safety and security, hazardous materials,
emergencies, fire safety, medical equipment, and
utility systems. The plan identifies specific proce-
dures that describe mitigation, preparedness,
response and recovery strategies, actions, and
responsibilities.
".2&-*"+1 *a&+1"+a+", -/"3"+1&3" The
planned, scheduled, visual, mechanical, engineering,
and functional evaluation of equipment conducted
before using new equipment and at specified inter-
vals throughout the equipments lifetime. The pur-
pose is to maintain equipment performance within
manufacturers guidelines and specifications and to
help ensure accurate diagnosis, treatment, or moni-
toring. It includes measuring performance specifica-
tions and evaluating specific safety factors.
".2&-*"+1 *a&+1"+a+", /,21&+" The per-
formance of basic safety checksthat isthe visual,
technical, and functional evaluations of equipment,
to identify obvious deficiencies before they have a
negative impact. It normally includes inspections of
the case, power cord, structural frame, enclosure,
controls, indicators, and so on, as appropriate.
"3&!"+"-ba0"! (,/ 0&"+1&#&-ba0"!)
$2&!")&+"0 Making clinical decisions based on
empirical evidence or, in the absence of empirical
evidence, expert consensus (such as consensus state-
ments promoted by professional societies). The
approach requires understanding conflicting results
and assessing the quality and strength of evidence.
Finally, practitioners must know how this applies to
patient care and health care policy.
#a&)2/" *,!" a+! "##"10 a+a)60&0 (FMEA)
A systematic way of examining a design prospective-
ly for possible ways in which failure can occur. It
assumes that no matter how knowledgeable or care-
ful people are, errors will occur in some situations
and may even be likely to occur.
#a*&)6 The person(s) with a significant role in the
patients life. This may include a person(s) not legal-
ly related to the patient. This person(s) is often
referred to as a surrogate decision maker if author-
ized to make care decisions for a patient if the
patient loses decision-making ability.
#2+1&,+a) 01a120 The ability of individuals to
take care of themselves physically and emotionally as
appropriate to their age group. Functional status
may be divided into social, physical, and psy-
chological functions. Functional status may be
assessed by asking questions during periodic health
examinations or using formal screening instruments.
Also see measure.
$,3"/+a+" The individual(s), group, or agency
that has ultimate authority and responsibility for
establishing policy, maintaining quality of care, and
providing for organization management and plan-
ning. Other names for this group include board,
board of trustees, board of governors, board of
commissioners, and governing body.
%a/3"01&+$, ,# ,/$a+0 Removal of an organ for
means of transplantation.
%a7a/!,20 *a1"/&a)0 a+! 4a01" Materials
whose handling, use, and storage are guided or
defined by local, regional, or national regulation,
hazardous vapors, and hazardous energy sources.
Although JCI considers infectious waste as falling
into this category of materials, not all laws and regu-
lations define infectious or medical waste as haz-
ardous waste.
%a7a/! 32)+"/ab&)&16 a+a)60&0 The identifica-
tion of potential emergencies and the direct and
indirect effects these emergencies may have on the
health care organizations operations and the
demand for its services.
%"a)1% a/"8a00,&a1"! &+#"1&,+(0) (HAI0)
Any infection(s) acquired by an individual while
receiving care or services in a health care organization.
Common HAIs are urinary infections, surgical wound
infections, pneumonia, and bloodstream infections.
%"a)1% a/" ,/$a+&7a1&,+ A generic term used
to describe many types of organizations that provide
health care services. This includes ambulatory care
centers, behavioral/mental health institutions, home
care organizations, hospitals, laboratories, and long
term care organizations. Also known as a health
care institution.
%"a)1% a/" ,/$a+&7a1&,+ *a+a$"*"+1
01a+!a/!0 For purposes of JCI accreditation,
standards that are organized according to what is
done directly or indirectly to provide for a safe,
effective, and well-managed organization and facility
(for example, prevention and control of infection,
facility management, staff qualifications).
%"a)1% a/" -/,#"00&,+a) Any person who has
completed a course of study and is skilled in a field
of health care. This includes a physician, dentist,
nurse, or allied health professional. Health care pro-
fessionals are often licensed by a governmental
agency or certified by a professional organization.
%&01,$/a* A graphic display, using a bar graph, of
the frequency distribution of a variable. Rectangles
are drawn so that their bases lie on a linear scale rep-
resenting different intervals, their heights are propor-
tional to the frequencies of the values within each of
the intervals.
&+!"-"+!"+1 -/a1&1&,+"/ Any individual per-
mitted by law and by the organization to provide
care and services, without direction or supervision,
within the scope of the individual's license. In many
countries licensed independent practitioners include
physicians, dentists, some categories of nurses, podi-
atrists, optometrists, and chiropractors.
&+!&a1,/ A measure used to determine, over time,
an organizations performance of functions, process-
es, and outcomes.
&+#"1&,20 4a01" See hazardous materials and
waste.
&+#,/*a1&,+ *a+a$"*"+1 The creation, use,
sharing, and disposal of data or information across
an organization. This practice is critical to the effec-
tive and efficient operation of organization activities.
It includes the role of management to produce and
control the use of data and information in work
activities, information resources management, infor-
mation technology, and information services.
&+#,/*"! ,+0"+1 Agreement or permission
accompanied by full information on the nature,
risks, and alternatives of a medical procedure or
treatment before the physician or other health care
professional begins the procedure or treatment. After
receiving this information, the patient either con-
sents to or refuses such a procedure or treatment.
&+-a1&"+1 Generally, persons who are admitted to
and housed in a health care organization at least
overnight.
&+-0"/3&" "!2a1&,+ Organized education,
usually provided in the workplace, designed to
enhance the skills of staff members or teach them
new skills relevant to their jobs and disciplines.
&+1"$/a1"! -/,3&!"/ (0601"*) A health care
provider that offers a broad corporate system for
managing a diversified health care delivery system.
150
151
GLOSSARY
The system typically includes one or more hospitals, a
large group practice, a health plan, and other health
care operations. Physicians practice as employees of the
system or in a tightly affiliated physician group. The
system can provide several levels of health care to
patients in the same geographic areas.
&+1"+1 01a1"*"+1 A brief explanation of a stan-
dards rationale, meaning, and significance, noted in
this manual under the heading Intent. Intent
statements may contain detailed expectations of the
standard that are evaluated in the on-site survey
process.
&+3a0&3" -/,"!2/" A procedure involving
puncture or incision of the skin, or insertion of an
instrument or foreign material into the body.
JCI A/"!&1a1&,+ P/,$/a* The division of
Joint Commission International responsible for
administration of all activities related to organiza-
tional health care accreditation or certification.
',b !"0/&-1&,+ Explanation of an employment
position including duties, responsibilities, and con-
ditions required to perform the job.
(&1 All components of a test packaged together.
)ab,/a1,/6 See pathology and clinical laboratory
services.
)"a!"/ An individual who sets expectations, devel-
ops plans, and implements procedures to assess and
improve the quality of the organizations governance,
management, clinical, and support functions and
processes. The leaders described in the JCI standards
include at least the leaders of the governing body;
the chief executive officer and other senior man-
agers; departmental leaders; the elected and the
appointed leaders of the medical staff and the clini-
cal departments and other medical staff members in
organizational administrative positions; and the
nurse executive and other senior nursing leaders.
)"3")0 ,# a/" A classification of health care ser-
vice levels. They are divided by the kind of care
given, the number of people served, and the people
providing the care. The main levels of care are pri-
mary, secondary, and tertiary. Levels of care classified
by the acuity of the patient or intensity of the servic-
es provided are emergency, intensive, and general.
Also see continuum of care.
)&"+02/" A legal right that is granted by a gov-
ernment agency in compliance with a statute gov-
erning an occupation (such as physicians, nurses,
psychiatry, or clinical social work, or the operation
of a health care facility).
*"a02/"
1. To collect quantifiable data about a function, sys-
tem, or process (one measures).
2. A quantitative tool. Also see indicator.
*"!&a) ".2&-*"+1 Fixed and portable equip-
ment used for the diagnosis, treatment, monitoring,
and direct care of individuals.
*"!&a) /",/! See patient record/medical
record/clinical record.
*"!&a) 4a01" See hazardous materials and waste.
*"!&a1&,+ Any prescription medications; sample
medications; herbal remedies; vitamins; nutriceuti-
cals; over-the-counter drugs; vaccines; diagnostic and
contrast agents used on or administered to persons
to diagnose, treat, or prevent disease or other abnor-
mal conditions; radioactive medications; respiratory
therapy treatments; parenteral nutrition; blood
derivatives; and intravenous solutions (plain, with
electrolytes and/or drugs).
*"!&a1&,+, %&$%-/&0( ,/ %&$%-a)"/1 Those
drugs that carry a risk for errors that can lead to sig-
nificant adverse outcomes.
*"!&a1&,+ "//,/ A preventable event that may
cause inappropriate medication use or jeopardize
patient safety. Also see sentinel event.
*&00&,+ 01a1"*"+1 A written expression that
sets forth the purpose, or mission, of an organization
or one of its components. The generation of a mis-
sion statement usually precedes the formation of
goals and objectives.
*,+&1,/&+$ The review of information on a regu-
lar basis. The purpose of monitoring is to identify
the changes in a situation. For example, the health
information specialist of district health management
team reports every month the cases of meningitis
occurring in villages at risk.
*2)1&!&0&-)&+a/6 Including representatives of a
range of professions, disciplines, or service areas.
NCCLS Formerly the National Committee for
Clinical Laboratory Standards.
+"a/ *&00 A process variation that did not affect an
outcome but for which a recurrence carries a significant
chance of a serious adverse outcome. A near miss falls
within the scope of the definition of an adverse event.
Also see adverse event.
+,+)&+&a) 01a## See staff.
+,0,,*&a) &+#"1&,+(0) See health care
associated infection(s).
+21/&1&,+a) a/" Interventions and counseling to
promote appropriate nutrition intake. This activity
is based on nutrition assessment and information
about food, other sources of nutrients, and meal
preparation. It considers the patients cultural back-
ground and socioeconomic status.
+21/&1&,+ 1%"/a-6 Medical treatment that
includes enteral and parenteral nutrition.
,b0"/3a1&,+ The time during which a patient is
watched closely by a caregiver (or caregivers).
,/$a+&7a1&,+a) %a/1 A graphic representation
of titles and reporting relationships in an organiza-
tion, sometimes referred to as an organogram or
organization table.
,/&"+1a1&,+ A process to provide initial training
and information and to assess new staff members
competence related to their job responsibilities and
the organizations mission, vision, and values.
,21,*" The effect(s) that an intervention has on
a specific health problem. It reflects the purpose of
the intervention. For example, the outcome(s) of a
rural health education program on safe drinking
water could be fewer diarrhea episodes in children
under 5 or decreased child mortality by diarrhea.
,21-a1&"+1 Generally, persons who do not
need the level of care associated with the more
structured environment of an inpatient or a resi-
dential program. In many countries, outpatient
care is also known as ambulatory care. In
some countries, outpatients are considered
admitted to a health care organization; in oth-
ers, outpatients are considered
9/"$&01"/"!.: Also see ambulatory care.
-a))&a1&3" 0"/3&"0 Treatments and support
services intended to alleviate pain and suffering
rather than to cure illness. Palliative therapy may
include surgery or radiotherapy undertaken to
reduce or shrink tumors compressing vital structures
and thereby improve the quality of life. Palliative
services include attending to the patients psycholog-
ical and spiritual needs and supporting the dying
patient and his or her family.
-a1%,),$6 a+! )&+&a) )ab,/a1,/6 0"/3&"0
The services that provide information on diagnosis,
prevention, or treatment of disease or the assessment
of health, through the examination of the structural
and functional changes in tissues and organs of the
body that cause or are caused by disease. It also
includes the biological, microbiological, serological,
chemical, immunohematological, hematological, or
other examination of materials derived from the
human body.
-a1&"+1 An individual who receives care, treat-
ment, and services. For JCI standards, the patient
and family are considered a single unit of care.
-a1&"+1 a/" -/,"00 The process of providing
accommodations, comfort, and treatment to an
individual. This implies responsibility for safety,
including treatment, services, habilitation, rehabilita-
tion, or other programs requested by the organiza-
tion or network for the individual.
-a1&"+1-"+1"/"! 01a+!a/!0 For purposes of
JCI accreditation, standards that are organized
according to what is done directly or indirectly for
or to patients (for example, patient education, cre-
ation of patient records, patient assessment).
-a1&"+1 /",/!/*"!&a) /",/!/)&+&a)
/",/! A written account of a variety of patient
health information, such as assessment findings,
treatment details, progress notes, and discharge
152
153
GLOSSARY
summary. This record is created by health care pro-
fessionals.
-%60&,),$&-ba0"! /&1"/&a Criteria centered
on the branch of biology dealing with the functions
of the living organism and its parts of the physical
and chemical factors and processes involved.
-)a+ A detailed method, formulated beforehand,
that identifies needs, lists strategies to meet those
needs, and sets goals and objectives. The format of
the plan may include narratives, policies and proce-
dures, protocols, practice guidelines, clinical paths,
care maps, or a combination of these.
-)a+ ,# a/" A plan that identifies the patients
care needs, lists the strategy to meet those needs,
documents treatment goals and objectives, outlines
the criteria for ending interventions, and documents
the individuals progress in meeting specified goals
and objectives. It is based on data gathered during
patient assessment. The format of the plan in some
organizations may be guided by specific policies and
procedures, protocols, practice guidelines, clinical
paths, or a combination of these. The plan of care
may include prevention, care, treatment, habilita-
tion, and rehabilitation. Also see plan.
-,&+1-,#-a/" 1"01&+$ Analytic testing per-
formed at sites outside the traditional laboratory
environment, usually at or near where care is deliv-
ered to individuals.
-/a1&" $2&!")&+"0 Tools that describe process-
es found by clinical trials or by consensus opinion of
experts to be the most effective in evaluating and/or
treating a patient who has a specific symptom, con-
dition, or diagnosis, or describe a specific procedure.
Synonyms include practice parameter, protocol, pre-
ferred practice pattern, and guideline. Also see evi-
dence-based (scientific-based) guidelines and clinical
practice guidelines.
-/"3"+1&3" a1&,+ An action taken to eliminate
the cause of a potentially undesirable result.
-/"3"+1&3" 0"/3&"0 Interventions to promote
health and prevent disease. This includes identifica-
tion of and counseling on risk factors (for example,
smoking, lack of physical activity), screening to
detect disease (for example, breast cancer, sexually
transmitted diseases), immunizations, and chemo-
prophylaxis (for example, hormone replacement
therapy).
-/&*a/6 0,2/" 3"/&#&a1&,+ Verification of an
individual health care practitioners reported qualifi-
cations by the original source or an approved agent
of that source. Methods for conducting primary
source verification of credentials include direct cor-
respondence, documented telephone verification, or
secure electronic verification from the original quali-
fication source or reports from credentials verifica-
tion organizations that meet JCI requirements.
-/&3&)"$&+$ The process whereby a specific scope
and content of patient care services (that is, clinical
privileges) are authorized for a health care practition-
er by a health care organization, based on evaluation
of the individuals credentials and performance.
-/,"00 A series of actions (or activities) that
transform the inputs (resources) into outputs (ser-
vices). For example, a rural health education pro-
gram will require that staff develop an education
strategy, develop educational materials, and deliver
the education sessions.
-/,#&&"+6 1"01&+$
1. The assessment of technical knowledge and skills
related to certain occupations.
2. A peer comparison program used by laboratories
to assess reliability of tests performed. Samples are
provided to laboratories, whose precise contents are
unknown to the testing laboratory, for periodic
analyses, the results of which are compared with
other laboratories that perform the same tests.
-/,1,,) Scientific treatment plan or study out-
lineincluding types of trial participants, schedule,
procedures, medications and dosages, and so forth
for using an experimental procedure or a new treat-
ment with the intent of measuring human applica-
tions.
.2a)&#&"! &+!&3&!2a) An individual or staff
member who can participate in one or all of the
organizations care activities or services. Qualification
is determined by the following: education, training,
experience, competence, applicable licensure, law or
regulation, registration, or certification.
.2a)&16 ,+1/,) The performance of processes
through which actual performance is measured and
compared with goals, and the difference is acted upon.
.2a)&16 &*-/,3"*"+1 An approach to the con-
tinuous study and improvement of the processes of
providing health care services to meet the needs of
patients and others. Synonyms include continuous
quality improvement, continuous improvement,
organizationwide performance improvement, and
total quality management.
.2a)&16 ,# a/" The degree to which health servic-
es for individuals and populations increase the likeli-
hood of desired health outcomes and are consistent
with current professional knowledge. Dimensions of
performance include the following: patient perspec-
tive issues; safety of the care environment; and accessi-
bility, appropriateness, continuity, effectiveness, effica-
cy, efficiency, and timeliness of care.
/"a00"00*"+1 Ongoing data collection that
begins on initial assessment, comparing the most
recent data collected on the previous assessment.
/"/2&1&+$ Seekingusually newemployees or
other members of an organization.
/"#"//a) The sending of an individual (1) from one
clinician to another clinician or specialist; or (2) from
one setting or service to another or other resource,
either for consultation or care that the referring source
is not prepared or qualified to provide.
/"%ab&)&1a1&,+ 0"/3&"0 The use of medical,
social, educational, and vocational measures together
for training or retraining individuals disabled by dis-
ease or injury. The goal is to enable patients to achieve
their highest possible level of functional ability.
/&0( *a+a$"*"+1 -/,$/a* Clinical and
administrative activities that an organizations under-
takes to identify, evaluate, and reduce the risk of
injury to patients, staff, and visitors and the risk of
loss to the organization itself.
/,,1 a20" a+a)60&0 A process for identifying
the basic or causal factor(s) that underlie variation in
performance, including the occurrence or possible
occurrence of a sentinel event. Also see sentinel
event.
0a#"16 The degree that the organizations build-
ings, grounds, and equipment do not pose a hazard
or risk to patients, staff, or visitors.
0,-" ,# -/a1&" The range of activities per-
formed by a practitioner in a health care organiza-
tion. The scope is determined by training, tradition,
law or regulation, or the organization.
0,-" ,# 0"/3&"0 The range of activities per-
formed by governance, managerial, clinical, and sup-
port personnel.
0/""+&+$ /&1"/&a A set of standardized rules or
tests applied to patient groups on which to base a
preliminary judgment that further evaluation is war-
ranted, such as the need for a nutritional evaluation
based on nutritional screening.
0"2/&16 Protection from loss, destruction, tam-
pering, or unauthorized access or use.
0"!a1&,+ See anesthesia and sedation.
0"+1&+") "3"+1 An unanticipated occurrence
involving death or major permanent loss of function.
0&!" "##"1 Pharmacological effect of a drug, nor-
mally adverse, other than the one(s) for which the
drug is prescribed.
0-"&a)16 )ab,/a1,/6 -/,$/a*0 Programs
that include laboratory disciplines such as chemistry
(including toxicology, therapeutic drug testing, and
drugs of abuse testing); clinical cytogenetics-
immunogenetics; diagnostic immunology;
embryology; hematology (including coagulation
testing); histocompatibility; immunohematology;
microbiology (including bacteriology, mycobacteri-
ology, mycology, virolology, and parasitology);
molecular biology; pathology (including surgical
pathology, cytopathology, and necropsy); and radio-
bioassay.
01a## As appropriate to their roles and responsibili-
ties, all people who provide care, treatment, and
services in the hospital (for example, medical staff
and nursing staff ), including those receiving pay
(permanent, temporary, and part-time personnel, as
well as contract employees), volunteers, and health
profession students.
154
155
GLOSSARY
)&+&a) 01a## Those who provide direct patient
care (physicians, dentists, nurses, and others).
+,+)&+&a) 01a## Those who provide indirect
patient care (admissions, food service, and others).
01a+!a/! A statement that defines the perform-
ance expectations, structures, or processes that must
be in place for an organization to provide safe and
high-quality care, treatment, and services.
01a+!a/!0-ba0"! "3a)2a1&,+ An assessment
process that determines a health care organizations
or practitioners compliance with preestablished
standards. Also see accreditation.
01"/&)" result of a physical or chemical procedure
being used to destroy all microbial life, including
highly resistant bacterial endospores.
02/3&3,/ /&0( #a1,/0 Chances for surviving
family members or other loved ones experiencing
difficulties with the death of a loved one.
06*-1,*, -/&*a/6 First or most prominent
indication of an illness, disease, or other disorder.
06*-1,*, 0",+!a/6 An indication of illness,
disease, or other disorder that appears after or
because of a primary symptom.
1%"/a-"21& !2-)&a1&,+ One person using two
drugs, usually unnecessarily, from the same thera-
peutic category at the same time.
1&*"-,21 A pause, just prior to performing a surgical
or other procedure, during which any unanswered
questions or confusion about patient, procedure, or
site are resolved by the entire surgical or procedural
team. Even when there is only one person doing the
procedure, a brief pause to confirm the correct
patient, procedure, and site is appropriate.
1/a"/ *"1%,!,),$6 A process that JCI survey-
ors use during the on-site survey to analyze an orga-
nizations systems by following individual patients
through the organizations health care process in the
sequence experienced by the patients. Depending on
the health care setting, this may require surveyors to
visit multiple care units, departments, or areas with-
in an organization or a single care unit to trace the
care rendered to a patient.
-a1&"+1 1/a"/ The process used by JCI to
evaluate an individual patients total care experi-
ence within a health care organization.
0601"* 1/a"/ A session during the on-site
survey devoted to evaluating high-priority safety
and quality-of-care issues on a systemwide basis
throughout the organization. Examples of such
issues may include infection prevention and
control, medication management, staffing effec-
tiveness, and the use of data.
1/a+0#"/ The formal shifting of responsibility for
the care of a patient from (1) one care unit to anoth-
er, (2) one clinical service to another, (3) one quali-
fied practitioner to another, or (4) one organization
to another.
21&)&16 0601"* Organizationwide system and
equipment that support the following: electrical
distribution; emergency power; water; vertical and
horizontal transport; heating, ventilating, and air-
conditioning; plumbing, boiler, and steam; piped
gases; vacuum systems; or communication systems,
including data-exchange systems. May also include
systems for life support; surveillance, prevention,
and control of infection; and environment support.
21&)&7a1&,+ The use, patterns of use, or rates of use
of a specified health care service. Overuse occurs
when a health care service is provided under circum-
stances in which its potential for harm exceeds the
possible benefits. Underuse is the failure to use a
necessary health care service when it would have
produced a favorable outcome for a patient. Misuse
occurs when an appropriate service has been selected
but a preventable complication occurs. All three
reflect a problem in quality of health care. They can
increase mortality risk and diminish quality of life.
Also see utilization management.
21&)&7a1&,+ *a+a$"*"+1 The planning, orga-
nization, direction, and control of resources. How
this relates to patient care by a health care organiza-
tion is significant.
3a/&a1&,+ The differences in results obtained in
measuring the same event more than once. The
sources of variations can be grouped into two major
classes: common causes and special causes. Too
much variation often leads to waste and loss, such as
the occurrence of undesirable patient health out-
comes and increased cost of health services.
156
157
A
ABO blood group
antibody testing and, 129130
determining, 128
donor blood testing for, 119, 120
reliability of reagents for, 129
whole blood and, 121, 130
Accreditation
application for, 11
benefits of, 1
certificates, 14, 22
defined, 1, 145
framework, 145
goal of, 2
maintaining, 22
renewal process, 27
service specialist, 11
status, 22
Accreditation awards
compliance with standards for, 9
display and use of, 22
effective date for, 10
length of, 10
ownership changes impact on, 10, 12, 18, 22, 23
renewal of, 10
re-survey and, 10
termination of, 12
Accreditation Committee (JCI), 9, 17, 20
Accreditation decisions
appeal policy, 2122
categories of, 9, 21
defined, 145
Accreditation process
communication issues and, 1213
confidentiality issues, 1920
defined, 145
information accuracy related to, 11
time line, 10
Accreditation Program (JCI). See JCI Accreditation
Program
Accreditation survey
billing procedure for, 1415
defined, 145
fee structure for, 1315
observation of, 16
outcomes of, 9
purpose of, 9
reporting requirements between, 2223
requirements for, 9
At Risk for Denial of Accreditation and, 12, 13
scheduling, 11
scope of, 9
travel costs related to, 14
Action plan, 24, 25
Adverse events
blood transfusion and, 133
defined, 146
preventing/reducing, 5455
Ambulatory care, 30, 146
Analytes
defined, 146
proficiency testing for, 9596
using different methodologies for, 9798
Analytic sensitivity, 146
Analytic specificity, 146
Analytic systems
calibration of, 100
validation for, 9899
Anatomic pathology, 146, 147
Antibody testing, 129130
Anti-D blood grouping reagent, 121
Antifungal susceptibility testing systems, 110
Antihemophilic factor (AHF), 124
Antimicrobial susceptibility testing systems, 110
Antimycobacterial susceptibility testing systems, 110
Antisera, 137, 138
Application for accreditation, 11
Index
09 JCIIL09 - Index - 4th Pages:Laout 1 9/17/2009 5:19 PM Page 157
Assessment
defined, 147
patient, 31, 152, 153
At Risk for Denial of Accreditation. See also Denial
of Accreditation
accreditation survey and, 12, 13
focused surveys and, 16, 21
policy related to, 20
procedure, 2021
purpose of, 20
Autologous blood, 118119
Automated differential counts, 109
Automated tests, 107108
Automated urine sediment method, 113
Autopsy tissues
assuring diagnosis quality from, 102
gross and microscopic analysis of, 103104
B
Backup procedure, 81, 101, 102
Bacteriology services, 109110
Basic facilities. See Facilities planning
Biohazard materials and waste. See Hazardous mate-
rials and waste
Blood
derivative, 147
film evaluation, 108109
specimens, 138139
Blood administration
acceptable practices for, 131
processes used prior to, 132
Blood and components
defined, 147
introduction to, 92
maintaining identification of, 127128
selecting, for transfusion, 130131
storage issues, 126127
Blood bank
checking blood out of, 131132
donor selection and testing and, 116120
introduction to, 9192
standards related to, 115116
Blood component preparation
introduction to, 92
Blood donor
autologous blood and, 118119
collecting blood from, 118
deferral of, 117
history of, 116117
HLA serologic typing of, 136137
identifying records of, 119
with incompatibility potential, 137
maintaining records of, 134
physical examination of, 117118
screening of, 116
testing blood of, 119120
whole blood and, 121
Blood transfusion
blood testing prior to, 128129
compatibility testing and, 129130
defined, 147
donor selection and testing and, 116120
introduction to, 9192, 9294
patient safety and, 130, 131
processes used during, 132
reactions during, 133
selecting blood and components for, 130131
whole blood and, 121
C
Calibration material, 147
Calibration verification, 147
Cancellation policy, 13
Capital cost, 147
Care orders, 30
Care process. See Patient care
Cell-exchange program, 138
Cellular-defined antigens, 135136
Certification, 2, 147
Chemotherapeutic materials and waste, 83, 84
Clinical chemistry tests, 107108
Clinical laboratory
defined, 147
services, 152
testing, 9091
Clinical microscopy, 113
Clinical pathology, 147
Clinical pathways, 147
Clinical practice guidelines, 147, 148
Clinical records. See Patient records
Clinical staff, 154
158
159
INDEX
Clinical trial, 148
Clinicians
communicating with, 4344, 64
meeting needs of, 43
notifying test results to, 63
Coagulation tests, 107108
Communicable diseases, 119, 121
Communication
accreditation process and, 1213
caregivers and, 30
effective, 3031
for improvement process, 47
laboratory planning and, 75
laboratory services and, 4244
proficiency testing and, 96
for quality management, 47
wrong-site, wrong-procedure, wrong-patient sur-
gery and, 31
Compatibility testing, 129130
Competence
assessment, 7374
defined, 148
Complaints
about patient care, 42
about sentinel events, 26
availability of information related to, 2627
from clinicians, 43
confidentiality issues, 20
quality control issues and, 102
Computer crossmatch. See Crossmatch
Computer software and information, maintaining,
8081
Confidentiality issues, 1920, 148
Contamination
defined, 148
nucleic acid, 141
Continuity of care, 148
Continuum of care, 148
Contracted services, 148
Contract laboratory services
reporting of results and, 62
Control limits, 142
Control results, 137
Corrected reports, generating, 64
Corrective action, 141
Correct-site, correct-procedure, correct-patient sur-
gery, 3132
Creutzfeldt-Jacob disease, 117
Critical test results, 30, 4344, 63
Crossmatch, 130, 131, 137
Cryoprecipitated AHF, standards related to, 125, 126
Cytogenetics testing, 139
Cytology evaluations, 106107
Cytopathology services, 105106
D
Data, defined, 148
Data analysis
frequency of, 52
goal of, 5253
quality management and, 52
reasons for conducting, 53
Data collection
frequency of, 51
for safety activities, 54
uses of, 51
Deep sedation/analgesia, 146
Denial of Accreditation
defined, 145
focused surveys and, 17
laws and regulations and, 20
on-site surveys and, 16
Development and Control of Policies and
Procedures (DCP) standards
analytic, 6162
control of, 58
discontinued, 58
introduction to, 57
postanalytic, 6264
preanalytic, 5961
requirement for, 5859
specimen retention, 6465
Dipstick testing, 113
Direct antiglobulin test, 129, 133
Documentation
corrective action, 101102
critical test results, 63
orientation, 72
pathologist's proficiency, 104
personnel information, 74
reagents, 8182
successful improvements, 54
test results, 101
verification checks, 99
in vivo testing, 115
Donor blood
collection of, 118
histocompatibility testing for, 135
release of, 120
retesting, 133
testing, 119120
"Do not use" list, 149
Du variant, 128, 129
E
Educational materials, 116, 117, 153
Education and training
continuing, 41
in-service, 73, 150
laboratory director, 71, 131
orientation and, 67, 72
pathologist's qualifications and, 103104
peer, 104
staff, 43, 54, 70, 71
Effective communication. See Communication
Electronic monitoring systems, 99100
Electronic testing equipment, 8081
Electron microscopy, 87
Emergency eyewash, 87
Emergency power, 77
Environmental management plans, 149
Equipment
electronic, 8081
for fire safety, 86
inspection of, 79
maintenance of, 7879, 149
medical, 151
personal protective, 83
providing space for, 76
safety evaluation of, 80
selecting and using, 78
syphilis test, 114
testing records, 101
Evacuation routes, 86
Extension survey
defined, 145
procedure, 18
External interlaboratory comparisons, 9597
Eyewash station, 87
F
Facilities planning
equipment and other materials, 7882
safety issues for, 82
space issues, 7576
utilities systems for, 7778
Failure mode and effects analysis (FMEA), 54, 149
Falsification, example of, 12
Fees
for accreditation survey, 1315
cancellation, 13, 14
for focused surveys, 14
payment of, 1415
postponement, 13
for validation survey, 18
Fire-extinguishing systems, 86, 87
Fire safety, 8687
Focused surveys
defined, 145
fee structure for, 1315
At Risk for Denial of Accreditation and, 16, 21
sentinel events and, 23, 26
travel costs related to, 14
unannounced, 17
Follow-up focused surveys
defined, 145, 146
description of, 16
procedure, 17
For-cause focused surveys
defined, 146
description of, 16
procedure, 17
Fresh frozen plasma, 123, 124, 126
Frozen red blood cells, 122
Functional status, 149
G
Genetic testing, 143
Graded interlaboratory comparison testing, 9597
Granulocytes, storage of, 126
160
161
INDEX
H
Hand hygiene, 32
Harvesting of organs, 150
Hazardous materials and waste
defined, 150
disposing of, 8485
electron microscopy, 87
emergency eyewash and, 87
handling and storage of, 8283
monitoring of, 85
risk of infection and, 83
safety issues, 83, 85
Hazard vulnerability analysis, 150
Health care
management standards, 150
organization, 150
process, 15, 155
professional, 150
provider, 150, 151
related infections, 32, 150
Hematology tests, 107108
High-risk processes, 54
Histocompatibility testing, 135
Histopathology
autopsy services, 102
immunohistochemistry, 103
introduction to, 90
HLA-A and -B antibodies, 135, 136
HLA testing, 135, 136137
Host systems, 112
Human resources, policies related to, 7071
I
Immunohistochemistry, 103
Immunological testing, 113114
Improvement program
approach to, 4445
communication for, 47
coordination of, 46
planning of, 4546
prioritizing, 49
processes design and, 4849
resources for, 47
review of, 55
Incorrect test results, policy for correcting, 64
Independent practitioner, 150
Infection prevention and control, 32, 83
Information accuracy
purpose of, 11
Information management, 52, 54, 150
Informed consent, 150
In-service education, 73, 150
Instruments. See Laboratory instruments
Integrated provider system, 150, 151
Intent statement, 151
Interlaboratory reproducibility, 138
Internal controls, validation for, 99100
International Patient Safety Goals (IPSG)
correct-site, correct-procedure, correct-patient
surgery, 3132
effective communication, 3031
health careassociated infections, 32
improvement activities and, 49
list of, 29
patient identification, 30
Interpretative report, 140
Invasive procedure, 151
In vitro radioassay procedures, 114115
In vivo testing, 115
J
Joint Commission International (JCI)
accreditation programs by, 23
certification programs by, 2
e-mail address, 11
fax number, 11
Joint Commission (US), relation to, 2
JCI Accreditation Program, 11, 12, 14, 16, 17, 18,
19, 20, 22, 26, 27
K
Karyotypes, 139, 140
L
Laboratory areas, 7576
Laboratory director. See also Leadership
laboratory equipment and, 78
qualifications, 71
responsibility of, 4142
role in laboratory services, 3840
Laboratory instruments
calibration of, 100
evaluating test results with different, 9798
function checks, 101, 119
validation for, 9899
Laboratory planning
authority issues and, 4142
for basic facilities, 7475
organization structure and, 41
responsibility for, 37
Laboratory processes/services
contract, 3839
improvement activities for, 49
monitoring, 51
number of staff for, 7172
performance criteria for, 4748
planning of, 3738
redesigning, 4849
reference, 3940
resources for, 40, 70
safety issues, 82
Laboratory tests
maintaining sample identification of, 140
measuring turnaround time for, 63
process for ordering, 59
records of, 139140
specimen collection for, 5960
Laws and regulations
contract and reference laboratories and, 38
denial of accreditation and, 20
hazardous materials and waste, 84, 85
policies and procedures and, 58
process deign and, 48
specimen retention and, 6465
staff qualifications, 71
Leadership
communication issues and, 4244, 47
for improvement process, 4546
laboratory planning and, 37, 7475
for laboratory services, 3839
process deign and, 4849
resource planning issues, 40
utilities systems and, 7778
Leukocyte-reduced red blood cells, 122
Licensure and certification, 38, 39, 151
Liquid plasma, 124
Lymphocyte cultures, 135136
M
Malarial parasites, 111, 112
Management and Leadership (MGT) standards
communication and coordination, 4244
laboratory planning, 3738
laboratory services, 3840
quality management and improvement process,
4455
resource planning, 40
responsibility and authority, 4142
Manual differential slide analyses, 108, 109
Manual tests, 107108
Medical record, 152
Medication(s)
blood donor history of, 116
defined, 151
error, 151
high-risk or high-alert, 151
patient identification and, 30
Minimal sedation, 146
Mixed lymphocytic culture (MLC) test, 136
Molecular microbiology testing, 111
Molecular testing
benefits of, 140141
genetic testing and, 143
reports/reporting, 142143
Monitoring process, 151
Mycobacteriology services, 109110
Mycology services, 109110
N
Near misses, 54, 152
New processes design. See Process design
Nonclinical staff, 154, 155
Nucleic acid contamination, 141
Nutritional care, 152
Nutrition therapy, 152
162
163
INDEX
O
Observation
of accreditation survey, 16
defined, 152
Official Accreditation Findings Report
accreditation awards and, 9
accreditation survey and, 14
confidentiality issues and, 1920
revision of, 21
On-site surveys
general information about, 15
observation of, 16
purpose of, 9
site visit for, 15
tracer methodology for, 1516
On-the-job training, 73
Organizational chart, 152
Organization Contact Information form, 12
Ownership changes, accreditation awards and, 10,
12, 18, 22, 23
P
Palliative services, 152
Parasitology services, 111112
Pathologists
documenting proficiency of, 104
evaluating qualifications of, 103104
Pathology and clinical laboratory services, 152
Patient(s)
assessment, 31, 152, 153
defined, 152
information, ensuring access to, 105
meeting needs of, 43
privacy and security issues, 42
tracer, 155
Patient care
complaints about, 42
process, 9, 15, 152
quality of, 1, 2
sentinel events and, 23
Patient identification
accuracy of, 30
blood transfusion and, 133
for specimen collection, 5960
Patient records
for blood transfusion, 132, 133
defined, 152
for electron microscopy, 87
molecular testing and, 143
Patient safety
blood transfusion and, 130, 131
laboratory facility and, 82
At Risk for Denial of Accreditation and, 20
Peer educational program, 104
Performance evaluation, 7374
Permanent stains, 111
Personal protective equipment, 83
Personnel information, documentation for, 74
Phlebotomy, 118
Physiologic-based criteria, 152
Plasma
cryoprecipitated AHF and, 125
maintaining quality of, 123125
platelet-rich, 124, 126
Platelets
storage of, 126
Point-of-care testing, 153
Policies and procedures
analytic, 6162
control of, 58
discontinued, 58
introduction to, 57
JCI, 729
postanalytic, 6264
preanalytic, 5961
requirement for, 5859
specimen retention, 6465
Postexamination processes, 62
Postponement policy, 13
Practice guidelines, 153
Preventive action, 153
Preventive services, 153
Primary source verification, 153
Privacy and security, patients' right to, 42
Privileging process, 153
Procedural (or moderate) sedation, 146
Process design
features of, 4849
measurable elements of, 49
Proficiency testing
defined, 153
purpose of, 96
requirement for, 96
slides, 111
Q
Qualifications. See Education and training
Quality and Safety Monitoring, 26
Quality Control Processes (QCP) standards
clinical laboratory testing, 107115
complaints and, 102
cytopathology, 105107
defined, 153
establishment of, 95
histopathology, 102105
instruments calibration and, 100
instruments testing and, 9899
monitoring systems validation and, 99100
for reagents, 109, 137138
test methods, 142
Quality improvement, 153, 154
Quality management. See also Improvement program
approach to, 4445
coordination of, 46
data analysis and, 5253
data collection for, 4951
planning of, 4546
resources for, 47
review of, 55
Quality of care, 154
R
Radioactive materials, 83, 85
Radiobioassay, standards related to, 114115
Reagents
for ABO group, 129
documentation of, 8182
evaluation of, 81
immunologic, 137
quality control process for, 109, 137138
for syphilis tests, 114
Reassessment, 154
Recipient blood
histocompatibility testing for, 135
HLA serologic typing of, 136137
retesting, 133
testing, 129
Records retention
for blood donor, 134
maintaining, 7980
for reagents, 8182
Records storage, policy related to, 6465
Recruiting process, 154
Red blood cells
plasma and, 124, 125
storage of, 126
Reference laboratory services, 3940
Reference organisms, 110
Reference ranges, 142
Refrigerator and freezer for blood storage, 127
Rehabilitation services, 154
Remedial action, 101102, 107
Reportable ranges, 142
Reports/reporting
corrected, generating, 64
molecular testing, 142143
procedure for, 62
sentinel events, 142143
Resource Management and Laboratory Environment
(RSM) standards
basic facilities, 7478
hazardous materials and waste, 8285
laboratory equipment, 7882
personnel information, 74
provision of resources, 7074
work environment, 8587
Rh type, 119, 120, 121, 128
Risk assessment, 85
Risk management program, 154
Risk of injuries, 85
Risk-reduction process, 54
Root cause analysis, 24, 25, 154
164
165
INDEX
S
Safety activities/issues
defined, 154
devices for, 87
electron microscopy, 87
fire safety and, 86
hazardous materials and waste, 83, 85
laboratory equipment, 80
laboratory services and, 82
work environment, 8586
Scope of practice, 154
Scope of services, 154
Screening criteria, 154
Self-assessment, 9
Sentinel events
defined, 23, 24, 154
disclosable information and, 26
focused surveys and, 23, 26
goal for, 23
implementing policy related to, 2526
on-site review of, 26
reasons for reporting, 25
response to, 24, 25
reviewable, 25
surveyors and, 24
Sera, 129
Serological testing, 113114
Site visit, 15
Specialty laboratory programs, 154
Specimen accession, 6061
Specimen collection
handling of, 84
procedure, 105
protocol for, 5960
sample identification and, 140
Specimen retention, 6465
Staff members. See also Education and training
defined, 154
human resources standards for, 7071
improving competence of, 73
orientation of, 72
performance evaluation of, 7374
personnel information of, 74
qualifications, 7172
Staining techniques, 106, 110111
Standards
availability of, 3
changes to, 4
communication, 3031, 34
compliance with, 9
correct-site, correct-procedure, correct-patient
surgery, 3132
development of, 23
effective date of, 4
health careassociated infections, 32
improvement process, 3435
laboratory planning, 33
management and leadership, 3335
measurable elements of, 3
organization of, 3
patient identification, 30
patient safety goals, 29
policies and procedures, 57
quality control processes, 8994
quality management, 3435
resource management and laboratory environ-
ment, 6769
responsibility and authority, 33
sentinel events, 23
updating of, 4
use of, 3
Standards-based evaluation, 155
Storage area/issues
for blood and components, 126127, 138139
hazardous materials and waste, 8283
monitoring, 127
Strategic Improvement Plan (SIP), 34
Surgical site, marking, 31
Surgical tissues
assuring diagnosis quality from, 102
gross and microscopic analysis of, 103104
identification of, 103
Surveyors
for focused surveys, 14, 16
qualifications and language skills of, 11
sentinel events and, 24
site visit by, 15
training of, 16
travel expenses, 11, 14, 15
Surveys. See Focused surveys; On-site surveys
Survivor risk factors, 155
Syphilis tests, 113, 114, 121
T
Temperature-recording probe, 127
Test methods/methodologies
instructions for, 6162
quality control process for, 142
Test results
evaluation, with different methodologies, 9798
notifying of, 63
review of, 101
verifying accuracy and reliability of, 97
Test run, 142
Therapeutic duplication, 155
Threat to public or patient safety
on-site surveys and, 16
procedure, 20
purpose of, 18
validation survey and, 18
Threshold Limit Values (TLV), 84
Time-out, 32, 155
Tracer methodology, 1516, 155
Transfusion service. See Blood transfusion
Travel costs, 11, 14, 15
Truthfulness policy
purpose of, 11
Turnaround time, measuring, 63
U
US Centers for Disease Control and Prevention (US
CDC), 32
Unannounced focused surveys, 17
United Network for Organ Sharing (UNOS)
Clinical Transplant Registry, 138
Universal Protocol, 31
Urinalysis, standards related to, 113
Utilities systems, 7778, 155
V
Validation
for electronic monitoring systems, 99100
for new instruments, 9899
for serological testing, 113
studies, 141142
survey, 18, 146
Verification checks, 99
Virology testing, 112
W
Washed red blood cells, 122
Whole blood
ABO blood group and, 121, 130
plasma and, 123125
platelets and, 122123
red blood cells and, 121122
storage of, 126
Work environment
fire safety issues and, 8687
hazardous materials and waste and, 87
safety devices for, 87
Work load limits, 107
World Health Organization (WHO), 32, 136
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2nd Edition

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