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Department of Health , I:
BUREAU OF RESEARCH AND LABORATORIES , I,
Manila, Phlllppines
First Edition
December, 997
:.'
. I ." ",if:
MANUAL
OF
STANDARDS
FOR
BLOOD
COLLECTION
UNITS
IN THE PHILIPPINES
Department of Health
11
1111111/11
0259
_ M31c 1997 I Manual of standards for blood collection unit
1stEdition
December, 1997
Printed in the Philippines
ISBN 971-91605-2-7
Equipment
3.9 Appropriate and Adequate Equipment 19
3.10 Quality of Equipment and Instruments 19
3.11 Proper Use of Equipment 19
3.12 Maintenance and Service 19
3.13 Calibration 21
3.14 Storage Equipment 21
3.15 Sterilization of Equipment 23
3.16 Breakdown of Equipment 23
Advocacy 32
4.1 Donor Recruitment and Retention 32
4.2 Donor Incentive Schemes 32
4.3 Avoiding Competition among BCUs for the Same
Population 33
Donor Selection 33
4.4 Target Groups for Blood Donation 33
4.5 Donor Temporary Deferment 33
4.6 Donors Needing Additional Medical Assessment
at the Time of Donation 35
4.7 Persons Who Cannot be Allowed to Donate Blood 36
Blood Collection 44
5.1 Prevention of Contamination 44
5.2 Training of Phlebotomists 44
5.3 Inspection of Biood Packs Priorto Venipuncture 44
5.4 Venipuncture 44
5.5 Individual Blood Handling Materials and Supplies 45
5.6 Mixing of Anticoagulant 45
5.7 Proper Recording and Labelling 45
5.8 Prolonged Duration of Blood Collection 45
5.9 Blood Samples for Testing 45
5.10 Volume of Whole Biood Collection 45
5.11 Labelling 46
5.12 Counterchecking of Labels Before Termination of
Collection and Discarding Unused Numbers 46
5.13 Terminating Blood Collection 46
5.14 Submission and Processing of Blood Units to BB/BC 47
Compatibility Testing 47
5.15 Compatibility of Donor Blood with Recipient Blood 47
General Requirements 60
7.1 Record Design 60
7.2 Record Changes 60
7.3 Confidentiality 60
7.4 Document Control 60
7.5 Security and Retrieval 61
7.6 Storage of Records 61
7.7 Retention of Record 61
Section 8 Research 69
8.1 BCU Operation Research Program 70
8.2 Personnel Training on Research Methodologies 70
8.3 Ethical Review 70
8.4 Funding 70
8.5 Data Submission and Utilization 70
Annexes 1,2,3,4 71-75
Abbreviations 76
Glossary 77-82
Acknowledgements 83-84
References 85-87
Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
SAN LAZARO COMPOUND, RlZAl AVENUE, STA. CRUZ, MANILA, PHILIPPINES
FOREWORD
The protection of the blood supply begins with the enunciation of principles and standards
which are indispensable for the safe and efficient practice of blood banking and blood transfusion in
the Philippines.
At a time when blood transmissible diseases and transfusion reactions are a growing problem, it
Is imperative that everyone concerned with these vital issues come together to define the standards of
professional practice. This Manual is a product of such cooperation.
The Standards for Blood Collection Units were prepared by the staff of the Bureau of
Research and Laboratories of the Department of Health (DOH), in collaboration with a technical panel
of experts, the DOH pathologists, representatives from the different specialty societies and various
resource persons.
We enjoin all concerned to strive towards the attainment of these Standards. Let us strive
towards the noble goal of ensuring the safety of the blood supply and achieving and maintaning its
adequacy through a fully voluntary system.
iii
INTRODUCTION
In an effort to move our country's blood banking system and blood transfusion services to a
totally voluntary system, the National Voluntary Blood Services Program (NVBSP) has classified Blood
Service Facilities (BSF) into: Blood Bank/Center (BB/BC), Blood Collection Unit (BCU) and Blood
Station (BS).
This Manual was prepared specifically for Blood Collection Units in the Philippines. The Manual
specifying the Standards for BB/BC was published in February,1996. The Manual of Standards for Blood
Stations is issued separately.
The relationships of the different Blood Service Facilities are briefly described' in Table 1 and
Figure 1. When the term BSF is used, it covers the central BB/BC to which the BCU or BS is linked within
the blood services network.
The Blood Collection Units will function under the license of their parent BB/BC. This means
that the parent BB/BC must closely supervise the BCU and guarantee its compliance with all standards.
Any violation or non-compliance with existing Standards by BCU will jeopardize the license of the parent
BB/BC.
In addition to compliance with the standards, the BCU shall also comply with the guidelines in
the establishment of blood services network set by the DOH Blood Program Management Unit.
As in the Standards for Blood Banks and Blood Centers, these Standards have been formulated
with careful consideration of major factors:
These Standards represent accepted performance guidelines and are classified into:
1. Mandatory: These are requirements necessary for a BCU to be given authorization to operate
by the concerned Regional Health Director. Each describes the single acceptable activity
or method. Failure to meet the specified requirement will constitute a deficiency and will
cause revocation of authorization to operate the BCU. Words like "shall" or "musf" are used
to signal these mandatory requirements. These are in bold print for emphasis.
2. Recommendatory: These are standards which have several acceptable alternatives or range
of acceptable values. These are indicated by the words "should" or "may".
These Standards are pursuant to Section 9 of R.A. 7719 and its Implementing Rules and Regu-
lations·(A.O. No.9, s. 1995). We welcome comments and suggestions that may find useful in subse-
quent editions. A page at the back has been provided for this purpose.
. ABESAMIS, M.D.,FPSP
( edical Officer VII)
Officer-in-Charge
Bureau of Research and Laboratories
Iv
FIGURE I
REGIONAL BLOOD SERVICES NETWORK
•
G
couron
Blood Urn'
Blood Station / B I O O d Station
Blood
II 8Collection Unit
BlOOD STATlON BlOOD COUEcnoN UNIT BlOOD BANK/BlOOD CENTER CATEGORV A BLOOD BANK/BLOOD CEHrER CATEGORY B
NON·HOSPITAL BASED HOSPITAL-BASED NON-HOSPITAl BASED HOSPITAL-BASED NON-HOSPITAl BASED HOSPITAL-BASED NON-HOSPITAL BASED HOSPITAL-BASED
Recruitment of Recruitment of Recruitment of voluntary Recruitment of voluntary Recruitment of voluntary Recruitment of voluntary
voluntary voluntary blood donors blood donors blood donors blood donors
blood donors blood donors
Health education and Health education Health education and Health education and Health education and Health education and
counselling and counselling counselling counselling counselling counselling
Donor screening and Donor screening and Donor screening and Donor screening and Donor screening and Donor screening and
selection selection selection selection selection selection
Blood collection Blood collection Blood collection Blood collection Blood collection Blood collection
Blood screening & testing of Blood screening & testing Blood screening & testing Blood screening & testing
transmissible diseases of transmissible diseases of transmissible diseases of transmissible diseases
Provision of whole blood & Provision of whole blood, Provision of whole blood, Provision of ....mole blood,
red blood celts (RBC) red blood cells (RBC) red blood cells (RBC) & red blood cells (RBC) &
blood products blood products
Storage of blood & blood Storage of blood & blood Storage of blood & blood Storage of blood & blood
products products products products
Storage and Storage and Transport of blood to Transport of blood to
issuance of issuance of Blood Banks/Blood Blood Banks/Blood Issuance, transport and Issuance, transport & Issuance, transport & Issuance, transport &
whole blood and whole blood and Centers Centers distribution of whole blood distribution of whole blood distribution of whole blood distribution of whole blood
red blood cells red blood cells and blood products & blood products & blood products & blood products
Investigation of
transfusion reactions
Resolution of incompatible
crossmalches
, I
Section 1
GENERAL PRINCIPLES
Section 1
GENERAL PRINCIPLES
Ensuring blood safety through quality blood bank services and blood
products, achieving and maintaining blood supply adequacy through a fully
voluntary system begin with enunciating the following principles:
1.1 All Blood Collection Units (BCUs) should place highest priority on the
health and safety of their donors, patients, personnel and the community.
1.2 All BCUs shall achieve.and maintain 100% voluntary blood donation. The key
function of the BCU is effective donor recruitment and safe blood collection.
1.4 Inspection and authorization should take into account the capability
and commitment of the BCU to continuously improve the safety and
quality of its services and products.
1.5 Every person involved in any aspect of the blood transfusion service from
collection to transfusion, auditinq to licensing or authorization must be
responsible for the quality of his! her work.
1.6 All BSF, hospitals and all other health facilities should mutually support and
assist each other to attain and maintain these Standards.
1.7 All BSF should endeavor to gain and sustain the public confidence
support and commitment through consistent high quality of its blood
services and products.
Section 2
QUALITY SYSTEM
REQUIREMENTS
Section 2
7
TABLE 2 PERSONNEL QUALIFICATION AND MINIMUM REQUIREMENTS FOR BLOOD COLLECTION UNIT
MANPOWER 2.1. . Pursuantto Section 36, DOH A.O. No. 9,s. 1995 2.2. Interim Requirements (Manual of Standards
(IRR ofRA 7719) for BBIBC, A.O. No.4 s. 1996)
Each staff should likewise be required to document the fact that they
have read the required manuals that apply to their tasks.
Each BCU shall develop and maintain clear, well-documented, updated and
detailed SOPs to cover all activities performed on-site and in the community
(E.g. mobile collection).
9
• Specimen Collection and Storage
• Quality Control
• Reagents, Equipment and Supplies
• Procedural Protocol
• Expected or Reference Values
• Interpretation of Results
• Sources of Error and Troubleshooting
• Laboratory Safety and Waste Disposal
The SOPs should be made readily available to all staff. The BCU head
should institute measures to assure that all concerned BCU staff have
read and understood all the procedures in their BCU.
The SOPs should be legibly printed, securely bound and signed and
dated by the BCU Head. It should be regularly reviewed and
updated at least yearly and initialed by the reviewer. Such review,
updates and changes should be well-documented and signed by
the BCU Head. Effectivity dates of these changes should be clearly
stated.
The training of auditors, the findings from reviews and audits, and the
actions required and executed should be properly documented.
r,
2.4.5 Quality Performance in BCU
Each Blood Collection Unit shall have procedures to maintain all records
related to all the activities within the BCU and the BB/BC to which it is affiliated within
the blood services network. These records are stated and elaborated in Section 7
(Quality Records). All personnel should not be permitted to sign or initial BCU records,
forms and documents unless they have been trained in the task and informed of the
significance of the signature. A registry of signatures and initials must be main-
tained.
12
-,
Section 3
The Physical Plant,
Equipment and Materials
Section 3
The physical arrangement should allow for the smooth and orderly flow of
activities and movement of people and supplies.
Work areas for blood collection, validation, packaging, release for transport
and special activities like apheresis should be separated and well-demarcated.
The BCU shall provide adequate space for the different activities applicable
to the services provided.
16
3.5.2 Donor Assessment Area
The education and counselling area must be well lighted and well
ventilated. It must provide adequate privacy to allay apprehensions of
donors and allow more time for necessary discussion and explanation.
3.5.7 Area for Packaging, Validation, Labelling and Other Finishing and
Documentation Operations
3.6 Storage
Storage areas should provide adequate space, suitable lighting, easy access,
arranged and equipped to allow dry, clean and orderly placement of stored
material under controlled temperature conditions."
17
3.6.3 Records, SOP Manuals and References
Eating, drinking and smoking are not permitted in any area where
activities might adversely influence product quality or where staff may
be exposed to potentially harmful agents. There should be areas
designated for eating, drinking and rest of personnel.
Doors that lead from blood collection and packaging areas directly
to the outside, e.g. fire exits, should be secured in such a way that
they may be used only as emergency exits.
3.8.4 Housekeeping
3.8.5 Drains
18
EQUIPMENT
Equipment that is technically suitable, properly located, easy to clean, and well-
maintained is essential for accurate testing; prevention of contamination and
ensurance of quality blood products.
Equipment should pass the standards set by the Bureau of Research and
Laboratories, Department of Health or the Bureau of Product Standards,
Department of Trade and Industry (DTI).
All surfaces that come in contact with plastic, such as blood bags, should be
smooth to avoid damage to the plastic. All equipment should prevent spills,
such as the use of sealed dome centrifuges.
19
TABLE 3.1 RECOMMENDED EQUIPMENT FOR BCU
LEGEND:
, Ootional
performance check for various types of equipment is in Table 3.2.
These tasks should be carried out before use if an instrument is
malfunctioning.
3.13 Calibration
ID\
0259
H46.45 M31c1997
TABLE 3.2 PERFORMANCE CHECK OF EQUIPMENT AND INSTRUMENTS FOR BCU
EQUIPMENT PERFORMANCE CHECK FREQUENCY OF FREQUENCY OF CALIBRATION
PERFORMANCE CHECK
1. Thermometer Mercury
a. Room thermometer Compare with other thermometer daily upon initial receipt or as needed
b. Laboratory thermometer Electronic
c. Clinical thermometer Compare with mercury thermometer
, .;
2. Adult Weighing Scale Zero check daily upon initial receipt or as needed
(for blood donors) Compare with known standard weight
5. Stethoscope Compare with other stethoscope day of use upon initial receipt or as needed
8. Computer Check validation, programming each use upon initial receipt or as needed
a. Hardware and updates or when parts are replaced
b. Software
9. Centrifuge
a. Serologic Centrifuge Determine (RPM) using day of use upon initial receipt or as needed
tachometer
Check timer-zero check
Check carbon brush
10. Blood Bank Refrigerator Monitor internal temperature daily upon initial receipt and when
Compare temperature recorder parts are replaced
against internal temperature
Check alarm systems
3.14.2 Temperature Monitoring and Alarm Systems
The following are the desirable temperature and duration of sterilization for each
general type of sterilization equipment:
Records should show that these requirements are met for every sterilization.
Each BCU should ensure the provision of adequate and suitable materials and
supplies for donor screening, blood collection, compatibility testing,storage and trans-
port of blood units.
23
3.17 Appropriate and Adequate Glassware, Reagents and Supplies
Blood bags shall be sterile and shall contain the allowable anti-
coagulants. Solutions with citrate, phosphate, and dextrose with
or without adenine, or solutions with sodium, adenine, glucose
and mannitol are allowable. The general rule is to have 7 parts
blood to 1 part anticoagulant for every bag.
24
TABLE 3.3 RECOMMENDED GLASSWARE AND REAGENTS
FOR BLOOD COLLECTION UNIT
RECRUITMENT OF HEALTH EDUCATION PRE-DONATION SCREENING BLOOD COLLECTION COMPATIBILITY TESTING STORAGE. VALIDATION &
VOLUNTARY BLOOD & FOR BCU HOSPITAL-BASED PACKAGING, DISPATCH,
DONORS ONLY RELEASE & ISSUE
ire materials lEe materials Donor Declaration Form Biosafery: for personnel protection Biosafety: for personnel protection Transport containers and supplies:
Posters Posters Donor Medical History and Physical Laboratory gown Laboratory gown Cold box with cold packs or ice
Leaflets Examination record in plastic folder Gloves, disposable, latex Gloves, disposable, latex bags
Brochures Mask, disposable Cryovials in cryoboxes or screw-
Brochures Biosafety: for personnel protection Eye protector
Video tapes Eyewash capped test tubes in test tube
>II "video tapes Laboratory gown Mask, disposable
Gloves, disposable. latex For skin preparation & disinfection Eyewash racks
Mask. disposable Cotton/gauze Laboratory plastic bag; suitable
Isopropyl alcohol, 70% For Test procedures rOT packing
Polyvidone iodine Pipette, disposable, Pasteur or plastic
For Hemoglobin determination Test Tube racks Stick on labels:
For phlebotomy "NOT FOR TRANSFUSION-
Cotton/gauze Test Tubes.plain
Blood bags with anticoagulant
Isopropyl alcohol, 70% Wash bottles For other Scientific Purposes"
Torniquet
Lancet Micropore tape/plaster , NSS
• Computer diskettes
Torniquet Metal dips
Evacuatcd tubes with EDTA Rubber sqeeze ball For proper waste disposal • Computer fonn feeds
Multi-sample needles with adaptor Biohazard plastic bags • Printer ribbon or toner
Test tube racks Labdling • Diskette filer
Sodium hypochlorite solution
Stick-on labels for: "Computer instruction sheet
Pipettes, disposable, Pasteur or plastic Disinfectant
ABO group/Rh Type
Scaling film Expiration date Transfusion forms
Unit identification Request forms for compatibility test
For ABOlRh Grouping Result forms for compatibility lest
Applicator stick Permanent or water proof ink pens Worksheets
NSS Tracer form or logbook
Emergency medical kit
Spirit of ammonia
For proper waste disposal
Stethoscope
Biohazard plastic bags Sphygmomanometer
Biohazard needles or "Sharps" Surgical tape/bandage
container Penlight
Sodium hypochlorite solution Intravenous fluid (lVF)
Disinfectant Intravenous set
Eyewash
Post-donation care
Receptacle with cover
IEC materials
Worksheets Refreshments (juice, biscuits, ctc.)
Logbooks
.. For mobile collection unit
Transport containers.Cold box/bag
with cold packs/ice bags
LEGEND,
* Optional
.. For mobile collection sites
3.19 Proper Use of Glassware, Reagents and Supplies
Defects in the blood bags and the quality of reagents should be properly documented
and reported to the BRL section of Licensing and Regulation or Quality
Assurance. BRL shall report appropriately to the BFAD of the DOH or the Bureau
of Product Standards of the DTI.
Other supplies such as coolants arnor.q others, should be of good quality and should
also be registered and approved by the appropriate government agencies.
These should also be inspected, stored and used properly according to the
manufacturers' instructions.
Only BCUs actively participating in the NVBSP may be recommended for tax-
free importation.
27
TABLE3.5 QUALITY CONTROL OF REAGENTS
1. Hemoglobin Determination
2. Blood Typing
2.1. ABO grouping (Forward Anti-A Known Al cells each batchj run of test
and Reverse) Anti-B Known Bcells
a. Slide method Anti-A1 Lectin
b. Tube method 0.9% NaG or NSS
2.2. Rh typing (Tube Method) Anti-D Known D positive cells each batchj run of test
Known D negative cells
.j Control system appro
;
priate to the anti-D
sera in use
3. Crossmatching Saline Phase (Coombs Control Cells) each batchj run of test
0.9% NaG or NSS IgG-coated Red Blood Cells
'" .-
Protein Phase
22% Bovine Serum
Albumin Solution
Antiglobulin Phase
Anti-Human Globulin
Reagent(Polyspecific)
Section 4
THE DONOR
Section 4
THEDONOR
Donated blood provides the material from which all blood products are derived.
Safe and correct blood collection shall be the responsibility of the BCU that collects
blood. It is therefore, imperative to obtain blood only from healthy voluntary blood
donors.
ADVOCACY
As a means to sustain and honor voluntary blood donors, the following are
the acceptable donor incentives in accordance to the Policies stated in the
NVBSP Strategic Plan: certificates and plaques of appreciation, medals and
pins, commemorative items, donor awarding and recognition ceremonies.
Low cost giveaway items for the general public may be allowed during
awareness raising campaigns.
The following are not acceptable donor incentives since these are either
unsafe or not sustainable: free or discounted screening tests; dlscounted or
free other serologic or clinical laboratory tests; consumer's goods or its equiva-
lent which are locally regarded to have intrinsic value.
Blood testing and screening, especially for HIV/AIDS and other bloodborne
diseases, shall not be used as incentive for blood donation because this will
attract individuals who suspect themselves to have the disease, which in
turn increases the likelihood of collecting infected blood from donors within
the window period. Persons who come to the blood collecting unit because
they want to get free testing for HIV/AIDS or other diseases shall not be
accepted as donors, but shall be appropriately counselled and referred to
HIV/STD testing or surveillance centers or other laboratories accredited for
HIV testing. Similarly, donors who want free serologic or other clinical labora-
tory tests shall be referred to appropriate testing facilities.
32
4.3 AVOIDANCE OF COMPETITION AMONG BCUs FORTHE SAME DONOR
POPULATlON
Blood Collection Units should be located within practical geographical distances from
each other to effectively serve the Blood Services Network and to avoid competition
for the same donor population. Clear. policies to prevent such competition should be
stated in the memoranda of agreement among the different BSFs within the Blood
Services Network. Schedules of community-based donations and mass blcodlettlnq
should be coordinated with other BCUs within the Network. Copies of such schedules
should be regularly submitted to the authorized leader or coordinator of the Blood
Services Network.
DONOR SELECTION
Healthy men and women with the following characteristics should be considered
"potential blood donor". They should be encouraged to regularly donate blood in
authorized blood collection facilities.
4.5.1 For the protection of the donor and recipient, donors with the following condi
tions should be deferred accordingly. Table 4.2 provide examples or conditions
with their stated duration and deferment. Details and updates on conditions for
donor deferment shall be issued through Bureau Circulars and Memoranda.
4.5.2 The period of deferment shall also vary according to the type of vaccine
and date when this was received. are listed In ,Table 4.3.
. ..
33
Table 4.2 *Donor Temporary Deferment
34
4.6 Donors Needing Additional Medical Assessment at the Time of Donation
The following donors may donate blood depending on the evaluation of the
authorized BSF personnel at the time of donation. Details and updates on
conditions for donof·'deferment shall be issued through Bureau Circulars-and
memoranda. _
Table 4.4 A Timing of Blood Donation When Medications Are Being Taken by
Donor"
Anorectics Anytime
Anticonvulsant If fits controlled for 2 years
Antifungal (Topical) Anytime. In case where fungal infections
involved the phlebotomy site, the donor
should be deferred temporarily.
Antihypertensive If blood pressure is controlled and without
serious side effects. May require assess-
';'
ment bv BCU ohvsician.
Antihistamine Anvtime
Anti-inflammatory Anytime - blood collected 'is not lor platelet
(Non-steroidal) concentrate oreoaration
Aspirin .. Anytime - blood collected is not for platelet
concentrate preparation
Contraceotive Pills Anvtlrne
Colchicine If over the acute eoisode of oout
Corticosteroid (Topical) Anytime'
Insulin Depends upon the discretion of BCU physician
Paracetamol Anvtime
Vitamins Anytime
Other drugs for symptomatic Anytime .
treatment
35
Table 4 4B Deferment of Donation While on Medication
Antibiotic for Infection Until 5 days after the last dose and reason
for takina antibiotics must be assessed
Antifunaal (Oral) Until 5 davs after comoletion of treatment
Anti-TB drugs Until tuberculosis is completely cured
AllergiC drugs like penicillin, aspirin, Until medications are stopped lor at least
others one dav
Corticosteriod (Oral) While on treatment
Retinoids (Anti-acne preparation) Until 2 months after treatment
Other drugs for symptomatic Anytime
treatment
• Australian Red Cross-Guidelines for the Selection of Blood Donors, April. 1994
4.6.3 Donors with hypertension (BP over 160/100) or hypotension (BP less than 90/
60), epilepsy, or medical conditions other that those stated In Item 4.6.
For the protection of the donor and the recipient, persons with the following condition
shall not be allowed to donate blood at any time. Details and updates on conditions
for donor deferment shall be issued through Bureau Circulars and memoranda.
4.7.1 Cancers
4.7.4 Viral hepatitis or jaundice of unknown origin and other severe liver
diseases like cirrhosis
36
4.7.6 High risk sexual behavior or continuing exposure to persons with
hepatitis, HIV/AIDS and other sexually transmitted diseases (STD)
including inmates of mental institution and prisons.
4.7.7 High risk occupations (e.g. prostitution)
4.7.8 Sexually transmitted disease(STD) (past or present)
4.7:9 Prolonged bleeding
4.7.10 Unexplained weight loss of more than 5 kg over six months
4.7.11 Chronic alcoholism
4.7.12 Autoimmune diseases like SLE, etc.
THEPRE-DONATION PROCESS
The donor must be assured that information concerning his medical and social history
shall be treated as highly confidential and shall not be discussed even with his relatives
or friends.
The BCU shall provide the necessary leaflets, information sheets, brochures, and other
visual aids to assure that the basic messages for donors are consistently and effectively
communicated.
On the day of donation and on every subsequent donation, the donor's medical and
. social history and his physical condition shall be assessed by an adequately trained
physician and/or qualified BSF staff under the supervision of a qualified physician to
determine his suitability as a donor. Donor assessment shall include criteria for the
protection of the donor and the recipient.
The medical and social history and the health status of the donor shall be
evaluated on the day of donation. The SOPs on the selection of donors should
be followed.
37
Any condition declared during interview which is not covered by the
standard interviewing procedures should be discussed with the Physician or
the person in charge of the donor session.
The hemoglobin level of the donor shall be determined before every dona-
tion using the standardtechniques defined in Section 5. Donors with hemo-
globin lower than 125 gil should be referred to his/her physician.
ABO grouping can be done using the slide or tube method. Routine Rh
typing by tube method mayor may not be taken during this time, unless Rh
negative donors are needed.
The BSF shall provide self-administered donor forms in the local dialect, with or without
English translations, which are legibly printed on sturdy paper. After the donor has filled
in the .torrns, interviewers and counsellors shall countercheck the understanding and
responses to selected crucial questions. The minimum contents of the, donor form shall
include:
In addition, each donor must sign a donor medical declaration form which is
witnessed and signed by the interviewer.
• At each critical stage of the collection procedure, the donor's name and
donation number must be checked to ensure that they correspond to all
respective donor records and blood units.
38
THE POST-DONATION PROCESSES
SOPs shall include specific instructions on the proper procedures for pre-
vention and management of common donor reactions during or after do-
nation. Table 4.5 lists the essential information concerning this.
There shall also be provisions for further medical care of donors who
suffer adverse reactions.
39
4.13.3 Counselling Donors With Negative Result
Counselling donors with negative results should be done for it is the best
opportunity to thank and motivate them for their regular donation. The
other purpose is to reinforce their knowledge and to motivate them to
keep fit and healthy and to avoid getting them infected with blood-borne
diseases. These measures among other ways of expression of apprecia-
tion and concern, strengthen the rapport between the donor and the
blood bank facility.
When a donor comes for a repeat blood donation, the BCU staff shall check his/her
previous laboratory examinations and tests . A donor with previous negative test results
shall follow the SOP for donor screening and his/her blood samples tested for diseases.
Measures to sustain regular blood donation should include timely invitation for repeat
donations and social affairs such as health education activities and seminars, among
others.
If a donor found positive or reactive to a previous screening test returns for repeat
donation, the BCU physician or counsellor shall provide counselling and Institute
referral and reporting measures as outlined in Item 4.13.2. (Counselling donore with
positive test results).
40
1:a hI e 45 P revention an dM anazement 0 fC ommon Donor R eactions
COMMON DONOR COMMONLY PREVENTION / MANAGEMENT
REACTIONS ATTRIBUTED TO
OOH-CEKTRAl
Section 5
The maintenance of quality blood for transfusion should start with the collection of
blood from properly selected and screened healthy voluntary blood donors, use of
dependable and verified starting material for the preparation of blood products,
reliable and quality result of compatibility testing, to the correct and safe procedures
for storage, handling and transport of blood and blood products.
The BCU is ultimately responsible for the correct and safe procedures for collec-
tion. handling, storage, and transport of all collected blood. Blood shall be collected,
stored, and transported to the testing or central blood bank/center using Good
Manufacturing Practices (GMP) guided by comprehensive Standard Operating
Procedures (SOPs) and work instructions.
BLOODCOLLECTION
All surfaces coming in contact with blood intended for transfusion shall be sterile,
pyrogen-free, and shall not interact with the blood in such a manner as to have an
adverse effect upon the safety, purity, potency and effectiveness of the blood for
transfusion.
Each blood collecting container and its satellite containers, if any, shall be examined
visually for damage or evidence of contamination prior to its use and lrnrnadtataly
after filling. Such examination shall include inspection for breakage of seals and
abnormal discoloration. Where any defect is observed, the container shall not be
used, or if detected after filling, shall be properly handled as biohazardous and
disposed of.
5.4 Venipuncture
The venipuncture procedure must be done using aseptic technique under closed system.
The procedure, especially skin disinfection and preparation, should be described in
detail in the SOP. If more than one (1) venipuncture is needed, a new donor set and
container must be used.
44
5.5 Individual Blood Handling Materials and Supplies
Each blood collection couch should have individual blood handling materials and
supplies during donation and labelling.
The blood bag should be mixed gently during blood collection by manual inversion, or,
if' available, by a mechanical device.
The organization of the blood collection area should ensure that no error is made with
donor records or labels. The SOP should state specific recording and labelling
procedures.
After commencement of blood collection, the blood donation number shall also be
placed on the primary and all satellite bags or transfer packs and on all laboratory
sample containers or cryovials. Use of sturdy cleanable plastic folders have been found
useful to organize donor records and labels.
The duration of whole blood collection shall be noted. A whole blood collection taking
longer than 15 minutes from the commencement of blood flow should not be used as
source of cryoprecipitate or AHF-ricll plasma and this should be indicated in its
respective donation record "NOT FOR AHF PREPARATION".
After each blood collection, blood samples for compatibility testing, screening and
serologic testing for blood transmissible diseases must be collected from the donor
tubing. Complete asepsis must be observed all the time.
Whole blood collection may either be a 450 ml or a 200 ml blood volume, depending
on the availability of blood bags and the donor's preference.
The blood volume can be estimated by weighing the blood unit. A 450 ml
collection should weigh at least 570 grams; and a 200 ml collection should weigh
at least 370 grams. A variation of ± 10 % from these prescribed volumes is
allowable.
Table 5.1 shows the specifications of whole blood and its storage requirement.
45
5.11 Labelling
The BRL shall assign a registration number for each Blood Service Facility.
Each blood donor shall also be assigned a Blood Donation Number which
shall be permanently marked or firmly attached during blood, collection to:
• All blood bags (i.e. including satellite bags)
• The donor form
• All blood sample containers or cryovials
The donation number on the pack, sample tubes and donor records must be checked
at the end of each collection before donor leaves th" bleeding couch to ensure that
all numbers arc identical.
At the end of blood collection, the tourniquet is released first and the needle is pulled
gently. The phlebotomy site should be covered with sterile gauze or cotton, and
pressure is applied to the site and the arm is elevated for few minutes.
The cut end of the collection tubing should be permanently sealed as soon as
possible. The blood unit and pilot tubing should be reinspected for defects prior to
release from the blood collection area.
46
5.14 Submission and Processing of Blood Units ,to BB/BC
,
Whole bloed collected in BCUs shall stored immediately after collection and vali-
dation in a blood bank refrigerator or cold box at 1-6 0C. As much as possible, blood
should be submitted to the Blood Bank/Center within 24 hours after collection.
Whole blood submitted by BCU to Blood Bank/Center within 6 hours after blood collec-
tion can be used for platelet preparation provided special handling procedures have
been pre-arranged.
COMPATlBIUTYlESTlNG
( For BCU Hospital- Based Only)
If the interval between transfusions for anyone patient is longer than 24 hours,
a fresh specimen must be obtained for crossmatching.
The BCU doing the crossmatch must confirm the ABO group of all
units of whole blood and blood products using a sample obtained
from an attached segment of the blood unit. Confirmatory testing
should be done after the original ABO label has been affixed
47
to the units to permit detection of labelling errors. Discrepancies
shall be reported to the collecting facility and shall be resolved
before issue of the blood for transfusion purposes.
5.15.2.2 Rh Typing
5.15.2.3 Crossmatching
Table 5.1 summarizes the handling 'and storage requirements of whole blood. Meticu-
lous care must be taken to ensure that these are met to avoid blood product deterio-
ration and bacterial growth.
Written directions on how to properly store each blood must be readily available and
clearly printed on wall posters located in strategic areas where blood is stored. These
directions shall include steps to follow in case of power failure or other emergency
conditions disrupting refrigeration.
48
Table 5.1 HANDLING AND STORAGE OF WHOLE BLOOD AND RED BLOOD CELLS
Whole Blood (WB) Unprocessed blood Single or multiple 450 ml (in 63 ml Erythrocyte volume 1-6"C
containing all cellular bag anticoagulant solution) fraction CPD - 21 days
and plasma or 200 ml (in 31.5 ml (EVF) =0.35 to 0:45 CPDA, - 35 days
components of donor anticoagulant solution) CPDA, - 42 days
blood SAG-M- 42 days
Red Blood Cells (RBC) Cellular products Double blood bag 350 ml Hematocrit = 55-70% 1-6°C
remaining after
removal of plasma by Same as WB from
sedimentation or which it has been
centrifugation of prepared under
whole blood; contains closed system.
RBC, platelets and
leucocytes which are If under open system
potential immunizing storage is up to 24
agents hours only.
RELEASE AND DISPATCH TO CENTRAL BB/BC
All blood units shall be inspected before packing. Those found to have signs of
contamination like significant hemolysis, change in color, presence of blood clots, or
leakage shall not be. packed or released.
The BCU shall retain records which allow the tracing of issued blood from a donor to
BB/BC destination of any issued product.
BCU records on blood donation and distribution must be retained for at least 5 years.
50
· 5.20 Transport of Blood Units
Cold storage shall be appropriately followed during transport of the blood. the
temperature of whole blood must be kept at 1-6°C during transport. Sturdy, well-
insulated cardboard and/or styrofoam shipping containers maintain this temperature
if they contain adequate cooling material.(Table 5.1).Cold temperature within the
transport containers must be maintained following the proper packing system stated
in item 5.17.2.1.
All blood units which have been found unsuitable for transfusion such as hemolyzed,
contaminated or punctured units shall be labelled "NOT FOR TRANSFUSiON, FOR
PROPER WASTE DISPOSAL". These shall be disposed of as waste products, see Section
6, Waste Management.
Each BSF shall have detailed SOPs regarding recall and handling of complaints. Any
blood unit implicated in disease transmission shall be immediately recalled. Mislabelled
blood packs or any blood packs with discrepancies in labelling shall be returned
immediately to the BCU for reconciliation of information and labels. The reasons for
return or recall shall be clearly and properly documented and reported to the
Hospital Blood Transfusion Committee and the issuing BCU.
Blood collection activities by BCUs and BBs/BCs should be adjusted to prevent over-
supply or shortage. A system for controlling and monitoring blood supply stocks shall
be instituted by each BSF particularly the BB/BC. One BCU staff shall be assigned to
record and monitor.
51
, ,
Section 6
WASTE MANAGEMENT
Section 6
WASTE MANAGEMENT
Each BCU shall be responsible to the community for the safe and proper disposal of
hazardous waste.
BCU Head or supervisors shall design a system for the handling of waste that
provides for proper collection, segregation, storage, transport, disposal,
monitoring, quality control and record keeping. Managers should design a
system that utilizes less hazardous materials wherever and whenever possible.
BCU personnel shall comply with established policies and procedures. Bench
technologists shall be assigned the important task of segregating, packing,
and labelling all waste requiring special handling. Employees should bring to
the management's attention the presence of any unsafe working condition
and identify opportunities for hazardous waste reduction.
Education and training of waste management of all personnel and supervisors shall be
required. Records of such training shall be documented and filed in the individual
personnel chart.
There shall be written procedures for the management of employee's injuries, spills and
disruption of treatment and disposal due to equipment failure or other problems.
54
6.4.1.2 Sharps
Water-resistant utility gloves rather than latex or vinyl gloves shall be used for
handling hazardous waste.
6.5.3 Treatment
55
To maintain effectiveness, the disinfectants must be properly stored
and freshly prepared using proper dilution.
All pathological wastes shall be decontaminated by autoclaving
before disposal.
6.5.3.2 Steam sterilization by autoclaving at 121 0 C for a minimum of 20
minutes.
6.5.3.3 Sterilization by dry heat for two (2) hours at 170°C (340°F). This
method is not suitable for reusable plastic items.
6.5.4 Packaging
Waste containers must be designed to maintain its integrity throughout
handling, storage, transportation and treatment.
• Red - sharps/needles
• Yellow - infectious waste
• Yellow
(w/ black band) - chemical waste
• Green - non-infectious wet waste
• Black - non-infectious dry waste
• Name of BCU
• "BIOHAZARD" sign for all hazardous waste
• Location of waste disposal if outside of the BCU premises
• Name of transporter of wasle, if applicable
6.5.8 Disposal
6.5.8.1 Sharps
Sharps contained in properly labelled puncture-resistant
containers shall be disposed of by any of the following:
• Buried within the BCU compound on an adequately secured
and identified lot intended for the purpose
• Pulverization or incineration.
57
Section 7
QUALITY RECORDS
Section 7
QUALl1Y RECORDS
Each BCU shall have at least one copy of the most recent edition of the Standards for
Blood Collection Units and the Standards for Blood Banks and Blood Centers. The Standards
should be easily accessible to all staff concerned for reference.
It shall provide a compilation of documents mainly for quality pariormance audit and
for other process review includinq clarification of legal issues.
GENERAL REQUIREMENTS
Record systems must meet the needs of the institution and be used in a manner that
satisfies this need. Each record should have a title that explains its intended use and
includes the name of the BCU and its identifying code or numbers and signature of the
person immediately responsible for each procedure performed.
If it is necessary to alter or correct any record, the change must be identifiable by date
and name of person responsible, and the reason for change should be noted.
The original recording must not be obliterated. It may be circled or crossed-out in hand-
written records, but it should remain legible. Computer records should permit tracking
of both original and corrected data to include the date and the user identification of
the person making the change.
Rubber stamps, brackets or ditto marks are not acceptable means of identifying
responsible personnel.
7.3 Confidentiality
Blood bank records like all medical information must not be released or made available
to unauthorized persons. Restricted access to computerized records must be insured
by an appropriately maintained computer access security system.
There should be a system for dissemination and recall of specified documents. The
system also includes cross-referencing with other related documents, references or
regulatory issuances.
60
The facility must have-an alternative system that ensures continuous operation in the
event that computerized data are not available.
All records should be stored in a restricted area accessed only by authorized BCU
personnel. The method and location of record storage depend on the volume of records
and available storage space. The degree of accessibility of records of the facility's
operation should be in direct proportion to the frequency of their use.
Records are retained to serve as references or basis for clarification of blood product or
blood bank issues including record use as basis for legal proceedings.
Records should be kept for a specified period of time. The required retention period for
specified records are listed in Annex 4.
This Manual shall be prepared by the BCU Head and personnel. It shall include but not
be limited to the following minimum information:
This Manual shall be prepared by the BCU Head and personnel. It describes the spe-
cific step-by-step procedures and techniques that the laboratory staff need for techni-
cal directions and quality control.
The procedure shall include, but not be limited to the following minimum information:
• Name of Examination/Test
• Principle of Test
• Materials and Reagents
• Methodology
• Reference Value (if applicable)
• Computation (if applicable)
• Interpretation
61
7.10 Biosafety and Waste Management Manual
Emphasis on biosafety will provide all health workers the necessary information and
tools for maintaining safe work environment. This Manual shall be prepared by the
BCU Head and personnel.
At each blood donation, there must be a record that provides true identification of
the donor and gives pertinent identification. Either single-use or multiple-donation forms
are acceptable. These records may be filed either by donor name or donation number
with appropriate cross-references. Minimum requirements are:
• Donor's identification like first, middle and last names, birth date,
address(es) and phone number(s)
• Date of last donation
• Identification of the person undertaking each impertant activity
associated with the donation
• Date and venue of the session
• Date of donation
• Donation number
• Record of medical history and physical examination results
63
• Recommendations made for further laboratory work-up and/or clinical
care of donor based on the medical physical and laboratory results;
whether the donor is accepted of deferred temporarily, indefinitely or
permanently with corresponding notations about the deferral
• Donor's signature on the donor's medical declaration form
All compatibility tests done on donor and recipient's blood should be recorded with
emphasis on the results observed and final interpretation of results. Data must be
entered as work is done, using symbols that clearly indicate positive or negative results.
The symbols musf be defined and used uniformly by all personnel. These records can
be incorporated in one worksheet to facilitate labelling and review of records before
release of blood units or components to hospitals.
7.15 Records of Storage, Transport and Submission of Collected Blood to Central BB/BC
Records for blood samples from patients and donors stored in blood bank
refrigerators should be provided.
64
Minimum requirements include:
• Recording charts for refrigerator temperatures, with iriclusive dates,
explanation of abnormal temperatures and action taken, and
initials of the certifying personnel
• Records of periodic testing of alarm systems
• Records of temperatures observed daily and their comparison to
automated temperature recordings.
• Notation of quarantine of unsatisfactory units, record of any' tests
performed and final disposition of each unit.
Records should demonstrate that a blood unit can be readily located during
transport to another site.
Each BCU should have a system for detecting, reporting and evaluating reported
errors and accidents. Copy of this record shall be submitted to BRL.The following infor-
mation is recommended in reporting errors and accidents:
• A written detailed description of the error or accident
• Name of the blood unit(s) involved
• Name of collecting or processing facility if not the same as the reporting facility
• Date of discovery or occurrence
• Name of person who discovered the error or accident
• Notation whether the blood component was transfused or not
•. Category of personnel responsible for the error (nurse, technologist, messenger,
others) and identity of the individual
• Corrective action taken
• Action taken to prevent a recurrence of the error or accident
• Name of the manufacturer, lot numbers, and expiration date of product if
defective reagents or supplies were implicated
• A copy of the notification of appropriate authorities/facilities when applicable
Summary record provides an overview of the BCU operations. It also contains useful
information for audits.
65
7.17.1 Records that demonstrate all inspection checks, quality controls, methods
and equipment used, results and interpre tation of laboratory tests, and au-
thorized signatures
7.17.2 Records that demonstrate that only blood units fit for further testing and
processing have been submitted to BB/BC
66
Sec.tion 8
RESEARCH
Section 8
RESEARCH
Each BCU should have a capability building IJrogram for research. Research protocols
can fall in the following areas, but are not limited to:
The designated BCU Head and selected personnel who will be involved in research
activities should undergo a training on research methodologies.
All research projects shall undergo ethical review by respective Ethical Review
Committee under the Regional Councils on Health Research and Development.
8.4 Funding
The reports of research studies shall be submitted to their respective Regional Blood
Program Coordinator and the National Committee of the NVBSP for appropriate policy
formulation or revision, decision-making, reference and publication.
70
ANNEX 1
DO YOU: YES NO
1. Feel you are in good health? [ J [ )
2. Have a flu or cold? [ ) [ 1
3. Take insulin/diabetic medication? [ ) [ I
ARE YOU:
4. Aware of activities which place you at risk tor AIDS?
5. Aware you must exclude yourself from donating if
you engage in any of these activities?
6. Aware that you can call to prevent your donation
being used as a transfusion?
HAVE YOU:
7. Ever been advised to stop giving blood?
8. Ever been hospitalized?
9. Ever had jaundice, hepatitis or a positive
hepatitis test?
10.Been exposed to jaundice or hepatitis in the [
past 6 months?
11.8. Ever received a blood transfusion in the
past year?
b. If not, have you received before?
12.Ever taken or injected addictive drugs?
13.:':'een tattooed/had ear piercing during the
past 6 months?
14.1 n the past 5 years visited or lived in other countries?
15 a. In the past 3 years had an attack or malaria?
b.Taken any medication to prevent malaria?
16.Ever had a serious illness? Have you seen a
doctor in the past 6 months?
17.Ever experienced unexplained night sweats.
evers, weight loss?
18.Ever had massively enlarged lymph nodes
(swollen glands)?
19.Had persistent diarrhea?
20.Any history of high blood pressure?
21.Any history of heart trouble? chest pain?
shortness of breath? persistent cough?
22.Any disease of the lungs. kidneys, liver or blood?
23.Had cancer?
24.Ever been subjected to fainting, unconsciousness,
convulsion, or epilepsy?
71
25. Any skin infection?
26. Any allergy that is bothering you today?
27. Been taking medication including in the past
6 months?
28. Received any injections, immunizations, or
vaccinations in the past year?
*29. Been pregnant or had abortion in the past
*30. Given birth to 3 or more children?
Physical Examination:
Laboratory Examination:
REMARKS:
M0
BCU Examining Physician
I am voluntarily giving blood through --;-_ _-:""""'=,- to be used as decided by the service.
( name of BCU)
I give the BCU the permission for detailed typing of my blood and the parent BB/BC for blood screening tests
for Hepatitis B, Malaria, Syphilis, HIV1& 2 and Hepatitis C virus. The results of these tests may be stored in' corn-
puterized files.
I certify that I have, to the best of my knowledge, truthfully answered the above questions and under-
stand that this information is important in determining whether I am acceptable as a blood donor.
Date
.'
Modified from 51. Luke's Medical Center Form
72
ANNEX 2
There are some people in the community who must not donate blood becayse it may transmit infections to
patients who receive it.
You must complete this form if you want to donate blood. If you do not know how to answer any of the questions,
please check with the interviewing BCU personnel before answering the questions.
It is against the law to knowingly make a false or misleading statement. If you do, you may receive a heavy
penalty.
_ _ 1. Have you or your partner any reason to believe that you have been infected with HIV, the virus that
causes AIDS?
2. In the last 6 months, have you had:
persistent night sweats persistent diarrhea
_ _ persistent swollen glands unexplained weight ·loss
_ _ persistent fever
_ _ 3. Have you or your partner had sexual activity within the last 12 months with any person whom you
know to have been exposed to HiV, the virus that causes AIDS?
_ _ 4. Have you had sexual activity with a person with hemophilia within the last 12 months?
5. Have you or your partner been a male or female sex worker {prostitute here or overseas within the
last 12 months?
6. Have you had sexual activity with a male or female sex worker (prostitute) here or overseas within
the last 12 months?
_ _ 7. Have you had male to male sexual activity within the last 12 months?
8. Have you had sexual activity with a male within the last 12 months who has had sexual activity with
another male?
9. Have you or your partner EVER injected yourself, or been injected with any drug not prescribed by a
doctor?
_ _ 10.Have you or your partner EVER shared needles and/or syringes?
_ _ 11.Have you been injured with a used needle within the last 12 months?
___ 12.Have you been tatooed within the last 12 months?
_ _ 13.Have you received a blood transfusion or treatment with human blood products in the last 12 months?
To the best of my knowledge, my answers to the following questions are true. I am signing this
Statement in the presence of a member of the staff of the Blood Collection Unit.
73
ANNEX 3
Because of extreme need of blood, I hereby direct the blood bank to release the following:
( Please check appropriate box or boxes as needed)
I. ) Crossmatched - (3 phases)
) Crossmatchcd Blood - Saline Phase Only
( ) Crossmatehed Blood - Saline and Albumin Phase Only
( ) ABO Type-Specific Uncrossmatchcd Blood
( ) Group" 0 " Blood Uncrossmatchcd
Requested by:
Modified from:
I. Forms of Puget sound Blood Center, Seattle Washington. USA
2. United Doctor's Medical Center, Manila
74
ANNEX 4
RETENTION OFRECORDS
All records either as hard copies or computer files relevant to the operation of the Blood Station
shall be kept accordingly to the recommended time period as specified below.
1. Processing Records
1.1. Information to identify facilities that carry out any part of the preparation of blood
components and functions performed
1.2. Information from any intermediate facility if it retains the unit number and identification of
the collecting facility
2. Records of Whole Blood and Packed Red Blood Cells Received From Outside Facilities
2.1. Numeric or alphanumeric identification of blood units and identification of the collecting
facility
3.1. Names, signatures and initials or identification code of those authorized to sign or initial or
review reports and records
4.2. Notffication to transfusing facility of previous receipt of 'units from donors subsequently found
positive for HIV
3.1 Blood and blood component inspection during storage and prior to issue
3.2 Storage temperature and control testing
75
ABBREVIATION
ADDITIVE SOLUTION. A solution added to whole blood used to extend its shelf life; usually contains
adenine, dextrose and other nutritional components.
AGGLUTINATION. Visible clumping as evidence of the interaction of red blood cells with antibody
directed toward the antigen on the red blood cells.
AIDS. A set of serious clinical ailments resulting from severe immune dysfunction caused by infection
with the human immunodeficiency virus (HIV).
ANTIBODY. Proteins produced by the immune system in response to the presence of a foreign sub-
stance inducing antigen or immunogen.
APHERESIS. Blood collection procedure in which whole blood is removed, a selected component
separated and the remainder returned to the donor.
ANTI-HEMOPHILIC FACTOR. Also known as Factor VIII, the coagulation factor deficient in Hemophilia
A, usually prepared from plasma or pools of plasma and package in Iyopholized form.
ATYPICAL ANTIBODY. Antibody to red cell antigens other than the natural or expected group ABO
antibodies.
AUTOLOGOUS DONATION. A blood donation in which the donor and the recipient are the same person.
BAR CODE. A series of marks on preprinted packaging or labelling materials that may be Visually
inspected or read by an optical scanning device.
BIOHAZARD. Substance derived from biological sources such blood or body fluid, capable of trans-
mitting pathogenic organisms ..
BLOOD. Whole blood (WB) collected from a single donor and processed either for transfusion or
further manufacturing.
BLOOD BAGS. Sterile, sturdy plastic bags containing anticoagulants which are especially designed for
blood collection and transfusion. Blood bags can either be single or multiple types with an
integral sterile needle attached to the collection tubinq.
BLOOD BANK/CENTER. A blood service facility with capability to recruit and screen blood donors,
collect, process, store, transport and issue blood for transfusion and provide information and/
or education on blood transmissible diseases.
BLOOD BANKING EQUIPMENT. Essential laboratory machines, instruments and their accessories used in
the different steps in the blood banking process such as those used to centrifuge blood or
separate blood into its various components; preserve blood or blood components in cold
storage or freezer; and perform blood tests such as hemoglobin tests and screening tests for
blood transmissible diseases. These equipment also include those used in specific supportive
processes such as sterilization and sanitary disposal of blood and blood products.
BLOOD COLLECTION UNIT. A blood service facility duly authorized by the Department of Health to
recruit and screen donors and collect blood. .
77
BLOOD COLLECTION COUCH. Blood collection couch is another term for blood' collection table or
bed. It is a furniture upon which the donor sits or reclines during blood collection.
BLOOD DONATION NUMBER. Number issued to each blood donor on the day of donation.
BLOOD SERVICE FACILITY. Any unit, office, or institution providing any of the blood transfusion services,
which can be a blood bank/center category A and B (non-hospital and hospital based), a
blood collection unit or a blood station.
BLOOD TRANSMISSIBLE DISEASES. Diseases which may be transmitted through blood transfusion,
including, but not limited to HIV infection, Hepatitis B, Hepatitis C, Malaria and Syphilis.
BLOOD STATION. A blood service facility which can be sited in either a government or private hospital
or a Philippine National Red Cross chapter which has not been licensed as a blood bank/
center but has been authorized by the Department to perform compatibility testing and to
store and issue blood and Packed Red Cellls.
CITRATE. Component of anticoagulant composed of citric acid and a base. Citrate binds calcium
and prevents coagulation.
CITRATE PHOSPHATE DEXTROSE. Anticoagulant that is used in routine blood collection; allows a 21-day
storage period.
CITRATE PHOSPHATE DEXTROSE ADENINE. Anticoagulant used in routine blood collection; allows a 35-
day storage period.
COMPETENCE. Capability to do a certain task or job according to set standard operating procedures.
COMPETENCY ASSESSMENT. A method which documents the performance abilities of the personnel
performing the various tasks within the blood service facility. Competency assessment/testing
programs should test technical skills and knowledge.
CONTROL. A device, compound or solution which has one or more accurately known characteristics
and which is used for the purpose of verifying the accuracy and precision of measurements of
these characteristics in unknown similar objects by being treated in the same manner as the
unknown.
DIASTOLIC BLOOD PRESSURE. The blood pressure in a large artery during the period when the cavities
of the heart rlilate and fill with blood. This is the lower number in a blood pressure reading.
DISINFECTION. A procedure that kills pathogenic microorganisms but not necessarily their spores. Chemi-
cal germicides formulated as disinfectants are used on inanimate surfaces (medical devices,
etc.) and should not be used on skin, tissue or any part of the body.
DISPOSAL. The act of eliminating or sequestering indefinitely or permanently either treated or un-
treated waste.
78
ENDEMIC. A disease that is prevalent in a particular geographic area throughout the year.
ERYTHROPOIESIS. The process of red blood cell production in the bone marrow.
FORWARD GROUPING. Test in which unknown red blood cells are mixed with typing sera of known
specitity to determine the presence or absence of antigens on the red blood cells. Agglutina-
tion with the reagent indicates the presence of the antigen.
FOUR-HUNDRED FIFTY (450 ) ml BLOOD COLLECTION. Amount of blood for collection in a 500 ml blood
bag containing 63 ml of anticoagulant.
GOOD MANUFACTURING PRACTICE. All the elements (ie. blood donor screening and testing, blood
collection, storage, transport and issuance, and others lin established practice that will
collectively lead to final products or services that consistently meet expected specifications.
HEMOLYSIS. The disruption of the red blood cell membrane resulting in a release of hemoglobin in to
the plasma or cell suspension medium.
HEPARIN. An anticoagulant but not a preservative; used when blood is to be filtered for the removal of
lymphocytes.
HIGH·RISK BEHAVIOR. Refers to a particular behavior and lifestyle predisposing to the occurrence of a
particular condition or illness.
HIV-1. Human Immunodeficiency Virus type 1, the causative agent of AIDS. Initially called HTLV-
IIlorLAV-1.
HIV-2. Human Immunodeficiency Virus type 2, also associated with AIDS and sharing partial homo-
logy with HIV-1.
HIV POSITIVE. Refers to laboratory evidence of exposure to human immunodeficiency virus. Such
people have had repeatedly reactive screening tests for HiV antibody and confirmed by
supplemental tests for HIV antibody; or persons positive for HIV antigen.
IMMUNE RESPONSE. The reaction of the body following an exposure to an antigen. This can result in
either cellular response or the formation of antibody or both.
INCINERATION. Use of high temperature to convert combustible solid waste material into residual ash
and gases, which are vented to the atmosphere. it is utilized as a treatment technique for
almost all types of infectious waste.
INFORMED CONSENT. Refers to an agreement to testing of blood which is obtained after informing the
blood donors of processes involved in blood donation, including screening and reporting of
posltlve test results as required by ethical rules and legal issuances.
-
INTERNAL QUALITY ASSESSMENT. Assessment of laboratory performance conducted by a staff within a
laboratory or blood bank/center.
NON-POROUS. Non-permeable to fluids or non-absorbent such as glazed tiles. acoustic tiles or formica,
or marine plywood ..
79
MOBILE BLOOD DONATION. A blood donation session conducted in a temporary site away from the
location of the Blood Collection Unit or Blood Bank/Center.
PACKED RED BLOOD CELLS. A blood component consisting mainly of red cell mass. It is prepared when
most of the plasma is removed following sedimentation or centrifugation.
PARALLEL TESTING. A comparison of performance of new lots of kits with the previous lots. Done at the
same time and utilizing common control material. Parallel testing is also performed on serial
samples to obtain results on the same run for comparison.
PHLEBOTOMY. The process of withdrawing blood from the circulatory system through a vein.
PLASMA. The fluid component of uncoagulated blood after cells are removed/settled.
PLATELET CONCENTRATE. A blood component which contains platelets as the major cellular element.
It is prepared from platelet-rich plasma by differential centrifugation or obtained by apheresis.
PROFICIENCY TESTING. External evaluation of performance by the use of unknown test samples.
PYCNOMETER. A device used to measure the specific gravity of Copper Sulfate solution.
QUALITY. The consistent and reliable performance of services or product in conformity with the speci-
fied standards.
QUALITY ASSURANCE. The combination of activities necessary for every blood service facility to ensure
quality blood products and blood services for patients, donors, fellow employees, doctors,
the community, and the regulatory agencies. It is a part of the broader and continuous quality
improvement process which ensures that quality will benefit the organization and its end-users.
QUALITY AUDIT. Formal examination and verification of laboratory performance as a part of the QAP.
It is conducted professionally in a constructive atmosphere without bias to compare some
aspects of quality performance with a standard.
QUALITY CONTROL. Part of the quality assurance system which consists of retrospective tests or other
measures that should provide satisfactory results before proceeding further in a given process
and which demonstrates compliance to certain defined limits and specifications.
QUARANTINE. The sequestration ot materials and blood products, whether physically or by a system,
while awaiting a decision on their suitability for further processing or use.
RECIPIENT. The person or a patient who receives a transfusion of whole blood or its products.
Rh FACTOR. A blood group antigen, named after the Rhesus monkey, from which it is originally identi-
fied because an antibody agglutinated the erythrocytes of all rhesus monkeys, 85% of Cauca-
sians and over 99% of Asians..
80
Rh NEGATIVE. An Rh blood type characterized by the absence of D (RHo) antigen and its variant Du
on the surface of a person's red blood cells.
Rh POSITIVE. An Rh blood type characterized by the presence of D (Rho) antigen or its variant Du on
the surface of a person's red blood cells.
RETROVIRUS. Virus that uses an enzyme reverse transcriptase to transcribe an RNA genome into DNA.
REVERSE GROUPING. A blood grouping test in which unknown serum is tested with red blood cells of
known ABO group using A1, B cells, and lor A2 red blood cells
sECRETARY OF HEALTH. The Secretary of Health or any other person to whom the Secretary delegates
the responsibility of carrying out the provisions of this Act.
SERUM. The straw-colored fluid remaining when blood has clotted and cellular components are
separated.
SPHYGMOMANOMETER. An instrument used to obtain a person's systolic and diastolic blood pressure.
STANDARD OPERATING PROCEDURE. A document that specifies the way that a paritcular task should
be underlaken within a particular work area.
STARTING MATERIAL. The starling material for component preparation is whole blood or the products
collected by apheresis.
SYMPTOM. A subjective complaint by the patient usually indicating a disturbance of body function or
of a disorder or disease.
SYSTOLIC BLOOD PRESSURE. The blood pressure in a 110Jrge arlery during which the hearl is contracting
to propel blood to the circulatory system. The upper number of a blood pressure reading.
TEST RUN. A group of specimens processed together with the reagent and in-house controls in one
batch.
TIERED DOCUMENTS. One of two or more related documents arranged one above the other in
succeeding degree of detailed information.
TRANSFUSION. The administration of blood or blood component to a person through the intravenous
route.
TWO HUNDRED (200)ml BLOOD COLLECTION. Amount of blood for collection in a 250 ml blood bag
containing 31.5 ml of anticoagulant.
UNIT. The volume of blood or one of its components in a suitable volume of anticoagulant obtained
from a single collection of blood from one donor.
VALIDATION. A procedure that shows that a piece of equipment or process does what it is supposed
to do. II assures that a process will consistently produce a product according to requirements:
81
VENIPUNCTURE. See Phlebotomy.
VOLUNTARY BLOOD DONOR. An individual who donates blood on one's own volition or initiative and
not induced, directly or indirectly, in any manner whatsoever, by any monetary compensation
nor blood relations/obligations.
WHOLE BLOOD. A unit of blood that contains all the cellular elements and its plasma derivatives. See
Blood.
WORK INSTRUCTIONS. Steps or procedures that are intended to cater for those activities requiring
detail beyond that included in the authorized procedures.
ACKNOWLEDGEMEmS
TECHNICAL ADVISERS
RESOURCE PERSONS
Drafting of Standards
83
Consultative Meetings
84
REFERENCES
1. Australia Code of Good Manufacturing Practice for Therapeutic Goods ( Blood and
Blood Product), 2nd Edition 1995
2. Blood Product Issue Policies, Red Cross Blood Bank Victoria, 1994.
3. Guidelines for the Selection of Blood Donors, Australian Red Cross, National Blood Transfu-
sion Center, April 1994.
4. and various Procedural Manuals of the Red Cross Blood Bank Victoria
Grateful acknowledgement is given to Dr. Gordon S. Whyte for providing the Australian
documents.
5. Standards for Blood Banks and Transfusion Services, American Association of Blood Banks,
16th Edition 1994
6. Code of Federal Regulations (Food and Drugs ),' USA, Parts 600 to 799, as of April 1, 1993.
7. Guidelines for Blood Transfusion Service, United Kingdom, Amendment 1, 2nd Ed. 1994
8. WHO Documents
8.1 Resolution WHO 28.72 The 28th World Health Assembly, 29 May 1975
8.2 Consensus Statement on How to Achieve a Safe and Adequate Blood Supply by
Recruitment and Retention of Voluntary, Non-Remunerated Blood Donors 1993 WHO/
LBS/93/2, WHO/GPNlNF/93.1 .
9.2 Walker, R.H. et al (1993). Technical Manual, 11th Ed. American Association
of Blood Banks, Arlington, Virginia
9.3 Taswell, H.F. & Saed, S.M. (1980). Principles and Practice of Quality Assurance in
Blood Bank, American Association of Blood Banks, Washington, D.C.
9.4 Dixon, M.R. et al (1987). Selection of Method and Instrument for Blood Banks. AABB,
Arlington, Virginia: 1 - 109
9.5 Nance, S.T. (1989).lmmune Destruction of Red Blood Cells. Ariington,VA. American
Association of Blood Bank : 227 • 261
85
,-
9.6 Nance, S.T. (1991). Clinical and Basic Services Aspect of Immunohematology,
American Association of Blood Bank, Arlington, Virginia: 73 -107 and 179 - 199
10. Bender, J.L., Anhalt, J.P. et al (1992). Quality Assurance Programs. Clinical laboratory
Technical Manuals, NCClS Document GP2-A2 2nd ed. 12 (10): 1
11. Calam, G.B. (1992). Quality Assurance, An Administrative Means to a Managerial End.
Clinical lab. Management Review 6 (5): 426
13. Constantine, N.T., Callahan, J.D. & Watts, D.M. (1992). Retroviral Testing Essentials for
Quality Control for laboratory Diagnosis, CRC Press, Florida, USA
14. Constantine, N.T., Groen, G.V. et al (1994). Sensitivity of HIV-Antibody Assays Deter-
mined by Seroconversion Panel. AIDS 8: 1715 - 1720
15. Garcia, L.S., Bullock, S.L., Fritsch, T.R., et al (1993). Slide Preparation and Staining of Blood
Films for the laboratory Diagnosis of Parasitic Diseases, NCClS Document 15-T12 (15)
16. Green, R.E., Ford, D.S., Condon, J.A., et al (1987). Basic Blood Grouping Technique
& Procedures, 2nd Ed. Victorian Immunohematology Group
17. Hoeltge, GA, Pollock, P.G., Reinharat, P.A. (1991). Waste Management Systems. Clini-
cal laboratory Waste Management NCClS Document GP5-T 11 (22): 8 - 13
18. Howanitz, P.J. et al (1987). laboratory Quality Assurance. Mc Graw Hill Inc.
19. Issitt, P.O. (1984). Applied Blood Group Serology. Montgomery Scientific Publication 3rd
Ed. : 31 - 37
20. Klein, R.E., Conley, J.E., Mackinney, K. et al (1986), Temperature, Monitoring & Recording
in Blood Banks, NCClS Document 11 O-T 6 (19)
21. Kelton, J.G., Heddle, N.M. & Blajchman, M.A. (1984). Blood Transfusion, A Conceptual
Approach, Churchill Livingstone, N.Y.
23. Mollison, P.L., Engelfriet, C.P. & Contreras (1989). Blood Transfusion in Clinical Medicine.
Blackwell Scientific Publication, 9th ed.: 710 - 785
24. National Committee for Clinical laboratory Standards (1989). Reference Procedure for
Qualitative Determination of Hemoglobin in Blood 4 (3): 54 - 62 Second Ed. Document M
29-T2 11 (14)
25. National Committee for Clinical laboratory Standards (1991). Protection of laboratory
Workers from Infectious Diseases Transmitted by Blood, Body Fluids and Tissue.
86
27. National Archives and Records Administration (1985). Code of Federal Regulations Food
and Drugs 21
28. National Committee for Clinical Laboratory Standards (1992). Internal Quality Control
Testing: Principles and Definitions Document C-24-A 11 (6)
31. Quinley, E.D. (1993). Compatibility Testing. In Immunohematology Principles and Prac-
tice. J.B. Lippincott Company, Philadelphia: 335 - 338; 1191 - 1206
32. Rossi, E.C., Simon, T.L. & Moss, G.S. (1991). Principles of Transfusion Medicine, William and
Wilkins: 709 - 751
33. Schochetman, G., George, J.R. (1992): AIDS Testing: Methodology and Management
Issues. Springer-Verlog 48 - 89 and 189 - 196
34. Tamashiro, H., Maskill, W., Emmanuel, J. et al (1993). Reducing The Cost of HIV Antibody
Testing. The Lancet: Public Health 342: 87 - 89
35. Tiehen, A. (1993). Competency Assessment in the Transfusion Service. Medical Labora-
tory Observer: 35 - 42
36. TIetz, NW. Rodgerson, D.O. & Laessig, R.H. (1992). Are Clinical Laboratory Proficiency
Tests as Good as They Can Be? 38 (4): 473
37. Tsu, V.D. et al (1991). Health Technology Direction: Major Equipment for Peripheral Labo-
ratory Program for Appropriate Technology in Health 11 (1)
38. Turgeon, M.L. (1989). Fundamentals of Immunohematology: Theory and Technique. Lea
& Farbriger:'3 -317
39.2 Manual of Standards for Blood Banks and Blood Centers in the Philippines.
Bureau of Research and Laboratories. Department of Health (February 1996)
39.3 Administrative Order NO.4 s. 1996. Standards for Blood Banks and Blood Centers
in the Philippines.
87
j()H-CfNTRAl UBRARV
Date:
The Director
Bureau of Research and Laboratories
Departmenf of Healfh
San Lazaro Compound
Sta. Cruz. Manila
Subject: Comments and/or Reactions to this First Edition of the Standards for consideration/
incorporation in subsequent editions
Name:
; ...
Ho46.45. _M31c
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1997 I. Manualof alaifdards tor, blood
_
collectJon unit--' '.
ISBN 971-91605-2-7
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