Professional Documents
Culture Documents
Box 2. Facility Administrator the issues and developed actions to address them.
Responsibilities Depending on what conditions are found to be de-
Fiscal management cient, the survey can nd the facility to be in full
Staff training and coverage compliance or can issue citations at the Standard,
Medical staff appointments and coverage
Condition, or Immediate Jeopardy level. In
Quality assessment and process improvement program
Internal grievance process for patients
circumstances of Immediate Jeopardy, considered
Emergency coverage and backup life-threatening situations, the state agency is autho-
Electronic data submission rized to close a facility until it is considered safe.
Relationship with ESRD Network Helpful information can be found in the ESRD Core
Qualifications Survey Field Manual, the surveyor Laminates, and
Must possess sufficient educational and practical experi- the Measures Assessment Tool (MAT) on CMS
ence to fulfill expectations of role website.
If also acting as nurse manager, then:
Registered nurse Additional Readings
At least 12 mo of clinical nursing experience
Centers for Medicare & Medicaid Services, HHS. Medicare
An additional 6 mo of experience providing nursing
and Medicaid programs; conditions for coverage for end-
care to dialysis patients
stage renal disease facilities. Final rule. Fed Regist. 2008;
Must be a full-time employee of the facility
73(73):20370-20484. https://www.cms.gov/Regulations-and-
May not cover .1 facility
Guidance/Legislation/CFCsAndCoPs/downloads/ESRD
Abbreviation: ESRD, End-Stage Renal Disease. nalrule0415.pdf.
Department of Health and Human Services, Centers for Medicare
& Medicaid Services. ESRD program interpretive guidance
facility to achieve certication as an ESRD provider, version 1.1 and measures assessment tool. https://www.cms.
as well as periodic resurveys thereafter. This survey is gov/Medicare/Provider-Enrollment-and-Certication/Survey
CerticationGenInfo/downloads/SCletter09-01.pdf.
delegated to the state departments of health by CMS. Department of Health and Human Services, Centers for Medi-
States may also require separate licensure. The survey care & Medicaid Services. ESRD survey training: ESRD core
process, known as the ESRD Core Survey, uses a survey eld manual version 1.2. https://www.cms.gov/
risk-based approach that is data driven. Data are Medicare/Provider-Enrollment-and-Certication/Guidancefor
obtained from the Dialysis Facility Report (DFR; see LawsAndRegulations/Downloads/ESRDCoreSurveyField
Manual.pdf.
Quality Metrics section of this article) and other Messana A. Managing a dialysis clinic: the ever changing
outcomes data sources to determine the priority of landscape. Nephrol News Issues. 2013;27(7):20-22.
facility surveys. The data also focus the survey to
problem areas for which outcomes are less than ex- PERSONNEL
pected. Trained surveyors assess safety hazards The facility administrator is responsible for
related to water and dialysate, reuse, machine opera- ensuring that adequate numbers of qualied staff are
tion and maintenance, direct care, interdisciplinary in place to care for patients. This includes the
assessment, care planning, and delivery of care. If recruitment and appointment of medical staff physi-
poor outcomes are identied, it would be expected cians and nonphysician practitioners such as
that the QAPI process in the facility had identied advanced practice nurses and physician assistants.
The CfC specify that an adequate number of qualied
Box 3. Selected Laws and Regulations Affecting and trained staff must be present when patients are
Dialysis Facilities undergoing dialysis to ensure that appropriate dialysis
State and Local care is delivered and patient needs are met. Although
Local life safety codes a specic staff to patient ratio is not dened, the fa-
Local building codes
cility administrator must meet any applicable state
State dialysis facility licensure laws (if applicable)
State board regulations regarding medical, nursing, and
regulations. Consideration must be given to the level
pharmacy practice of independence and care needs of the patients who
will be served and the expertise of the staff in those
Federal
Occupational Safety and Health Administration
areas. Adequate stafng ratios must be present to be
Office of the Inspector General able to see every patient during treatment and provide
Clinical Laboratory Improvement Act routine care, assessment, and monitoring, as well as
Centers for Disease Control and Prevention respond to changes in patient conditions and attend to
Americans With Disabilities Act
emergency situations. The roles and qualications of
Family and Medical Leave Act
key patient care personnel in the dialysis facility are
National Organizations summarized in Table 1.
Association for the Advancement of Medical
Instrumentation
The interdisciplinary team is composed of the pa-
tients nephrologist, a registered nurse (RN) familiar
with the patient, the dietitian, the social worker the patients and familys input into care goals.
involved in the patients care, and other personnel as The patient is expected to be a member of his/her
appropriate. The RN performs an initial and ongoing interdisciplinary team and a participant in the dis-
comprehensive assessment of the patient and seeks cussion regarding the plan of care. On a regular basis,
the RN reviews the patients laboratory work, medi- Table 2. Comparison Between Interdisciplinary Team and QAPI
cations, and other concerns and brings them to the Committee
attention to the interdisciplinary team to re-evaluate Interdisciplinary Team QAPI Committee
and revise the plan of care as needed. Patients are
taught about their disease and the various aspects of Level of Individual patient Facility system
their treatment. Patients are informed about all renal focus
replacement options, including transplantation, and Goal Develop individualized Improve system
are supported in their decisions to investigate these plan of care processes and
outcomes
options. Chair Patients nephrologist Facility medical director
The facility administrator must ensure that all Members Nurse, dietitian, social Facility administrator,
staff have the appropriate licensure and certi- worker; patient dietitian, social
cations and have successfully completed a training participates during or worker; other
program and orientation to prepare them for their after meeting by stakeholders of
discussing and processes as
role in the care of dialysis patients. There must be a signing off on appropriate
process to provide and document ongoing educa- patients plan of care
tion and competency testing to ensure safe effective Frequency of Within 30 d of patients Monthly; more
practice, including emergency situation response. meetings arrival in facility, 3 mo frequently as
Staff not found to be competent must be retrained. after patients arrival, appropriate for rapid-
annually after cycle improvement
Employees must have periodic health screening patients arrival;
and must meet the federal and state guidelines, monthly if patient is
including testing for tuberculosis and hepatitis unstable
B virus (HBV). Abbreviation: QAPI, Quality Assurance and Performance
The facility administrator must also ensure that Improvement.
there are adequate numbers of staff and professionals
needed to support the QAPI process. The facility
treatment, infection control, patient education con-
administrator has the responsibility, along with the
cepts, and understanding of quality components and
medical director, to ensure the quality of services
the QAPI process. Effective staff recruitment and
being provided in the facility. Communication be-
hiring, as well as ongoing staff retention, is an
tween the facility administrator and the governing
important area of focus for the facility administrator.
body regarding the QAPI program is a must. Areas of
Reviews of salaries and benet options for competi-
need require planning and action, with follow-up
tiveness, as well as nancial impact, must be done on
to determine the effectiveness of interventions. The
a regular basis. This also requires an understanding
need for staff requires a thorough assessment of
of labor laws and practices, workers compensation,
quality data by the governing body and QAPI com-
Family Medical Leave Act regulations, Americans
mittee to identify areas requiring improvement. When
with Disabilities Act requirements, afrmative action,
the areas have been identied, the facility adminis-
and other human resourcesrelated topics.
trator must develop a plan to meet the needs in a
scally responsible manner. If it is determined that Additional Readings
issues are more related to a need for practice or Burrows-Hudson S, Kammerer J, Farrow B, Zimmerman J,
process changes or education, the facility adminis- Yang A. Perceived status of patient care technician training
trator must ensure that those plans are developed, and certication impact in U.S. hemodialysis facilities.
operationalized, and evaluated to determine effec- Nephrol Nurs J. 2014;41(3):265-273, 287.
tiveness. If individual performance issues are found, Callahan MB. Begin with the end in mind: the value of
outcome-driven nephrology social work. Adv Chronic
staff must be held accountable and a plan of re- Kidney Dis. 2007;14(4):409-414.
education and competency testing or corrective Department of Health and Human Services, Centers for
disciplinary action must be taken. This is reported to Medicare & Medicaid Services. Approval of State and Na-
the governing body as well. Differences between the tional Certication Programs for Patient Care Dialysis
interdisciplinary team and QAPI committee are Technicians (PCTs) under the new End Stage Renal Disease
(ESRD) Conditions for Coverage. Ref: S&C-10-03-ESRD.
summarized in Table 2. https://www.cms.gov/Medicare/Provider-Enrollment-and-
Education needs are considerable in dialysis facil- Certication/SurveyCerticationGenInfo/downloads/SCLetter
ities and include orientation and initial competency 10_03.pdf.
testing of all staff, as well as ongoing education and Hand RK, Burrowes JD. Renal dietitians perception of roles
retesting. The development and provision of a patient and responsibilities in outpatient dialysis facilities. J Ren
Nutr. 2015;25(5):404-411.
care technician training program must include Yoder LA, Xin W, Norris KC, Yan G. Patient care stafng
the elements of patient care, understanding ESRD levels and facility characteristics in US hemodialysis facil-
and its related conditions, machine technology, water ities. Am J Kidney Dis. 2013;62(6):1130-1140.
for both patients and staff to give regular feedback and should review the AAMI guidelines annually and
share concerns about safety or quality issues. incorporate the most recent recommendations into
practice. State surveyors will directly observe chlo-
Emergency Preparedness rine/chloramine testing in a dialysis unit, interview
Dialysis facilities must have plans for emergency staff to assess their fund of knowledge and compe-
preparedness that include re, equipment or power tency regarding water quality, and review documen-
failures, care-related emergencies, interruption of the tation of testing and maintenance of the water system.
water supply, and likely natural disasters based on the The recommended frequency of checking for chlo-
facilitys geographic area. Facilities may prepare for rine/chloramines, the appropriate calibration of a
other types of emergencies, including bioterrorism or conductivity meter, and the proper preparation of the
active shooters, that are identied after the perfor- bicarbonate mix are all processes that involve multi-
mance of a facility risk assessment. In addition to ple individuals, and the procedures must be stan-
having a plan for emergency management, it is dardized to minimize error.
necessary for the dialysis facility to provide appro- Water quality measurements include chemical,
priate training and orientation in emergency pre- electrolyte, and microbial levels. Some compounds
paredness to the staff that are assessed at least that deserve special attention include aluminum,
annually. This includes quarterly re drills that chloramine, uoride, and nitrate. Aluminum at high
involve both staff and patients. Patients also must be levels is detrimental to bone and hematologic and
educated and prepared for emergency situations. This neurologic axes. Chloramines and nitrates can induce
training must occur often enough so that staff and methemoglobinemia. CMS requires that the total
patients can implement emergency plans. State or viable microbial count must be ,200 colony-forming
local re codes must be met. All other Life Safety units (CFU)/mL and endotoxin concentration ,2
Code provisions in New and Existing Ambulatory endotoxin units (EU)/mL. However, the action level
Health Care Occupancies apply to dialysis facilities, is 50 CFU/mL and 1 EU/mL, respectively, for prod-
including those about automatic notication uct water, that is, water used to prepare dialysate. At
equipped re detection and alarm systems. Dialysis the action level, the typical plan is to repeat cultures,
facilities must have a plan and educate staff and sometimes to disinfect the system and again repeat
patients where to go during an emergency. Dialysis cultures. Documentation of the testing, results, and
facilities should provide an alternate telephone the action plan for water quality is critical to the
number for patients to use when the dialysis facility successful management of a hemodialysis unit.
is unable to receive telephone calls because of an Whether to continue dialysis or stop dialysis and the
emergency. The facility administrator should establish specics of the action plan are based on the nal
contact with its local disaster management agency at determination of the medical director; however, the
least once a year to check that they are aware of the medical director relies on the QAPI team, and in
dialysis facilitys needs in cases of emergency. particular, the lead water technician to present the
Nurses at the facility should be trained and ready to abnormal data and potential action plans. Water
handle clinical emergencies that are likely to happen quality is an important component in the monthly
in dialysis. The facility should have equipment QAPI meetings, and the status of the facilitys water
available for treating medical emergencies such as and any deviations in protocols or quality metrics are
suction machines and debrillators. Nurses and pa- subject for review. It can be helpful to have logs
tient care technicians must be certied in cardiopul- available to the group at the monthly QAPI meetings
monary resuscitation. The medical director should to make everyone aware of the shared responsibility
decide the specic emergency drugs to be available, of water quality. Water quality assurance is a team
and they should be described in the facilitys policies effort and vital for the safe care of dialysis patients.
and procedures.
Infection Control
Water Quality Infection control is the responsibility of the medical
Water quality is the responsibility of the medical director, and a detailed discussion is beyond the scope
director, and a detailed discussion is beyond the scope of this article. Infection control issues are often cited
of this article. Without appropriate monitoring and by state surveyors. All facility staff should be held
maintenance of water quality, the lives of patients are accountable for infection control. Handwashing is
placed at signicant risk. There have been numerous essential for infection control in a hemodialysis unit.
incidents with catastrophic consequences as a result of Gloves should be worn prior to patient contact or
poor water quality. Water quality is mentioned equipment manipulation. Hands should be washed
frequently in the CfC and is a frequent trigger for before and after use of gloves. Gloves should be
citation by state surveyors. The water technician changed when soiled or when moving from one
patient chair to another, as well as any time that ac- must be separate equipment for HBsAg-positive pa-
cess manipulation or intravenous medication admin- tients, and staff members should not be caring for
istration occurs. The facility must be designed with both HBsAg-positive and HBsAg-negative patients
enough sinks to facilitate handwashing, with separate simultaneously.
utility sinks for cleaning equipment. In January 2016, the Centers for Disease Control
Staff should wear personal protective equipment, and Prevention (CDC) issued an advisory to dialysis
which includes designated garments with sleeves facilities because of an increased number of reports of
appropriate to the anticipated potential exposure. The newly acquired hepatitis C virus (HCV) infection
most robust protection should be used during high- among hemodialysis patients. The CDC urged dialysis
risk components of the dialysis procedure, such as providers to assess current infection control practices
treatment initiation and termination. Any items that to ensure that infection control standards are being
are in the patients dialysis station could become followed; any gaps identied by the assessments are
contaminated and should be handled with caution and addressed; patients are screened for HCV according to
cleaned after the treatment (ie, a patients blanket). CDC guidelines to detect infections, determine treat-
Staff, along with patients, should be vigilant not to ment potential, and halt secondary transmission; and
cross-contaminate clean and dirty equipment. For all acute HCV infections are promptly reported to
example, unused medications would be clean and health authorities. The CDC recommends that all he-
used needles would be considered dirty. The patient modialysis patients be screened for HCV antibody
treatment area should have designated clean and dirty (anti-HCV) upon admission to the dialysis facility and
partitions. Disinfection of the dialysis treatment every 6 months thereafter. For patients with positive
equipment should be done according to manufac- anti-HCV results, nucleic acid testing for HCV RNA
turers guidelines. At the end of every patient treat- is recommended to conrm infection. Any HCV
ment, the dialysis station needs to be thoroughly seroconversion of a hemodialysis patient should
cleaned. trigger QAPI activities to determine the source of the
transmission.
Hepatitis and Isolation Staff must be oriented to infection control policies
Cleaning equipment and following proper isolation and procedures at the start of employment and
protocols is essential to infection control. Hepatitis annually at a minimum. Infection control is another
serologic evaluation is important to prevent the integral part of the facilitys QAPI meetings, and
transmission of HBV in patients with ESRD. All new discussion of infections and action plans should be
patients should have hepatitis B surface antigen recorded and available for review.
(HBsAg), total antibody to hepatitis B core antigen
(anti-HBc), and antibody to HBsAg (anti-HBs) results Immunizations
determined before admission for treatment. When It is recommended that susceptible patients under-
results of this testing are unknown at admission as a going maintenance dialysis receive HBV vaccination.
result of an emergency, the patient should be tested as All patients should undergo annual inuenza vacci-
soon as possible. Any patient whose anti-HBs level nations unless there is a specic contraindication. The
is ,10 mIU/mL should have HBsAg tested monthly. newer pneumonia vaccination guidelines recommend
Patients who have received and responded to the that for patients who have never received the pneu-
HBV vaccine should have an anti-HBs titer measured mococcal vaccine, adults should receive a dose of the
annually to determine whether a booster dose of the pneumococcal conjugate vaccine (PCV-13) followed
vaccine is needed. All patients and staff whose anti- by a dose of the pneumococcal polysaccharide vac-
HBs levels are ,10 mIU/mL should be offered the cine (PPSV23) a minimum of 8 weeks later. Patients
vaccine. Cases of HBsAg-positive seroconversions who previously received PPSV23 should receive a
must be reported to the health department as dose of PCV-13 at least 1 year after the most recent
mandated by local regulation. Patients who have PPSV23.
positive test results for HBsAg must be isolated, and
follow-up testing should be performed to determine Violence in the Dialysis Facility
when the patient may be taken out of isolation. State The dialysis facility has many diverse people in one
surveyors may look for documentation for serocon- space at a given time. Conicts are inevitable but need
versions, including actions taken in response and to be addressed in a systematic way to help diffuse
analysis to evaluate for potential transmission of the tension and promote safety for both patients and staff.
virus within the facility. Any HBsAg-positive patients CMS and ESRD Networks carefully review all
should dialyze in separate isolation rooms, although involuntary patient discharges. Facilities must follow
in facilities built prior to the 2008 update in regula- protocols carefully for any involuntary discharges or
tions, any separate isolation area would sufce. There involuntary transfers or the facility may be subject to
sanctions from CMS. There must be documentation have a signicant impact on patient census and the
of multiple attempts to resolve the issues of conict nancial health of the facility.
prior to patient discharge or transfer, including the
following required steps: (1) notication of the ESRD The MAT
Network, (2) comprehensive reassessment and revi- The CfC for dialysis facilities were last revised in
sion to plan of care to address the problem, (3) 2008, and because the CfC cannot adapt to changes
documentation of the ongoing issues and their effect in the standards of care for anemia, mineral meta-
on others and the facility, (4) documentation of steps bolism, and vascular access, for example, CMS has
to resolve conict, (5) documentation of patients purposely excluded such quality metrics from the
response to interventions, (6) written orders for CfC. Instead, these measures are included in the
involuntary discharge or involuntary transfer must be ESRD Interpretive Guidelines used by state surveyors
signed by the attending physician and medical as a guide to the survey process. Metrics included in
director, and (7) the patient must be given a minimum the interpretive guidelines can be changed at will by
of 30 days notice of impending involuntary discharge CMS in response to changes in medical practice
or involuntary transfer. If a patient is an imminent because they do not require written legislation or
threat to the safety of patients or staff, the patient can regulation. The set of quality metrics used by state
be immediately transferred or discharged and law surveyors is known as the MAT, and because these
enforcement authorities should be promptly notied. measures do not involve public reporting or payment,
The social worker is a critical liaison in helping their use does not require a strong evidence basis or
address conict. vetting by a consensus panel from the ESRD com-
Any member of the facility staff could also be munity. It is intended that state surveyors use these
participating in disruptive behavior. Ultimately, the measures not as a pass/fail grading system, but
staff managers should give feedback and develop a rather to determine whether a facility has undertaken
plan to improve behavior, but if these interventions the appropriate QAPI process if the results of the
are not productive, disciplinary action may need to be measure demonstrate opportunities for improvement.
taken. The medical director should be notied in a Key patient-level indicators in the MAT at the time of
timely manner in order to contribute to the improve- this writing include hemoglobin level, indicators of
ment plan. iron status, serum calcium level, serum phosphorus
level, parathyroid hormone level, dialysis adequacy,
Additional Readings dialysis session duration, serum albumin level, weight
Garrick R, Kliger A, Stefanchik B. Patient and facility safety loss, overall infection rate, patient immunizations,
in hemodialysis: opportunities and strategies to develop arteriovenous stula (AVF) prevalence, prevalence of
a culture of safety. Clin J Am Soc Nephrol. 2012;7(4): central venous catheters longer than 90 days, vascular
680-688.
Jones ER, Goldman RS. Managing disruptive behavior by access thrombosis rates, vascular access infection
patients and physicians: a responsibility of a dialysis facility rates, vascular access patency, patient quality of life,
medical director. Clin J Am Soc Nephrol. 2015;10(8): patient experience of care, patient grievances, patient
1470-1475. survival, and hospitalizations.
Kapoian T, Meyer K, Johnson D. Infection prevention and
the medical director: unchartered territory. Clin J Am Soc The DFR
Nephrol. 2015;10(5):863-874.
Kasparek T, Rodriguez O. What a medical director needs to The DFR is an annual report provided as a resource
know about dialysis facility water management. Clin J Am to each dialysis facility for describing certain aspects
Soc Nephrol. 2015(6);10:1061-1071. of clinical experience at the facility compared with
Kliger AS. Maintaining safety in the dialysis facility. Clin those of other caregivers in the state, ESRD Network,
J Am Soc Nephrol. 2015;10(4):688-695.
and United States. The DFR is based on data from
Medicare claims and CROWNWeb and provides de-
QUALITY METRICS mographics of patients in the facility; standardized
The QAPI team is responsible for ongoing quality ratios (observed to expected counts based on case-mix)
assessment and performance improvement in the for mortality, hospitalization, and transplantation;
dialysis facility. The QAPI team includes the medical transplant waitlist and inuenza vaccination rates; and
director, facility administrator, social worker, dieti- clinical data including hemoglobin level, adequacy of
tian, and any other stakeholders in the quality dialysis, and vascular access. The DFR can be useful
improvement effort, such as a water treatment system for internal quality improvement activities at a facility.
technician, infection control expert, and/or nurse with The report is also distributed to the respective state
a particular area of responsibility (eg, anemia or department of health and may trigger a facility survey
vascular access management). Some quality metrics if there are signicant perceived deciencies. The DFR
are publicly reported and affect payment, so these can is distributed to the ESRD Network and may trigger
targeted quality improvement activities directed by the benchmarks. Because the QIP allows the provider to
Network. earn some or all of its bundled payment back, but
does not provide any additional payment to high
Dialysis Facility Compare and 5-Star Rating achievers, it is a penalty system and not a reward
Dialysis Facility Compare is a publicly available system. The QIP penalty, if there is one, is in in-
website (www.medicare.gov/dialysisfacilitycompare) crements of 0.5% and affects all of a dialysis facilitys
that allows any individual to view quality metrics Medicare payments for an entire calendar year,
from dialysis facilities and compare selected facilities known as the payment year (PY). The QIP penalty is
side by side. The data derived primarily from determined for a given PY based on the facilitys
CROWNWeb and Medicare claims are usually performance 2 years prior. Therefore, for example, a
revised in the third or fourth calendar quarter to facilitys QIP penalty for PY 2019 will be based on its
include the previous calendar year. Dialysis Facility performance in 2017. The performance data are
Compare metrics at the time of this writing include: collected in real time during the performance year
(1) standardized transfusion ratio (based on Medicare from Medicare claims and from additional informa-
claims and case-mix adjusted), (2-4) dialysis ade- tion submitted electronically to the CROWNWeb
quacy (adult hemodialysis, pediatric hemodialysis, reporting system, which has been used since 2013.
and adult peritoneal dialysis, respectively), (5) stula Mandatory QIP measures in MIPPA are anemia
prevalence, (6) prevalence of dialysis catheters longer management, dialysis adequacy, and patient satisfac-
than 90 days, (7) hypercalcemia (percentage of pa- tion (as possible). Discretionary QIP measures in
tients with 3-month average serum calcium . 10.2 g/ MIPPA are iron management, mineral metabolism,
dL), (8) standardized mortality ratio, (9) standardized and vascular access. The QIP began in PY 2012,
hospitalization ratio, and standardized hospital read- based on performance data from 2010. At that time,
mission ratio. These 9 metrics (ie, excluding stan- CMS was able to collect performance data only for
dardized hospital readmission ratio) are grouped into anemia management and dialysis adequacy from
3 domains: (1) standardized outcomes (STrR stan- claims, so those were the only 2 domains in the QIP
dardized transfusion ratio, standardized mortality ra- for PYs 2012 and 2013. By 2012, Medicare claims
tio, and standardized hospitalization ratio), (2) forms were modied to include vascular access, so the
vascular outcomes (stula prevalence and catheter QIP for PY 2014 included anemia management,
prevalence), and (3) other outcomes (all dialysis ad- dialysis adequacy, and vascular access. The inclusion
equacy and hypercalcemia). Each domain is given a of data from CROWNWeb in performance year 2013
score from 0 to 100 by averaging the normalized has allowed Medicare to expand the QIP to embrace
scores within that domain. A nal score between additional domains as directed by MIPPA, starting in
0 and 100 is obtained by averaging the 3 domain PY 2015. The QIP for PY 2015 and beyond includes
scores. A dialysis facility is awarded its star rating clinical measures and reporting measures. The clinical
based on its total scores relative position compared measures are scored according to national bench-
with all other facilities, rather than the total score it- marks established during the year prior to the per-
self. The facilities with top 10% scores receive 5 stars, formance year. Therefore, for clinical measures in
facilities with the next 20% highest scores receive 4 PY 2019, the performance year was 2017 and the
stars, facilities in the middle 40% of scores receive 3 benchmarks are established based on national data
stars, facilities with the next 20% lower scores receive from 2016. For each of the clinical measures, there is
2 stars, and facilities with the bottom 10% of scores an achievement score and an improvement score. The
receive 1 star. facility is able to claim the better of these 2 scores.
The achievement score is calculated on a 10-point
The QIP scale between the national achievement threshold
The 2009 MIPPA legislation established the (15th percentile from the year prior to the perfor-
bundled payment system for dialysis and mandated mance year) and the national benchmark (90th
the establishment of a QIP. The rationale is that percentile). Thus, for example, if a facility has an
because bundling shifts what were previously sepa- AVF prevalence rate of 54%, the achievement
rately billable items from being prot centers to being threshold is 46%, and the benchmark is 74%, the
cost centers for the provider, the patient must be facility would receive 3 points for that measure
protected from underutilization of resources with because 54% is 3/10 of the distance from 46% to
performance measures that affect payment and public 74%. The improvement score is calculated on a 9-
reporting. The MIPPA legislation prescribes that the point scale between the facilitys prior year perfor-
QIP for dialysis is a 2% withhold from the bundled mance on the measure and the national benchmark.
payment, some or all of which can be earned back by Therefore, for example, if a facility has an AVF
the provider by achieving prespecied performance prevalence rate of 54%, a prior year AVF prevalence
Table 3. Quality Metrics for Dialysis Facilities readmission ratio, standardized transfusion ratio, and
patient experience of care (In-Center Hemodialysis
DFC and QIP: PY Networks:
Measure MAT DFR 5-Star 2019 2016 SOW Consumer Assessment of Healthcare Providers and
Systems [ICH-CAHPS] survey outcomes, not just
Hemoglobin x x Reporting reporting that the instrument was administered).
ESA dose Reporting Reporting measures for PY 2019 will include anemia
Iron status x management (hemoglobin level and erythropoiesis-
Transfusions x Clinical
Serum calcium x x Clinical x
stimulating agent dose), mineral management (serum
Serum phosphorus x Reporting calcium, phosphorus, and parathyroid hormone
PTH x Reporting levels), pain assessment and follow-up, depression
Dialysis adequacy x x x Clinical screening and follow-up, personnel inuenza vacci-
Dialysis session x nation, and rate of uid removal during hemodialysis.
duration
Serum albumin x
Clinical measures will constitute 90% of the weighted
Body weight loss x score, and reporting measures, 10%.
Overall infections x x
Immunization of x x x ESRD Networks
patients
AVF prevalence x x x Clinical x
The ESRD Networks work with consumers and
CVC prevalence x x x Clinical x providers of care for ESRD patients to rene care de-
VA infections x x livery systems and improve the quality of care for this
VA thrombosis x vulnerable population. The Networks have access to
VA patency x facility-specic data from the DFR and CROWNWeb,
Patient QoL x
Experience of care x Clinical x
which allows them to target quality activities to facil-
Patient grievances x x ities with the greatest opportunity for improvement.
Survival: SMR x x x The Networks provide educational resources, support
Hospitalizations: SHR x x x services, and other tools to assist both patients and
Readmissions x Clinical providers. The Network also provides assistance to
Care transitions x
Transplantation x x x
evaluate and resolve patient grievances and ensure
referral that patients rights are maintained while reducing
Home dialysis referral x involuntary discharges. ESRD Network activities are
Immunization of staff Reporting dened by their scope of work, which is revised
Rate of fluid removal Reporting annually based on what CMS perceives as the greatest
Abbreviations: AVF, arteriovenous fistula; CVC, central areas of need for quality improvement in the ESRD
venous catheter; DFC, Dialysis Facility Compare; DFR, Dialysis program. Quality metrics for the MAT, DFC, 5-Star
Facility Report; ESA, erythropoiesis-stimulating agent; MAT,
Medical Assessment Tool; PTH, parathyroid hormone; PY,
Rating, QIP for PY 2019, and domains of network
payment year; QIP, Quality Incentive Program; QoL, quality of quality improvement activities for the 2016 scope of
life; SHR, standardized hospitalization ratio; SMR, standardized work are summarized in Table 3.
mortality ratio; SOW, scope of work; VA, vascular access. The ESRD Networks offer a 5-Diamond Safety
Program to assist dialysis facilities in improving
rate of 26%, and the benchmark is 74%, the facility staff and patient awareness regarding specic patient
would receive 5 points for that measure because 54%
is 5/9 of the distance from 26% to 74%. Because the
improvement score is higher than the achievement Box 5. Topic Areas in the 5-Diamond Safety Program
score in this example, the facility can claim the 5-
point improvement score for that measure. Patient safety principles
Communication
In addition to the clinical measures for PY 2015 Constant site cannulation
and beyond, there are also reporting measures that are Emergency preparedness
scored based on whether a facility provided the Hand hygiene
required data to Medicare, but not on the quality of Health literacy
care represented by those data. For PY 2019, the Influenza vaccination
Transplantation
clinical measures will include adequacy of dialysis (a Medication reconciliation
composite of adult hemodialysis, adult peritoneal Missed treatments
dialysis, pediatric hemodialysis, and pediatric perito- Patient-provider conflict
neal dialysis), vascular access (prevalence of AVFs Patient self-managed care
and catheters . 90 days), hypercalcemia, National Sharps safety
Slips, trips, and falls
Healthcare Safety Network bloodstream infections Stenosis/vascular access monitoring
(outcomes, not just reporting), standardized hospital
safety issues and promoting a culture of safety. The Schiller B. The medical director and quality requirements in
program consists of educational modules, and the the dialysis facility. Clin J Am Soc Nephrol. 2015;10(3):
493-499.
completion of each module earns a Diamond for
the facility. The topics of the modules are listed
in Box 5. ACKNOWLEDGEMENTS
The authors thank Fresenius Medical Care North America for
sharing their Detailed Design Document for New Clinical
Additional Readings Managers.
DeOreo PB, Wish JB. Medical director responsibilities to the Support: None.
ESRD Network. Clin J Am Soc Nephrol. 2015;10(10): Financial Disclosures: Ms Blankschaen has administrative re-
1852-1858. sponsibility for the dialysis program at University Hospitals Case
Krishnan M, Brunelli SM, Maddux FW, et al. Guiding Medical Center, a not-for-prot hospital-based facility. Dr Saha is
principles and checklists for population-based quality met- medical director for the dialysis program at University Hospitals
rics. Clin J Am Soc Nephrol. 2014;9(6):1124-1131. Case Medical Center. Dr Wish is medical director for the out-
National Forum of ESRD Networks. QAPI toolkit. http:// patient hemodialysis unit at IU Health University Hospital, a
esrdnetworks.org/mac-toolkits-1/qapi-toolkit/qapi-toolkit/view. not-for-prot hospital-based facility, and is a paid consultant to
Nissenson AR. Improving outcomes for ESRD patients: DaVita HealthCare Partners Inc. on quality of care issues.
shifting the quality paradigm. Clin J Am Soc Nephrol. Peer Review: Evaluated by 4 external peer reviewers, the
2014;9(2):430-434. Education Editor, and the Editor-in-Chief.