CMS SOM App. H, Tag V773

In accordance with § 420.200 through §

420.206 of this chapter, the governing body must report ownership interests of 5 percent or

more to its State survey agency.

Interpretive Guidance § 494.180(j):

The governing body of the ESRD facility must report to the State survey agency a full and

complete listing of any individuals with ownership of 5% or more of the facility.

Any change in ownership must be reported to the State survey agency in a timely manner.

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Part II - The ESRD Core Survey Process

Overview

Section 1881(b)(1) of the Social Security Act (the Act) requires facilities to be approved to

participate in the end-stage renal disease (ESRD) program. The regulations at 42 CFR Part 494

specify the Conditions that facilities must meet to achieve and maintain approval.

The ESRD survey process represents the relevant areas and issues that should be

surveyed/reviewed under each regulation, and in some cases, the methods that should be used to

survey those areas and issues. The use of these protocols will promote consistency in the

survey/review process. The protocols also ensure that a facility’s compliance with regulations is

reviewed in a thorough, efficient, and consistent manner so that, at the completion of the survey,

surveyors have sufficient information to make compliance decisions.

This survey protocol is designed around survey tasks that involve observing areas and actions,

interviewing patients and staff, and reviewing records and documents. The core survey process

is designed to directly observe patient care and assess key areas of patient management,

infection control, and facility operations. It should be used for all initial and recertification

surveys. During an initial survey, the core survey process should be used, along with additional

key considerations provided in each applicable task.

Method and Structure of the ESRD Core Survey

The ESRD core survey process is organized by survey tasks specific to the dialysis facility

environment and the care of ESRD patients, along with the corresponding core survey

worksheets associated with each task.

The “core” activities and guidance for each ESRD core survey task are listed, followed by a list

of survey “triggers” pertinent to that area of review. Supplemental procedures reviewing home

dialysis services in a long-term care or nursing home setting are included.

Reviewing Dialysis in Nursing Homes: The survey protocol includes additional survey activities

and guidance that address dialysis services provided by the ESRD facility to residents in a

nursing home setting. These sections will be labeled as “Home Dialysis in LTC”. The survey

team should schedule on-site visits to nursing homes, including, at a minimum, direct

observations of machine preparation, initiation of dialysis, vascular access care, and

discontinuation of dialysis. In the event that only one patient is receiving services in a nursing

home, the ESRD surveyor may need to conduct their observations over multiple days to observe

both initiation and disconnection.

Please note that nursing home, long-term care facility, and long-term care setting are used

interchangeably throughout this survey protocol and the corresponding survey worksheets.

If, during the onsite visit at a nursing facility, ESRD facility surveyors identify concerns about

the quality of the care provided to a nursing home resident(s) that is unrelated to dialysis facility

requirements or dialysis-related concerns that overlap with existing nursing home requirements,

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those concerns should be communicated to the appropriate SA authorities for a possible nursing

home complaint investigation.

Triggers are prompts during a surveyor’s observations that may warrant a deficiency citation or

indicate the need for further investigation to determine the depth of noncompliance. Further

investigation may be limited to the specific issue or may include expanding that survey task,

referred to as “extending” the task. Guidance for extending a core Survey task appears after the

applicable tasks or triggers in the core survey process.

Throughout this ESRD core survey document, reference documents are listed where applicable

ESRD core survey worksheets are available to guide the surveyor during the survey task. A

compilation of the ESRD Core Survey Worksheets can be found in the Addendum.

Data-driven Survey Process

The Dialysis Facility Report (DFR) identifies areas of clinical performance compared to the

national average. The comprehensive DFR is updated annually, with select data measures

updated quarterly throughout the fiscal year. The clinical data from the DFR will be used to

determine measures that are below the national benchmark and incorporate them as data-driven

focus areas throughout the dialysis facility survey. Surveyors should review the most recent DFR

to appropriately evaluate data elements to include in the ESRD Core Survey.

ESRD Core Survey Tasks:

Task 1 – Pre-survey Preparation

Task 2 – Introductions

Task 3 – Environmental Flash Tour

Task 4 – Entrance Conference

Task 5 – Observations of Hemodialysis Care and Infection Control Practices

Task 6 – Patient Sample Selection

Task 7 – Water Treatment Room and Dialysate Review

Task 8 – Dialyzer Reprocessing/Reuse Review (if applicable)

Task 9 – Dialysis Equipment Maintenance Review

Task 10 – Home Dialysis Training and Support Review

Task 11 – Medical Record Review

Task 12 – Patient Interviews

Task 13 – Personnel Record Review

Task 14 – Personnel Interviews

Task 15 – Quality Assessment & Performance Improvement (QAPI) Review

Decision Making

Exit Conference

Task 1: Pre-Survey Preparation

Reference Document: Core Survey Data Worksheet

General Purpose: Surveyors must analyze clinical data and facility information prior to

entrance to prepare for and determine the preliminary data-driven focus area(s) to be reviewed

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during the survey. Data-driven focus areas are clinical measures (e.g., anemia management) in

which the facility's results for that given measure are determined to be lower than the national

average.

Initial Survey Key Consideration: Inform the facility that it must submit to the SA evidence of

acceptable water and dialysate quality (i.e., cultures/endotoxins, product water chemical

content) for hemodialysis and notify the SA when the facility has admitted at least one patient in

each requested dialysis service/modality.

• Review the CMS-3427 Form: Before an ESRD initial or recertification survey, review

applicable Forms CMS-3427 on file to determine if the ESRD facility has patients who

receive their dialysis treatments at a nursing home and plan the survey team composition and

schedule to accommodate onsite visit(s) to the nursing home(s). The review of dialysis

services in a nursing home should be considered an extension of the ESRD Core Survey and,

as such, will require additional survey time.

• Review the most current Dialysis Facility Report (DFR) along with the most current QDFR.

The comprehensive DFR contains detailed information on patient characteristics, treatment

patterns, hospitalization, mortality, and transplantation patterns in Medicare-certified

dialysis facilities. The QDFR is a one-page document that contains key data elements from

the facility's comprehensive DFR to be reviewed during Pre-Survey Preparation and guides

the identification of the preliminary data-driven focus areas. Follow the instructions in the

most current QDFR to compare facility characteristics to the national average. If the

facility’s outcome in a clinical area is worse than the national average, include that area as

a preliminary data-driven focus area. If a facility has clinical outcomes that are better than

or equal to the national average, a review of that clinical measure and management thereof

is not required.

o The most recent data reflected in the DFR can be up to eight (8) months old.

o During the Introductions task, surveyors should request that the facility submit

more recent data and compare it with the data from the most recent DFR. This

will allow the surveyor to determine whether improvements were made for any

clinical indicator reported during the time period not covered in the DFR.

o The final data-driven focus area(s) will be confirmed after it is determined that a

clinical indicator has outcomes lower than the national average and has not

improved after reviewing the facility’s more recent clinical outcomes report.

• Review the facility complaint and survey history for the past 12-18 months. Look for trends

in patient and/or staff complaint allegations and survey deficiency citations.

• Copy the “Entrance Conference Materials List” from the ESRD Core Survey Data

Worksheet, Section II, for the current fiscal year. This will be presented to the facility

administrator or person in charge during “Introductions.” Gather other documents needed

to conduct the survey (e.g., Form CMS-3427, survey worksheets).

• Obtain contact information of the respective ESRD Network. To ensure the survey remains

unannounced, surveyors may not contact the network until they are on-site for the survey.

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Surveyors will contact the appropriate representative for the respective ESRD network after

entering the facility to inquire about any quality concerns, information regarding involuntary

discharges and transfers, and to ask about the receipt of any patient complaints. Network

contact information is available on each individual Network’s website.

Task 2: Introductions

General Purpose: The Introductions task is conducted to announce the survey, introduce the

survey team, and inform the facility administrator (or a key person in the facility if the

administrator is unavailable) about the purpose of the survey and the anticipated timeline.

Explain that the survey will include observations within the facility, record reviews, and interviews

with patients and staff. Inform the staff that they will have the opportunity to discuss areas and

provide additional information. This introduction should be extremely brief to allow you to observe

tasks as quickly as possible.

Contact the administrator (or the person in charge if the administrator is unavailable) and

present them with the “Entrance Conference Materials” list (Section II of the Core Data

Worksheet). This list includes several documents that will be reviewed during the survey. The

materials should be submitted to the survey team within the timeframes identified on the form.

Information and documents collected from this list will be required when determining the patient

sample selection and for surveyor reference during the Entrance Conference.

Also, surveyors will request that the facility submit its clinical outcomes report, which represents

data more recent than the time period covered in the DFR. This data will be used to determine

the final data-driven focus areas.

The administrator (or person in charge if the administrator is not available) should also be given

a copy of the CMS-3427 (“End Stage Renal Disease Application and Survey and Certification

Report”) to be completed by the facility staff and submitted to the survey team by Day 2 of the

survey. A review of the CMS-3427 completed by the facility during the survey will be done to

confirm that the information on the form is accurate and consistent with the information

available to CMS.

Task 3: Environmental “Flash” Tour

General Purpose: Observe the patient care-related areas for an initial assessment of conditions

that may have an immediate impact on patient safety, such as infection control, physical

environment hazards, serious lapses in equipment and building maintenance, and the availability

of emergency equipment. Surveyors should request that the facility appoint a staff member to

accompany them during the flash tour.

Observe the following patient-related areas of the facility as listed:

• Patient treatment area (for in-center dialysis)

• Water treatment/dialysate preparation area

• Reuse room (if applicable)

• Home dialysis treatment area

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This is a “flash” tour of the patient-related areas, looking for observable indicators of patient

safety concerns. It begins immediately after the Introductions task.

Additional in-depth guidance from the surveyor is provided below for each area.

In-center dialysis patient treatment area - Observe the general environment and atmosphere of

the treatment area. Observe a sample of 25% (minimum of 3) dialysis stations with patients

undergoing treatments. Observe the patient, their vascular access, and the surroundings of the

dialysis station. This is a “flash” look, and not a verification of their dialysis prescription

delivery, which is done during “Observations of Hemodialysis Care and Infection Control

Practices.” Observe the availability and functionality of emergency resuscitation and evacuation

equipment.

Triggers for citation or further investigation of concerns:

• Equipment is not used in accordance with the manufacturer’s instructions for use, for

example, dummy drip chambers present in the patient treatment area (V400, 403)

• Patients' vascular accesses covered, not consistently uncovered/corrected by staff

(V407)

• No Registered Nurse (RN) on duty (V759)

• Evidence of poor staffing, e.g., machine alarms not answered, patients not regularly

monitored, no dietitian or social worker currently on staff (V757)

• Blood spills not immediately cleaned; equipment and/or surfaces visibly spattered

with dried or wet blood (V122)

• HD machine transducer protectors wetted with blood not changed - observe/interview

staff regarding the practice of inspecting the internal transducer for blood prior to

machine use for another patient (V120)

• Insufficient space to prevent cross-contamination and use emergency equipment

(V404)

• Absence of functional emergency resuscitation equipment (i.e., AED/defibrillator,

oxygen, suction, emergency medications, Ambu bag); emergency evacuation

equipment insufficient or unavailable (E-0028)

• Hemodialysis machines in observable poor repair (e.g., alarms not functional,

missing components) (V403)

• If dialyzer reuse, germicide odors are noticeable in the patient treatment area (V318)

• Disrespectful communication, e.g., rude, demeaning, harassing, name calling, loudly

calling out weight; disrespectful or punitive actions toward patients, e.g., physical or

chemical restraints, involuntary seclusion (V452, V627)

• Failure to offer patients confidentiality when discussing their condition/treatment;

failure to protect the patients’ confidentiality by allowing exposure of patients’

sensitive body parts during procedures (V454)

Water treatment/dialysate preparation area - Observe the carbon system, the chlorine testing

equipment and reagents, and current day/shift total chlorine test results. Look at the

alarm/monitoring systems for the reverse osmosis (RO) and/or deionization (DI) components,

and the dialysate concentrate proportioning ratios listed on the packaging.

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Triggers for citation:

• Carbon system: absence of 2 or more carbon beds, with sampling port between

(V192), current shift total chlorine test not done, testing reagents not sensitive to

0.1mg/L total chlorine, expired or don’t match testing equipment (V196)

• RO: absence of functioning water quality monitor; no audible alarm in patient

treatment area (V200)

• DI (if present): absence of functioning resistivity monitor, no audible AND visible

alarm in patient treatment area, absence of automatic divert-to-drain or automatic

stop valve to prevent unsafe water flow to the dialysis stations if resistivity falls <1

megohm, DI not monitored twice/day (V202, V203)

• Water distribution equipment in observable disrepair or contaminated state, e.g., the

presence of algae or discoloration of water (V403)

• Acid and bicarbonate dialysate concentrates of different proportioning ratios present

- interview staff regarding the use of the different concentrates and verify that only

matching ratios are used with machines programmed to that ratio (V249)

• Acid or bicarbonate dialysate concentrate mixing and distribution equipment in

observable disrepair or contaminated state, e.g., algae (V403)

Reuse room - Observe the condition of the reprocessing equipment, dialyzer storage, and

dialyzer refrigerator, if present.

Triggers for citation:

• Stored reprocessed dialyzers aesthetically unacceptable, e.g., header caps with blood,

leaking, port caps off (V343)

• Stored dialyzers not protected from unauthorized access (V321); Not within the

germicide manufacturer’s temperature range (V345)

• Reprocessing room or equipment in observable disrepair (V318, V403)

• Dirty dialyzers kept at room temperature >2 hrs. before reprocessing (V331)

• Dialyzer refrigerator temperature not monitored (V331)

Home dialysis training area - Observe the physical environment, infection control, availability

of emergency equipment, and the method for summoning immediate assistance.

Triggers for citation or further investigation of concerns:

• Insufficient space in patient training area to prevent cross-contamination and provide

emergency care if >1 patient trained at a time (V404)

• Insufficient methods to provide patient privacy (V406)

• Blood or PD effluent spills not immediately cleaned; equipment and/or surfaces

visibly spattered with dried or wet blood or PD effluent (V122)

• Absence of functional, immediately available emergency resuscitation equipment (E-

0028)

• Absence of a method for summoning immediate assistance for the patient or solitary

staff (V402)

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Extending the “flash” tour to other areas of the facility: If pervasive concerns are identified

during the flash tour of the above four clinical areas, consider examining other patient-related

areas of the facility, such as the waiting room, patient bathrooms, supply storage room,

hazardous waste storage, and laboratory area. Examples which may suggest a serious lack of

environmental maintenance that has the potential to impact patient safety include:

• Large areas of water damage

• Presence of mold in patient-related areas

• Uneven/broken floor surfaces creating multiple trip hazards where patients ambulate

(V401, V402)

TASK 4: Entrance Conference

Reference Document: Entrance Conference Worksheet

General Purpose: The Entrance Conference is held at the conclusion of the flash tour and is

conducted with the administrator or designee and any other staff the administrator selects for

participation. During the Entrance Conference, the lead surveyor should provide details

regarding the expectations, workflow, and approximate timeline for conducting the survey.

Obtain and review documentation submitted by the facility, including current facility-specific

clinical data related to performance and outcomes. Using this data, identify any trends and

determine how the facility is performing in comparison with the preliminary focus areas. If the

facility is currently meeting thresholds in an area where the DFR review indicated problems,

performance improvement may have taken place. Upon validation of the improvement, you may

choose not to include that as a final data-driven focus area for review.

Ask the administrative person, or their designee, the facility-specific questions from the

“Entrance Conference Questions” worksheet.

Home Dialysis in LTC: To facilitate planning for on-site visits to nursing homes, the following

information should be requested (also noted in the Entrance Conference Materials List) at the

time of the ESRD survey entrance conference:

• List of all nursing homes with which the ESRD facility has a current written agreement to

provide dialysis services and the address for each nursing home, including how

treatments are provided in each distinct nursing home, i.e., in the patient’s private room,

in a common area, or both.

• The names of all patients currently receiving dialysis services from the ESRD facility at

each nursing home.

• The modality and treatment schedule (including the scheduled times for the hemodialysis

treatments) for each nursing home resident named above.

• Names and credentials (e.g., RN, PCT) of any nursing home personnel who deliver the

residents’ dialysis treatments.

• A copy of the written agreement between the ESRD facility and each nursing home.

Task 5: Observations of Hemodialysis Care and Infection Control Practices

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Reference Document: Observations of Care and Infection Control Worksheets

General Purpose: Make general observations about overall patient care practices related to the

safety of the facility, comfort of the patient/staff interactions, and technical aspects of dialysis.

This task will focus on patient safety in infection control, equipment operation, the use of

reprocessed dialyzers, and patient assessment.

Depending on a facility’s unique schedule and your travel requirements, you may arrive during

the start of the dialysis procedure, at the initiation or conclusion of a patient shift, or while a

treatment is being conducted. Each time presents unique opportunities to view special aspects of

the dialysis treatment. If possible, conduct observations on different days, shifts, and with

different staff. It may be possible to observe several of the procedures at one dialysis station

during the changeover between patient shifts.

During start up times, you can view equipment preparation (preparing dialysate, assembling the

extracorporeal system, priming the dialyzer and extracorporeal circuit) and the pre-dialysis

assessment of the patient (weighing the patient, taking the blood pressure, taking the patient’s

pulse, assessing heart and lung sounds, taking the patient’s temperature, communicating with

the patient, evaluating the vascular access). Whenever you arrive, you will be able to observe

staff documentation of these actions as they occur.

When the shift starts, you can observe the staff placing a needle into a fistula or graft access and

checking reused dialyzers for patient identification.

During a treatment, you will note the staff monitoring patients (taking vital signs, performing

safety checks, monitoring the general condition of the patient), giving medications and solutions,

and monitoring equipment.

At the end of a treatment, you can observe the staff discontinuing dialysis, taking vital signs, and

cleaning equipment.

In order to facilitate a comprehensive and thorough review, while making efficient use of the

surveyor’s time, this task consists of observations in the following four (4) areas:

• The direct care staff delivering care

• Medication preparation and administration

• Facility isolation practices

• Dialysis treatment prescription delivery

Observe the direct care staff delivering care – Using the applicable observational checklists

from the “Observations of Hemodialysis Care and Infection Control Practices” worksheet,

conduct at least two (2) separate observations, at random, of each of the procedures listed

below:

• Initiation of Hemodialysis with Central Venous Catheter (CVC) (CVC) (Checklist 1)

• Central Venous Catheter Exit Site Care (Checklist 2)

• Discontinuation of Hemodialysis with Central Venous Catheter (Checklist 3)

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• Initiation of Hemodialysis with Arteriovenous Fistula (AVF) or Arteriovenous Graft

(AVG) (Checklist 4)

• Discontinuation of Hemodialysis with AV Fistula or AV Graft (Checklist 5)

• Cleaning and Disinfection of the Dialysis Station (Checklist 6)

• Preparation of the Hemodialysis Machine/Extracorporeal Circuit (Checklist 7)

• Dialysis Supply Management and Contamination Prevention: This checklist should

be completed after the surveyor has conducted the above critical observations

(Checklist 9)

Observe each procedure listed above one at a time, to ensure focus on that activity.

Triggers for citation:

• Observed breaches in infection control patient care practices:

o Poor hand hygiene and glove use practices (V113)

o Supplies taken to the station are not disposed of, disinfected, or dedicated to that

patient (V116)

o Clean dialysis supplies not protected from potential contamination (V119)

o Breaches in aseptic practices for CVC (V147) or AVF/AVG care (V550)

• Not adequately disinfecting the HD station & equipment between patients (V122)

• Not using dialysis equipment and supplies in accordance with manufacturer’s

instructions for use, for example, not priming reprocessed or dry pack dialyzers and

using dummy drip chamber to set up HD machine for patient treatment (V336, V352,

V400, 403)-Use of dummy drip chamber during patient treatment bypasses safety

mechanisms innate to the dialysis machine and has been determined to be a serious

risk to patient safety. This observation should be considered an Immediate Jeopardy.

• Not testing hemodialysis machine alarms per manufacturer's DFU (V403)

• Not testing dialysate pH/conductivity with an independent method per manufacturer

DFU, or lack of staff knowledge of acceptable parameters for pH/conductivity (V250)

• Not performing reprocessed dialyzer germicide tests (V350, V353) or patient/dialyzer

identification by 2 people (V348) when patient is at the station

• Not assessing patients before and after treatment or monitoring during treatment

according to facility policy (V504, V543, V550, V551, V715)

Observe medication preparation and administration: Use the applicable observational checklist

8 to observe this process. Conduct 2 observations of different staff preparing and administering

medications for 1-2 patients.

Triggers for citation:

• Medications not prepared in a clean area away from the dialysis stations (V117)

• Single-dose medication vials punctured more than once or used for multiple patients

(V118)

• Multi-dose medication vials punctured with a previously used syringe or needle

(V143)

• Poor aseptic technique when dispensing and administering intravenous medications

from vials and ampules (V143)

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• Medications for multiple patients taken to a patient station (V117)

• Medications prepared and/or administered by unqualified personnel (V681)

• Not disposing of needles in a sharps disposal container (V121)

Review facility isolation practices: If there is a Hepatitis B positive (HBV+) patient on in-center

hemodialysis at the facility:

• Observe the isolation room/area and the equipment and supplies contained within it.

If possible, observe the care delivery for an HBV-positive patient to observe direct

care procedures as described in the section above. Observe for separation of care

practices from the HBV-susceptible patients.

• Review staff/patient assignments for the current week, looking at which patients are

concurrently assigned to the staff caring for HBV-positive patients.

• Ask the staff on duty how staff assignments are made when the facility census

includes HBV+ patient(s).

Note: If the dialysis facility does not have any patients requiring isolation, the surveyor should

ensure that the facility is prepared to provide isolation services as needed or has an isolation

waiver on file.

Triggers for citation:

• HBV+ patient(s) not isolated (V110, V128)

• Observed breaches in infection control practices when caring for HBV+ patients

(V113, V116, V117, V119, V121)

• Staff assigned/delivering care to HBV+ patients and HBV negative patients on the

same shift - Investigate the extent of the practice (V110, V131). (Note: Exceptions to

this should be rare. If this occurs, the facility’s efforts to avoid this situation should

be clearly explained to the surveyor. Examples of such efforts are to schedule

patients in a manner to avoid overlap between HBV+ and HBV-susceptible patients

or scheduling HBV+ patients on shifts when there are 2 RNs on duty so that one RN

may access the HBV+ patient's vascular access and administer their medications,

while the other RN does so for the other patients. Emergency medical situations may

be a justifiable exception.)

• Isolation equipment not dedicated for use on HBV+ patients (V130)

• HBV negative patient(s) dialyzed in the isolation room/area when an HBV+ patient is

on in-center HD census (V110, 128, 130)

Verify dialysis treatment prescription delivery: Select a sample of 4-5 patients who are actively

receiving their dialysis treatment during this review. Review and compare the dialysis

prescription delivery (dialysate, dialyzer, blood flow rate, dialysate flow rate) to patients'

dialysis orders for each observation of care. The dialysis prescription being delivered should be

consistent with the physician’s treatment order.

Trigger for citation:

• 1 or more patients not dialyzed on ordered prescription, e.g., wrong dialysate,

dialyzer type, blood flow rate, dialysate flow rate (V543, 544)

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Task 6: Patient Sample Selection

Reference Document: Patient Sample Selection Worksheet

General Purpose: Surveyors should select a patient sample that represents the complexities and

services provided at the facility. Whenever possible, select patients who are in the facility during

the time of the onsite survey. This will enable the surveyor to validate information obtained

through the Medical Record Review task, as well as gather information from the patient

regarding their perception of the quality of care and their understanding of their plan of care.

Initial Survey Key Consideration: Dialysis facilities requesting initial approval may have a

small patient census. If there are fewer than five patients, include all patients in the sample

selection. Surveyors may review closed medical records, if available, when selecting samples.

Home Dialysis in LTC: When an ESRD facility has patients on their current census receiving

home hemodialysis (HD) or peritoneal dialysis (PD) treatments in a nursing home under a

written agreement, the ESRD survey team will include on-site visits to the nursing home(s) as

part of the ESRD survey. The total number of nursing home onsite visits will be guided by the

number of agreements established with the dialysis facility (see the table below). Refer to the

table below for guidelines on the total number of on-site visits. If an ESRD facility provides

dialysis services to residents in more than one nursing home, surveyors should review any

available clinical information at the time of the entrance conference to identify indicators of

poor outcomes, which can assist in selecting nursing homes and nursing home residents for the

sample. If no concerns are identified, the nursing homes and residents may be selected at

random.

Use the following three sources when selecting the patient sample:

• ESRD Core Survey Worksheet: Patient Roster

• Information obtained from the Entrance Conference Materials List

• Observations of Care

Use entrance conference materials gathered from the facility to identify dialysis recipients that

represent criteria from the Patient Roster, such as “unstable,” “recent admission, and

“hospitalization.” Record selections on the Patient Roster, which displays patient information

and the reason for sampling.

Sample Selection Size

Surveyors should select a patient sample size that accurately represents the facility’s patient

volume and the range of clinical services provided.

Attempt to include in-center hemodialysis patients from different days/shifts to determine

whether there are trends in deficient practice.

Use the table below to determine the sample selection size:

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A B C D

Facility Census Patient Sample Size

(minimum)

Number of Nursing

Home Agreements

Number of Nursing

Home Visits*

1 to 50 5 1-10 2

51 to 100 7 11-20 3

101-150 10 20+ 4

>150 15

*If the dialysis facility offers home dialysis services in the nursing home in addition to in-center dialysis, select an additional two patients (minimum) from each nursing home visit. If

the dialysis facility only offers home dialysis services in the nursing home, use Column B to

determine patient sample size.

If the dialysis facility census includes fewer than five patients, which may occur for facilities

requesting initial approval, it should include all patients for review.

Surveyors may expand the patient sample to include additional patients at their discretion if

quality of care and safety concerns related to dialysis care and services are identified during the

survey.

Additional guidance for review criteria is found below:

• Unstable: Surveyors should look at IDT involvement, functionality, and coordination

for assessing and planning care for unstable patients, i.e., the most fragile patients.

“Unstable” is defined at §494.80(d)(2) as patients with “(i) [e]xtended or frequent

hospitalizations; (ii) [m]arked deterioration in health status; (iii) [s]ignificant

change in psychosocial needs; or (iv) concurrent poor nutritional status, unmanaged

anemia, and inadequate dialysis.”

• New admission <90 days: Surveyors should look at facility processes for assuring

timely evaluation and appropriate care of patients new to the facility before and

during their first treatment and first weeks at the facility. Pull at least one sample.

• Observed patients: You may also sample patients you have observed during the

Observations of Care task, with possible concerns during the survey.

• Complaints: Patients who have filed or are involved in a complaint should be

included in the patient sample. All named patients in a complaint investigation

should be reviewed.

• Involuntarily discharged (IVD) in the past 12 months, if applicable: Surveyors

should review documentation in the medical record to confirm IDT’s reassessments,

ongoing problem(s), and actions taken to resolve the problem(s) before the patient's

involuntary discharge. Review all records of patients who have been involuntarily

discharged. Note: Do not include patients who voluntarily or involuntarily

transferred to other dialysis facilities.

• Home Dialysis in LTC: The purpose of conducting the on-site nursing home portion

of the ESRD survey is to verify that:

o Dialysis is being administered in a safe and sanitary environment.

o Treatments are administered by qualified, trained, and competent dialysis

administering personnel.

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o Coordination between the ESRD facility and the nursing home is occurring to

ensure that the nursing home residents on dialysis receive quality care and timely

and appropriate interventions to optimize their dialysis outcomes.

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TASK 7: Water Treatment Room and Dialysate Review

Reference Document: Water Treatment and Dialysate Review Worksheet

General Purpose: Verify that the facility monitors the quality of the water used in treatments and

the equipment used in water treatment.

Review critical water treatment components with on-site staff routinely responsible for the

activity and daily monitoring of the facility's water treatment system.

Tour of the water treatment room

Observe

• The required water system components of the water treatment room (carbon tanks,

RO unit, audible and visual alarms, DI requirements, if applicable) are present.

• Total chlorine test being performed and interview staff to assess their knowledge of

the test and allowable limits.

• Chlorine testing is performed before the first shift of patient treatment and repeated

before each shift, or at least every four hours.

• Maximum allowable level of 0.1mg/L total chlorine.

• Chlorine “breakthrough” procedure.

• Amount of carbon in the system (empty bed contact time- EBCT).

Triggers for citation:

• Absence of 2 carbon beds with a sample port in an outpatient water treatment system

is citable on identification and should be considered an immediate jeopardy situation.

Absence of 2 or more carbon beds with a sample port between (V192)

• Insufficient carbon empty bed contact time (<10 minutes total EBCT) or equivalency

documentation for block carbon used with portable RO-verify this by interview

and/or record review-surveyors are not expected to calculate EBCT (V195)

• Observed total chlorine test result >0.1mg/L; test done incorrectly or with incorrect

reagents/equipment (V196)

• Staff assigned to total chlorine testing have inadequate knowledge of testing

procedure, maximum allowable level of 0.1mg/L total chlorine, and/or breakthrough

procedures (V260)

Extending may include an additional observation of another staff member conducting the

chlorine test, or additional staff interviews.

Observe the reverse osmosis (RO) unit for the following:

• Water quality monitoring

• Monitoring RO function by % rejection

• Product water quality by total dissolved solids (TDS) or conductivity.

• The alarm system must be audible. No visual alarm is required for the RO unit.

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• Interview with designated water treatment staff to assess their knowledge of the

facility’s water quality monitoring system. Refer to the Water and Dialysate Review:

Observation and Interview worksheet.

Note that if block carbon is used to supply dechlorinated water to a portable RO unit, there must

be evidence from the manufacturer that the system attains equivalency to the 10-minute EBCT

requirement, based on performance data of the block carbon. In addition, there must be one

dual-block carbon system per portable RO unit, and each portable RO unit must supply one

hemodialysis machine, per the manufacturer’s directions. If the facility uses a continuous online

chlorine monitor, inquire about periodic (daily on treatment days) validation testing using an

alternative method.

Trigger for citation:

• RO percent rejection and product water conductivity or TDS not monitored and

recorded daily, water quality alarm non-functional, not audible in patient treatment

area (V199, V200)

Extending should include an interview with the technical administrative staff. Note that the

absence of acceptable water treatment monitoring methods of the facility’s RO function is citable

upon identification. If the water treatment components appear in observable disrepair, consider

reviewing the pre-treatment and water distribution components for compliance with the

applicable V-tags (V188-V191, V198-V215).

Observe the deionization (DI) and resistivity monitor and alarm, if present.

If DI is present or included in a back-up plan, observe for the presence of:

• Functional, continuous resistivity monitor after the DI system, with an audible and

visual alarm in the patient treatment area

• Presence of an automatic divert-to-drain or automatic stop valve to prevent unsafe

water flow to the dialysis stations

• Ultrafilter (UF) after the DI system

Interview facility staff about the DI system and determine if there is a plan to utilize DI as a

backup. Ask about the following:

• How is monitoring conducted?

• What is the minimum allowable resistivity level?

• What actions are taken when resistivity falls <1 megohm? (i.e., STOP dialysis).

Note: DI should not be used as the primary water purification component in a centralized water

treatment system, except as a temporary emergency backup due to RO failure (V205).

Triggers for citation: (Note if DI is part of a backup plan, all of the triggers below are

applicable)

• Absence of functional resistivity monitor or alarm; alarm not audible or visible in the

treatment area; resistivity not monitored/recorded at least twice per treatment day

(V202, V203)

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• Absence of a functional automatic divert-to-drain or automatic stop valve to prevent

unsafe water flow to the dialysis machines (V203)

• Staff unaware of accurate monitoring, minimum allowable resistivity of 1.0 megohm,

or actions for DI tank exhaustion (i.e., stop dialysis) (V260)

• No ultrafilter in-line post DI (V204)

All of the above DI triggers are citable on identification, due to the serious safety hazard that

poorly managed and monitored DI systems pose to patients.

Initial Survey Key Consideration: Chemical analysis for contaminants should be conducted

when the Reverse Osmosis (RO) and Deionization (DI) systems are installed, when the

membranes are replaced, and at least annually thereafter to ensure that AAMI limits are met.

(V201, V206)

Interview the person responsible for microbiological sampling and monitoring of water and

dialysate regarding the following:

• System disinfection

• Sample sites

• Collection methodology

• Sample timing (before disinfection)

• How often dialysate cultures are done for each HD machine

Interview the person responsible for bicarbonate and acid dialysate concentrate mixing

regarding the following:

• Verification of proper mixing

• Testing of acid concentrate

• Bicarbonate concentrate time frame for use (24 hours or per manufacturer’s DFU)

• “Spiking” (inserting additives) into individual dialysate containers

Initial Survey Key Consideration: New bicarbonate concentrate systems must be tested weekly

for one month to ensure compliance with maximum/action levels of bacteria and endotoxins

(V242).

Triggers for citation:

• Water/dialysate samples not drawn before disinfection (V254); sampling methods not

per Conditions for Coverage (CfCs) (V252, V253, V255, V258)

• Water distribution system not disinfected at least monthly (V219)

• Each HD machine has not been cultured at least annually (V253)

• Staff unaware of correct dialysate concentrate mixing, acid concentrate batch testing,

“spiking”, duration of bicarbonate usability, etc. (V229, V233, V235, V236, V260)

Review facility documentation of oversight of water & dialysate systems in the following areas:

Chemical and microbiological monitoring

• Total chlorine testing - every 2 months

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• RO monitoring by % rejection and product water quality by TDS or conductivity,

NOT all gauge and component readings – every 2 months

• If DI present or has been used in the past 12 months, 2 months of resistivity readings

at least twice per treatment day

• Product water chemical analysis – every 12 months

• Microbiological monitoring of water, including in the reuse room, and dialysate;

both colony-forming units (CFU) and endotoxin units (EU) - every 6 months

• Practice audits of the operators' compliance with technical procedures - Look at 12

months of facility documentation of observations of staff conducting water testing,

dialysate mixing, dialysate pH/conductivity testing, etc. (V260)

Triggers for citation:

• Total chlorine results exceeding 0.1mg/L without documentation of appropriate

actions taken (V197)

• Failure to complete chemical analysis of product water at least annually (V201)

• Irregularities, trends of omitted tests (V178, V180, V196, V199, V200, V202, V203,

V213, V252, V253)

• Microbiological results of water or dialysate exceeding action or maximum levels

without documentation of appropriate actions taken (V178, V180)

• Practice audits of staff conducted less than annually (V260)

If deficiencies are observed in the logs, interview technical and administrative staff and include

a review of an equal number of additional logs, e.g., two (2) more months of total chlorine logs

or RO logs, or 12 more months of chemical analysis.

Home Dialysis in LTC: A review of water treatment and dialysate monitoring will be conducted

at the dialysis facility after the survey team's on-site visit to the nursing home.

The ESRD facility is responsible for ensuring that the water and dialysate for nursing home

hemodialysis equipment meet the quality standards outlined in the ESRD Conditions for

Coverage. The documentation of water and dialysate quality used in hemodialysis machines in

the nursing home must be maintained at the ESRD facility. Although duplicate records may be

kept at the nursing home, the ESRD surveyor must conduct this review at the ESRD facility to

ensure that ESRD technical personnel are available to facilitate the review.

Review the water and dialysate quality results during the “Review of water/dialysate logs” in the

Core Survey task. Verify that the tests listed below were performed by the ESRD facility and that

corrective actions were taken as appropriate by the ESRD facility pursuant to the results of the

tests. Additional information about each test is available in the Water Treatment and Dialysate

Review Worksheet.

• Total chlorine

• Product water conductivity/TDS

• Product water chemical analysis

• Microbial surveillance of water

• Microbial surveillance of dialysate

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TASK 8: Dialyzer Reprocessing/Reuse Review (If Applicable)

Reference Document: Dialyzer Reprocessing and Reuse Worksheet

General Purpose: To ensure, through observations, interviews, and record reviews, that the

reprocessing of each dialyzer is done appropriately and consistently.

Initial Survey Key Consideration: New facilities or facilities that add dialyzer reprocessing must

validate the safety of the water supply to the reprocessing system by testing for bacteria

(microbial content) and pyrogens (endotoxins) weekly for at least three (3) months. Less

frequent testing, but not less than monthly, may be appropriate if there is a documented history

of at least three (3) months of results consistently below the required levels. (V314)

Observe the following high-risk components of dialyzer reprocessing, and interview the reuse

technician, as indicated:

• Transportation of used/dirty dialyzers to the reprocessing area—how promptly

reprocessing occurs; if refrigerated, ask about refrigeration procedures and

maximum refrigeration time. Dialyzers must be reprocessed within two hours of use.

• Pre-cleaning procedures—If manual pre-cleaning, header removal/cleaning, and/or

reverse ultrafiltration are conducted, observe these processes for 1-2 dialyzers and

interview about the procedures, the water source for pre-cleaning, and the maximum

allowable water pressures at the pre-rinse sink.

• Infection control considerations: Ensure appropriate personal protective equipment

is used for dialyzer reuse. Verify the presence of designated clean and dirty areas to

minimize the risk of cross-contamination.

Interview the reuse technician about the facility procedures for the following:

• Germicide mixing

• Storage and spill management

• Dialyzer labeling/similar names warnings

• Reprocessing procedures

• Dialyzer refrigeration and storage

Review the documentation of facility oversight of dialyzer reprocessing/reuse program in the

following areas:

Quality Assurance (QA) audits - Review 12 months of facility documentation of the following

reuse observational audits. For clarification about the audits, you may need to interview a

technical administrative person, instead of the reuse technician:

• Observations of reprocessing procedures -each reuse technician observed at least

semi-annually

• Observations of preparation of dialysis machines with reprocessed dialyzers for

patients’ treatments, i.e., germicide tests, priming, two-person identification of

patient/dialyzer quarterly

• Dialyzer labeling, including similar names labeling, quarterly

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• Reprocessing equipment preventative maintenance—Briefly review 12 months of

documentation to verify adherence to the manufacturer's directions for daily

calibration of automated equipment (this may be located on a daily “start-up” log)

and routine maintenance procedures.

• Reuse the adverse events/dialyzer “complaint” log. Look at the last 12 months for

actions taken in response to occurrences possibly related to reprocessing.

Triggers for citation:

• Improperly performed dialyzer pre-cleaning, header removal/cleaning (V334)

• Water used for pre-cleaning dialyzers is not purified to AAMI standards (V333)

• Absence of a functional water pressure gauge at the pre-cleaning sink (V332)

• Germicide not stored, mixed, or handled per manufacturer's DFU (V319, V321,

V339)

• Reuse tech unaware of requirements in key patient safety areas per interview guide

(V309, V319, V320, V328, V330, V345)

• Dialyzers not transported in a sanitary manner (V331)

• Dirty/used dialyzers left at room temperature for >2 hours before reprocessing

(V331)

• Reprocessed dialyzers stored for extended periods, i.e., exceed the facility’s maximum

storage time or are not documented as safe and effective (V345)

• QA audits listed above are not done or incomplete - Extend to review all of the

required QA audits for reuse (V360-V368)

• Reprocessing equipment maintenance and repair activities not documented and/or

not per manufacturer’s directions (V316, V317)

• Noticeably strong germicide odors and/or patient or staff complaints regarding

germicide odors- review the last 12 months of ambient air vapor testing for the

germicide (V318)

• Serious adverse events possibly related to dialyzer reprocessing/reuse, e.g., dialyzing

a patient on another patient's dialyzer, without documentation of appropriate actions

taken to prevent future similar events (V355-V357, V635)-Extend to include reuse as

a focus area for QAPI Review.

Extending the facility-based reprocessing/reuse review may include Observing the complete

dialyzer reprocessing procedures, i.e., pre-rinse, automated cleaning, testing, germicide

instillation, and labeling for at least 2-3 dialyzers (V327-V345); and additional interviews with

reuse technicians and/or technical supervisory personnel.

Note: If centralized dialyzer reprocessing is conducted with the dialyzers transported to an off-site location for reprocessing, refer to the current CMS Survey and Certification guidance in the

State Operations Manual, Chapter 2, Section 2284A.

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TASK 9: Dialysis Equipment Maintenance Review

Reference Document: Dialysis Equipment Maintenance Review Worksheet

General Purpose: To ensure, through interviews, observations, and record reviews, that all

dialysis equipment is appropriately maintained by facility staff members who conduct functional,

available, and routine preventive maintenance.

Interview the technician responsible for maintaining the machine or equipment. Ask about the

hemodialysis machine manufacturer’s directions for preventative maintenance and repair, as

well as the prescribed intervals for preventative maintenance, i.e., per operating hours or

calendar.

Review Preventive Maintenance documentation for:

• Home Machines – pick three at random from the log

• In-center Machines – pick three at random

• Reviewing logs to confirm that DFU was followed

Review the calibration documentation for the dialysis machine and dialysate pH and

conductivity meters based on the manufacturer’s DFU. Briefly look at two (2) months of logs for

pH and conductivity meters and the most recent documentation of calibration of the equipment/

meters used to conduct the hemodialysis machine maintenance and repairs.

Triggers for citation:

• Trends of non-adherence to the hemodialysis machine manufacturer’s directions for

preventative maintenance (V403)

• No calibration of pH and conductivity meters or calibration of equipment meters or

calibration not per manufacturer's directions (V403)

• Observations of severe lack of maintenance of ancillary equipment, e.g., scales,

chairs, infusion pumps, oxygen concentrators, that have the potential to impact

patient safety (V403)

Extending the review of dialysis equipment maintenance may include reviewing the PM logs for

an additional 10% of HD machines, 2-3 additional months of calibration meter logs, or

maintenance documentation of equipment in observable disrepair (V403).

Home Dialysis in LTC: The ESRD facility is responsible for maintaining and repairing the

dialysis equipment used at the nursing home. While equipment maintenance and repair

documentation may be kept on-site at the nursing home, it must also be maintained at the

ESRD facility to ensure proper monitoring and review. Note that some of the dialysis

equipment that may be used for dialysis in the nursing home setting is not maintained by the

ESRD facility (e.g. NxStage System One, PD cyclers), and malfunctioning equipment is

exchanged by the equipment supplier. It is the responsibility of the ESRD facility to ensure

that the equipment exchange occurs in a timely manner.

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Review the preventive maintenance logs for the hemodialysis equipment for the sampled

nursing home residents. If issues are identified, surveyors should use their discretion to

expand the sample. Additional information about dialysis equipment review areas are

available in the Dialysis Equipment Maintenance worksheet. Surveyors will review:

• Conventional HD machines and portable RO units

• Non-conventional HD and PD cyclers

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TASK 10: Home Dialysis Training and Support Review

Reference Documents: Home Dialysis PD Worksheet; Home Dialysis HD Worksheet, Home

Dialysis in LTC Worksheet.

General Purpose: Surveyors must verify that facilities that provide home dialysis training and

support services adequately train and support staff as well as patients/caregivers to facilitate

safe and successful home dialysis.

The survey of a home dialysis-only facility must include all applicable survey tasks, e.g., Pre-survey Preparation, Entrance Conference, Patient Sample Selection, Environmental “Flash”

Tour, Water/Dialysate Review, Dialysis Equipment Maintenance (as applicable to the equipment

in use), Personnel Record Review, and QAPI Review.

Home Dialysis in LTC: Surveyors will conduct onsite visits to the nursing homes where home

dialysis is provided to nursing home residents. The focus of this review is to ensure that the

administration of dialysis treatments and the management of residents receiving home dialysis

are consistent with the training and education provided by the dialysis facility. Once on-site, the

survey team lead will conduct introductions to:

• Explain the purpose of the visit.

• Provide an overview of the survey activities that will take place.

• Estimate the amount of time to be spent on-site.

Survey activities that will be performed on-site at the nursing home include:

• Introductions

• Tour of the Nursing Home Environment

• Observations of Home Dialysis Care

• Nursing Home Medical Record Reviews

• Nursing Home Resident (Patient) and Personnel Interviews

• Training and Competency Reviews

Refer to the Home Dialysis in LTC worksheet for additional information about the survey

activities that will occur at the nursing home.

Interview the home training nurse(s) about the home training and support program, including

evaluating patient candidacy, training patient/caregivers, verifying patient/caregiver

understanding, providing IDT support, and providing QAPI oversight. You may need to

interview different home training nurses for home hemodialysis and peritoneal dialysis.

Interview questions are provided in the Personnel Interviews worksheet.

If the opportunity arises during the survey to observe the direct care of home dialysis patients

when they are being treated or trained at the facility, look for adherence to infection control

standards.

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Interviews and medical record reviews of home dialysis patients are conducted during the tasks

for Patient Interviews and Medical Record Reviews.

Triggers for citation:

• Home training nurse(s) interview or observation of care identifies concerns about

knowledge, infection control practices, or other aspects of the home training program.

For infection control concerns, refer to the applicable triggers for infection control listed

in the Observations of Hemodialysis Care and Infection Control Practices task.

• Patient/caregiver interviews identify concerns about the adequacy of training,

competency, and support from the IDT, i.e., registered dietitian, social worker, physician,

and home training nurse (V581, 585, 586, 592).

• Medical record reviews of home dialysis patients identify concerns related to training or

monitoring of home dialysis patients, including monitoring water/dialysate quality for

HHD patients, if applicable (V585, 586, 593-595).

• The dialysis facility does not evaluate home program outcomes separately in QAPI

(V626, 628).

Extending the review of the home dialysis training and support program may include reviewing

the patient/caregiver training materials (V585), sampling additional home dialysis patients for

interview or medical record review and further evaluating the surveillance of the home dialysis

environment, i.e., home visits (V589).

Surveyors may conduct on-site visits to LTC facilities to further evaluate the home dialysis care

and services provided to patients in the LTC facility if quality of care and/or safety concerns are

identified during the ESRD facility survey or when investigating a complaint directly related to

the home dialysis services provided in an LTC facility. Surveyors may also conduct on-site visits

to the LTC facility to observe the home dialysis environment when the ESRD facility only

provides home dialysis services to residents of LTC facilities and does not have community

patients on census.

Note: The ESRD survey team does not have the authority to review non-dialysis-related care and

services provided directly within a Medicare-certified LTC facility. If an on-site visit to an LTC

facility is indicated based on survey findings, the review's focus should be directly related to the

dialysis care and services provided to residents who are patients of the dialysis facility being

surveyed. If at any time during the survey, a concern or issue arises regarding the non-dialysis-related care provided by the LTC facility to a sampled home dialysis patient, the survey team

should report this as a complaint to the State Agency survey unit responsible for oversight of the

Medicare-certified LTC entity.

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Task 11: Medical Record Review

Reference Documents: Medical Record Review Worksheets for In-Center HD, PD, and Home

HD. For each medical record review, complete a separate Medical Record Review Worksheet.

General Purpose: Conduct a focused medical record review to assess the quality of care

provided to each sampled patient related to poor outcomes and the final data-driven focus areas.

For patients who receive home dialysis services in the nursing home, nursing home medical

records will be reviewed on-site. Refer to the Home Dialysis in LTC worksheet for additional

guidance.

Review the current dialysis prescription, medication orders, and dialysis treatment records for

all sampled patients. Exclude closed records of patients who were involuntarily discharged.

Guidance for the medical record review for all sampled patients is found below:

• In-center HD patients—Look at 2-3 consecutive weeks of hemodialysis treatment records

for machine safety checks, treatments and medications delivered as ordered, blood

pressure/fluid management, and patient monitoring per policy.

• Home HD patients—Look at 2-3 consecutive weeks of hemodialysis treatment records

for staff monitoring of the patient's adherence to treatment and medication orders,

machine safety checks, blood pressure/fluid management, and recognizing and

addressing issues. Note: For sampled home HD patients, review the water/dialysate

chemical and microbiological quality documentation, as applicable, for the hemodialysis

equipment in use.

• PD patients—Look at 8-12 consecutive weeks of PD documentation, e.g., flow sheets for

staff monitoring the patient's adherence to treatment and medication orders, blood

pressure/fluid management, and recognizing and addressing issues.

• Residents receiving home dialysis treatments in the LTC facility- Along with the other

components of the medical record review for home dialysis patients, surveyors should

review home training and competency records of personnel who administer home dialysis

treatments in the LTC facility to verify that individuals who administer home dialysis

treatments have received the appropriate training before performing dialysis care as

required under [V582, V586]. The training should be tailored to meet the individual

needs of the residents. Following the requirements established at § 494.100(a) for home

dialysis training, surveyors should also verify the ESRD facility’s method of continuously

evaluating and documenting the competency of administering personnel and addressing

problems or concerns when identified.

Data-driven focus areas for the survey: Review the interdisciplinary team’s attention to care

and coordination by reviewing patient outcomes and interventions for all sampled patients in the

data-driven focus areas. Assess the ESRD facility's actions by looking at the physician’s orders,

interdisciplinary progress notes, patient care plans, and other applicable medical record

components.

Expect to see that one or more IDT members monitored the patient’s outcome in the identified

focus area(s), recognized when the patient was not achieving their goal, and responded with

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meaningful interventions aimed at improvement/resolution. Verify that if the interventions were

unsuccessful, the IDT continued to make improvements by adjusting strategies with alternative

interventions.

Note: This is a focused review examining facility systems for addressing poor patient outcomes

in the data-driven focus areas. You are not expected to search each patient’s record for all

outcomes. If, during your review of the data-driven focus areas, you discover poor outcomes for

the patient in another area, use your judgment about whether reviewing the additional area

would be of value, and follow the guidance in the survey protocol above for that area.

The remainder of each patient’s medical record review should be focused on the criteria for

sampling that patient, using the following guidelines:

Guidance for review of anemia management concerns (Patients with Hgb <10 g/dL)

Look for evaluation of the patient for:

• Treatable causes of anemia, e.g., infection, inflammation.

• GI blood loss.

• Iron studies such as ferritin and transferrin saturation.

• Symptoms of anemia.

• Erythropoiesis-stimulating agent (ESA) prescribed or increased; and,

• Avoidance of transfusion.

Guidance for review of fluid management concerns (Patients with >13mL/kg/hr average

ultrafiltration rate (UFR) for intradialytic fluid removal)

Review available documentation for the presence of:

• Interventions that address cause(s) for fluid gains between treatments.

• Interventions to mitigate the effects of rapid fluid removal during dialysis (e.g.

hypotension, cramping, loss of consciousness).

• IDT recognition of the potential risks to the patient posed by both failures to control fluid

gain between treatments and consistent rapid fluid removal (>13mL/kg/hour UFR

average in any treatment length), and,

• Interventions to minimize those risks.

Guidance for review of patients sampled as “Unstable” (described at V520 guidance for

§494.80(d)(2) as patients with extended or frequent hospitalizations, marked deterioration in

health status, significant change in psychosocial needs, or concurrent poor nutritional status,

unmanaged anemia, and inadequate dialysis).

• Plan to review IDT documentation in:

• progress notes

• physician’s orders

• assessments and plan of care

• Verify that the IDT, including the social worker, uses a standardized mental and physical

assessment tool to evaluate the patient’s psychosocial status, e.g., age-appropriate

Healthcare Related Quality of Life-HRQOL survey

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Note: The IDT process and thoroughness of the patient’s assessments and plans of care should

be reviewed in detail. Ensure that an assessment of the patient was conducted and that the

clinical and/or psychosocial issues contributing to the patient’s instability were addressed

through an appropriate plan of care interventions. There should be evidence of a functional IDT

process, including substantive contributions from and communication among all required IDT

members.

Guidance for review of patients sampled as newly admitted (<90 days)

Review the admission orders, labs, and progress notes. Review the process for ensuring the new

patient was appropriately evaluated on admission, prior to the first dialysis treatment, and

during their first weeks of care at the facility.

• Expect to see that the patient had written orders by a physician or non-physician

practitioner (if allowed by state law) and was evaluated by an RN prior to their first

dialysis treatment at the facility.

• The patient must be evaluated for Hepatitis B and tuberculosis and offered Hepatitis B

vaccination and pneumococcal vaccination, if indicated.

• The facility staff should have evaluated and addressed the issues related to the patient’s

labs, fluid management, dialysis-related problems, as well as other clinical, nutritional,

and psychosocial needs.

• For home dialysis patients and their partners, their training and home dialysis

environmental needs must be evaluated and addressed.

Patients sampled due to observations

• Focus review on the circumstances pertinent to the concerns raised from your

observations and/or random interview(s) regarding the patient.

Patients sampled as part of a complaint investigation

• Follow the applicable complaint investigation process.

• To preserve the intention of the Core Survey Patient Sample Selection process, patients

sampled as part of complaint investigations must not make up more than 25% of the

survey patient sample.

Patients sampled as involuntarily discharged (IVD)

The primary focus of your investigation into a patient who has been involuntarily discharged

should be on the meaningful actions taken by the facility in an attempt to avert the IVD, and to

preserve the health and safety of the patient.

Note: The ESRD CfCs severely limit the option of involuntarily discharging a patient without

transferring the patient’s care to another outpatient dialysis facility. When one of the criteria for

consideration of involuntary transfer/discharge listed at V766 is identified, the facility and ESRD

Network are fully expected to exhaust all resources to address the problems and prevent the

patient’s transfer or discharge. If there is no resolution, the facility must make meaningful

attempts to transfer that patient’s care to another outpatient dialysis facility. The only exception

to this expectation is in the case of an immediate severe threat to the health and safety of others

when the facility may utilize an abbreviated IVD procedure.

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Review the documentation pertaining to the actions taken in an attempt to avert the IVD, to

locate and arrange for the transfer of the patient's care to another dialysis provider, and, if all

meaningful efforts are unsuccessful, the procedures followed prior to discharging the seriously

abusive/disruptive patient. You should interview the facility’s qualified social worker, other

applicable staff, and the patient to supplement and/or support the medical record review.

Guidance for review of IVD of the seriously abusive/disruptive patient

Patients’ rights protect a patient’s right to refuse treatment. Therefore, skipping or shortening

treatments and/or failing to meet facility set goals for clinical outcomes, as well as verbal

outbursts or verbal abuse that do not present an immediate severe threat, are not acceptable

reasons for involuntary discharge.

Review of the medical record and other documentation must show written evidence of/that:

• The IDT took meaningful actions to attempt to avert the IVD. At a minimum, these efforts

must include a full IDT reassessment of the patient involving the professional IDT, the

medical director, and patient’s attending physician to investigate and determine the root

causes of the patient’s disruptive or abusive behavior and actions to resolve the issues

before considering involuntary discharge of the patient. The facility investigation should

include evaluation of the possible roles mental illness, cognitive impairment, cultural or

language differences, or staff behaviors and interactions with the patient may play in the

patients’ problematic behaviors, with interventions implemented to address and resolve

the conflict(s).

• The facility staff contacted and collaborated with the applicable ESRD Network to

resolve the problems, avert the discharge, and, if unsuccessful, facilitate a transfer to

another facility.

• The facility staff contacted other dialysis facilities, including those outside their

corporate parent company, to attempt to transfer the patient before considering IVD.

• The facility fully implemented/conducted ALL of the above actions before proceeding

with the procedures for IVD.

• Once the decision for IVD was made, the facility notified the patient at least 30 days

before the IVD, notified the applicable ESRD Network, obtained a written physician’s

order for the IVD that was signed by the medical director and the patient's attending

physician, and notified the State survey agency of the IVD.

Triggers for citation:

• Lack of evidence of a functional IDT process to monitor, recognize, and address barriers

to attaining identified patient outcome goals in one or more clinical and psychosocial areas

• Incomplete, inaccurate, inaccessible, or insecure medical records. Extend to look at

medical records management systems to ensure mechanisms are in place to facilitate the

maintenance of complete, accurate, and accessible records on all patients (V726)

• Concerns identified in other survey tasks, which can be investigated further through

medical record review to support or dispel findings

Home Dialysis in LTC:

In addition to the dialysis order/prescription and dialysis treatment records reviewed at the

nursing home, review information listed below in the ESRD facility medical record of the

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sampled nursing home patients. Additional survey instructions for each review area is

available in the Medical Record Review worksheet.

• Labs/Indicators

• Interdisciplinary Clinical Care

• Self-Monitoring Data

• Patient Education

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Task 12: Patient Interviews

Reference Document: Patient Interview Worksheets for In-Center HD, PD, and Home HD

General Purpose: The surveyor will conduct patient interviews to verify information obtained

during observations and record reviews throughout the survey. For patients who receive home

dialysis services in the nursing home, on-site interviews with the patient (resident) will be

conducted. Refer to the Home Dialysis in LTC worksheet for additional guidance.

Interview all sampled patients selected during “Patient Sample Selection.” If the sampled

patient is unavailable or refuses to be interviewed, replace each patient you cannot interview

with an alternative patient. Enter these additional patients on the Patient Roster and document

that they were interviewed. Unless their interview indicates a reason to do so, you are not

required to review their medical records. Interviews should take approximately 15-20 minutes.

Patient interviews should be conducted with patients in the facility at the time of the survey.

Explain that the interview will be conducted privately unless the interviewee requests otherwise.

If an interview cannot be completed in person, the surveyor should request assistance from a

facility staff member to reach the patient by phone.

There will be general questions asked of every patient in every interview; however, patient

interviews should include questions specific to the patient’s condition, reason for admission,

quality of care, and knowledge of their plan of care.

Refer to the Patient Interview Worksheet for additional guidance.

Note: For patients sampled due to being involuntarily discharged, some of the Interview Guide

“core” questions may not be applicable.

Interview techniques – use plain language, be aware of the patient’s level of understanding, and

maintain cultural awareness.

Triggers for citation:

• Home dialysis patient interviews or staff interviews indicate concerns about the training

program - Extend to review documentation of patient/caregiver training and

demonstration of comprehension (V585, V586)

• Patient or caregiver interviews indicate a lack of functional patient education program

and patients’ rights concerns - Extend review to documentation of patient education and

patients’ rights

• Patients express concerns regarding:

o Patients’ rights and responsibilities (V451)

o Education about transplant and all options of dialysis modalities and settings,

including those not offered at the facility (V451, V453, V458)

o Disrespectful treatment from staff (V452)

o How to prevent infections and protect their dialysis access (V562)

o The safety and comfort of the physical environment of the facility (V401, 402)

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o Disaster preparedness at home and how to evacuate the facility in an emergency

Refer to Emergency Preparedness tag at EP-0038 and EP-0040)

o Communication with the IDT and involvement in planning their care (V501, V541)

o Staff proficiency in delivering safe, adequate care (V681, V713)

o Problems due to inadequate numbers of qualified trained staff, e.g., nursing, dietitian,

social worker, patient care technicians (V757-759)

o Culture of Safety: freedom to report care concerns, ask questions, make suggestions,

or file a grievance/complaint without fear of reprisal (V465-V467

o Adequate training and IDT support for home dialysis patients and caregivers to

facilitate successful home dialysis (V585, V592)

Be alert to trends of any complaints or triggers and incorporate those “triggers” in each

subsequent patient interview.

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Task 13: Personnel Record Review

Reference Documents: Personnel Record Review Worksheet

General Purpose: All dialysis facility staff members must meet the applicable scope of practice

and State licensure requirements. Additionally, all dialysis facility staff must meet personnel

qualifications and demonstrate the competencies necessary to effectively serve the needs of their

patients. The surveyor will review personnel files to determine if staff members are licensed (if

applicable), have the necessary educational requirements, training, and ongoing competencies

required to perform the specific duties of their positions.

Verify that staff and personnel are licensed, certified, and or permitted in accordance with State

and local requirements.

Verify that staff and personnel meet all standards (such as licensure, board certification, and

work experience requirements) in accordance with personnel qualifications at §494.140.

Review a sample of personnel files representing staff from each of the disciplines listed below for

verification of qualifications, training, and competency:

• Medical director

• Nurse manager

• Home dialysis training nurse

• Charge nurse

• Staff nurse

• Patient Care Technician (PCT)

• Registered dietitian

• Master's-prepared social worker

• Water treatment system technician

• Reuse technician

• Machine/equipment technician

Audits of personnel practice: The Core Survey process includes the expectation that the dialysis

facility will continuously monitor its operations, including auditing staff competency and

compliance with implementation of technical and patient care procedures, to ensure patient

safety. The Core Survey supports the requirements of the ESRD CfCs and recommendations of

the Centers for Disease Control and Prevention (CDC) in that facility staff must be periodically,

but not less than annually, audited through direct observation while performing water testing,

dialysate mixing and testing, dialysis equipment operation (V260), dialyzer reprocessing/reuse

procedures (V360, V367, V368), and direct patient care infection prevention practices (V132,

V142, V147). During the course of the Core Survey, surveyors should expect to see that required

staff practice audits are conducted by observers who possess the qualifications and training to

evaluate the accuracy of the specific procedure implementation. The practice audit

documentation must clearly show that the observed staff demonstrated competency in the

procedure(s), or what lapses in practice were observed. When lapses in practices are observed,

facility documentation must demonstrate evidence of follow-up with investigation and

performance improvement actions.

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Triggers for citation:

• Personnel lack required qualifications, training, or competency verification (EP-0038,

V681, V684-V696)

• PCTs listed with no current certification-check for hire date within 18 months; Note that

medical, military, or other approved leave of absence extends the time allowed for

certification/recertification (V695)

Extending personnel file review may include review of additional personnel files to verify

accuracy of the facility-submitted documentation or investigate the extent of personnel

qualifications, training, and competency issues.

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Task 14: Personnel Interviews

Reference Documents: Personnel Interview Worksheets for the Medical Director, Staff Nurse,

Patient Care Technician, Dietitian, Social Worker, Administrator, Other Medical Staff

General Purpose: The surveyor will conduct personnel interviews to assess staff members’

knowledge of their responsibilities in relation to regulatory requirements, as well as facility

policies and procedures. Personnel interviews will also aid in clarifying or validating

observations throughout the survey process. Note: For patients who receive home dialysis

services in the nursing home, nursing home staff will also be interviewed. Refer to the Home

Dialysis in LTC worksheet for additional guidance.

Surveyors should interview personnel associated with concerns identified during the survey

process, such as Observations of Care, Medical Record Review, and Patient Interview, to

determine and/or support staff competency and compliance with the requirements necessary to

perform their duties.

Interviews may be conducted in person or by phone. Tailor the staff interviews to address the

specific survey issues and concerns. Surveyors should also utilize the applicable ESRD Core

Survey interview worksheets for additional “core” questions. The interview worksheets have

been segregated by personnel type.

Home Dialysis in LTC: The surveyor will interview dialysis facility staff before conducting the

nursing home onsite visit. Before visiting the nursing home onsite, ESRD surveyors should

interview the home training nurse, social worker, and dietician to gather information regarding

the services provided by the ESRD facility to the nursing home and/or the resident(s) of the

nursing home. Interview questions are outlined in the Personnel Interviews worksheet.

Note: The biomedical technician may be interviewed during the Water and Dialysate Review

task, and the home training nurse(s) may have been interviewed during the Home Dialysis

Training and Support task.

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Task 15: Quality Assessment & Performance Improvement (QAPI) Review

Reference Document: QAPI Review Worksheet

General Purpose: Verify that the facility’s QAPI program is sufficiently comprehensive and

robust to monitor and track all facility operations/services, recognize when performance

improvement is indicated, respond with effective actions to attain and sustain improvements, and

support a facility-wide culture that ensures optimum patient safety.

QAPI Scope: Each facility is required to develop and implement a QAPI program tailored to its

specific needs and characteristics. The surveyor must review each facility’s QAPI program to

determine the presence of active involvement of the professional members of the IDT. At a

minimum, members of the QAPI team must include the medical director/physician, a registered

nurse, a social worker, and a dietitian. The facility’s QAPI program may also include patients,

caregivers, and other technical facility personnel.

Active involvement is demonstrated by the routine presence and participation of QAPI team

members in identifying and analyzing facility practices and goals, as well as implementing

improvement activities.

The facility is expected to recognize when performance improvement is needed in any area and

respond with performance improvement actions tailored to the unique aspects of that facility and

its patient population, aimed at achieving improved patient safety and quality of care.

Some dialysis corporations implement a comprehensive corporate-based program. A facility’s

utilization of a corporate-based QAPI program is not the sole basis for citation. The surveyor

must review and determine whether the corporate QAPI program includes:

• Participation from facility staff members.

• Representation of all the dialysis facility’s operations and services; and,

• Measurable clinical indicators related to outcomes and prevention/reduction of medical

errors.

Preparation for QAPI Review: Although portions of the QAPI review may occur throughout the

survey, the bulk should be conducted toward the end of the survey. Conducting the review after

most of the survey is completed allows the surveyor to determine if the facility has identified the

same concerns as the survey team and whether performance improvement actions have been

initiated to address them.

Review the facility QAPI documentation for the last six (6) months in the areas listed below.

The QAPI survey review is divided into three Segments:

Segment I: Facility Monitoring of Care and Operations

Segment II: Patient-related Data and Survey Findings

Segment III: Culture of Safety

Segment I: Facility Monitoring of Care and Operations

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The review of Segment I is brief and is conducted to verify that the facility's QAPI program has

sufficient infrastructure to enable sustainable quality improvement. Specifically, the program

framework is designed to continuously monitor all areas of dialysis-related care and services

using indicators and performance measures.

The facility’s QAPI program should include all the services provided by the facility and be

segregated by modality and setting (e.g., in-center conventional HD, in-center nocturnal HD,

daily HD, conventional home HD, home PD, in-center PD, HD or PD provided in LTC

facilities).

The review of Segment I incorporates two areas:

• Clinical and operational indicators; and

• Oversight of technical operations and practice audits.

Clinical and Operational Indicators

The facility must measure, analyze and track, at a minimum, all required clinical and quality

indicators at §494.110. This includes, but is not limited to the following:

• Adequacy of dialysis

• Nutritional status

• Mineral metabolism and renal bone disease

• Anemia management

• Vascular access

• Medical injuries and medical errors identification

• Hemodialyzer reuse program, if the facility reuses hemodialyzers

• Patient satisfaction and grievances

• Infection control

The facility must identify outcome goals reflecting the most current community standards and

best practices. Surveyors should reference current national standards from sources such as the

Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines produced by the National

Kidney Foundation and the recommendations for water and dialysate safety from the Association

for the Advancement of Medical Instrumentation (AAMI).

The QAPI documentation must show the active involvement of all personnel necessary to

adequately address and resolve problems/issues, including members of the IDT, i.e., medical

director, nurse manager, master's-prepared social worker (V691), registered dietitian, and other

personnel such as technical staff and patient care staff (V626, V628).

Home Dialysis in LTC: During the QAPI Review at the ESRD facility, expect to see the

inclusion of nursing home dialysis in the QAPI process (V626). Look for:

• Evaluation of outcomes for nursing home residents on dialysis at the nursing home: The

ESRD facility must track, trend, and analyze data for residents on dialysis from each

nursing home with which it has a current agreement.

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• Performance Improvement: The ESRD facility must identify and investigate any

problems/poor outcomes experienced by nursing home residents, develop and implement

performance improvement plans, and evaluate the results and plans of action.

• Collaboration/coordination: There must be evidence of an effective working relationship

between the nursing home and the ESRD facility. Evidence of collaboration and

coordination may include, but is not limited to:

o Recurring meetings and bi-directional communication for information exchanges

between the ESRD facility and the nursing home leadership/staff.

o Communication plans for reporting adverse events and appropriate interventions;

and

o Timely and prompt response to dialysis-related issues.

Deficiencies related to the roles and responsibilities of the ESRD facility regarding its

delivery of ESRD services to nursing home residents should be cited at the corresponding

ESRD regulatory citation.

Oversight of Technical Operations and Practice Audits

Technical Operations: Verify the presence of consistent QAPI oversight and performance

improvement actions, when indicated, for the following technical areas:

• Water/dialysate quality (in-center and home hemodialysis)

• Dialysis equipment maintenance and repair

• Dialyzer reuse

Practice Audits: If surveyors have observed deficient findings during observations or practice

audits during the Personnel Record Review, determine whether the facility successfully

maintained oversight by appropriately identifying this lapse, and expect to see an evaluation to

determine the cause(s) of the issue and actions taken to resolve it.

Segment II: Patient-Related Data and Survey Findings

General Purpose: Surveyors will review the patient-related data maintained by the facility in

four critical areas to assess how the facility monitors and implements provisions of care using

clinical data. Through this review, the surveyor should assess the facility’s QAPI activities to

identify issues, prioritize areas for improvement, and respond to problematic areas in order to

attain and sustain improvements.

Critical review areas include the following:

• Mortality

• Infection prevention and control

• Medical errors/adverse occurrence tracking system

• Data-driven focus areas (identified through the DFR)

Mortality review

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Review QAPI activities relating to any patient death trends and evaluation of patient deaths

and/or trends, and efforts implemented to address adverse trends potentially related to care

received at the facility.

Review, with the responsible facility person, the QAPI documentation for evaluating the facility's

mortality data. Focus the discussion on the analysis and trending of causes of patient deaths and

their relationship to the care received at the facility.

Ask: What information do you collect about patient deaths? How does the QAPI Team conduct

analyses of individual patient deaths and recognize trends in causes and contributory factors to

these deaths? Expect to see evidence that the facility reviewed and evaluated all patient deaths

and analyzed trends in causes of patient deaths (V628).

Expect to see, for identified trends in cause of deaths, that the IDT investigated the issues and

conducted QAPI review focused on the aspects of care.

For example, a high rate of deaths due to infection should prompt the facility to review their

central venous catheter (CVC) rate, CVC reduction efforts, hospitalization patterns,

water/dialysate cultures, and staff compliance with infection control practices.

Infection prevention and control

Review of the facility’s program for infection occurrence tracking/trending, vaccination rates,

personnel infection control education and visual auditing, and patient education in infection

prevention.

Infections are a leading cause of death in dialysis patients, and protection from infection is vital

to their health and safety. This QAPI review aims to ensure that the facility’s activities support a

multifaceted and effective facility-wide program for the prevention, detection, and

management/control of infections, with the goal of minimizing or eliminating healthcare-associated infections (HAIs) acquired at the facility.

There are four (4) areas of the infection prevention and control review:

• Infection Occurrence Tracking/Trending/Surveillance

• Vaccination: High-Risk Disease Management

• Staff Education and Visual Practice Audits for Infection Control

• Patient Education for Infection Prevention

Infection Occurrence Tracking/Trending/Surveillance

Review the infection tracking logs.

• All positive culture results, dialysis access, bloodstream infections (BSI), and peritonitis

episodes, if applicable, should contain sufficient information for each (i.e., patient name,

date, infecting organism, culture site, antibiotic use)

• Trends in infections should be recognized, evaluated/investigated, and performance

improvement strategies implemented and monitored for effectiveness (V637).

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Review the documentation of the facility's dialysis-related infection rates.

Expect to see that the facility routinely calculates dialysis-related infection rates as

applicable to the modalities offered (i.e., hemodialysis vascular access, peritoneal

dialysis catheter, peritonitis) using an accepted formula. Vascular access and peritoneal

dialysis catheter infection rates are generally expressed as events per 100 patient months

[(# of events ÷ total months patients on HD/PD in 12 months) x 100]. Peritonitis rates

are either expressed as episodes per patient year at risk [episodes ÷ (total PD patient

months ÷ 12 months)] or episodes per 100 patient months; high infection rates and

upward trends are recognized, investigated, and performance improvement actions are

implemented and monitored for effectiveness (V637).

Vaccination: High-Risk Disease Management

Refer to the facility vaccination information obtained from the Entrance Conference Materials

List.

Request the QAPI documentation of oversight for surveillance and vaccinations, including, but

not limited to:

• Hepatitis B patient surveillance: susceptible patients and personnel offered vaccination

(V125-V127).

• Tuberculosis surveillance of patients on admission or exposure.

• Influenza vaccinations are offered to patients and personnel seasonally.

• Pneumococcal pneumonia vaccination offered to patients.

• New Hepatitis C (HCV) infections (i.e. antibody elevation for facilities that test for HCV)

or unexplained ALT elevations; and,

• Surveillance and vaccinations offered (if available) of Emerging Infectious Diseases,

such as Influenza, Ebola, Zika Virus, COVID-19, and others.

Expect to see evidence of active QAPI oversight of the high-risk disease surveillance and

vaccination programs listed above. If trends or lapses in surveillance or vaccination are

identified, verify that the QAPI Team thoroughly investigates the problem, implements

performance improvement actions, and monitors them for effectiveness (V637).

Staff Education and Visual Practice Audits for Infection Control

During staff interview, ask the following questions:

• What are staff taught about the patient care practices for the prevention of infections?

• How often are they re-educated in infection prevention?

During interviews with the training director, ask the following questions:

• What methods are used to conduct and ensure visual audits are performed on all

staff performing clinical and technical functions within the dialysis facility?

• How often are the visual audits conducted?

• If unsatisfactory results are evident in practice audits, how are corrective actions

implemented?

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• How are staff involved in developing and implementing corrective action(s)?

Review the facility documentation for all visual audits conducted to observe personnel infection

control practices while delivering care to patients.

CDC guidelines for Infection Control Training and Education in dialysis facilities recommend

that training and education for all employees at risk for occupational exposure to blood be

provided at least annually, given to new employees before they begin working in the unit, and

documented. Expect to see evidence of active staff education and at least annual verification of

competency of infection prevention and control practices through visual audits of each staff

member who provides direct patient care. Competency verification should include, but is not

limited to, staff’s ability to demonstrate initiation and discontinuation of hemodialysis, vascular

access care, medication preparation and administration, and hand hygiene. When lapses in

practice were observed by the dialysis facility through their surveillance and monitoring efforts,

expect to see evidence of actions taken for improvement and staff involvement during the

planning and development of improvement plans. (V637, V132, V142, V147).

Patient Education for Infection Prevention

During interviews with patients and staff, ask the following:

• How are patients educated about infection prevention?

• How are patients encouraged to be engaged and aware of infection prevention practices

that both patients and dialysis facility staff should follow? (e.g., changing gloves, hand

hygiene, cleaning/disinfecting equipment)

• How are patients encouraged to voice concerns about personnel infection control

practices?

Expect to see that the facility’s infection prevention and control program includes educating

patients and families about strategies for remaining infection-free (V637, V562, V585).

When facility data indicates high rates of infection or the potential for high rates of infection

(for example, high rates of CVC >90 days), or patterns of problematic survey findings in

infection control: Ask the following:

• What investigations have been conducted into your facility's problematic infection issue?

• What QAPI strategies have been implemented to improve the problem?

• What improvements have been achieved?

Expect to see that a facility with high patient infection rates has fully investigated for trends and

causes of the infections, including but not limited to staff care practices, water/dialysate, and

dialyzer reprocessing sources. For high rates of CVC>90 days, there should be evidence of

meaningful strategies implemented for reducing CVC rates. When reductions in infection rates

or CVC >90 days are not attained, there should be evidence of revisions and changes in

performance improvement actions until improvements are achieved (V637).

Medical error/adverse occurrence/clinical variance tracking and investigation system

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Verify the presence of an effective system for responding to events, investigating, and addressing

causal or contributory factors to prevent occurrence or recurrence. During this review, the

surveyor should “follow” an error/event and the facility’s performance improvement actions, as

evidenced in the facility system.

The intent of this review is to ensure that there is an effective QAPI system in place for reporting,

investigating, and responding to errors/occurrences.

Review the facility error/occurrence log for the past 6 months. Select one error/occurrence from

the log. The error/occurrence may be randomly selected or may be pertinent to concerns

identified during the survey. Review the investigation and outcome of the error/occurrence with

the appropriate facility personnel. The surveyor should determine whether the investigation into

the circumstances was thorough, possible cause(s) were investigated, and QAPI actions to

prevent future similar occurrences occurred.

Expect to see evidence that the facility thoroughly investigated the error/occurrence by

examining the circumstances surrounding it, including interviews with all applicable staff to

understand the context, and that these staff members were involved in the development of the

resolution plan. There must be evidence that the facility implemented a meaningful action plan

to mitigate factors that contributed to the error/occurrence, monitored the plan for effectiveness

in preventing recurrence, and, if a similar error/occurrence happened, revised and implemented

the revised plan (V634).

The error/occurrence log is not automatically a source for survey deficiency citations. However,

if a facility fails to investigate the causes of errors or adverse events, this may indicate a citation.

Data-driven focus areas

Individualize the review of the data-driven focus areas pertinent to this facility survey. In all

areas, conduct a detailed review to determine the quality and effectiveness of the facility QAPI

actions for addressing problematic areas and attaining and sustaining improvements in

outcomes.

See the ESRD Core Survey QAPI Review Worksheet for additional guidance on this review.

Review data-driven focus areas and survey findings in more detail with the responsible facility-based person.

Ask the facility-based person the following questions:

• How are facility performance improvement activities prioritized?

• How did the facility-based QAPI program recognize the focus area problem/issue and

investigate the root cause(s)?

• What actions were taken for improvement, and how were the actions and subsequent

outcomes monitored to ensure improvements were attained and sustained?

• If improvements were not attained, what actions were taken?

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For each data-driven focus area and survey finding you reviewed, expect to see evidence that the

facility:

• Prioritized improvement activities to ensure the areas with the highest potential for

impacting patient safety were given priority and aggressively addressed in a timely

manner (V639)

• Routinely monitored the focus area, recognized that a problem/opportunity for

improvement existed, thoroughly investigated root/multiple causes of the issues, and

developed and implemented performance improvement plans (V638)

• Monitored the performance improvement plan to attain and sustain improvements, or, if

goals were still not achieved, revised the actions until improvements were attained and

sustained (Note: repeated entries of “will monitor” over several consecutive months

without active revisions to action plans is not sufficient evidence of effective QAPI)

(V626, 628-637)

Segment III: Facility Culture of Safety

Verifying the presence of a facility-wide culture that promotes and protects patient safety. The

primary components of a culture of safety are a robust and proactive system for reporting and

addressing errors/events, open blame-free communication between all levels of staff and

patients, and clearly communicated expectations of staff and patients. A facility-wide culture of

safety enables staff and patients to participate in ensuring that everyone at the facility is

committed to identifying and mitigating risks to patients.

The culture of safety review has two (2) components:

• Staff participation

• Patient participation

Staff Participation Review

Verify the presence of open communication among all levels of facility staff and encouragement

for staff to voice concerns without fear of retribution. The surveyor will review the facility's

method for promoting and gathering staff feedback or questions as well as providing information

related to expectations among all levels of staff.

There should be evidence that the facility has an organized, facility-based system in place for

staff to submit written or verbal suggestions for improvement, communicate concerns about their

work environment, and file complaints.

If the surveyor has gathered evidence of staff complaints not being addressed, for example,

during staff interviews, confirm with an appropriate member of the QAPI team whether the

complaints were received, reviewed, and addressed.

Expect to see evidence that the facility administration educates and encourages staff to make

suggestions and voice concerns and complaints about their work environment. There should be

evidence that administrative personnel recognize and acknowledge staff concerns in a timely,

non-judgmental manner, conduct substantive investigation into the concerns, and include

applicable staff in resolution to the issues (V626).

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Patient Engagement Review

The surveyor will review the facility’s method for promoting and gathering patient feedback.

Verify facility participation with all dialysis patients that provide feedback on the overall care

and operations at the dialysis facility to promote patient satisfaction. The surveyor should

review the facility patient grievance, complaint, or suggestion system by “following” a patient

complaint through the process.

If the patient interviews task indicated a reluctance to voice complaints, follow up with facility-based personnel for further investigation. Review the record to see if the complaints were

documented and ask staff whether the complaints were received. Is there a QAPI process that

allows patients to complain or submit grievance without fear of retribution?

Ask: How are staff taught to respond to patients’ concerns? What types of patient concerns do

you educate and expect staff to report and record?

Ask: How are patients educated about and encouraged to freely speak up and voice suggestions

and complaints/grievances without fear of retribution or retaliation? How are their concerns,

verbal or written suggestions, and complaints/grievances recorded and responded to? What is

your facility’s system for communicating with patients and reporting the resolution to them?

(V465, V466, V467)

Review the patient suggestion/complaint/grievance log with the responsible facility-based

person. Select one patient suggestion/complaint/grievance to review how it was investigated,

resolved, and the result communicated to the patient. You may wish to interview the involved

patient about their experience using the facility's patient suggestion/complaint/grievance system.

Expect to see that facility management and staff encourage patients to verbalize suggestions and

concerns, in addition to written complaints/grievances. Staff should be educated on how to

respond professionally to patients’ verbalized concerns and to report them to their supervisor for

recording and follow-up (V636, V765).

There must be evidence that the patient’s concern you reviewed was recorded, the circumstances

investigated, mutually acceptable resolution reached, and the result communicated to the patient

(V636, V465, V765).

Verify that the facility routinely assesses the patients’ satisfaction with the facility services and

care received and acts upon the identified opportunities to improve care.

Ask the following: How do you assess patient satisfaction/perceptions of care at this facility?

How do you use that information to improve programs or care delivery? (V636)

Triggers for citation:

The QAPI program does not:

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• Administer oversight of all facility operations including monitoring all areas and

conducting practice audits as required by the CfC (V260, V362-V368, V403)

• Recognize and address risk areas where facility outcomes and/or survey findings indicate

performance improvement is needed/indicated (V625-V640)

• Follow up on performance improvement plans, resulting in improvements not attained or

sustained or recurring similar adverse events (V634, V638)

Extending the QAPI review should be considered if there are serious, pervasive deficient

practices identified during the survey and were not recognized and/or adequately addressed by

the dialysis facility. Extending the QAPI review should include investigating the facility’s

compliance with the Conditions for Coverage of Medical Director and Governance. This may

include interviews with the facility administrator, medical director, and governing body

members to determine what administrative failures have contributed to the pervasive problems,

through lack of adequate staff and/or resources (V754, V756, V757); lack of staff training and

education (V713, V715, V760, V761, V763); and/or lack of involvement or leadership of the

medical director (V712, V714).

Decision Making:

General Purpose: To facilitate communication and collaboration among survey team members

regarding potential survey findings and to prepare for the Exit Conference.

• Meet with the survey team to discuss the survey findings

• Refer to reference documents on ESRD decision making

• Make copies of evidence as needed to document survey findings

Exit Conference:

General Purpose: To notify the facility of the concerns identified during the survey, and the

preliminary findings of deficient practice.

Verbally present findings in order of severity; do not provide specific V-tags.

Follow relevant SOM & State procedures.

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Part III: Surveyor Worksheets

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Task 1: Pre-Survey Preparation

ESRD Core Survey Data Worksheet

Facility: __________________________________________ CCN: ________________________

Surveyor: ______________________________________ Date: _______________________

Instructions: Use this worksheet to gather essential information for reviewing the pre-survey

and entrance conference tasks.

Contents: There are 2 sections of this worksheet:

Section 1: Pre-survey Preparation and Dialysis Facility Report (DFR) Review (pages 2-4):

To review and evaluate the facility outcomes data from the current FY DFR and

quarterly DFR (QDFR), as well as facility survey history review, and ESRD Network

contacts

Section 2: Entrance Conference Materials List (pages 5-6): To be copied and given to the

facility

PRESURVEY PREPARATION AND DIALYSIS FACILITY REPORT REVIEW

The following dialysis facility reports are created under contract to the Centers for Medicare &

Medicaid Services (CMS) to provide state surveyors and the CMS Location with information on

clinical performance and outcomes. Dialysis facility reports contain data pertaining to patient

characteristics, treatment patterns, hospitalization, mortality, and transplantation patterns in

dialysis facilities.

Dialysis Facility Report (DFR): Provided as a resource for characterizing selected

aspects of clinical experience at a given facility relative to other caregivers in the state,

End Stage Renal Disease (ESRD) Network, and across the United States. Since these

data could be useful in quality improvement and assurance activities, each state’s

surveying agency may utilize the DFRs as a resource during their survey and

certification process. This report is updated annually.

Quarterly DFR (QDFR): The QDFRs for State Surveyors provide quarterly updates of

select measures from the DFRs in December, March, and June of each year. These

reports are utilized by each state surveyor’s agency as a resource during the survey

process and guide the pre-survey identification of the preliminary data-driven focus

areas

Download and review the current FY DFR for the facility. The DFR, QDFR, as well as the State

Profiles may be accessed at https://dialysisdata.org/.

Enter your Username and Password then click “Log in” to log onto the Secure

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DialysisData.org web site.

The DFR tab contains the current comprehensive FY DFR for all facilities in the

respective State or Region.

The QDFR tab contains more recent results of select measures from the FY DFR

The Profiles tab contains the:

State Profile

Confidential Outcomes List

Review how the facility is ranked on the State Profile/Outcomes List. Review the

information about the facility on pages 1-3 of the DFR.

Review the most current fiscal year’s DFR in conjunction with the facility QDFR. Review each

pre-populated data element on the QDFR, which are key aspects of facility performance and

assists the surveyor’s identification of the preliminary data-driven focus areas during the pre-survey preparation. Note trends in outcomes over the 4-year period. For standardized mortality

(SMR) and transplant ratios (STR), the 4-year average is a more consistent measure of facility

performance. For standardized hospitalization ratio (SHR) and standardized readmission ratio

(SRR) the most recent 1-year measurement is most meaningful.

Review how the facility compares with U.S. Averages. Note declining or improving trends and

flag which elements are worse than the U.S. Average. Consider those clinical areas for

preliminary data-driven focus areas for the survey.

Preliminary data-driven focus areas based on DFR review:

1. _____________________________ 4. _____________________________

2. _____________________________ 5. _____________________________

3. _____________________________ 6. _____________________________

During the entrance conference:

Review and confirm the preliminary data-driven focus areas by reviewing more recent

facility data. This will allow the surveyor to determine whether improvements were made

for any clinical indicator reported during the time period not covered in the DFR. The

final data-driven focus area(s) will be confirmed after it is determined that a clinical

indicator has outcomes lower than the national average and has not improved after

reviewing the facility’s more recent clinical outcomes report.

Discuss the selection of the data-driven focus areas for the survey with the administrative

person. If SHR &/or SRR on DFR are high, include hospitalization/readmission as a

data-driven focus area. If the facility is currently meeting the thresholds in an area where

the DFR review indicated problems, performance improvement may have taken place.

Upon validation of the improvement, you may choose not to include that as a data-driven

focus area for review.

Review of Transplant Waitlist: If the facility DFR and current transplant % is lower than

Page 341 of 420

the national threshold, review requested information and gather additional information

during the medical record review and patient interviews to ensure patients are being

educated and referred as required (V-458, V-513, V-554, V-561).

Final data-driven focus areas for survey:

1. _____________________________ 4. _____________________________

2. _____________________________ 5. _____________________________

3. _____________________________ 6. _____________________________

Review ESRD Facility Survey and Complaint History (12-18 months): This information may be

obtained from facility files maintained by the State Agency, the CMS national database, and in

Table 15 of the facility DFR. Note any survey and complaint information in the space provided

below.

Areas of concern: _______________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

Contact the ESRD Network: After entrance into the facility, call the Network to ask about

concerns related to involuntary discharges, complaints, and other survey issues related to the

ESRD Core Survey process.

Network person contacted: _____________________________ Position: __________________

Is the facility under any special Network quality monitoring? If yes, describe: ______________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

Have there been any involuntary discharges or patterns of involuntary transfers from the

facility? If yes, how many, and describe any pattern(s) identified: ________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

Have there been patterns of patient complaints about the facility? If yes, describe any pattern(s)

identified: _____________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

Are there any other concerns you have about the facility that the survey team should be aware

of? If yes, describe your concerns: _________________________________________________

Page 342 of 420

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

Areas of concern based on facility survey/complaint history and contact with the ESRD

Network:

1. _____________________________ 4. _____________________________

2. _____________________________ 5. _____________________________

3. _____________________________ 6. _____________________________

Page 343 of 420

Task 2: Introductions

[Placeholder]

Task 3: Environmental Flash Tour

[Placeholder]

Page 344 of 420

Task 4: Entrance Conference

ENTRANCE CONFERENCE MATERIALS LIST

Surveyor: Make a copy of this list and provide it to the facility-based staff member for

submission of requested information.

Facility: Review this list and submit the requested information to the survey team leader. Items

must be submitted within the timeframes indicated.

Timeframe for submission: within 3 hours of receipt of materials list

• List of current patients by name, separated into modalities.

• List of facility key personnel: medical director, administrator, nurse manager, social

worker, dietitian, chief technician, and home training nurse(s).

• Current in-center hemodialysis patient schedule by days & shifts with any isolation

patients identified (seating chart or assignment sheet).

• List of patients admitted to this facility within the past 90 days who are currently on

census (do not include visiting patients) separated by modality with date of admission.

• List of patients who have been designated as “unstable” for any month in the past 3

months, including reason for unstable designation and month.

• List of all patients who were involuntarily discharged (not transferred to another

outpatient dialysis facility) from this facility in the past 12 months.

• List of all discharged patients categorized as “lost to follow up” (i.e., not transferred out

or discontinued dialysis) for the past 12 months.

• List of home hemodialysis (HHD) or peritoneal dialysis (PD) patients scheduled to be

seen at the facility during the survey.

• List of all nursing homes with which the ESRD facility has a current written agreement to

provide dialysis services and the address for each nursing home, including:

o How treatments are provided in each distinct nursing home, i.e., in the patient’s

private room, in a common area, or both.

o The names of all patients currently receiving dialysis services from the ESRD

facility at each nursing home.

o The modality and treatment schedule (including the scheduled times for the

hemodialysis treatments) for each nursing home resident named above.

o Names and credentials (e.g., RN, PCT) of any nursing home personnel who

deliver the residents’ dialysis treatments.

o A copy of the written agreement between the ESRD facility and each nursing

home.

• Hospitalization logs with admitting diagnoses listed for 6 months.

• List of current patients readmitted to the hospital within 30 days of discharge in past 6

months, separated by modality.

• Infection logs for past 6 months.

• List of in-center HD patients who are dialyzed with 0 K+ or 1.0 K+ dialysate.

• All patients’ individual laboratory results for hemoglobin, Kt/V, uncorrected calcium,

phosphorus and albumin for the current 3 months; separated by modality.

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Timeframe for submission: End of survey, Day 1

• Vaccination information

o # of patients who received complete series of Hepatitis B vaccine _______

o # of patients who received the influenza vaccine between August 1 and March 31

_________

o # of patients who received the pneumococcal vaccine _______

• Staff schedule for the previous two weeks, organized by days of the week

• Policies and procedures for the following:

o Patient care (admissions, transfers, discharge, involuntary discharge, clinical

care policies)

o Water treatment

o Dialysate preparation and delivery

o Dialyzer reprocessing and reuse, if applicable

• Patient suggestions, complaints, and grievances for last six months

• Adverse event documentation for the last six months

• QAPI meeting minutes for last 6 months. Include any supporting documentation and/or

materials

• Copy of any CMS-approved waivers, i.e. medical director, life safety code, and/or

isolation room waivers. Note: Life Safety Code waiver cannot apply to dialysis facilities

that do not provide an exit to grade (42 CFR 494.60(d)(1)).

• Staff practice audits for infection prevention while performing direct patient care. Submit

practice audits for most recent 12 months.

• Routine maintenance and testing logs for the following water and dialysate components:

o Daily water system monitoring, submit for last two months

o Total chlorine testing, submit for last two months

o Bacterial cultures and endotoxin results (water and dialysate cultures), submit for

last 6 months

o Product water chemical analysis, submit for last 12 months

o Staff practice audits for water testing, dialysate mixing and testing, and

microbiological sampling, submit for last 12 months

• Documentation of the following equipment maintenance:

o Preventative maintenance and repair of hemodialysis machines, submit for last 12

months

o Calibration of equipment for machine maintenance, submit for last 12 months

o Calibration of equipment for dialysate pH and conductivity testing, submit for last

two months

• Logs for the following dialyzer reprocessing components, if applicable:

o Bacterial cultures and endotoxin results from reuse room sites, submit for the last

six months

o Preventative maintenance and repair of reprocessing equipment, submit for last

12 months

o Reuse QA audits, submit for the last 12 months

Timeframe for submission: Day 2 of survey

Completed “CMS 3427-End Stage Renal Disease Application and Survey and

Page 346 of 420

Certification Report”

Page 347 of 420

Entrance Conference Questions

Facility: ________________________________________ Date: ________________________

Instructions: A surveyor must gather preliminary information to aid in their review of a dialysis

facility. Ask the facility representative for the information listed below.

FACILITY CENSUS

Current in-center census (hemodialysis only): ____

Number of hemodialysis treatment stations currently in use: _____

FACILITY HOURS OF OPERATION

What time is the facility open? _____________________________________________

What time do staff arrive? __________________________________________________

How many patient shifts are there? M/W/F _________________ T/Th/Sa ____________

What time do patient shifts start? ____________________________________________

FACILITY ISOLATION/INFECTION CONTROL

Does the facility have an isolation room or area? Yes _____ No _____

If yes, how many isolation stations are available? _____

If not, does the facility have an active isolation room waiver? Yes _____ No _____

Does the facility have a written agreement with a local facility which accepts patients requiring

isolation? Yes _____ No _____

Name of alternate facility: _________________________________________________

Number of HBV+ patients on census: _____

Number of patients on census with MRSA and/or VRE: _____

Has the facility had patients (or staff) with Tuberculosis conversions (- to +) in the last 3 years?

Yes _____ No _____

If yes, was the appropriate State Health Department notified? Yes _____ No _____

DIALYZER REUSE

Does the facility reprocess/reuse dialyzers? Yes _____ No _____

If yes, name of germicide used: ______________________________________________

Does the facility use a centralized reprocessing facility? Yes _____ No _____

If yes, name of centralized reprocessing facility: ________________________________

HOME DIALYSIS

Does the facility have a home dialysis training and support program? Yes ____No _____

If yes, number of patients: Peritoneal Dialysis (PD) ____Home Hemodialysis (HHD) ___

If not, how does the facility provide access to this home dialysis? _________________________

______________________________________________________________________________

______________________________________________________________________________

Page 348 of 420

Does the facility have home dialysis patients receiving services in a nursing home? Yes____ No

____

If yes, number of patients: PD _____ HHD _____ and number of nursing homes where home

dialysis services are provided ______

Who administers the home dialysis treatments in the nursing home?

Dialysis facility personnel _____ Nursing home personnel _____ Existing caregiver ___

SPECIAL CONSIDERATIONS

Does the facility have patients on census who weigh less than 30 kg or who are under 18 years of

age? Yes _____ No _____

PERSONNEL

Staff members currently in orientation: ________________________________________

Does the facility use contracted staff to provide care in the facility? Yes _____ No _____

MEDICAL RECORDS

What system for patient medical records is used? ________________________________

Is part or all of the medical record computerized? Yes _____ No _____

Page 349 of 420

Task 5: Observations of Hemodialysis Care and Infection Control Practices

Facility _________________________ CCN ______________ Surveyor __________________

This worksheet is intended to guide the surveyor through the Observations of Hemolysis Care

and Infection Control Practices in the ESRD Core Survey Process.

There are three parts to this survey task:

Observation of care delivery

Review of facility isolation practices

Verification of dialysis treatment prescription delivery

Observation of care delivery:

Observe the following activities using the applicable observational checklists in this worksheet:

Hemodialysis patient care and dialysis station & equipment preparation: Attempt to capture

at least 2 separate observations of each of the procedures listed below. Try to conduct

observations on different days and of different staff. It may be possible to observe several of

the procedures at one dialysis station during the changeover between patient shifts. Observe

each procedure listed below one at a time, to ensure focus on that activity.

Initiation of Hemodialysis with Central Venous Catheter (CVC) (Checklist 1)

Central Venous Catheter Exit Site Care (Checklist 2)

Discontinuation of Hemodialysis with Central Venous Catheter (Checklist 3)

Initiation of Hemodialysis with Arteriovenous Fistula (AVF) or Arteriovenous Graft

(AVG) (Checklist 4)

Discontinuation of Hemodialysis with AV Fistula or AV Graft (Checklist 5)

Cleaning and Disinfection of the Dialysis Station (Checklist 6)

Preparation of the Hemodialysis Machine/Extracorporeal Circuit (Checklist 7)

Dialysis Supply Management and Contamination Prevention: This checklist should be

completed after the surveyor has conducted the above critical observations (Checklist 9)

Medication preparation and administration: Use observational Checklist 8 to capture two

observations of different licensed nursing staff preparing and administering medications.

Include two patients in each observation to identify trends in practice and technique.

Facility isolation practices: Observe the isolation room or area, and the equipment and supplies

contained within it. Is the isolation room/area:

Separated from other in-center stations? (V110, V128)

Equipped with dedicated equipment and supplies for single-patient use? (V110,

V130)

Page 350 of 420

Determine if there are any HBV+ patients who will be receiving hemodialysis at the facility

during the survey. Complete this section if there are HBV+ patients receiving in-center

hemodialysis at the facility.

Review staff assignments to ensure staff member for HBV+ is dedicated to one or more

HBV+ or HBV immune patient. Staff should not simultaneously be caring for patients who are

HBV susceptible. (V110, V131). Are staff members dedicated?

Yes _____ No _____

(Note: Exceptions to this should be rare. Emergency medical situations may be a justifiable

exception.)

Staff members are observed practicing appropriate isolation techniques, e.g. removal of PPE

and hand hygiene when entering and leaving the isolation room/area. (V113, V130)

Yes _____ No _____

Notes: ________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

Verification of dialysis treatment prescription delivery: Complete this section to verify that

dialysis treatments being delivered are administered in accordance with the physician’s

ordered dialysis prescriptions.

Select four to five patients that are actively receiving hemodialysis treatments during this review.

Observe the following treatment prescription components for each of the selected patients:

Dialyzer

Blood flow rate

Dialysate flow rate

Dialysate

Review the dialysis orders/prescription in the medical record for each of the selected patients.

Compare the order with the delivered treatment parameter set on the dialysis machine while the

patient is being dialyzed.

Note: If the facility utilizes an electronic medical record, request the facility-based staff member

to assist in retrieving the electronic treatment orders/prescription.

Are delivered patient treatment parameters consistent with physician dialysis

orders/prescriptions? (V543, V544) Yes _____ No _____

Note: Observational Checklists 1 through 9 are intended to focus observations on the

elements/steps of the procedures that would be expected to prevent the transmission of infections

and ensure safe operation of dialysis equipment.

Additional Comments:

______________________________________________________________________________

______________________________________________________________________________

Page 351 of 420

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

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Page 352 of 420

Checklist 1: Initiation of Hemodialysis with Central Venous Catheter (CVC)

Facility __________________________________________ Surveyor _____________________

Obs. #1: Patient ID ________Date/time __________ Station # __________ Staff ____________

Obs. #2: Patient ID ________Date/time __________ Station # __________ Staff ____________

Notes: The patient should wear a mask whenever CVC is accessed. Staff PPE must include a

gown, mask, eye protection, and gloves (V115, V113). All antiseptics and disinfectants must be

used per the manufacturer's instructions.

ACTION OBSERVATION 1 OBSERVATION 2

No common tray/cart brought to dialysis station

(supplies for only that patient brought to

station) (V116)

Yes ____ No ____ Yes ____ No ____

Hand hygiene, don clean gloves (V113) Yes ____ No ____ Yes ____ No ____

Place clean field under CVC ports (V147) Yes ____ No ____ Yes ____ No ____

Close the catheter clamps.

Disinfect CVC hubs, using an appropriate

antiseptic. May perform external disinfection

by:

Open hub disinfection by wiping the

threads and top of uncapped hub with

antiseptic, removing any residue/blood

and/or.

Closed connector devices which have

penetrable caps not removed, wipe

outside connecting surfaces of device

(V147)

Yes ____ No ____ Yes ____ No ____

Connect sterile syringes aseptically to each

port to remove indwelling solutions and/or

flush with sterile saline; initiate treatment

Yes ____ No ____ Yes ____ No ____

Remove gloves, hand hygiene (V113) Yes ____ No ____ Yes ____ No ____

Additional Notes: _______________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

Page 353 of 420

Checklist 2: Central Venous Catheter Exit Site Care

Facility __________________________________________ Surveyor _____________________

Obs. #1: Patient ID ________Date/time __________ Station # __________ Staff ____________

Obs. #2: Patient ID ________Date/time __________ Station # __________ Staff ____________

Notes: Patient should wear a mask whenever CVC is accessed (V147). Staff PPE must include

gown, mask, eye protection, and gloves (V115, V113). All antiseptics and disinfectants must be

used per manufacturer's instructions.

ACTION OBSERVATION 1 OBSERVATION 2

No common tray/cart brought

to dialysis station (supplies

for only that patient brought

to station) (V116)

Yes ____ No ____ Yes ____ No ____

Hand hygiene, don clean

gloves (V113)

Yes ____ No ____ Yes ____ No ____

Remove old dressing and

discard

Yes ____ No ____ Yes ____ No ____

Remove gloves, hand hygiene,

clean gloves (V113)

Yes ____ No ____ Yes ____ No ____

Cleanse area around CVC

exit site with antiseptic ;

allow to dry before applying

dressing (V147)

Sterile dressing applied to

CVC exit site; may apply

antimicrobial ointment if not

contraindicated or

chlorhexidine- impregnated

dressing if no sensitivity

(V147)

Yes ____ No ____ Yes ____ No ____

Remove gloves, hand hygiene

(V113)

Yes ____ No ____ Yes ____ No ____

Additional Notes: _______________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

Page 354 of 420

Checklist 3: Discontinuation of Hemodialysis with Central Venous Catheter

Facility __________________________________________ Surveyor _____________________

Obs. #1: Patient ID ________Date/time __________ Station # __________ Staff ____________

Obs. #2: Patient ID ________Date/time __________ Station # __________ Staff ____________

Notes: Patient should wear a mask whenever CVC is accessed (V147). Staff PPE must include

gown, mask, eye protection, and gloves (V115, V113). All antiseptics and disinfectants must be

used per manufacturer's instructions.

ACTION OBSERVATION 1 OBSERVATION 2

No common tray/cart brought to dialysis

station; supplies for only that patient brought to

station (V116)

Yes ____ No ____ Yes ____ No ____

Hand hygiene, don clean gloves (V113) Yes ____ No ____ Yes ____ No ____

Place clean field under CVC ports (V147) Yes ____ No ____ Yes ____ No ____

Reinfuse extracorporeal circuit Yes ____ No ____ Yes ____ No ____

Remove gloves, hand hygiene, don clean gloves

(V113)

Close CVC clamps; Disinfect CVC connections

with appropriate antiseptic. May perform

external disinfection by:

Wiping exterior of connections before

disconnecting blood lines: Open hub

disinfection wiping threads and top of

open CVC hubs, removing any

residue/blood after disconnecting blood

lines and/or;

Closed connector devices: wiping

exterior of connections before

disconnecting blood lines (V147)

Yes ____ No ____ Yes ____ No ____

Disconnect blood lines aseptically (V147) Yes ____ No ____ Yes ____ No ____

Apply sterile port caps aseptically after post

treatment protocol (applicable to closed

connector devices when changed) (V147)

Yes ____ No ____ Yes ____ No ____

Discard unused supplies or dedicate them to

that patient; no disposable supplies returned to

common supplies (V116)

Yes ____ No ____ Yes ____ No ____

Remove gloves, hand hygiene (V113) Yes ____ No ____ Yes ____ No ____

Additional Notes: _______________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

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Checklist 4: Initiation of Hemodialysis with Arteriovenous Fistula (AVF) or

Arteriovenous Graft (AVG)

Facility __________________________________________ Surveyor _____________________

Obs. #1: Patient ID ________Date/time __________ Station # __________ Staff ____________

Obs. #2: Patient ID ________Date/time __________ Station # __________ Staff ____________

Notes: Staff PPE must be gown, face shield or mask/eye protection, and gloves (V115, 113). All

antiseptics and disinfectants must be used per manufacturer's instructions.

ACTION OBSERVATION 1 OBSERVATION 2

No common tray/cart brought to dialysis

station (supplies for only that patient brought

to station) (V116)

Yes ____ No ____ Yes ____ No ____

Wash skin over access with soap and water or

antibacterial scrub (patient or staff may do

this-patients should be instructed to wash their

access upon entering facility & staff verbally

confirm with patient that it was done; for

dependent patients, staff must do this before

proceeding with skin antisepsis) (V550)

Yes ____ No ____ Yes ____ No ____

Evaluate access; Locate/palpate cannulation

sites

Yes ____ No ____ Yes ____ No ____

Hand hygiene (remove gloves, if worn); don

clean gloves (V113)

Yes ____ No ____ Yes ____ No ____

Apply antiseptic to skin over cannulation sites

and allow to dry; sites not touched again after

skin antisepsis, without repeating skin

antisepsis (V550)

Insert cannulation needles; tape in place;

initiate treatment

Yes ____ No ____ Yes ____ No ____

Remove gloves, hand hygiene (V113) Yes ____ No ____ Yes ____ No ____

Note: This checklist is not intended for use with buttonhole cannulation technique

Additional Notes: _______________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

Page 356 of 420

Checklist 5: Discontinuation of Hemodialysis with AV Fistula or AV Graft

Facility __________________________________________ Surveyor _____________________

Obs. #1: Patient ID ________Date/time __________ Station # __________ Staff ____________

Obs. #2: Patient ID ________Date/time __________ Station # __________ Staff ____________

Notes: Staff PPE must be gown, face shield or mask/eye protection, and gloves (V115, 113). All

antiseptics and disinfectants must be used per manufacturer's instructions.

ACTION OBSERVATION 1 OBSERVATION 2

No common tray/cart brought to dialysis station

(supplies for only that patient brought to

station) (V116)

Yes ____ No ____ Yes ____ No ____

Hand hygiene, don clean gloves (V113) Yes ____ No ____ Yes ____ No ____

Reinfuse extracorporeal circuit; disconnect

bloodlines aseptically

Yes ____ No ____ Yes ____ No ____

Remove gloves, hand hygiene, don clean gloves

(V113)

Remove needles aseptically; discard needles in

Sharps container at point of use; Needle sites

held with clean gauze or bandage using clean

gloved hands (patient, staff or visitor) or

disinfected clamps (V550, 113)

Yes ____ No ____ Yes ____ No ____

Remove gloves, hand hygiene (V113) Yes ____ No ____ Yes ____ No ____

When hemostasis is achieved: Hand hygiene,

don clean gloves; replace blood- soiled

bandage/ gauze on needle sites; Bandage/gauze

on each needle site is clean & dry prior to

discharge (V550, 113)

Yes ____ No ____ Yes ____ No ____

Discard unused supplies or dedicate them to

that patient (no supplies returned to common

supplies) (V116)

Yes ____ No ____ Yes ____ No ____

Remove gloves, hand hygiene (patient or visitor

who held sites, remove gloves, hand hygiene)

(V113)

Yes ____ No ____ Yes ____ No ____

Additional Notes: _______________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

Page 357 of 420

Checklist 6: Cleaning and Disinfection of the Dialysis Station

Facility __________________________________________ Surveyor _____________________

Obs. #1: Patient ID ________Date/time __________ Station # __________ Staff ____________

Obs. #2: Patient ID ________Date/time __________ Station # __________ Staff ____________

Notes: All items listed in this checklist must be disinfected using an EPA-registered hospital

disinfectant prepared and used in accordance with manufacturer's instructions (V122)

Staff PPE must be gown, face shield or mask/eye protection, and gloves (V115, 113)

ACTION OBSERVATION 1 OBSERVATION 2

Remove all bloodlines and disposable

equipment; discard in biohazards waste;

dialyzer for reprocessing: all ports capped,

dialyzer and bloodlines transported in a

manner to prevent contamination of other

surfaces (V122)

Yes ____ No ____ Yes ____ No ____

Empty prime waste receptacle, if present on

machine

Yes ____ No ____ Yes ____ No ____

Remove gloves, hand hygiene, don clean gloves

(V113)

Yes ____ No ____ Yes ____ No ____

Use disinfectant-soaked cloth/wipe to visibly

wet all machine top, front and side surfaces,

dialysate hoses, Hansen connectors, and

outside surfaces of dialysate concentrate

containers ( V122)

Wipe wet all internal and external surfaces of

prime waste container and allow to dry if

present; prime waste container must be

disinfected before used to prepare for another

patient’s treatment (V122)

Yes ____ No ____ Yes ____ No ____

When chair vacated: discard unused disposable

supplies (or dedicate to that patient); chair fully

reclined, fresh disinfectant cloth/wipe used to

visibly wet all external front-facing and side

chair surfaces, including down sides of seat

cushion and tops of side tables (V116, V122)

Yes ____ No ____ Yes ____ No ____

Non-disposable items: BP cuff & tubing, TV

controls, call button, data entry station and

counters around dialysis station wiped wet with

disinfectant (V122)

Yes ____ No ____ Yes ____ No ____

If clamps are used, cleaned of visible blood and

disinfected (V116)

Yes ____ No ____ Yes ____ No ____

Page 358 of 420

ACTION OBSERVATION 1 OBSERVATION 2

Discard cloths/wipes; remove gloves, hand

hygiene (V113)

Yes ____ No ____ Yes ____ No ____

Attention: The previous patient must fully vacate the dialysis station before surface cleaning,

disinfection and set up for the next patient begins.

Additional Notes: _______________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

Page 359 of 420

Checklist 7: Preparation of the Hemodialysis Machine/Extracorporeal

Circuit

Facility __________________________________________ Surveyor _____________________

Obs. #1: Patient ID ________Date/time __________ Station # __________ Staff ____________

Obs. #2: Patient ID ________Date/time __________ Station # __________ Staff ____________

Notes: Hemodialysis machines must be operated in accordance with the manufacturer's

directions for use for internal function verification and dialysate testing. Artificial dialyzers must

be rinsed and tested in accordance with the germicide (if reprocessed) and dialyzer

manufacturer's directions for use. Dummy drip chambers must never be used to prepare a

machine for patient treatment (V400, V403)

Staff PPE must include gloves; if reprocessed dialyzer, gown, face shield or mask/eye protection

(V115, V113, and V320)

ACTION OBSERVATION 1 OBSERVATION 2

Reprocessed dialyzer germicide tests done

(i.e., presence test before rinsing/priming,

absence of residual test prior to treatment

initiation) (V350, 353)

Yes ____ No ____ Yes ____ No ____

Dialyzer rinsed/primed with sufficient saline

(note that single use dialyzers not chemically

sterilized may require less saline for rinsing

than reprocessed dialyzers and chemically

sterilized single use dialyzers) (V352, 403)

Yes ____ No ____ Yes ____ No ____

Dialysate pH and conductivity tested with an

independent method; Staff aware of allowable

pH range and variation from machine

conductivity reading (V250)

Yes ____ No ____ Yes ____ No ____

Machine alarms and internal functions (e.g.,

pressure holding test) tested (V403)

Yes ____ No ____ Yes ____ No ____

Reprocessed dialyzer: patient and dialyzer

matched and identified by 2 people while

patient is at dialysis station (V348)

Yes ____ No ____ Yes ____ No ____

Additional Notes: _______________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

Page 360 of 420

Checklist 8: Parenteral Medication Preparation and Administration

Facility __________________________________________ Surveyor _____________________

Obs. #1: Patient ID ________Date/time __________ Station # __________ Staff ____________

Obs. #2: Patient ID ________Date/time __________ Station # __________ Staff ____________

Notes: Medications must be prepared in a clean area on a clean surface away from dialysis

stations (V117).

ACTION OBSERVATION 1 OBSERVATION 2

Hand hygiene (V113) Yes ____ No ____ Yes ____ No ____

Single dose vials used for one patient only and

discarded (V118)

Yes ____ No ____ Yes ____ No ____

Multiple dose vials are only entered with a new,

sterile syringe and needle, labeling with date

opened and discarded within 28 days or by

manufacturer's instructions (V143)

Yes ____ No ____ Yes ____ No ____

Wipe stopper with alcohol or other antiseptic

(V143)

Yes ____ No ____ Yes ____ No ____

Withdraw medication into sterile syringe;

Label syringe if medication not immediately

administered;

Medications may be prepared for multiple

patients at one time, but administration must be

to one patient at a time, leaving remainder of

medications in the clean preparation area

(V117)

Yes ____ No ____ Yes ____ No ____

Only individual patient's medications taken to

their dialysis station (V117)

Yes ____ No ____ Yes ____ No ____

Hand hygiene, don clean gloves and other PPE

as indicated by potential exposure (e.g., gown

and mouth/nose/eye protection if injecting into

blood lines) (V113, 115)

Yes ____ No ____ Yes ____ No ____

Wipe injection port with antiseptic; inject

medication (V143)

Yes ____ No ____ Yes ____ No ____

Discard syringe into sharps disposal container

Exception: If using a needleless system with no

attached needle, disposal into a sharps

container is not necessary (V121)

Yes ____ No ____ Yes ____ No ____

Remove gloves, hand hygiene (V113) Yes ____ No ____ Yes ____ No ____

Additional Notes: _______________________________________________________________

Page 361 of 420

Checklist 9: Dialysis Supply Management and Contamination Prevention

Facility __________________________________________ Surveyor _____________________

Observation period #1: Date ____________________ Time of observation period ___________

Observation period #2: Date ____________________ Time of observation period ___________

NOTE: This checklist is intended to be completed after observations of care using checklists 1

through 8 have been completed, to record your observations related to the facility supply

management in general throughout that observation periods. Record details of specific stations,

staff, and patients involved in the applicable fields below.

ACTION OBSERVATION 1 OBSERVATION 2

Supplies are stored and kept in designated

clean areas, sufficient distance from dialysis

stations to prevent contamination from

potentially infectious materials/substances

(V119)

Yes ____ No ____ Yes ____ No ____

Supplies for next patient are not brought to the

station before the prior patient's treatment is

terminated and applicable piece of equipment

(machine, chair) is cleaned/disinfected (i.e.,

supplies are not placed on or near the machine

until it has been “stripped” and surface

disinfected) (V119)

Yes ____ No ____ Yes ____ No ____

Carts or trays containing supplies are not

taken to or moved between dialysis stations

(V119)

Yes ____ No ____ Yes ____ No ____

Staff do not store patient care supplies in

pockets or on their person (V119)

Yes ____ No ____ Yes ____ No ____

Non-disposable equipment (e.g., thermometer,

pH/conductivity meter, access flow device, O2

saturation meter, blood glucose meter,

stethoscope diaphragm/bell end) brought to

the dialysis station is disinfected before being

returned to a common area or taken to another

dialysis station Disinfection=all surfaces

wiped visibly wet with EPA-registered hospital

disinfectant and allowed to dry (V116)

Yes ____ No ____ Yes ____ No ____

Medication vials are not taken to the dialysis

station (V117)

Yes ____ No ____ Yes ____ No ____

Disposable supplies taken to the dialysis

station not used on the patient are discarded

or dedicated to that patient and not returned to

common supplies (V116)

Yes ____ No ____ Yes ____ No ____

Page 362 of 420

Additional Notes: _______________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

Page 363 of 420

Task 6: Patient Sample Selection - Roster

Instructions: Select patients using the criteria provided on the table below. Record patient

information in the appropriate fields and mark the appropriate column to indicate the “Reason

Sampled”. During the Medical Records Review, focus each review on the sampling criteria.

Facility: ________________________ CCN: ___________ Census: ____ Date: ____________

Abbreviations Reason Sampled

Modality:

ICHD: In-center Hemodialysis

ICPD: In-center Peritoneal

Dialysis

HHD: Home Hemodialysis

PD: Home Peritoneal Dialysis

Unstable

New Admission (<90 days)

Involuntary Discharge

Home Dialysis in LTC

Infection

Recent Hospitalization/

Readmission

CVC > 90 Days

Observation

Complaint

Random Sample

Survey Method:

I: Interview

O: Observation

R: Record Review

Name:

ID:

Admit Date:

Modality:

Method:

Surveyor:

Name:

ID:

Admit Date:

Modality:

Method:

Surveyor:

Name:

ID:

Admit Date:

Modality:

Method:

Surveyor:

Page 364 of 420

Modality:

ICHD: In-center Hemodialysis

ICPD: In-center Peritoneal

Dialysis

HHD: Home Hemodialysis

PD: Home Peritoneal Dialysis

Unstable

New Admission (<90 days)

Involuntary Discharge

Home Dialysis in LTC

Infection

Recent Hospitalization/

Readmission

CVC <90 Days

Observation

Complaint

Random Sample

Survey Method:

I: Interview

O: Observation

R: Record Review

Name:

ID:

Admit Date:

Modality:

Method:

Surveyor:

Name:

ID:

Admit Date:

Modality:

Method:

Surveyor:

Name:

ID:

Admit Date:

Modality:

Method:

Surveyor:

Name:

ID:

Admit Date:

Modality:

Method:

Surveyor:

Name:

ID:

Admit Date:

Modality:

Method:

Surveyor:

Page 365 of 420

Task 7: Water Treatment and Dialysate Review Worksheet

Facility __________________________ CCN ______________ Surveyor __________________

Technician(s) _________________________ ID ____________ Date/Time ________________

Instructions: Conduct this review with on-site staff routinely responsible for the water and

dialysate monitoring and testing. Multiple technicians or staff may need to be interviewed.

Carbon System and Chlorine Removal Trigger

Observe for presence of two carbon beds, or banks of tanks with sample port in

between

Comment: If block carbon is used to supply dechlorinated water to a portable RO

unit, there must be one dual block carbon system (two block carbon or one block

carbon and one granular activated carbon tank) per portable RO and each portable

RO must supply one hemodialysis machine, per manufacturer’s directions.