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CMS ESRD Conditions for Coverage: Review and Questions Alex Rosenblum RN, VP Quality SWBU – Fresenius Medical Care The Stephen Z. Fadem Update Professional Symposium February 27, 2009 CONDITIONS FOR COVERAGE Provide an opportunity for Q&A related to specific practice areas

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CMS ESRD Conditions for Coverage: Review and Questions

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CMS ESRD Conditions for Coverage:Review and Questions

Alex Rosenblum RN, VP Quality SWBU – Fresenius Medical Care

The Stephen Z. Fadem Update

Professional Symposium

February 27, 2009

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Provide an opportunity for Q&A related to specific practice areas

These questions have been called into the regulatory department of a large dialysis organization and will be discussed here

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ESRD Conditions for Coverage

The ESRD Conditions for Coverage are the minimum health and safety rules that all Medicare and Medicaid participating dialysis facilities must meet. The April 15, 2008 ESRD Conditions Final Rule modernizes Medicare's ESRD health and safety conditions for coverage and updates CMS standards for delivering safe, high-quality care to dialysis patients. The revised regulations are patient-centered; reflect improvements in clinical standards of care, the use of more advanced technology, and, most notably, a framework to incorporate performance measures viewed by the scientific and medical community to be related to the quality of care provided to dialysis patients.

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History of Regulations in Houston

  • In the early 1990s there was a 6 person hepatitis outbreak in Houston. This was investigated, and 23 days later everything turned out OK.

  • Rose Bell from the Health Department said – One cannot give people hepatitis and not have consequences. She also said tattoo parlors have more rules than dialysis units.

  • By 1996 Texas had rules and regulations

  • In 2005 CMS started organizing them, and they were passed in 2008

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Condition for Coverage

  • Initial Conditions for Coverage- 1976        

  • 2008 ESRD Conditions Final Rule- April 15, 2008

  • All provisions of the ESRD Conditions Final Rule were effective 10/14/08.

  • Delayed effective dates:  

    • a. Dialysis providers had until 2/9/09 to comply with the requirement that dialysis providers building new facilities add on an isolation room. 

    • b. Dialysis providers had until 2/9/09 to comply with the requirement to install the safety items mandated by the Life Safety Code of 2000.    

    • c. Dialysis providers had until 2/1/09 to comply with the requirement to submit data to CROWNWeb. – This was delayed until summer

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Some have not changed

  • Medical records, special purpose dialysis facilities and laboratory services have not changed.

  • However many other components have changed.

  • Here are what surveyors around the country are citing, and what questions are being asked.

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CFC Organization

  • Part C: Patient Care

    • Patients’ rights

    • Patient assessment

    • Patient plan of care

    • Care at home

    • QAPI

    • Special purpose dialysis facilities

    • Laboratory services

  • Part D: Administration

    • Personnel

    • Medical director responsibilities

    • Medical records

    • Governance

Part A: General

  • Compliance: state/local “adjudicated”

    Part B: Patient Safety

  • Infection control

  • Water/dialysate

  • Reuse

  • Physical environment

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Conditions for Coverage(CFR Part 494)

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494.30: Infection Control

  • Adopts CDC guidelines by reference:

  • 29 Standards

    • Sanitary environment

    • PPE/gloves/hand hygiene

    • Nondisposable items

    • Medication preparation area

    • Potentially infectious waste

    • Cleaning/disinfection contaminated surfaces, medical devices and equipment

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Changes in Infection Control

  • Infection control used to be mixed in with environmental conditions, and surveyors would cite differently than now where they cite on 29 tags .

  • What is your staff doing with hand hygiene, how do they handle things that are shared?

  • How do you prevent hepatitis spread?

  • Are patients changing gloves between patients, typing with a glove on one hand and none on another. People get caught up in what they are doing.

  • Do you have handwashing sinks distinct from dirty sinks?

  • Are there clamps in the facilities?

  • Can you access water hands free?

  • Do you have to touch handles?

  • What is the staff doing with the gloves. Are they taking the gloves to the clean areas?.

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CDC Regulations

  • They base the infection control conditions on two regulations – one on catheter care and one on hepatitis

  • Read the CDC guidelines Pages 18 through 28

  • These ten pages are the most important and you need to know them

  • Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients (MMWR April 27, 2001 / 50 (RR05);1-43)


  • Guidelines for the Prevention of Intravascular Catheter-Related Infections (MMWR August 9, 2002 / 51(RR10);1-26)


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Infection Control – What is being cited?

  • The second area you need to know are –

  • how are you doing disinfection? –

  • How are you allowing for things that are done between two patients?

  • They are going to the dialysis chairs and flip them into trendelenberg – if there is blood in the cracks or on the side, or if the chairs are ripped, torn or rusty – you will be cited. This must be addressed. Is the laminate cracked? Are there floor tiles coming us.

  • Anything that cannot be cleaned is cited. TV controls, clamps, stethoscopes – cited. How are you mixing your bleaches? That is being cited.

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Hepatitis really very, very important to understand –

  • Patients with hepatitis antibody status. How are they tracking it? Do patients finish the whole series – they may know, or not know.

  • It always happens the day the surveyor comes

    • Patients in a buffer zone and someone else sits in a chair - the day a negative antibody in a area near an isolation room.

  • What are the procedures in the isolation room? How are people changing their gowns and their personal protective equipment (ppe). People need to be cited if they do not follow the rules.

  • Does the staff understand that there needs to be a buffer zone.

  • All of the things are being looked at and being cited?

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Infection Control – What is being cited?

  • The medical director and Quality Assessment and Performance Improvement (QAPI) are also cited – If you have an infection, it needs to be tracked. Present it to the medical director so he can provide oversight. The medical director is one of the most cited tags in the country.

  • Sanitizers on the side of the dialysis machine – the whole world of going to electronic medical records – never designed to do this way. If an entry screen is away from the area make sure everyone uses the same hand hygiene. Either wear clean gloves or wash hands.

  • Wheels on physician rounds table – depends on distance from the patient

  • Rolling cart – wheels chart – that will get cited –

  • In the era October 14, 2008 the regulations were not specific for infection control.

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Infection Control

  • If you do not touch the patient, but it is turnover, everyone near the patient must wear PPE. The physicians have to wear PPE. (Yes, even the medical director!)

  • If you touch something, patient – machine – etc – use hand hygiene. If the physician is making rounds is can use the hand sanitizer. If the PCT is with 4 patients and an alarm goes off – use hand sanitizer.

  • How do you get patients to sign a care plan - pens – this is a good question (We need digital signatures)

  • Hepatitis isolation room - There is information online about how many miles the dialysis units have to be apart regarding hepatitis B isolation. If a patient is referred with hepatitis, have an isolation room, boundary or a neighboring unit.

  • Hepatitis B can survive on an inanimate surface for several days, hence the precautions in dialysis units are much more stringent than universal precautions.

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Infection Control

  • The guidelines are not as specific, but designed to make sure that the staff understands and practices proper technique

  • There is a fallback codeword – “hey, hey, observe the care.”

  • Depending upon what you are doing. If you had a patient holding the sites while the PCT is setting up the machine, this is now allowed.

  • The regulations in infection control have been valid.

  • Most citations for breaking practice are legitimate.

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Infection Control“Questions”

Can we place hand sanitizers on the side of the dialysis machines?

If a computer data entry screen is located away from the patient area, what are the infection control requirements?

Can sinks used to drain saline bags, disinfect clamps and/or prime buckets be used for handwashing?

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494.30 Infection Control

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Infection Control

  • Hepatitis B:

    • Hepatitis B screening

    • Patient serological status

    • Vaccination, patients/staff

    • Isolation practices

  • Infection control education

  • Infection control reporting/tracking

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Infection Control“Questions”

If a facility has an isolation room, may they refuse to accept HBV+ patients, so that the isolation room can be used as a regular station and used for all shifts?

If the HBV+ patient runs 2X week only and the room is terminally cleaned and the machine removed, why can’t the room be used for HBV- patients?

What supplies should be kept in an isolation room or area?

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494.30 Infection Control

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494.40: Water and Dialysate Quality

  • Adopts ANSI/AAMI RD52

  • Standards:

    • Water purity i.e. chemical analysis, bacteriology

    • Water purification systems

    • Alarms, diagrams & labels

    • Water treatment system components

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Water system

  • There are pages of specifics for the water system. We provide maintenance for the water system

  • Chlorine/chloramines PH and conductivity – if they do not do the test right – what does it mean – what do you do if it is out. As clinical managers you need to be familiar with every component of the water, particularly the water. How are you keeping the logs. If there is an abnormal finding how are you tracking it through QAI. The worst way to hurt patients is through the water system, so it is expected that you know what is going on.

  • The medical director must understand the water system.

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Water and Dialysate Quality

  • Chlorine/chloramine

    • Two tanks / back-up system

    • Monitoring, testing frequency

    • Testing equipment

    • Staff proficiency, training

    • Observation of testing processes

  • Disinfection processes

  • Mixing systems

  • Monitoring

  • Adverse Event reporting

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  • Test strips

    • This is to be used after the machines have been bleached once a week. They are then rinsed and there is a check for residual chlorine.

    • These strips go to 0.5

  • The chlorine in the water system has to be tested to < 0.1. Therefore strips cannot be used, and one use a meter. Do not test the water system with strips

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Water and Dialysate Quality“ Questions”

  • Can test strips sensitive to 0.5 be used to test for residual bleach after rinsing?

  • Are facilities required to test water system alarms for water quality and low tank level?

  • How many dialysis machine/dialysate cultures must be done each month?

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494.40 Water and Dialysis Quality

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494.50: Reuse of Hemodialyzers and Bloodlines

  • General requirements for use of hemodialyzers and bloodlines

  • Reprocessing requirements

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Reuse of Hemodialyzers & Bloodlines“Questions”

  • If dialyzer reuse labels are affixed to individual patient reprocessing records, must those logs be filed in the patient’s medical record?

  • Are there some types of dialyzers that require that the end caps be removed and the header spaces cleaned?

  • When a dialyzer must be replaced mid-treatment, can a preprocessed dialyzer be used?

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  • Reuse – they adopted the AAMI guidelines according to reuse –

    • What are the requirements?

    • How do you get the dialyzers?

    • How are they labeled?

    • Reuse labels are part of the medical record

    • How is the dialyzer itself reprocessed?

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494.50 Reuse of Hemodialyzers & Bloodlines

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494.60 Physical Environment

Building/furnishings/equipment - safe and functional

All equipment operated according to manufacturer’s guidelines

Patient care environment sufficient prevent cross contamination and accommodate emergency equipment

Comfortable temperature

Accommodations patient privacy

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Physical Environment

  • On the physical environment –

  • The buildings must be safe and secure –

  • Are there any safety issues-

  • Is the area functional –

  • Are tiles on the floor that someone will slip on?

  • Are there chair that are torn?

  • Is the laminate coming up?

  • Can it be cleaned?

  • Do the fire alarms work?

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Physical Environment

Emergency preparedness:

Patient/staff education and training

Emergency equipment

Emergency plans

Notification local “Disaster Management Agency”

Fire safety

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Disaster Preparedness

  • After Katrina, CMS realized the need to regulate disaster planning and this too was built into the conditions for coverage.

  • Therefore, they are looking at, and their regulations are very specific about emergency care

  • How is contact being made with the Emergency Operations Center (EOC) department?

  • You must talk with the EOC?

  • What do you do if you have an emergency?

  • The disaster plan needs to be reviewed annually. This is something that will be brought up.

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Physical Environment“Questions”

What are the expectations for refrigerators for medication storage?

Does the “no video surveillance” apply to nocturnal dialysis?

What if the patients’ refuse to keep their vascular accesses uncovered? Is having the patient sign a waiver acceptable?

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494.60 Physical Environment

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494.70: Patients’ Rights

  • Informed first six treatments

  • Informed regarding:

    • Right participation in care

    • Advance directives

    • Treatment modalities

    • Facility policies regarding patient care & isolation

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Patients’ Rights

  • Informed Regarding

    • Patient’s medical status by physician or physician extender

    • Expected patient conduct & responsibilities

    • Facility internal/external grievance process

    • Facility’s discharge and transfer policies including involuntary discharges

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494.70 Patients’ Rights

Patient rights and quality of care :

As long as you provide education to the patient and document it you should be fine on patient rights. The CMS answer is that while you are making walking rounds, get the patients approval to discuss clinical issues. Do not talk about sex, financial or HIV issues. It is permissible to talk about phosphorus. Alternative is that patient must come to a meeting outside the treatment area, and most will be reluctant to do so.

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Patients’ Rights“Questions”

  • Does the patient right to privacy prohibit conducting chair-side care planning with the patient if other patients can hear what is being said?

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494.80: Patient Assessment

  • The IDT is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs.

  • The comprehensive plan must be used to develop the patients’ treatment plan and expectations for care i.e. Plan of Care.

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Patient Assessment

  • Frequency:

    • Initial comprehensive assessment must be conducted on all new patients within the latter of 30 calendar days or 13 outpatient hemodialysis sessions

    • Follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient plan of care

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Patient Assessment

  • Patient Reassessment:

    • At least annually for stable patients

    • At least monthly for unstable patients defined as follows:

      • Extended or frequent hospitalizations

      • Marked deterioration in health status

      • Significant change in psychosocial needs

      • Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis

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Patient Assessment“Questions”

  • Can the Medical Director substitute for the “treating physician” in the IDT?

  • Please expand upon the initial assessment requirements?

  • Discuss the expectations for compliance “within a year”. Does this mean “don’t cite” within the first year?

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494.80 Patient Assessment

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494.90 Patient Plan of Care

  • The Patient’s Plan of Care must:

    • Be completed, dated and signed by IDT members

    • Begin within 30 days or 13 outpatient treatments

    • Include monthly and/or annual updates of the plan performed within 15 days of the completion of the additional patient assessments

    • Be adjusted, as frequently as monthly, if the expected Plan of Care outcome(s) are not being achieved

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Patient Plan of Care

  • Patient Plan of Care:

    • The outcomes must be consistent with current evidence-based professionally-accepted clinical practice standards (MAT)

    • Include defined criteria

    • Include, as appropriate, defined “Home Specific” criteria

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Patient assessment and plan of care

  • The new Conditions for Coverage say that the care plans are gone and now patients must be completed within the first 30 days – month by the the members of the IDT (Interdisciplinary Team).

  • The social worker, RN, RD must do this process.

  • It must be done again in 90 days on new patients.

  • If the patient is stable you look at that, but do NOT put “NA” or leave blank. If the patient is stable reassess once a year.

  • Everyone is getting into trouble if the patients are not getting individualized care.

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Plan of care

  • In center the patient is seen 12 times a month with 12 to 14 interactions.

  • However, the surveyor comes in and looks at the plan of care.

  • For instance, they might note a high blood pressure, and that there is no documentation that this was addressed – if one is to maintain blood pressure and they see high pressures or the goal is not met. They will be cited. Therefore, it must be documented that the abnormal test was addressed, and there needs to be a follow up note indicating the outcome.

  • This is the same for anemia or anything else. If the come in February and did not meet target, was the prescription changed? Then, what was the result?

  • It may be monthly on one element on STABLE patients. People need to understand this – stable patients are being cited for this reason. .

  • CMS is strong on intent, not single patient – Have you adopted a culture of documenting?

  • Document in one place – or in a progress note.

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Patient Plan of Care“Questions”

  • What documentation is expected for the medication review?

  • Discuss the mechanics of updating an assessment; what would the document look like, a series of assessments? ?

  • If a stable patient does not meet one quality indicator in the POC does the entire IDT need to reassess or can only one member of the team update and revise the POC?

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494.90 Plan of Care

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494.100:Care at Home

  • Care at least equivalent to in-facility patients

  • Patient’s training must be:

    • Provided by a facility that is approved to provide home dialysis services

    • Conducted by a registered nurse (qualified)

    • Conducted for each home dialysis patient and address the specific needs of the patient

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Care at Home

  • Monitoring:

    • Documentation of patient/caregiver completion and adequate comprehension of training

    • Retrieval and timely review of self monitoring data from self-care patients or their designated caregiver(s) at least every 2 months

    • Maintain information in the patient medical record

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Care at Home“Questions”

  • Does home therapy include patients who are dialyzing in nursing homes as their place of residence?

  • What are acceptable reasons for a home patient not to be seen by a physician every month?

  • How frequently should data be reviewed for home patients?

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494.100 Care at Home

What ever you do for center, you must do for home and home care patients. Assessments, visit, QAPI.

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494.110: Quality Assessment & Performance Improvement

Program must:

  • Achieve measurable improvement in health outcomes and reduction of medical errors

  • Measure, analyze and track quality indicators

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Quality Assessment & Performance Improvement

Program must:

  • Continuously monitor performance, take actions that result in improvement and track performance to ensure that improvements are sustained over time

  • Prioritize by prevalence and severity of identified problems

  • Immediately correct any identified problems that threaten patient health or safety

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Quality Assessment & Performance Improvement“Questions”

  • Is there a requirement for documentation of the QAPI program activities?

  • If the facility incident reports are sent to a corporate risk management dept., is it acceptable to only review the aggregate data kept by the facility or are we authorized to request the actual incident reports?

  • What should be tracked and trended for medical injuries and errors?

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494.110 Quality Assessment & Performance Improvement

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494.140: Personnel Qualifications

  • Medical Director

    • Board-certified in internal medicine or pediatric by a professional board who has completed a board training program in nephrology and has at least 12-months experience in providing care to patients receiving dialysis

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Personnel Qualifications

  • Nursing Services *

    • Nurse Manager: FT RN dedicated to one facility, 18 months experience 6 of which is in the care of dialysis patients.

    • Self-care and home training nurse, RN with 12 months experience in providing nursing care with an additional 3 months of experience in the specific modality for which the nurse will provide self-care training.

      * Texas Licensure Regulations

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Personnel Qualifications

  • Nursing Services

    • Charge Nurse: RN, LPN, or LVN with 12 months experience with 3 in the care of maintenance dialysis

      • If such nurse is a LPN or LVN, work under the supervision of a RN in accordance with state nursing practice act provisions

    • Staff Nurse RN or LVN meeting state practice requirements

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Personnel Qualifications

  • Dietitian

    • Must be registered with the commission on dietetic registration


    • Have a minimum of one year work experience in clinical nutrition as an RD.

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Personnel Qualifications

  • Social Worker

    • Holds a master’s degree in Social work with specialization in clinical practice from an accredited school


    • Has served at least two years as a social worker one year of which was prior to 9/1/1976 and has a consultative relationship with a “qualified” social worker

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Personnel Qualifications

  • Patient Care Technicians

    • Must meet all applicable State requirements

    • Have a high school diploma or equivalency

    • Completed a training program approved by the Medical Director and Governing Body

    • Be certified under a State certification program or a national commercially available certification program

  • Dialysis Assistants (Patient care/dialysis machine set up)

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Personnel Qualifications

  • Water Treatment System Technicians

    • Technicians who perform monitoring and testing of the water treatment system must complete a training program that has been approved by the Medical Director and GB

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Personnel Qualifications“Questions”

  • Can you explain if we hire a new PCT today, how much time does he/she have to obtain their certification?

  • What happens if the dietitian does not have at least one year in a clinical setting?

  • Does the nurse manager need to be on site every day the facility is open, even Saturdays?

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494.140 Personnel Qualifications

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494.150: Responsibilities of the Medical Director

  • Medical Director responsibilities include:

    • Quality assessment and performance improvement program

    • Staff education, training and performance

    • Policies and procedures

      • Participate in the development, periodic review and approval

      • Ensure adherence of all individuals treating patients

      • Interdisciplinary team adheres to discharge and transfer policies

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494.150: Responsibilities of the Medical Director“Questions”

  • In facilities that had co-medical directors prior to the effective date of Part 494, can one now be the medical director and the other be an associate medical director?

  • If our Medical Director does not currently meet the new qualifications, is there a waiver process?

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494.150 Responsibilities of the Medical Director

QAPI is the medical director’s responsibility. What CMS surveyors are claiming is that there must be a process in place. What is the description, what is the scope – how are you tracking, recognizing?


The world has changed – it is not the tag, but the doctor. It is critically important that the doctor know what is going on. Doctors must attend surveys. Make sure you review all results with them.

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494.180: Governance

  • Governance

    • The Governing Body is responsible for:

      • Designating a chief executive officer

      • Staff appointments

      • RN responsible nursing care – present at all times patients are in the facility

      • Fiscal operations

      • Maintaining adequate numbers of qualified and trained staff

      • Furnishing services

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  • Are all medical staff members required to attend QAPI meetings?

  • Does the facility need a contract with a hospital for admission of patients in an emergency?

  • If patients are not being treated but are in the facility, e.g. in the waiting room, must a registered nurse be present?

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494.180 Governance

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ESRD Conditions for Coverage Resources

  • Network 14 (ESRD Renal Network of Texas):

  • CMS:

  • Email contact for questions (Glenda Payne):

  • NKF:

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Other Vital Resources

  • 42 CFR Parts 405, 410, 413 et al. Medicare and Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule


  • Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients (MMWR April 27, 2001 / 50 (RR05);1-43)


  • Guidelines for the Prevention of Intravascular Catheter-Related Infections (MMWR August 9, 2002 / 51(RR10);1-26)


  • Infection Control Requirements for Dialysis Facilities and Clarification Regarding Guidance on Parenteral Medication Vial (MMWR August 15, 2008 / 57(32);875-876)


  • Guidance for Surveyors


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