Transcript PowerPoint Presentation - CMS ESRD Part 494 Conditions for

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
These questions have been called into
the regulatory department of a large
dialysis organization and will be
discussed here
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.
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
Condition for Coverage
 Initial Conditions for Coverage- 1976
 2008 ESRD Conditions Final Rule- April 15, 2008
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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
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.
CFC Organization
Part A: General
– Compliance: state/local
“adjudicated”
Part B: Patient Safety
– Infection control
– Water/dialysate
– Reuse
– Physical environment
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
Conditions for Coverage
(CFR Part 494)
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
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?.
CDC Regulations
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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)
– http://www.cdc.gov/mmwR/preview/mmwrhtml/rr5005a1.htm

Guidelines for the Prevention of Intravascular Catheter-Related
Infections (MMWR August 9, 2002 / 51(RR10);1-26)
– http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5110a1.htm
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.
Hepatitis
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?
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.
Infection Control
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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.
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.
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?
494.30 Infection Control
Question
Answer
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?
Yes, if the dispenser is included in the cleaning done
between uses of the machines for different patients
When data entry stations are located away from the
immediate treatment stations, staff leaving the patient
stations should wash or sanitize hands before touching the
computer station
No, handwashing sinks should be dedicated for that purpose
and remain clean.
Yes, if the dispenser is included in the cleaning done
between uses of the machines for different patients
Can sinks used to drain saline bags, disinfect clamps and/or
prime buckets be used for handwashing?
Can we place hand sanitizers on the side of the dialysis
machines?
Infection Control
 Hepatitis B:
– Hepatitis B screening
– Patient serological status
– Vaccination, patients/staff
– Isolation practices
 Infection control education
 Infection control reporting/tracking
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 HBVpatients?
 What supplies should be kept in an isolation
room or area?
494.30 Infection Control
Question
Answer
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?
Each facility must have provision for
isolation of HBV+ patients. If a facility has
no current HBV+ patients, they may use
their isolation room for any patient. While
the medical staff may choose to admit or
refuse to accept a patient, a pattern of
refusal to accept HBV+ patients in these
circumstances would not meet the intent of
the regulations, and could result in a
complaint investigation and citations for not
having the provision for isolation.
According to the CDC, the difference is the
risk of inadequate cleaning. When the
cleaning has to happen after each
treatment, the risk of exposure of patients
to HBV is greater. The regulation requires
the room/area be reserved for HBV+
patients use until there are no longer any
HBV+ patients on the census
Supplies routinely used for the care of
patients, such as alcohol swabs, gloves,
gauze pads and hemostats.
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?
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
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.
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
 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
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?
494.40 Water and Dialysis Quality
Question
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?
Answer
Yes
The requirement is that the alarm sound in the treatment
area: in order to know if the alarm sounds, the alarm must
either be tested or the facility staff must note when the
alarms sound during operation.
Dialysate cultures must be collected from at least 2 dialysis
machines per month, and each machine must be cultured
annually, at a minimum.
494.50: Reuse of Hemodialyzers
and Bloodlines
 General requirements
for use of
hemodialyzers and
bloodlines
 Reprocessing
requirements
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?
Reuse
 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?
494.50 Reuse of Hemodialyzers & Bloodlines
Question
Answer
If dialyzer reuse labels are affixed to individual patient
The reprocessing records have to be treated as a medical
reprocessing records, must those logs be filed in the patient’s records, but may be maintained separately. When the patient
is no longer treated at the facility, the facility might choose to
medical record?
combine these records with the other records of that patient’s
care.
Are there some types of dialyzers that require that the end
No. If the facility opts to remove dialyzer end caps and
perform header space cleaning, it must be done within the
caps be removed and the header spaces cleaned?
guidelines at V334.
When a dialyzer must be replaced mid-treatment, can a
Yes, as long as the pre-processes dialyzer is labeled with
that patient’s name and the original TCV of the dialyzer is
preprocessed dialyzer be used?
known.
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
Physical Environment
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On the physical environment –
The buildings must be safe and secure –
Are there any safety issuesIs 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?
Physical Environment
 Emergency preparedness:
– Patient/staff education and training
– Emergency equipment
– Emergency plans
– Notification local “Disaster Management
Agency”
– Fire safety
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.
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?
494.60 Physical Environment
Question
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?
Answer
V403 requires equipment maintenance and includes the
maintenance of medication refrigerators to be clean and have
evidence the temperature required for the medications being
stored is maintained.
Yes, if nocturnal dialysis is occurring in the dialysis facility,
the patients must all be visualized by staff throughout the
treatment and video surveillance can not be substituted. This
requirement does not apply to home hemodialysis patients
on nocturnal dialysis.
Patients have the right to refuse aspects of their treatment
plans. If the patient refuses to keep his/her access
uncovered, the facility would be expected to educate the
patient about the risks associated with covering the access
during dialysis; assess the patient’s reasons for the decision’
and develop a plan of care to address the issue. Having a
patient sign a waiver does not remove the responsibility of
the facility to monitor the patient’s access.
494.70: Patients’ Rights
 Informed first six treatments
 Informed regarding:
– Right participation in care
– Advance directives
– Treatment modalities
– Facility policies regarding patient
care & isolation
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
494.70 Patients’ Rights
Question
Does the patient right to privacy prohibit conducting chairside care planning with the patient if other patients can hear
what is being said?
Answer
The IDT should ask the patient is he/she wishes to have the
POC in a private space or in the treatment area. If the patient
agrees to have the POC in the treatment area, it would not
violate HIPAA or privacy in this regulation.
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.
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?
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.
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
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
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?
494.80 Patient Assessment
Question
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?
Answer
The regulation expects “a physician treating the patient” to be
a member of the IDT. If the medical director is not one of the
physician’s treating the patient, he/she would not be allowed
to routinely substitute on the IDT.
When a new patient is admitted, a member of the medical
staff must assess the patient, provide treatment orders and
identify any needs for immediate action. In addition, an RN is
expected to make a nursing assessment of the patient prior
to the first treatment.
Allowing facilities up to a year from October 14, 2008 to
come into compliance with these two Conditions for current
patients does not mean “don’t cite” these requirements for a
year. Patients new to dialysis or returning form
transplantation or changing modalities, are expected to have
an assessment within 30 days/13 treatment of admission and
a POC immediately implemented. When a transferred patient
is received with a PA/POC from the transferring unit, the
receiving unit is expected to reassess that patient within 3
months of the admission. The requirements discussed above
are expected to be “met” at the time of surveys during this
first year of implementation. In addition, the facility should
have a plan for completing PA/POC for all current patients
within the year, and have begun accomplishment of that plan.
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
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
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.
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.
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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.
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?
494.90 Plan of Care
Question
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?
Answer
A list of the medications with evidence of review for possible
adverse events/interactions and need for continued use.
If a patient is stable, but does not achieve or maintain the
goal for one or more areas in the POC, the facility would
need to update that portion of the POC. This could be done
on the assessment form, or in the progress notes of one or
more of the IDT members. The form of the documentation is
not specified.
If the patient does not meet the expected goal, the IDT must
reassess that specific area. POC does not “require” a patient
to meet every goal. Any member of the team including the
patient may document why goals are not met. In some areas,
such as rehabilitation, volume status and nutritional status
the majority of the actions taken might be developed by one
team member.
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
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
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?
494.100 Care at Home
Question
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?
Answer
If the ESRD facility is involved in the delivery of care to those
patients, the ESRD facility is responsible for meeting these
CfC for the patients dialyzed in nursing homes. The S&C
letter addressing this service will be updated to reflect the
new ESRD regulations.
If a home patient chooses not to be seen by a physician
every month that is an “acceptable reason” because patient
choice is a hallmark of these ESRD regulations. However, if
there is a pattern of a home-based patient consistently not
seeing a physician, the patient’s IDT should assure that
he/she is not unstable according to the definition in these
regulations and address the lack of medical oversight with
the patient through the “Plan of care” process.
Time sensitive data and information such as radiology,
pathology, and lab results along with hospitalization reports,
should be reviewed upon receipt by a physician or
practitioner functioning in lieu of a physician. “Self
monitoring” data from the home patient must be retrieved and
reviewed by the facility at least every two months.
What ever you do for center, you must do for home and
home care patients. Assessments, visit, QAPI.
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
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
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?
494.110 Quality Assessment &
Performance Improvement
Question
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?
Answer
V626 requires the facility to “maintain and demonstrate
evidence” of the QAPI program for review by CMS. This
means there must be documentation of the QAPI activities
demonstrating focus on, at a minimum, the indicators
specified in V629-637 and performance improvement activity.
By virtue of the facility signing a Medicare agreement, a
surveyor has the right to review any and all records of the
facility, including adverse occurrences or incident reports.
The facility must provide the actual incident report (or a copy)
on the surveyor’s request.
Facilities are expected to track patient/staff injuries,
treatment errors, medication errors, hospitalizations, deaths,
cardiac arrests in the facility, acute allergic-type reactions
and major blood loss – at a minimum.
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
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
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
Personnel Qualifications
 Dietitian
– Must be registered with the
commission on dietetic registration
AND
– Have a minimum of one year
work experience in clinical
nutrition as an RD.
Personnel Qualifications
 Social Worker
– Holds a master’s degree in Social work with
specialization in clinical practice from an
accredited school
or
– 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
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)
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
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?
494.140 Personnel Qualifications
Question
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?
Answer
Existing PCT on 10/14/08 = 4/15/2010
New PCT – 18 months
CMS does not maintain a registry of technicians. However,
CMS intends to “count” experience from one facility to
another in determining the 18 months time limit for
completing certification, unless the PCT has at least an 18
month break in employment as a PCT.
The dietitian must have one year of clinical experience to be
categorized as the qualified dietitian required at each dialysis
facility. A dietitian with less than one year of clinical
experience cannot do the patient assessments, plans of care,
QAPI program review or care at home components of the
regulations. The facility may define other tasks for a dietitian
with less than one year of experience n a clinical setting.
NO- the facility must employ a full-time nurse manager who
is available at all hours the facility is open.
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
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?
494.150 Responsibilities of the
Medical Director
Question
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?
Answer
CMS requires a single medical director who takes
responsibility as outline in the regulations.
YES
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?
IN ORDER FOR THE MEDICAL DIRECTOR TO EVERYTHING THEY ARE SUPPOSED
TO DO THEY HAVE TO BE PRESENTED IN QAI EVERYTHING. THERE ARE CITATIONS
THAT MEDICAL DIRECTOR DID NOT ENSURE THAT THE FACILITY STAFF WERE
FOLLOWING POLICY AND PROCEDURE. WHEN THE SURVEYORS SEE A BREAK IN
PROCEDURE THEY CITE THE MEDICAL DIRECTOR BECAUSE HE HAS NOT
ASSURED IT. THE WAY HE CAN BE ABLE TO ASSURE IT IS THAT IT IS IN THE
QUALITY ASSESSMENT/IMPROVEMENT MEETING.
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.
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
Governance
“Questions”
 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?
494.180 Governance
Question
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?
Answer
The medical director is responsible for the facility’s QAPI
program; at least one member of the medical staff needs to
participate on the interdisciplinary team. The medical director
may serve as the medical staff representative for the QAPI
program.
V770 requires that each facility have an agreement with an
inpatient hospital that provides inpatient dialysis
NO, the regulation requires that a registered nurse who is
responsible for the nursing care provided is present in the
facility at all times that in-center dialysis patients are being
treated.
ESRD Conditions for Coverage
Resources
 Network 14 (ESRD Renal Network of
Texas): www.esrdnetwork.org
 CMS: www.cms.gov
 Email contact for questions (Glenda
Payne): [email protected]
 NKF: www.kidney.org
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
– http://www.cms.hhs.gov/CFCsAndCoPs/downloads/ESRDfinalrule0415.pdf

Recommendations for Preventing Transmission of Infections Among
Chronic Hemodialysis Patients (MMWR April 27, 2001 / 50 (RR05);1-43)
– http://www.cdc.gov/mmwR/preview/mmwrhtml/rr5005a1.htm

Guidelines for the Prevention of Intravascular Catheter-Related Infections
(MMWR August 9, 2002 / 51(RR10);1-26)
– http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5110a1.htm

Infection Control Requirements for Dialysis Facilities and Clarification
Regarding Guidance on Parenteral Medication Vial (MMWR August 15,
2008 / 57(32);875-876)
– http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5732a3.htm
 Guidance for Surveyors
– http://www.cms.hhs.gov/manuals/Downloads/som107ap_h_esrd.pdf