CMS%20ESRD%20Conditions%20for%20Coverage:%20Review%20and%20Questions

1
CMS ESRD Conditions for CoverageReview and
Questions
Alex Rosenblum RN, VP Quality SWBU Fresenius
Medical Care
The Stephen Z. Fadem Update Professional
Symposium February 27, 2009
2
CONDITIONS FOR COVERAGE

• Provide an opportunity for QA related to
  specific practice areas

These questions have been called into the
regulatory department of a large dialysis
organization and will be discussed here
3
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.

4
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

5
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.

7
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)
9
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

10
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?.

11
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)
• 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

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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.

13
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?

14
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.

17
Infection ControlQuestions

• 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
Question Answer
Can we place hand sanitizers on the side of the dialysis machines? Yes, if the dispenser is included in the cleaning done between uses of the machines for different patients
If a computer data entry screen is located away from the patient area what are the infection control requirements? 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
Can sinks used to drain saline bags, disinfect clamps and/or prime buckets be used for handwashing? No, handwashing sinks should be dedicated for that purpose and remain clean.
Can we place hand sanitizers on the side of the dialysis machines? Yes, if the dispenser is included in the cleaning done between uses of the machines for different patients
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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 ControlQuestions

• 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 cant 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
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.
If the HBV patient runs 2X week only and the room is terminally cleaned and the machine removed, why cant the room be used for HBV- patients? 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
What supplies should be kept in an isolation room or area? Supplies routinely used for the care of patients, such as alcohol swabs, gloves, gauze pads and hemostats.
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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 lt 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
Question Answer
Can test strips sensitive to 0.5 be used to test for residual bleach after rinsing? Yes
Are facilities required to test water system alarms for water quality and low tank level? 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.
How many dialysis machine/dialysate cultures must be done each month? Dialysate cultures must be collected from at least 2 dialysis machines per month, and each machine must be cultured annually, at a minimum.
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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 BloodlinesQuestions

• If dialyzer reuse labels are affixed to
  individual patient reprocessing records, must
  those logs be filed in the patients 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

• 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
Question Answer
If dialyzer reuse labels are affixed to individual patient reprocessing records, must those logs be filed in the patients medical record? The reprocessing records have to be treated as a medical records, but may be maintained separately. When the patient is no longer treated at the facility, the facility might choose to combine these records with the other records of that patients care.
Are there some types of dialyzers that require that the end caps be removed and the header spaces cleaned? No. If the facility opts to remove dialyzer end caps and perform header space cleaning, it must be done within the guidelines at V334.
When a dialyzer must be replaced mid-treatment, can a preprocessed dialyzer be used? Yes, as long as the pre-processes dialyzer is labeled with that patients name and the original TCV of the dialyzer is known.
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494.60 Physical Environment

• Building/furnishings/equipment - safe and
  functional
• All equipment operated according to
  manufacturers 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?

34
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.

36
Physical EnvironmentQuestions

• 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
Question Answer
What are the expectations for refrigerators for medication storage? 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.
Does the no video surveillance apply to nocturnal dialysis? 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.
What if the patients refuse to keep their vascular accesses uncovered? Is having the patient sign a waiver acceptable? 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 patients 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 patients access.
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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
• Patients medical status by physician or
  physician extender
• Expected patient conduct responsibilities
• Facility internal/external grievance process
• Facilitys discharge and transfer policies
  including involuntary discharges

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494.70 Patients Rights
Question Answer
Does the patient right to privacy prohibit conducting chair-side care planning with the patient if other patients can hear what is being said? 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.
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Patients RightsQuestions

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

42
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 AssessmentQuestions

• 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 dont cite within the
  first year?

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494.80 Patient Assessment
Question Answer
Can the medical director substitute for the treating physician in the IDT? The regulation expects a physician treating the patient to be a member of the IDT. If the medical director is not one of the physicians treating the patient, he/she would not be allowed to routinely substitute on the IDT.
Please expand upon the initial assessment requirements? 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.
Discuss the expectations for compliance within a year. Does this mean Dont cite within the first year? Allowing facilities up to a year from October 14, 2008 to come into compliance with these two Conditions for current patients does not mean dont 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.
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494.90 Patient Plan of Care

• The Patients 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 CareQuestions

• 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?

52
494.90 Plan of Care
Question Answer
What documentation is expected for the medication review? A list of the medications with evidence of review for possible adverse events/interactions and need for continued use.
Discuss the mechanics of updating an assessment what would the document look like, a series of assessments? 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 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? 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.
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494.100Care at Home

• Care at least equivalent to in-facility patients
• Patients 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

54
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

55
Care at HomeQuestions

• 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?

56
494.100 Care at Home
Question Answer
Does home therapy include patients who are dialyzing in nursing homes as their place of residence? 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 SC letter addressing this service will be updated to reflect the new ESRD regulations.
What are acceptable reasons for a home patient not to be seen by a physician every month? 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 patients 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.
How frequently should data be reviewed for home patients? 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.
57
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

58
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

59
Quality Assessment Performance
ImprovementQuestions

• 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?

60
494.110 Quality Assessment Performance
Improvement
Question Answer
Is there a requirement for documentation of the QAPI program activities? 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.
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? 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 surveyors request.
What should be tracked and trended for medical injuries and errors? 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.
61
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

62
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

63
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

64
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.

65
Personnel Qualifications

• Social Worker
• Holds a masters 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

66
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 QualificationsQuestions

• 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
Question Answer
Can you explain if we hire a new PCT today, how much time does he/she have to obtain their certification? 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.
What happens if the dietitian does not have at least one year in a clinical setting? 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.
Does the nurse manager need to be on site every day the facility is open, even Saturdays? NO- the facility must employ a full-time nurse manager who is available at all hours the facility is open.
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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
DirectorQuestions

• 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
Question Answer
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? CMS requires a single medical director who takes responsibility as outline in the regulations.
If our Medical Director does not currently meet the new qualifications, is there a waiver process? YES
QAPI is the medical directors 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.
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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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GovernanceQuestions

• 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
Question Answer
Are all medical staff members required to attend QAPI meetings? The medical director is responsible for the facilitys 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.
Does the facility need a contract with a hospital for admission of patients in an emergency? V770 requires that each facility have an agreement with an inpatient hospital that provides inpatient dialysis
If patients are not being treated but are in the facility, e.g. in the waiting room, must a registered nurse be present? 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.
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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)
  esrdsurvey_at_cms.hhs.gov
• NKF www.kidney.org

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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
• http//www.cms.hhs.gov/CFCsAndCoPs/downloads/ESRDf
  inalrule0415.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