The Stephen Z. Fadem Update Professional Symposium February 27, 2009 Alex Rosenblum RN, VP Quality SWBU – Fresenius Medical Care
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
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.
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.
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.
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.
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? 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
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?
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 can’t 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.
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.
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 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.
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 reprocessing records, must those logs be filed in the patient’s 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 patient’s 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 patient’s name and the original TCV of the dialyzer is known.
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 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 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.
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 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. 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.
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 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 physician’s 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 “Don’t 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 “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.
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?
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 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.
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 What ever you do for center, you must do for home and home care patients. Assessments, visit, QAPI. 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 S&C 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 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. 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.
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 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 surveyor’s 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.
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
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.
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 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.
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 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 . 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
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 Answer Are all medical staff members required to attend QAPI meetings? 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. 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.