- Emergency preparedness training for facility staff must be provided and evaluated at least annually.
- The dialysis facility must provide appropriate orientation and training to patients, to include what to do, where to go, and whom to contact in the event of an emergency.
- Emergency equipment, including drugs, must be immediately available on site at all times.
- The facility must have an emergency management plan in place, which is evaluated for effectiveness at least annually. Facilities are now required to contact their local disaster management agency at least annually to ensure that such agency is aware of the facility's needs in the event of an emergency. To determine your locality's emergency management and health department contacts, visit MARC's Emergency Contacts webpage http://www.esrdnet5.org/emergencycontacts.asp .
As we anticipate hurricane Hanna's projected impact on our region this week, remember that September is also National Preparedness Month (NPM). To learn more about what you can do in your facility and at home, visit the U.S. Department of Homeland Security's (DHS) Ready http://www.ready.gov Campaign. For tools and resources specific to dialysis, check out MARC's emergency preparedness webpage http://www.esrdnet5.org/emergencyprep.asp .
Electronic Data Submission - CROWNWeb
Section 494.180(h) of the Conditions for Coverage requires facilities to furnish data and information for ESRD program administration. Beginning February 1, 2009, providers must begin using CROWNWeb to electronically submit data to CMS. Here are a few things to remember:
- Providers will no longer submit CMS-2728 (Medical Evidence), CMS-2746 (Death Notification), MPAR (Monthly Patient Activity Report) or CPM (Clinical Performance Measure) forms to the Network. All data will be entered at your facility using the new CROWNWeb application. The Network will no longer accept hardcopy forms after December 31, 2008. This does not include Veterans Administration hospitals or transplant units. These facilities will continue to submit hardcopy forms to the Network.
- CMS will provide each dialysis facility with access to CROWNWeb free of charge once the facility completes a verification and authorization process. This verification process will require proper ID and a notarized application. Your facility may begin the verification process starting in October 2008.
- CMS will provide training on CROWNWeb for facility staff. Training locations and dates, as well as other information, can be found at http://www.fmqai.com/ESRD/CROWNWeb. The only training sites in Network 5 will be in Richmond, VA, and Baltimore, MD.
- System Requirements: In order to access CROWNWeb, a facility must have a computer connected to the Internet that meets the minimum specifications outlined below:
Minimum Suggested Internet Brower IE 6.0 IE 6.0 or later Operating System Windows 98 SE2 Windows 2000 or XP Processor Speed Pentium (or equivalent) 66 Megahertz (MHz) Pentium 4 (or equivalent) 1.8 gigahertz (GHz) or faster Available RAM 64 megabytes (MB) 128 megabytes (MB) Document Viewer Adobe Acrobat Reader 6 Adobe Acrobat Reader 6+ Internet Connection 56 KBps dial-up High Speed (DSL, Cable, or faster)
- Frequently Asked Questions about the CROWNWeb application can be found at http://www.fmqai.com/esrd/crownweb/crownwebfaq
Medical directors must be Board-certified in internal medicine or pediatrics (or nephrology) AND have completed a board-approved nephrology fellowship AND have 12 months' experience.
No medical director will be "grand-fathered" in under these regulations. CMS expects there to be one (1) medical director per facility (not a shared position among several physicians) who devotes approximately 10 hours per week to medical director duties.
- Quality Assessment & Performance Improvement Program - QAPI (described in next week's Quick Tips)
- Staff education, training, and performance
- Development and review of patient care policies and procedures and holding medical staff accountable for compliance.
- Policies include infection control, physical environment, and personnel qualifications.
- Monitoring, review, and documentation of every involuntary patient discharge to assure that patients are not discharged unless:
- There is failure to pay
- Facility ceases to operate
- Facility can no longer meet the patient's documented medical needs
- Patient is disruptive and abusive to the extent that the facility's ability to operate is seriously impaired.
Quality Assessment and Performance Improvement (QAPI)
A dialysis facility must have an effective, data-driven QAPI program with participation by the professional members of its interdisciplinary team. The medical director is responsible for the program.
The QAPI program encompasses all aspects of the facility's organization and services, including services provided under arrangement. This ongoing program must achieve measurable improvement in health outcomes and a reduction in medical errors, as demonstrated by appropriate quality indicators or performance measures. Among the areas for which dialysis facilities must measure, analyze, and track performance are:
- Adequacy of dialysis
- Nutritional status
- Mineral metabolism and renal bone disease
- Anemia management
- Vascular access
- Medical injuries and medical error identification
- Hemodialyzer reuse (if facility reuses)
- Patient satisfaction and grievances
- Infection control
Performance monitoring must be a continuous activity, with actions undertaken to improve performance. Continuous tracking allows the facility to ensure improvements are sustained over time.
In setting priorities for performance improvement, dialysis facilities must consider the prevalence and severity of identified problems, giving priority to improvement activities that affect clinical outcomes or patient safety. Any identified problems that threaten the health and safety of patients must be immediately corrected.
Patient Assessment and Plan of Care
The revised Conditions for Coverage include standards related to patient assessment and plan of care. The requirements are not new for facilities , but the timeline and many of the particulars are. Following are some of the highlights:
- In practice, completion of the assessment is likely to be as familiar as before. The concept in the new regulations, however, is that the assessment be a single document to which each discipline contributes, as opposed to each conducting its own isolated evaluation and likely never reviewing the others'. The assessment can be one document or separate sections, but must demonstrate a congruent integration of each team member's evaluation. The assessment is then used to develop the plan of care.
- The plan of care flows from the assessment by indicating how the patient's identified needs are to be addressed, and provides measurable expected outcomes with an estimated timetable to achieve those outcomes. The plan of care is to be completed and signed by the interdisciplinary team, which includes the patient and/or designee if the patient desires. Activities such as telephone conferencing are acceptable to assure that the entire team is present when developing the plan.
- The timeline for these documents poses the greatest challenge for facilities. An initial assessment for a new patient is to be completed within 30 days or 13 treatments (whichever is longer) of the first outpatient session, and a reassessment is to be completed three (3) months after to assure the patient's adjustment is in keeping with expectations. Routine reassessments are then conducted at least annually for stable patients or monthly for unstable patients. Implementation of a plan of care must begin within 30 days or 13 treatments (whichever is longer) of the first outpatient session, and then within 15 days of any reassessment. Facilities will have one (1) year from October 14, 2008, to complete the assessment and plan of care on existing patients, and will be expected to have an implementation plan for doing so.
The Condition (ref: §494.80) identifies several specific criteria that must be included in these documents, as well as defining characteristics of the "unstable" patient. Facilities are encouraged to familiarize themselves with these criteria. A comprehensive, multidisciplinary patient assessment (CMPA) has been developed by the professional councils of the National Kidney Foundation (NKF) and the American Nephrology Nurses Association (ANNA), and is available free to download at http://www.kidney.org/professionals/CNSW/.
Advanced Care Planning
The revised Conditions for Coverage include a standard addressing the patient's right with regard to advance directives (ref: §494.70(a)(6)). Following are some of the highlights:
- Patients should be informed about and participate in all aspects of their care and be informed of their right to refuse or discontinue treatment.
- Patients should be informed about advance directives and their right to execute them.
- Patients should be informed about the extent to which the facility is willing to honor their advance directives.
Many states have enacted laws requiring healthcare providers to honor patients' advance directives and "do not resuscitate" (DNR) orders. Facilities are required to know and comply with such state laws. If state law does not address this facet of healthcare, and the facility's policy does not allow the honoring of a patient's advance directive, there must be a protocol in place for facilitating the patient's transfer to a facility that will honor the advance directive, if the patient so chooses.
The Mid-Atlantic Renal Coalition was instrumental in forming the national Kidney End-of-Life Coalition, and its website, http://www.kidneyeol.org , provides resources and tools for both professionals and patients/families related to this topic:
The revised Conditions for Coverage include standards related to infection control in the dialysis facility. Following are some of the highlights:
- The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infections.
- The dialysis facility must make provisions for and establish a room or area to dialyze an HBV+ patient.
- Staff must wear disposable gloves when caring for the patient or touching equipment such as the dialysis machine.
- No aprons are allowed, and gowns must be buttoned from neck to mid-thigh.
- Medications must be drawn up in a clean area, clearly separated from contaminated or dirty areas.
- IV medication vials labeled for single use can only be punctured once.
- Infection control practices should include:
- Education of both staff and patients
- Implementation of standard infection control precautions as stated in the CDC's "Recommendations for Preventing Transmissions of Infections among Chronic Hemodialysis Patients," which may be found at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm.
- Implementation of recommendations as stated in the CDC's "Guidelines for the Prevention of Intravascular Catheter-Related Infections," which may be found at http://www.cdc.gov/ncidod/dhqp/gl_intravascular.html.
- Implementation of tracking tools by October 14, 2008, to track infection rates, cultures, and immunizations (specifically hepatitis, pneumococcal, and influenza immunizations).
Section 494.140 of the revised Conditions for Coverage includes standards related to personnel qualifications in the dialysis facility. Following are some of the highlights:
Note: "All dialysis facility staff must meet the applicable qualifications, scope of practice, and board and licensure requirements in effect in the State in which they are employed."
Water treatment system technicians must complete a training program that has been approved by the medical director and the governing body of the facility.
Involuntary Discharge / Tranfer
The Conditions for Coverage now include a standard addressing involuntary discharge and transfer policies and procedures (ref: §494.180(f)). Following are some of the highlights:
- Appropriate reasons for involuntary discharge/transfer include
- Facility closure
- Facility can no longer meet the patient's documented medical needs.
- Patient's behavior is seriously impacting the facility's ability to operate effectively
- A good-faith effort on the part of the facility must be clearly documented and include reassessments, ongoing problem(s), and efforts made to resolve the problem(s)
- The patient and the Network must be provided with a 30-day notice of discharge.
- Both the medical director and the patient's attending physician must sign a written physician's order concurring with the discharge/transfer decision.
- The facility must make a good-faith effort to place the patient.
- The facility must notify the state survey agency of the involuntary discharge/transfer.
- An abbreviated involuntary discharge can be used in the case of an imminent severe threat to safety of other patients or staff (i.e., threat of physical harm). In such a case, the state survey agency and Network should be notified.
The Mid-Atlantic Renal Coalition expects to be notified of problematic patient situations before a 30-day notice is issued. Facilities would benefit from contacting the Network within this timeframe to assure that steps taken are satisfactory.
Patient plan of Care - Transplantation Status
The interdisciplinary team must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient's needs, and must include measurable and expected outcomes and an estimate of when these outcomes will be achieved. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally accepted clinical practice standards.
The Conditions list eight (8) minimal standards that must be addressed by the patient plan of care, one of which includes transplantation status.
When the patient is a transplant referral candidate, the interdisciplinary team must develop plans for pursuing transplantation. The patient's plan of care must include documentation of
the plan for transplantation, if the patient accepts the transplantation referral;
the patient's decision, if the patient is a transplantation referral candidate but declines the transplantation referral; or
the reason(s) for the patient's non-referral as a transplantation candidate.
Surveyors may determine if the patient record agrees with the patient's understanding of his/her status as a transplant candidate.
Patient Assessment - Immunization Status
The revised Conditions for Coverage address interdisciplinary teams' responsibilities for providing each patient with an individualized and comprehensive assessment that includes an immunization history. This immunization record is expected to include at a minimum the patient's immunization history as of October 14, 2008.
Interpretative Guidance indicates that the immunization history should include whether the patient has received standard immunizations (pneumococcal, hepatitis, and influenza) and been screened for tuberculosis.
The Centers for Disease Control and Prevention (CDC) recommend* that all dialysis patients be
- screened at least once for baseline tuberculin skin test results (TST) and re-screened if TB exposure is detected. Chest X-rays may be used for individuals for whom the TST is not an option.
- offered influenza and pneumococcal vaccines and have immunization histories to track those vaccinations.
- vaccinated for Hepatitis B (applicable to all susceptible chronic hemodialysis patients and staff members), whether or not the facility accepts HBV+ patients. This requirement is further addressed by §494.30 Condition - Infection Control.
- Dialysis Guide.