Summary of Conditions

494:30 Condition: Infection Control.

• The rule adopts updated Centers for Disease Prevention and Control (CDC) guidelines for hemodialysis facilities to increase patient infection control procedures. 

494.40 Condition: Water and Dialysate Quality.

• The rule adopts updated American Association for Medical Instrumentation (AAMI) water quality guidelines to promote safer water for dialysis use.  dialysis.

494.50 Condition: Reuse of Hemodialyzers and Bloodlines.

• The rule sets requirements for the reuse of hemodialyzers and bloodlines, whereby certain hemodialyzers and bloodlines may be reused for certain patients with the exception of Hepatitis B positive patients.  They must be reused only for the same patients, and must be labeled for multiple reuse.  A dialysis facility that reuses hemodialyzers and bloodlines must also meet AAMI guidelines governing reuse, as well as monitoring, evaluation, and reporting requirements.

494.60 Condition: Physical Environment.

• The rule sets forth requirements on the type of building, equipment maintenance, and patient care environment that dialysis facilities must follow.  Additionally, a dialysis facility must implement processes and procedures to manage medical and non-medical emergencies that are likely to threaten the health or safety of the patients, the staff, or the public.  As part of the requirement, defibrillators must be in every dialysis facility, to allow facility staff to respond rapidly to individuals that may be having heart attack.  The rule also incorporates sections of the 2000 Life Safety Code, which upgrades fire safety standards. 

 494.70 Condition: Patients’ Rights.

• The rule expands patients’ rights protections, including requiring facilities to inform beneficiaries of their right to have advance directives.  Facilities must also have a facility-level grievance process that explains how the facility must respond to a patient’s grievances, and a policy that provides a 30-day written notice to the patient before the facility can involuntary discharge a patient.  The facility must prominently display a copy of the patient’s rights in the facility.

 494.80 Condition: Patient Assessment.

• The rule requires a comprehensive patient assessment based on current medical practices and the patient’s unique needs.   An initial comprehensive assessment must be conducted on all new patients (all admissions to a dialysis facility) within the latter of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session.  A follow-up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care.  Additionally, the adequacy of the patient’s dialysis prescription must be assessed (by calculating delivered Kt/V or an equivalent measure) on an ongoing basis at least monthly for hemodialysis patients, and at least every 4 months for peritoneal dialysis patients.  A comprehensive reassessment of each patient and a revision of the plan of care must e conducted at least annually for stable patients and at least monthly for unstable patients.

494.90 Condition: Patient Plan of Care.

• The rule requires an interdisciplinary team to develop and implement a personalized patient plan of care, based on current standards of care   The plan of care must address, but not be limited to: dose of dialysis; nutritional status; mineral metabolism; anemia; vascular access; psychosocial status; modality (for home dialysis, the team must identify a plan for the patient’s home dialysis or explain why the patient is not a candidate for home dialysis; for transplantation status, the team must develop plans for pursuing transplantation); and rehabilitation status. 
   Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session.  The plan of care must also include, as application, education and training for patients and family members or caregivers or both in aspects of the dialysis experience, dialysis management, transplantation, and other applicable topics.  The interdisciplinary team must also track the results of each kidney transplant center referral.

494.100 Condition: Care at Home. 

• A dialysis facility that is certified to provide services to home patients must ensure through its interdisciplinary team, that home dialysis services are at least equivalent to those provided to in-facility patients.  Such facilities must also meet standards for: training (of the home dialysis patient, the designated caregiver, or self-dialysis patient); home dialysis monitoring; and home dialysis support services (regardless of whether dialysis supplies are provided by the facility or a durable medical equipment company).  As part of the support services, dialysis facilities must identify a plan and arrange for emergency back-up services when needed. 

494.140 Condition: Personnel Qualifications.

• The rule sets forth minimum qualifications and training requirements for dialysis facility staff including: medical directors; nurse managers; self-care and home dialysis training nurses; charge nurses; staff nurses; dieticians; social workers; patient care dialysis technicians; and water treatment system technicians. 

494.180 Condition: Governance.

• The rule requires that the ESRD facility be under the control of an identifiable governing body, or the facility.  The governing body must adopt and enforce rules and regulations relative designated person(s) with full legal authority and responsibility for the governance and operation of to its own governance and to the health care and safety of patients, to the protection of the patients’ personal and property rights, and to the general operation of the facility.

DPC would like to thank the Kidney Care Council for providing this summary