10.05.04.06

.06 Personnel.

A. Medical Director.

(1) The medical director shall:

(a) Be a nephrologist or other physician with at least 12 months experience in the treatment of patients requiring chronic hemodialysis;

(b) Be responsible for the development of patient care policies; and

(c) Provide medical guidance in the provision of patient care.

(2) If the medical director is not available to provide medical guidance, the administrator shall ensure the availability of an alternate physician with the same qualifications of the medical director as specified in §A(1)(a) of this regulation.

B. Charge Nurse. The charge nurse shall be a registered nurse with training in the provision of kidney dialysis services and at least 6 months experience in a dialysis center.

C. Dialysis Monitoring.

(1) Staffing Ratio.

(a) In-Center Daytime Hemodialysis. When in-center daytime hemodialysis is performed, the monitoring individual-to-patient ratio at each center shall be:

(i) A minimum of one staff member to three participants; and

(ii) Sufficient to meet the needs of patients.

(b) In-Center Nocturnal Hemodialysis. When in-center nocturnal hemodialysis is performed, the monitoring individual-to-patient ratio at each center for in-center nocturnal hemodialysis shall be:

(i) A minimum of one staff member to five participants; and

(ii) Sufficient to meet the needs of the patients.

(c) The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays.

(d) The charge nurse may not be included in the staffing ratio except:

(i) When there are nine or fewer patients; or

(ii) In the event of an emergency.

(2) Staffing Exception Reporting.

(a) The center shall have a staffing exception reporting protocol in a format approved by the Department for reporting to the governing body when emergency staffing situations arise that require the charge nurse to be included in the staffing ratio. The report shall include, at a minimum:

(i) The date and shift of the exception;

(ii) A description of the emergency staffing situation;

(iii) Actions taken in response; and

(iv) Any measures taken to ensure the center's future compliance.

(b) The exception reporting protocol shall be included in the center's quality assurance process.

(c) The staffing exception reports shall be made available to the Office of Health Care Quality and the Commission on Kidney Disease when they are conducting an inspection or survey of the center to assure compliance with §C(1) of this regulation.

(3) Monitoring individuals shall be trained in dialysis procedures and may be a:

(a) Physician;

(b) Physician assistant;

(c) Registered nurse;

(d) Licensed practical nurse; or

(e) Certified nursing assistant — dialysis technician.

D. The kidney dialysis center shall also provide dietetic and social work services and consultation by individuals with experience or training in caring for dialysis and transplant patients sufficient to meet the needs of patients.