Sec. 10.30.02.07. Self-Care Dialysis Facilities

A. Location and Program Affiliation.

(1) Self-care dialysis facilities may be situated in free-standing dialysis facilities as long as appropriate standards are satisfied.

(2) To assure quality and continuity of patient care, including backup dialysis, the self-care dialysis facility or a hospital shall negotiate a formal affiliation agreement compliant with COMAR 10.30.01.08.

(3) Self-care dialysis facilities shall make arrangements for appropriate medical records, patient care policies, sanitation standards, and fire and life safety standards as defined in federal regulations for Medicare Programs and those of the Commission.

(4) Self-care dialysis facilities shall keep records of dialysis frequency and other factors relating to cost determination.

(5) For the purpose of protecting patient safety and welfare, a self-care dialysis facility may not withdraw or phase out services until:

(a) The self-care dialysis facility has notified the Commission as soon as possible of the self-care dialysis facility's intention to discontinue services;

(b) Patients being treated by that self-care dialysis facility have been transferred to another facility or the patients' continuing care assured to the satisfaction of the patients and the Commission;

(c) The self-care dialysis facility submits to the Commission evidence that transfer of patients to another facility has been satisfactorily accomplished; and

(d) Patients previously certified and being treated in a self-care dialysis facility that is being withdrawn from the Kidney Disease Program continue to have access to the same reimbursement principles of the Kidney Disease Program.

B. Physical Standards.

(1) A self-care dialysis facility shall:

(a) Make available adequate floor space that may include bed or chair space, nursing space, and work area, but excludes storage space;

(b) Arrange the space to be sufficiently flexible to provide access to any of the four extremities;

(c) Provide patient privacy and comfort;

(d) Provide refrigerated and nonrefrigerated storage space;

(e) Provide sufficient work area and space for:

(i) Maintenance of equipment;

(ii) Storage of equipment and supplies; and

(iii) Preparing and testing dialyzers; and

(f) Utilize water of sufficient purity, according to current Association for the Advancement of Medical Instrumentation recommendations which are incorporated by reference in Regulation .01B(4) and (5) of this chapter, to prevent bacterial contamination, endotoxin, or toxic accumulation of trace elements in patients undergoing long-term dialysis.

(2) Training. Self-care dialysis facilities shall provide training that includes:

(a) Visual aids to complement the instructional program; and

(b) Training periods that vary depending on the various needs of the patient and training program of the self-care dialysis facility.

C. Staffing.

(1) Nephrologist or Physician.

(a) The director of the self-care dialysis facility shall be a nephrologist or a physician with at least 1 year of experience in chronic dialysis.

(b) At least one additional nephrologist or a physician trained in dialysis shall be available to provide adequate continuous coverage.

(2) Medical Director. A self-care dialysis facility shall appoint a medical director with the qualifications and responsibilities set forth in Regulation .04B(2) and (3) of this chapter.

(3) Additional Self-Care Dialysis Facilities Requirements.

(a) Direct patient care providers shall be trained in dialysis procedures and may be a:

(i) Registered nurse;

(ii) Licensed practical nurse; or

(iii) Certified nursing assistant-dialysis technician.

(b) A charge nurse:

(i) Shall be a registered nurse;

(ii) Shall be on duty in the treatment area, except for while on breaks, when the charge nurse shall be readily available, at all times when patients are being treated;

(iii) Shall have at least 12 months experience in providing nursing care, including 6 months of experience in providing nursing care to patients on maintenance dialysis; and

(iv) May not be included in the staffing ratio except when there are nine or fewer patients or in the event of an emergency.

(c) Staffing Exception Reporting. The facility 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; and

(ii) A description of the emergency staffing situation.

(d) Additional staffing may be achieved with the use of licensed practical nurses or certified nursing assistant-dialysis technicians.

(e) Supervisory nursing personnel, which includes the charge nurse, may not be included in the calculation of staff/patient ratio if the supervisory nursing personnel do not participate in the monitoring of dialysis.

(4) Technical assistance by qualified technicians shall be available for the repair and maintenance of equipment.

(5) In addition, the self-care dialysis facility shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the dialysis patients.

(6) The self-care dialysis facility shall have psychiatric services available to patients by referral.

(7) Social Worker. The social worker shall comply with the duties and responsibilities set forth in Regulation .04G of this chapter.

D. Administration.

(1) The administration of the self-care dialysis facility shall provide a copy of the Medicare cost report to the Department, or the Department's duly authorized agents, upon request.

(2) The self-care dialysis facility shall provide designated administrative assistance to keep the necessary records as well as other information needed for accurate determination of cost.

E. Compliance. Self-care dialysis programs shall comply with the provisions set forth in Regulation .01B of this chapter and with the requirements of this subtitle for certification purposes with the Commission.