Sec. 10.30.02.03. Freestanding Dialysis Facilities — General

A. Location and Program Affiliation.

(1) Freestanding dialysis facilities seeking a certification as a freestanding dialysis facility, under the terms of Health-General Article, Title 13, Subtitle 3, Annotated Code of Maryland, shall have, for the diagnosis and treatment of irreversible renal failure and its complications, arrangements with:

(a) A laboratory that meets the needs of end-stage renal disease patients;

(b) A hospital that can provide acute care services to meet the needs of end-stage renal disease patients;

(c) A backup dialysis facility; and

(d) Transplant services.

(2) A freestanding dialysis facility desiring to phase out or discontinue dialysis services shall notify the Commission as soon as the decision to withdraw the facility from the Kidney Disease Program has been made by the administration of the facility.

(3) A freestanding dialysis facility withdrawal from the Kidney Disease Program may not be accomplished until:

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

(b) The freestanding dialysis facility has submitted to the Commission evidence that transfer of patients to another facility has been satisfactorily accomplished; and

(c) Patients previously certified and being treated in a freestanding dialysis facility that is being withdrawn from the Kidney Disease Program have continued access to the same reimbursement principle of the Kidney Disease Program.

B. Physical Standards. The freestanding dialysis facility shall:

(1) Have usable floor space of at least 80 square feet per patient station that may include bed or chair space, nursing space, and work area but excludes storage space;

(2) Have at least 20 square feet of the patient station floor space available on the side of the patient to be occupied by the dialysis assembly;

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

(4) Contain a nursing station and be designed for patient privacy, surveillance, and isolation when indicated;

(5) Provide refrigerated and nonrefrigerated storage space;

(6) Provide sufficient area and space for:

(a) Maintenance of equipment;

(b) Storage of the equipment and supplies; and

(c) Preparing and testing dialyzers;

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

(8) Comply with medical records, patient care policies, sanitation standards, and fire and life safety standards as defined in Regulation .01B of this chapter and this subtitle; and

(9) Comply with the quality assurance program as identified in Regulation .04B(3)(s)of this chapter and provide:

(a) Summarized format documentation, upon request, of the facility’s quality assurance program; and

(b) Written documentation of the facility’s meeting attendance, goals, outcomes, and action plans, including evaluation and revision of the plans, as appropriate.

C. Administration.

(1) The freestanding dialysis facility shall be under the supervision of the governing body. The governing body shall:

(a) Identify the center administrator who has been given the authority and responsibility for the overall policy and fiscal management of the facility; and

(b) Develop a written organizational plan.

(2) The freestanding dialysis facility administration shall:

(a) Be under the supervision of the governing body; and

(b) Provide a copy of the Medicare cost report to the Department, or the Department's duly authorized agents, upon request.

(3) The freestanding dialysis facility shall provide designated administrative personnel to keep necessary records as well as other information for accurate determination of costs.

(4) The freestanding dialysis facility administration shall assure that patients are informed of the facility's internal and external grievance mechanisms.

D. Compliance. Freestanding dialysis facilities shall comply with:

(1) The provisions set forth in Regulation .01B of this chapter;

(2) Regulation .04 of this chapter; and

(3) The requirements of this subtitle for certification purposes with the Commission.

E. Governing Body. The governing body shall:

(1) Identify the facility administrator who has been given the authority and responsibility for the overall policy and fiscal management of the facility; and

(2) Develop a written organizational plan.

F. Administrator.

(1) Qualifications.

(a) The kidney dialysis facility administrator, if not the chief executive officer, shall at a minimum:

(i) Be 21 years old or older;

(ii) Possess a high school diploma or a high school equivalency diploma and have experience to conduct the responsibilities specified in §B(2) of this regulation;

(iii) Have at least 1 year of dialysis experience; and

(iv) Have no criminal conviction or other criminal history that indicates behavior that is potentially harmful to patients, documented through either a criminal history records check or a criminal background check completed within 1 month before employment.

(b) The administrator, if not the chief executive officer, shall have knowledge in:

(i) Infection control;

(ii) Principles of dialysis;

(iii) Water treatment;

(iv) Reuse;

(v) Data collection and quality assurance;

(vi) Emergency procedures;

(vii) Fiscal operations, including business management and personnel;

(viii) Regulations; and

(ix) Policies and procedures.

(2) Duties.

(a) The administrator shall be on site or available on call.

(b) The administrator shall have overall responsibility for:

(i) Implementing the facility's policies and coordinating the provision of services that the facility provides;

(ii) Organizing and coordinating the administrative functions of the facility;

(iii) Establishing procedures for the accountability of those personnel involved in patient care;

(iv) Familiarizing the staff with the facility's policies and procedures, and with applicable federal, State, and local laws and regulations;

(v) Participating in the development, negotiation, and implementation of agreements or contracts into which the facility enters;

(vi) Participating in the development of organizational and fiscal planning for the facility;

(vii) Implementing and evaluating, under the direction of the clinical team, the patient care plan and the long-term care program for each patient; and

(viii) Informing patients of the availability of emergency services.

(3) Waiver of Requirements for Administrator.

(a) The Department may grant a kidney dialysis facility a waiver, with or without conditions, for a center that operates an administrator-in-training program.

(b) A facility with an administrator-in-training program shall submit to the Department the:

(i) Administrator-in-training curriculum, including course outline and supporting materials;

(ii) Facility requirements for individuals who are selected to participate in the administrator-in-training program; and

(iii) Protocols in place that assure that the approval of the waiver will not adversely affect the quality of care received by patients.

(c) In evaluating a waiver request submitted under this regulation, the Department shall review the statements in the application and may:

(i) Inspect the kidney dialysis center; or

(ii) Confer with the governing body.

(d) Grant or Denial of Waiver. The Department may grant a waiver request if it determines that:

(i) The administrator-in-training program sufficiently meets the requirements of this regulation; and

(ii) A waiver will not adversely affect patients.

(e) If the Department determines that the conditions of §F(1) and (2) of this regulation are not met, the Department shall deny the request for a waiver. The denial of a waiver may not be appealed.

(f) Written Decision.

(i) The Department shall issue and mail to the licensee a final written decision regarding a waiver request submitted under this regulation within 45 days from receipt of the request.

(ii) If the Department grants a waiver, the written decision shall include the waiver's duration and any conditions imposed by the Department.

(g) If a licensee violates any condition of the waiver, or if it appears to the Secretary that the health or safety of patients will be adversely affected by the continuation of the waiver, the waiver may be revoked. The revocation of a waiver may not be appealed.

(h) Any substantive changes to the administrator-in-training program shall be submitted to the Department for prior approval.

(4) Policies and Procedures. The administrator shall:

(a) In consultation with the governing body, develop and implement policies and procedures governing the operation of the facility, which include at a minimum those items in §F(1) and (2) of this regulation; and

(b) Ensure that all policies and procedures are:

(i) Reviewed by staff at least annually and are revised as necessary;

(ii) Available at all times for staff inspection and use; and

(iii) Appropriate personnel implement all policies and procedures adopted.