A. Governing Body. The governing body shall:
(1) Identify the center 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.
(a) The kidney dialysis center 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;
(v) Data collection and quality assurance;
(vi) Emergency procedures;
(vii) Fiscal operations, including business management and personnel;
(viii) Regulations; and
(ix) Policies and procedures.
(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 center a waiver, with or without conditions, for a center that operates an administrator-in-training program.
(b) A center with an administrator-in-training program shall submit to the Department the:
(i) Administrator-in-training curriculum, including course outline and supporting materials;
(ii) Center's 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 §B(3)(d) 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.
C. Policies and Procedures.
(1) The administrator, in consultation with the governing body, shall develop and implement policies and procedures governing the operation of the facility, which includes at a minimum those items in COMAR 10.05.01.06D and the following:
(a) The provision of dialysis and other end-stage renal disease services;
(b) The reuse of dialysis supplies including hemodialyzers and blood tubing, if reuse of supplies is practiced by the facility;
(c) Implementing and evaluating the patient care plan and the long-term care program for each patient; and
(d) Informing patients of the availability of emergency services.
(2) The administrator shall ensure that all:
(a) Policies and procedures are:
(i) Reviewed by staff at least annually and are revised as necessary; and
(ii) Available at all times for staff inspection and use; and
(b) Appropriate personnel implement all policies and procedures adopted.