(a) There shall be an identified governing body responsible for the organization, management, control, and operation of the facility, including the appointment of the facility's medical director as defined in §117.2(48) of this title (relating to Definitions).
  (1) A qualified medical director is a physician who is board certified in internal medicine by the American Board of Internal Medicine or pediatrics by the American Board of Pediatrics or is board certified in nephrology or pediatric nephrology, and has at least 12 months of experience providing care to patients receiving dialysis.
  (2) A facility may request a waiver to appoint or retain as medical director a physician who does not meet one or more of the qualifications in paragraph (1) of this subsection. The waiver shall explain why a physician meeting the board certification requirement is not available and include a resume of the physician the facility seeks to appoint or retain. A written request for waiver shall be made through the Texas Department of State Health Services, Health Facility Compliance Group, Mail Code 1979, P.O. Box 149347, Austin, Texas, 78714-9347 for transmission to CMS.
(b) The governing body shall develop, implement, and enforce policies and procedures for all services provided by the facility.
(c) The governing body shall ensure that the medical staff has current bylaws, rules and regulations that are adopted, implemented, and enforced.
(d) The governing body shall ensure that effective administrative rules, regulations, and policies designed to protect the health and safety of patients are implemented and reviewed annually.
(e) The governing body shall ensure that there is a quality assessment and performance improvement (QAPI) program to evaluate the provision of patient care. The governing body shall review and monitor QAPI activities quarterly.
(f) The governing body shall ensure that all facility staff are qualified (i.e., advanced practice registered nurse, physician assistant, registered nurse, licensed vocational nurse, licensed master social worker, registered dietitian, patient care technician, and other technical staff) to serve the complex needs of dialysis patients and deliver dialysis services. The registered nurse, licensed vocational nurse, patient care technician and other technical staff must demonstrate and sustain the skills needed to perform the specific duties of their positions.
(g) The governing body shall ensure adequate numbers of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.
(h) The governing body shall review and approve the facility's training program for staff, patients, and/or patient's caregiver.
(i) The governing body shall develop, implement, and enforce policies and procedures relating to the facility's disaster preparedness plan, to meet the requirements of §117.45(b) of this title (relating to Provision and Coordination of Treatment and Services). The plan shall address the continuity of essential building systems including emergency power and water, or a contract with another licensed ESRD facility to provide emergency contingency care to patients to meet the requirements of §117.91(h) of this title (relating to Fire Prevention, Protection, and Emergency Contingency Plan).
(j) The governing body shall ensure that all equipment utilized by facility staff and/or patients is properly maintained in accordance with the manufacturer's direction for use.
(k) The governing body shall ensure a physical environment that protects the health and safety of patients, personnel, and the public. The physical premises of the facility and those areas of the facility's surrounding physical structure that are used by the patients (including stairwells, corridors, and passageways) shall meet the local building and fire safety codes as they relate to design and space requirements for safe access and patient privacy.
(l) The governing body shall develop, implement, and enforce policies and procedures regarding disruptive patients or family members to ensure the health and safety of patients, personnel and the public.
(m) The governing body shall ensure that personnel shall be assigned to assist a social worker(s) with ancillary tasks (e.g., assistance with financial services, transportation, administrative, clerical, etc.), when the patient load, including all modalities, exceeds 100 patients per facility. The maximum patient load, including all modalities, per full-time equivalent qualified social worker, with assigned personnel assistance, is 125 patients.

Source Note: The provisions of this §117.41 adopted to be effective July 6, 2010, 35 TexReg 5835; amended to be effective February 21, 2023, 48 TexReg 893