Texas Administrative Code › Title 26 - HEALTH AND HUMAN SERVICES › Part 1 - HEALTH AND HUMAN SERVICES COMMISSION › Chapter 511 - LIMITED SERVICES RURAL HOSPITALS › Subchapter C - OPERATIONAL REQUIREMENTS › Section 511.58 - Renal Dialysis Services

Current through Reg. 49, No. 28; July 12, 2024
(a) A limited services rural hospital (LSRH)
				  may provide dialysis services as a patient medical service in an emergency or
				  to stabilize a patient without an additional license under Texas Health and
				  Safety Code (HSC) Chapter 251. An LSRH may not provide outpatient dialysis
				  services or seek licensure under HSC Chapter 251 except if providing services
				  during a state of disaster as allowed by HSC §251.012(2)(B) (relating to
				  Exemptions from Licensing Requirement) and subsection (b) of this
				  section.
(b) An LSRH may provide
				  outpatient dialysis services when the governor declares a state of disaster or
				  the president of the United States declares a federal disaster in this state or
				  another state. The LSRH may provide outpatient dialysis only during the term of
				  the disaster declaration.
(c) All
				  equipment used in the process for providing dialysis, including backup
				  equipment, shall be operated within manufacturer's specifications, and
				  maintained free of defects that could be a potential hazard to patients, staff,
				  or visitors. Maintenance and repair of all equipment shall be performed by
				  qualified staff or contract personnel.
(d) Staff shall be able to identify
				  malfunctioning equipment used in the process for providing dialysis and report
				  such equipment to the appropriate staff for immediate repair.
(e) Medical equipment used in the process for
				  providing dialysis that malfunctions must be clearly labeled and immediately
				  removed from service until the malfunction is identified and corrected. Written
				  evidence of all maintenance and repairs shall be maintained.
(f) After repairs or alterations are made to
				  any equipment or system used in the process for providing dialysis, the
				  equipment or system shall be thoroughly tested for proper operation before
				  returning to service. This testing must be documented.
(g) An LSRH shall comply with the federal
				  Food, Drug, and Cosmetic Act, 21 United States Code (USC), §360i(b),
				  relating to reporting when a medical device as defined in
				  21 USC §
											321(h) has or may have
				  caused or contributed to the injury or death of a patient of the
				  facility.
(h) An LSRH shall
				  develop, implement, and enforce a written preventive maintenance program to
				  ensure patient care related equipment used in a facility receives electrical
				  safety inspections, if appropriate, and maintenance at least annually or more
				  frequently as recommended by the manufacturer. The preventive maintenance may
				  be provided by LSRH staff or by contract.
(i) At least one complete dialysis machine
				  shall be available on site as backup for every 10 dialysis machines in use. At
				  least one of these backup machines must be completely operational during hours
				  of treatment. Machines not in use during a patient shift may be counted as
				  backup except at the time of an initial or an expansion survey.
(j) An LSRH shall have emergency equipment
				  and supplies immediately accessible in the treatment area. The emergency
				  equipment and supplies shall include at least the following:
(1) oxygen;
(2) mechanical ventilatory assistance
				  equipment, to include airways, manual breathing bag, and mask;
(3) suction equipment;
(4) supplies specified by the medical
				  director;
(5) electrocardiograph;
				  and
(6) automated external
				  defibrillator or defibrillator.