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RULE §511.58Renal Dialysis Services

(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.

(k) If pediatric patients are treated, the LSRH shall have the appropriate type and size emergency equipment and supplies listed in subsection (j) of this section for this special population.

(l) If pediatric patients are treated, an LSRH shall use equipment and supplies, to include blood pressure cuffs, dialyzers, and blood tubing, appropriate for this special population.

(m) An LSRH shall establish, implement, and enforce a policy for the periodic testing and maintenance of the emergency equipment. Staff shall properly maintain and test the emergency equipment and supplies and document the testing and maintenance.

(n) A transducer protector shall be replaced when wetted during a dialysis treatment and shall be used for one treatment only.

(o) Water treatment and dialysate supply systems shall meet the requirements of this subsection. An LSRH may follow more stringent requirements than the standards required by this subsection.

  (1) The LSRH administrator and medical director shall each demonstrate responsibility for the water treatment and dialysate supply systems to protect hemodialysis patients from adverse effects arising from known chemical and microbial contaminates that may be found in improperly prepared dialysate, to ensure that the dialysate is correctly formulated and meets the requirements of all applicable quality standards.

  (2) The LSRH administrator and medical director must assure that policies and procedures related to water treatment and dialysate are understandable and accessible to the operator and that the training program includes quality testing, risks and hazards of improperly prepared concentrate and bacterial issues.

  (3) The LSRH administrator and medical director must be informed before any alteration of, or any device being added to, the water system.

  (4) These requirements apply to water intended for use in the delivery of hemodialysis, including the preparation of concentrates from powder at a dialysis facility and dialysate.

  (5) The design for the water treatment system in an LSRH shall be based on considerations of the source water for the LSRH and designed by a water quality professional with education, training, or experience in dialysis system design.

  (6) When an LSRH does not use a public water system supply, the LSRH shall test the source water at monthly intervals in the same manner as a public water system as described in Texas Administrative Code Title 30 §290.104 (relating to Summary of Maximum Contaminant Levels, Maximum Residual Disinfectant Levels, Treatment Techniques, and Action Levels), and §290.109 (relating to Microbial Contaminants) as adopted by the Texas Commission on Environmental Quality (TCEQ).

  (7) The physical space in which the water treatment system is located must be adequate to allow for maintenance, testing, and repair of equipment. If mixing of dialysate is performed in the same area, the physical space must also be adequate to house and allow for the maintenance, testing, and repair of the mixing equipment and for performing the mixing procedure.

  (8) The water treatment system components shall be arranged and maintained so that bacterial and chemical contaminant levels in the product water do not exceed the standards for hemodialysis water quality described in §4.2.1 (relating to Water Bacteriology) and §4.2.2 (relating to Maximum Level of Chemical Contaminants) of the American National Standard, Water Treatment Equipment for Hemodialysis Applications, August 2001 Edition, published by the Association for the Advancement of Medical Instrumentation (AAMI).

  (9) Written policies and procedures for the operation of the water treatment system must be developed and implemented. Parameters for the operation of each component of the water treatment system must be developed, in writing, and known to the operator. Each major water system component shall be labeled in a manner that identifies the device, describes its function, how performance is verified and actions to take in the event performance is not within an acceptable range.

  (10) The materials of any components of water treatment systems (including piping, storage, filters and distribution systems) that contact the purified water shall not interact chemically or physically so as to affect the purity or quality of the product water adversely. Such components shall be fabricated from unreactive materials (e.g., plastics) or appropriate stainless steel. The use of materials that are known to cause toxicity in hemodialysis, such as copper, brass, galvanized material, or aluminum, is prohibited.

  (11) Chemicals infused into the water such as iodine, acid, flocculants, and complexing agents shall be shown to be nondialyzable or shall be adequately removed from product water. Monitors or specific test procedures to verify removal of additives shall be provided and documented.

  (12) Each water treatment system shall include reverse osmosis (RO) membranes or deionization (DI) tanks and a minimum of two carbon tanks in series. If the source water is from a private supply that does not use chlorine/chloramine, the water treatment system shall include RO membranes or deionization tanks and a minimum of one carbon tank.

  (13) Reverse osmosis membranes, if used, shall meet the standards in §4.3.7 (relating to Reverse Osmosis) of the American National Standard, Water Treatment Equipment for Hemodialysis Applications, August 2001 Edition, published by the AAMI.


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