Section 511.58 - Renal 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: (2) mechanical ventilatory assistance equipment, to include airways, manual breathing bag, and mask;(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.(14) Deionization systems, if used, shall be monitored continuously to produce water of one megohm-centimeter (cm) or greater specific resistivity (or conductivity of one microsiemen/cm or less) at 25 degrees Centigrade. An audible and visual alarm shall be activated when the product water resistivity falls below this level and the product water stream shall be prevented from reaching any point of use.(15) Patients shall not be dialyzed on deionized water with a resistivity less than 1.0 megohm-cm measured at the output of the deionizer.(16) A minimum of two DI tanks in series shall be used with resistivity monitors including audible and visual alarms placed pre and post the final DI tank in the system. The alarms must be audible in the patient care area.(17) Feed water for deionization systems shall be pretreated with activated carbon adsorption, or a comparable alternative, to prevent nitrosamine formation.(18) If a deionization system is the last process in a water treatment system, it shall be followed by an ultrafilter or other bacteria and endotoxin reducing device.(19) The carbon tanks must contain acid washed carbon, 30-mesh or smaller with a minimum iodine number of 900.(20) A minimum of two carbon adsorption beds shall be installed in a series configuration.(21) The total empty bed contact time (EBCT) shall be at least 10 minutes, with the final tank providing at least five minutes EBCT. Carbon adsorption systems used to prepare water for portable dialysis systems are exempt from the requirement for the second carbon and a 10-minute EBCT if removal of chloramines to below 0.1 milligram (mg)/1 is verified before each treatment.(22) A means shall be provided to sample the product water immediately prior to the final bed(s). Water from this port(s) must be tested for chlorine/chloramine levels immediately prior to each patient shift.(23) All samples for chlorine/chloramine testing must be drawn when the water treatment system has been operating for at least 15 minutes.(24) Tests for total chlorine, which include both free and combined forms of chlorine, may be used as a single analysis with the maximum allowable concentration of 0.1 mg/liter (L). Test results of greater than 0.5 parts per million (ppm) for chlorine or 0.1 ppm for chloramine from the port between the initial tank(s) and final tank(s) shall require testing to be performed at the final exit and replacement of the initial tank(s).(25) In a system without a holding tank, if test results at the exit of the final tank(s) are greater than the parameters for chlorine or chloramine described in this subclause, dialysis treatment shall be immediately terminated to protect patients from exposure to chlorine/chloramine and the medical director shall be notified. In systems with holding tanks, if the holding tank tests <1 mg/L for total chlorine, the RO may be turned off and the product water in the holding tank may be used to finish treatments in process. The medical director shall be notified.(26) If means other than granulated carbon are used to remove chlorine/chloramine, the facility's governing body must approve such use, in writing, after review of the safety of the intended method for use in hemodialysis applications. If such methods include the use of additives, there must be evidence the product water does not contain unsafe levels of these additives.(27) Water softeners, if used, shall be tested at the end of the treatment day to verify their capacity to treat a sufficient volume of water to supply the facility for the entire treatment day and shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration.(28) If used, the face(s) of timer(s) used to control any component of the water treatment or dialysate delivery system shall be visible to the operator at all times. Written evidence that timers are checked for operation and accuracy each day of operation must be maintained.(29) Filter housings, if used during disinfectant procedures, shall include a means to clear the lower portion of the housing of the disinfecting agents. Filter housings shall be opaque.(30) Ultrafilters, or other bacterial reducing filters, if used, shall be fitted with pressure gauges on the inlet and outlet water lines to monitor the pressure drop across the membrane. Ultrafilters shall be included in routine disinfection procedures.(31) If used, storage tanks shall have a conical or bowl-shaped base and shall drain from the lowest point of the base. Storage tanks shall have a tight-fitting lid and be vented through a hydrophobic 0.2 micron air filter. Means shall be provided to effectively disinfect any storage tank installed in a water distribution system.(32) Ultraviolet (UV) lights, if used, shall be monitored at the frequency recommended by the manufacturer. A log sheet shall be used to record monitoring.(33) Water treatment system piping shall be labeled to indicate the contents of the pipe and direction of flow.(34) The water treatment system must be continuously monitored during patient treatment and be guarded by audible and visual alarms that can be seen and heard in the dialysis treatment area should water quality drop below specific parameters. Quality monitor sensing cells shall be located as the last component of the water treatment system and at the beginning of the distribution system. No water treatment components that could affect the quality of the product water as measured by this device shall be located after the sensing cell.(35) When deionization tanks do not follow an RO system, parameters for the rejection rate of the membranes must assure that the lowest rate accepted would provide product water in compliance with §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 AAMI.(36) An LSRH shall maintain written logs of the operation of the water treatment system for each treatment day. The log book shall include each component's operating parameter and the action taken when a component is not within the facility's set parameters.(37) Microbiological testing of product water shall be conducted.(A) Microbiological testing shall be conducted monthly and following any repair or change to the water treatment system. For a newly installed water distribution system, or when a change has been made to an existing system, weekly testing shall be conducted for one month to verify that bacteria and endotoxin levels are consistently within the allowed limits.(B) At a minimum, sample sites chosen for the testing shall include the beginning of the distribution piping, at any site of dialysate mixing, and the end of the distribution piping.(C) Samples shall be collected immediately before sanitization/disinfection of the water treatment system and dialysis machines. Water testing results shall be routinely trended and reviewed by the medical director in order to determine if results seem questionable or if there is an opportunity for improvement. The medical director shall determine if there is a need for retesting. Repeated results of "no growth" shall be validated via an outside laboratory. A calibrated loop may not be used in microbiological testing of water samples. Colonies shall be counted using a magnifying device.(38) Product water used to prepare dialysate, concentrates from powder, or to reprocess dialyzers for multiple use, shall contain a total viable microbial count less than 200 colony forming units (CFU)/millimeter (ml) and an endotoxin concentration less than 2 endotoxin units (EU)/ml. The action level for the total viable microbial count in the product water shall be 50 CFU/ml and the action level for the endotoxin concentration shall be 1 EU/ml.(39) Required action for unacceptable results. If the action levels described at paragraph (6) of this subsection are observed in the product water, corrective measures shall be taken promptly to reduce the levels into an acceptable range.(40) All bacteria and endotoxin results shall be recorded on a log sheet in order to identify trends that may indicate the need for corrective action.(41) If ozone generators are used to disinfect any portion of the water or dialysate delivery system, testing based on the manufacturer's direction shall be used to measure the ozone concentration each time disinfection is performed, to include testing for safe levels of residual ozone at the end of the disinfection cycle. Testing for ozone in the ambient air shall be conducted on a periodic basis as recommended by the manufacturer. Records of all testing must be maintained in a log.(42) If used, hot water disinfection systems shall be monitored for temperature and time of exposure to hot water as specified by the manufacturer. Temperature of the water shall be recorded at a point furthest from the water heater, where the lowest water temperature is likely to occur. The water temperature shall be measured each time a disinfection cycle is performed. A record that verifies successful completion of the heat disinfection shall be maintained.(43) After chemical disinfection, means shall be provided to restore the equipment and the system in which it is installed to a safe condition relative to residual disinfectant prior to the product water being used for dialysis applications.(44) Samples of product water must be submitted for chemical analysis every six months and must demonstrate that the quality of the product water used to prepare dialysate or concentrates from powder, meets §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 AAMI.(45) Samples for chemical analysis shall be collected at the end of the water treatment components and at the most distal point in each water distribution loop, if applicable. All other outlets from the distribution loops shall be inspected to ensure that the outlets are fabricated from compatible materials. Appropriate containers and pH adjustments shall be used to ensure accurate determinations. New LSRHs or LSRHs that add or change the configuration of the water distribution system must draw samples at the most distal point for each water distribution loop, if applicable, on a one time basis.(46) Additional chemical analysis shall be submitted if substantial changes are made to the water treatment system or if the percent rejection of an RO system decreased 5.0% or more from the percent rejection measured at the time the water sample for the preceding chemical analysis was taken.(47) LSRH records must include all test results and evidence that the medical director has reviewed the results of the water quality testing and directed corrective action when indicated.(48) Only persons qualified by the education or experience may operate, repair, or replace components of the water treatment system.(49) Quality control procedures shall be established to ensure ongoing conformance to policies and procedures regarding dialysate quality.(p) Each LSRH shall set all hemodialysis machines to use only one family of concentrates. When new machines are put into service or the concentrate family or concentrate manufacturer is changed, samples shall be sent to a laboratory for verification.(q) Prior to each patient treatment, LSRH staff shall verify the dialysate conductivity and pH of each machine with an independent device.(r) The LSRH shall conduct bacteriological testing.(s) Responsible LSRH staff shall develop a schedule to ensure each hemodialysis machine is tested quarterly for bacterial growth and the presence of endotoxins. Hemodialysis machines of home patients shall be cultured monthly until results not exceeding 200 CFU/ml are obtained for three consecutive months, then quarterly samples shall be cultured.(t) Dialysate shall contain less than 200 CFU/ml and an endotoxin concentration of less than 2 EU/ml. The action level for total viable microbial count shall be 50 CFU/ml and the action level for endotoxin concentration shall be 1 EU/ml.(u) Disinfection and retesting shall be done when bacterial or endotoxin counts exceed the action levels. Additional samples shall be collected when there is a clinical indication of a pyrogenic reaction and/or septicemia.(v) Only a licensed nurse may use an additive to increase concentrations of specific electrolytes in the acid concentrate. Mixing procedures shall be followed as specified by the additive manufacturer. When additives are prescribed for a specific patient, the container holding the prescribed acid concentrate shall be labeled with the name of the patient, the final concentration of the added electrolyte, the date the prescribed concentrate was made, and the name of the person who mixed the additive.(w) All components used in concentrate preparation systems (including mixing and storage tanks, pumps, valves, and piping) shall be fabricated from materials (e.g., plastics or appropriate stainless steel) that do not interact chemically or physically with the concentrate so as to affect its purity, or with the germicides used to disinfect the equipment. The use of materials that are known to cause toxicity in hemodialysis such as copper, brass, galvanized material, and aluminum is prohibited.(x) LSRH policies shall address means to protect stored acid concentrates from tampering or from degeneration due to exposure to extreme heat or cold.(y) Procedures to control the transfer of acid concentrates from the delivery container to the storage tank and prevent the inadvertent mixing of different concentrate formulations shall be developed, implemented, and enforced. The storage tanks shall be clearly labeled.(z) Concentrate mixing systems shall include a purified water source, a suitable drain, and a ground fault-protected electrical outlet.(aa) Operators of mixing systems shall use personal protective equipment as specified by the manufacturer during all mixing processes.(bb) The manufacturer's instructions for use of a concentrate mixing system shall be followed, including instructions for mixing the powder with the correct amount of water. The number of bags or weight of powder added shall be determined and recorded.(1) The mixing tank shall be clearly labeled to indicate the fill and final volumes required to correctly dilute the powder.(2) Systems for preparing either bicarbonate or acid concentrate from powder shall be monitored according to the manufacturer's instructions.(3) Concentrates shall not be used, or transferred to holding tanks or distribution systems, until all tests are completed.(4) If an LSRH designs its own system for mixing concentrates, procedures shall be developed and validated using an independent laboratory to ensure proper mixing.(5) Acid concentrate mixing tanks shall be designed to allow the inside of the tank to be rinsed when changing concentrate formulas.(6) Acid mixing systems shall be designed and maintained to prevent rust and corrosion.(7) Acid concentrate mixing tanks shall be emptied completely and rinsed with product water before mixing another batch of concentrate to prevent cross contamination between different batches.(8) Acid concentrate mixing equipment shall be disinfected as specified by the equipment manufacturer or in the case where no specifications are given, as defined by LSRH policy.(9) Records of disinfection and rinsing of disinfectants to safe residual levels shall be maintained.(10) Bicarbonate concentrate mixing tanks shall have conical or bowl-shaped bottoms and shall drain from the lowest point of the base. The tank design shall allow all internal surfaces to be disinfected and rinsed.(11) Bicarbonate concentrate mixing tanks shall not be prefilled the night before use.(12) If disinfectant remains in the mixing tank overnight, this solution must be completely drained and the tank must be rinsed and tested for residual disinfectant prior to preparing the first batch of that day of bicarbonate concentrate.(13) Unused portions of bicarbonate concentrate shall not be mixed with fresh concentrate.(14) At a minimum, bicarbonate distribution systems shall be disinfected weekly. More frequent disinfection shall be done if required by the manufacturer, or if dialysate culture results are above the action level.(15) If jugs are reused to deliver bicarbonate concentrate to individual hemodialysis machines: (A) jugs shall be emptied of concentrate, rinsed, and inverted to drain at the end of each treatment day;(B) at a minimum, jugs shall be disinfected weekly, and more frequent disinfection shall be considered by the medical director if dialysate culture results are above the action level; and(C) following disinfection, jugs shall be drained, rinsed free of residual disinfectant, and inverted to dry. Testing for residual disinfectant shall be done and documented.(16) All mixing tanks, bulk storage tanks, dispensing tanks, and containers for single hemodialysis treatments shall be labeled as to the contents.(17) Prior to batch preparation, a label shall be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling shall remain on the mixing tank until the tank has been emptied.(18) Mixing tanks shall be permanently labeled to identify the chemical composition or formulation of their contents.(19) At a minimum, single machine containers shall be labeled with sufficient information to differentiate the contents from other concentrate formulations used in the LSRH and permit positive identification by users of container contents.(20) Permanent records of batches produced shall be maintained to include the concentrate formula produced, the volume of the batch, lot number(s) of powdered concentrate packages, the manufacturer of the powdered concentrate, date and time of mixing, test results, person performing mixing, and expiration date (if applicable).(21) If dialysate concentrates are prepared in the facility, the manufacturers' recommendations shall be followed regarding any preventive maintenance. Records shall be maintained indicating the date, time, person performing the procedure, and the results (if applicable).(cc) With the advice and consent of a patient's attending nephrologist, facility staff shall make the hepatitis B vaccine available to a patient who is susceptible to hepatitis B, provided that the patient has coverage or is willing to pay for vaccination.(dd) The LSRH shall make available to patients literature describing the risks and benefits of the hepatitis B vaccination.(ee) A patient new to dialysis shall have been screened for hepatitis B surface antigen (HBsAg) within one month before or at the time of admission to the facility or have a known hepatitis B surface antibody (anti-HBs) status of at least 10 milli-international units per milliliter no more than 12 months prior to admission. The LSRH shall document how this screening requirement is met. (1) Repeated serologic screening shall be based on the antigen or antibody status of the patient.(2) Monthly screening for HBsAg is required for patients whose previous test results are negative for HBsAg.(3) Screening of HBsAg-positive or anti-HBs-positive patients may be performed on a less frequent basis, provided that the LSRH's policy on this subject remains congruent with Appendices i and ii of the National Surveillance of Dialysis Associated Disease in the United States, 2000, published by the United States Department of Health and Human Services.(ff) The LSRH shall treat patients positive for HBsAg in a segregated treatment area that includes a hand washing sink, a work area, patient care supplies and equipment, and sufficient space to prevent cross-contamination to other patients. (1) A patient who tests positive for HBsAg shall be dialyzed on equipment reserved and maintained for the HBsAg-positive patient's use only.(2) When a caregiver is assigned to both HBsAg-negative and HBsAg-positive patients, the HBsAg-negative patients assigned to this grouping must be hepatitis B antibody positive. Hepatitis B antibody positive patients are to be seated at the treatment stations nearest the isolation station and be assigned to the same staff member who is caring for the HBsAg-positive patient.(3) If an HBsAg-positive patient is discharged, the equipment that had been reserved for that patient shall be given intermediate level disinfection prior to use for a patient testing negative for HBsAg.(4) In the case of patients new to dialysis, if these patients are admitted for treatment before results of HBsAg or anti-HBs testing are known, these patients shall undergo treatment as if the HBsAg test results were potentially positive, except that they shall not be treated in the HBsAg isolation room, area, or machine.(A) The LSRH shall treat potentially HBsAg-positive patients in a location in the treatment area that is outside of traffic patterns until the HBsAg test results are known.(B) The dialysis machine used by this patient shall be given intermediate level disinfection prior to its use by another patient.(C) The LSRH shall obtain HBsAg status results of the patient no later than three days from admission.26 Tex. Admin. Code § 511.58
Adopted by Texas Register, Volume 48, Number 39, September 29, 2023, TexReg 5682, eff. 10/5/2023