TITLE 26. HEALTH AND HUMAN SERVICES

PART 1. HEALTH AND HUMAN SERVICES COMMISSION

CHAPTER 507. END STAGE RENAL DISEASE FACILITIES

The executive commissioner of the Texas Health and Human Services Commission (HHSC) adopts new §§507.1, 507.2, 507.11 - 507.24, 507.30 - 507.38, 507.41 - 507.49, 507.51 - 507.60, 507.71 - 507.75, and 507.81 - 507.93, concerning End Stage Renal Disease Facilities.

New §§507.2; 507.11 - 507.17; 507.21 and 507.31; 507.33 - 507.36; 507.38, 507.41, 507.42, 507.48, and 507.49; 507.51 - 507.57; 507.59, 507.60, 507.72, 507.73, and 507.75; 507.82; and 507.90 are adopted with changes to the proposed text as published in the June 6, 2025, issue of the Texas Register (50 TexReg 3367). These rules will be republished.

New §§507.1; 507.18 - 507.20; 507.22 - 507.24; 507.30, 507.32, and 507.37; 507.43 - 507.47; 507.58, 507.71, and 507.74; 507.81, 507.83 - 507.89 and 507.91 - 507.93 are adopted without changes to the proposed text as published in the June 6, 2025, issue of the Texas Register (50 TexReg 3367). These rules will not be republished.

BACKGROUND AND JUSTIFICATION

The new sections are necessary to comprehensively update the end stage renal disease (ESRD) facility rules to align with Texas Health and Safety Code Chapter 251. The new sections ensure patient safety while reducing unnecessary administrative burdens and allowing ESRDs more flexibility in the delivery of care. The new sections ensure alignment with current facility licensing, inspection, and investigation procedures; and reflect current technologies. The new sections also provide updated definitions and improve rule organization and readability.

The new sections require ESRD facilities to comply with the most current applicable guidelines and standards, for example, those from the Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention, U.S. Food and Drug Administration, and Association for the Advancement of Medical Instrumentation, to ensure patient safety.

The new sections improve consistency across HHSC Health Care Regulation (HCR) rulesets and correct outdated language, references, and citations. The new sections reflect the transition of regulatory jurisdiction from the Texas Department of State Health Services (DSHS) to HHSC and replace the ESRD facility rules in Title 25 of the Texas Administrative Code (25 TAC).

HHSC's adoption of the repeal of 25 TAC Chapter 117, End Stage Renal Disease Facilities, is published elsewhere in this issue of the Texas Register.

COMMENTS

The 31-day comment period ended July 7, 2025.

During this period, HHSC received comments regarding the proposed rules from 20 commenters. HHSC received comments from American Renal Associates LLC D/B/A Innovative Renal Care (IRC/ARA), DaVita, Inc., ESRD Network 14 Medical Review Board, Fresenius Medical Care North America, Texas Medical Association, Texas Nurses Association, U.S. Renal Care (USRC), and eleven individuals. A summary of comments relating to the rules and HHSC's responses follows.

Comment: Innovative Renal Care/American Renal Associates (IRC/ARA) thanked HHSC for modernizing ESRD regulations and collaborating on rulemaking. IRC/ARA also urged HHSC to allow implementation flexibility for rural and underserved communities and align regulations with national standards. Additionally, IRC/ARA stated clear, practical guidance is essential to safe and high-quality dialysis care.

Response: HHSC acknowledges this comment and revises the rules to allow flexibility for facilities and more alignment with certain CMS standards. Revisions include clarifying staffing ratios and removing the additional nurse requirement, extending the amount of time a facility may remain open without providing services, and providing flexibility for patient training and routine provider visits with patients.

Comment: DaVita stated that HHSC used the terms "days," "business days," and "calendar days" inconsistently throughout the proposed rules in 26 TAC Chapter 507 and requested that HHSC use a single standard.

Response: HHSC declines to revise the rules further based on this comment because it is necessary to use business days in some instances, such as when HHSC or facilities send correspondence via U.S. Postal Service and in timelines for facilities to correct deficiencies.

Comment: USRC and Fresenius commented that the last two sentences in the definition of "direct care staff" in §507.2(26) expand the definition and are unnecessary. Fresenius also commented that they are not part of the definition.

Response: HHSC revises the definition of "direct care staff" in §507.2(26) to remove the sentence, "This does not include the Charge Nurse as shown in §507.60 of this chapter (relating to Staffing Table)." HHSC revises §507.48(j) and Figure: 26 TAC §507.60, as explained later in this adoption preamble, to clarify that a charge nurse may be considered part of direct care staff when there are seven or fewer patients. HHSC keeps the sentence, "These staff members fulfill the patient to staff ratio requirement."

Comment: An individual requested an update to the definition to "ESRD Network" to remove "not-for-profit" as several ESRD Networks are now owned by for profit corporations.

Response: HHSC agrees with the comment and revises the ESRD Network definition in §507.2(31) to remove the term "not-for-profit."

Comment: DaVita requested HHSC clarify the definition in §507.2(48) of "licensed vocational nurse (LVN)," specifically, the requirement for an LVN to meet "the competency requirements specified for dialysis technicians." The commenter added that the definition does not properly differentiate the LVN role from the dialysis technician role and is also inconsistent with §507.48(o), which only requires LVNs to meet the requirements for a dialysis technician when they are acting in the capacity of a dialysis technician.

Response: HHSC agrees with the comment and revises §507.2(48) by creating a separate sentence after the licensure requirement for an LVN. The separate sentence clarifies that an LVN may act in the capacity of a dialysis technician after meeting the competency requirements specified in §507.48(o) of this chapter.

Comment: DaVita objected to the definition of "single patient device" in §507.2(69) which requires devices to be prescribed to a patient for individual use, citing the CMS ESRD Conditions for Coverage (CfCs), which do not include this requirement. DaVita stated the definition limited care settings such as on-site home hemodialysis in skilled nursing facilities as DaVita believes multi-patient reuse of dialysis machines is safe and clinically appropriate.

Response: HHSC declines to revise the definition in §507.2(69) in response to the comment because home dialysis service is currently defined in this chapter as dialysis performed at home by an end stage renal disease patient or the patient's caregiver and does not include on-site home hemodialysis in skilled nursing facilities. It would be an infection risk for home dialysis patients to share a dialysis machine. As multiple stakeholders requested clarification about dialysis services in skilled nursing facilities, HHSC is currently assessing regulatory authority for multi-patient reuse of dialysis machines in skilled nursing facilities.

Comment: The ESRD Network 14 Medical Review Board requested that the definition of "single patient device" in §507.2(69) be revised to reference the need to assign a patient a single device in the traditional home setting, where it is appropriate. This commenter added that the dialysis machine is not an alternate method of providing dialysis nor prescribed to a patient, but simply a need to assign the machine to a home patient in their home.

Response: HHSC agrees with the commenter and revises the definition of single patient device in §507.2(69) to "A dialysis machine, as designated by the FDA, assigned to a patient for individual use at home."

Comment: An individual requested that HHSC update the "social worker" definition to remove the "grandfather" clause for certain social workers with two years of work experience as a social worker, one year of experience having been in a dialysis facility or transplantation program before September 1, 1976, and a consultive relationship with a social worker with a master's degree from an accredited graduate school of social work.

Response: HHSC declines to revise the definition of "social worker" in §507.2(70) as suggested because that definition aligns with the definition in CMS CfCs for ESRDs in the Code of Federal Regulations (CFR), Title 42, HHSC intends to provide facilities with the same flexibility provided by the CFR as there may be individuals that still qualify under the definition.

Comment: Fresenius Kidney Care and USRC thanked HHSC for changing the experience required for a supervising nurse in the definition of "supervising nurse" from 18 to 12 months as an RN and from 12 to 6 months in dialysis within the last 24 months.

Response: HHSC acknowledges this comment relating to the definition of "supervising nurse" proposed in §507.2(73)(A)(i) and (A)(ii).

Comment: DaVita appreciates the proposed definition of "supervising nurse" in §507.2(73) to allow for a supervising nurse to have twelve months of experience as an RN, consistent with the CMS CfCs. However, DaVita objects to the requirement that the additional six months of experience in dialysis be obtained in the last 24 months. DaVita requested that HHSC revise this part of the definition by removing "obtained within the last 24 months," to further align the requirement with the CMS CfCs that do not require the 6 months of experience in dialysis to be obtained within the last 24 months. DaVita believes this requirement would create staffing limitations and difficulties for clinics

Response: Currently, 25 TAC §117.2(71)(A), proposed for repeal, requires 12 months of experience in dialysis within the last 24 months. Proposed §507.2(73)(A)(ii), reduced the experience in dialysis to six months, but maintains the requirement for the experience to be within the last 24 months. HHSC declines to revise §507.2(73)(A)(ii) as requested because reducing the supervising nurse's experience in dialysis any further presents a risk to patient health and safety.

Comment: DaVita and ESRD Network 14 Medical Review Board requested that HHSC update the definition of "Training (Patient)" to allow for training in small groups. DaVita also recommended that group training always take place in person and that individual needs are identified and addressed. ESRD Network 14 Medical Review Board stated that group training is efficient, can create a healthy shared learning environment, and that a hybrid model that includes group and individual training is ideal.

Response: HHSC agrees with the comment and revises §507.53 to add a new subsection (c) to allow patient training to be provided individually or in a small group setting, require a facility to offer patients the choice of an individual or small group training setting based on the patient's preference and individual needs, and require patient training to take place in person. HHSC revises §507.53 after new subsection (c) to renumber subsections (c)- (h) as (d) - (i). HHSC also revises the definition of "Training (Patient)" in §507.2 to add patient training must "meet the requirements in §507.53 of this chapter (relating to Home Dialysis Service)" to replace "take place in person;" and to add "home dialysis" in front of "treatment modality" to clarify the definition applies to home dialysis.

Comment: ESRD Network 14 Medical Review Board expressed full agreement with proposed §507.11(a) that all dialysis services providers must be licensed, regardless of affiliation or modality, and that home dialysis services must be under the purview of a licensed ESRD facility.

Response: HHSC acknowledges the comment.

Comment: DaVita requests that HHSC change §507.11(b), which requires a facility to obtain a license before admitting patients, to add "except as required for initial inspection under §507.12(f)."

Response: HHSC disagrees with the comment and declines to revise §507.11(b) as requested because there are no exceptions to obtaining a license before admitting patients. The subsection the commenter referred to as §507.12(f) is now §507.12(h), which requires the facility to admit and provide services to at least one patient before an HHSC inspection, but not before licensure.

Comment: DaVita and ESRD Network 14 Medical Review Board requested that HHSC amend §507.11(h)(1) to require a home and community support services agency (HCSSA) with a home dialysis designation to be Medicare certified as an ESRD dialysis facility. DaVita also suggested requiring a HCSSA to have five or fewer dialysis patients if the agency is not Medicare certified.

ESRD Network 14 Medical Review Board noted that Texas is the only state that allows providers to provide dialysis services without certification and that the exempted providers cannot process 2728 ESRD Medical Evidence Reports, which interferes with a patient's ability to receive a kidney transplant. Additionally, they stated the exemption puts patient safety, federal program integrity, and the state's monitoring ability at risk.

Response: HHSC declines to revise §507.11(h)(1) in response to this comment because the rule aligns with Texas Health and Safety Code §251.012(1), which exempts a HCCSA, licensed under Texas Health and Safety Code Chapter 142 with a home dialysis designation, from being licensed as an ESRD facility under 26 TAC Chapter 507.

Comment: An individual asked if §507.11(h)(1) means that entities providing only home staff assisted dialysis are required to be licensed solely under Texas Health and Safety Code Chapter 142, or if this interpretation is misleading because of the requirement under Texas Health and Safety Code Chapter 142 to have an agreement with an ESRD licensed facility.

Response: In accordance with Texas Health and Safety Code §251.012(1), §507.11(h)(1) exempts a home and community support services agency (HCSSA) licensed under Texas Health and Safety Code Chapter 142 with a home dialysis designation from required licensure under 26 TAC Chapter 507. Therefore, HHSC disagrees that §507.11(h)(1) is misleading because a HCSSA must be licensed under Texas Health and Safety Code Chapter 142 and there is not a requirement under that chapter for a HCSSA with the dialysis designation to have an agreement with an ESRD licensed facility to provide home staff-assisted dialysis. HHSC declines to revise the rules in response to this comment.

Comment: DaVita requested HHSC amend §507.11(h)(5) to only exempt a physician's office from licensure if the office is used primarily as an ESRD facility and either has five or fewer dialysis patients or is Medicare certified as an ESRD dialysis facility.

Response: HHSC declines to revise §507.11(h)(5) in response to this comment because the rule is consistent with Texas Health and Safety Code §251.012(5).

Comment: Fresenius Kidney Care and USRC requested HHSC revise the rule in §507.12(a)(1)(B) to allow for dialysis technicians to be in the process of completing training program requirements.

Response: HHSC declines to revise §507.12(a)(1)(B) because the rule is consistent with Texas Health and Safety Code §251.013(c).

Comment: USRC requested that HHSC revise §507.12(e) to allow facilities to prove active process towards completion to avoid the application withdrawal at six months.

Response: HHSC declines to revise §507.12(e) because the rule allows adequate time to communicate with HHSC and complete the process.

Comment: U.S. Renal Care, Inc. suggested HHSC revise §507.13(f)(2) to allow a facility making an ongoing attempt to obtain required documents for a license renewal application to avoid the requirement to cease operation 30 days after license expiration. USRC stated that document availability may be outside of the facility's control.

Response: HHSC declines to revise §507.13(f)(2) as suggested because the rules allow adequate time to communicate with HHSC to complete the process.

Comment: DaVita expressed concern that 10 business days may not be enough time to respond to information requests resulting from a renewal application, and notes that 10 business days is inconsistent with most of the regulations in Chapter 507, which uses calendar days to measure deadlines. DaVita requested that HHSC revise §507.13(h) to allow 20 business days to correct a deficiency in the renewal application.

Response: HHSC agrees and revises §507.13(h) to change "10 business days" to "15 business days" for the timeline in which a facility must correct a deficiency in the renewal application after being notified.

Comment: DaVita requested that HHSC remove §507.14(a)(4) and allow the facility to continue to operate as a change in ownership is being processed. DaVita stated the rule could lead to gaps in patient care if the change in ownership application is not required to be submitted until five days after the change, and HHSC may take up to 45 days or more to process the application and issue a new license.

Response: HHSC agrees with the comment and revises §507.14(a) by removing paragraph (4), then renumbering paragraphs (5) - (8) as paragraphs (4) - (7).

Comment: DaVita suggested HHSC remove the requirement proposed in §507.14(a)(5) because the language in §507.14(e) is already permissive and states that HHSC "may" inspect the facility.

Response: HHSC agrees with the comment and removes §507.14(a)(5), renumbered as §507.14(a)(4), because §507.14(e), renumbered as §507.14(d), already states HHSC "may" inspect the facility.

Comment: DaVita requested that HHSC revise §507.16(a) to keep the requirement for notifying HHSC of certain architectural projects at 30 days in advance rather than the proposed 90 days in advance. DaVita stated this change would allow for a licensee to react to changing circumstances.

Response: HHSC agrees with the comment and revises §507.16(a) to revert the notification requirement from at least 90 calendar days to at least 30 calendar days before the activities listed in the rule.

Comment: DaVita asserts that certain activities listed in proposed in §507.16(a), such as "submission of an initial application," or "minor alterations, renovations, remodeling, equipment and finish upgrades," should not be subject to the notice required in this rule because the activities are not subject to HHSC approval and do not affect patient care.

Response: HHSC declines to revise the list of activities in §507.16(a) based on this comment. HHSC requires notification before a facility begins the activities listed in §507.16(a)(1) - (7) because even small changes might have unintended consequences for patient health and safety. The notification allows HHSC to inform facilities when proposed changes could impact the facility's compliance.

Comment: DaVita requested HHSC remove §507.16(a)(6) because it is unclear and may be duplicative of (a)(7), which also includes a change of services or changes in treatment modality. The commenter also noted the term "invasive procedural service" is not defined and is inconsistent with the type of care given at a dialysis facility.

Response: HHSC agrees with the comment and revises §507.16(a)(6) to remove "or changing an invasive procedural service" because it does not apply to ESRD facilities. HHSC declines to remove §507.16(a)(6) entirely as it is not duplicative of (a)(7). Retrofitting, in §507.16(a)(6), may have a greater architectural scope than simply changing treatment modality or station designation. Service changes, in §507.16(a)(7), may encompass more than a retrofit; it may include changes to treatment modality or station designations.

Comment: DaVita requested HHSC update §507.17(3) to align with CMS practice which considers any closure less than 90 days as temporary and make a case-by-case determination based on facts and circumstances for any closure greater than 90 days to determine whether a particular closure is temporary or permanent. DaVita believes 60 days is overly restrictive and can create hurdles to patient access.

Response: HHSC agrees with the comment and revises §507.17(3) by changing 60 calendar days to 90 calendar days. For consistency, HHSC revises §507.17 to change the number of days without offering services before HHSC may close a license from 60 calendar days to 90 calendar days; and revises §507.17(4) and (6) to change 60 calendar days to 90 calendar days related to inactive status and reactivating the license, respectively.

Comment: Fresenius, DaVita, and ESRD Network 14 Medical Review Board requested that HHSC revise §507.21(a) to allow a facility to request an exception described in the rule that may be temporary or permanent. DaVita suggested that HHSC strike "temporary" in §507.21(c) to allow facilities to submit permanent exceptions when appropriate.

Response: HHSC agrees with the comment and revises §507.21(a) to allow a facility, in a new paragraph (1), to request a temporary exception related to alternative concepts, methods, procedures, or techniques, or for conducting pilot projects or research; and to allow a facility, in a new paragraph (2), to request a permanent exception related to United States Food and Drug Administration-approved equipment. Because of the revisions in §507.21(a)(1) and (2) to allow temporary and permanent exceptions, HHSC also revises §507.21(c) to require a facility to request an exception by submitting a form to HHSC; removes proposed paragraph (1) that would have required submitting a written request to HHSC, and then renumbers proposed paragraphs (2) - (6) as paragraphs (1) - (5). In renumbered paragraphs (1) - (5), HHSC made necessary editorial changes at the beginning of each paragraph; and, in renumbered paragraph (5), added that the form submitted shall include the duration of the exception, "if the facility submits a request for a temporary exception." HHSC revises §507.21 to remove proposed subsection (d) that would have contained the process to request an exception, then renumbers proposed subsections (e) - (h) as subsections (d) - (g). HHSC revises renumbered subsection (e) to clarify that the timeframe in the rule begins "after the date HHSC receives the request" instead of "after receipt;" to change "an exception" to "a temporary or permanent" exception;" and to clarify "that HHSC" notifies the facility an exception has been granted. HHSC also revises renumbered subsection (f) by replacing "after receiving" with "the date the facility receives" to clarify the timeframe to implement an exception.

Comment: DaVita suggested that HHSC strike "temporary" in §507.21(c) to allow facilities to submit permanent exceptions when appropriate.

Response: HHSC revises §507.21(c) to remove "temporary" because facilities may apply for rule exceptions as provided by §507.21.

Comment: DaVita objected to limiting temporary exceptions in an emergency to a maximum of 120 days with a single renewal period of an additional 120 days in §507.22(c). The commenter requested that HHSC revise the rule to allow temporary exceptions to remain in effect until the emergency or disaster declaration is officially lifted. DaVita stated the limited time period and requiring renewal thereafter may create an administrative burden during extended emergency and disaster situations when resources need to be focused on direct patient care.

Response: HHSC declines to revise §507.22(c), because HHSC must reassess temporary exceptions to determine whether the conditions requiring the temporary exceptions still exist. HHSC notes there are sections in the chapter, including §507.23, §507.24, §507.58 and §507.59 that allow flexibility during an emergency or disaster.

Comment: An individual stated the references to technical standards in §507.30 that facilities must comply with should be revised to reflect updates to those standards that are expected to be endorsed by the respective national standard-setting organizations, which should be complete prior to the adoption of these rules.

Response: HHSC declines to revise §507.30 in response to this comment because HHSC cannot refer to technical standards that have not yet been approved.

Comment: USRC stated that in §507.31(a)(1) it may not be possible to repair a machine immediately and suggested using the term "urgent" instead.

Response: HHSC agrees with the comment but does not revise §507.31(a)(1) as suggested. Instead, HHSC revises §507.31(a)(1) to require staff to "immediately" report malfunctioning equipment and remove the requirement for "immediate repair." This revision better aligns with the requirement in §507.31(a)(2) to remove malfunctioning equipment until the facility can correct the malfunction.

Comment: An individual and DaVita pointed out that §117.31(c), proposed for repeal, requires a facility to have at least one dialysis machine available on site as backup for every ten dialysis machines in use. The individual requested that HHSC revise proposed §507.31(c) to require at least one backup dialysis machine to be available. DaVita requested that HHSC maintain the current rule, including that machines not in use during a patient shift may count as backup, consistent with HHSC draft rules at 26 TAC Chapter 520, Requirements for Design, Construction, and Fire Safety in Health Care Facilities posted for informal comment in April 2025. Fresenius and USRC thanked HHSC for removing the requirement to have one backup dialysis machine for every 10 patients.

Response: HHSC revises §507.31(c) to reinstate the requirement for at least one available back up dialysis machine for every 10 machines in use; that one of these backup machines shall be completely operational during hours of treatment; and that machines not in use during a patient shift may be counted as backup except at the time of an initial or an expansion survey. This revision meets operational requirements to avoid disruptions to patient services and ensures patients can receive dialysis on schedule even in cases of dialysis machine malfunction. Since HHSC reinstated the requirement for back up dialysis machines in §507.31(c), HHSC removes the requirement for a facility to have a policy requiring an emergency plan for when a patient cannot complete dialysis due to machine malfunction and to communicate the plan to each patient at admission. The rule requiring at least one backup dialysis machine to be available was not in the proposed ESRD rule because it was intended to be addressed in HHSC draft rules for 26 TAC Chapter 520, Requirements for Design, Construction, and Fire Safety in Health Care Facilities posted for informal comment in April 2025. Chapter 520 is still in development and has not been finalized.

Comment: DaVita expressed support for proposed §507.31(f), but stated it is inconsistent with HHSC draft rules at 26 TAC Chapter 520, Requirements for Design, Construction, and Fire Safety in Health Care Facilities posted for informal comment in April 2025. DaVita requested the requirement remain as written in §507.31(f).

Response: HHSC acknowledges the comment related to proposed §507.31(f), renumbered as §507.31(g), requiring a facility to have emergency equipment and supplies immediately accessible in the treatment area and may revise the draft rules in 26 TAC Chapter 520 for consistency with §507.31(f), renumbered as §507.31(g), as Chapter 520 is still in development and has not been finalized.

Comment: An individual commented that updates to the standards listed in §507.30 that are expected to be endorsed by national standard-setting organizations do not specify a recommended flow velocity in the distribution system and suggested deleting the requirement in §507.33(3)(A).

Response: HHSC agrees and revises §507.33(3) by removing the requirement proposed in subparagraph (A), for indirect feed systems to have a minimum of three feet per second of water flow in the distribution loop. Because of this revision, HHSC renumbered subparagraphs (B) - (D) as (A) - (C), and in renumbered subparagraph (A), made revisions so that the water flow rate for direct and indirect feed systems shall comply with the standards listed in §507.30.

Comment: An individual recommended that HHSC revise §507.33(8)(D)(iii) to specify "removal of total chlorine" instead of "removal of chloramine" since chloramine cannot be directly measured. The commenter also suggested that HHSC revise §507.33(8)(D)(iv), (vii), and (viii) to use "total chlorine" or "chlorine/chloramine" rather than "chlorine or chloramine."

Response: HHSC agrees with the comment and revises §507.33(8)(D)(iii) as recommended. For consistency, HHSC also revises §507.33(8)(D)(ii), (iv), (vii), and (ix) to use "total chlorine" instead of "chlorine or chloramine."

Comment: An individual commented that §507.33(8)(D)(iv) reads as a requirement for the facility to test at opening, and then again before the first shift, and asked whether this is the intent.

Response: The intent of §507.33(8)(D)(iv) does include testing at the beginning of each treatment day and before patients initiate treatment. To clarify this intent, HHSC revises 507.33(8)(D)(iv) by adding a comma after "treatment day" and changing "before patients initiating treatment" to "before patients initiate treatment."

Comment: DaVita requested that HHSC remove the requirement in §507.33(8)(D)(v) for staff to manually test the automated chlorine monitoring system. DaVita stated the requirement would be burdensome for staff and that the chlorine monitoring systems do not require verification of water quality per manufacturer instructions.

Response: HHSC declines to revise §507.33(8)(D)(v) as requested because manual testing of an automated chlorine monitoring system ensures the internal monitoring system is correctly calibrated and performing correctly.

Comment: An individual, referencing §507.33(19)(A), commented that the current practice recommended by the International Organization for Standardization (ISO) 23500 Standards for routine microbiological testing is monthly testing except for home programs and integrated dialysis systems where quarterly testing is allowed.

Response: HHSC agrees with the comment and revises §507.33(19)(A) to require testing at least quarterly or more frequently, as needed or required by the technical standards outlined in §507.30. HHSC also revises §507.33(19)(A) by using a separate sentence for the requirement that routine microbiological testing must ensure the water and dialysate bacteria and endotoxin levels are within the limits described in the standards listed in §507.30.

Comment: An individual, referencing proposed §507.33(19)(C), commented that the current technical standards do not allow internal testing and that laboratories should not use a calibrated loop either. The commenter suggested that HHSC revise the rule to use "A calibrated loop shall not be used in microbiological testing of water or dialysate samples."

Response: HHSC agrees with the comment and revises proposed §507.33(19)(C) to remove the requirements for internal testing, including the requirement that colonies shall be counted using a magnifying device. HHSC also revises §507.33(19)(C) to remove, "A facility shall not use a calibrated loop in microbiological testing of water samples." These changes are made for consistency with current technical standards.

Comment: An individual, referencing §507.33(19)(D), commented that it was a good idea to spell out the maximum levels for the total viable microbial count and endotoxin concentration. The commenter suggested that HHSC also include the action levels. The commenter also pointed out that the endotoxin levels, maximum and action level, are different for dialysate.

Response: HHSC declines to revise proposed §507.33(19)(D) as requested because the rule requires the action level for the total viable microbial count in the product water to be consistent with the standards listed in §507.30.

Comment: An individual commented on the monthly frequency of water disinfection proposed in §507.33(21) because heat disinfection is usually done at least each day of use. The commenter suggested that HHSC avoid defining a heat disinfection frequency, and rather include how the facility should monitor effectiveness of heat disinfection.

Response: HHSC declines to revise §507.33(21) as suggested. Instead, HHSC revises §507.33(21) to add that facilities may conduct hot water disinfection more frequently as needed or required by the technical standards in §507.30.

Comment: DaVita recommended HHSC revise §507.34(b) to follow the standard set by the CMS CfCs for dialysate testing when the concentrate manufacturer changes.

Response: HHSC declines to revise §507.34(b) in response to this comment because the CfCs do not contemplate concentrate manufacturer changes and because mixing families of concentrates can be detrimental to patient health and safety due to chemical incompatibilities and variations in chemical composition that can lead to severe and potentially fatal patient outcomes.

Comment: DaVita commented that with ever-improving technology and machine capabilities, verification of dialysate conductivity is no longer required and, in some cases, no longer able to be tested. DaVita recommends for HHSC to add in §507.34(c) that verification of dialysate conductivity is only required when specified in the manufacturer's directions for use. DaVita stated that linking the requirement to manufacturer instructions will have the effect of not excluding newer machines where dialysate conductivity is no longer required.

Response: HHSC declines to revise §507.34(c) and instead revises §507.34(d) to clarify that for machines with internal independent testing, staff must verify and document that the machine conducted internal testing before each patient treatment.

Comment: Fresenius Kidney Care and US Renal Care thanked HHSC for acknowledging machines with internal independent testing for conductivity and pH in §507.34(d).

Response: HHSC acknowledges these comments.

Comment: IRC/ARA expressed appreciation of the intent behind proposed §507.34(d) and the emphasis on maintaining high standards to ensure the quality of dialysate solution being provided, but noted that the six-month testing requirement in §507.34(d) may present operational challenges because it may be more stringent than equipment manufacturer requirements. The comment from IRC/ARA asked for clarification of the following: (1) if the proposed rule considers equipment from manufacturers that might require service intervals longer than yearly; (2) if the proposed rule would require modifications to a manufacturer's recommended services for an equipment model where independent conductivity/pH testing is not applicable; and (3) on the meaning in the proposed rule of "shall test," for an equipment model for which the six month Preventative Maintenance recommendation is to only "check" the conductivity display against an external meter.

Response: HHSC revises §507.34(d) to clarify that for machines with internal independent testing, staff must verify and document that the machine conducted internal testing before each patient treatment. The requirement to test calibration every six months is to ensure patient health and safety.

Comment: An individual suggested that HHSC revise §507.34(e) to replace the term "water" with "dialysate." The individual also suggested including the bacteriological maximum and action levels in this rule.

Response: HHSC agrees with the comment and revises §507.34(e) to replace the term "water" with "dialysate" as suggested. However, HHSC declines to revise §507.34(e) to include the bacteriological maximum and action levels because the rule already requires the bacteriological levels to meet the technical standards listed in §507.30.

Comment: An individual requested that HHSC move the rule proposed in §507.35(c) to §507.31, because transducer protectors are not devices related to hemodialyzer reuse, and the requirement is more closely related to the topic of "Equipment," the title of §507.31. The individual also stated that the quarterly inspection of equipment with internal transducer protectors in §507.35(c) is an added burden and that many of the machines now require only annual maintenance.

Response: HHSC agrees and revises proposed §507.35(c) to remove the requirement for a facility to "quarterly inspect equipment with internal transducer protectors to ensure the equipment is not contaminated," and replace it in a new subsection (d) in §507.31, where HHSC also changes the frequency of inspections from "quarterly" to "annually;" and adds "If the transducer protector is wetted or fluid or blood is visible, a facility must follow instructions as described in §507.36 of this chapter (relating to Infection Control). In addition, HHSC revises proposed §507.35(c) to remove the requirement for facility staff to "replace a transducer protector when wetted during a dialysis treatment and use a transducer protector for only one treatment," and replace it in a new subsection (d) in §507.36, where HHSC also adds "If fluid or blood is visible on the side of the transducer protector that faces the machine, the machine must be opened by qualified personnel after the dialysis treatment to allow the internal transducer to be inspected for contamination, including inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port." Because HHSC removes the requirements proposed in §507.35(c), HHSC renumbers subsections (d) - (j) as subsections (c) - (i). HHSC added subsection (d) to clarify infection control standards if the transducer protector is contaminated to ensure patient health and safety.

Comment: An individual suggested that HHSC move the rule in §507.35(k) to §507.42 on patient rights because §507.35(k) relates to obtaining written informed consent for dialysis services.

Response: HHSC agrees with the comment and revises §507.35 to remove subsection (k) and add this requirement for informed consent in §507.42 as a new subsection (c). Because of this change in §507.35, HHSC renumbers subsection (l) as subsection (j).

Comment: An individual requested that HHSC add a requirement in §507.36 for signage designating clean and contaminated areas in the company's official language, as well as additional languages based on the preferred languages of facility employees.

Response: HHSC declines to revise §507.36 as requested because the rule already requires facilities to clearly designate clean and contaminated areas.

Comment: An individual requested that HHSC revise §507.36(a)(2)(B) to specify the number of sinks as one hands-free operable sink per dialysis station.

Response: HHSC declines to revise §507.36(a)(2)(B) as requested because the requirement to have one hands-free operable sink per dialysis station would be too burdensome and cost prohibitive for facilities.

Comment: DaVita recommended that HHSC remove the term "hands-free" in proposed §507.36(a)(2)(B) because many older facilities have standard sinks and having to install handsfree sinks would be financially burdensome to facilities and could be disruptive to patient care.

Response: HHSC declines to remove "hands-free" in proposed §507.36(a)(2)(B) as recommended. Currently 25 TAC §117.33(a)(1)(C)(ii), proposed for repeal, requires a sufficient number of sinks with hands-free operable controls. Therefore, sinks for handwashing with hands-free controls should not introduce a new financial burden. However, HHSC revises proposed §507.36(a)(2)(B) to remove the requirements to have enough sinks with hands-free operable controls and provisions for hand drying. HHSC revises §507.36(a)(2) to add a new subparagraph (C) as follows "Enough sinks, with water and soap shall be available to facilitate handwashing. Sink faucets shall have hands-free operable controls to activate the water flow, which may include a single-lever, wrist blade lever, electronic sensor faucet, or an elbow or wrist action faucet. Provisions for hand drying shall be included at each handwashing sink." Because HHSC added a new subparagraph (C) in §507.36(a)(2), HHSC also renumbered subparagraphs (C) - (O) as subparagraphs (D) - (P).

Comment: One individual, U.S. Renal Care, Inc., ESRD Network 14 Medical Review Board, DaVita, IRC/ARA, and Fresenius Kidney Care suggested removing the limit in proposed §507.36(a)(2)(C) to the number of times alcohol-based hand rub can be used unless hands are visibly soiled.

Response: HHSC revises proposed §507.36(a)(2)(C), renumbered as §507.36(a)(2)(D), by removing how many times staff may use a waterless antiseptic hand rub before using soap and water and replacing it with a requirement for staff to wash with soap and water when hands are visibly soiled.

Comment: DaVita stated that the requirement for sinks to be installed in locations permitting ease of access and proper use is of concern because of how older facilities were designed and built and that updating the location and arrangement of sinks would be financially burdensome for facilities to comply with and could disrupt patient care. DaVita requested that HHSC revise §507.36(a)(3) to clarify that facilities should comply to the extent possible for the layout and design of the facility.

Response: HHSC declines to revise §507.36(a)(3) as recommended because this requirement is currently in 25 TAC §117.33(a)(1)(D), proposed for repeal, and therefore, should not introduce a new financial burden and because sinks must be accessible and working properly for the health and safety of staff and patients.

Comment: U.S. Renal Care, Inc. commented that "three calendar days" proposed in §507.38(a)(5)(I)(iii), for the facility to obtain the results of the patient's Hepatitis B surface antigen (HBsAg) status, can be affected by the holiday schedules. USRC suggested that HHSC change "three calendar days" to "four calendar days" for maximum opportunity at compliance.

Response: HHSC declines to revise §507.38(a)(5)(I)(iii) as suggested because this requirement is currently in 25 TAC §117.(d)(2)(ix)(III), proposed for repeal. Because dialysis treatment may begin within three calendar days, it is crucial for patient health and safety for the facility to obtain a patient's HBsAg status within that time frame to determine if certain precautions are required prior to the patient beginning dialysis treatment.

Comment: An individual recommended that HHSC revise proposed §507.38(c)(1) to include the following "the COVID-19 vaccine shall be offered in accordance with the CDC's current immunization schedules and public health guidance, including any recommended booster doses."

Response: HHSC declines to revise §507.38 in response to this comment. HHSC will not add COVID-19 vaccination requirements to this rule because §507.38 is not intended to address all diseases. Facilities are free to require additional vaccination requirements if they wish to do so.

Comment: Texas Medical Association requested that HHSC update §507.41(g) to expressly state that advanced practice registered nurses (APRNs), physician assistants (PAs), licensed master social workers, and registered dietitians must demonstrate and sustain their necessary skills and licensures.

Response: HHSC agrees with the comment and revises §507.41(g) to add APRNs, PAs, licensed master social workers, and registered dietitians to the list of staff who must demonstrate and sustain the necessary skills and licensures.

Comment: U.S. Renal Care, Inc. and Fresenius Kidney Care requested HHSC revise §507.45(i) to align with CMS guidance and allow an ESRD to skip contacting the ESRD Network before considering involuntary discharge of a disruptive patient due to a "severe and immediate threat to the health and safety of others." The commenters requested HHSC include this as a reason a clinic may not be able to contact their ESRD Network for assistance prior to considering an involuntary discharge of a disruptive patient.

Response: HHSC declines to revise §507.45(i) as requested because the ESRD Network should be notified immediately for an involuntary discharge due to a severe or immediate threat to the health and safety of others. The requirement to provide this notice to the ESRD Network prior to considering an involuntary discharge of a disruptive patient ensures patients are treated fairly.

Comment: DaVita requested HHSC clarify whether the reporting requirements in §507.46(b)(3)(A) may be met by reporting through EMResource, a Department of State Health Services system for tracking available hospital and emergency medical services resources and other emergency response data. DaVita explained that reporting facility closures or reductions in hours to the multiple entities listed, and on various platforms, would be burdensome to clinics and not practical to comply with during an emergency.

Response: HHSC declines to revise §507.46(b)(3)(A) as requested because EMResource does not have the capability to share information with ESRD reporting systems at this time.

Comment: U.S. Renal Care, Inc. and Fresenius Kidney Care requested HHSC revise §507.47(c) to allow a sponsoring physician to countersign orders within 30 calendar days instead of within 15 calendar days.

Response: HHSC declines to revise §507.47(c) in response to this comment. It can be crucial to a dialysis patient's health and safety to have orders authenticated or countersigned by the sponsoring physician to check for accuracy because high-risk patients may require frequent monitoring and updating of orders. HHSC believes that in an ESRD facility "within 15 calendar days" provides enough time to comply with this rule.

Comment: DaVita voiced concern that the language in §507.47(j) regarding the types of anesthetics that can be administered by qualified dialysis technicians is too broad because lidocaine (subcutaneous or topical) is only one type of anesthetic, with most topicals not being lidocaine, or a combination of lidocaine and other anesthetics. DaVita suggested HHSC revise §507.47(j) by replacing the listed types of lidocaine with "lidocaine and other anesthetics (prior to cannulation)" and replacing heparin with "heparin and other anticoagulants."

Response: HHSC declines to revise §507.47(j) as suggested because the rule states that licensed nurses, PAs, or physicians must administer all medications except intravenous normal saline, intravenous heparin, subcutaneous lidocaine, topical lidocaine, and oxygen, which may be administered by qualified dialysis technicians. Using the term "other" as a category for anesthetics other than lidocaine and for anticoagulants other than heparin is too broad of a category for dialysis technicians to administer.

Comment: An individual requested HHSC revise §507.48 to decrease the ratio of dialysis technicians and nurses to patients to at least 1:2 at all times. The individual notes that this would improve proper hand hygiene, decrease patient infection risk, ensure small centers are not overextended, and allow for better patient care.

Response: HHSC declines to revise §507.48 based on this comment because the rule, as written, is sufficient protection for patient health and safety.

Comment: U.S. Renal Care and Fresenius Kidney Care thanked HHSC for adding §507.48(c) regarding the required presence of a registered nurse in the facility and situations when patients may enter the facility when a registered nurse is not present.

Response: HHSC acknowledges the comments.

Comment: U.S. Renal Care, Inc. and Fresenius Kidney Care requested that HHSC revise §507.48(d)(3) to remove "pre" from the dialysis evaluation because "pre-dialysis" indicates before the start of treatment and not within the first hour of initiation of treatment.

Response: HHSC agrees with the comment and revises §507.48(d)(3) to replace "pre-dialysis" with "dialysis." HHSC also replaced the term "evaluation" in §507.48(d)(3) with "assessment" because the subject matter in subsection (d) relates to conducting assessments.

Comment: DaVita requested that HHSC revise §507.48(d)(4) to replace "immediate" with "timely" because immediate post-dialysis assessments may not be feasible when there are abnormal findings or changes in condition. DaVita also stated that the term may cause confusion.

Response: HHSC declines to remove the term "immediate" in §507.48(d)(4) because an immediate assessment is essential for patient safety, if an abnormal finding or change of condition is identified pre-dialysis, intradialytic, or post-dialysis. However, HHSC revises §507.48(d)(4) to replace the term "immediate post-dialysis assessments" with "immediate assessments" to provide clarity and alleviate confusion.

Comment: Fresenius Kidney Care, US Renal Care, Inc., ESRD Network 14 Medical Review Board, DaVita, and IRC/ARA requested HHSC revise §507.48(j)(2) to match the staffing ratio chart in §507.60. Fresenius Kidney Care also noted that staffing flexibility helps with the nursing shortage.

Response: HHSC revises §507.48(j)(2), renumbered §507.48(j)(3), to remove the requirement for two licensed nurses for the treatment of 8-12 patients, matching Figure: 26 TAC §507.60. Additional updates in §507.48 and Figure: 26 TAC §507.60 clarify staffing requirements and ratios to help with staffing flexibilities due to nursing shortages which in part, include that the direct care staff requirement can be fulfilled by a patient care technician (PCT), registered nurse (RN), or licensed vocational nurse (LVN) as applicable.

Comment: DaVita requested HHSC revise §507.48(l) to require a facility to educate a patient on the importance of leaving their access sites uncovered only when staff observe their access site is covered, when appropriate, or as needed. DaVita stated providing and documenting the education for every treatment is burdensome.

Response: HHSC declines to revise §507.48(l) because this education is important for patient health and safety.

Comment: DaVita requested HHSC revise §507.49(d) to remove the allowance for a dietitian's designee to conduct a nutrition reassessment, aligning with CMS requirements. DaVita noted that it is unclear who would be able to complete a nutrition assessment.

Response: HHSC agrees and revises §507.49(d) to remove the allowance for a dietitian's designee to conduct a nutrition reassessment.

Comment: DaVita, ESRD Network 14 Medical Review Board, US Renal Care, Inc., IRC/ARA, and Fresenius requested HHSC keep the current ratio for dietitians in rule §507.49(e)(1) at one full-time dietitian per 125 patients because lowering the dietitian ratio to one dietitian for every 100 patients would create staffing issues particularly in rural areas.

Response: HHSC agrees and revises §507.49(e)(1) to change the maximum caseload for a full-time equivalent dietitian from 100 to 125 patients. To avoid a staffing issue, HHSC revises proposed §507.49(e)(2) to remove the requirement for a facility to have a second full time equivalent dietitian if the first dietitian's caseload is over 100, and added in §507.49(e)(1) that a facility shall employ or contract a second dietitian for a patient caseload over 125 patients. In addition, HHSC revises proposed §507.49(e)(2) to require the governing body to ensure the facility assigns personnel to assist dietitians with ancillary tasks when the patient load, including all modalities, exceeds 100 patients per facility.

Comment: DaVita appreciated HHSC for changing the requirement in proposed §507.51(c) related to documenting the first encounter with a new patient to align with CMS requirements.

Response: HHSC acknowledges the comment.

Comment: Fresenius Kidney Care and US Renal Care requested HHSC revise §507.52(b)(3) to state that more than two visits a month may be conducted by a physician and additional visits may be conducted via telemedicine. Nine individual commenters request the rule in §507.52(b)(3) be updated to one visit per month, with the option of visits being via telemedicine; and for HHSC to revise the rule in to align with federal guidelines of requiring monthly in person visits. One individual commenter suggested unstable patients should be seen more often in person and by telemedicine. Another individual commenter suggested that visit frequency be tailored to a patient's needs.

Response: In response to these comments, HHSC revises §507.52(b)(3) by removing "with visits separated by at least 10 calendar days," and adding after the requirement for a physician to see the patient at least twice a month, "The physician shall conduct the first visit in person. The second visit is required unless the patient is stable, as justified in the patient record by the physician. If the second visit is necessary, it shall be separated from the first visit by at least 10 calendar days and may be conducted in person or using telemedicine. Additional visits conducted in the same month by a physician may be conducted using telemedicine." These revisions allow the frequency of visits, after the first physician visit, to be based on a patient's needs. These revisions also give a physician the option to conduct visits, other than the first visit, using telemedicine.

Comment: One commenter suggests the rule in §507.52(b)(3) be updated to monthly check-ins complemented by weekly updates from nursing staff.

Response: HHSC declines to revise the rule in §507.52(b)(3) based on the comment because the rule, as written, is sufficient protection for patient health and safety.

Comment: DaVita requested HHSC revise §507.52(b)(4) to allow the use of telemedicine for home dialysis patients as permitted by federal regulations. ESRD Network 14 Medical Review Board requested HHSC revise §507.52(b)(4) to allow an APRN or a PA to use telemedicine for home dialysis patients. ESRD Network 14 Medical Review Board stated this change would help address transportation and geographical challenges.

Response: HHSC revises §507.52(b)(4)(A) to require a physician to see a patient in person at least once every three months if a home dialysis patient is seen by an APRN or a PA no less than once a month. HHSC also revises §507.52(b)(4)(B) to replace "The provider" with "The physician;" to add "shall conduct physician visits in person" in front of "in the dialysis facility, at the physician's office, or in the patient's home;" and to add "A physician may conduct additional visits in the same month using telemedicine." HHSC revises §507.52(b)(4) by adding a new subparagraph (C) to add "An APRN or a PA may conduct visits using telemedicine." Because of adding a new subparagraph (C), HHSC revises proposed §507.52(b)(4)(C) to renumber it as §507.52(b)(4)(D).

Comment: DaVita requested HHSC revise §507.52(c)(6)(A) by replacing "jointly developed by" with "reviewed and approved by."

Response: HHSC declines to revise the rule in response to this comment because §507.52(c)(6)(A) contains "reviewed and approved by."

Comment: Fresenius Kidney Care and U.S. Renal Care Inc. requested HHSC revise §507.52(e) to incorporate dieticians and social work students.

Response: HHSC declines to revise §507.52(e) in response to this comment because the rule is specific to clinical students providing medical services to patients.

Comment: ESRD Network 14 Medical Review Board and DaVita requested HHSC revise §507.52(e)(1) to clarify that the instructor does not need to be on the premises because a qualified dialysis nurse may provide appropriate guidance and supervision.

Response: HHSC revises §507.52(e)(1) to clarify the instructor must be "on the premises" and provide "direct supervision to the student." Direct supervision as defined by §507.2(74)(B) requires the supervisor, in this case the instructor, to be in the facility but not necessarily immediately present where the task or activity is being performed. Additionally, HHSC revises §507.52(e)(2)(B) to change "direct supervision" to "immediate supervision" because an RN on staff at the facility must be immediately present if a student administers medications.

Comment: Fresenius Kidney Care and U.S. Renal Care, Inc. requested HHSC revise §507.53(b) to remove the requirement for a separate room for home dialysis services to align with CMS, increase access in rural areas, and allow for group training with patient consent.

Response: HHSC declines to revise 507.53(b) as requested because a separate room is necessary for patient privacy and for training based on patient's preference and individual needs as stated in 507.53(c). However, HHSC revises §507.53(b) to note that home dialysis services are defined in §507.2 of this chapter (relating to Definitions) to add clarity to the rule.

Comment: Fresenius Kidney Care ESRD Network 14 Medical Review Board, DaVita, and US Renal Care, Inc. requested HHSC revise proposed §507.53(c) to allow an exception for single use machines to be assigned to multiple home dialysis patients when patients are in a skilled nursing facility or transitional care unit.

Response: HHSC declines to revise proposed §507.53(c), renumbered as §507.53(d), which requires the facility to assign each individual home dialysis patient, regardless of modality, one machine for the patient's exclusive use in the home, and prohibits the facility from assigning multiple home dialysis patients to the same machine. Home dialysis service is currently defined in this chapter as dialysis performed at home by an end stage renal disease patient or the patient's caregiver. It would be an infection risk for home dialysis patients to share a dialysis machine.

Comment: An individual asked if §507.53(c) applied to long-term care settings.

Response: HHSC acknowledges the comment, however, "home dialysis service" is defined in §507.2 as dialysis performed at home by an end stage renal disease patient or the patient's caregiver. 26 TAC Chapter 507 does not address long-term care settings.

Comment: DaVita requested HHSC clarify the meaning of "or portion thereof" in §507.53(d). DaVita also requested HHSC revise §507.53(d) to increase nurse staffing flexibility by allowing an licensed vocational nurse or patient care technician to provide support and serve as a bridge to a second registered nurse when there are between 21 and 25 patients.

Response: HHSC revises §507.53(d), renumbered as §507.53(e), to clarify the meaning by removing "or portion thereof" and replacing it with "for every group of." HHSC revises renumbered §507.53(e) to increase the ratio of 20 patients to 25 patients for one full-time equivalent registered nurse and to add that "For 21 - 25 patients, the facility shall assign a licensed vocational nurse or a dialysis technician to assist the registered nurse."

Comment: DaVita is seeking clarification on the requirement in §507.53(e)(3), specifically, what evidence or documentation (check list, competency evaluation, etc.) will be required to show that competency was reassessed.

Response: HHSC revises §507.53(e)(3), renumbered as §507.53(f)(3), to remove "reassess" and replace it with "document" to show the nurse's competency to provide home dialysis three months after passing the initial competency exam. The facility is not limited to any particular type of documentation to show competency.

Comment: DaVita requested HHSC revise §507.53(g) to align with CMS and allow a home visit at the initiation of home therapy, instead of before beginning training.

Response: HHSC declines to revise §507.53(g), renumbered as §507.53(h), in response to this comment because identifying whether the patient's home is appropriate for home dialysis before beginning training avoids wasting patient time and resources.

Comment: DaVita and ESRD Network 14 Medical Review Board requested HHSC revise §507.53(g) to allow an exception for urgent starts and allow the home visit to be conducted via audio-visual means to prevent central venous catheter placement.

Response: HHSC declines to revise §507.53(g), renumbered as §507.53(h), in response to this comment because the facility must complete a home visit even in case of urgent start peritoneal dialysis to ensure patient health and safety.

Comment: DaVita requested HHSC revise §507.53(h) to clarify that a facility team should make a reasonable attempt to retrieve self-monitoring data because retrieving complete self-monitoring data may not always be possible due patient compliance issues.

Response: HHSC agrees and revises §507.53 by adding in a new subsection (j), "If a facility is unable to obtain a patient's self-monitoring data after an appropriate number of attempts, the physician shall refer the case to the medical director for a determination about a potential modality change for the patient." The revision is needed so that when a facility cannot obtain the patient's self-monitoring data after an appropriate number of attempts, the physician may refer the case to the medical director to determine whether a modality change is appropriate for the patient. Because of this revision in §507.53, HHSC also renumbered subsections (i) - (s) as (k) - (u).

Comment: U.S. Renal Care, Inc. and Fresenius requested HHSC revise proposed §507.53(j)(1) to exempt initial monitoring home visits when urgent peritoneal dialysis begins in the hospital.

Response: HHSC declines to revise proposed §507.53(j)(1), renumbered as subsection (l)(1), in response to this comment. The facility must complete this initial monitoring home visit to ensure patient health and safety even when urgent peritoneal dialysis begins in the hospital.

Comment: U.S. Renal Care, Inc. and Fresenius Kidney Care requested HHSC clarify whether proposed §507.53(j)(3)(A) allows for two visits within three months to be conducted via telemedicine when an APRN or a PA sees a patient monthly when medically appropriate and the patient consents. DaVita and ESRD Network 14 Medical Review Board requested HHSC revise proposed §507.53(j)(3)(A) to allow for two visits within three months to be conducted via telemedicine when an APRN or a PA sees a patient monthly.

Response: HHSC revises proposed §507.53(j)(3), renumbered as subsection (l)(3), by adding "in accordance with §507.52(b)(4) of this subchapter (relating to Medical Services)." This change is made because the requirement in renumbered subsection (l)(3), for a patient to be seen by a physician, an APRN, or a PA, is the same as in the revisions HHSC made in §507.52(b)(4). HHSC also removes proposed subparagraphs (A) and (B) in renumbered subsection (l)(3) because the reference added makes them unnecessary to include. In addition, HHSC made editorial changes to refer to "a physician" instead of "prescribing physician" and to refer to "the patient" as "a home dialysis patient" to use consistent terminology.

Comment: An individual requested HHSC revise proposed §507.53(k)(3) to remove the reference to chloramines testing.

Response: HHSC revises proposed §507.53(k)(3), renumbered as subsection (m)(3) to remove the reference to chloramine testing and only refer to total chlorine testing.

Comment: U.S. Renal Care, Inc. and Fresenius Kidney Care requested HHSC revise proposed §507.53(p) to allow the patient or caregiver to culture and measure home patient hemodialysis machines with facility oversight.

Response: HHSC revises proposed §507.53(p), renumbered as subsection (r), to allow the patient or the patient's caregiver with facility oversight to do the testing.

Comment: An individual requested HHSC revise proposed §507.53(p) to require quarterly culture and endotoxin testing to align the rule with CMS.

Response: HHSC revises 507.53(p), renumbered as subsection (r), to require testing at least quarterly or more frequently as needed or required by the standards listed in §507.30 of this subchapter.

Comment: An individual requested HHSC revise §507.53(s)(1)(C) to remove the reference to chloramines testing and require that testing results align with the technical standards.

Response: HHSC agrees with the comment and revises §507.53(s)(1)(C), renumbered as subsection (u)(1)(C), to remove the reference to chloramine testing and only refer to total chlorine testing; and to add a reference to the technical standards in §507.30.

Comment: DaVita requested HHSC revise §507.53(s)(1)(C) to allow a caregiver to document water testing results.

Response: HHSC agrees with the comment and revises §507.53(s)(1)(C), renumbered as subsection (u)(1)(C), to allow the patient's caregiver to document the total chlorine level by adding "or the patient's caregiver."

Comment: U.S. Renal Care, Inc. and Fresenius Kidney Care requested HHSC revise §507.53(s)(1)(D) to allow the patient or caregiver to obtain the microbiological quality of the dialysate with facility oversight.

Response: HHSC agrees with the comment and revises §507.53(s)(1)(D), renumbered as subsection (u)(1)(D), to allow the patient or the patient's caregiver with facility oversite to obtain the microbiological quality of the dialysate.

Comment: One individual, U.S. Renal Care, Inc., Fresenius Kidney Care, ESRD Network 14 Medical Review Board, and DaVita requested HHSC revise §507.54(a)(2) to reduce the patient care technician certification period from 24 months to 18 months to align with CMS. IRC/ARA asked HHSC to provide rationale for extending the patient care technician certification period to 24 months, which exceeds CMS's 18-month requirement.

Response: HHSC agrees with the comment and revises §507.54(a)(2) to change the requirement for all dialysis technicians to receive certification within 18 months rather than the proposed 24 months, which aligns with CMS requirements.

Comment: DaVita objected to §507.54(b), which requires a facility administrator to have at least one year of experience in a healthcare facility because it makes hiring more difficult and facilities already have qualified medical directors and supervising nurses.

Response: HHSC agrees with the comment and removes subsection §507.54(b), which was burdensome for facilities. Because of this change, HHSC also renumbered subsections (c) - (g) as (b) - (f).

Comment: An individual requested HHSC add a rule to §507.54(c) to require at least five hours of annual ESRD-specific continuing education for physicians, APRNs, and PAs.

Response: HHSC declines to revise §507.54(c), renumbered as subsection (b), because the licensing boards for these professions already specify minimum requirements for continuing education to ensure patient health and safety, and a facility may provide and require additional staff trainings as needed.

Comment: U.S. Renal Care, Inc. and Fresenius Kidney Care thanked HHSC for the rule proposed in §507.54(d)(2)(A), which allows a newly licensed registered nurse's last six months of clinical experience to run concurrently with six months of dialysis experience.

Response: HHSC acknowledges these comments related to proposed §507.54(d)(2)(A), renumbered as §507.54(c)(2)(A).

Comment: DaVita appreciated HHSC aligning proposed §507.54(d)(4) with §507.52(e)(1) but requested HHSC revise §507.54(d)(4) to use the term "self-care training" for clarity and consistency and require a registered nurse to have at least three months experience with the self-care training modality rather than six months.

Response: HHSC declines to revise proposed §507.54(d)(4), renumbered as subsection (c)(4), related to the experience of a registered nurse because the rule as proposed requires the registered nurse to have "three months experience in the specific modality," not six months. HHSC agrees to use the term "self-care training" and revises renumbered subsection (d)(4) and (5) to use "self-care training" to replace "training" as needed. HHSC revises renumbered subsection (c)(4) to clarify that the patient self-care training a facility provides by a qualified registered nurse is "either in-center or at home." In addition, HHSC revises renumbered subsection (c)(4) to remove the requirement for supervision by the qualified registered nurse when other facility staff assist in the training and add this requirement in renumbered subsection (c)(5) for the qualified registered nurse to supervise the self-care training when other facility staff assist in the self-care training in-center. These revisions to use consistent terminology are necessary to promote the clarity of these rules.

Comment: DaVita recommended a change to proposed §507.54(d)(4), to allow a qualified charge nurse with preceptor experience (one year experience in hemodialysis obtained within the last 24 months) to provide self-care training in-center.

Response: HHSC declines to revise §507.54(d)(4), renumbered as subsection (c)(4), because having three months experience in the specific modality ensures patient health and safety. The rule allows for other qualified facility staff to assist under the supervision of a qualified registered nurse.

Comment: U.S. Renal Care, Inc. asked whether the nursing peer review committee required under §507.54(d)(6) can be on a regional or national level. Fresenius Kidney Care asked HHSC to clarify Texas Occupations Code Chapter 303 with regard to other health care facilities and asked if dialysis facilities are only required to establish a nursing peer review committee if they have more than 8 nurses.

Response: Section 507.54(d)(6), renumbered subsection (c)(6), requires a facility to establish a nursing peer review committee to conduct nursing peer review, as required by Texas Occupations Code Chapter 303. HHSC does not provide interpretation or clarification on this statute. HHSC declines to revise the rule in response to these comments.

Comment: An individual requested HHSC revise proposed §507.54(f)(2) to remove the reference to a transplantation program before September 1, 1976.

Response: HHSC declines to revise §507.54(f)(2), renumbered subsection (e)(2), in response to this comment because it aligns with the CMS CfCs.

Comment: U.S. Renal Care, Inc. and Fresenius Kidney Care asked why HHSC added §507.54(g)(2) requiring written physician standing orders authorizing delegation of biomedical technical staff responsibilities.

Response: HHSC revises §507.54(g)(2), renumbered as subsection (f)(2), to remove this requirement in paragraph (2). Upon further review, HHSC determined that this requirement is not necessary to comply with physician delegation requirements as set out elsewhere in statute, which the original requirement sought to address. Because HHSC removes paragraph (2) from renumbered subsection (f), HHSC renumbers paragraphs (3) - (7) as paragraphs (2) - (6) and updates references to the renumbered paragraphs where needed.

Comment: Fresenius Kidney Care requested HHSC clarify whether the word "or" in §507.54(g)(3)(A)(ii)(III) means only one item from the list is needed as minimum education or training for technical staff. DaVita requested HHSC revise §507.54(g)(3)(A)(ii) to allow technical staff to meet "one or more" of the listed requirements and notes it would be difficult to hire and retain staff that meet all the requirements.

Response: The use of "or" in §507.54(g)(3)(A)(ii), renumbered as subsection (f)(2)(A)(ii), means any single item in renumbered subsection (2)(A)(ii)(I) - (IV) can satisfy this training or experience requirement for technical staff. Also, renumbered subsection (f)(2)(A)(ii) does not limit the number of the listed requirements a technician can obtain. Therefore, HHSC revises renumbered subsection (f)(2)(A)(ii) to add "in one or more of the following" as requested to make it clear that staff do not need to meet all of the training or experience requirements listed in the rule. HHSC also revises renumbered subsection (f)(2)(A)(ii) to remove "including at least," because it is not necessary to use this phrase in the rule.

Comment: DaVita requested HHSC clarify §507.55(a)(8)(C) and state what evidence or documentation will be required to show the facility explained consent, rights, and responsibilities to the patient.

Response: HHSC revises §507.55(a)(8)(C) to add "when a patient requires an accommodation," to clarify this is when a clinical record must include details on how staff explained consent forms for treatment to the patient.

Comment: An individual noted that the list of reportable incidents in §507.56(a) does not include death of a patient and hospital transfers and suggested that if hospital transfers were reportable before an incident in Lufkin in 2012 related to multiple patient deaths, patient lives may have been saved.

Response: HHSC notes the ESRD rules at the time of the Lufkin incident required facilities to report hospital transfers. HHSC revises §507.56(a) to add the following reportable incidents back into the rule: new paragraph (1) death of a dialysis patient that occurs in the facility; new paragraph (2) death of a dialysis patient that occurs within 24 hours after the last dialysis treatment; and new paragraph (3) emergent hospital transfers from the dialysis facility. Because of adding new paragraphs (1) - (3), HHSC renumbered the paragraphs proposed as paragraphs (1) - (4) as paragraphs (4) - (7). To correct formatting errors, HHSC replaces a period at the end of renumbered paragraph (4) to replace it with a semicolon and also removes "and" between renumbered paragraphs (6) and (7) to replace it with "or." The reason to use "or" is that it means any one of these incidents in §507.56(a) can be met for the rule to apply and for the required action to be taken.

Comment: U.S. Renal Care, Inc. and Fresenius Kidney Care requested HHSC update the HHSC Complaint and Incident Intake online portal to remove the fields for perpetrator and social security number.

Response: HHSC acknowledges the comment and notes such an update does not require any changes to the proposed rules.

Comment: DaVita requested HHSC engage with stakeholders to review the incident report form before requiring facilities to use it.

Response: HHSC acknowledges the comment.

Comment: DaVita requested HHSC clarify whether "self-care" in §507.57(a) applies to all modalities.

Response: HHSC revises §507.57(a) to clarify the rule applies to in-center self-care modality.

Comment: Fresenius Kidney Care requested HHSC revise §507.59(c) to allow telemedicine for the required monthly physician visit during a public health disaster.

Response: HHSC declines to revise §507.59(c) as requested. Upon review of the "notwithstanding" clause in §507.59(c), and because of the revisions HHSC is making in §507.52(b)(3), described previously in this section of the preamble, HHSC changes the reference in the "notwithstanding" clause from "§507.52" to "§507.52(b)(3)." This change helps facilities locate the exceptions to §507.52(b)(3) that may be applied during a public health disaster, for example, the requirement for a physician on the facility's medical staff to see the patient at least twice a month.

Comment: Fresenius Kidney Care requested for HHSC to clarify whether §507.59(f) includes annual home visits.

Response: Proposed §507.59(f) relates to conducting a home dialysis patient visit required by §507.53 using telemedicine medical services during a public health disaster. HHSC is making additional revisions to §507.59, including removing proposed subsection (f).

Comment: Texas Nurses Association commented that they support §507.71 through §507.75 and that these rules are sufficient to ensure dialysis technicians have adequate knowledge to ensure patient safety when initiating or discontinuing dialysis via central venous catheter (CVC) or manipulating the CVC.

Response: HHSC acknowledges the comment.

Comment: An individual expressed support for §507.72 through §507.75 which allow dialysis technicians to access CVCs because it allows nurses to have more capacity to focus on their nursing duties, perform better patient care, and results in no difference in infection rates.

Response: HHSC acknowledges the comment.

Comment: An individual thanked HHSC for allowing certified clinical hemodialysis technicians to assist with catheter care and improving nurse to patient staffing ratios.

Response: HHSC acknowledges the comment.

Comment: The Texas Medical Association recommended that HHSC maintain the requirements in §507.71(d) and §507.71(e) regarding delegation and supervision of dialysis technicians when initiating or discontinuing dialysis via CVC or manipulating a CVC, as well as required certification, training, and competency to promote patient safety.

Response: HHSC acknowledges the comment.

Comment: Fresenius Kidney Care and U.S. Renal Care, Inc. request HHSC revise §507.71(e)(1) to allow dialysis technicians to initiate or discontinue dialysis via CVC or manipulate a CVC prior to being nationally certified if they are under direct supervision.

Response: HHSC declines to revise §507.71(e)(1) as requested because it is crucial for patient health and safety that a dialysis technician is certified before being allowed to initiate or discontinue dialysis via a CVC or manipulating a CVC.

Comment: DaVita requested that HHSC make the references to "lidocaine" and "heparin" in §507.72(c)(2) and §507.73(e) consistent with the references in §507.47(j).

Response: HHSC agrees that the references to these medications in §507.72(c)(2) and §507.73(e), for the training and competency evaluation for a dialysis technician or trainee to administer "lidocaine" and "heparin," need to be consistent with the references used in §507.47(j). In addition, the reference to "normal saline" in §507.72(c)(2) and §507.73(e) needs to be consistent with §507.47(j). Therefore, HHSC revises §507.72(c)(2) and §507.73(e) to use "intravenous" normal saline, "intravenous" heparin, "subcutaneous" lidocaine, and "topical" lidocaine.

Comment: An individual asked if required training content on potential complications included prevention of air embolism and requested HHSC revise §507.72(c)(3) to require training content to include prevention of air embolism because air embolisms can result in patient death.

Response: HHSC declines to revise §507.72(c)(3) because the rule already includes "materials used and prevention of complications" and the training content must include prevention of air embolism. Facilities are responsible for ensuring staff are adequately trained within the parameters provided in §507.72(c)(3).

Comment: DaVita suggested HHSC revise §507.73(e) to make terminology for "lidocaine" and "heparin" consistent with §507.47(j) and §507.72(c)(2).

Response: HHSC agrees that the references to "heparin" and "lidocaine" in §507.72(c)(2) related to the training for dialysis technicians should be consistent with the requirements in §507.47(j) for dialysis technicians to administer these medications as part of a routine hemodialysis treatment. Therefore, HHSC revises §507.72(c)(2) to refer to " intravenous heparin, "subcutaneous lidocaine," and "topical lidocaine" instead of "heparin" and "lidocaine." HHSC declines to use the term "other" because this category is broad and may include drugs that HHSC does not approve for this use. HHSC may amend the rules in the future to add any new anesthetics that become standard for this use.

Comment: DaVita expressed appreciation to HHSC for modifying the requirements in §507.75 to allow for dialysis technicians to perform CVC care to patients under the supervision of a registered nurse.

Response: HHSC acknowledges the comment.

Comment: DaVita disagreed with the inclusion of "listen to" in the list of prohibited activities in §507.81(a)(1) because in many instances it is necessary and appropriate to have a facility representative present during an HHSC interview with staff or patients.

Response: HHSC declines to revise §507.81(a)(1) based on this comment because the rule allows a facility to inform HHSC and record or listen to an HHSC internal discussion if it obtains approval.

Comment: DaVita disagreed with §507.81(d), which states that section does not prohibit staff, patients, or others being interviewed from recording an interview with HHSC. DaVita stated that recording the interview should at least be subject to permission from the facility representative.

Response: HHSC declines to revise §507.81(d) based on this comment because under the state law regarding one-party consent, HHSC cannot prevent a party to the conversation from recording an interview.

Comment: An individual requested that resources should be allocated by HHSC to randomly check facilities for compliance. The individual requested that HHSC edit §507.82 to require ESRDs to comply with these random checks.

Response: HHSC declines to revise §507.82(b) because the rule already requires compliance with any inspection as stated in §507.82(e) and HHSC has authority to conduct inspections at its discretion.

Comment: DaVita disagreed with the addition of video surveillance in §507.82(e) to the items HHSC may examine upon a facility inspection as such broad access by HHSC may lead to privacy concerns and impact the facility's ability to comply with federal patient privacy laws.

Response: HHSC declines to revise the rule because it is necessary to verify a facility's compliance with applicable laws and rules and because Texas Health and Safety Code §251.051(a) authorizes HHSC to conduct an inspection to verify a facility's compliance.

Comment: DaVita opposed the elimination of the appeal process for challenging deficiencies identified during inspection in §507.82(e), previously §117.18(c)(4)(C)(vi)(I), which is proposed for repeal. They also opposed the removal of the language that a "signature does not indicate the administrators or designees agreement with deficiencies stated on the form."

Response: HHSC declines to revise §507.82(e), previously §117.18(c)(4)(C)(vi)(I), based on this comment because the rule in §507.82(j), requires the HHSC representative to hold an exit conference with the facility representative at an inspection's or investigation's conclusion and inform the facility representative of any preliminary inspection or investigation findings, which is consistent with current practice.

Comment: DaVita disagreed with the requirement in §507.82(f) that members of the governing body or personnel be required to submit a written statement to HHSC and recommend it be limited to topics that are not already addressed through the governing body minutes and related documentation.

Response: HHSC declines to revise §507.82(f) based on this comment because it is important for HHSC staff to have the opportunity to talk to and request statements from relevant individuals, including, at times, members of a facility's governing body. HHSC notes this subsection does not require a written statement and only allows HHSC the opportunity to request one.

Comment: DaVita requested clarification in §507.83 on which accreditation organizations are allowed to do complaint investigations. DaVita asked HHSC to add which accreditation organizations may conduct complaint investigations.

Response: HHSC declines to revise §507.83 as requested because the rule accurately states HHSC investigates complaints directed to HHSC against a facility. Any complaints investigated by accreditation organizations are outside the scope of the rules in 26 TAC Chapter 507.

Comment: One commenter thanked HHSC for adding "within the past two years" to the requirement in §507.87(c)(5)(A).

Response: HHSC acknowledges this comment.

Comment: DaVita requests HHSC clarify §507.90 to outline specifically which employees the rule applies to, which types of actions are grounds for revocation, and an option for avoiding a penalty if the facility takes appropriate action against the employee.

Response: HHSC declines to revise §507.90 because the rule, as written, applies to the facility or any of its employees and outlines the actions that may be grounds for revocation. HHSC declines to add an option for avoiding a penalty because the facility may show compliance as part of due process in any action under the Administrative Procedure Act.

HHSC revises §507.2(1) to spell out what "ESRD" means when used in the definition of "action level."

HHSC revises §507.2(9) to replace federal holiday with national holiday and add "listed in Texas Government Code §662.003" to define business day.

HHSC revises the definition in §507.2(22) of "dialysate supply system" to remove "for the characteristics listed above" and replace it with "devices" as used in this definition" in front of the list of devices this term includes. The revisions change "system" to "dialysate supply system" to clarify the name of this device and changes the punctuation between the list of devices to improve readability and understanding.

HHSC revises §507.11(a) to differentiate between the "home dialysis services" provided under 26 TAC Chapter 507 by an ESRD facility and the home dialysis services provided by a HCSSA under 26 TAC Chapter 558.

HHSC revises §507.12(a)(4) to remove subparagraph (B) because it is not necessary for the application process for the applicant to attend an additional prelicensure conference when there is a change in the supervising nurse before the facility opens. HHSC further revises §507.12(a)(4) to remove "(A)" to update the formatting of the rule because of removing subparagraph (B). HHSC revises §507.12(e) to clarify that the application HHSC receives is the "license" application.

HHSC revises §507.13(h) to change that HHSC may "consider the renewal application as withdrawn" to may "deny the license" if the facility does not correct a deficiency in the renewal application within the timeframe specified in the rule. Because of this change, HHSC also revises §507.13(h) to change that any license fee paid is nonrefundable because the renewal application is withdrawn if HHSC denies the license. Changes to the rule clarify the current process HHSC follows.

HHSC changed the processing time for change of ownership applications in §507.14(a)(3) from five to ten calendar days to align with other facility change of ownership rules.

HHSC removed §507.14(c) because it is redundant with §507.14(a)(6), renumbered as (a)(5). Due to this change, HHSC renumbered subsections (d) and (e) as subsections (c) and (d).

HHSC revises §507.14(e), renumbered as §507.14(d), to align with §507.12(h) by replacing "during the initial licensing period" with "Within the first two years of licensure."

HHSC revises §507.15(c) to change "revised license" to "new license" because HHSC issues a new license after approval of a relocation.

HHSC revises §507.16(a)(4) to refer to "an ESRD license" to replace "a different license."

HHSC revises §507.17 to add a new paragraph (7) to describe the current facility requirements and process followed, if the facility does not resume patient services within 10 calendar days after the date the facility's license is placed on inactive status.

HHSC revises §507.21 to remove subsection (d) because it is redundant with §507.21(c) on how to submit a request for an exception. The remaining sections (e) - (h) were renumbered (d) - (g).

HSC revises §507.30 by removing "all applicable technical standards, including those listed below" and replacing it with "the following technical standards" that ESRD facilities must comply with.

HHSC revises §507.33(8)(D)(ii) to change "in the event of free chlorine or chloramine breaking through the first bed" to "in the event of total chlorine (the sum of free chlorine and chloramine) breaking through the first bed." This change to use "total chlorine" is consistent with the revisions HHSC is making in §507.33(8)(D)(iii), (iv), (vii), and (ix).

HHSC revises §507.33(8)(D)(v) to clarify that an automated chlorine monitoring system will provide "the equivalent frequencies of testing as required in clause (iv) of this subparagraph" instead of "the equivalent frequencies of monitoring as defined above."

HHSC revises §507.33(19)(D) to replace "units/millimeter" with "units/milliliter" to correct the meaning of the acronym "ml" in (CFU/ml).

HHSC revises §507.34(l)(4) and (l)(5)(C) to remove "are above the action level" and replace this with "comply with §507.30 of this subchapter," the Technical Standards section in 26 TAC Chapter 507.

HHSC revises §507.36(a)(2)(C) to remove "warm" from the water requirement for hand washing as it is no longer required.

HHSC adds §507.36(g) due to health and safety to replace a transducer protecter when wet and check for contamination if fluid or blood is visible.

HHSC revises §507.38(a)(4)(A) to change "must maintain" to "shall maintain" to use "shall" as construed by Texas Government Code §311.016.

HHSC revises §507.42 by adding subsection (d) prohibiting discrimination based on a patient's disability and requiring compliance with Texas Health and Safety Code Chapter 161, Subchapter S (relating to Allocation of Kidneys and Other Organs Available for Transplant) as found in 25 TAC §117.49, proposed for repeal.

HHSC revises §507.51(e)(1) by adding "The caseload is cumulative across all modalities and facilities where the dietitian is employed." This change clarifies the caseload requirement.

HHSC revises §507.51(e)(2) to remove "The maximum patient load is 125 patient per full time equivalent qualified social worker with assigned personnel assistance, including all modalities" because it was duplicative of the rule in §507.51(e)(1).

HHSC revises §507.53(b)(1) to remove "warm" from the water requirement for hand washing as it is no longer required.

HHSC revises §507.53(j)(3), renumbered as §507.53(l)(3), to add a reference to the revisions HHSC is making in §507.52(b)(4), related to medical services for home dialysis patients. HHSC also revises renumbered §507.53(l)(3) to remove subparagraphs (A) and (B). These changes avoid repeating the same rules in both sections.

HHSC revises §507.53(p), renumbered as §507.53(r), to remove "as they may not require disinfection, culture, and measurement for colony forming units and endotoxins." This change removes redundant manufacturing recommendation topics.

HHSC revises §507.54(d)(4), renumbered as §507.54(c)(4), to replace "family" with "caregiver" to use consistent terminology. HHSC also revises renumbered §507.54(c)(4) to remove "When other personnel assist in the training, the qualified registered nurse shall supervise the training," to move this requirement to §507.54(c)(5) for organizational purposes.

HHSC revises §507.54(d)(5), renumbered as §507.54(c)(5), to replace "personnel" with "facility staff" to use consistent terminology.

HHSC revises §507.59(d) for consistency with §507.59(c) by adding a "notwithstanding" clause that references the revisions HHSC is making in §507.52(b)(4) for home dialysis patients to be seen by a physician, an APRN, or a PA in the absence of a public health disaster. HHSC revises §507.59(d) to add "The visit by a physician, an APRN, or a PA may be conducted using telemedicine medical services." HHSC revises §507.59(d) to remove paragraphs (1) - (3) proposed in §507.59(d) because these are the same requirements in §507.52(b)(4) that apply in the absence of a public health disaster. HHSC revises §507.59(e) to change the reference in the "notwithstanding" clause from "§507.53" to "§507.53(l)(1)" for a registered nurse to conduct an initial monitoring visit of a patient's home adaptation before the home dialysis patient begins training. This change helps facilities locate the exceptions to §507.53(l)(1) that may be applied during a public health disaster. HHSC also revises §507.59 to remove subsection (f) because this exception during a public health disaster is covered by the revisions in §507.59(d).

HHSC revises §507.72(c)(1) - (c)(3) to refer to "the facility's training curricula" for consistency and clarification.

HHSC revises §507.73(e)(2) and (4) to remove "or other prescribed anticoagulants" and "other anesthetics," respectively, because the list of these medications in subsection (e) that dialysis technician trainees will be cannulating dialysis access and administering are limited to intravenous heparin, subcutaneous lidocaine, and topical lidocaine.

HHSC revises §507.73(f)(6) to remove "or other prescribed anticoagulants" because the anticoagulant dialysis technician trainees will be initiating or discontinuing is limited to intravenous heparin.

HHSC revises §507.73(g) and §507.75(4) for consistency with the revisions HHSC is making in §507.72(c)(2) and §507.73(e) to use intravenous normal saline, intravenous heparin, subcutaneous lidocaine, and topical lidocaine. HHSC also revises §507.73(g) and §507.75(4) to remove "or other anesthetics" because this broad category of anesthetics cannot be used in these rules.

HHSC revises §507.90(d)(2)(G)(ii) to remove the reference to Texas Penal Code Title 5 because Title 5 is already listed in §507.90(d)(2)(F). HHSC also revises §507.90(d)(2)(G) to renumber clauses (iii) - (vii) as clauses (ii) - (vi).

SUBCHAPTER A. GENERAL PROVISIONS

STATUTORY AUTHORITY

The new rules are adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system; Texas Health and Safety Code §251.003, which requires HHSC to adopt rules for the issuance, renewal, denial, suspension, and revocation of a license to operate an end stage renal disease facility; and Texas Health and Safety Code §251.014, which requires these rules to include minimum standards to protect the health and safety of a patient of an end stage renal disease facility.

§507.2. Definitions.

The following words and terms when used in this chapter have the following meanings, unless the context clearly indicates otherwise.

(1) Action level--The point at which end stage renal disease (ESRD) facility staff shall take steps to interrupt the trend towards unacceptable levels.

(2) Administrator--An individual responsible for implementation and proper application of policies, programs, and services established for the ESRD facility.

(3) Advanced practice registered nurse (APRN)--A registered nurse authorized by the Texas Board of Nursing to practice as an advanced practice registered nurse in Texas. The term includes a nurse practitioner and clinical nurse specialist. The term is synonymous with "advanced nurse practitioner" and "advanced practice nurse."

(4) Adverse event--An event that results in unintended harm to the patient because of an act of commission or omission by the ESRD facility or ESRD facility staff rather than by the patient's underlying disease or condition or those events affecting patient's family members, visitors, or staff.

(5) Applicant--The person who seeks an ESRD facility license from the Texas Health and Human Services Commission (HHSC) and is legally responsible for the ESRD facility's operation, whether by lease or ownership.

(6) Architectural inspection--An inspection HHSC conducts to ensure compliance with all applicable federal and state regulations relating to the ESRD facility physical plant and to verify project construction aligns with submitted contract construction documents.

(7) Audio-only telecommunication--An interactive, two-way audio communication that uses only sound and that meets the privacy requirements of the federal Health Insurance Portability and Accountability Act. Audio-only includes the use of telephonic communication.

(8) Biofilm--A coating on surfaces consisting of microcolonies of bacteria embedded in a protective extracellular matrix. The matrix, a slimy material secreted by the cells, protects the bacteria from antibiotics and disinfectants.

(9) Business day--Any weekday from Monday through Friday that is not a state or national holiday listed in Texas Government Code §662.003.

(10) Calendar day--All days, including weekends and holidays.

(11) Caregiver--A person trained, qualified, and competent in using a device for the selected modality prescribed to the patient.

(12) Charge nurse--A practicing licensed registered nurse in accordance with applicable provisions of law who is responsible for making daily staff assignments based on patient needs, providing immediate supervision and support of patient care, monitoring patients for changes in condition, and communicating with the physician, dietitian, and social worker regarding patient needs.

(13) Closed system--A dialysis system for hemodialysis or peritoneal dialysis, that uses sterile manufactured bagged dialysate or dialysate solution.

(14) CMS--Centers for Medicare and Medicaid Services.

(15) Competency--Demonstrated ability to carry out specified tasks or activities with reasonable skill and safety that adheres to the prevailing standard of practice.

(16) Conditions for Coverage (CfCs)--The minimum health and safety rules that all Medicare and Medicaid participating ESRD facilities must meet. The basic health and safety requirements that an ESRD facility must meet to receive payment from the Medicare program.

(17) Conventional dialysis system--The ESRD facility's water treatment components and single pass dialysis machines.

(18) Core staff members--The ESRD facility's medical director, supervising nurse, dietitian, social worker, administrator, and approved biomedical representative.

(19) Corrective action plan--An alternative to enforcement action, as outlined in Texas Health and Safety Code §251.061 (relating to Corrective Action Plan).

(20) Delegation--Transfer of the authority to perform a selected task or activity in a selected situation to a qualified and properly trained individual.

(21) Dialysate--An aqueous fluid made from water and concentrate, containing electrolytes and usually dextrose that exchanges solutes with blood during hemodialysis that is delivered to the dialyzer by the dialysate supply system. This term does not include peritoneal dialysis fluid.

(22) Dialysate supply system--Devices that prepare dialysate on line from water and concentrates, or store and distribute premixed dialysate; circulate the dialysate through the dialyzer; monitor the dialysate for temperature, conductivity, pressure, flow, and blood leaks; and prevent dialysis during disinfection or cleaning modes. The term "devices" as used in this definition includes reservoirs; conduits; proportioning devices for the dialysate; monitors and associated alarms; and controls assembled as a dialysate supply system. The dialysate supply system is often an integral part of single patient dialysis machines.

(23) Dialysis--A process to remove dissolved substances from a patient's body by diffusion, osmosis, and convection (ultrafiltration) from one fluid compartment to another across a semipermeable membrane.

(24) Dialysis technician--An individual who is not a registered nurse or physician and provides dialysis care under the supervision of a registered nurse or physician. This individual may also be known as a Patient Care Technician (PCT) or Certified Clinical Hemodialysis Technician (CCHT).

(25) Dietitian--An individual who:

(A) is currently licensed by the Texas Department of Licensing and Regulation under the laws of this state as a licensed dietitian;

(B) is a registered dietitian; and

(C) has one year of experience in clinical dietetics after becoming a registered dietitian.

(26) Direct care staff--Staff who provide hands-on dialysis care to specifically assigned patients during their dialysis treatment (e.g., registered nurse, licensed vocational nurse, patient care technician). These staff members fulfill the patient to staff ratio requirement.

(27) Education--Presenting and teaching informative materials, including to licensed ESRD facility's patients, about treatment modalities, options, and overall health literacy. An ESRD facility may conduct education individually or in a group setting.

(28) Empty bed contact time (EBCT)--A measure of how much contact occurs between particles, such as activated carbon, and water as the water flows through a bed of the particles. EBCT = (7.48 x V)/Q where V is the volume of particles in the bed (feet), Q is the flow rate of the water through the bed (gallon/minute), and 7.48 is the conversion factor for gallons to feet.

(29) End stage renal disease--The stage of renal impairment that appears irreversible and permanent and that requires a regular course of dialysis or kidney transplantation to maintain life (also known as chronic kidney disease stage V).

(30) End stage renal disease (ESRD) facility--A facility that provides dialysis treatment or dialysis training and support to individuals with end stage renal disease.

(31) ESRD Network--An organization consisting of all Medicare-approved ESRD facilities in the designated geographic area specified by CMS. The network is operated by a corporation that functions under a federal government contract. The network organization is the administrative governing body to the network and acts as a liaison to the Federal government. The network helps ensure quality of care and coordinated delivery of end stage renal disease services.

(32) Endotoxin--Lipopolysaccharides consisting of a polysaccharide chain covalently bound to lipid A and the major component of the outer cell wall of gram-negative bacteria.

(33) Endotoxin-retentive filter--Membrane filter specifically proven to remove bacteria and endotoxins.

(34) Executive commissioner--The executive commissioner of the Texas Health and Human Services Commission.

(35) Facility--A contiguous, identifiable location HHSC approved for use as a licensed ESRD facility that is either a freestanding building or a single, distinct, contiguous space in a multi-tenant building.

(36) Full-time--The time period established by an ESRD facility as a full working week, as defined and specified in the facility's policies and procedures.

(37) Full-time equivalent--Work time equivalent to 2,080 hours per 12 consecutive months.

(38) Governing body--The governing authority of a licensed ESRD facility responsible for organization, management, control, operation, and appointment of medical staff. The governing body includes the medical director and representatives of the ESRD facility's owner. The governing body has the overall legal responsibility for the ESRD facility's governance and operation.

(39) Health care facility--Any type of facility or home and community support services agency licensed to provide health care in any state or certified for Medicare (Title XVIII) or Medicaid (Title XIX) participation in any state.

(40) Home dialysis service--Dialysis performed at home by an end stage renal disease patient or caregiver who has completed an appropriate course of training, as described in §507.53 of this chapter (relating to Home Dialysis Service).

(41) Hospital--A entity licensed under Texas Health and Safety Code Chapter 241 (relating to Hospitals), or when exempt from licensure, certified by the United States Department of Health and Human Services as in compliance with conditions of participation for hospitals in Title XVIII, Social Security Act (42 United States Code §1395 et seq.).

(42) In-center dialysis--Dialysis provided within the ESRD facility's licensed patient care area.

(43) Inspection--A survey conducted by a representative of HHSC to determine whether an applicant or licensee is in compliance with this chapter and Texas Health and Safety Code Chapter 251 (relating to End Stage Renal Disease Facilities).

(44) Integrated hemodialysis system--A preconfigured hemodialysis system, as designated by the United States Food and Drug Administration (FDA), in which dialysis-quality water and concentrate is prepared and used at the patient's station in the approved and licensed dialysis unit. In licensed facilities that use this modality of delivery of dialysis services, the conventional water distribution system may not be necessary, as each unit contains its own water purification system, produces dialysate, and makes individualized adjustments as needed.

(45) Interdisciplinary team (IDT)--A group composed of the primary dialysis physician, registered nurse, dietitian, and social worker who are responsible for planning care for the patient.

(46) Intermediate-level disinfection--A surface treatment using chemical germicides or disinfectants that are capable of inactivating various classes of microorganisms including viruses (primarily medium to large viruses and lipid-containing viruses), fungi, and actively growing bacteria (including tubercle bacteria) when such chemical germicides or disinfectants are used in accordance with the manufacturer's directions for use or per established guidelines. Intermediate-level disinfection is generally not effective in inactivating or eliminating bacterial endospores. Examples of intermediate-level disinfectants include bleach, 70 - 90 percent ethanol or isopropanol, and certain phenolic or iodophor preparations.

(47) Licensed nurse--A registered nurse or licensed vocational nurse.

(48) Licensed vocational nurse (LVN)--An individual who is currently licensed under Texas Occupations Code Chapter 301 (relating to Nurses) by the Texas Board of Nursing as a licensed vocational nurse, or who holds a valid vocational nursing license with multi-state licensure privilege from another compact state. An LVN may act in the capacity of a dialysis technician after meeting the competency requirements specified in §507.48(o) of this chapter (relating to Nursing Services).

(49) Medical director--A physician who:

(A) is board certified in internal medicine by the American Board of Internal Medicine or in pediatrics by the American Board of Pediatrics; has completed a board-approved training program in nephrology; and has at least 12 months of experience providing care to patients receiving dialysis; or

(B) is board certified in nephrology or pediatric nephrology and has at least 12 months of experience providing care to patients receiving dialysis.

(50) Medical review board--A review board appointed by the ESRD Network that has a contract with CMS.

(51) Modality--A particular treatment option and settings for a patient with end stage renal disease, for example, in-center hemodialysis, home hemodialysis, home peritoneal dialysis, self-care dialysis, nocturnal dialysis, or transplantation.

(52) Owner--The legal or governmental entity that holds or will hold a license issued under this chapter and Texas Health and Safety Code Chapter 251.

(53) Patient--An individual receiving dialysis treatment or training from an ESRD facility.

(54) Patient plan of care--Documentation of the interactive process by which the interdisciplinary team and the patient and family members or guardian develop and implement a plan, based on the assessments performed by the interdisciplinary team members, to assist the end stage renal disease patient in managing the disease and its complications.

(55) Pediatric patient--An individual under 18 years of age.

(56) Person--An individual, corporation, or other legal entity.

(57) Physician--An individual who is licensed by the Texas Medical Board to practice medicine under Texas Occupations Code, Subtitle B, Title 3.

(58) Physician assistant--An individual licensed as a physician assistant by the Texas Physician Assistant Board.

(59) Plan of Correction (POC)--A written plan developed by the ESRD facility that lists specific actions the ESRD facility will take to correct specific deficiencies of state licensing regulations.

(60) Prelicensure conference--A meeting between HHSC staff and the administrator or licensed professional listed on the license application to review licensure standards and provide consultation before HHSC issues a license. The prelicensure conference is not an architectural review feasibility conference.

(61) Product water--Water produced by a water treatment system or by an individual component of a system.

(62) Progress note--A physical or electronic record of an event dated and signed by facility staff, which summarizes facts about the patient's care and the patient's response during a given time period.

(63) Pyrogen--A fever producing substance. Pyrogens are most often lipopolysaccharides of gram-negative bacterial origin.

(64) Quality assessment and performance improvement (QAPI)--An ongoing program that measures, analyzes, and tracks quality indicators related to improving health outcomes. The program implements improvement plans and evaluates the implementation until resolution is achieved.

(65) Registered nurse (RN)--An individual currently licensed by the Texas Board of Nursing as a registered nurse, or who holds a valid registered nursing license with multi-state licensure privilege from another compact state.

(66) Second-chance patient--A patient voluntarily or involuntarily discharged from a facility, or pending involuntary discharge due to behavioral or compliance issues, chosen by the ESRD Network to participate in the second chance program set forth by the ESRD Network who agrees to receive treatment at another licensed ESRD facility. The patient will have specific behavioral expectations compliance expectations, or both, that shall be achieved and maintained to successfully participate in the second chance program and remain a patient at the accepting facility.

(67) Self-care patient--An in-center patient who performs all or part of their dialysis treatment, including, at a minimum, set up and tear down of machinery, holding their own site at termination of treatment, and taking and recording their own vital signs.

(68) Self-care service--A service where patients participate in their self-care with supervision by a qualified registered nurse as approved and delegated by the medical director.

(69) Single patient device--A dialysis machine, as designated by the FDA, assigned to a patient for individual use at home.

(70) Social worker--An individual who:

(A) is currently licensed by the Texas Behavioral Health Executive Council as a social worker under Texas Occupations Code Chapter 505 (relating to Social Workers), and holds a master's degree from a graduate school of social work accredited by the Council on Social Work Education; or

(B) has at least two years of work experience as a social worker, one year of which was in a dialysis facility or transplantation program before September 1, 1976, and has established a consultative relationship with a social worker who has a master's degree from a graduate school of social work accredited by the Council on Social Work Education.

(71) Sorbent regeneration system--A system that regenerates dialysate by passing the dialysate through substances that restore the dialysate to a condition comparable to fresh dialysate.

(72) Station--An area in the ESRD facility in which a patient receives in-center hemodialysis treatment, or dialysis instruction, such as home hemodialysis training or home peritoneal dialysis training.

(73) Supervising nurse (Director of Nursing)--A registered nurse who has:

(A) clinical experience including:

(i) at least 12 months of clinical nursing experience as an RN, and

(ii) an additional 6 months of experience in dialysis obtained within the last 24 months, or

(B) at least 18 months experience as an RN and holds a current certification from a nationally recognized board in nephrology nursing or hemodialysis.

(74) Supervision--Authoritative procedural guidance by a qualified individual for accomplishing a function or activity with initial direction and periodic inspection of the actual act of accomplishing the function or activity.

(A) Immediate supervision--The supervisor is observing the task or activity as it is performed.

(B) Direct supervision--The supervisor is at the licensed ESRD facility site but not necessarily immediately physically present where the task or activity is being performed.

(C) Indirect supervision--The supervisor is not at the licensed ESRD facility site but is accessible by two-way communication, able to respond to an inquiry when made, and readily available for consultation.

(75) Technical supervisor--The supervisor of the ESRD facility's mechanical, reuse, and water treatment systems.

(76) Telehealth or telehealth service--A health service, other than a telemedicine medical service, delivered by a health professional licensed, certified, or otherwise entitled to practice in this state and acting within the scope of the health professional's license, certification, or entitlement to a patient at a different physical location than the health professional using telecommunications or information technology, in accordance with Texas Occupations Code Chapter 111 (relating to Telemedicine, Teledentistry, and Telehealth).

(77) Telemedicine or telemedicine medical service--A health care service delivered by a physician licensed in this state, or a health professional acting under the delegation and supervision of a physician licensed in this state, and acting within the scope of the physician's or health professional's license to a patient at a different physical location than the physician or health professional using telecommunications or information technology, in accordance with Texas Occupations Code Chapter 111.

(78) Training (Patient)--The process of developing, practicing, and maintaining specific skills of an individual patient related to the patient's home dialysis treatment modality, including self-care, home hemodialysis, peritoneal dialysis, and other modalities. Patient training must meet the requirements in §507.53 of this chapter.

(79) Training (Staff)--The process of teaching tasks through on-the-job experience or instruction from an individual who has the capacity through education or experience to perform the delegated task or activity.

(80) Transitional care--Services to transition a patient from a current modality to a self-care modality in-center or at home.

(81) Transitional services--In-center dialysis intended to transition a patient from a current modality to a self-care modality whether in-center or at home.

(82) Ultrafilter--A membrane filter with a pore size in the range of 0.001 to 0.05 micrometer. Performance is usually rated in terms of a nominal molecular weight cut off (MWCO), which is defined as the smallest molecular weight species for which the filter membrane has more than 90 percent rejection.

(83) Water distribution system--Storage tanks and piping used to distribute the product water from the purification cascade to or from its point of use, including individual hemodialysis machines, dialyzer reprocessing equipment, and dialysate concentrate preparation systems.

(84) Water treatment system--A collection of water purification devices and associated piping, pumps, valves, gauges, and other related components that together produce purified water for hemodialysis applications and deliver it to the point of use.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on December 3, 2025.

TRD-202504415

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 23, 2025

Proposal publication date: June 6, 2025

For further information, please call: (512) 834-4591

SUBCHAPTER B. LICENSING REQUIREMENTS

STATUTORY AUTHORITY

The new rules are adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system; Texas Health and Safety Code §251.003, which requires HHSC to adopt rules for the issuance, renewal, denial, suspension, and revocation of a license to operate an end stage renal disease facility; and Texas Health and Safety Code §251.014, which requires these rules to include minimum standards to protect the health and safety of a patient of an end stage renal disease facility.

§507.11. General Requirements for a License.

(a) All facilities that provide dialysis services, regardless of affiliation or modality, shall be licensed as an end stage renal disease (ESRD) facility. A patient of an ESRD facility receiving home dialysis services, as defined in §507.2 of this chapter (relating to Definitions), shall receive the services under the purview of a licensed ESRD facility.

(b) A facility shall obtain a license before admitting patients.

(c) A facility shall prominently and conspicuously display the license in a public area of the facility that is readily visible to patients, employees, and visitors.

(d) A facility shall not alter the ESRD facility license.

(e) An ESRD facility license is nontransferable. The facility shall comply with the provisions of §507.12 of this subchapter (relating to Application and Issuance of Initial License) in the event of a change in the ownership.

(f) The Texas Health and Human Services Commission (HHSC) issues an ESRD facility license for the facility site and person named in the application.

(g) An ESRD facility may share a building with other licensed health care facilities.

(1) The ESRD facility shall be licensed separately from the other licensed facilities.

(2) No identifiable part of the building may be dually licensed by more than one person.

(h) The following facilities are not required to be licensed under this chapter:

(1) a home and community support services agency licensed under Texas Health and Safety Code Chapter 142 (relating to Home and Community Support Services), with a home dialysis designation;

(2) a hospital licensed under Texas Health and Safety Code Chapter 241 (relating to Hospitals) that provides dialysis only to individuals receiving:

(A) inpatient services from the hospital; or

(B) outpatient services due to a disaster declared by the governor or a federal disaster declared by the president of the United States occurring in this state or another state during the term of the disaster declaration;

(3) a hospital operated by, or on behalf of, the state as part of the managed health care provider network established under Texas Government Code Chapter 501 (relating to Inmate Welfare) that provides dialysis only to individuals receiving:

(A) inpatient services from the hospital; or

(B) outpatient services while the individual is serving a term of confinement in a facility operated by, or under contract with, the Texas Department of Criminal Justice;

(4) an ESRD facility operated by, or on behalf of, the state as part of the managed health care provider network established under Texas Government Code Chapter 501 that provides dialysis only to individuals receiving those services while serving a term of confinement in a facility operated by, or under contract with, the Texas Department of Criminal Justice; or

(5) the office of a physician unless the office is used primarily as an ESRD facility.

§507.12. Application and Issuance of Initial License.

(a) An applicant shall comply with this subsection before receiving an initial license.

(1) The applicant shall submit an accurate and complete application form to the Texas Health and Human Services Commission (HHSC) in accordance with HHSC instructions, including evidence that:

(A) the facility has at least one qualified physician on staff; and

(B) each dialysis technician on staff completed the training program requirements as required by §507.72 of this chapter (relating to Training Curricula and Instructors).

(2) The applicant shall submit the appropriate license fee, as required in §507.20 of this subchapter (relating to Fees).

(3) The applicant for a new or existing facility that is increasing the number of in-center dialysis treatment stations shall have an isolation room, as specified in the current CMS Conditions for Coverage or shall provide a CMS waiver.

(4) The applicant shall attend a prelicensure conference conducted by HHSC to review facility staff qualifications and licensure rules, and to receive consultation before the on-site licensure inspection. HHSC may waive the prelicensure conference requirement at its discretion.

(5) The applicant shall submit a copy of a fire safety inspection that:

(A) indicates approval by an individual certified by the Texas Commission on Fire Protection; and

(B) is dated no earlier than 12 months before the facility licensure date.

(6) The facility physical plant shall meet the requirements set forth in Subchapter Z of this chapter (relating to Physical Plant and Construction Requirements) before HHSC issues an end stage renal disease (ESRD) facility license for a newly constructed ESRD facility or an ESRD facility converted from a non-ESRD facility building.

(7) The applicant shall submit to HHSC, in accordance with HHSC instructions, a complete chemical analysis of the product water and reports to verify that bacteriological and endotoxin levels of product water and dialysate are compliant with §507.33 of this chapter (relating to Water Treatment) and §507.34 of this chapter (relating to Dialysate). The facility shall keep the reports on file at the facility and make the reports available to HHSC staff during an on-site inspection or when requested by HHSC.

(b) When HHSC determines the applicant has complied with subsection (a) of this section, HHSC issues the license to the applicant.

(1) The license is effective on the issue date.

(2) The license expires on the last day of the month two years after the issue date.

(c) HHSC will not process an application until HHSC receives the fee required in subsection (a)(2) of this section.

(d) An applicant may withdraw their application by notifying HHSC in accordance with HHSC instructions.

(e) If the applicant does not complete all requirements of subsection (a) of this section within six months after the date HHSC receives the license application and appropriate fee, HHSC will consider the application withdrawn. The applicant must reapply for an initial license in accordance with this section.

(f) Any fee paid for a withdrawn application is nonrefundable, as indicated by §507.20(a) of this subchapter.

(g) Denial of a license is governed by §507.90 of this chapter (relating to Enforcement).

(h) Within the first two years of licensure, HHSC inspects the facility to determine the facility's compliance with the provisions of Texas Health and Safety Code Chapter 251 (relating to End Stage Renal Disease Facilities) and this chapter.

(1) HHSC may conduct this inspection at the same time as the inspection to determine compliance with Code of Federal Regulations Title 42, Part 494 (relating to Conditions for Coverage for End-Stage Renal Disease Facilities).

(2) After the facility admits and provides services to at least one patient, the facility shall request an on-site inspection in accordance with HHSC instructions. An HHSC representative will conduct the inspection while patients are in the facility being dialyzed.

(3) At the time of inspection, the facility shall provide services to at least one patient in each modality the facility requested in their application. An HHSC representative may interview patients at the time of the inspection, either in the patient's home or at the facility. An HHSC representative may interview peritoneal and home hemodialysis patients trained or retrained at the facility as part of the inspection.

§507.13. License Renewal.

(a) The Texas Health and Human Services Commission (HHSC) sends written notice of license expiration to a facility at least 90 calendar days before the expiration date of a license. If the facility does not receive the notice, it is the facility's duty to notify HHSC and request a renewal notice.

(b) HHSC renews the license of a facility that meets the minimum requirements for a license.

(c) The facility shall submit to HHSC before the license expiration date:

(1) a complete and accurate renewal application form;

(2) a copy of two fire safety inspections indicating approval by an individual certified by the Texas Commission on Fire Protection, which includes:

(A) one approved within the 12 months before the submission date or the license expiration date, whichever is earlier, and

(B) one approved within the last 13 - 24 months before the submission date or the license expiration date, whichever is earlier; and

(3) the license renewal fee.

(d) HHSC may conduct an inspection before issuing a renewal license in accordance with §507.82 of this chapter (relating to Inspections).

(e) A renewal license is valid for two years from the previous expiration date.

(f) A facility must submit a complete renewal application, including all required documents and the fee, at least 30 days before the license expiration date.

(1) If the facility does not submit the completed renewal application, required documents, and license renewal fee until after the license expiration date, the facility must pay a late fee of half of the renewal fee based on the facility's number of stations, as listed in §507.20(c) of this subchapter (Relating to Fees).

(2) If the facility does not submit the completed renewal application, required documents, license renewal fee, and late fee within 30 days after the expiration date, HHSC notifies the facility to immediately cease operation.

(A) If HHSC notifies a facility to immediately cease operation, the facility must apply for and receive an initial license under §507.12 of this subchapter (relating to Application and Issuance of Initial License) to resume services.

(B) If HHSC requires the facility to apply for an initial license, the facility shall not provide services until HHSC issues the initial license.

(3) HHSC issues a renewal license only after the facility submits the renewal application, required documents, license renewal fee and any applicable late fee.

(g) If the facility does not wish to provide services after the license expiration date, the facility must close in accordance with §507.18 of this subchapter (relating to Closure).

(h) After the license expiration date, if the facility does not correct a deficiency in the renewal application within 15 business days after being notified, HHSC may assess a late fee as described in subsection (f)(1) of this section or deny the license. If HHSC denies the license, any license fee paid is nonrefundable, as indicated by §507.20(a) of this subchapter.

(i) Denial of a license is governed by §507.90 of this chapter (relating to Enforcement).

§507.14. Change of Ownership.

(a) A change of ownership occurs when there is a change in the person legally responsible for the facility's operation, whether by lease or ownership.

(1) If a corporate licensee amends its articles of incorporation to revise its name and the tax identification number does not change, this subsection does not apply, except for the following notification requirement. The corporation shall notify the Texas Health and Human Services Commission (HHSC) within 10 calendar days after the effective date of the name change.

(2) The sale of stock of a corporate licensee does not cause this subsection to apply.

(3) The new owner shall submit a license application, documents, and fee in accordance with §507.12 of this subchapter (relating to Application and Issuance of Initial License) to HHSC before the date of the change of ownership or within 10 calendar days after the change of ownership date.

(4) HHSC may waive the inspection required by subsection (d) of this section.

(5) When HHSC determines the new owner complied with provisions of §507.12 of this subchapter, HHSC issues a license, which is effective on the date of the change of ownership.

(6) The license expiration date shall be in accordance with §507.12(b)(2) of this subchapter.

(7) The previous owner's license shall be void on the effective date of the new owner's license, and the facility shall return the voided license to HHSC.

(b) The facility shall comply with §507.12(a)(7) of this subchapter.

(c) Applications under this section are subject to §507.12(d) and (e) of this subchapter.

(d) Within the first two years of licensure, HHSC may inspect the facility to determine the facility's compliance with the provisions of Texas Health and Safety Code Chapter 251 (relating to End Stage Renal Disease Facilities) and this chapter in accordance with §507.12(h) of this subchapter.

§507.15. Relocation.

(a) A facility planning to relocate shall notify the Texas Health and Human Services Commission (HHSC) in accordance with HHSC instructions at least 90 calendar days before the planned relocation. Relocations shall be within the state of Texas.

(1) The facility shall submit a license application in accordance with §507.12 of this subchapter (relating to Application and Issuance of Initial License) to HHSC before relocation.

(2) HHSC may waive the inspection required by §507.12 of this subchapter.

(3) The license is effective on the issue date.

(4) The license expires on the last day of the month two years after the issue date.

(5) The previous facility license is void once the relocation is effective and after the facility ceases all services at the previous location. The facility must return the voided license to HHSC.

(b) The facility shall comply with §507.12(a)(7) of this subchapter.

(c) When HHSC determines the facility complied with this section, HHSC issues a new license to the applicant, when applicable.

(d) Applications under this subsection are subject to §507.12(d) and (e) of this subchapter.

(e) Within the first two years of licensure after relocation, HHSC may inspect the facility to determine the facility's compliance with the provisions of Texas Health and Safety Code Chapter 251 (relating to End Stage Renal Disease Facilities) and this chapter in accordance with §507.12(h) of this subchapter.

§507.16. Change in Status.

(a) A facility shall notify the Texas Health and Human Services Commission (HHSC) in writing in accordance with HHSC instructions at least 30 calendar days before:

(1) any construction;

(2) addition, alteration, renovation, or remodeling;

(3) equipment and finish upgrade;

(4) conversion of a licensed or previously licensed facility to an ESRD license designation;

(5) demolition;

(6) retrofitting a function, such as changing end stage renal disease treatment modality or training station designations; or

(7) change of services, including change in treatment modality, station type, and station number.

(b) A facility shall notify HHSC in writing and in accordance with HHSC instructions within 10 calendar days following:

(1) a change in the facility name, mailing address, facility administrator email address, telephone number, or fax number;

(2) a change of administrator; or

(3) the facility ceasing operation.

(c) A facility shall request and receive HHSC written approval in accordance with HHSC instructions before changes in services or the number of stations.

(1) The facility shall request HHSC approval at least 90 calendar days before the planned change and must receive HHSC approval before implementing the changes.

(2) The change shall comply with Subchapter Z of this chapter (relating to Physical Plant and Construction Requirements).

(3) For an additional service or increase in stations, HHSC may require the facility to provide evidence of appropriate staffing, policies and procedures, or any other documentation it determines is necessary to evaluate the request.

(4) For an increase in stations, the facility shall also submit written evidence that the water treatment system is of sufficient size to accommodate the increase and maintain a safe water supply.

(5) HHSC may conduct an on-site inspection before acting on the requested changes.

(6) The facility shall comply with §507.12(a)(7) of this subchapter (relating to Application and Issuance of Initial License).

(7) HHSC sends the facility written notice of HHSC approval or denial of the requested change.

(8) All existing facilities increasing the number of in-center dialysis treatment stations shall have an isolation room, as specified in the current CMS Conditions for Coverage, or shall provide a waiver. Refer to isolation room requirements in Subchapter Z of this chapter.

§507.17. Inactive Status.

A facility that stops offering services under its license shall first ensure the safety of the facility's patients, staff, and visitors, then inform the Texas Health and Human Services Commission (HHSC) and request inactive status within five calendar days of ceasing operations, in accordance with HHSC instructions. HHSC may close a license if the facility does not offer services for more than 90 calendar days unless the facility sends a written request to place the license on inactive status.

(1) To be eligible for inactive status, a facility must be in good standing with no pending legal action or investigation.

(2) The facility is responsible for any license renewal requirements or fees, and for proper maintenance of patient records, while the license is inactive.

(3) A license may not remain inactive for more than 90 calendar days without an approved extension from HHSC.

(4) A facility that does not reactivate its license within 90 calendar days after it stopped offering services may request a single 90-day renewal period of the inactive status from HHSC through a written request in accordance with HHSC instructions.

(5) A facility may request HHSC to place the license on inactive status once during each two-year licensing period.

(6) If the facility does not reactivate its license or request a renewal for inactive status by the 90th calendar day after the facility stopped offering services, HHSC may consider the facility closed and the license invalid.

(7) If the facility does not resume patient services within 10 calendar days after the date the facility's license is placed on inactive status:

(A) the facility shall submit to HHSC an application for inspection and water culture testing results;

(B) the facility's water culture testing results submitted to HHSC with the application shall meet the requirements of §507.33 of this chapter (relating to Water Treatment); and

(C) the facility shall not resume providing patient services until after HHSC inspects the facility.

§507.21. Exceptions to These Rules.

(a) An end stage renal disease (ESRD) facility may request the following types of exceptions from a requirement in this chapter.

(1) An ESRD facility may request a temporary exception related to alternative concepts, methods, procedures, or techniques, or for conducting pilot projects or research.

(2) An ESRD facility may request a permanent exception related to United States Food and Drug Administration-approved equipment.

(b) Exceptions related to operating a facility during an emergency or disaster situation are governed by §507.22 of this subchapter (relating to Exceptions During Emergency or Disaster Situations).

(c) To request an exception to a requirement in this chapter, a facility shall submit a form to the Texas Health and Human Services Commission (HHSC) that includes:

(1) the specific rule for which the facility requests an exception;

(2) a detailed description of the specific circumstances the facility administration believe justify the exception;

(3) a detailed description of what alternatives the facility considered, if any, and why the facility did not select any of the identified alternatives, including compliance with the rule;

(4) a detailed description of how the proposed exception is desirable to maintain or improve the health and safety of the patients, will not jeopardize patient health and safety, and will maintain patient access to care; and

(5) the proposed duration of the exception, if the facility submits a request for a temporary exception.

(d) HHSC may conduct an inspection and may consult with the medical review board before approving an exception.

(e) HHSC responds to an exception request within 90 calendar days after the date HHSC receives the request. On finding that the facility satisfied the conditions of this section, HHSC may grant a temporary or permanent exception and shall specify the exception duration when notifying the facility that HHSC granted the exception.

(f) The facility may implement an exception only after the date the facility receives written approval from HHSC.

(g) Granting of an exception is public information, is subject to disclosure, and may be posted on the HHSC website.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on December 3, 2025.

TRD-202504416

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 23, 2025

Proposal publication date: June 6, 2025

For further information, please call: (512) 834-4591

SUBCHAPTER C. OPERATIONAL REQUIREMENTS FOR EQUIPMENT, WATER TREATMENT AND REUSE, AND SANITARY AND HYGIENIC CONDITIONS

STATUTORY AUTHORITY

The new rules are adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system; Texas Health and Safety Code §251.003, which requires HHSC to adopt rules for the issuance, renewal, denial, suspension, and revocation of a license to operate an end stage renal disease facility; and Texas Health and Safety Code §251.014, which requires these rules to include minimum standards to protect the health and safety of a patient of an end stage renal disease facility.

§507.31. Equipment.

(a) All equipment used by a facility, including backup equipment, shall be approved by the United States Food and Drug Administration (FDA), operated in accordance with the manufacturer's direction for use, and maintained free of defects that could be a potential hazard to patients, staff, or visitors. Qualified staff or contract personnel shall perform maintenance and repair of all equipment.

(1) Staff shall be able to identify malfunctioning equipment and immediately report such equipment to the appropriate staff for repair.

(2) Staff shall clearly and immediately label medical equipment that malfunctions and promptly remove the equipment from service until the facility ensures identification and correction of the malfunction.

(3) A facility shall maintain a record of all maintenance and repairs.

(4) After the facility ensures necessary repair or alteration to any equipment or system, the facility shall thoroughly test the equipment or system for proper operation and disinfect the equipment or system before returning the equipment or system to service.

(5) A facility shall comply with the Federal Food, Drug, and Cosmetic Act, 21 United States Code (USC) §360i(b) (relating to Records and Reports on Devices), concerning reporting when a medical device, as defined in 21 USC §321(h) (relating to Definitions; Generally), has or may have caused or contributed to the injury or death of a patient of the facility.

(6) A facility shall document completion of the requirements listed in paragraphs (1) - (5) of this subsection on the facility's equipment or system repair log (electronic or paper).

(b) A facility shall develop, implement, and enforce a written preventive maintenance program to ensure patient care related equipment used in the facility, or provided by the facility for use by a patient in the patient's home, receives electrical safety inspections, when appropriate, and maintenance at least annually, or more frequently in accordance with the manufacturer's direction for use. Facility staff or contract personnel may provide the preventive maintenance.

(c) At least one complete dialysis machine shall be available on site as backup for every 10 machines in use. At least one of these backup machines shall 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.

(d) A facility shall annually inspect equipment with internal transducer protectors to ensure the equipment is not contaminated. If the transducer protector is wetted or fluid or blood is visible, the facility must follow instructions as described in §507.36 of this subchapter (relating to Infection Control).

(e) If a facility treats pediatric patients, the facility shall use equipment and supplies, to include blood pressure cuffs, dialyzers, and blood tubing, appropriate for this special population.

(f) All equipment and appliances shall be properly grounded in accordance with the National Fire Protection Association (NFPA 99), Standard for Health Care Facilities, §4.3.2.2.2, 2002 Edition.

(g) A facility shall have emergency equipment and supplies immediately accessible in the treatment area.

(1) At a minimum, the emergency equipment and supplies shall include:

(A) oxygen;

(B) ventilatory assistance equipment, to include airways, manual breathing bag, and mask;

(C) suction equipment;

(D) supplies specified by the medical director; and

(E) automated external defibrillator.

(2) If a facility treats pediatric patients, the facility shall have the appropriate type and size emergency equipment and supplies listed in paragraph (1) of this subsection for this special population.

(3) A facility shall establish, implement, and enforce a policy for 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.

§507.33. Water Treatment.

The requirements in this section apply to water used for hemodialysis, including preparation of concentrates from powder at a dialysis facility and dialysate, and reprocessing dialyzers for multiple use.

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

(2) When a facility does not use a public water system supply, the facility shall test the source water monthly in the same manner as a public water system, as required by the Texas Commission on Environmental Quality (TCEQ) under Texas Administrative Code, Title 30, Chapter 290, Subchapter F (relating to Drinking Water Standards Governing Drinking Water Quality and Reporting Requirements for Public Water Systems).

(3) The physical space in which the water treatment system is located shall be adequate to allow for maintenance, testing, and repair of equipment. If facility staff mixes concentrates in the same area, the physical space shall also be adequate to house and allow for maintenance, testing, and repair of the mixing equipment and for performing the mixing procedure. When a facility uses a water distribution system, the system shall be configured as a continuous recirculation loop. To minimize biofilm formation, there shall always be flow in a piping system, except during the backwash cycle of the carbon tanks for direct feed systems.

(A) For direct and indirect feed systems, the water flow rate shall comply with the standards listed in §507.30 of this subchapter (relating to Technical Standards).

(B) This section shall not apply to facilities providing only home training and services utilizing single patient devices. Devices used in the facility for training and support services shall be compliant with the United States Food and Drug Administration (FDA) and Underwriters' Laboratories (UL) requirements.

(C) The water treatment and distribution system shall include appropriate pressure gauges, flow meters, sample ports, and other ancillary equipment necessary to allow monitoring of the performance of individual system components and the system as a whole, as determined by the facility medical director.

(4) 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 by the standards listed in §507.30 of this subchapter.

(A) Direct feed systems shall include a means of verifiably preventing retrograde flow of water into the distribution loop from the feed side of the reverse osmosis unit.

(B) Dead-end piping (risers with no flow, branches with no fixture) shall not be installed. In any renovation work, dead-end piping shall be removed.

(5) The facility shall develop written policies and procedures for operating the water treatment system, receiving approval from the medical director, and implementing and enforcing the approved policies and procedures. The facility shall develop written parameters for operating each water treatment system component and ensuring the operator is trained and knowledgeable on these parameters. Each major water system component shall be labeled in a manner that identifies the device, describing its function, how performance is verified, and actions to take in the event performance is not within an acceptable range. The facility's policies and procedures for the bypass valves for the carbon tanks, and any other bypass valves considered to be critical by the medical director, shall have a means to minimize the likelihood the device will be inadvertently bypassed during the normal operation of the system.

(6) The materials of any components of water treatment systems (including piping, storage, filters, and distribution systems) that contact the product water shall not interact chemically or physically to adversely affect the product water purity or quality. 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 at any point beyond the water treatment component used to remove contaminating metal ions (e.g., reverse osmosis system or deionizer).

(7) 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. Systems shall be monitored in accordance with the manufacturer's direction for use, and specific test procedures to verify removal of additives shall be provided and documented. Chemical injection systems shall include a means of regulating the metering pump to control the addition of a chemical. This control system shall be designed to tightly control addition of the chemical. This control system shall ensure the chemical is added only when the water is flowing through the pre-treatment cascade and in fixed proportion to the water flow. If an automated control system is used to inject the chemical, there shall be an independent monitor of the controlling parameter.

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

(A) Reverse osmosis systems, if used, shall meet the standards set forth by the CMS Conditions for Coverage.

(B) Single patient devices used in a dialysis facility shall meet the appropriate standards set forth in the CMS Conditions for Coverage to provide dialysis-quality water. Once the designated patient no longer needs the single patient device, the facility may process, disinfect, and prepare the device for another designated patient's use, per manufacturer's directions for use.

(C) A facility shall meet the following requirements for deionization systems.

(i) Deionization systems, if used, shall be monitored continuously to produce water of one megohm-centimeter or greater specific resistivity (or conductivity of 1.0 microsiemens/centimeter or less) at 25 degrees Celsius. The system shall have an audible and visual alarm which activates in the facility to include the patient care area when the product water resistivity falls below this level, and the product water stream shall be prevented from reaching any point of use.

(ii) A facility shall not dialyze patients on deionized water with a resistivity less than 1.0 megohm-centimeter measured at the output of the final deionizer.

(iii) Deionization tanks, if used, shall be a minimum of two mixed beds in series and shall be used with resistivity monitors including audible and visual alarms placed pre and post the final deionization tank in the system and audible in the patient care area.

(iv) Feed water for deionization systems shall be pretreated with activated carbon adsorption, or a comparable alternative, to prevent nitrosamine formation.

(v) 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.

(vi) Facilities shall ensure all devices that are regenerated or reconstituted off site, such as deionizers, shall be disinfected at the time of regeneration or reconstitution, so contaminated water is not reintroduced into the system after regeneration or reconstitution.

(D) A facility shall meet the following requirements for carbon tanks.

(i) The carbon tanks shall contain granular activated carbon, with a minimum iodine number of 900 or equivalent, as indicated by the medical device manufacturer. The facility shall not use previously used carbon.

(ii) A minimum of two carbon adsorption beds shall be installed in series with a sample port following the first bed. A sample port shall also be installed following the second bed for use in the event of total chlorine (the sum of free chlorine and chloramine) breaking through the first bed.

(iii) The total empty bed contact time (EBCT) shall be at least 10 minutes, with the final tank providing at least five minutes EBCT at the maximum flow rate through the bed. Carbon adsorption systems used to prepare water for home dialysis or for portable dialysis systems are exempt from the requirement for the second carbon and a 10-minute EBCT, if removal of total chlorine to below 0.1 milligram/liter (mg/L) is verified before each treatment.

(iv) Water from the sample ports following the first carbon bed shall be tested for total chlorine levels at the beginning of each treatment day, before patients initiate treatment, before reprocessing of dialyzers, and again before the beginning of each patient shift. If there are no set patient shifts, testing shall be performed every four hours until all activities that require use of dialysis-quality water are completed.

(v) If used, an automated chlorine monitoring system will provide, at minimum, the equivalent frequencies of testing as required in clause (iv) of this subparagraph and used in accordance with the manufacturer's direction for use. Facility staff shall manually test the automated chlorine monitoring system before the first patient treatment every morning to verify that the device is functioning within manufacturer's specifications to ensure water quality. If a breakdown in the system occurs at any time before or during the treatment day, the facility shall return to manually testing the system every four hours during the treatment day and maintain the appropriate records for manual monitoring.

(vi) Carbon beds are sometimes arranged as series-connected pairs of beds so that they need not be overly large. The beds within each pair are of equal size and water flows through them are parallel. In this situation, each pair of beds shall have a minimum empty bed contact time of five minutes at the maximum flow rate through the bed. When series connected pairs of beds are used, the piping shall be designed to minimize differences in the resistance to flow from inlet and outlet between each parallel series of beds, to ensure an equal volume of water flows through all beds.

(vii) All samples for total chlorine testing shall be drawn when the water treatment system has been operating for at least 15 minutes.

(viii) A facility may use tests for total chlorine, which include both free and combined forms of chlorine, as a single analysis with the maximum allowable concentration of 0.1 mg/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 tanks and final tanks shall require testing to be performed at the final exit and replacement of the initial tanks. A facility shall use testing equipment, supplies, and procedures in accordance with the manufacturer's directions for use.

(ix) In a system without a holding tank, if test results at the exit of the final tanks are greater than the parameters for total chlorine described in this subparagraph, dialysis treatment shall be immediately terminated to protect patients from exposure to chlorine or chloramines, and the medical director shall be notified. In systems with holding tanks, if the holding tank tests less than 0.1 mg/L for total chlorine, the reverse osmosis 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.

(x) If means other than granulated carbon is used to remove chlorine or chloramine, the facility governing body shall approve such use, in writing, after reviewing the intended method's safety for use in hemodialysis applications. If such methods include the use of additives, there shall be evidence the product water does not contain unsafe levels of these additives.

(9) 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.

(10) If used, the faces of timers used to control any component of the water treatment or dialysate delivery system shall always be visible to the operator. The facility shall maintain written evidence that staff checked timers for operation and accuracy each day of operation.

(11) 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.

(12) 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. Ultrafilters with a nominal molecular weight cut off (MWCO) of 20,000 or less are generally adequate for endotoxin removal.

(13) If used, storage tanks shall have a conical or bowl-shaped base and 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. A means shall be provided to effectively disinfect any storage tank installed in a water distribution system.

(14) Ultraviolet (UV) lights, if used, shall be monitored at the frequency in accordance with the manufacturer's direction for use and have an endotoxin-reducing filter located downstream of the device. Records shall be maintained for monitoring, as outlined by the manufacturer's directions for use. Monitoring of all water system components shall be maintained on water system logs (electronic or paper).

(15) Water treatment system piping shall be labeled to indicate the pipe contents and direction of flow.

(16) The water treatment system shall be continuously monitored during patient treatment and guarded by audible and visual alarms, which can be seen and heard in the dialysis treatment area should water quality drop below specific parameters. Quality monitor sensing cells shall be located at the last component of the water treatment system and at the beginning of the distribution system. No water treatment components that could affect the product water quality, as measured by this device, shall be located after the sensing cell.

(17) When deionization tanks do not follow a reverse osmosis system, the facility shall ensure the parameters for the rejection rate of the membranes assure that the lowest rate accepted would provide product water with a level of chemical contaminants in compliance with the standards listed in §507.30 of this subchapter.

(18) A facility shall maintain water treatment system operation records for each treatment day. The logbook (electronic or paper) shall include each component's operating parameter and the action taken when a component is not within the facility's set parameters.

(19) Microbiological testing of product water shall be conducted.

(A) Routine microbiological testing shall be conducted on a quarterly, or more frequent basis as needed, or required by the standards listed in §507.30 of this subchapter. Routine microbiological testing shall ensure the water and dialysate bacteria and endotoxin levels are within the limits described in the standards listed in §507.30 of this subchapter. For a newly installed water distribution system, or when any repairs, modifications, or changes to the configuration have been made to an existing system, weekly testing shall be conducted for four weeks to verify that bacteria and endotoxin levels are consistently within the allowed limits. Changes to components that are designed to be replaced on a routine schedule such as filters, ultrafilters, and ultraviolet lamps do not require a period of more frequent testing.

(B) At a minimum, sample sites chosen for testing shall include the beginning of the distribution piping, product water in the reuse room at any site of concentrate mixing, and end of the distribution piping.

(C) Samples shall be collected before sanitizing or disinfecting the water treatment system and dialysis machines. Water testing results shall be routinely trended and reviewed by the medical director 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.

(D) Product water used to prepare dialysate, concentrates from powder, or to reprocess dialyzers for multiple use shall contain a total viable microbial count of less than 100 colony forming units/milliliter (CFU/ml) and an endotoxin concentration of less than 0.25 endotoxin units (EU)/ml. The action level for the total viable microbial count in the product water shall be consistent with the standards listed in §507.30 of this subchapter.

(E) If the action levels described at subparagraph (D) of this paragraph are observed in the product water, the medical director shall be notified, and corrective measures shall be taken promptly to reduce the levels into an acceptable range.

(F) All bacteria and endotoxin results shall be recorded to identify trends that may indicate the need for corrective action.

(20) If ozone generators are used to disinfect any portion of the water or dialysate delivery system, the ozone generator shall be capable of delivering ozone at the concentration and for the exposure time specified and in accordance with the manufacturer's direction for use. 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. The records of all testing shall be maintained in a log (electronic or paper). The frequency of disinfection shall be performed at least monthly.

(21) If used, hot water disinfection systems shall use water that meets the standards listed in §507.30 of this subchapter, which must be capable of delivering hot water at the temperature and for the exposure time specified and in accordance with the manufacturer's direction for use, and be monitored for temperature and time of exposure to hot water, as specified by the manufacturer. Water temperature shall be monitored 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. The frequency of disinfection shall be performed at least monthly or more frequently, as needed or required by the standards listed in §507.30 of this subchapter.

(22) After chemical disinfection, a mechanism shall be incorporated to ensure that the equipment and system are restored to a safe condition before using the equipment and product water being used for dialysis applications. The results of all absence testing shall be documented. The frequency of disinfection shall be performed at least monthly. A mechanism shall be incorporated in the distribution system to ensure disinfectant does not drain from pipes during the disinfection period.

(23) Users shall establish and implement a procedure for regular disinfection of the line between the outlet from the water distribution system and the back of the dialysis machine.

(24) Samples of product water used for dialysis shall be submitted for chemical analysis every six months, after a change of the reverse osmosis membranes, and demonstrate that the quality and level of chemical contaminants of the product water used to prepare dialysate, concentrates from powder, or to reprocess dialyzers for multiple use meets the standards listed in §507.30 of this subchapter.

(A) Samples for chemical analysis shall be collected at the most distal point in each water distribution loop. 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 facilities, or facilities that add or change the water distribution system configuration, shall draw samples at the most distal point for each water distribution loop and then every six months thereafter.

(B) Additional chemical analysis shall be submitted when any modification or change to the existing system configuration is made to the water treatment system, or if the percent rejection of a reverse osmosis system decreased 5.0 percent or more from the percent rejection measured at the time the water sample for the preceding chemical analysis was taken.

(25) Facility records shall include all test results and provide evidence the medical director has reviewed the water quality testing results and directed corrective action when indicated.

(26) Only individuals qualified by the education or experience described in §507.54 of this chapter (relating to Staff Qualifications) may operate, repair, or replace water treatment system components.

§507.34. Dialysate.

(a) The facility shall develop, implement, maintain, and evaluate quality assessment and performance improvement (QAPI) procedures to ensure ongoing conformance to policies and procedures regarding dialysate quality.

(b) Each facility shall set all hemodialysis machines to use only one family of concentrates. When new machines are put into service, the concentrate family changes, or the concentrate manufacturer changes, dialysate samples shall be taken from each machine and sent to a laboratory for verification of the dialysate electrolyte values.

(c) Before each patient treatment, facility staff shall verify the dialysate conductivity and pH of each machine with an independent method, following the manufacturer's guidance.

(d) For machines with internal independent conductivity and pH testing, the staff must verify and document that the machine conducted internal testing before each patient treatment. The facility shall test the machine's calibration every six months and maintain logs of the calibration testing.

(e) Bacteriological testing shall be conducted, and bacteriological levels shall meet the hemodialysis dialysate quality required by the standards listed in §507.30 of this subchapter (relating to Technical Standards).

(f) Only a qualified, licensed nurse may use an additive to increase concentrations of specific electrolytes in the acid concentrate. The nurse shall follow mixing procedures, as specified by the additive manufacturer. For additives prescribed for a specific patient, the nurse shall label the container holding the prescribed acid concentrate with the patient name, final concentration of the added electrolyte, date the prescribed concentrate was made, and the facility staff name who mixed the additive. Facility staff may use additives only:

(1) when other interventions were not effective;

(2) per physician order; and

(3) when the additive is reviewed by the governing body.

(g) A facility shall ensure all components used in concentrate preparation systems (including mixing and storage tanks, pumps, valves, and piping) are only made from materials (e.g., plastics or appropriate stainless steel) that do not interact chemically or physically with the concentrate to affect its purity, or with the germicides used to disinfect the equipment. The facility shall ensure components are not made of or use materials known to cause toxicity in hemodialysis such as copper, brass, galvanized material, and aluminum.

(h) Facility policies shall address means to protect stored dialysate components (acid concentrates, bicarbonate concentrates, or bulk storage of dialysate components) from tampering or degeneration due to exposure to extreme heat or cold.

(i) The facility shall develop, implement, and enforce procedures to:

(1) control the transfer of acid concentrates from the delivery container to the clearly labeled storage tank and prevent the inadvertent mixing of different concentrate formulations;

(2) form an integral system of the tank and associated plumbing to prevent contamination of the acid concentrate; and

(3) secure and clearly label the storage tank and inlet and outlet connections, if remote from the tank.

(j) Concentrate mixing systems shall include a purified water source, a suitable drain, and an acceptable electrical outlet, as specified by the manufacturer's recommendations, directions, or instructions.

(1) Mixing system operators shall use personal protective equipment as specified and in accordance with the manufacturer's direction for use during all mixing processes.

(2) Operators shall follow the manufacturer's directions for use of a concentrate mixing system, including instructions for mixing the powder with the correct amount of water, and determine and record the number of bags or weight of powder added.

(3) The facility shall use clear mixing tank labeling to indicate the fill and final volumes required to correctly dilute the powder.

(4) The facility shall monitor systems for preparing either bicarbonate or acid concentrate from powder according to the manufacturer's directions for use to ensure compliance with subsection (k)(1) of this section.

(5) Facility staff shall not use or transfer concentrates to holding tanks or distribution systems until staff complete all tests per the manufacturer's specifications and in accordance with the manufacturer's directions for use. Facility staff shall document the test results and include the facility staff signature who completed the tests.

(6) Where a facility designs its own system for mixing concentrates, the facility shall develop and validate procedures using an independent laboratory to ensure proper concentrate mixing, including establishing acceptable limits for proper concentration tests.

(k) The facility shall ensure the design of acid concentrate mixing tanks allow the inside of the tank to be rinsed when changing concentrate formulas.

(1) The facility shall ensure that the design and maintenance of acid mixing systems prevent rust and corrosion.

(2) Facility staff shall empty acid concentrate mixing tanks completely and rinse with dialysis-quality water before mixing another batch of concentrate to prevent cross-contamination between different batches.

(3) Facility staff shall disinfect acid concentrate mixing equipment, as specified by the equipment manufacturer or, in the case where no specifications are given, as defined by facility policy.

(4) The facility shall maintain records of disinfecting and rinsing disinfectants to safe residual levels.

(l) 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 disinfection and rinsing of all internal surfaces.

(1) Facility staff shall not pre-fill bicarbonate concentrate mixing tanks the night before use, and mixed solution shall not remain in mixing or holding tanks overnight.

(2) If disinfectant remains in the mixing tank overnight, facility staff shall completely drain this solution, rinse the tank and test for residual disinfectant before preparing the first batch of that day of bicarbonate concentrate.

(3) Facility staff shall empty the container and rinse with dialysis-quality water before mixing a new batch of bicarbonate solution, and staff shall not mix unused portions of bicarbonate concentrate with fresh concentrate.

(4) At a minimum, facility staff shall disinfect bicarbonate distribution systems weekly. Facility staff shall disinfect the bicarbonate distribution systems more frequently if required by the manufacturer's directions for use, or if dialysate culture results comply with §507.30 of this subchapter.

(5) If facility staff reuse jugs to deliver bicarbonate concentrate to individual hemodialysis machines, staff shall:

(A) empty jugs of concentrate, rinse jugs with dialysis-quality water, and invert jugs to drain at the end of each treatment day;

(B) rinse pick-up tubes with dialysis-quality water and allow tubes to air dry at the end of each treatment day;

(C) at a minimum, disinfect jugs and pick-up tubes weekly, and the facility QAPI committee shall consider more frequent jug and pick-up tube disinfection if dialysate culture results comply with §507.30 of this subchapter; and

(D) following disinfection:

(i) drain jugs, rinse jugs using dialysis-quality water to ensure jugs are free of residual disinfectant, and invert jugs to dry;

(ii) rinse pick-up tubes using dialysis-quality water to ensure tubes are free of residual disinfectant, and allow the tubes to air dry; and

(iii) test jugs and pick-up tubes for residual disinfectant and document the test results.

(m) The facility shall label all mixing tanks, bulk storage tanks, dispensing tanks, and containers for single hemodialysis treatments to indicate the contents of the tank or container.

(1) Before batch preparation, facility staff shall affix a label to the mixing tank that includes the date of preparation, tank contents, and chemical composition or formulation of the concentrate being prepared. This labeling shall remain on the mixing tank until the tank has been emptied.

(2) A facility shall permanently label bulk storage and dispensing tanks to identify the chemical composition or formulation of their contents.

(3) A facility shall, at a minimum, sufficiently label single-machine containers to differentiate the contents from other concentrate formulations used in the facility and permit positive identification by users of container contents.

(n) A facility shall maintain permanent records of batches produced to include the concentrate formula produced, volume of the batch, lot numbers of powdered concentrate packages, manufacturer of the powdered concentrate, date and time of mixing, test results, person performing mixing, and expiration date, if applicable.

(o) If facility staff prepare acid and bicarbonate concentrates in the facility, the facility shall ensure completion of preventive maintenance in accordance with the manufacturer's direction for use. The facility shall maintain records indicating the date, time, facility staff performing the procedure, and results, if applicable.

§507.35. Reuse of Hemodialyzers and Related Devices.

(a) Reuse practice in a facility shall comply with the standards listed in §507.30 of this subchapter (relating to Technical Standards) and the CMS Conditions for Coverage.

(b) Facility staff shall review the dialyzer manufacturer's labeling to determine whether a specific dialyzer requires special considerations.

(c) Facility staff shall reuse arterial lines only when the arterial lines are labeled for reuse by the manufacturer, and the manufacturer-established protocols for the specific line are approved by the United States Food and Drug Administration.

(d) The water supply in the reuse room shall incorporate a check valve to prevent chemical agents used from inadvertently back flowing into the water distribution system.

(e) Ventilation systems in the reuse room shall meet the requirements of Subchapter Z of this chapter (relating to Physical Plant and Construction Requirements) and be connected to an exhaust system to the outside that is separate from the building exhaust system, have an exhaust fan located at the discharge end of the system, and have an exhaust duct system of noncombustible corrosion-resistant material, as needed to meet the planned usage of the system. Exhaust outlets shall be above the roof-level and arranged to minimize recirculation of exhaust air into the building.

(f) A facility shall establish, implement, and enforce a policy for dialyzer reuse criteria (including any facility-set number of reuses allowed) that is included in patient education materials and posted in the waiting room and patient treatment areas. A dialyzer may be reused only if the dialyzer's original volume is measured and recorded before its first use, and the volume of that dialyzer is used as the basis for discard for that dialyzer.

(g) A facility shall consider and address the health and safety of patients sensitive to disinfectant solution residuals.

(h) A facility shall provide each patient with information regarding the reuse practices at the facility and the opportunity to have questions answered.

(i) A facility shall restrict the reprocessing room to authorized personnel during the reprocessing of dialyzers.

(j) If a facility participates in centralized reprocessing at a different location, in which dialyzers from multiple facilities are reprocessed at one site, the facility shall:

(1) ensure direct communication with the medical director at the centralized reprocessing center and the facility medical director;

(2) require the use of an automated reprocessing facility;

(3) maintain responsibility and accountability for the entire reuse process;

(4) adopt, implement, and enforce policies to ensure the transfer and transport of used and reprocessed dialyzers to and from the off-site location does not increase contamination of the dialyzers or the environment;

(5) ensure that each dialyzer is returned to the appropriate facility or patient home, and a system shall be established to verify that the correct dialyzers are being returned to each patient's home in the case of home patients who participate in a dialyzer reprocessing program; and

(6) provide Texas Health and Human Services Commission staff access to the off-site reprocessing site as part of a facility inspection.

§507.36. Infection Control.

(a) A facility shall follow Standard Precautions for all patient care activities in accordance with Code of Federal Regulations, Title 29 §1910.1030(d)(1) - (3) (relating to Bloodborne Pathogens) and Texas Health and Safety Code Chapter 85, Subchapter I (relating to Prevention of Transmission of HIV and Hepatitis B Virus by Infected Health Care Workers).

(1) The facility shall demonstrate that it follows standard infection control precautions by implementing the most current Recommended Infection Control Practices for Hemodialysis Units developed by the Centers for Disease Control and Prevention, to prevent and control cross-contamination and the spread of infectious agents.

(2) The facility and facility staff shall take infection control precautions for all patients.

(A) Facility staff shall wear disposable gloves when caring for a patient or touching the patient's equipment or bloodlines at the dialysis station.

(B) Facility staff shall remove gloves and clean hands between each patient contact, and after touching blood, body fluids, secretions, excretions, and contaminated items or station.

(C) Enough sinks, with water and soap shall be available to facilitate handwashing. Sink faucets shall have hands-free operable controls to activate the water flow, which may include a single-lever, wrist blade lever, electronic sensor faucet, or an elbow or wrist action faucet. Provisions for hand drying shall be included at each handwashing sink.

(D) If hands are not visibly soiled, staff may substitute use of a waterless antiseptic hand rub for handwashing. Staff shall wash with soap and water when hands are visibly soiled.

(E) Facility staff shall wear gowns, eye protection, and, where applicable, masks to protect themselves and prevent soiling clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning dialyzers, and centrifuging blood). If visibly soiled, gowns shall be changed and discarded immediately.

(F) Facility staff shall not eat, drink, or smoke in the dialysis treatment area or laboratory.

(G) For an item taken to the dialysis station, facility staff shall:

(i) dispose of the item;

(ii) dedicate the item for use only on a single patient; or

(iii) clean and disinfect the item before taking the item to a common clean area or using the item on another patient.

(H) Facility staff shall dedicate non-disposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) for use on only a single patient.

(I) Facility staff shall use unused medications or supplies (syringes, alcohol swabs, etc.) taken to the patient's station for only that patient and not return the medications or supplies to a common clean area or use the medications or supplies on other patients.

(J) A facility shall clearly designate clean areas for preparing, handling, and storing medications and unused supplies and equipment. Facility staff shall not handle or store medications or clean supplies in the same or an immediately adjacent area where facility staff handle used supplies, equipment, or blood samples.

(K) A facility shall clearly designate contaminated areas where staff handle used supplies, equipment, or blood samples.

(L) When facility staff use multiple dose medication vials (including vials containing diluents), staff shall prepare individual patient doses in a clean, centralized area away from dialysis stations and deliver the medication separately to each patient.

(M) Facility staff shall not carry multiple dose medication vials from station to station.

(N) Facility staff shall not use common medication carts to deliver medications to patients. If facility staff use trays to deliver medications to individual patients, staff shall clean and disinfect the trays after delivering medications to each patient.

(O) If facility staff use a common supply cart to store clean supplies in the patient treatment area, this cart shall remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Staff shall not move such carts between stations to distribute supplies.

(P) Facility staff shall not carry medication vials, syringes, alcohol swabs, or supplies in their pockets.

(3) The facility shall ensure the location and arrangement of handwashing sinks permit ease of access and proper use.

(4) Facility staff shall explain the potential risks associated with blood and blood products to patients and family members and provide the indicated personal protective equipment to a patient or family member, if the patient or family member assists in procedures that could result in contact with blood or body fluids. Facility staff shall encourage patients to clean their access sites before each treatment and their hands following their treatment.

(b) A facility shall designate a staff member to monitor and coordinate infection control activities.

(c) A facility shall develop, maintain, and enforce a system to identify and track infections to allow identification of trends or patterns. This activity shall be reviewed as a part of the facility's quality assessment and performance improvement (QAPI) program described in §507.43 of this chapter (relating to Quality Assessment and Performance Improvement). The record shall include trends, corrective actions, and improvement actions taken.

(d) Facility staff shall replace a transducer protector when wetted during a dialysis treatment and use a transducer protector for only one treatment. If fluid or blood is visible on the side of the transducer protector that faces the machine, the machine must be opened by qualified personnel after the dialysis treatment to allow the internal transducer to be inspected for contamination, including inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port.

§507.38. Disease Prevention.

(a) The facility shall take the following measures for Hepatitis B prevention.

(1) The facility shall offer Hepatitis B vaccination to all previously unvaccinated, susceptible new staff members in accordance with Code of Federal Regulations, Title 29 §1910.1030(f)(1) - (2) (relating to Bloodborne Pathogens). Staff vaccination records shall be maintained in each staff member's health record.

(2) With an order from the patient's 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 the vaccination.

(3) The facility shall ensure the most recent Centers for Disease Control and Preventions (CDC) Hepatitis B Vaccine Information Statement is available to patients.

(4) The facility shall ensure serologic screening of patients.

(A) The facility must record the Hepatitis B virus (HBV) serological status to include Hepatitis B surface antigen (HbsAg), total anti-Hepatitis B core antibody (anti-HBc), and antibody to Hepatitis B surface antigen (anti-HBs) of all patients before admission to the hemodialysis unit. The facility shall maintain the anti-HBc results obtained previously or on admission in the clinical record and repeated only if clinically indicated.

(B) A patient returning to a facility after extended hospitalization or absence of 30 calendar days or longer shall have been screened for HbsAg within one month before or at the time of admission to the facility or have a known anti-HBs status of at least 10 milli-international units per milliliter no more than 12 months before admission. The facility shall document how this screening requirement is met.

(C) Repeated serologic screening shall be based on the patient's antigen or antibody status.

(i) Monthly screening for HbsAg is required for patients whose previous test results are negative for anti-HBs.

(ii) Screening of HbsAg-positive or anti-HBs-positive patients may be performed on a less frequent basis but shall be performed at least annually.

(5) The facility shall follow appropriate isolation procedures for an HBsAg-positive patient.

(A) An end stage renal disease (ESRD) facility licensed before February 9, 2009, shall comply with §507.16(c)(8) of this chapter (relating to Change in Status). An ESRD facility licensed after February 9, 2009, shall treat patients positive for HBsAg in a separate treatment room that complies with Subchapter Z of this chapter (relating to Physical Plant and Construction Requirements).

(B) Separate dedicated supplies and equipment, including blood glucose monitors, shall be used to provide care to the Hepatitis B positive patients. All supplies used in the isolation area or room, such as clamps, blood pressure cuffs, testing reagents, etc., shall be labeled "isolation" and not routinely removed from the isolation area or room.

(C) Refillable concentrate containers shall be surface disinfected at the completion of each treatment. Refillable acid concentrate containers shall be kept in the isolation area or room and refilled at the door. Refillable bicarbonate concentrate containers shall be removed for cleaning and disinfection. In the disinfection area, containers labeled "isolation" containers and pick-up tubes shall be segregated in a dedicated, designated area away from all other containers and pick-up tubes.

(D) Separate gowns shall be used in the isolation area or room and removed before leaving the isolation area or room. Anyone entering the isolation area or room during the patient's treatment shall wear a protective gown. Gowns used in the isolation area or room shall be discarded at the end of each treatment day. If visibly soiled, gowns shall be changed and discarded immediately.

(E) Dedicated cleaning supplies (such as a mop and bucket) for cleaning the isolation area or room and blood spills shall be used and labeled "isolation."

(F) A patient who tests positive for HBsAg shall be dialyzed on equipment reserved and maintained for an HBsAg-positive patient's use only.

(G) When a direct patient care staff member is assigned to both HBsAg-negative and HBsAg-positive patients, the HBsAg-negative patients assigned to this grouping shall be Hepatitis B antibody positive. Hepatitis B antibody positive patients are to be seated at the treatment stations nearest the isolation station and assigned to the same staff member who is caring for the HBsAg-positive patient.

(H) If an HBsAg-positive patient is discharged, the equipment that had been reserved for that patient shall be given intermediate-level disinfection before use for a patient testing negative for HBsAg.

(I) In the case of patients new to dialysis or a patient returning to a facility after extended hospitalization or absence of 30 calendar days or longer, 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.

(i) The facility shall treat potentially HBsAg-positive patients in a location in the treatment area that is outside of traffic patterns and shall not reuse the dialyzer until the HBsAg test results are known.

(ii) The dialysis machine used by the HBsAg-positive patient shall be given intermediate-level disinfection before its use by another patient.

(iii) The facility shall obtain the patient's HBsAg status results within three calendar days of admission.

(b) The facility shall take the following measures for tuberculosis prevention.

(1) The facility direct care staff shall be screened for tuberculosis upon employment before patient contact, or provide documentation of negative tuberculosis status, per current CDC recommendations.

(2) Subsequent screening of facility staff shall be performed after any potential exposure to laryngeal or pulmonary tuberculosis, per current CDC recommendations.

(3) Facility staff shall follow the facility's respiratory isolation procedures and precautions when providing treatment to patients with pulmonary tuberculosis.

(4) The facility shall screen patients for tuberculosis when indicated by the presence of risk factors for, or the signs and symptoms of tuberculosis. Screening shall be performed after potential exposure to active laryngeal or pulmonary tuberculosis, per current CDC recommendation.

(c) The facility shall adopt, implement, and enforce a policy for offering and providing pneumococcal and influenza vaccines. The policy shall:

(1) include provisions that the influenza vaccine shall be offered according to the CDC annual recommendations, and the pneumococcal vaccine shall be offered throughout the year;

(2) require the facility staff administering the vaccine to ask the patient if they are currently vaccinated against influenza or pneumococcal disease, assess potential contraindications, and then, if appropriate, administer the vaccine under approved facility protocols;

(3) address required vaccination documentation in the patient clinical record; and

(4) include that the Texas Health and Human Services Commission may waive vaccine administration requirements based on established vaccine shortages.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on December 3, 2025.

TRD-202504417

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 23, 2025

Proposal publication date: June 6, 2025

For further information, please call: (512) 834-4591

SUBCHAPTER D. OPERATIONAL REQUIREMENTS FOR PATIENT CARE AND TREATMENT

STATUTORY AUTHORITY

The new rules are adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system; Texas Health and Safety Code §251.003, which requires HHSC to adopt rules for the issuance, renewal, denial, suspension, and revocation of a license to operate an end stage renal disease facility; and Texas Health and Safety Code §251.014, which requires these rules to include minimum standards to protect the health and safety of a patient of an end stage renal disease facility.

§507.41. Governing Body.

(a) The facility shall have an identified governing body responsible for the facility's organization, management, control, and operation, including appointing the facility's medical director as defined in §507.2 of this chapter (relating to Definitions).

(b) A facility may request in writing a waiver to appoint or retain as medical director a physician who does not meet one or more of the qualifications in §507.2(49)(B) of this chapter. The request shall explain why a physician meeting the board certification requirement is not available and include the physician's resume for the physician the facility seeks to appoint or retain. The facility shall make the request through the Texas Health and Human Services Commission (HHSC) Health Facility Licensing Unit, for transmission to the CMS. The facility may not appoint or retain as medical director a physician who does not meet one or more of the qualifications in §507.2(49)(B) of this chapter until the facility receives approval from CMS.

(c) The governing body shall develop, implement, and enforce policies and procedures for all services provided by the facility.

(d) The governing body shall adopt, implement, and enforce policies and procedures to ensure compliance with current laws, rules, and regulations pertaining to medical staff.

(e) The governing body shall implement and annually review current and effective administrative rules, regulations, and policies designed to protect patient health and safety.

(f) The governing body shall ensure 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 at least biannually.

(g) The governing body shall ensure all facility staff, including advanced practice registered nurses (APRN), physician assistants (PAs), registered nurses, licensed vocational nurses, licensed master social workers, registered dietitians, patient care technicians, and other technical staff, are qualified to serve the complex needs of dialysis patients and deliver dialysis services. APRNs, PAs, registered nurses, licensed vocational nurses, licensed master social workers, registered dietitians, patient care technicians, and other technical staff shall demonstrate and sustain the skills and any professional licensures required to perform the specific duties of their positions.

(h) The governing body shall ensure adequate numbers of qualified personnel are present whenever patients are undergoing dialysis so that the patient to staff ratio is appropriate to the level of dialysis care given and meets the needs of patients, including meeting the minimum staffing requirements demonstrated in §507.60 of this chapter (relating to Staffing Table).

(i) The governing body shall review, approve, and implement the facility's training program for staff, patients, and caregivers.

(j) The governing body shall develop, implement, and enforce policies and procedures relating to the facility's emergency preparedness plan to meet the requirements of §507.46 of this subchapter (relating to Emergency Preparedness). The plan shall address the continuity of essential building systems including emergency power and water, or a contract with another licensed end stage renal disease (ESRD) facility to provide emergency contingency care to patients to meet the requirements of Subchapter Z of this chapter (relating to Physical Plant and Construction Requirements).

(k) The governing body shall ensure all equipment used by facility staff or patients is properly maintained in accordance with the manufacturer's directions.

(l) The governing body shall ensure the facility's physical environment protects the health and safety of patients, personnel, and the public. The licensed facility site and the facility's surrounding physical structure used by the patients (including stairwells, corridors, and passageways) shall meet the local building and fire safety codes and standards as they relate to design and space requirements for safe access and patient privacy.

(m) 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.

(n) The governing body shall ensure that all facility staff members have access to the most current version of all applicable laws, rules, and regulations.

§507.42. Patient Rights.

(a) Each facility shall adopt, implement, and enforce policies and procedures appropriate to the patient population served to ensure each patient is:

(1) treated with respect, dignity, and full recognition of the patient's individuality and personal needs;

(2) provided privacy and confidentiality for the patient and the patient's clinical record;

(3) provided a safe, sanitary, and comfortable treatment environment;

(4) provided information in a manner to facilitate understanding by the patient and the patient's legal representative, family member, or significant other, as applicable, including patient information materials available in the appropriate language;

(5) provided an interpreter, interpreter service, or visual and hearing assistance if written materials in the patient's primary language are not available or not appropriate for the patient's needs;

(6) informed by a physician of the patient's medical status;

(7) informed of and provided education regarding all treatment modalities and settings, including self-care and transplant, for the treatment of end stage renal disease upon initiating treatment and an annual basis thereafter;

(8) informed about and provided the opportunity to participate in all aspects of care, including plan of care meetings, the right to refuse treatment, and the medical consequences of such refusal;

(9) informed of all services available in the facility and all charges for services provided;

(10) informed about the facility's reuse of dialysis supplies, including hemodialyzers, and if printed materials such as brochures are used to describe a facility and its services the brochures shall contain a statement describing the methods and procedures used when such supplies are reused;

(11) assured of a reasonable response by the facility to the patient's requests and needs for treatment or service, within the facility's capacity, the facility's stated mission, and applicable law and regulation;

(12) provided hours of dialysis that are scheduled for patient convenience whenever feasible or possible, with consideration is given to the patient's work or school schedule;

(13) transferred or discharged only for medical reasons, for the patient's welfare or that of other patients or staff members, or for nonpayment of fees; and given 30 calendar days advance notice in the event of a transfer or discharge, except in cases where the patient presents an immediate risk to others;

(14) given an opportunity and assistance to improve problematic behavior before dismissal from the facility;

(15) protected from abuse, neglect, or exploitation;

(16) provided information regarding advance directives and allowed to formulate such directives to the extent permitted by law, including documents executed under Texas Health and Safety Code Chapter 166 (relating to Advance Directives);

(17) fully informed on how to file a complaint against the facility without fear of reprisal or denial of services, including a written statement provided at the time of admission informing patients of their rights to make a complaint directly to Texas Health and Human Services Commission (HHSC) Complaint and Incident Intake;

(18) fully informed of the rights listed in this section, the responsibilities established by the facility, and all rules and regulations governing patient conduct and responsibilities, including a written copy of the patient's rights and responsibilities provided upon admission to each patient or the patient's legally authorized representative; and

(19) fully informed of the patient plan of care process, including the necessary services outlined in the patient plan of care.

(b) A facility shall prominently and conspicuously post a legible and current copy of the patient rights and facility license certificate in one or more public areas of the facility, so that the posting is readily available and observable to all facility patients, staff, and visitors.

(c) A facility shall obtain written informed consent for dialysis services from the patient or the patient's legally authorized representative.

(d) A facility shall not discriminate based on a patient's disability and shall comply with Texas Health and Safety Code Chapter 161, Subchapter S (relating to Allocation of Kidneys and Other Organs Available for Transplant).

§507.48. Nursing Services.

(a) The facility shall provide nursing services to prevent or reduce complications, maximize the patient's functional status, and educate the end stage renal disease patient, patient's family, patient's caregiver, or significant other.

(b) The facility shall employ a full-time supervising nurse to supervise and manage the provision of safe patient care. A facility shall not use contract staff as a full-time supervising nurse.

(c) The facility shall ensure a registered nurse is in the facility when patients are present in the facility.

(1) The facility's governing body shall develop policies and procedures for allowing patients in the building when a registered nurse is not present and inclement weather or safety concerns exist. The policies and procedures shall require a review of any occurrence when patients are allowed in the building when a registered nurse is not present. Facility staff shall present the date of the incident, reasons, patients affected, and staff present to the facility's quality assessment and performance improvement (QAPI) committee and governing body for review and development of an appropriate plan.

(2) In inclement weather or due to safety concerns, when two or more basic cardiopulmonary life support-trained staff members are in the facility, patients may enter the facility lobby in accordance with the facility's policies and procedures.

(d) A registered nurse shall conduct:

(1) admission nursing assessments;

(2) assessments of a patient upon a change in the patient's status, extended or frequent hospitalizations, or at the patient's request;

(3) dialysis assessments on all patients within the first hour of treatment each time the patient receives treatment; and

(4) immediate assessments if an abnormal finding or change of condition is identified pre-dialysis, intradialytic, or post-dialysis.

(e) A registered nurse shall participate in the interdisciplinary team review of a patient's progress and recommend changes in treatment based on the patient's current needs and facilitate communication between the patient, patient's family, and the patient's significant other, as applicable, and other interdisciplinary members, to ensure the facility delivers the necessary care.

(f) A registered nurse shall provide oversight and direction to dialysis technicians and licensed vocational nurses.

(g) A registered nurse shall participate in the facility's QAPI activities.

(h) A registered nurse functioning in the charge role shall be present during all dialysis treatments.

(i) If the facility provides pediatric dialysis, a registered nurse with experience or training in pediatric dialysis shall be available to provide care for pediatric dialysis patients smaller than 35 kilograms in weight.

(j) The facility shall ensure sufficient direct care staff, as defined in §507.2(26) of this chapter (relating to Definitions), are on site to meet the needs of the patients, and at least one licensed nurse is available on site for every 12 patients or portion thereof, as demonstrated in §507.60 of this subchapter (relating to Staffing Table). The nurse can be either a registered nurse (RN) or licensed vocational nurse (LVN). A registered nurse functioning in the charge role shall be present during all dialysis treatments. Each direct care staff shall only be assigned a maximum of four patients.

(1) During treatment of seven or fewer patients, direct care staff shall consist of at least one registered nurse and one direct care staff, as demonstrated in §507.60 of this subchapter.

(2) For one to seven patients, the direct care staff may be assigned a maximum of four patients and the charge nurse may be assigned a maximum of three patients.

(3) During treatment of 8-12 patients, the registered nurse functioning as charge nurse shall not be assigned as direct care staff, as demonstrated in §507.60 of this subchapter.

(4) For pediatric dialysis patients, one registered nurse shall be provided on site for each patient weighing less than 10 kilograms and one registered nurse provided on site for every two patients weighing from 10 to 20 kilograms.

(k) A facility shall ensure patients are in view of staff during hemodialysis treatments, and staff shall observe the patient, their access site, and their bloodline connections during the dialysis treatment.

(l) The facility shall include documentation in the patient's record verifying the patient was educated during treatment, upon admission, and annually on the importance of leaving their access sites uncovered.

(m) A licensed nurse or dialysis technician shall collect and document objective and subjective data for each patient before and after treatment, according to facility policy and the staff member's level of training.

(1) The facility shall have written policies and procedures specific to the facility to guide nursing staff actions in the event a patient's condition deteriorates during treatment to identify parameters which would require a patient be referred to a nurse for evaluation.

(2) A registered nurse shall conduct a patient assessment when indicated by a question relating to a change in the patient's status or at the patient's request.

(n) A registered nurse shall conduct the initial patient assessment before the patient's first dialysis treatment by the facility.

(o) This chapter does not preclude a licensed vocational nurse (LVN) from practicing in accordance with the rules adopted by the Texas Board of Nursing. If the LVN is acting in the capacity of a dialysis technician, the facility shall determine that the LVN has passed a training and competency evaluation curriculum that meets the requirements in §507.72 of this chapter (relating to Training Curricula and Instructors) and §507.73 of this chapter (relating to Competency Evaluation).

(p) A dialysis technician providing direct patient care shall demonstrate knowledge and competency for the responsibilities specified in §507.72 and §507.73 of this chapter.

§507.49. Nutrition Services.

(a) A facility shall provide nutrition services to a patient and the patient's caregivers to maximize the patient's nutritional status.

(b) The dietitian shall be responsible for:

(1) conducting a nutrition assessment of a patient;

(2) participating in an interdisciplinary team review of a patient's progress;

(3) recommending therapeutic diets in consideration of cultural preferences and changes in treatment based on the patient's nutritional needs in consultation with the patient's physician;

(4) counseling a patient, a patient's family, and a patient's significant other, as applicable, on prescribed diets and monitoring adherence and response to diet therapy;

(5) referring a patient for assistance with nutrition resources such as financial assistance, community resources, or in-home assistance;

(6) participating in the facility's quality assessment and performance improvement (QAPI) activities; and

(7) providing ongoing monitoring of subjective and objective data to determine the need for timely intervention and follow-up, including weight changes, blood chemistries, adequacy of dialysis, and medication changes that affect nutrition status and potentially cause adverse nutrient interactions.

(c) The dietitian shall contact the patient to document and complete the patient's comprehensive nutrition assessment with an educational component no later than 30 calendar days or 13 treatments after the patient's admission to the facility, whichever occurs later.

(d) The dietitian shall conduct a nutrition reassessment no less than annually or upon a change in the patient's status, extended or frequent hospitalizations, a change in the patient's modality, or at the patient's request.

(e) Each facility shall employ or contract with a dietitian to provide clinical nutrition services for each patient.

(1) The maximum caseload for a full-time equivalent dietitian is 125 patients. The caseload is cumulative across all modalities and facilities where the dietitian is employed. A facility shall employ or contract a second dietitian for a patient caseload over 125 patients.

(2) The governing body shall ensure the facility assigns personnel to assist dietitians with ancillary tasks when the patient load, including all modalities, exceeds 100 patients per facility.

(f) The facility shall ensure nutrition services are available at the facility during scheduled patient treatment times. A patient may need an appointment to access nutritional services.

(g) A facility shall have written physician standing orders specific to that facility authorizing delegation of responsibilities for the facility dietitian, as determined by the medical director and the facility.

(1) The medical director shall review and approve the standing orders at least annually.

(2) The standing orders shall be consistent with the statutes and rules of the Texas Medical Board, Texas Board of Nursing, and Texas Department of Licensing and Regulation.

(h) When the facility uses a medication algorithm or protocol for managing renal bone disease, the nutritional care for each patient shall be individualized.

§507.51. Social Services.

(a) A facility shall provide social services to patients and their families that are directed at supporting and maximizing the patient's adjustment, social functioning, and rehabilitation.

(b) The social worker is responsible for:

(1) conducting psychosocial evaluations, which include health-related quality of life surveys;

(2) participating in the interdisciplinary team review of a patient's progress;

(3) providing an ongoing assessment and recommend changes in treatment based on the patient's current psychosocial needs;

(4) providing social work interventions including counseling, case work, and group work services to patients and their families experiencing special problems associated with end stage renal disease;

(5) identifying community social agencies and other community resources, and assisting patients and families to use them;

(6) participating in the facility's quality assessment and performance Improvement (QAPI) activities; and

(7) assisting patients to achieve optimum levels of productive activity and making rehabilitation referrals as appropriate.

(c) The facility shall ensure the social worker initially contacts the patient and documents the initial contact no later than 30 calendar days or 13 treatments from the patient's admission, whichever occurs later. Qualified facility staff shall complete comprehensive psychosocial assessment no later than 30 calendar days or 13 treatments from the patient's admission to the facility, whichever occurs later.

(d) Qualified facility staff shall conduct a governing-body-approved psychosocial and quality of life reassessment as needed, but no later than 90 calendar days after the initial assessment and at least annually thereafter, and when there is:

(1) a significant change to the patient's psychosocial needs;

(2) extended or frequent hospitalizations;

(3) any event that would interfere with the patient's ability to follow aspects of the plan of care;

(4) a change in the patient's modality; or

(5) at the patient's request.

(e) Each facility shall employ or contract with a social worker to meet the psychosocial needs of the patients.

(1) The facility shall ensure one full-time equivalent of qualified social worker time is available for up to 125 patients per facility, which is the maximum case load for all modalities available in the facility. The caseload is cumulative across all modalities and facilities where the social worker is employed. The facility shall employ or contract a second social worker for a patient caseload over 125.

(2) The governing body shall ensure the facility assigns personnel to assist social workers with ancillary tasks, such as assistance with financial services, transportation, and administrative and clerical duties, when the patient load, including all modalities, exceeds 100 patients per facility.

(f) The facility shall ensure social services are available at the facility during scheduled patient treatment times. A patient may need an appointment to access social services.

§507.52. Medical Services.

(a) The medical director shall meet the requirements set forth in the CMS Conditions for Coverage and is responsible for:

(1) developing facility treatment goals that are based on review of aggregate data assessed through quality assessment and performance improvement (QAPI) activities;

(2) ensuring adequate training of licensed nurses and dialysis technicians;

(3) adequate monitoring of patients and the dialysis process;

(4) developing, implementing, and enforcing all policies required by this chapter;

(5) ensuring the facility's attending physicians follow the facility's policies and procedures, and the physicians follow the facility's established treatment and clinical standards, including quality, safety, and infection control standards; and

(6) ensuring all facility care staff, including nurses, patient care technicians, social workers, dietitians, physicians, and other ancillary staff receive annual training in all modalities, including transplant.

(b) The facility shall meet the following requirements regarding medical staff responsibilities.

(1) Each patient shall be under the care of a licensed and qualified nephrologist on the medical staff, or a physician on the medical staff who has demonstrated experience treating dialysis patients for at least 18 months.

(2) Each pediatric dialysis patient shall be under the care of a pediatric nephrologist or under the care of an adult nephrologist with direct patient evaluation by a pediatric nephrologist as follows:

(A) for patients two years of age or younger, monthly (two of three evaluations may be conducted by phone);

(B) for patients 3-12 years of age, quarterly; and

(C) for patients 13-18 years of age, semiannually.

(3) For each patient receiving dialysis in the facility, a physician on the facility's medical staff shall see the patient at least twice a month. The physician shall conduct the first visit in person. The second visit is required unless the patient is stable, as justified in the patient record by the physician. If the second visit is necessary, it shall be separated from the first visit by at least 10 calendar days and may be conducted in person or using telemedicine. Additional visits conducted in the same month by a physician may be conducted using telemedicine.

(4) Home dialysis patients shall be seen by a physician, an advanced practice registered nurse (APRN), or a physician assistant (PA) no less than once a month.

(A) The physician shall see the patient in person at least once every three months.

(B) The physician shall conduct physician visits required by subparagraph (A) of this paragraph in person and may conduct the visit in the dialysis facility, at the physician's office, or in the patient's home. The physician may conduct additional visits in the same month using telemedicine.

(C) An APRN or a PA may conduct the visits required by this paragraph using telemedicine.

(D) The record of these contacts shall include evidence of assessment for new and recurrent problems and review of dialysis adequacy each month.

(5) The facility shall ensure a physician on the medical staff is on call and available 24 hours a day (in person or by telecommunication) to patients and staff.

(6) The physician shall verify and sign all orders for treatment. Facility staff shall update routine orders for treatment at least annually. Any changes in patient treatment shall be per physician's order.

(A) Orders for hemodialysis treatment shall include length of treatment, dialyzer, blood flow rate, dialysate composition, target weight, all medications administered during or needed for treatment, and specific infection control measures, as needed.

(B) Orders for peritoneal dialysis treatment shall include fill volumes, number of exchanges, dialysate concentrations, catheter care, medications, and specific infection control measures, as needed.

(c) If the facility uses APRNs or PAs:

(1) the facility shall ensure documented evidence of communication with the treating physician whenever the APRN or PA changes treatment orders;

(2) the APRN or (PA) shall not replace the physician in participating in patient care planning or in QAPI activities;

(3) the APRN or PA shall not replace the physician for the completion of assessments, as defined by the CMS Conditions for Coverage, or for the twice monthly evaluation of the in-center dialysis patient;

(4) the APRN or PA shall notify the treating physician of patient medical emergencies;

(5) the APRN or PA shall meet the requirements established by the Texas Board of Nursing (for an APRN) or the Texas Physician Assistant Board (for a PA); and

(6) the APRN or PA shall use mechanisms that provide authority for that care, which shall include protocols or other written authorization:

(A) reviewed and approved by the APRN or PA and the appropriate physician;

(B) signed by both the APRN or PA and the physician;

(C) reviewed and re-signed at least annually;

(D) maintained in the practice setting of the APRN or PA; and

(E) made available as necessary to the Texas Health and Human Services Commission (HHSC) to verify authority to provide medical aspects of care.

(d) The facility shall comply with Texas Health and Safety Code Chapter 166 (relating to Advance Directives) concerning out-of-hospital do-not-resuscitate orders.

(e) If the facility has a contract or agreement with an accredited school of health care for the school to use their facility for a portion of the students' clinical experience, those students may provide care under the following conditions.

(1) The facility may offer clinical experience to students, provided the instructor is present at the facility, provides direct supervision to the student, and assumes responsibility for all student activities occurring within the facility.

(2) A student may administer medications only if:

(A) on assignment as a student at their school of health care; and

(B) under the immediate supervision of a qualified registered nurse on staff at the facility.

(3) A facility shall not use a student to fulfill the requirement for administration of medications by licensed personnel.

(4) A facility shall not consider a student when determining staffing levels required by the facility.

(5) A student shall not mix concentrate or test water quality.

(6) A student shall not accept or transcribe physician orders.

(7) A student shall not conduct the assessments of new or unstable patients.

(8) A qualified registered nurse shall directly supervise the students to protect the students and facility patients.

§507.53. Home Dialysis Service.

(a) A facility that provides home dialysis training, and support shall ensure through its interdisciplinary team that home dialysis services are at least equivalent to those provided to in-facility patients and meet all applicable licensure rules.

(b) A facility shall provide a separate room for home dialysis services, as defined in §507.2 of this chapter (relating to Definitions).

(1) The room shall include a handwashing sink with water and soap available to facilitate handwashing. Sink faucets shall have a hands-free operation to activate the water flow, which may include a single-lever, wrist blade lever, electronic sensor faucet, or an elbow or wrist action faucet. Provisions for hand drying shall be included at each handwashing sink.

(2) The facility shall clearly designate clean areas for preparing, handling, and storing medications and unused supplies and equipment. Facility staff shall not handle or store medications or clean supplies in the same or an immediately adjacent area where facility staff handle used supplies, equipment, or blood samples.

(3) The facility shall have a designated area with a separate sink for disposal of blood or body fluids. The facility shall clearly designate contaminated areas where staff handle used supplies, equipment, or blood samples.

(c) Patients may receive Training (Patient), as defined in §507.2 of this chapter (relating to Definitions), individually or in a small group setting. A facility must offer patients a choice of an individual or small group training setting and ensure the facility meets each patient's preferences and individual needs. Patient training must take place in person.

(d) When a patient completes home dialysis training, the facility shall assign each individual home dialysis patient, regardless of modality, one machine for the patient's exclusive use in the home. A facility shall not assign multiple home dialysis patients to the same machine.

(e) For home dialysis patients, including all modalities, a facility shall maintain a staffing level of one full-time equivalent registered nurse for every group of 25 patients. For 21 - 25 patients, the facility shall assign a licensed vocational nurse or a dialysis technician to assist the registered nurse.

(f) A registered nurse shall conduct home dialysis training. Before permitting a registered nurse to provide home dialysis training to a patient and a patient's caregiver, the facility shall:

(1) verify the registered nurse has:

(A) at least 12 months clinical nursing experience; and

(B) a minimum of three months experience, occurring within the last 24 months, in the specific modality with the responsibility for training the patient and the patient's caregiver;

(2) evaluate and document the nurse's ability to independently provide home dialysis training;

(3) document the nurse's competency to provide home dialysis training three months after passing the initial competency exam; and

(4) ensure all competency evaluations administered under this subsection contain the facility staff's signature evaluating the nurse's competency to provide home dialysis training.

(g) A facility's medical director shall develop and approve the home dialysis training curriculum. The home dialysis training curriculum shall comply with the following requirements.

(1) Training for each home dialysis patient shall address the patient's specific needs in the nature and management of end stage renal disease in a manner that complies with all patient privacy and infection control requirements.

(2) Training shall include the full range of techniques associated with the treatment modality selected, including the effective use of dialysis supplies and equipment in achieving and delivering the physician's prescription.

(3) Training of the patient and caregiver, as applicable, shall include:

(A) effective and safe administration of erythropoiesis-stimulating agents (if prescribed) to achieve and maintain a target level hemoglobin, hematocrit, and blood pressure levels, or hematocrit, as written in the patient's plan of care;

(B) how to detect, report, and manage potential dialysis complications, including water treatment problems;

(C) availability of support resources and how to access and use resources;

(D) how to self-monitor health status and record and report health status information;

(E) how to handle medical and nonmedical emergencies;

(F) infection control precautions;

(G) proper waste storage and disposal procedures;

(H) how to order supplies on an ongoing basis;

(I) not using non-medical electrical equipment within six feet of the home hemodialysis machine; and

(J) notifying the facility of any change in machinery used in home dialysis.

(4) Staff shall include documentation in the clinical record that the patient, the caregiver, or both, received and demonstrated adequate comprehension of the training.

(h) The interdisciplinary team shall oversee training of a home dialysis patient and the designated caregiver before the initiation of home dialysis, and when the home dialysis caregiver or home dialysis modality changes.

(i) A home dialysis training facility shall retrieve and review complete self-monitoring data and other information from the home dialysis self-care patient, or their designated caregiver, at least every two months, and maintain this information in the patient's clinical record in the facility.

(j) If a facility is unable to obtain a patient's self-monitoring data after an appropriate number of attempts, the physician must refer the case to the medical director for a determination about a potential modality change for the patient.

(k) A home dialysis training facility shall furnish home dialysis support services, regardless of whether dialysis supplies may be provided by the dialysis facility or a durable medical equipment company.

(l) A home dialysis training facility shall provide services as follows.

(1) The facility shall complete an initial monitoring visit of the patient's home adaptation by facility personnel (including the registered nurse responsible for training the patient in the chosen modality and technical staff as appropriate) in accordance with the patient's plan of care, before the patient begins training for the selected home modality, and periodically thereafter.

(2) The facility must make a monitoring visit to the patient's home in case of:

(A) patient's change of address,

(B) change in the patient's primary caregiver,

(C) disaster that impacts the patient's home,

(D) major renovation, or

(E) any other event that may impact the patient's care.

(3) A physician, an advanced practice registered nurse, or a physician assistant shall see a home dialysis patient in accordance with §507.52(b)(4) of this subchapter (relating to Medical Services).

(4) The interdisciplinary team shall develop and periodically review an individualized and comprehensive plan of care for the patient. The plan of care shall specify the services necessary to address the patient's needs and meet the measurable and expected outcomes, which meet a hemodialysis Kt/Vurea (Kt/V) of at least 1.2 (three times a week), or standard Kt/V of 2.0 (four to six times a week), or a peritoneal dialysis weekly Kt/V of at least 1.7, or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis.

(5) The facility shall provide patient consultation with interdisciplinary team members as needed.

(m) A home dialysis training facility shall monitor the quality of water and dialysate used by a home hemodialysis patient, including an initial on-site evaluation and testing of the water and dialysate system, and any time facility staff repairs or exchanges the water treatment equipment.

(1) A home dialysis training facility shall annually analyze the product water used for dialysate preparation to ensure the water meets the standards listed in §507.30 of this chapter (relating to Technical Standards).

(2) A home dialysis training facility shall test the water and dialysate system in accordance with the manufacturer's direction for use.

(3) A home dialysis training facility shall test the water and dialysate system in accordance with the system's United States Food and Drug Administration (FDA) approved labeling, for integrated hemodialysis system designed, tested, and validated to meet the quality (including standards for chemical and total chlorine testing) water and dialysate required by standards listed in §507.30 of this chapter. The facility shall meet testing and other requirements of the standards listed in §507.30 of this chapter, when using an integrated water and dialysate system, which is designed and validated to meet the standards listed in §507.30 of this chapter.

(4) A home dialysis training facility shall perform bacteriological and endotoxin testing of water used for dialysate preparation and dialysate monthly and ensure the results are within the limits allowed by the standards listed in §507.30 of this chapter.

(n) The dialysis facility shall correct any water and dialysate quality problem for the home hemodialysis patient, and if necessary, arrange for backup dialysis until the facility corrects the problem if:

(1) an analysis of the water and dialysate quality indicates contamination; or

(2) the home hemodialysis patient demonstrates clinical symptoms associated with water and dialysate contamination.

(o) The dialysis facility shall be responsible for arranging the purchase, lease, or rental of medically necessary home dialysis supplies and equipment, and the delivery, installation, repair, and maintenance of these supplies and equipment (including supportive equipment), as prescribed by the attending physician. If the patient purchases, leases or rents dialysis equipment, the facility shall ensure the equipment's installation, repair, and maintenance in accordance with the manufacturer's directions for use.

(p) The dialysis facility shall identify a plan and arrange for emergency backup dialysis services when needed.

(q) The dialysis facility shall maintain a recordkeeping system that ensures continuity of care and patient privacy.

(r) The dialysis facility, or the patient or patient's caregiver with facility oversight, shall culture and measure the hemodialysis machines of home patients for colony forming units and endotoxins before disinfection, at least quarterly or more frequently, as needed, or required by the standards listed in §507.30 of this chapter. The facility shall follow the manufacturer's recommendations regarding the proper procedure for disinfection. For integrated hemodialysis system devices, facility staff shall follow the device's FDA labeling and manufacturer's recommendations.

(s) As applicable, the facility shall maintain maintenance records for all dialysis machines and dialysis equipment at the licensed facility site.

(t) If required, the electrical connection for the home hemodialysis machines shall be connected to a ground-fault circuit interrupter (GFCI) receptacle in accordance with Subchapter Z of this chapter (relating to Physical Plant and Construction Requirements).

(u) The dialysis machine shall comply with the requirements of §507.33 of this chapter (relating to Water Treatment). The facility shall ensure that the water pressure in the patient's home meets the minimum requirement specified by the water treatment system's manufacturer.

(1) The facility shall meet the following requirements for an integrated hemodialysis system.

(A) The facility shall analyze the source water used for dialysate annually or if there is a change in the source water, to ensure the water quality meets the manufacturer's guidelines for source water purity.

(B) The facility shall obtain the product water chemical quality every six months before replacing the water purification disposable component, or when any modifications are made to the integrated hemodialysis system to ensure that the product water meets the current CMS guidelines.

(C) The facility shall provide a means for the patient or patient's caregiver to sample the product water to test for total chlorine levels immediately before using the dialysate. The total chlorine level shall comply with the standards listed in §507.30 of this chapter, and the results shall be documented by the patient or the patient's caregiver.

(D) If applicable, the facility, or the patient or patient's caregiver with facility oversight, shall obtain the microbiological quality of the dialysate at the end of a prepared dialysate bag, with the requirements at §507.33 of this chapter and §507.34 of this chapter (relating to Dialysate).

(2) If using a dialysis system that uses manufactured dialysate solution in its existing form, the facility shall use the system according to manufacturer's directions. The facility shall ensure patients receive necessary training and can demonstrate competencies to follow the manufacturer's directions for use.

(3) If using a peritoneal dialysis system that uses manufactured dialysis solution the facility shall use the system according to manufacturer's directions. The facility shall ensure that patients are trained and can demonstrate competencies to follow the manufacturer's directions for use.

(4) If using sorbent technology, the patient or facility staff shall test the sorbent regeneration dialysis system (machine) before each treatment with the manufacturer's self-test method, and the patient or facility staff shall document evidence of the self-test. The facility shall analyze the source water used for dialysate to ensure the water quality meets the manufacturer's guidelines for source water purity annually or if there is a change in the source water.

§507.54. Staff Qualifications.

(a) Facility staff (whether employees or contractors) shall meet the personnel qualifications and demonstrated competencies necessary to serve the needs of the patients. Facility staff shall demonstrate and sustain the skills needed to perform the specific duties of their positions.

(1) The facility shall develop and implement a written orientation program to familiarize all new employees (including office staff) with the facility, its policies, and their job responsibilities. The facility shall ensure that each new direct care staff member (whether employee or contractor) receives sufficient time to become familiar with the facility.

(A) The orientation program shall meet the following minimum time requirements.

(i) For individuals with previous dialysis experience, the orientation program shall be two weeks.

(ii) For new direct care staff members with no previous dialysis experience, the orientation program shall be two weeks plus additional time as determined by the facility.

(B) In facilities with similar policies and equipment, staff with dialysis experience oriented to one facility may be shared with another facility after a shorter orientation period. Each facility where a shared employee works shall keep documentation on file of the shared staff's current competency and tasks delegated by that facility's medical director to unlicensed technicians.

(C) A facility shall provide registered nurses with no previous dialysis experience an orientation program of a minimum of seven weeks. The seven-week orientation program shall contain content specific to end stage renal disease patient management and appropriate to the population served by the facility, including at least:

(i) fluid, electrolyte, and acid-base balance;

(ii) kidney disease and treatment;

(iii) dietary management of kidney disease;

(iv) principles of dialysis;

(v) dialysis technology;

(vi) venipuncture technique;

(vii) care of the dialysis patient;

(viii) psychological, social, financial, and physical complications of long-term dialysis;

(ix) prevention of hepatitis and other infectious diseases;

(x) risks and benefits of reuse (if reuse is practiced); and

(xi) all available treatment modalities, including the availability of kidney transplantation.

(2) A facility shall ensure each licensed nurse and dialysis technician demonstrates competency through written and skills testing after they complete the orientation program and annually thereafter. The facility shall maintain documented evidence of competency in writing in personnel files. Current certification by a nationally recognized board may substitute for the annual written test. The facility shall ensure all dialysis technicians receive certification from a national commercially available certification program within 18 months of being hired as a dialysis technician.

(b) A facility shall ensure medical staff meet the following requirements.

(1) Each physician on the medical staff shall have a current license to practice medicine in the state of Texas.

(2) If a facility uses an advanced practice registered nurse, that individual shall meet the requirements established by the Texas Board of Nursing in Texas Administrative Code, Title 22 (22 TAC), Chapter 221 (relating to Advanced Practice Nurses).

(3) If a facility uses a physician assistant, that individual shall meet the requirements established by the Texas Medical Board in 22 TAC Chapter 185 (relating to Physician Assistants).

(c) A facility shall ensure nursing staff meet the following requirements.

(1) Each individual licensed as a nurse shall have a current Texas license to practice nursing in accordance with the statutes and rules of the Texas Board of Nursing, or a current license from another state in the Nurse Licensure Compact (NLC).

(2) Each registered nurse assigned charge nurse responsibilities shall have at least 12 months of clinical experience and six months experience in hemodialysis after completing the facility's training program.

(A) For a newly licensed registered nurse, the last six months of clinical experience may run concurrently with the six months of dialysis experience.

(B) The hemodialysis experience shall be within the last 24 months.

(C) A registered nurse who holds a current certification from a nationally recognized board in nephrology nursing or hemodialysis may substitute the certification for the six months experience in dialysis obtained within the last 24 months.

(3) The facility shall document written physician standing orders, specific to the facility, in the patient's clinical record to guide nursing staff actions in the event a patient's condition deteriorates during treatment. The medical director shall review and approve these standing orders at least annually, consistent with the Texas Medical Board statutes and rules and the Texas Board of Nursing statutes, rules, and policy statements for registered nurses and licensed vocational nurses.

(4) If a facility provides patient self-care training, either in-center or at home, a registered nurse with at least 12 months clinical experience and three months experience in the specific modality, shall be responsible for providing self-care training to the patient or caregiver in that modality.

(5) When other facility staff assist in the self-care training in-center, the qualified registered nurse shall supervise the self-care training. When other facility staff assist in training a patient or the patient's caregiver in self-care training, the facility shall document in the employee's personnel record that the employee is qualified, as approved by the medical director, to assist in the self-care training.

(6) The facility shall establish a nursing peer review committee to conduct nursing peer review, as required by Texas Occupations Code Chapter 303 (relating to Nursing Peer Review).

(d) Each dietitian shall have a current Texas license, be a registered dietitian, and have a minimum of one year of professional work experience in clinical dietetics after becoming a registered dietitian.

(e) Each social worker shall:

(1) hold a current license as a social worker under Texas Occupations Code Chapter 505 (relating to Social Workers) and hold a master's degree in social work from a graduate school of social work accredited by the Council on Social Work Education; or

(2) have at least two years of work experience as a social worker, one year of which was in a dialysis facility or transplantation program before September 1, 1976, and have an established consultative relationship with a social worker who has a master's degree in social work from a graduate school of social work accredited by the Council on Social Work Education.

(f) A facility shall ensure biomedical technical staff meet the following requirements.

(1) The facility's biomedical technical staff may be one or more individuals (including nursing staff) employed by or under contract with the facility as long as the individual meets the minimum qualifications for each required level of responsibility, as described in this subsection.

(2) Only individuals qualified by training, education, or experience may operate, repair, or replace components of the systems used in providing dialysis treatment or reprocessing dialyzers.

(A) Technical staff shall have minimum education, training, and experience documented and maintained on file in the facility, which includes:

(i) a high school diploma or equivalent, except for technical staff employed by the facility for two or more years before April 11, 1999, who are exempt from this requirement; and

(ii) training or experience, in one or more of the following:

(I) completion of a college-based technical dialysis program;

(II) completion of the didactic training and education requirement for patient care technicians set out in §507.72(a) and (b) of this chapter (relating to Training Curricula and Instructors);

(III) current certification in technical aspects of dialysis by a nationally recognized testing organization; or

(IV) 12 months experience in dialysis within the last two years.

(B) Any staff member assigned responsibilities in the technical area shall pass an annual written competency examination, demonstrate skills related to the required level of responsibility, and be certified by the facility's medical director as competent to perform their assigned duties. Current certification by a national board in dialysis technology may substitute for the written test.

(C) The technical staff shall annually complete a minimum of five hours of continuing education with a technical or end stage renal disease focus. Facility staff may provide continuing education. Continuing education documentation shall include the continuing education course title, duration, and author or instructor.

(3) The technical supervisor is responsible for supervision of technical services. The technical supervisor shall meet the education, training, and experience requirements described in this paragraph.

(A) The technical supervisor shall meet the requirements in paragraph (3) of this subsection.

(B) The technical supervisor shall ensure technical staff demonstrate competency in equipment maintenance and repair, mechanical service, water treatment systems, and reprocessing of hemodialyzers, if applicable.

(i) Before assuming technical supervisory responsibility, a technical supervisor trainee shall successfully complete the facility's orientation and training courses as established for each technical area.

(ii) The medical director shall approve the training courses. The training courses shall follow a written curriculum with stated objectives. The curriculum shall include all items noted in this clause and paragraph (4)(B) of this subsection.

(4) Facility staff responsible for the water treatment and dialysate systems shall demonstrate understanding of the risks to patients of exposure to water that has not been treated to remove contaminants and impurities.

(A) The facility shall maintain training documentation for each individual who operates (regularly or intermittently) these systems to ensure safe operation of the water treatment and dialysate systems.

(B) The staff responsible for water treatment and dialysate systems shall meet the education, training, and experience requirements described in paragraph (2) of this subsection and shall demonstrate competency by:

(i) successful completion of the facility training course specific to water treatment, dialysate preparation, and related tasks, which must be approved by the medical director and follow a written curriculum with state objectives;

(ii) completion of a training curriculum that includes

(I) introduction to end stage renal disease;

(II) principles of hemodialysis;

(III) principles of infection control and basic microbiology for water treatment systems, machines, and sampling techniques;

(IV) rationale for water treatment for dialysis;

(V) risks and hazards of using unsafe water for dialysis;

(VI) current water standards;

(VII) source water characteristics;

(VIII) communication with source water agencies and water treatment vendors;

(IX) selection of water treatment equipment;

(X) water purification equipment, to include filtration, carbon adsorption, and reverse osmosis;

(XI) ion exchange to include softeners and deionizers;

(XII) water distribution system and other equipment specific to the facility;

(XIII) monitoring system performance, to include online and offline monitoring, aseptic sample collection, incubation of samples, and interpretation of results;

(XIV) evaluation of water treatment component performance, to include filters, activated carbon adsorption beds, reverse osmosis, and ion exchange;

(XV) evaluation of system performance, to include monitoring schedules and review of system failures;

(XVI) purpose of each component of dialysate, to include electrolytes, glucose, acid, and buffer;

(XVII) hazards of exposure of patients to a dialysate containing a different concentration of electrolytes than prescribed;

(XVIII) testing methods in use to verify expected concentrations in any reconstituted components of the dialysate are achieved;

(XIX) action to take in the event testing of a mixed batch of dialysate concentrate does not meet the expected parameters;

(XX) labeling employed to positively identify each concentrate; and

(XXI) procedures to ensure the proper transfer of concentrates from the manufacturer's drums to the holding tanks;

(iii) confirmation of the ability to distinguish all primary colors; and

(iv) successful completion of the facility's orientation and training course as established for the water treatment and dialysate preparation systems technician trainee before the trainee's initial assumption of responsibility.

(5) The staff responsible for equipment maintenance and repair shall meet the education, training, and experience requirements described in paragraph (2) of this subsection and shall demonstrate competency by:

(A) successful completion of the facility training course outlined in paragraph (2) of this subsection, relating to water treatment systems;

(B) successful completion of a training curriculum, which includes:

(i) prevention of transmission of hepatitis through dialysis equipment;

(ii) safety requirements of dialysate delivery systems;

(iii) repair and maintenance of dialysis and other equipment specific to the facility;

(iv) electrical safety, including lockout or tagout;

(v) emergency equipment maintenance;

(vi) building maintenance;

(vii) fire safety and prevention requirements; and

(viii) emergency response procedures; and

(C) successful completion of a written competency exam and demonstration of skills specific to the facility's mechanical and equipment service and water treatment and distribution systems.

(6) The staff responsible for reprocessing hemodialyzers and other supplies shall meet the education, training, and experience requirements described in paragraph (2) of this subsection and shall demonstrate competency by:

(A) successful completion of a training curriculum that includes the components of the standards for reuse of hemodialyzers listed in §507.30 of this chapter (relating to Technical Standards); and

(B) successful completion of a written competency exam that includes return demonstration of skills specific to reprocessing of hemodialyzers and other dialysis supplies.

§507.55. Clinical Records.

(a) A facility shall develop, implement, and enforce policies and procedures for a clinical record system to ensure complete and accurate documentation of care provided to each patient. The clinical record system shall make documentation readily available and systematically organized to facilitate the compilation and retrieval of information.

(1) The facility shall centralize all information in the patient's clinical record and protect the record against loss or damage in accordance with state and federal regulations.

(2) The facility shall provide an area for clinical records storage that is separate from all patient treatment areas and secured from unauthorized access. The facility shall store the active clinical record of each patient currently treated by the facility on site.

(3) The facility shall maintain the confidentiality of each patient's personal and clinical records.

(4) The facility shall not use signature stamps to authenticate clinical record entries.

(5) The facility may preserve clinical records electronically. Electronic records shall meet all requirements of paper records, including protection from casual access and retention for the specified period. Systems shall ensure that facility staff may not alter entries regarding the delivery of care without evidence and explanation of such alteration.

(6) The facility shall preserve inactive clinical records by electronic means and may store inactive records off site, as long as the facility maintains security, and ensures the record is readily retrievable for review by the Texas Health and Human Services Commission (HHSC) or HHSC designee.

(7) Each patient's clinical record, whether hard copy, electronic, or a combination of both, shall include complete and pertinent information about the patient's condition, assessments by the interdisciplinary team, updated plans of care, all interventions and treatments prescribed and delivered, and details of any events occurring with the patient during treatment. The record of care shall be readily accessible to every authorized interdisciplinary team member so that safe care can be coordinated to best meet the patient's needs.

(8) Each clinical record shall include:

(A) identifying information;

(B) consents and notifications;

(C) if the patient requires an accommodation, details on how staff explained consent forms for treatment, whether staff obtained the patient's consent, and how staff explained to the patient the patient's rights and responsibilities;

(D) documentation that the physician explained the treatment risks, benefits, and complications to the patient before the patient's first treatment;

(E) documentation that a licensed registered nurse witnessed the patient signing the consent forms before the patient's first treatment;

(F) physician orders;

(G) progress notes;

(H) problem list;

(I) medical history and physical examination;

(J) professional assessments by the registered nurse, social worker, and dietitian;

(K) medications given during treatment, which may be listed on the treatment record; and a list of medications the patient takes at home;

(L) transfusion records;

(M) laboratory reports;

(N) diagnostic studies;

(O) hospitalization records;

(P) consultations;

(Q) records of creation and revision of access for dialysis;

(R) plans of care, including evidence of interdisciplinary team review and adjustment;

(S) evidence of patient education;

(T) daily treatment records; and

(U) discharge summary, if applicable.

(b) A facility physician shall complete a comprehensive medical history and physical examination no later than 30 calendar days from the patient's admission to the facility and at least annually thereafter.

(1) For a patient new to dialysis, the physician responsible for the dialysis care shall complete the history and examination.

(2) For an established dialysis patient, the history and examination may be completed by an advanced practice registered nurse or physician assistant.

(3) Before the first treatment in the facility, the physician shall inform the registered nurse functioning in the charge role of at least the patient's diagnoses, medications, hepatitis status, allergies, and dialysis prescription. The patient's clinical record shall include this data.

(c) The patient's clinical record shall provide an ongoing and accurate report of the patient's progress, reflecting changes in patient status, plans for and results of changes in treatment, diagnostic testing, consultations, and unusual events. Each interdisciplinary team member shall record the patient's progress as indicated by any change in the patient's medical, nutritional, or psychosocial condition.

(d) Facility staff shall note the patient's condition and response to treatment on the daily treatment record.

(e) A facility shall ensure care for transient patients meets the following requirements.

(1) Except as provided by paragraph (2)(B) of this subsection, before providing dialysis treatment to a transient patient the facility shall obtain and include, at a minimum:

(A) orders for treatment in this facility;

(B) a list of medications and allergies;

(C) laboratory testing results no earlier than one month before treatment, which include screening for Hepatitis B status;

(D) the most current plan of care;

(E) the most current treatment records from the home facility; and

(F) records of care and treatment at this facility.

(2) If a facility dialyzes a patient who is normally dialyzed in another facility, the facility shall meet the following requirements.

(A) The facility shall continuously evaluate staffing levels and use this information in determining whether to accept a transient patient for treatment.

(B) If a transient patient arrives unannounced, the facility may provide dialysis after obtaining, at a minimum, from the patient records:

(i) orders for treatment;

(ii) Hepatitis B status; and

(iii) medical justification by the physician ordering treatment that the patient's need for dialysis outweighs the need for the additional clinical information set out in this subsection.

(3) In the event a transient patient's hepatitis status is unknown, the patient may undergo treatment as if the Hepatitis B surface antigen (HbsAg) test results were potentially positive, except that the facility shall not treat such a patient in the HBsAg isolation room, area, or machine.

(f) Facility staff shall complete clinical records within 30 days after discharge. The discharge summary shall clearly identify the patient's disposition and include the diagnosis or cause of death, date of discharge or death, location of death, transplant, or relocation information when appropriate, and reason for discharge if not for transplantation or death.

(g) Clinical records are the facility's property, and the facility shall safeguard clinical records against loss, destruction, or unauthorized use.

(h) The facility shall provide copies of pertinent portions of a patient's record when the patient is transferred. The records provided shall include, at a minimum, the most current orders for dialysis treatment, last three treatment records, he current hepatitis status, and current plan of care. If the facility transfers the patient to another outpatient facility, the facility shall provide copies of the most recent history and physical and assessment of each interdisciplinary team member.

(i) The facility shall retain records for a minimum of five years after the patient's discharge and in accordance with state and federal regulations. The facility shall not destroy clinical records that relate to any matter that is involved in litigation, unless the litigation has been finally resolved.

(j) If a facility ceases operation, it shall arrange for the preservation of records to ensure compliance with this section. The facility shall notify HHSC in writing of the location of the clinical records and the clinical records custodian's name and address.

§507.56. Incident Reports.

(a) A facility shall report only the following incidents to the Texas Health and Human Services Commission (HHSC). The facility shall report these incidents to HHSC within 10 business days after the facility being informed or possessing knowledge of:

(1) the death of a dialysis patient that occurs in the facility;

(2) the death of a dialysis patient that occurs within 24 hours after the patient's last dialysis treatment, unless the death is related to:

(A) an accident unrelated to dialysis care and services;

(B) a pre-scheduled elective surgery;

(C) a previously executed do-not-resuscitate order or advance directive;

(D) a hospice patient; or

(E) a patient who withdraws from dialysis;

(3) emergent hospital transfers from the dialysis facility;

(4) the confirmed conversion of staff or a patient to Hepatitis B surface antigen (HbsAg) positive, unless it is a verified false positive;

(5) the involuntary transfer or discharge of a patient, unless the involuntary transfer or discharge is due to nonpayment or the patient was a participant in the ESRD Network's Second Chance program, in which case there is no incident report required if the patient is involuntarily discharged within the first 90 days of placement;

(6) a fire in the facility; or

(7) a generator out of operation.

(b) The facility shall report an incident listed in subsection (a) of this section to HHSC Complaint and Incident Intake through the HHSC online portal.

§507.57. Nonconventional Dialysis.

(a) A facility shall meet the following requirements for in-center self-care.

(1) If a licensed dialysis facility offers in-center self-care in addition to conventional hemodialysis, the facility shall develop, implement, and maintain policies and procedures related to self-care, including policies regarding staffing levels in the self-care milieu.

(2) While nurse to patient ratios must remain the same, the facility may reduce the number of patient care technicians from a 4:1 ratio to a 6:1 ratio if:

(A) the self-care area is separated from the conventional dialysis area, such as in a separate bay or room within the facility; and

(B) self-care patients can, at a minimum, demonstrate the ability to:

(i) set up and tear down the machinery used in their treatment;

(ii) hold their own sites at termination of treatment, except for a catheter patient; and

(iii) monitor and record their own vital signs before beginning and ending the day's treatment.

(3) A licensed facility that offers the option of in-center self-care shall ensure that all assessments, evaluations, history and physicals, treatment plans, modality options education, and similar documents and activities are completed before starting or moving to self-care.

(4) Before a patient moves from conventional dialysis to self-care in a licensed dialysis facility, the patient shall demonstrate verbal understanding of competencies in the self-care areas, as determined by the facility staff.

(5) The facility shall maintain written documentation of self-care competencies via checklists and competency testing in the patient's medical record.

(6) The facility shall annually evaluate a patient's competency and skills to verify the patient maintains the abilities and knowledge to continue self-care. The facility shall document the annual evaluation in the patient's medical record. A patient may take on additional aspects of self-care. Before the patient may independently complete the additional self-care aspects, the facility shall evaluate the patient's competency to perform the self-care aspects and document the evaluation for additional self-care aspects in the patient's medical record. The facility shall annually re-evaluate the patient's competency to perform the additional self-care aspects.

(b) A facility shall meet the following requirements for transitional care services.

(1) A facility offering transitional services shall develop, implement, and enforce policies and procedures specific to operation of transitional services.

(2) Licensed dialysis facilities that offer transitional care shall ensure that all assessments, evaluations, history and physicals, treatment plans and similar documents and activities are completed before beginning treatment.

(3) A facility offering transitional services shall provide the patient with appropriate education regarding end-stage renal disease, its treatment and treatment availability, and advisability of all modalities to include renal transplant, dietary concerns and needs, and social services.

(4) A facility offering transitional services shall ensure the patient retains all rights applicable to treatment in a licensed dialysis facility. The interdisciplinary treatment team shall assess a patient for transitioning services no later than 30 calendar days after entry into the program. If the team determines a patient requires continued services only available in a conventional dialysis setting, the facility shall consider the patient for transfer to a conventional setting to continue the benefits of dialysis. The facility shall not consider this transfer as an involuntary discharge from the transitional facility.

(5) Transitional direct care staff shall receive equivalent training to both in-center and home hemodialysis staff, including training to the manufacturer's specifications of the hemodialysis machine being used. The facility shall keep available upon request documentation of the transitional direct care staff's:

(A) training and skills, and

(B) competencies as approved by the medical director.

(c) A facility shall meet the following requirements for integrated hemodialysis systems.

(1) A licensed facility offering the use of self-contained or integrated hemodialysis systems shall develop, implement, and enforce policies and procedures related to these systems and staff shall have verification of competency for each type of machine they perform or monitor treatments on.

(2) If the licensed dialysis facility uses self-contained or integrated hemodialysis systems along with conventional hemodialysis machines, the facility shall separate the self-contained units or integrated hemodialysis systems from the conventional machines.

(3) Each patient shall receive education on the self-contained unit's use and efficacy.

(4) A facility using solely self-contained or integrated hemodialysis systems shall follow the manufacturer's recommendations and instructions for the use of the machines.

(5) A licensed facility offering the use of self-contained or integrated hemodialysis systems shall maintain a copy of the manufacturer's instructions on each type of unit used in the facility. The facility shall provide inspectors with a copy of the manufacturer's instructions and recommendations upon request.

(6) A facility shall ensure a registered nurse is present in the integrated hemodialysis systems treatment area, and the facility shall maintain the same staffing ratios as for conventional dialysis.

§507.59. Medical Services and Home Dialysis During a Public Health Disaster.

(a) This section applies only to an end stage renal disease (ESRD) facility located in a county for which:

(1) the governor declared a state of disaster due to a pandemic or epidemic, pursuant to Texas Government Code Chapter 418 (relating to Emergency Management);

(2) the commissioner of the Texas Department of State Health Services determined that a public health disaster exists, pursuant to Texas Health and Safety Code Chapter 81 (relating to Communicable Diseases; Public Health Disasters; Public Health Emergencies); and

(3) the Texas Health and Human Services Commission (HHSC) designated this section as applicable, pursuant to paragraphs (1) and (2) of this subsection.

(b) An ESRD facility may temporarily adopt accommodations under this section to meet patient needs, support infection control procedures, and maintain necessary social distancing in response to a public health disaster.

(c) Notwithstanding §507.52(b)(3) of this subchapter (relating to Medical Services), at a minimum, each patient receiving dialysis in the facility shall be seen by a physician on the medical staff once a month during the patient's treatment time.

(d) Notwithstanding §507.52(b)(4) of this subchapter, home dialysis patients shall be seen by a physician, an advanced practice registered nurse (APRN), or a physician assistant (PA) no less than once a month. This visit by a physician, an APRN, or a PA may be conducted using telemedicine medical services.

(e) Notwithstanding §507.53(l)(1) of this subchapter (relating to Home Dialysis Service), a registered nurse may conduct an initial monitoring visit of a patient's home adaptation before the patient beginning training for the selected home modality from outside the patient's home if the nurse performs the visit using a synchronous audiovisual interaction between the registered nurse and the patient while the patient is at home.

(1) The nurse shall conduct the visit to the same review standards as a normal face-to-face visit.

(2) If the nurse cannot perform the visit using a synchronous audiovisual interaction between the nurse and the patient, the nurse must conduct the visit in the patient's home.

§507.60. Staffing Table.

The attached graphic sets out minimum staffing levels for nursing staff, direct care staff, and total clinical staff.

Figure: 26 TAC §507.60 (.pdf)

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on December 3, 2025.

TRD-202504418

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 23, 2025

Proposal publication date: June 6, 2025

For further information, please call: (512) 834-4591

SUBCHAPTER E. REQUIREMENTS FOR DIALYSIS TECHNICIANS

STATUTORY AUTHORITY

The new rules are adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system; Texas Health and Safety Code §251.003, which requires HHSC to adopt rules for the issuance, renewal, denial, suspension, and revocation of a license to operate an end stage renal disease facility; and Texas Health and Safety Code §251.014, which requires these rules to include minimum standards to protect the health and safety of a patient of an end stage renal disease facility.

§507.72. Training Curricula and Instructors.

(a) Each training program for dialysis technicians shall develop a written curriculum with objectives specified for each section.

(b) The training curriculum for dialysis technicians shall include:

(1) an introduction to dialytic therapies, history, and major issues to include:

(A) a history of dialysis;

(B) definitions and terminology;

(C) communication skills;

(D) ethics and confidentiality;

(E) multidisciplinary process;

(F) roles of other team members; and

(G) information about renal organizations and resources;

(2) the principles of hemodialysis to include:

(A) principles of dialysis;

(B) access to the circulatory system; and

(C) anticoagulation, local anesthetics, and normal saline;

(3) understanding the individual with kidney failure to include:

(A) basic renal anatomy, physiology, and pathophysiology;

(B) the effect of renal failure on other body systems;

(C) symptoms and findings related to the uremic state;

(D) modes of renal replacement therapy, including transplantation;

(E) basic renal nutrition;

(F) basic psychosocial aspects of end stage renal disease;

(G) medications commonly administered to patients with end stage renal disease;

(H) confidentiality of patient personal and clinical records;

(I) professional conduct;

(J) patient rights and responsibilities; and

(K) rehabilitation;

(4) dialysis procedures to include:

(A) using aseptic technique;

(B) technical aspects of dialysis, operation and monitoring of equipment, initiation and termination of dialysis;

(C) delivering an adequate dialysis treatment and factors that may result in inadequate treatment;

(D) observing and reporting patient reactions to treatment;

(E) glucose monitoring and hemoglobin and hematocrit monitoring;

(F) emergency procedures and responses, such as cardiopulmonary resuscitation, air embolism management, and response to line separation and hemolysis;

(G) external and internal disasters, fire, natural disasters, and emergency preparedness; and

(H) safety and quality assurance and performance improvement (QAPI);

(5) hemodialysis devices to include:

(A) theory and practice of conventional, high efficiency, and high flux dialysis;

(B) dialysate composition, options, indications, complications, and safety;

(C) monitoring and safety; and

(D) disinfection of equipment;

(6) water treatment to include:

(A) standards for water treatment used for dialysis listed in §507.30 of this chapter (relating to Technical Standards);

(B) systems and devices;

(C) monitoring; and

(D) risks to patients of unsafe water;

(7) reprocessing, if the facility practices reuse, to include:

(A) principles of reuse;

(B) safety, QAPI, universal precautions, and water treatment; and

(C) standards for reuse in the standards listed in §507.30 of this chapter;

(8) patient teaching to include:

(A) the technician's role in supporting patient education goals; and

(B) adult education principles;

(9) infection control and safety to include:

(A) risks to patients of nosocomial infections, accidents, and errors in treatment;

(B) universal precautions, aseptic technique, sterile technique, and specimen handling;

(C) basic bacteriology and epidemiology;

(D) risks to employees of blood and chemical exposure; and

(E) electrical, fire, disaster, environmental safety, and hazardous substances; and

(10) QAPI to include:

(A) the technician's role in QAPI activities;

(B) principles of QAPI; and

(C) the importance of ongoing QAPI activities in ensuring the facility provides safe dialysis treatments to patients.

(c) The facility's training curricula shall comply with the following requirements related to a dialysis technician's additional responsibilities.

(1) If a dialysis technician is to assist with training or treatment of peritoneal dialysis patients, the facility's training curricula shall include:

(A) principles of peritoneal dialysis;

(B) sterile technique;

(C) peritoneal dialysis delivery systems;

(D) symptoms of peritonitis; and

(E) other complications of peritoneal dialysis.

(2) If a dialysis technician, other than a licensed vocational nurse (LVN), is to cannulate access or administer intravenous normal saline, intravenous heparin, subcutaneous lidocaine, topical lidocaine, or oxygen, the facility's training curricula shall include:

(A) access to the circulation to include:

(i) for a fistula, creation, development, needle placement, and prevention of complications;

(ii) for a graft, creation, materials, needle placement, and prevention of complications; and

(iii) symptoms to report;

(B) safe administration of medications to include:

(i) identifying the correct patient;

(ii) ensuring the appropriate medication;

(iii) measuring the appropriate dose;

(iv) determining the appropriate route; and

(v) checking the appropriate time for administration;

(C) administration of normal saline to include:

(i) reasons for administration;

(ii) potential risks and complications;

(iii) administration limits; and

(iv) information to report and record;

(D) administration of heparin to include:

(i) reasons for administration;

(ii) methods of administration;

(iii) preparation of ordered dose;

(iv) potential risks and complications; and

(v) information to report and record;

(E) administration of lidocaine to include:

(i) reasons for administration;

(ii) method of administration;

(iii) preparation of ordered dose;

(iv) potential complications and risks; and

(v) information to report and record; and

(F) administration of oxygen to include:

(i) reasons for administration;

(ii) method of administration;

(iii) delivery of the ordered flow rate;

(iv) potential complications and risks; and

(v) information to report and record.

(3) If a dialysis technician, other than a licensed vocational nurse, is to initiate or discontinue dialysis via a central venous catheter or manipulate a central venous catheter, the facility's training curricula shall include:

(A) patient assessment;

(B) infection control and aseptic technique;

(C) materials used and prevention of complications;

(D) observing and reporting patient reactions to treatment;

(E) safety checks, potential complications, and risks; and

(F) information to report and record.

(d) The instructor shall maintain a roster of attendance for each training class.

(e) The instructor shall evaluate each trainee weekly during the training program to determine the trainee's progress.

(f) The facility shall administer a written examination encompassing the required content. The dialysis technician trainee shall pass the exam with a score of at least 80 percent before the trainee's release from orientation.

(1) The examination shall encompass the content required in subsection (b) of this section.

(2) When the dialysis technician trainee cannulates access, administers medications, initiates or discontinues dialysis via a central venous catheter, or manipulates a central venous catheter, the examination shall encompass the content required in subsection (c) of this section.

(3) Other than the first examination for a specific responsibility in a facility, current certification as a dialysis technician by a nationally recognized testing organization may be substituted for the written examination.

(g) An instructor for the course to train an individual as a dialysis technician shall be:

(1) a physician who qualifies as a medical director;

(2) a registered nurse with at least 12 months of experience in hemodialysis obtained within the last 24 months and a current competency skills checklist on file in the facility, or a registered nurse instructor of a dialysis technician training course of an accredited college or university;

(3) a qualified dietitian or social worker providing training only within the individual's area of expertise; or

(4) a technician with at least 12 months experience, qualified by training and experience in water treatment, dialysate preparation, reprocessing, or other technical aspects of dialysis providing training only within their area of expertise.

(h) Licensed nurses and patient care technicians who have at least one year of experience in hemodialysis and a current competency skills checklist on file in the facility may assist in didactic sessions and serve as preceptors.

(i) For an individual with no previous experience in direct patient care, a minimum of 80 clock hours of classroom education and 200 clock hours of supervised clinical training shall be required. Training programs for dialysis technician trainees who have previous direct patient care experience may be shortened if they demonstrate competency with the required knowledge and skills but may not be less than a total of 80 clock hours of combined classroom education and clinical training.

§507.73. Competency Evaluation.

(a) The governing body shall ensure the facility's core staff members review the training records of each trainee, including tests and skills checklists, hear comments from the training instructors and preceptors, and validate that the trainee has successfully completed the training program and is competent to perform their job duties and tasks.

(b) An individual who completes the facility's orientation and training program and the facility determines is qualified to deliver dialysis patient care may qualify as a dialysis technician by passing the written examination described in §507.72(f) of this subchapter (relating to Training Curricula and Instructors) and demonstrating competency by completing the skills checklist described in subsection (c) of this section.

(c) The supervising nurse or a registered nurse who qualifies as an instructor under §507.72(g)(2) of this subchapter shall complete a competency skills checklist to document each dialysis technician trainee's knowledge and skills for:

(1) assembling necessary supplies;

(2) preparing dialysate according to procedure and dialysis prescription;

(3) assembling and preparing the dialysis extracorporeal circuit correctly;

(4) securing the correct dialyzer for the specific patient;

(5) installing and rinsing dialyzer and all necessary tubing;

(6) testing monitors and alarms, conductivity, and presence and absence of residual sterilants, if applicable;

(7) setting monitors and alarms according to facility and manufacturer protocols;

(8) obtaining pre-dialysis evaluation to include vital signs, weight, and temperature according to facility protocol and informing the registered nurse of unusual findings;

(9) inspecting access for patency and, after cannulation is performed and heparin administered, initiating dialysis according to the patient's prescription, observing universal precautions, and reporting unusual findings to the registered nurse;

(10) adjusting blood flow rates according to established protocols and the patient's prescription;

(11) calculating and setting the dialysis machine to allow fluid removal rates according to established protocols and the patient's prescription;

(12) monitoring the patient and equipment during treatment, responding appropriately to patient needs and machine alarms, and reporting unusual occurrences to the registered nurse;

(13) changing fluid removal rate, placing patient in Trendelenburg position, and administering replacement normal saline as directed by the registered nurse, physician order, or facility protocol;

(14) documenting findings and actions per facility protocol;

(15) describing appropriate response to dialysis-related emergencies such as cardiac or respiratory arrest, needle displacement or infiltration, clotting, blood leaks, or air emboli, and nonmedical emergencies such as power outages or equipment failure;

(16) discontinuing dialysis and establishing hemostasis by:

(A) inspecting, cleaning, and dressing access according to facility protocol; and

(B) reporting unusual findings and occurrences to the registered nurse;

(17) obtaining and recording post-dialysis vital signs, temperature, and weight and reporting unusual findings to the registered nurse;

(18) discarding supplies and sanitizing equipment and treatment chair according to facility protocol;

(19) communicating the patient's emotional, medical, psychological, and nutritional concerns to the registered nurse;

(20) maintaining current certification in cardiopulmonary resuscitation; and

(21) maintaining professional conduct, good communication skills, and confidentiality in the care of patients.

(d) For dialysis technician trainees who will be assisting with training or treatment of peritoneal dialysis patients, each trainee shall satisfactorily:

(1) assist patients in ordering supplies;

(2) make a dialysate exchange (draining and refilling the peritoneal space with dialysate) to include continuous ambulatory peritoneal dialysis exchange procedures, and initiation or discontinuation of continuous cycling peritoneal dialysis;

(3) observe peritoneal effluent;

(4) know what observations to report;

(5) collect dialysate specimen; and

(6) set up and operating continuous cycling peritoneal dialysis equipment.

(e) For dialysis technician trainees who will be cannulating dialysis access and administering intravenous normal saline, intravenous heparin, subcutaneous lidocaine, topical lidocaine, or oxygen, each trainee shall satisfactorily:

(1) cannulate to include:

(A) inspecting the access for patency;

(B) preparing the skin;

(C) using aseptic technique;

(D) placing needles correctly;

(E) establishing blood access;

(F) replacing needles;

(G) knowing when to call for assistance;

(H) securing needles; and

(I) removing needles;

(2) administer intravenous heparin to include:

(A) checking the patient's individual prescription;

(B) preparing the dose;

(C) labeling the prepared syringe;

(D) administering the dose; and

(E) observing for complications;

(3) administer normal saline to include:

(A) understanding unit protocol;

(B) checking the patient's prescription;

(C) recognizing signs of hypotension;

(D) notifying the registered nurse;

(E) administering normal saline; and

(F) rechecking vital signs;

(4) administer subcutaneous or topical lidocaine to include:

(A) checking the patient's prescription;

(B) identifying the correct medication;

(C) preparing the dose;

(D) administering the dose; and

(E) observing for complications; and

(5) administer oxygen to include:

(A) verifying the ordered flow rate from the nurse functioning in the charge role;

(B) setting up the equipment; and

(C) connecting the tubing for the patient.

(f) For dialysis technician trainees who will be initiating or discontinuing dialysis via a central venous catheter or manipulating a central venous catheter, each trainee shall satisfactorily:

(1) use aseptic technique;

(2) establish blood access;

(3) observe for complications;

(4) document findings and actions per facility protocol;

(5) know when to call for assistance and reporting unusual findings and occurrences to the registered nurse; and

(6) administer intravenous heparin to include:

(A) checking the patient's individual prescription;

(B) preparing the dose;

(C) labeling the prepared syringe;

(D) administering the dose; and

(E) observing for complications.

(g) If a dialysis technician is to cannulate a dialysis access, initiate or discontinue dialysis via a central venous catheter, manipulate a central venous catheter, administer intravenous normal saline, intravenous heparin, subcutaneous lidocaine, topical lidocaine, or oxygen, the medical director shall verify and document the dialysis technician's competency to perform these tasks and delegate authority to the technician in accordance with Texas Occupations Code Chapter 157 (relating to Authority of Physician to Delegate Certain Medical Acts).

§507.75. Prohibited Acts.

The facility shall ensure a dialysis technician does not:

(1) initiate patient education;

(2) alter ordered treatment, including shortening the treatment time;

(3) change central venous catheter dressings;

(4) administer any medications other than intravenous normal saline, intravenous heparin, subcutaneous lidocaine, topical lidocaine, or oxygen, which may only be administered during a routine dialysis treatment;

(5) administer blood or blood products;

(6) perform nonaccess site arterial puncture;

(7) accept physician orders;

(8) provide hemodialysis treatment to pediatric patients under the age of 18 who weigh less than 35 kilograms; or

(9) alter the level of electrolytes in dialysate through use of additives ("spiking").

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on December 3, 2025.

TRD-202504419

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 23, 2025

Proposal publication date: June 6, 2025

For further information, please call: (512) 834-4591

SUBCHAPTER F. INSPECTIONS, INVESTIGATIONS, AND ENFORCEMENT

STATUTORY AUTHORITY

The new rules are adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system; Texas Health and Safety Code §251.003, which requires HHSC to adopt rules for the issuance, renewal, denial, suspension, and revocation of a license to operate an end stage renal disease facility; and Texas Health and Safety Code §251.014, which requires these rules to include minimum standards to protect the health and safety of a patient of an end stage renal disease facility.

§507.90. Enforcement.

(a) Enforcement is a process by which a sanction is proposed, and if warranted, imposed on an applicant or licensee regulated by the Texas Health and Human Services Commission (HHSC) for failure to comply with applicable statutes, rules, or orders.

(b) HHSC has jurisdiction to enforce violations of Texas Health and Safety Code Chapter 251 (relating to End Stage Renal Disease Facilities) and this chapter. HHSC may deny, suspend, or revoke a license or impose an administrative penalty for:

(1) failure to comply with any applicable provision of Texas Health and Safety Code, including Chapter 251;

(2) failure to comply with any provision of this chapter or any other applicable laws;

(3) the facility, or any of its employees, committing an act that causes actual harm or risk of harm to the health or safety of a patient;

(4) the facility, or any of its employees, materially altering any license issued by HHSC;

(5) failure to comply with minimum standards for licensure;

(6) failure to provide a complete license application;

(7) failure to comply with an order of the executive commissioner or another enforcement procedure under Texas Health and Safety Code Chapter 251;

(8) a history of failure to comply with the applicable rules relating to patient environment, health, safety, and rights that reflects more than nominal noncompliance;

(9) the facility aiding, committing, abetting, or permitting the commission of an illegal act;

(10) the facility, or any of its employees, committing fraud, misrepresentation, or concealment of a material fact on any documents a facility is required to submit to HHSC or required to maintain pursuant to Texas Health and Safety Code Chapter 251, and the provisions of this chapter;

(11) failure to comply with other state and federal laws affecting the health, safety, and rights of facility patients;

(12) failure to timely pay an assessed administrative penalty as required by HHSC;

(13) failure to submit an acceptable plan of correction (POC) for cited deficiencies within the timeframe required by HHSC;

(14) failure to timely implement a POC for deficiencies cited by HHSC within the dates designated in the POC;

(15) failure to comply with applicable requirements within a designated probation period; or

(16) if the facility is participating under Title XVIII, and the CMS terminates the facility's Medicare provider agreement.

(c) HHSC has jurisdiction to enforce violations of Texas Health and Safety Code Chapter 251 and this chapter. HHSC may deny a license if the applicant:

(1) fails to provide timely and sufficient information or fees required by HHSC that is directly related to the application;

(2) has had the following actions taken against the applicant within the two-year period preceding the application:

(A) decertification or cancellation of its contract under the Medicare or Medicaid program in any state;

(B) federal Medicare or state Medicaid sanctions or penalties;

(C) unsatisfied federal or state tax liens;

(D) unsatisfied final judgments;

(E) eviction involving any property or space used as an end stage renal disease (ESRD) facility or health care facility in any state;

(F) unresolved federal Medicare or state Medicaid audit exceptions;

(G) denial, suspension, or revocation of an ESRD facility license, a private psychiatric hospital license, or a license for any health care facility in any state; or

(H) a court injunction prohibiting ownership or operation of an ESRD facility.

(d) HHSC may deny a person or entity a license or suspend or revoke an existing license on the grounds that the person or entity has been convicted of a felony or misdemeanor that directly relates to the duties and responsibilities of the ownership or operation of a facility. HHSC applies the requirements of Texas Occupations Code Chapter 53 (relating to Consequences of Criminal Conviction).

(1) In determining whether a criminal conviction directly relates, HHSC considers the provisions of Texas Occupations Code §53.022 (relating to Factors in Determining Whether Conviction Directly Relates to Occupation) and Texas Occupations Code §53.023 (relating to Additional Factors for Licensing Authority to Consider After Determining Conviction Directly Relates to Occupation).

(2) The following felonies and misdemeanors directly relate to the duties and responsibilities of a licensed facility because these criminal offenses indicate an inability or a tendency for the person to be unable to own or operate a facility:

(A) a misdemeanor violation of Texas Health and Safety Code Chapter 251;

(B) a misdemeanor or felony involving moral turpitude;

(C) a misdemeanor or felony relating to deceptive business practices;

(D) a misdemeanor or felony of practicing any health-related profession without a required license;

(E) a misdemeanor or felony under any federal or state law relating to drugs, dangerous drugs, or controlled substances;

(F) a misdemeanor or felony under Texas Penal Code (TPC) Title 5 (relating to Offenses Against the Person), involving a patient, resident, or client of any health care facility, a home and community support services agency, or a health care professional; or

(G) a misdemeanor or felony under TPC:

(i) Title 4 (relating to Inchoate Offenses);

(ii) Title 7 (relating to Offenses Against Property);

(iii) Title 8 (relating to Offenses Against Public Administration);

(iv) Title 9 (relating to Offenses Against Public Order and Decency);

(v) Title 10 (relating to Offenses Against Public Health, Safety, and Morals); or

(vi) Title 11 (relating to Organized Crime).

(H) Offenses listed in this paragraph are not exclusive in that HHSC may consider similar criminal convictions from other state, federal, foreign, or military jurisdictions that indicate an inability or tendency for the person or entity to be unable to own or operate a facility.

(3) HHSC revokes a license on the licensee's imprisonment following a felony conviction, felony community supervision revocation, revocation of parole, or revocation of mandatory supervision.

(e) If HHSC proposes to deny, suspend, or revoke a license, HHSC sends a notice of the proposed action by certified mail, return receipt requested, at the address shown in the current records of HHSC or HHSC may personally deliver the notice. The notice to deny, suspend, or revoke a license, or impose an administrative penalty, states the alleged facts or conduct to warrant the proposed action, provide an opportunity to demonstrate or achieve compliance, and states that the applicant or license holder has an opportunity for a hearing before taking the action.

(1) The facility must request a hearing within 30 calendar days after receipt of the notice. Receipt of the notice is presumed to occur on the third business day after the notice is mailed by HHSC to the applicant's or licensee's last known address.

(2) The request for a hearing shall be in writing and submitted to the Texas Health and Human Services Commission, Enforcement Unit, Regulatory Services Division.

(3) A hearing shall be conducted pursuant to Texas Government Code Chapter 2001 (relating to Administrative Procedure) and Texas Administrative Code, Title 1 Chapter 357, Subchapter I (relating to Hearings Under the Administrative Procedure Act).

(4) If the facility does not request a hearing in writing within 30 calendar days after receiving the notice, the facility is deemed to have waived the opportunity for hearing, and the proposed action shall be taken.

(5) If the facility fails to appear or be represented at the scheduled hearing, the facility has waived the right to a hearing, and the proposed action shall be taken.

(f) If HHSC suspends a license, the suspension shall remain in effect until HHSC determines that the reason for suspension no longer exists. An authorized representative of HHSC investigates before making a determination.

(1) During the time of suspension, the suspended license holder shall return the license to HHSC.

(2) If a suspension overlaps a renewal date, the suspended license holder shall comply with the renewal procedures in this chapter; however, HHSC may not renew the license until HHSC determines that the reason for suspension no longer exists.

(g) If HHSC revokes or does not renew a license, a person may reapply for a license by complying with the requirements and procedures in this chapter at the time of reapplication. HHSC may refuse to issue a license if the reason for revocation or nonrenewal continues to exist.

(h) Upon revocation or nonrenewal, a license holder shall return the license to HHSC within 30 calendar days after notification from HHSC.

(i) In lieu of denying, suspending, or revoking the license, HHSC may place the facility on probation for a period of not less than 30 calendar days if the facility is found in repeated noncompliance and the facility's noncompliance does not endanger the public's health and safety.

(1) HHSC provides the facility notice of probation and the items of noncompliance at least 10 calendar days before the probation period begins.

(2) During the probation period, the facility must correct the items of noncompliance and report corrections to HHSC for approval.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on December 3, 2025.

TRD-202504420

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 23, 2025

Proposal publication date: June 6, 2025

For further information, please call: (512) 834-4591