TITLE 26. HEALTH AND HUMAN SERVICES

§ 507.1. Purpose.

(a) The chapter's purpose is to implement Texas Health and Safety Code Chapter 251 (relating to End Stage Renal Disease Facilities), which requires an end stage renal disease facility providing routine, repetitive, outpatient dialysis to be licensed by the Texas Health and Human Services Commission.

(b) This chapter provides minimum standards for:

(1) equipment used by the facility;

(2) water treatment and reuse;

(3) sanitary and hygienic conditions;

(4) quality assessment and performance improvement;

(5) indicators of quality of care;

(6) provision and coordination of treatment and services;

(7) professional staff qualifications and supervision, including physicians and other personnel;

(8) clinical records, curricula, and instructors used to train dialysis technicians;

(9) competency evaluation of dialysis technicians;

(10) enforcement standards;

(11) fire prevention and safety requirements; and

(12) physical plant and construction requirements.

(c) Compliance with this chapter does not constitute release from the requirements of other applicable federal, state, or local laws, codes, standards, rules, regulations, and ordinances. The more stringent standard, code, or requirement shall apply when a difference in requirements exists.

§ 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 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 federal holiday.

(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 includes reservoirs, conduits, proportioning devices for the dialysate, and monitors, associated alarms, and controls assembled as a system for the characteristics listed above. 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. This does not include the Charge Nurse, as shown in §507.60 of this chapter (relating to Staffing Table).

(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 not-for-profit 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, and who may provide dialysis treatment after meeting the competency requirements specified for dialysis technicians.

(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--An alternate method of providing hemodialysis, as designated by the FDA and prescribed to a patient for their individual use, during their need for dialysis.

(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 treatment modality, including self-care, home hemodialysis, peritoneal dialysis, and other modalities. Patient training must take place in person.

(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.

§ 507.11. General Requirements for a License.

(a) All providers who provide dialysis services, regardless of affiliation or modality, shall be licensed. Patients receiving home dialysis services shall be under the purview of a licensed end stage renal disease (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.

(A) HHSC may waive the prelicensure conference requirement at its discretion.

(B) When there is a change in the supervising nurse before the facility opens, the applicant shall attend an additional prelicensure conference.

(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 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 (relating to Fees).

(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 10 business days after being notified, HHSC may assess a late fee as described in subsection (f)(1) of this section, consider the renewal application withdrawn, or both. Any fee paid for a withdrawn renewal application 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 five calendar days after the change of ownership date.

(4) The facility shall not provide services until HHSC issues the initial license.

(5) HHSC may waive the inspection required by subsection (e) of this section.

(6) 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.

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

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

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

(e) During the initial licensing period, 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 revised 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 90 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 a different license designation;

(5) demolition;

(6) retrofitting a function, such as changing end stage renal disease treatment modality or training station designations or changing an invasive procedural service; 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 60 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 60 calendar days without an approved extension from HHSC.

(4) A facility that does not reactivate its license within 60 calendar days after it stopped offering services may request a single 60-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 60th calendar day after the facility stopped offering services, HHSC may consider the facility closed and the license invalid.

§ 507.18. Closure.

A license becomes invalid when a facility closes. A facility shall notify the Texas Health and Human Services Commission (HHSC) in writing in accordance with HHSC instructions before or immediately upon facility closure.

(1) The facility shall discharge or transfer all patients before the facility closes.

(2) The facility shall dispose of or store medical records in compliance with federal and state law as well as HHSC rules.

(3) When notifying HHSC of the facility closure, the facility shall inform HHSC how the facility disposed of or stored patient records.

(4) The facility shall return the license certificate to HHSC immediately after the facility closes.

§ 507.19. Time Periods for Processing and Issuing a License.

(a) The application receipt date for an initial license or a renewal license is the date the Texas Health and Human Services Commission (HHSC) receives the application and fee.

(b) An initial license application is complete when HHSC receives, reviews, and finds acceptable the information described in §507.12 of this subchapter (relating to Application and Issuance of Initial License).

(c) A renewal license application is complete when HHSC receives, reviews, and finds acceptable the information described in §507.13 of this subchapter (relating to License Renewal).

(d) An application for a change of ownership or relocation is complete when HHSC receives, reviews, and finds acceptable the information described in §507.14 of this subchapter (relating to Change of Ownership) or §507.15 of this subchapter (relating to Relocation).

(e) An application for a request in change in services or number of stations is complete when HHSC receives, reviews, and finds acceptable the information described in §507.16 of this subchapter (relating to Change in Status). HHSC acknowledges receipt of a request for change in services or number of stations within 15 calendar days after receipt.

(f) HHSC processes an end stage renal disease (ESRD) facility initial license or a renewal license in accordance with the following time periods.

(1) After receiving an application, HHSC takes one of the following actions within 45 calendar days:

(A) issues a license for a complete and approved application; or

(B) for an incomplete application, sends a written notice to the applicant describing the documents or information required to complete the application.

(2) After HHSC determines an application is complete per subsections (b) - (e) of this section, HHSC issues a license for an approved application within 45 calendar days.

(g) If HHSC does not process an application in the time periods stated in subsection (f) of this section, the applicant has the right to request HHSC to fully reimburse the fee paid. If HHSC does not agree that the established periods have been violated or finds good cause, in accordance with subsection (h) of this section, existed for exceeding the established periods, HHSC denies the request.

(h) The following circumstances are good cause for HHSC exceeding the established time period:

(1) the number of applications for licenses to be processed exceeds by 15 percent, or more, the number processed in the same calendar quarter the preceding year;

(2) another public or private entity utilized in the application process caused the delay; or

(3) other conditions existed which gave good cause for HHSC exceeding the established periods.

(i) If HHSC denies the request for full reimbursement authorized by subsection (g) of this section, the applicant may appeal the decision to the executive commissioner. The applicant may request reimbursement in writing to the executive commissioner of up to the amount of all filing fees paid to HHSC. The executive commissioner shall make a final decision based on facts related to the application processing and good cause and provide written notification of the decision to the applicant.

§ 507.20. Fees.

(a) All fees paid to the Texas Health and Human Services Commission (HHSC) are nonrefundable.

(b) All fees shall be paid by check or money order made payable to HHSC.

(c) The fees for both initial and renewal license applications are:

(1) $3,500 for facilities licensed for 1 to 10 dialysis stations;

(2) $4,300 for facilities licensed for 11 to 20 dialysis stations;

(3) $5,100 for facilities licensed for 21 to 30 dialysis stations;

(4) $5,900 for facilities licensed for 31 to 40 dialysis stations; and

(5) $6,700 for facilities licensed for 41 or more dialysis stations.

(d) All licenses are valid for 24 months.

(e) HHSC collects subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online, in accordance with Texas Government Code §2054.111 (relating to Use of State Electronic Internet Portal Project) and §2054.252 (relating to State Electronic Internet Portal Project).

(f) If the Texas Comptroller of Public Accounts notifies HHSC that a fee payment in connection with a license application did not clear, HHSC informs the applicant and stops processing that license application until the payment clears.

§ 507.21. Exceptions to These Rules.

(a) An end stage renal disease (ESRD) facility may request a temporary exception from a requirement in this chapter. A temporary exception may be related to alternative concepts, methods, procedures, techniques, or United States Food and Drug Administration-approved equipment, or for conducting pilot projects or research.

(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) A facility submitting a request for a temporary exception to a requirement in this chapter shall do so by:

(1) submitting a written request to the Texas Health and Human Services Commission (HHSC);

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

(3) describing in detail the specific circumstances the facility administration believe justify the exception;

(4) describing in detail what alternatives the facility considered, if any, and why the facility did not select any of the identified alternatives, including compliance with the rule;

(5) demonstrating that 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

(6) describing the proposed exception duration.

(d) A facility shall submit a request for an exception to this chapter to HHSC in accordance with HHSC instructions.

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

(f) HHSC responds to an exception request within 90 calendar days after receipt. On finding that the facility satisfied the conditions of this section, HHSC may grant an exception and shall specify the exception duration when notifying the facility of the granted exception.

(g) The facility may implement an exception only after receiving written approval from HHSC.

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

§ 507.22. Exceptions During Emergency or Disaster Situations.

(a) An end stage renal disease facility shall submit a request for an exception during an emergency or disaster situation to the Texas Health and Human Services Commission (HHSC). To request an exception during an emergency or disaster situation, a facility:

(1) shall make the request in accordance with HHSC instructions;

(2) shall develop an action plan to resolve the situation, including any staffing crisis;

(3) shall submit the action plan to HHSC within 60 calendar days after HHSC grants the exception;

(4) shall monitor outcome data related to quality of care and report these outcomes monthly to HHSC during the granted exception period, including granted exception periods for staffing requirements; and

(5) may request an exemption from clinical records for evacuees, except that the facility shall assess and document the hepatitis and tuberculosis status of the affected patients.

(b) If the facility requests an exemption under subsection (a)(5) of this section, at minimum, the facility must obtain:

(1) the patient's name, address, date of birth, and payor information, if available; and

(2) the name, address, and telephone number of the patient's usual dialysis facility.

(c) HHSC may only grant a temporary exception in an emergency for a maximum of 120 calendar days, with a single renewal period for an additional 120 calendar days.

§ 507.23. License Renewal 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) Notwithstanding §507.13 of this subchapter (relating to License Renewal), an ESRD facility applying for a renewal license may request an exemption for the current fire safety survey requirement by providing evidence to HHSC that the local fire authority is not performing fire inspections.

§ 507.24. Use of Off-Site Facility 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 licensed under Texas Health and Safety Code Chapter 251 (relating to End Stage Renal Disease Facilities) that meets the requirements of this section may apply to HHSC to temporarily use an off-site facility under its current license for added services or an increased number of stations to meet patient needs for the public health disaster's duration.

(c) The ESRD facility may only use the off-site facility after HHSC approves the off-site facility and when the off-site facility is:

(1) an ESRD facility no longer licensed under Texas Health and Safety Code Chapter 251 that closed within the past 36 months, or a facility with a pending application for such a license that has passed its final architectural review inspection that:

(A) can meet the current licensing requirements at §507.33 of this chapter (relating to Water Treatment) and §507.34 of this chapter (relating to Dialysate); or

(B) shall provide integrated hemodialysis machines, which incorporate water treatment and dialysis preparation and delivery into one system;

(2) a mobile, transportable, or relocatable medical unit using integrated dialysis systems, defined as any trailer or self-propelled unit:

(A) equipped with a chassis on wheels;

(B) without a permanent foundation; and

(C) intended for provision of medical services on a temporary basis;

(3) a physician's office built after January 1, 2015, that is currently in use, which a facility may use for home training of dialysis patients;

(4) a physician's office built after January 1, 2015, that has closed within the past 12 months, which a facility may use for home training of dialysis patients and:

(A) is well maintained with all building systems in good working condition; and

(B) has manual fire extinguishers in accordance with the latest National Fire Protection Association (NFPA) code and standard;

(5) an ambulatory surgical center no longer licensed under Texas Health and Safety Code Chapter 243 (relating to Ambulatory Surgical Centers) that closed within the past 36 months, which an ESRD facility may use for either home training or providing in-center dialysis treatment where:

(A) the ESRD facility only provides integrated hemodialysis machines; and

(B) the building layout provides a direct view of all patient stations from a nurse's station;

(6) a freestanding emergency medical care facility no longer licensed under Texas Health and Safety Code Chapter 254 (relating to Freestanding Emergency Medical Care Facilities) that closed within the past 36 months, which an ESRD facility may use for either home training services or providing in-center dialysis treatment where:

(A) the ESRD facility only provides integrated hemodialysis machines; and

(B) the building layout provides a direct view of all patient stations from a nurse's station;

(7) a hospital or portion of a hospital currently licensed under Texas Health and Safety Code Chapter 241 (relating to Hospitals); or

(8) a building or structure of opportunity temporarily converted for health care use, including an alternate care site, that is created or maintained by the ESRD facility in partnership with or under the supervision of the health authority, local health department, public health district, or public health consortium that has jurisdiction over the site location.

(d) To request approval for an off-site facility under this section, the ESRD facility must submit in accordance with HHSC instructions:

(1) an application to use an off-site facility for the addition of services or increased number of stations; and

(2) water culture testing results that meet the requirements of §507.33 of this chapter (relating to Water Treatment).

(e) HHSC may approve or deny an ESRD facility application to use an off-site facility under this section. HHSC may require an off-site facility inspection or additional documentation before considering an application.

(f) To protect the health, safety, and welfare of patients and the public, HHSC may withdraw its approval for an ESRD facility to use the off-site facility under this section at any time. The facility shall safely relocate any patients being treated in the off-site facility at the time HHSC withdraws its approval as soon as practicable according to the ESRD facility's policies and procedures.

§ 507.30. Technical Standards.

An end stage renal disease (ESRD) facility must comply with all applicable technical standards, including those listed below.

(1) American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)/International Organization for Standardization (ISO) 23500-1:2019, Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements.

(2) ANSI/AAMI/ISO 23500-2:2019, Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies.

(3) ANSI/AAMI/ISO 23500-3:2019, Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies.

(4) ANSI/AAMI/ISO 23500-4:2019, Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies.

(5) ANSI/AAMI/ISO 23500-5:2019, Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies.

(6) ANSI/AAMI/ISO 8637-1:2017, Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators.

(7) ANSI/AAMI/ISO 8637-2:2018, Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters.

(8) ANSI/AAMI/ International Electrotechnical Commission (IEC) 8637-3:2018, Extracorporeal systems for blood purification - Part 3: Plasmafilters.

(9) ANSI/AAMI/IEC 60601-2-16:2018, Medical electrical equipment - Part 2 - 16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment.

(10) ANSI/AAMI/IEC 60601-2-39:2018, Medical electrical equipment - Part 2 - 39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment.

(11) AAMI Technical Information Report (TIR)72:2017, Dialysis fluid chemical composition.

(12) AAMI TIR58:2021/(R)2025, Water testing methodologies.

(13) AAMI TIR43:2021/(R)2025, Ultrapure dialysis fluid for hemodialysis and related therapies.

(14) AAMI TIR77:2018, Sorbent-based regenerative hemodialysis systems.

(15) ANSI/AAMI Renal Disease (RD)47:2020, Reprocessing of hemodialyzers.

(16) Acute Dialysis: Survey Readiness Handbook, 2nd edition, 2021.

§ 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 report such equipment to the appropriate staff for immediate 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) If a facility does not have at least one backup dialysis machine, the facility must adopt, implement, and enforce a policy requiring an emergency plan for when a patient cannot complete dialysis due to machine malfunction. The facility must communicate the emergency plan to each patient at admission.

(d) 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.

(e) 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.

(f) 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.

§ 507.32. General.

(a) A facility shall meet the requirements of this subchapter and Subchapter Z of this chapter (relating to Physical Plant and Construction Requirements). A facility may follow more stringent requirements than the minimum standards required by this subchapter.

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

(c) The facility medical director and biomedical technical staff shall each ensure that policies and procedures related to water treatment, dialysate, and reuse are understandable and accessible to the operators, and the training program includes quality testing, risks, and hazards of improperly prepared concentrate and bacterial issues.

(d) Facility staff shall inform the facility owner, medical director, biomedical technical staff, and any other staff members as required by facility policy before any alteration of, or any device being added to, the water system.

§ 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 indirect feed systems, a minimum of three feet per second water flow shall be achieved in the distribution loop.

(B) For direct feed systems, a minimum flow rate in the distribution shall comply with the standards listed in §507.30 of this subchapter (relating to Technical Standards).

(C) This section shall not apply to facilities providing only home training and support 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.

(D) 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 free chlorine or 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 chloramines 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 chlorine or chloramine, or total chlorine levels at the beginning of each treatment day before patients initiating 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 monitoring as defined above 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 chlorine or chloramine, or 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 chlorine or chloramine, or 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, to ensure the water and dialysate are within the limits 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. If internal testing is performed with repeated results of "no growth" for three consecutive months, the testing shall be validated via an outside laboratory. A facility shall not use a calibrated loop in microbiological testing of water samples. Colonies shall be counted using a magnifying device.

(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/millimeter (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.

(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) If the facility is using a machine with internal independent testing for conductivity and pH, 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 water 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 are above the action level.

(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 are above the action level; 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 replace a transducer protector when wetted during a dialysis treatment and use a transducer protector for only one treatment. A facility shall quarterly inspect equipment with internal transducer protectors to ensure the equipment is not contaminated.

(d) 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.

(e) 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.

(f) 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.

(g) 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.

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

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

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

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

(l) 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. Enough sinks, with hands-free operable controls, warm water, and soap shall be available to facilitate handwashing. Provisions for hand drying shall be included at each handwashing sink.

(C) If hands are not visibly soiled, staff may substitute use of a waterless antiseptic hand rub for handwashing. Staff members may use a waterless antiseptic hand rub up for up to three consecutive uses, after which washing with soap and water is required.

(D) 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.

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

(F) 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.

(G) 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.

(H) 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.

(I) 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.

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

(K) 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.

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

(M) 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.

(N) 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.

(O) 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.

§ 507.37. Environmental.

(a) A facility shall comply with Subchapter Z of this chapter (relating to Physical Plant and Construction Requirements).

(b) Facility staff shall clean blood spills immediately, as required by the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standards.

(1) The facility must follow all appropriate requirements in the OSHA Bloodborne Pathogens Standards.

(2) Facility staff shall ensure the surface is subjected to intermediate-level disinfection in accordance with the manufacturer's directions for use if a facility uses commercial liquid chemical disinfectant.

(3) If using a solution of chlorine bleach (sodium hypochlorite), facility staff shall ensure the solution is at least 1:100 sodium hypochlorite and water. Facility staff shall mix the solution in accordance with the manufacturer's directions for use. Facility staff shall ensure the surface being treated is compatible with this type of chemical treatment. Facility staff shall label the solution with the date and time the staff mixed the solution. Facility staff shall only use the solution for 24 hours after being mixed.

(c) The facility shall adhere to the following procedures for equipment and dialysis machines.

(1) The facility shall routinely disinfect active and backup dialysis machines according to facility defined protocol, accomplishing at least intermediate-level disinfection, per Centers for Disease Control and Prevention (CDC) guidelines. The facility staff responsible for disinfecting the dialysis machines shall document the date and the time they disinfected the dialysis machines, verified facility staff rinsed the dialysis machines, and verified facility staff removed the disinfectant.

(2) Between patient shifts, facility staff shall clean machine exteriors, treatment chairs, tourniquets, blood pressure cuffs, facility individual television sets at each treatment station, and hemostats. Facility staff shall remove blood pressure cuffs that become contaminated with blood from service, disinfect the cuffs, and allow the cuffs to dry before using the cuffs, per CDC recommendations.

(d) The facility shall comply with the requirements set forth by the Texas Health and Human Services Commission in Texas Administrative Code, Title 25 (25 TAC) Chapter 1, Subchapter K (relating to Definition, Treatment, and Disposition of Special Waste from Health Care-Related Facilities); the Texas Commission on Environmental Quality (TCEQ) requirements in 30 TAC Chapter 326 (relating to Medical Waste Management); and Subchapter Z of this chapter (relating to Physical Plant and Construction Requirements).

(e) The facility shall dispose all sewage and liquid wastes in a municipal sewerage system or a septic tank system permitted by the TCEQ in accordance with 30 TAC Chapter 285 (relating to On-Site Sewage Facilities).

(f) Waste containers shall comply with Subchapter Z of this chapter.

§ 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 must 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.

§ 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(50)(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, physician assistants, 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. Registered nurses, licensed vocational nurses, 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) The 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.

§ 507.43. Quality Assessment and Performance Improvement.

(a) A facility shall develop, implement, maintain, and evaluate an effective, ongoing, facility-wide, data-driven, interdisciplinary quality assessment and performance improvement (QAPI) program. The program shall be individualized to the facility and meet the criteria and standards described in this section.

(b) The program shall reflect the complexity of the facility's organization and services involved. All facility services (including services furnished under contract or arrangement), shall focus on indicators related to improved health outcomes and prevention and reduction of medical errors.

(c) The program shall include an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with identification and reduction of medical errors.

(d) The facility shall demonstrate that facility staff evaluate the provision of dialysis care and patient services, set treatment goals, identify opportunities for improvement, develop and implement improvement plans, and evaluate the implementation until resolution is achieved.

(e) The facility shall measure, analyze, and track quality indicators or other aspects of performance it adopts or develops that reflect processes of care and facility operations. The facility shall provide evidence to show that it continuously reviews aggregate patient data, including identifying and tracking patient infections for trends.

(f) Core staff members shall actively participate in the QAPI activities, including QAPI meetings.

(1) A facility shall hold QAPI meetings monthly, or more often as necessary, to identify or correct problems.

(2) A facility shall conduct QAPI meetings separately from a patient plan of care conference.

(3) A facility shall document QAPI meetings.

(4) A facility shall invite and encourage the facility patient representatives to attend QAPI meetings.

(g) The facility's QAPI program shall include:

(1) an ongoing review of key elements of care using comparative and trend data to include aggregate patient data;

(2) identifying areas where performance measures or outcomes indicate an opportunity for improvement, including review of the progress of End Stage Renal Disease (ESRD) Network Program and CMS assigned activities;

(3) appointing interdisciplinary improvement teams to:

(A) identify, measure, analyze, and track indicators for variation from desired outcomes;

(B) create and implement improvement plans;

(C) evaluate improvement plan implementation; and

(D) continue monitoring and improvement activities until the improvement plan resolution; and

(4) establishing and monitoring quality indicators related to improved health outcomes.

(h) For each quality assessment indicator, the facility shall establish and monitor a level of performance consistent with current professional knowledge. These performance components shall influence or relate to the desired outcomes themselves. At a minimum, the facility shall measure, analyze, and track monthly:

(1) water quality (chemical, bacteriological analysis, and other indicators specific to the facility's water treatment system);

(2) equipment preventive maintenance and repair;

(3) reprocessing of hemodialyzers (dialyzer performance measures, labeling, and disinfection);

(4) infection control (staff and patient screening; standard precautions; bacteriological monitoring of dialyzers, water, machines, and dialysate; pyrogen reactions; sepsis episodes; patient infections; and peritonitis rate);

(5) adverse events;

(6) vascular access;

(7) reportable incidents as required to be reported under §507.56 of this subchapter (relating to Incident Reports);

(8) mortality (review of each death and monitoring modality specific mortality rates);

(A) complaints and suggestions (from patients, family, or staff);

(B) staffing to include orientation, training, delegation, licensing and certification, and non-adherence to policies and procedures by facility staff;

(C) safety (fire and emergency preparedness, use of a Texas Health and Human Services Commission (HHSC) approved reporting system, and disposal of special waste);

(D) clinical records review to include dialysis treatment errors, and medication errors;

(E) clinical outcomes (laboratory indicators, hospitalizations, vascular access complications, intradialytic complications, fluid management, patient no-shows, patient non-adherence to the dialysis prescription, and transplantation);

(F) patient's health-related quality of life surveys; and

(G) involuntary transfer or discharge of a patient.

(9) The dialysis facility shall continuously monitor performance, take actions that result in performance improvement, and track performance to ensure that improvements are sustained over time. The facility shall immediately correct any identified problems that threaten health and safety of patients.

(i) HHSC may review a facility's QAPI activities to determine compliance with this section.

(1) An HHSC inspector shall verify the facility has a QAPI program that addresses concerns relating to quality of care provided to its patients and the core staff members have knowledge of and the ability to access the facility's QAPI program.

(2) HHSC requires disclosure of QAPI program records when disclosure is necessary to determine compliance with this section.

§ 507.44. Indicators of Quality of Care.

(a) The facility shall regularly review the facility's data to identify opportunities to improve care. Assistance in improving care from the Texas Health and Human Services Commission (HHSC) or HHSC designee may include feedback of comparative data, a plan of correction, or an on-site inspection.

(b) The facility shall adopt, implement, and enforce procedures for resolution of complaints relevant to quality of care or services rendered by licensed health care professionals and other facility staff members, including contract services or staff.

(c) The facility shall document complaint receipt and the disposition. The investigation and documentation shall be completed within 30 calendar days after the facility receives the complaint unless the facility has and documents reasonable cause for a delay.

§ 507.45. Patient Assessment and Plan of Care.

(a) A facility shall develop, implement, and enforce policies and procedures regarding the patient's plan of care process, which specifies the services necessary to address the patient's comorbid conditions and other needs based on the patient's interdisciplinary assessment. The facility shall coordinate patient services using an interdisciplinary team approach, per CMS guidance. The interdisciplinary team shall consist of the patient, the patient's primary dialysis physician, registered nurse, social worker, and dietitian.

(b) The interdisciplinary team shall engage in an interactive conference to develop a written, individualized, comprehensive patient plan of care that specifies the services necessary to address the patient's medical, psychological, social, and functional needs, and includes treatment goals.

(c) The patient plan of care shall include measurable and expected outcomes and estimated timetables to achieve these outcomes. The patient plan of care shall include the patient's current dose of dialysis, dialysis adequacy, other medical comorbidity issues, nutritional status, mineral metabolism, anemia, vascular access, psychosocial status, modality, transplantation status, rehabilitation status, goals, and education and training.

(d) The patient plan of care shall include evidence of coordination with other service providers (e.g., hospitals, long term care facilities, home and community support services agencies, and transportation providers) as needed to ensure continuity of safe care.

(e) The patient plan of care shall include evidence of the patient's (or patient's legal representative's) input and participation unless they refuse to participate. If the patient refuses to participate, the facility shall document the patient refusal in the patient's record. At a minimum, the patient plan of care shall demonstrate an interdisciplinary team member discussed the content with the patient or the patient's legal representative.

(f) Facility staff shall develop and implement the patient plan of care within 30 calendar days, or 13 outpatient dialysis treatments from the patient's admission to the facility, whichever occurs later. Facility staff shall revise the patient plan of care due to changes in the patient's personal treatment goals, lack of progress towards the patient's plan of care goals, marked deterioration in health status, significant changes in the patient's psychosocial needs, or changes in the patient's nutritional condition, as needed, but no less than annually after the date of the patient's last plan of care.

(g) The facility shall monitor the patient plan of care at least monthly to recognize and address any deviations from the patient plan of care by:

(1) implementing changes in interventions due to the lack of progress toward the patient's plan of care goals;

(2) documenting the reasons why the patient was unable to achieve the goals; and

(3) implementing changes to address the revised patient plan of care.

(h) Facility staff may conduct an interdisciplinary team conference via telehealth or telemedicine, which may include audio-only telecommunications. A telehealth or telemedicine patient plan of care conference conducted with the interdisciplinary team and the patient (or their legally authorized representative) shall be documented as such.

(i) In the case of disruptive patients or family members or patients who do not conform to the treatment plan, the facility shall develop, implement, and enforce a process for more intensive interdisciplinary team intervention with this patient to include assessment of needs and planned interventions to assist the patient in adjusting to the requirements for safe care.

(1) The facility shall contact the End Stage Renal Disease Network for assistance with these patients before considering an involuntary discharge of the disruptive patient.

(2) The facility shall establish, implement, and enforce a policy allowing a disruptive or noncompliant patient or family member the opportunity and assistance to improve any problematic behavior before their dismissal from the facility, in accordance with the requirements of this section.

(j) A facility shall not violate Texas Occupations Code Chapter 102 (relating to Solicitation of Patients).

§ 507.46. Emergency Preparedness.

(a) In this section, unless the context clearly indicates otherwise, "emergency" means an incident likely to threaten the health, welfare, or safety of a facility's patients, facility staff, or the public, including a fire, equipment failure, power outage, flood, interruption in utility service, medical emergency, or natural or other disaster.

(b) In accordance with Texas Health and Safety Code §251.016 (relating to Emergency Preparedness and Contingency Operations Planning), a facility shall implement a written emergency preparedness and contingency operations plan that describes staff and patient actions to manage potential medical and nonmedical emergencies, including fire, equipment failure, power outages, medical emergencies, and natural or other disasters that are likely to threaten the health, welfare, or safety of the facility patients, staff, or public. The plan shall comply with the following requirements.

(1) The facility shall update the plan at least annually.

(2) The facility's leadership shall approve the plan each time the facility updates the plan.

(3) The plan shall include:

(A) procedures for notifying each of the following entities, as soon as practicable, regarding facility closure or reduction in hours of operation due to an emergency:

(i) the Texas Health and Human Services Commission (HHSC);

(ii) each hospital with which the facility has a transfer agreement in accordance with subsection (j) of this section;

(iii) the trauma service area regional advisory council that serves the geographic area in which the facility is located; and

(iv) each applicable local emergency management agency;

(B) a documented patient communications plan that includes procedures for notifying a patient when that patient's scheduled dialysis treatment is interrupted;

(C) a continuity of care plan for the provision of dialysis treatment to facility patients during an emergency that meets the requirements under subsection (d) of this section; and

(D) a disaster preparedness plan for natural and other disasters that:

(i) is specific to the facility based on an assessment of the probability and type of disaster in the region and the local resources available to the facility;

(ii) incorporates the use of the HHSC-approved reporting system and participation in the End Stage Renal Disease (ESRD) Network disaster preparedness activities;

(iii) includes procedures designed to minimize harm to patients and staff along with ensuring safe facility operations;

(iv) along with in-service programs for patients and staff, includes provisions or procedures for responsibility of direction and control, communications, alerting and warning systems, evacuation, and closure;

(v) requires each staff member employed by or under contract with the facility to be able to demonstrate their role or responsibility to implement the facility's disaster preparedness plan.

(vi) designates a staff member in each facility to monitor and coordinate disaster preparedness activities;

(vii) maintains in each facility documentation of the monitoring and coordination of disaster preparedness activities; and

(viii) addresses the continuity of essential building systems, including emergency power and water, or a contract with another licensed ESRD facility to provide emergency contingency care to patients to meet the requirements of §507.501(i) of this chapter (relating to Fire Prevention, Protection, and Emergency Contingency Plan); and

(4) except as provided by subsection (c) of this section, requires a facility to execute a contract with another ESRD facility located within a 100-mile radius of the facility stipulating that the other ESRD facility will provide dialysis treatment to facility patients who are unable to receive scheduled dialysis treatment due to the facility's closure or reduction in hours.

(c) A facility is not required to contract with another ESRD facility under subsection (b)(4) of this section if:

(1) no other ESRD facility is located within a 100-mile radius of the facility; and

(2) the facility obtains written approval from HHSC exempting the facility from that requirement.

(d) A facility shall develop a continuity of care plan for provision of dialysis treatment to facility patients during an emergency that:

(1) includes procedures for distributing written materials to facility patients that specifically describe the facility's emergency preparedness and contingency operations plan;

(2) includes detailed procedures on the facility's continency plans, based on the facility's patient population, including transportation options, for patients to access dialysis treatment at each ESRD facility with which the facility has an agreement or made advance preparations to ensure that the facility's patients have the option to receive dialysis treatment and procedures for notifying a patient when that patient's scheduled dialysis treatment is interrupted;

(3) is approved by the facility's leadership; and

(4) is provided by the facility to each patient before providing or scheduling dialysis treatment.

(e) On request, a facility shall provide the facility's emergency preparedness and contingency operations plan adopted under subsection (b) of this section to:

(1) HHSC;

(2) each hospital with which the facility has a transfer agreement in accordance with subsection (j) of this section;

(3) the trauma service area regional advisory council that serves the geographic area in which the facility is located; and

(4) each applicable local emergency management agency.

(f) A facility shall provide annual training to facility staff on the facility's emergency preparedness and contingency operations plan required by subsection (b) of this section.

(g) A facility shall annually contact a local and state disaster management representative, an emergency operations center in its local jurisdiction, and a trauma service area regional advisory council to:

(1) request comments on whether the emergency preparedness and contingency plan adopted by the facility under subsection (b) of this section should be modified; and

(2) ensure that local agencies, regional agencies, state agencies, and hospitals are aware of the facility, the facility's policy on provision of life saving treatment, the facility's patient population and potential transportation needs, and the anticipated number of patients affected.

(h) A facility shall have a functional plan to access emergency medical services.

(i) A facility shall have personnel qualified to operate emergency equipment and provide emergency care to patients on site and available during all treatment times. A charge nurse qualified to provide basic cardiopulmonary life support (BCLS) shall be on site and available to the treatment area whenever patients are present. All direct care staff members shall maintain current certification and competency in BCLS.

(j) A facility shall have a transfer agreement with one or more hospitals that provide acute dialysis service for provision of inpatient care and other hospital services to the facility's patients. The facility shall have documentation from the hospital to the effect that patients from the facility shall be accepted and treated in emergencies. There shall be reasonable assurances in the transfer agreement that:

(1) whenever a transfer or referral is deemed medically appropriate by the attending physician, the hospital and facility shall coordinate the patient's transfer or referral to ensure timely acceptance and admission;

(2) the interchange of medical and other information necessary or useful in the transferred patient's care and treatment shall occur within one business day; and

(3) the facility shall ensure the security and accountability of the transferred patient's personal effects.

(k) A facility shall post a telephone number specific to the facility's equipment and locale to assist staff in contacting mechanical and technical support in the event of an emergency.

(l) The facility shall maintain information on the HHSC-approved reporting system and update online monthly.

§ 507.47. Medication Storage and Administration.

(a) The facility shall provide pharmaceutical and therapeutic items in accordance with accepted professional principles and federal and state laws and regulations.

(b) Facility staff shall administer medications only when the patient's physician, attending physician, physician assistant (PA) or an advanced practice registered nurse (APRN) orders the medication. Facility staff shall administer medication as ordered.

(c) The sponsoring physician shall document and authenticate or countersign all physician, PA, or APRN orders within 15 calendar days from the date the physician, PA or APRN gave the order.

(d) The facility shall properly store and safeguard medications maintained in the facility in enclosures of sufficient size, which are not accessible to unauthorized individuals. The facility shall maintain refrigerators used for medication storage with documentation of the appropriate temperatures for such storage.

(e) A facility shall maintain emergency medications, as specified by the medical director, to treat the emergency needs of patients.

(f) Facility staff shall not prepare medications for administration in the patient's immediate treatment area. The medication preparation area shall include a work counter and a sink in an area to prevent contamination of medicines being prepared for administration.

(g) Facility staff shall not take medication vials to a patient station. Facility staff shall not puncture more than once intravenous medication vials labeled for single use.

(h) Facility staff shall label medications not given immediately with the patient's name, medication name, dosage prepared, and initials of the staff member preparing the medication. Facility staff shall protect medications not given immediately to prevent contamination and casual access of the prepared medications to unauthorized individuals. The facility staff who prepared the medication shall administer the medication.

(i) Facility staff shall not draw saline from the IV bag or tubing in use for the patient and shall prepare saline in a clean medication preparation area separate from potentially contaminated items and surfaces.

(j) Licensed nurses, physician assistants, or physicians shall administer all medications except intravenous normal saline, intravenous heparin, subcutaneous lidocaine, topical lidocaine, and oxygen, which may be administered as part of a routine hemodialysis treatment by dialysis technicians qualified according to §507.72 of this chapter (relating to Training Curricula and Instructors) and §507.73 of this chapter (relating to Competency Evaluation). Such administration by dialysis technicians shall comply with Texas Occupations Code Chapter 157 (relating to Authority of Physician to Delegate Certain Medical Acts).

§ 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) pre-dialysis evaluations on all patients within the first hour of treatment each time the patient receives treatment; and

(4) immediate post-dialysis 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 Figure: 26 TAC §507.60. 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.

(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 Figure: 26 TAC §507.60.

(2) During treatment of 8-12 patients, two licensed nurses shall be available, only one of which shall be a charge nurse with no direct patient care assignment, as demonstrated in Figure: 26 TAC §507.60. The nurse can be either an RN or LVN.

(3) 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 or their designee 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 100 patients. The caseload is cumulative across all modalities and facilities where the dietitian is employed.

(2) A facility shall employ or contract a second full-time equivalent dietitian if the first dietitian's patient caseload is over 100.

(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 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. The maximum patient load is 125 patients per full-time equivalent qualified social worker with assigned personnel assistance, including all modalities.

(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, with visits separated by at least 10 calendar days.

(4) Home dialysis patients shall be seen by a physician, advanced practice registered nurse, or physician assistant no less than once a month.

(A) If a home dialysis patient is seen by an advanced practice registered nurse or a physician assistant, the physician shall see the patient at least once every three months.

(B) The provider may conduct this visit in the dialysis facility, at the physician's office, or in the patient's home.

(C) 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 advanced practice registered nurses or physician assistants:

(1) the facility shall ensure documented evidence of communication with the treating physician whenever the advanced practice registered nurse or physician assistant changes treatment orders;

(2) the advanced practice registered nurse or physician assistant shall not replace the physician in participating in patient care planning or in QAPI activities;

(3) the advanced practice registered nurse or physician assistant 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 advanced practice registered nurse or physician assistant shall notify the treating physician of patient medical emergencies;

(5) the advanced practice registered nurse or physician assistant shall meet the requirements established by the Texas Board of Nursing (for an advanced practice registered nurse) or the Texas Physician Assistant Board (for a physician assistant); and

(6) the advanced practice registered nurse or a physician assistant shall use mechanisms that provide authority for that care, which shall include protocols or other written authorization:

(A) reviewed and approved by the advanced practice registered nurse or physician assistant and the appropriate physician;

(B) signed by both the advanced practice registered nurse or physician assistant and the physician;

(C) reviewed and re-signed at least annually;

(D) maintained in the practice setting of the advanced practice registered nurse or physician assistant; 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 provides student supervision 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 direct 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.

(1) The room shall include a handwashing sink with hands-free operable controls, warm water, and soap to facilitate handwashing. 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) 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.

(d) For home dialysis patients, including all modalities, a facility shall maintain a staffing level of one full-time equivalent registered nurse per 20 patients, or portion thereof.

(e) 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) reassess 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.

(f) 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.

(g) 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.

(h) 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.

(i) 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.

(j) 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) The prescribing physician, advanced practice registered nurse, or physician assistant shall see the patient no less than once a month.

(A) The prescribing physician shall see the patient at least once every three months if an advanced practice registered nurse or physician assistant sees the patient monthly.

(B) The prescribing physician may conduct the visit in the dialysis facility, at the physician's office, or in the patient's home.

(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.

(k) 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 or chloramines 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.

(l) 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.

(m) 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.

(n) The dialysis facility shall identify a plan and arrange for emergency backup dialysis services when needed.

(o) The dialysis facility shall maintain a recordkeeping system that ensures continuity of care and patient privacy.

(p) The dialysis facility shall culture and measure the hemodialysis machines of home patients for colony forming units and endotoxins before disinfection. 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 as they may not require disinfection, culture, and measurement for colony forming units and endotoxins.

(q) As applicable, the facility shall maintain maintenance records for all dialysis machines and dialysis equipment at the licensed facility site.

(r) 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).

(s) 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 patients to sample the product water to test for chlorine or chloramines, or total chlorine levels immediately before using the dialysate. The chlorine or chloramines level shall be less than 0.1 mg/L, and the results shall be documented by the patient.

(D) If applicable, the facility 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 24 months of being hired as a dialysis technician.

(b) The facility administrator shall have at least one year of experience working in a health care facility as defined in section §507.2(40) of this chapter (relating to Definitions).

(c) 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).

(d) 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 in-center or home training, a registered nurse with at least 12 months clinical experience and three months experience in the specific modality, shall be responsible for training the patient or family in that modality. When other personnel assist in the training, the qualified registered nurse shall supervise the training.

(5) When other personnel assist in training a patient or the patient's caregiver for 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 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).

(e) 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.

(f) 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.

(g) 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) The facility shall have written physician authorized delegation of responsibilities for the biomedical technical staff as determined by the medical director and the facility.

(3) 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, including at least:

(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.

(4) 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 (5)(B) of this subsection.

(5) 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 (3) 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.

(6) The staff responsible for equipment maintenance and repair shall meet the education, training, and experience requirements described in paragraph (3) of this subsection and shall demonstrate competency by:

(A) successful completion of the facility training course outlined in paragraph (3) 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.

(7) The staff responsible for reprocessing hemodialyzers and other supplies shall meet the education, training, and experience requirements described in paragraph (3) 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) 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 confirmed conversion of staff or a patient to Hepatitis B surface antigen (HbsAg) positive, unless it is a verified false positive.

(2) 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;

(3) a fire in the facility; and

(4) 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 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.

§ 507.58. Staffing and Reporting Requirements 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 that is experiencing a documented, significant staffing shortage may temporarily adopt the accommodations under this section to meet patient needs for the duration of the public health disaster.

(c) Subject to HHSC approval, an ESRD facility may request a temporary exemption from staffing requirements:

(1) for nursing services, as specified in §507.48 of this subchapter (relating to Nursing Services);

(2) for nutrition services, as specified in §507.49 of this subchapter (relating to Nutrition Services);

(3) for social services, as specified §507.51 of this subchapter (relating to Social Services); and

(4) for staffing levels of direct care staff, as specified in §507.60 of this subchapter (relating to Staffing Table).

(d) Notwithstanding §507.43(e) of this subchapter (relating to Quality Assessment and Performance Improvement), core staff members shall actively participate in quality assessment and performance improvement (QAPI) activities and attend meetings every other month.

(e) Notwithstanding §507.47 of this subchapter (relating to Medication Storage and Administration), all verbal or telephone physician orders shall be documented and authenticated or countersigned by the physician not more than 30 calendar days from the date the order was given.

(f) Notwithstanding §507.53 of this subchapter (relating to Home Dialysis Service), the staffing level for home dialysis patients, including all modalities, shall be one full-time equivalent registered nurse per 25 patients, or portion thereof.

(g) Notwithstanding §507.54(d)(2) of this subchapter (relating to Staff Qualifications), each registered nurse who is assigned charge nurse responsibilities shall have at least 12 months of clinical experience and have three months of experience in hemodialysis after completion of the facility's training program. In addition:

(1) the registered nurse shall be able to demonstrate competency for the required level of responsibility and the facility shall maintain documentation of that competency;

(2) the registered nurse shall be certified by the facility's medical director and governing body;

(3) the hemodialysis experience shall be within the last 24 months; and

(4) a registered nurse who holds a current certification from a nationally recognized board in nephrology nursing or hemodialysis may substitute the certification for the three months experience in dialysis obtained within the last 24 months.

(h) Notwithstanding §507.54(d)(4) of this subchapter, if patient self-care training is provided, a registered nurse who has at least 12 months of clinical experience and three months of experience in the specific modality shall be responsible for training the patient or family in that modality. When other personnel assist in the training, supervision by the qualified registered nurse shall be demonstrated.

(i) Notwithstanding the deadline provision of §507.56(a) of this subchapter (relating to Incident Reports), a facility shall report an incident listed in §507.56(a)(1) - (5) of this subchapter to HHSC within 20 business days of the incident.

(j) Notwithstanding §507.72(i) of this chapter (relating to Training Curricula and Instructors), for individuals 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 for dialysis technicians. Training programs for dialysis technician trainees who have confirmed previous direct patient care experience may be shortened to a total of 40 clock hours of combined classroom education and clinical training if they demonstrate competency with the required knowledge and skills and there has not been more than a year of time elapsed since they provided patient care in a licensed ESRD facility setting.

§ 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 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) Home dialysis patients shall be seen by a physician, advanced practice registered nurse, or physician assistant no less than once a month.

(1) If home dialysis patients are seen by an advanced practice registered nurse or a physician assistant, the physician shall see the patient at least once every three months.

(2) This visit may be conducted using telemedicine medical services.

(3) The record of these contacts shall include evidence of assessment for new and recurrent problems and review of dialysis adequacy each month.

(e) Notwithstanding §507.53 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.

(f) A provider may conduct a home patient visit required by §507.53 of this subchapter using telemedicine medical services.

§ 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)

§ 507.71. General Requirements.

(a) An individual shall not act as a dialysis technician unless that individual is trained and competent as described in this subchapter.

(b) A trainee shall identify themselves as a trainee during any time spent in the patient treatment area.

(c) Until a trainee successfully completes the competency evaluation, a trainee may provide patient care only as part of a training program and under the immediate supervision of a registered nurse or an assigned preceptor. A preceptor shall be a licensed nurse or dialysis technician who has one year of experience in hemodialysis obtained within the last 24 months, a recommendation by the supervising nurse to be a preceptor, and a current competency skills checklist on file in the facility.

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

(e) A facility allowing a dialysis technician who is not a licensed vocational nurse to initiate or discontinue dialysis via a central venous catheter or manipulate a central venous catheter shall adopt, implement, and enforce policies and procedures that require:

(1) the dialysis technician to be certified as a Certified Clinical Hemodialysis Technician (CCHT);

(2) the dialysis technician to take the training described in §507.72(c)(3) of this subchapter (relating to Training Curricula and Instructors);

(3) the dialysis technician to pass the competency evaluation described in §507.72(f) of this subchapter; and

(4) a nurse to supervise the dialysis technician and ensure the dialysis technician follows all facility policies and procedures.

§ 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 training 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 normal saline, heparin, lidocaine, or oxygen, the content 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 content 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 heparin, normal saline, 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 heparin or other prescribed anticoagulants 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 lidocaine and other anesthetics 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 heparin or other prescribed anticoagulants 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 normal saline, heparin, lidocaine or other anesthetics, 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).

§ 507.74. Documentation of Competency.

(a) A facility's training program shall provide a certification or verification document to the dialysis technician trainee, documenting their successful completion of the training program and competency evaluation. This document shall indicate that the training program the trainee completed meets the requirements of this subchapter.

(b) Another facility that may later employ the dialysis technician may accept the document described in subsection (a) of this section. Each employing facility shall have each newly hired experienced dialysis technician complete a written test and competency checklist in accordance with §507.73(c) - (e) of this subchapter (relating to Competency Evaluation) within a minimum 80 work hours after hire.

§ 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 normal saline, heparin or other prescribed anticoagulants, lidocaine or other anesthetics, 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").

§ 507.81. Integrity of Inspections and Investigations.

(a) In order to preserve the integrity of the Texas Health and Human Services Commission (HHSC) inspection and investigation process, an end stage renal disease (ESRD) facility:

(1) may not record, listen to, or eavesdrop on any HHSC interview with facility staff or patients that the facility staff knows HHSC intends to keep confidential as evidenced by HHSC taking reasonable measures to prevent from being overheard; or

(2) may not record, listen to, or eavesdrop on any HHSC internal discussions outside the presence of facility staff when HHSC has requested a private room or office or distanced themselves from facility staff unless the facility first informs HHSC and the facility obtains written approval from HHSC before beginning to record or listen to the discussion.

(b) A facility shall inform HHSC when security cameras or other existing recording devices in the facility are in operation during any internal discussion by or among HHSC staff.

(c) When HHSC by words or actions permits facility staff to be present, an interview or conversation for which facility staff are present does not constitute a violation of this rule.

(d) This section does not prohibit an individual from recording an HHSC interview with the individual.

§ 507.82. Inspections.

(a) The Texas Health and Human Services Commission (HHSC) may conduct an inspection of each end stage renal disease (ESRD) facility prior to the issuance or renewal of a license.

(1) A facility is not subject to additional annual licensing inspections subsequent to the issuance of the initial license while the facility maintains:

(A) certification under Title XVIII of the Social Security Act, 42 United States Code §§1395 et seq.; or

(B) accreditation from a national accreditation organization for the offered services.

(2) HHSC may conduct an inspection of a facility exempt from an annual licensing inspection under paragraph (1) of this subsection before issuing a renewal license to the facility if the certification or accreditation body has not conducted an on-site inspection of the facility in the preceding three years and HHSC determines that an inspection of the facility by the certification or accreditation body is not scheduled within 60 days of the license expiration date.

(b) HHSC may conduct an unannounced, on-site inspection of a facility at any reasonable time, including when treatment services are provided, to inspect, investigate, or evaluate compliance with or prevent a violation of:

(1) any applicable statute or rule;

(2) a facility's plan of correction;

(3) an order or special order of the HHSC executive commissioner or the executive commissioner's designee;

(4) a court order granting injunctive relief; or

(5) for other purposes relating to regulation of the facility.

(c) An applicant or licensee, by applying for or holding a license, consents to entry and inspection of any of its facilities by HHSC.

(d) HHSC inspections to evaluate a facility's compliance may include:

(1) initial, change of ownership, or relocation inspections for the issuance of a new license;

(2) inspections related to changes in status, such as new construction or changes in services, designs, or licensed station numbers;

(3) routine inspections, which may be conducted without notice and at HHSC discretion, or prior to renewal;

(4) follow-up on-site inspections, conducted to evaluate implementation of a plan of correction for previously cited deficiencies;

(5) inspections to determine if an unlicensed facility is offering or providing, or purporting to offer or provide, treatment; and

(6) entry in conjunction with any other federal, state, or local agency's entry.

(e) A facility shall cooperate with any HHSC inspection and shall permit HHSC to examine the facility's grounds, buildings, books, records, video surveillance, and other documents and information maintained by or on behalf of the facility, unless prohibited by law.

(f) A facility shall permit HHSC access to interview members of the governing body, personnel, and patients, including the opportunity to request a written statement.

(g) A facility shall permit HHSC to inspect and copy any requested information, unless prohibited by law. If it is necessary for HHSC to remove documents or other records from the facility, HHSC provides a written description of the information being removed and when it is expected to be returned. HHSC makes a reasonable effort, consistent with the circumstances, to return any records removed in a timely manner.

(h) Upon entry, HHSC holds an entrance conference with the facility's designated representative to explain the nature, scope, and estimated duration of the inspection.

(i) During the inspection, the HHSC representative gives the facility representative an opportunity to submit information and evidence relevant to matters of compliance being evaluated.

(j) When an inspection is complete, the HHSC representative holds an exit conference with the facility representative to inform the facility representative of any preliminary findings of the inspection, including possible health and safety concerns. The facility may provide any final documentation regarding compliance during the exit conference.

(k) HHSC maintains the confidentiality of facility records as applicable under state or federal law.

§ 507.83. Complaint Investigations.

(a) A facility shall provide each patient and applicable legally authorized representative at the time of admission with a written statement identifying the Texas Health and Human Services Commission (HHSC) as the agency responsible for investigating complaints against the facility.

(1) The statement shall inform persons that they may direct a complaint to HHSC Complaint and Incident Intake (CII) and include current CII contact information, as specified by HHSC.

(2) The facility shall prominently and conspicuously post this statement in patient common areas and in visitor's areas and waiting rooms so that it is readily visible to patients, employees, and visitors. The information shall be in English and in a second language appropriate to the demographic makeup of the community served.

(b) HHSC evaluates all complaints. A complaint must be submitted using HHSC current CII contact information for that purpose, as described in subsection (a) of this section.

(c) HHSC documents, evaluates, and prioritizes complaints directed to HHSC CII based on the seriousness of the alleged violation and the level of risk to patients, personnel, and the public.

(1) Allegations determined to be within HHSC regulatory jurisdiction relating to health care facilities may be investigated under this chapter.

(2) HHSC may refer complaints outside HHSC jurisdiction to an appropriate agency, as applicable.

(d) HHSC conducts investigations to evaluate a facility's compliance following a complaint of abuse, neglect, or exploitation; or a complaint related to the health and safety of patients. Complaint investigations may be coordinated with the federal Centers for Medicare & Medicaid Services and its agents responsible for the inspection of ESRD facilities to determine compliance with the Conditions of Participation under Title XVIII of the Social Security Act, (42 United States Code, §§1395 et seq.), to avoid duplicate investigations.

(e) HHSC may conduct an unannounced, on-site investigation of a facility at any reasonable time, including when treatment services are provided, to inspect or investigate:

(1) a facility's compliance with any applicable statute or rule;

(2) a facility's plan of correction;

(3) a facility's compliance with an order of the HHSC executive commissioner or the executive commissioner's designee;

(4) a facility's compliance with a court order granting injunctive relief; or

(5) for other purposes relating to regulation of the facility.

(f) An applicant or licensee, by applying for or holding a license, consents to entry and investigation of any of its facilities by HHSC.

(g) A facility shall cooperate with any HHSC investigation and shall permit HHSC to examine the facility's grounds, buildings, books, records, video surveillance, and other documents and information maintained by, or on behalf of, the facility, unless prohibited by law.

(h) A facility shall permit HHSC access to interview members of the governing body, personnel, and patients, including the opportunity to request a written statement.

(i) A facility shall permit HHSC to inspect and copy any requested information, unless prohibited by law. If it is necessary for HHSC to remove documents or other records from the facility, HHSC provides a written description of the information being removed and when it is expected to be returned. HHSC makes a reasonable effort, consistent with the circumstances, to return any records removed in a timely manner.

(j) Upon entry, the HHSC representative holds an entrance conference with the facility's designated representative to explain the nature, scope, and estimated duration of the investigation.

(k) The HHSC representative holds an exit conference with the facility representative to inform the facility representative of any preliminary findings of the investigation. The facility may provide any final documentation regarding compliance during the exit conference.

(l) Once an investigation is complete, HHSC reviews the evidence from the investigation to evaluate whether there is a preponderance of evidence supporting the allegations contained in the complaint.

(m) HHSC maintains the confidentiality of facility records as applicable under state or federal law.

(n) HHSC notifies complainants regarding the investigation's outcome within 10 business days after completing the investigation.

§ 507.84. Notice.

(a) A facility is deemed to have received any Texas Health and Human Services Commission (HHSC) correspondence on the date of receipt, or three business days after mailing, whichever is earlier.

(b) When HHSC finds deficiencies:

(1) HHSC provides the facility with a written Statement of Deficiencies (SOD) within 10 business days after the exit conference via U.S. Postal Service or electronic mail.

(2) Within 10 calendar days after the facility's receipt of the SOD, the facility shall return to HHSC a written Plan of Correction (POC) that addresses each cited deficiency, including timeframes for corrections, together with any additional evidence of compliance.

(A) HHSC determines if a POC and proposed timeframes are acceptable, and, if accepted, notifies the facility in writing.

(B) If HHSC does not accept the POC, HHSC notifies the facility in writing and requests the facility submit to HHSC a modified POC and any additional evidence of compliance no later than 10 business days after HHSC notifies the facility in writing.

(C) The facility shall correct the identified deficiencies and submit to HHSC evidence verifying implementation of corrective action within the timeframes set forth in the POC, or as otherwise specified by HHSC.

(3) Regardless of a facility's compliance with this subsection or HHSC acceptance of a facility's POC, HHSC may, at any time, propose to take enforcement action as appropriate under this chapter.

§ 507.85. Professional Conduct.

In addition to any enforcement action under this chapter, the Texas Health and Human Services Commission reports, in writing, to the appropriate licensing board any issue or complaint relating to the conduct of a licensed professional, intern, or applicant for professional licensure.

§ 507.86. Complaint Against an HHSC Representative.

A facility may register a complaint against a Texas Health and Human Services Commission (HHSC) representative who conducts an inspection or investigation under this subchapter by following the procedure listed on the HHSC website.

§ 507.87. Corrective Action Plan.

(a) The medical review board (MRB) may assist the Texas Health and Human Services Commission (HHSC) in determining the corrective action required when the results of an inspection or an annual report indicate significant problems potentially impacting patient outcomes exist. At the conclusion of an on-site inspection, HHSC may refer an end stage renal disease facility to the MRB if the results of the inspection present concerns related to patient outcomes. These facilities may be requested to provide additional information, or may be subject to an on-site inspection, corrective action plan, or enforcement action.

(b) A corrective action plan may be used in accordance with Texas Health and Safety Code §251.061 (relating to Corrective Action Plan).

(1) HHSC may use a corrective action plan as an alternative to enforcement action under Texas Health and Safety Code §251.061.

(2) Before taking enforcement action, HHSC considers whether the use of a corrective action plan is appropriate. In determining whether to use a corrective action plan, HHSC considers whether:

(A) the facility has violated Texas Health and Safety Code Chapter 251 (relating to End Stage Renal Disease Facilities), or this chapter, and the violation has resulted in an adverse patient result;

(B) the facility has a previous history of lack of compliance with the statute, this chapter, or a previously executed corrective action plan; or

(C) the facility fails to agree to a corrective action plan.

(c) HHSC may use a level one, level two, or level three corrective action plan, as determined by HHSC in accordance with this subsection, after inspection of the facility.

(1) A level one corrective action plan is appropriate if HHSC finds the facility is not in compliance with Texas Health and Safety Code Chapter 251 or this chapter, but the circumstances are not serious or life-threatening. HHSC or a monitor may supervise the implementation of the plan.

(2) A level two corrective action plan is appropriate if HHSC finds the facility is not in compliance with Texas Health and Safety Code Chapter 251 or this chapter and the circumstances are potentially serious or life-threatening, or if HHSC finds that the facility failed to implement or comply with a level one corrective action plan. HHSC or a monitor shall supervise the implementation of the plan. Supervision of the plan's implementation may include on-site supervision, observation, and direction. The facility is expected to comply with all HHSC requests, including supervision, observation, and direction, as requested by HHSC.

(3) A level three corrective action plan is appropriate if HHSC finds that the facility is not in compliance with Texas Health and Safety Code Chapter 251 or this chapter and the circumstances are serious or life-threatening, or if HHSC finds that the facility failed to comply with a level two corrective action plan or cooperate with HHSC in connection with that plan. HHSC may require the appointment of a monitor to supervise the implementation of the plan, appointment of a temporary manager, or appointment of a monitor and temporary manager. Appointment of a temporary manager by agreement shall be in accordance with §507.88 of this subchapter (relating to Voluntary Appointment of a Temporary Manager). Involuntary appointment of a temporary manager shall be in accordance with §507.89 of this subchapter (relating to Involuntary Appointment of a Temporary Manager).

(4) A corrective action plan is not confidential. Information contained in the plan may be exempted from required disclosure under Texas Government Code Chapter 552 (relating to Public Information) or other applicable law.

(5) HHSC approves the monitor for a corrective action plan. The monitor shall be an individual or team of individuals and may include a professional with end stage renal disease experience or a MRB member.

(A) The monitor shall not be a current employee or former employee within the past two years of the dialysis organization or an affiliated facility.

(B) The monitor's purpose is to observe, supervise, consult, and educate the facility and the facility's employees under a corrective action plan and bring the facility into substantial compliance with the regulations of this chapter and all other state and federal laws and regulations in as short a time as practicable.

(C) The monitor shall report their findings no less than once a month to facility management, administrators, and HHSC to report goals and accomplishments and set forth further improvements needed in the facility. Monitors shall reduce their time spent in the facility to allow staff to practice what they have learned, to the point that continued monitoring is no longer necessary nor desired.

(D) HHSC may conduct an on-site inspection to determine the facility's progress under the monitor's direction. HHSC staff inspects monitored facilities within six months after imposing a facility monitor to determine whether the facility must maintain the corrective action plan under which the monitor was placed.

(E) The facility shall pay the cost of the monitor.

(F) A facility shall not use a monitor who is currently acting as a full-time monitor for another facility under a corrective action plan.

(G) A facility shall select a monitor and submit the monitor's resume for HHSC approval of the monitor. Once the facility selects and HHSC approves a monitor, the facility shall ensure only the approved monitor is used. The facility shall not allow a subcontractor to take the place of the approved monitor.

§ 507.88. Voluntary Appointment of a Temporary Manager.

(a) A person holding a controlling interest in a facility may, at any time, request the Texas Health and Human Services Commission (HHSC) to assume the facility's management by appointing a temporary manager in accordance with Texas Health and Safety Code §251.091 (relating to Appointment by Agreement).

(b) After receiving the request, HHSC may enter into an agreement providing for the appointment of a temporary manager to manage the facility under conditions considered appropriate by both parties, if HHSC considers the appointment desirable.

(c) An agreement under this section shall:

(1) specify all terms and conditions of the temporary manager's appointment and authority; and

(2) preserve all rights of individuals served by the facility granted by law.

(d) The temporary manager's primary duty is to ensure adequate and safe services are provided to patients until temporary management ceases.

(e) The appointment terminates at the time specified by the agreement.

§ 507.89. Involuntary Appointment of a Temporary Manager.

(a) Under Texas Health and Safety Code §251.092 (relating to Involuntary Appointment), the Texas Health and Human Services Commission (HHSC) may request the attorney general to bring an action in the name and on behalf of the state to appoint a temporary manager to manage a facility if:

(1) the facility is operating without a license;

(2) HHSC has denied, suspended, or revoked the facility's license but the facility continues to operate;

(3) license denial, suspension, or revocation proceedings against the facility are pending, and HHSC determines that an imminent or reasonably foreseeable threat to the health and safety of a facility's patient exists;

(4) HHSC determines that an emergency exists that presents an immediate threat to the facility's patient's health and safety;

(5) the facility is closing and arrangements for the care of patients by other licensed facilities have not been made before closure; or

(6) HHSC determines a level three corrective action plan, under §507.87(c)(3) of this subchapter (relating to Corrective Action Plan) that includes appointment of an involuntary temporary manager, is necessary to address serious or life-threatening conditions at the facility.

(b) After a hearing under Texas Health and Safety Code §251.092, a court appoints a temporary manager to manage a facility, if the court finds appointing the manager is necessary.

(1) The court order addresses the temporary manager's duties and authority, which may include facility management and providing dialysis services to facility patients until specified circumstances occur, such as new facility ownership, compliance with the statute or this chapter, or facility closure.

(2) If possible, the court appoints as temporary manager an individual whose background includes administration of end stage renal disease facilities or similar facilities.

(3) The venue for an action under this section is in Travis County.

(c) A temporary manager appointed under this section is entitled to a reasonable fee, as determined by the court in accordance with Texas Health and Safety Code §251.093 (relating to Fee; Release of Funds).

(1) The facility shall pay the fee.

(2) The temporary manager may petition the court to order the release of any payment owed to the manager for care and services provided to facility patients if the facility withholds payment.

(3) Withheld payments that may be released may include payments withheld by a governmental agency or other entity before or during the temporary manager's appointment, including:

(A) Medicaid, Medicare, or insurance payments; or

(B) payments from another third party.

§ 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 5;

(iii) Title 7 (relating to Offenses Against Property);

(iv) Title 8 (relating to Offenses Against Public Administration);

(v) Title 9 (relating to Offenses Against Public Order and Decency);

(vi) Title 10 (relating to Offenses Against Public Health, Safety, and Morals); or

(vii) 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.

§ 507.91. Emergency Orders.

The Texas Health and Human Services Commission (HHSC) may issue an emergency order to suspend a license issued under this chapter, if HHSC has reasonable cause to believe that the conduct of a license holder creates an immediate danger to the public health and safety.

(1) An emergency suspension is effective immediately without a hearing or notice to the license holder.

(2) On the license holder's written request, HHSC refers the matter to the State Office of Administrative Hearings and an administrative law judge of that office is required to conduct a hearing, not earlier than the 10th day or later than the 30th day after the date the hearing request is received, to determine if the emergency suspension is to be continued, modified, or rescinded. The hearing and any appeal are governed by HHSC rules for a contested case hearing and Texas Government Code Chapter 2001 (relating to Administrative Procedure).

§ 507.92. Administrative Penalties.

(a) The Texas Health and Human Services Commission (HHSC) may assess an administrative penalty against a person who violates Texas Health and Safety Code Chapter 251 (relating to End Stage Renal Disease Facilities) or this chapter, under:

(1) Texas Health and Safety Code (HSC) §251.066 (relating to Administrative Penalty),

(2) HSC §251.067 (relating to Report Recommending Administrative Penalty),

(3) HSC §251.068 (relating to Hearing; Order),

(4) HSC §251.069 (relating to Notice and Payment of Administrative Penalty; Judicial Review; Refund),

(5) HSC §251.070 (relating to Penalty Deposited to State Treasury), and

(6) HSC §251.071 (relating to Recovery of Costs).

(b) The penalty may not exceed $1,000 for each violation. Each day of a continuing violation constitutes a separate violation.

(c) In determining the amount of an administrative penalty assessed under this section, HHSC considers:

(1) the violation's seriousness;

(2) the history of previous violations;

(3) the amount necessary to deter future violations;

(4) efforts made to correct the violation; and

(5) any other matters that justice may require.

(d) All proceedings for the assessment of an administrative penalty are subject to Texas Government Code Chapter 2001 (relating to Administrative Procedure).

(e) If after investigation of a possible violation and the facts surrounding that possible violation, HHSC determines that a violation has occurred, HHSC gives written notice of the violation to the person alleged to have committed the violation. The notice will include:

(1) the alleged violation's summary;

(2) a statement of the proposed penalty amount, based on the factors listed in subsection (c) of this section; and

(3) a statement of the person's right to a hearing on the violation's occurrence, the penalty amount, or both the violation's occurrence and the penalty amount.

(f) Within 20 calendar days after receiving the notice, the person notified may accept the determination of HHSC made under this section, including the recommended penalty, or make a written request for a hearing on that determination.

(g) If the person notified of the violation accepts the determination of HHSC, the executive commissioner issues an order approving the determination and ordering that the person pay the recommended penalty.

(h) If the person notified fails to respond in a timely manner to the notice or if the person requests a hearing, the executive commissioner's designee:

(1) refers the matter to the State Office of Administrative Hearings for an administrative law judge of that office to conduct a hearing; and

(2) gives written notice of the hearing to the person.

(i) At the hearing, the administrative law judge makes findings of fact and conclusions of law and promptly issues the executive commissioner a decision proposal regarding the violation's occurrence and the recommended proposed penalty amount, if the judge determines a penalty is warranted.

(j) Based on the findings of fact and conclusions of law and the administrative law judge's recommendation, the executive commissioner by order may find that a violation has occurred and may assess a penalty or may find that no violation has occurred. The executive commissioner or the executive commissioner's designee gives notice of the executive commissioner's order to the person notified. The notice includes:

(1) separate statements of the findings of fact and conclusions of law;

(2) the amount of any penalty assessed; and

(3) a statement regarding the person's right to judicial review of the executive commissioner's order.

(k) Within 30 calendar days after the date the decision is final, the person shall:

(1) pay the penalty in full;

(2) pay the penalty amount and file a petition for judicial review contesting the violation's occurrence, the penalty amount, or both the violation's occurrence and the penalty amount; or

(3) without paying the penalty amount, file a petition for judicial review contesting the violation's occurrence, the penalty amount, or both the violation's occurrence and the penalty amount. Within the 30-day period, a person who acts under this paragraph may:

(A) stay the penalty's enforcement by:

(i) paying the penalty amount to the court for placement in an escrow account; or

(ii) giving to the court a supersedeas bond that is approved by the court for the penalty amount and that is effective until all judicial review of the executive commissioner's order is final; or

(B) request the court to stay the penalty's enforcement by:

(i) filing with the court a person's affidavit stating that the person is financially unable to pay the penalty amount and give the supersedeas bond; and

(ii) giving a copy of the affidavit to HHSC by certified mail.

(l) If HHSC receives a copy of an affidavit under subsection (k)(3)(B) of this section, HHSC may file with the court, within five calendar days after the date the copy is received, a contest to the affidavit.

§ 507.93. Recovery of Costs.

(a) The Texas Health and Human Services Commission (HHSC) may assess reasonable expenses and costs against a person in an administrative hearing if, as a result of the hearing, the person's license is denied, suspended, or revoked, or if administrative penalties are assessed against the person.

(b) The person shall pay expenses and costs assessed under this section within 30 calendar days after the date of an order requiring the payment of expenses and costs is final.

(c) HHSC may refer the matter to the attorney general for collection of the expenses and costs.

(d) If the attorney general brings an action against a person under Texas Health and Safety Code §251.063 (relating to Injunction) or §251.065 (relating to Civil Penalty), or to enforce an administrative penalty assessed, and an injunction is granted against the person or the person is found liable for a civil or administrative penalty, the attorney general may recover, on behalf of the attorney general and HHSC, reasonable expenses and costs.

(e) For purposes of this section, "reasonable expenses and costs" include expenses incurred by HHSC and the attorney general in the investigation, initiation, or prosecution of any actions, including reasonable investigative costs, court costs, attorney's fees, witness fees, and deposition expenses.

(19) Facility--A limited services rural hospital as defined at paragraph (29) of this section unless context clearly indicates otherwise.

§ 511.79. Workplace Violence Prevention.

(a) In accordance with Texas Health and Safety Code (HSC) §331.002, an LSRH shall establish a workplace violence prevention committee or authorize an existing LSRH committee to develop a workplace violence prevention plan.

(b) An LSRH shall ensure the committee includes at least:

(1) one registered nurse who provides direct care to the LSRH's patients;

(2) one physician licensed to practice medicine in this state who provides direct care to the LSRH's patients; and

(3) one LSRH employee who provides security services for the LSRH if any and if practicable.

(c) A health care system that owns or operates more than one facility, as that term is defined by HSC §331.001, which includes an LSRH, may establish a single workplace violence prevention committee for all of the system's facilities if:

(1) the committee develops a violence prevention plan for implementation at each facility in the system; and

(2) data related to violence prevention remains distinctly identifiable for each facility in the system.

(d) An LSRH shall adopt, implement, and enforce a written workplace violence prevention policy to protect health care providers and employees from violent behavior and threats of violent behavior occurring at the LSRH. In accordance with HSC §331.003, the policy shall:

(1) require the LSRH to:

(A) provide significant consideration of the violence prevention plan recommended by the LSRH's committee; and

(B) evaluate any existing LSRH violence prevention plan;

(2) encourage health care providers and employees to provide confidential information on workplace violence to the committee;

(3) include a process to protect from retaliation health care providers or employees who provide information to the committee; and

(4) comply with HHSC rules relating to workplace violence.

(e) An LSRH shall adopt, implement, and enforce a written workplace violence prevention plan developed by the committee. In accordance with HSC §331.004, the plan shall:

(1) be based on an LSRH setting;

(2) adopt a definition of "workplace violence" that includes:

(A) an act or threat of physical force against a health care provider or employee that results in, or is likely to result in, physical injury or psychological trauma; and

(B) an incident involving the use of a firearm or other dangerous weapon, regardless of whether a health care provider or employee is injured by the weapon;

(3) require the LSRH to at least annually provide workplace violence prevention training or education that may be included in other required training or education provided to the health care providers and employees who provide direct patient care;

(4) prescribe a system for responding to and investigating violent incidents or potentially violent incidents at the LSRH;

(5) address physical security and safety;

(6) require the LSRH to solicit information from the health care providers and employees when developing and implementing a workplace violence prevention plan;

(7) allow health care providers and employees to report workplace violence incidents through the LSRH's existing occurrence reporting systems; and

(8) require the LSRH to adjust patient care assignments, to the extent practicable, to prevent a health care provider or employee from treating or providing services to a patient who has intentionally physically abused or threatened the provider or employee.

(f) The written workplace violence prevention plan may satisfy the requirements of subsection (e) of this section by referencing other internal LSRH policies and documents.

(g) At least annually after the date an LSRH adopts a written workplace violence prevention plan required by subsection (e) of this section, the committee shall:

(1) review and evaluate the workplace violence prevention plan; and

(2) report the results of the evaluation to the LSRH's governing body.

(h) Each LSRH shall make available on request an electronic or printed copy of the LSRH's workplace violence prevention plan to each health care provider or LSRH employee. If the committee determines the plan contains information that would pose a security threat if made public, the committee may redact that information before providing the plan.

(i) In accordance with HSC §331.005, after an incident of workplace violence occurs, an LSRH shall offer immediate post-incident services, including any necessary acute medical treatment for each LSRH health care provider or employee who is directly involved in the incident.

(j) In accordance with HSC §331.005, an LSRH may not discourage a health care provider or employee from exercising the provider's or employee's right to contact or file a report with law enforcement regarding a workplace violence incident.

(k) In accordance with HSC §331.005, an LSRH shall prohibit LSRH personnel from disciplining, including by suspension or termination of employment, discriminating against, or retaliating against another person who:

(1) in good faith reports a workplace violence incident; or

(2) advises a health care provider or employee of the provider's or employee's right to report a workplace violence incident.

(4) Variance--A decision by Child Care Regulation (CCR) that there is good and just cause for an operation to meet the purpose of a minimum standard in a different way.