(a) Facility staff (whether employees or contractors) shall meet the personnel qualifications and demonstrated competencies necessary to serve the needs of the patients. Facility staff shall demonstrate and sustain the skills needed to perform the specific duties of their positions.
(1) The facility shall develop and implement a written orientation program to familiarize all new employees (including office staff) with the facility, its policies, and their job responsibilities. The facility shall ensure that each new direct care staff member (whether employee or contractor) receives sufficient time to become familiar with the facility.
(A) The orientation program shall meet the following minimum time requirements.
- (i) For individuals with previous dialysis experience, the orientation program shall be two weeks.
- (ii) For new direct care staff members with no previous dialysis experience, the orientation program shall be two weeks plus additional time as determined by the facility.
- (B) In facilities with similar policies and equipment, staff with dialysis experience oriented to one facility may be shared with another facility after a shorter orientation period. Each facility where a shared employee works shall keep documentation on file of the shared staff's current competency and tasks delegated by that facility's medical director to unlicensed technicians.
(C) A facility shall provide registered nurses with no previous dialysis experience an orientation program of a minimum of seven weeks. The seven-week orientation program shall contain content specific to end stage renal disease patient management and appropriate to the population served by the facility, including at least:
- (i) fluid, electrolyte, and acid-base balance;
- (ii) kidney disease and treatment;
- (iii) dietary management of kidney disease;
- (iv) principles of dialysis;
- (v) dialysis technology;
- (vi) venipuncture technique;
- (vii) care of the dialysis patient;
- (viii) psychological, social, financial, and physical complications of long-term dialysis;
- (ix) prevention of hepatitis and other infectious diseases;
- (x) risks and benefits of reuse (if reuse is practiced); and
- (xi) all available treatment modalities, including the availability of kidney transplantation.
- (2) A facility shall ensure each licensed nurse and dialysis technician demonstrates competency through written and skills testing after they complete the orientation program and annually thereafter. The facility shall maintain documented evidence of competency in writing in personnel files. Current certification by a nationally recognized board may substitute for the annual written test. The facility shall ensure all dialysis technicians receive certification from a national commercially available certification program within 18 months of being hired as a dialysis technician.
(b) A facility shall ensure medical staff meet the following requirements.
- (1) Each physician on the medical staff shall have a current license to practice medicine in the state of Texas.
- (2) If a facility uses an advanced practice registered nurse, that individual shall meet the requirements established by the Texas Board of Nursing in Texas Administrative Code, Title 22 (22 TAC), Chapter 221 (relating to Advanced Practice Nurses).
- (3) If a facility uses a physician assistant, that individual shall meet the requirements established by the Texas Medical Board in 22 TAC Chapter 185 (relating to Physician Assistants).
(c) A facility shall ensure nursing staff meet the following requirements.
- (1) Each individual licensed as a nurse shall have a current Texas license to practice nursing in accordance with the statutes and rules of the Texas Board of Nursing, or a current license from another state in the Nurse Licensure Compact (NLC).
(2) Each registered nurse assigned charge nurse responsibilities shall have at least 12 months of clinical experience and six months experience in hemodialysis after completing the facility's training program.
- (A) For a newly licensed registered nurse, the last six months of clinical experience may run concurrently with the six months of dialysis experience.
- (B) The hemodialysis experience shall be within the last 24 months.
- (C) A registered nurse who holds a current certification from a nationally recognized board in nephrology nursing or hemodialysis may substitute the certification for the six months experience in dialysis obtained within the last 24 months.
- (3) The facility shall document written physician standing orders, specific to the facility, in the patient's clinical record to guide nursing staff actions in the event a patient's condition deteriorates during treatment. The medical director shall review and approve these standing orders at least annually, consistent with the Texas Medical Board statutes and rules and the Texas Board of Nursing statutes, rules, and policy statements for registered nurses and licensed vocational nurses.
- (4) If a facility provides patient self-care training, either in-center or at home, a registered nurse with at least 12 months clinical experience and three months experience in the specific modality, shall be responsible for providing self-care training to the patient or caregiver in that modality.
- (5) When other facility staff assist in the self-care training in-center, the qualified registered nurse shall supervise the self-care training. When other facility staff assist in training a patient or the patient's caregiver in self-care training, the facility shall document in the employee's personnel record that the employee is qualified, as approved by the medical director, to assist in the self-care training.
- (6) The facility shall establish a nursing peer review committee to conduct nursing peer review, as required by Texas Occupations Code Chapter 303 (relating to Nursing Peer Review).
- (d) Each dietitian shall have a current Texas license, be a registered dietitian, and have a minimum of one year of professional work experience in clinical dietetics after becoming a registered dietitian.
(e) Each social worker shall:
- (1) hold a current license as a social worker under Texas Occupations Code Chapter 505 (relating to Social Workers) and hold a master's degree in social work from a graduate school of social work accredited by the Council on Social Work Education; or
- (2) have at least two years of work experience as a social worker, one year of which was in a dialysis facility or transplantation program before September 1, 1976, and have an established consultative relationship with a social worker who has a master's degree in social work from a graduate school of social work accredited by the Council on Social Work Education.
(f) A facility shall ensure biomedical technical staff meet the following requirements.
- (1) The facility's biomedical technical staff may be one or more individuals (including nursing staff) employed by or under contract with the facility as long as the individual meets the minimum qualifications for each required level of responsibility, as described in this subsection.
(2) Only individuals qualified by training, education, or experience may operate, repair, or replace components of the systems used in providing dialysis treatment or reprocessing dialyzers.
(A) Technical staff shall have minimum education, training, and experience documented and maintained on file in the facility, which includes:
- (i) a high school diploma or equivalent, except for technical staff employed by the facility for two or more years before April 11, 1999, who are exempt from this requirement; and
(ii) training or experience, in one or more of the following:
- (I) completion of a college-based technical dialysis program;
- (II) completion of the didactic training and education requirement for patient care technicians set out in §507.72(a) and (b) of this chapter (relating to Training Curricula and Instructors);
- (III) current certification in technical aspects of dialysis by a nationally recognized testing organization; or
- (IV) 12 months experience in dialysis within the last two years.
- (B) Any staff member assigned responsibilities in the technical area shall pass an annual written competency examination, demonstrate skills related to the required level of responsibility, and be certified by the facility's medical director as competent to perform their assigned duties. Current certification by a national board in dialysis technology may substitute for the written test.
- (C) The technical staff shall annually complete a minimum of five hours of continuing education with a technical or end stage renal disease focus. Facility staff may provide continuing education. Continuing education documentation shall include the continuing education course title, duration, and author or instructor.
(3) The technical supervisor is responsible for supervision of technical services. The technical supervisor shall meet the education, training, and experience requirements described in this paragraph.
- (A) The technical supervisor shall meet the requirements in paragraph (3) of this subsection.
(B) The technical supervisor shall ensure technical staff demonstrate competency in equipment maintenance and repair, mechanical service, water treatment systems, and reprocessing of hemodialyzers, if applicable.
- (i) Before assuming technical supervisory responsibility, a technical supervisor trainee shall successfully complete the facility's orientation and training courses as established for each technical area.
- (ii) The medical director shall approve the training courses. The training courses shall follow a written curriculum with stated objectives. The curriculum shall include all items noted in this clause and paragraph (4)(B) of this subsection.
(4) Facility staff responsible for the water treatment and dialysate systems shall demonstrate understanding of the risks to patients of exposure to water that has not been treated to remove contaminants and impurities.
- (A) The facility shall maintain training documentation for each individual who operates (regularly or intermittently) these systems to ensure safe operation of the water treatment and dialysate systems.
(B) The staff responsible for water treatment and dialysate systems shall meet the education, training, and experience requirements described in paragraph (2) of this subsection and shall demonstrate competency by:
- (i) successful completion of the facility training course specific to water treatment, dialysate preparation, and related tasks, which must be approved by the medical director and follow a written curriculum with state objectives;
(ii) completion of a training curriculum that includes
- (I) introduction to end stage renal disease;
- (II) principles of hemodialysis;
- (III) principles of infection control and basic microbiology for water treatment systems, machines, and sampling techniques;
- (IV) rationale for water treatment for dialysis;
- (V) risks and hazards of using unsafe water for dialysis;
- (VI) current water standards;
- (VII) source water characteristics;
- (VIII) communication with source water agencies and water treatment vendors;
- (IX) selection of water treatment equipment;
- (X) water purification equipment, to include filtration, carbon adsorption, and reverse osmosis;
- (XI) ion exchange to include softeners and deionizers;
- (XII) water distribution system and other equipment specific to the facility;
- (XIII) monitoring system performance, to include online and offline monitoring, aseptic sample collection, incubation of samples, and interpretation of results;
- (XIV) evaluation of water treatment component performance, to include filters, activated carbon adsorption beds, reverse osmosis, and ion exchange;
- (XV) evaluation of system performance, to include monitoring schedules and review of system failures;
- (XVI) purpose of each component of dialysate, to include electrolytes, glucose, acid, and buffer;
- (XVII) hazards of exposure of patients to a dialysate containing a different concentration of electrolytes than prescribed;
- (XVIII) testing methods in use to verify expected concentrations in any reconstituted components of the dialysate are achieved;
- (XIX) action to take in the event testing of a mixed batch of dialysate concentrate does not meet the expected parameters;
- (XX) labeling employed to positively identify each concentrate; and
- (XXI) procedures to ensure the proper transfer of concentrates from the manufacturer's drums to the holding tanks;
- (iii) confirmation of the ability to distinguish all primary colors; and
- (iv) successful completion of the facility's orientation and training course as established for the water treatment and dialysate preparation systems technician trainee before the trainee's initial assumption of responsibility.
(5) The staff responsible for equipment maintenance and repair shall meet the education, training, and experience requirements described in paragraph (2) of this subsection and shall demonstrate competency by:
- (A) successful completion of the facility training course outlined in paragraph (2) of this subsection, relating to water treatment systems;
(B) successful completion of a training curriculum, which includes:
- (i) prevention of transmission of hepatitis through dialysis equipment;
- (ii) safety requirements of dialysate delivery systems;
- (iii) repair and maintenance of dialysis and other equipment specific to the facility;
- (iv) electrical safety, including lockout or tagout;
- (v) emergency equipment maintenance;
- (vi) building maintenance;
- (vii) fire safety and prevention requirements; and
- (viii) emergency response procedures; and
- (C) successful completion of a written competency exam and demonstration of skills specific to the facility's mechanical and equipment service and water treatment and distribution systems.
(6) The staff responsible for reprocessing hemodialyzers and other supplies shall meet the education, training, and experience requirements described in paragraph (2) of this subsection and shall demonstrate competency by:
- (A) successful completion of a training curriculum that includes the components of the standards for reuse of hemodialyzers listed in §507.30 of this chapter (relating to Technical Standards); and
- (B) successful completion of a written competency exam that includes return demonstration of skills specific to reprocessing of hemodialyzers and other dialysis supplies.
Source Note:The provisions of this §507.54 adopted to be effective December 23, 2025, 50 TexReg 8289.