(a) The dialysis facility's staff (whether employees or contractors) shall meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility's staff shall have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions.
  (1) The facility shall have a written orientation program to familiarize all new employees (including office staff) with the facility, its policies, and job responsibilities. The orientation program shall be developed and implemented.
  (2) The facility shall ensure that each new direct care staff member (whether employee or contractor) is provided sufficient time to become familiar with the facility. The orientation program provided by the facility shall be a minimum time of two weeks for individuals with previous dialysis experience. For new direct care staff members with no previous dialysis experience, the orientation program shall be two weeks plus additional orientation time as determined by the facility.
  (3) The facility shall ensure that, in facilities with similar policies and equipment, experienced staff oriented to one facility may be shared with another facility after a shorter orientation period. Documentation of current competency of any shared staff and delegation by that facility's medical director to unlicensed technicians shall be on file in each facility where the shared employee works.
  (4) The facility shall ensure that registered nurses with no previous dialysis experience shall be provided an orientation program of a minimum of six weeks. For these registered nurses, the six-week orientation program shall contain at least the following subject content specific to the management of the end stage renal disease patient and appropriate to the population served by the facility:
    (A) fluid, electrolyte and acid-base balance;
    (B) kidney disease and treatment;
    (C) dietary management of kidney disease;
    (D) principles of dialysis;
    (E) dialysis technology;
    (F) venipuncture technique;
    (G) care of the dialysis patient;
    (H) psychological, social, financial, and physical complications of long-term dialysis;
    (I) prevention of hepatitis and other infectious diseases; and
    (J) risks and benefits of reuse (if reuse is practiced).
  (5) The facility shall ensure that each licensed nurse and dialysis technician demonstrate competency through written and skills testing after the completion of the training program and annually thereafter. Evidence of competency shall be documented in writing and maintained in personnel files. Current certification by a nationally recognized board may substitute for the annual written test. All dialysis technicians must be certified under a national commercially available certification program, within 18 months of being hired as a dialysis technician.
  (6) The facility shall ensure that documentation shall be maintained to demonstrate that each staff member providing patient care completes at least five hours of continuing education related to end stage renal disease annually. Continuing education may be provided by facility staff. Documentation shall include the title, duration, and the author or instructor of the continuing education course.
(b) Medical staff.
  (1) Each physician on the medical staff shall have a current license to practice medicine in the State of Texas.
  (2) The members of the medical staff may include nephrologists and other physicians with training or demonstrated experience in the care of end stage renal disease patients.
  (3) If an advanced practice registered nurse is utilized, such individuals shall meet the requirements established by the Texas Board of Nursing in Texas Administrative Code, Title 22, Part 11, Chapter 221, Advanced Practice Registered Nurses.
  (4) If a physician assistant is utilized, such individuals shall meet the requirements established by the Texas Medical Board in Texas Administrative Code, Title 22, Part 9, Chapter 185, Physician Assistants.
(c) Nursing staff.
  (1) Each person 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.
  (2) Each registered nurse assigned charge nurse responsibilities shall have at least 12 months of clinical experience and have six months experience in hemodialysis subsequent to completion of the facility's training program. The hemodialysis experience shall be within the last 24 months. 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) There shall be written physician standing orders specific to the facility to guide actions to be taken by the nursing staff in the event a patient's condition deteriorates during treatment. These standing orders shall be reviewed and approved by the medical director at least annually, and be consistent with the Texas Medical Board statutes and rules, and the Texas Board of Nursing practice act, rules, and policy statements for registered nurses and licensed vocational nurses.
  (4) If patient self-care training is provided, a registered nurse who has at least 12 months clinical experience and six 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, supervision by the qualified registered nurse shall be demonstrated.
  (5) When other personnel assist in the training of a patient and the patient's caregiver for self-care training, there shall be documentation in the personnel record that the employee is qualified.
(d) Each dietitian shall have a current Texas license, be a registered dietitian, and have a minimum of one year professional work experience in clinical dietetics after becoming a registered dietitian.
(e) Each social worker shall:
  (1) be licensed as a social worker under the Occupations Code, Chapter 505, and hold a masters degree in social work from a graduate school of social work accredited by the Council on Social Work Education; or
  (2) have worked for at least two years as a social worker, one year of which was in a dialysis facility or transplantation program prior to September 1, 1976, and have established a consultative relationship with a social worker who has a masters degree in social work from a graduate school of social work accredited by the Council on Social Work Education.
(f) A facility shall have the technical staff as described in this subsection. The facility's technical staff may be one or more individuals (including nursing staff) employed by or under contract with the facility as long as the individual(s) meets the minimum qualifications for each required level of responsibility as described in this subsection.
  (1) Only individuals qualified by training, education, or experience may operate, repair, or replace components of the systems utilized in providing dialysis treatment or reprocessing dialyzers.
    (A) Technical staff shall have the following minimum education, training, and experience and documentation of such education, training, and experience shall be maintained on file in the facility:
      (i) high school diploma or equivalent. For technical staff employed by the facility for two or more years prior to April 11, 1999, this requirement is waived; 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 §117.62(a) and (b) of this title (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 a 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 demonstrate competency for the required level of responsibility through written and skills testing annually. Current certification by a national board in dialysis technology may substitute for the written test. Evidence of competency shall be documented in writing and maintained in the personnel file.
Cont'd...
(D) The technical staff shall complete a minimum of five hours of continuing education with a technical or end stage renal disease focus annually. Continuing education may be provided by facility staff. Documentation shall include the title, duration, and the author or instructor of the continuing education course.
  (2) The technical supervisor is responsible for the 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 (1) of this subsection.
    (B) At a minimum, the technical supervisor shall demonstrate competency in equipment maintenance and repair; mechanical service; water treatment systems; and reprocessing of hemodialyzers (if applicable).
      (i) Prior to initially assuming technical supervisory responsibility, a technical supervisor trainee shall successfully complete the facility's orientation and training course(s) as established for each technical area.
      (ii) The training course(s) shall be approved by the medical director and follow a written curriculum with stated objectives. The curriculum shall include all items noted in paragraphs (3)(B)(ii), (4)(B), and (5)(A) of this subsection.
  (3) Staff responsible for water treatment and dialysate systems.
    (A) Facility staff responsible for the water treatment and dialysate systems shall demonstrate understanding of the risks to patients of exposure to water which has not been treated so as to remove contaminants and impurities. Documentation of training to assure safe operation of the water treatment and dialysate systems shall be maintained for each individual who operates (regularly or intermittently) these systems.
    (B) The staff responsible for the water treatment and dialysate systems shall meet the education, training, and experience requirements described in paragraph (1) 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. The training course shall be approved by the medical director and follow a written curriculum with stated objectives;
      (ii) completion of a training curriculum which includes the following minimum components:
        (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 the use of 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 on-line and off-line 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 prior to the trainee's initial assumption of responsibility.
  (4) The staff responsible for equipment maintenance and repair shall meet the education, training, and experience requirements described in paragraph (1) 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 the following minimum components:
      (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.
    (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.
  (5) The staff responsible for reprocessing hemodialyzers and other supplies shall meet the education, training, and experience requirements described in paragraph (1) of this subsection and shall demonstrate competency by:
    (A) successful completion of a training curriculum which includes the components in the American National Standards Institute (ANSI), Reuse of Hemodialyzers, Third Edition, ANSI/AAMI RD47:2002 and RD47:2002/A1:2003, §5.2.1 published by the Association for the Advancement of Medical Instrumentation, 1110 North Glebe Road, Suite 220, Arlington, Virginia 22201; and
    (B) successful completion of a written competency exam which includes return demonstration of skills specific to reprocessing of hemodialyzers and other dialysis supplies.

Source Note: The provisions of this §117.46 adopted to be effective July 6, 2010, 35 TexReg 5835