| (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. |
