§ 494.140 - Condition: Personnel qualifications.

§ 494.140 Condition: Personnel qualifications.

All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility's staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility's staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions.

(a) Standard: Medical director.

(1) The medical director must be a board-certified physician in internal medicine or pediatrics by a professional board who has completed a board-approved training program in nephrology and has at least 12-months of experience providing care to patients receiving dialysis.

(2) If a physician, as specified in paragraph (a)(1) of this section, is not available to direct a certified dialysis facility another physician may direct the facility, subject to the approval of the Secretary.

(b) Standard: Nursing services -

(1) Nurse manager. The facility must have a nurse manager responsible for nursing services in the facility who must -

(i) Be a full time employee of the facility;

(ii) Be a registered nurse; and

(iii) Have at least 12 months of experience in clinical nursing, and an additional 6 months of experience in providing nursing care to patients on maintenance dialysis.

(2) Self-care and home dialysis training nurse. The nurse responsible for self-care and/or home care training must -

(i) Be a registered nurse; and

(ii) Have at least 12 months experience in providing nursing care and an additional 3 months of experience in the specific modality for which the nurse will provide self-care training.

(3) Charge nurse. The charge nurse responsible for each shift must -

(i) Be a registered nurse, a licensed practical nurse, or vocational nurse who meets the practice requirements in the State in which he or she is employed;

(ii) Have at least 12 months experience in providing nursing care, including 3 months of experience in providing nursing care to patients on maintenance dialysis; and

(iii) If such nurse is a licensed practical nurse or licensed vocational nurse, work under the supervision of a registered nurse in accordance with state nursing practice act provisions.

(4) Staff nurse. Each nurse who provides care and treatment to patients must be either a registered nurse or a practical nurse who meets the practice requirements in the State in which he or she is employed.

(c) Standard: Dietitian. The facility must have a dietitian who must -

(1) Be a registered dietitian with the Commission on Dietetic Registration; and

(2) Have a minimum of 1 year professional work experience in clinical nutrition as a registered dietitian.

(d) Standard: Social worker. The facility must have a social worker who -

(1) Holds a master's degree in social work with a specialization in clinical practice from a school of social work accredited by the Council on Social Work Education; or

(2) Has served at least 2 years as a social worker, 1 year of which was in a dialysis unit or transplantation program prior to September 1, 1976, and has established a consultative relationship with a social worker who qualifies under § 494.140(d)(1).

(e) Standard: Patient care dialysis technicians. Patient care dialysis technicians must -

(1) Meet all applicable State requirements for education, training, credentialing, competency, standards of practice, certification, and licensure in the State in which he or she is employed as a dialysis technician; and

(2) Have a high school diploma or equivalency;

(3) Have completed a training program that is approved by the medical director and governing body, under the direction of a registered nurse, focused on the operation of kidney dialysis equipment and machines, providing direct patient care, and communication and interpersonal skills, including patient sensitivity training and care of difficult patients. The training program must include the following subjects:

(i) Principles of dialysis.

(ii) Care of patients with kidney failure, including interpersonal skills.

(iii) Dialysis procedures and documentation, including initiation, proper cannulation techniques, monitoring, and termination of dialysis.

(iv) Possible complications of dialysis.

(v) Water treatment and dialysate preparation.

(vi) Infection control.

(vii) Safety.

(viii) Dialyzer reprocessing, if applicable.

(4) Be certified under a State certification program or a national commercially available certification program, as follows -

(i) For newly employed patient care technicians, within 18 months of being hired as a dialysis patient care technician; or

(ii) For patient care technicians employed on October 14, 2008, within 18 months after such date.

(f) Standard: Water treatment system technicians. Technicians who perform monitoring and testing of the water treatment system must complete a training program that has been approved by the medical director and the governing body.