1. (a) The licensee shall provide administrative services that include the appointment of a full-time administrator who:

   1. (1) Meets one of the following requirements:

      1. a. Has a bachelor’s degree in business administration or a health-related field; or
      2. b. Is a registered nurse currently licensed in the state of New Hampshire with at least 12 months experience in clinical nursing with 6 months of the experience being in the care of patients with nephrology disorders;
   2. (2) Is responsible for the day-to-day operations of the ESRDDC;
   3. (3) Delegates, in writing, an alternate onsite, qualified designee who shall assume the responsibilities of the administrator in their absence; and
   4. (4) May hold more than one position within the facility if qualified.
2. (b) The administrator shall be responsible for maintaining the ESRDDC in full compliance with all federal, state, and local laws, rules, codes, and ordinances at all times.

3. (c) The licensee shall credential licensed practitioners involved in the direct care of patients as follows:

   1. (1) The licensee shall establish a credentialing committee composed of, at a minimum, the medical director, the administrator, and the director of nursing; and

   2. (2) The credentialing committee shall be responsible for:

      1. a. Establishing the education and experience requirements of each direct-care position;

      2. b. Establishing a system for determining that the person being credentialed is:

         1. 1. Licensed or certified to practice health care in New Hampshire; and
         2. 2. Qualified by education and experience to meet the requirements of the position in a. above;
      3. c. Approving, and documenting the approval of, the duties that may be performed by the person being credentialed;
      4. d. Establishing a procedure for updating the approvals in b. above as necessary; and
      5. e. The annual review of all credentialed personnel.

4. (d) The licensee shall provide medical services that meet the guidelines in the Association for the Advancement of Medical Instrumentation’s (AAMI) “American National Standard for Dialysate for Hemodialysis” (RD 52:2009 edition), available as noted in Appendix A for:

   1. (1) Water quality requirements and testing; and
   2. (2) The reuse of hemodialyzers and other dialysis supplies.
5. (e) The licensee shall provide instructions and education to patients, including but not limited to medical needs, nutrition, hygiene, medical emergencies, community support, and resources.

6. (f) The licensee shall appoint a medical director who:

   1. (1) Is a physician licensed in the state of New Hampshire;
   2. (2) Is board certified in internal medicine or pediatrics;
   3. (3) Has completed a board-approved training program in nephrology;
   4. (4) Has at least 12 months experience providing care to patients receiving dialysis; and

   5. (5) Shall perform the following duties:

      1. a. Participate in the ESRDDC’s quality assurance program;
      2. b. Participate in the implementation of corrective action plans in affected problem areas;
      3. c. Participate in the credentialing process for all licensed health care practitioners;
      4. d. Act as a liaison between the licensed practitioners and the patient;
      5. e. Be available to consult with the patient’s licensed practitioner, as needed;
      6. f. Participate in the development of medical emergency procedures and all standing orders;
      7. g. Be available to respond to the center by phone or in person in the case of an emergency or shall ensure that a physician meeting the qualifications of the medical director is available; and
      8. h. Review and approve all patient care policies including infection control for the ESRDDC.

7. (g) The licensee shall provide nursing services that include:

   1. (1) A department of nursing that is under the supervision of a director of nursing;

   2. (2) The appointment of a full time director of nursing who:

      1. a. Is a registered nurse currently licensed in the state of New Hampshire;
      2. b. Has at least one year of experience as a registered nurse caring for patients with nephrology disorders; and

      3. c. Shall perform the following duties:

         1. 1. Provide nursing direction, supervision, and staff evaluations to promote quality nursing care;
         2. 2. Be a member of the ESRDDC’s quality improvement committee; and
         3. 3. Participate in the development of nursing protocols and procedures; and
   3. (3) Sufficient staff to meet the dialysis needs of patients at all times while in the care of the facility.
8. (h) The licensee shall provide dialysis technician services that include the employment of dialysis technicians who are qualified through education and technical training as required by the center’s policies and procedures.
9. (i) The licensee shall only perform point of care testing (POCT), that is waived complexity as designated by the federal drug administration (FDA) and known as CLIA-waived laboratory tests, unless the facility is also licensed by the state of New Hampshire as a laboratory under He-P 808.

10. (j) If CLIA-waived laboratory testing is performed by personnel, the licensee shall:

    1. (1) Obtain the appropriate CLIA certificate pursuant to 42 CFR Part 493.15; and
    2. (2) Develop and implement a POCT policy, which educates and provides procedures for the proper handling and use of POCT devices, including the documentation of training and demonstrated competency of all testing personnel.

11. (k) The licensee shall have current copies of manufacturer’s instructions and package inserts and shall follow all manufacturer’s instructions and recommendations for the use of POCT meters and devices to include, but not limited to:

    1. (1) Storage requirements for POCT meters and devices, test strips, test cartridges, and test kits;
    2. (2) Performance of test specimen requirements, testing environment, test procedure, troubleshooting error codes, and reporting results; and
    3. (3) All recommended and required quality control procedures for POCT meters and devices.
12. (l) Licensees performing CLIA-waived laboratory testing or specimen collection shall be in compliance with He-P 808, He-P 817, and 42 CFR 493, as applicable.
13. (m) The licensee shall not be required to have a separate home health license, pursuant to He-P 809, to provide staff-assisted home dialysis in a patient’s place of residence.

14. (n) The licensee shall provide social work services, including the employment of a sufficient number of social workers to meet the needs of their patients and who:

    1. (1) Have at least a master’s degree in social work; or

    2. (2) Have a bachelor’s degree in a health or human services field, plus:

       1. a. Two years experience as a social worker; and
       2. b. Have proof of an established consultative relationship with a person holding a master’s degree in social work, that shall be retained in the personnel file.

15. (o) The licensee shall provide dietary services, including the employment of a sufficient number of dietitians to meet the needs of patients and who:

    1. (1) Are registered by the American Dietetic Association and have one year of experience in clinical nutrition; or
    2. (2) Have a bachelor’s or advanced degree with major studies in food and nutrition or dietitian and one year of experience in clinical nutrition.

16. (p) All volunteers shall be oriented and educated relative to their prescribed function according to the ESRDDC’s policies and procedures.

    1. (1) Recruitment and retention;
    2. (2) Health screening and 2-step tuberculosis (TB) testing;
    3. (3) Orientation;
    4. (4) Scope of function;
    5. (5) Supervision;
    6. (6) Ongoing training and support;
    7. (7) Record of volunteer activities; and
    8. (8) Criminal record checks.

    ( q) The licensee shall develop and maintain policies and procedures for its volunteer services that address the following areas:

Source. #9963, eff 7-28-11; ss by #12827, INTERIM, eff 7-20-19, EXPIRED: 1-16-20 New. #12985, eff 1-29-20; ss by #14206, eff 2-28-25 -(formerly He-P 811.15)