1. (a) Any NEWCC which obtains or performs tests on human samples for diagnostic or treatment purposes shall meet the requirements of this section.
2. (b) The licensee may only perform POCT that are 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.

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

   1. (1) Obtain the appropriate CLIA certificate as per 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.

4. (d) 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, reporting results; and
   3. (3) All recommended and required quality control procedures for POCT meters and devices.
5. (e) 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.

6. (f) The licensee shall implement and maintain a laboratory service procedure manual that shall:

   1. (1) Be readily accessible at all times to testing personnel; and

   2. (2) Contain:

      1. a. The written procedure for each test performed in the laboratory;
      2. b. A copy of the package insert for each test performed;
      3. c. The laboratory’s procedure for test requisition and specimen collection;
      4. d. The specimen handling and follow-up procedure for all patient samples that are referred to another laboratory for testing;
      5. e. The phlebotomy procedure;
      6. f. Job descriptions for the testing personnel and specimen collection personnel; and
      7. g. Documentation that the medical director has approved all procedures.
7. (g) Unless the facility holds a separate, He-P 808 license for the laboratory, the medical director required by He-P 806.16(e) shall be the director for all laboratory testing.
8. (h) All patient test requisitions, reports, and records shall be completed and maintained in accordance with 42 CFR 493.
9. (i) All patient test requisitions, reports, and records shall be safeguarded against loss, damage, tampering, and unauthorized access and maintained for a minimum of 4 years.

10. (j) Refrigerator and freezer temperatures shall be recorded each day specimens, reagents, or test kits are stored and must fall within the following ranges:

    1. (1) Refrigerator temperatures shall be between 2 and 8 degrees centigrade; and
    2. (2) Freezer temperatures shall be colder than minus 10 degrees centigrade.
11. (k) Centrifuge speed shall fall between 2800 and 3500 revolutions per minute or as specified by the manufacturer and be verified by tachometer on an annual basis.
12. (l) No expired specimen collection equipment and reagents, such as vacutainer tubes and glucola, shall be retained in the station or used for specimen collection.
13. (m) Corrective measures such as repair or replacement shall be made in the event of an equipment failure and a written record of the corrective measures shall be kept at the NEWCC.
14. (n) The medical director shall assure that all testing and phlebotomy personnel have a documented annual competency review that shall include a visual inspection of the performance of a phlebotomy and each test method performed.

15. (o) If the NEWCC performs phlebotomies to collect blood specimens for testing, the facility shall have:

    1. (1) A blood collection chair with a device to prevent patient falls or a reclining chair;
    2. (2) A cot or an alternative method that allows a patient to lie down in the event of dizziness or illness;

    3. (3) A specimen collection area that:

       1. a. Is separate from the reception area;
       2. b. Contains a work counter and hand washing facilities;
       3. c. Measures, at a minimum, 36 square feet; and
       4. d. Maintains patient confidentiality and privacy; and
    4. (4) A processing area that, at a minimum, has 6 linear feet of counter space.

Source. #9655, eff 2-13-10, EXPIRED: 2-13-18 New. #12674, INTERIM, eff 11-19-18, EXPIRED: 5-20-19 New. #12795, eff 5-30-19 (formerly provisions of He-P 806.21); ss by #13987, eff 5-30-24 (formerly He-P 806.25)