N.H. Admin. Code § He-P 806.25

Current through Register No. 45, November 7, 2024

Section He-P 806.25 - Laboratory

Any NEWCC which obtains or performs tests on human samples for diagnostic or treatment purposes shall meet the following:

(a) Only tests designated as "CLIA waived" by the FDA shall be performed unless the facility is also licensed by the State of New Hampshire as a laboratory under He-P 808;

(b) The NEWCC shall hold a CLIA "certificate of waiver" if only CLIA waived testing is performed, the NEWCC shall have the appropriate CLIA certificate under 42 CFR 493, and have a laboratory license under He-P 808;

(c) A procedure manual shall:

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

(2) Contain:

a. The written procedure for each test performed in the laboratory;

b. A copy of the package insert for each test performed;

c. The laboratory's procedure for test requisition and specimen collection;

d. The specimen handling and follow-up procedure for all patient samples that are referred to another laboratory for testing;

e. The phlebotomy procedure;

f. Job descriptions for the testing personnel and specimen collection personnel; and

g. Documentation that the medical director has approved all procedures;

(d) Unless the facility holds a separate He-P 808 license for the laboratory, the medical director required by He-P 806.15(d) shall be the director for all laboratory testing;

(e) All patient test requisitions, reports and records shall be completed and maintained in accordance with 42 CFR 493;

(f) 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;

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

(1) Refrigerator temperatures shall be between 2 and 8 degrees centigrade; and

(2) Freezer temperatures shall be colder than minus 10 degrees centigrade;

(h) 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;

(i) No expired specimen collection equipment and reagents, such as vacutainer tubes and glucola, shall be retained in the station or used for specimen collection;

(j) 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;

(k) 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; and

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

(1) A blood collection chair with a device to prevent patient falls or a reclining chair;

(2) A cot or an alternative method that allows a patient to lie down in the event of dizziness or illness;

(3) A specimen collection area that:

a. Is separate from the reception area;

b. Contains a work counter and hand washing facilities;

c. Measures, at a minimum, 36 square feet; and

d. Maintains patient confidentiality and privacy; and

(4) A processing area that, at a minimum, has 6 linear feet of counter space.

N.H. Admin. Code § He-P 806.25

#9655, eff 2-13-10, EXPIRED: 2-13-18

New. #12674, INTERIM, eff 11-19-18, EXPIRED: 5-20-19

Derived from Volume XXXIX Number 24, Filed June 13, 2019, Proposed by #12795, Effective 5/30/2019, Expires 5/30/2029.