Section He-P 817.15 - Collection Station Standards(a) Except as allowed by (b) below, the collection station shall collect or receive specimens only at the written or electronic request of a physician, dentist, chiropractor, court of law, or any other person authorized by state statute to order and receive laboratory tests.(b) The collection station shall follow up with all telephone requests for the collection or receipt of specimens with a written confirmation within 30 days.(c) At a minimum, the written or electronic test request required by (a) above, shall include: (1) The client's identifier;(2) The client's sex and age or date of birth;(3) The specific test(s) to be performed;(4) The name or unique identification such as an account number of the authorized person requesting the tests;(5) The date of specimen collection;(6) The name or other identifier such as test code number of the test requested;(7) The time of specimen collection when required by the collection procedure; and(8) The body source of the specimen when required by the collection procedure.(d) At a minimum, written documentation for the collection or receipt of a specimen shall be maintained and include the following information: (1) The unique identifier assigned to the specimen;(2) The date of specimen receipt;(3) The time of specimen receipt when required by the collection procedure; and(4) Information contained on the test request as described in (c) above.(e) At a minimum, the specimen label shall include the patient name and birth date, date and time of collection, and the initials of the person collecting the sample.(f) The collection station shall have documentation of the specimen collection, handling, and processing requirements, from the laboratory performing the test, for all analytes collected, to include requirements pertaining to storage, temperature, transport, collection media, preservatives, centrifuge speed, light protection, and any other special collection or handling requirements of the laboratories test system.(g) Recordings of refrigerator and freezer temperatures shall be done each day the collection station operates and shall 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, for spinning blood samples, shall:(1) Fall between 2800 and 3500 revolutions per minute or as specified by the manufacturer and be verified by tachometer on an annual basis; and(2) For mobile collection station vans, be verified whenever the van is moved.(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 collection station.(k) All clinical equipment shall be: (1) In good working order; and(2) Serviced in accordance with manufacturers' instructions and a written record of the service maintained by the collection station.(l) Sharps containers shall be secured so as to prevent unauthorized access, tampering, or both.(m) Collection stations performing waived glucose screening by glucometer tests shall: (1) Acquire and maintain a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver, pursuant to 42 CFR 493.15;(2) Perform quality controls each day of testing;(3) Have a written procedure for the collection station response to a high patient glucometer reading that clearly identifies the response required, who to notify, and any other actions required by collection station personnel; and(4) Clean the glucometer between patients with an appropriate cleaner.N.H. Admin. Code § He-P 817.15
#5775, eff 1-24-94, EXPIRED: 1-24-00
New. #8410 eff 8-19-05; ss by #8853, eff 3-24-07
Amended by Volume XXXV Number 49, Filed December 10, 2015, Proposed by #10979, Effective 11/20/2015, Expires11/20/2025.