Haw. Code R. § 11-110.1-18 - Collecting depot

(a) A clinical laboratory certified under 42 C.F.R. part 493 subpart A may operate collecting depots after first obtaining written approval from the department for the establishment of each depot.

(b) A collecting depot shall:

(1) Have a current, written manual of methods and procedures used to ensure the satisfactory collection of specimens including patient preparation prior to specimen collection, proper specimen identification, and storage and preservation of specimens;

(2) Collect specimens only at the request of authorized persons;

(3) Be adequate for the proper collection of specimens. This shall include adequate and proper staffing, plumbing, heating, cooling, lighting, ventilation, refrigeration, electrical services, sanitary conditions, fire protection within the collecting depot and its surroundings, water supply, sewage disposal, procedures for handling and disposal of specimens, and safety measures for personnel;

(4) Keep and maintain a record indicating the daily accession of specimens. The record shall contain the following information:

(A) The name or other unique identification of the person from whom the specimen was taken;

(B) The name of the person who requested the test;

(C) The date and time when the specimen was received or when it was collected;

(D) Signature or suitable identification of the person receiving or collecting the specimen;

(E) The type or source of the specimen; and

(F) The test(s) requested.

(5) The results of a test shall be reported only to the person described in paragraph(2).

(c) No laboratory tests shall be performed in a collecting depot.

Notes

Haw. Code R. § 11-110.1-18

[Eff JUL 05 2007] (Auth: HRS § 321-11) (Imp: HRS § 321-11)