10 CRR-NY 58-1.10NY-CRR

OFFICIAL COMPILATION OF CODES, RULES AND REGULATIONS OF THE STATE OF NEW YORK
TITLE 10. DEPARTMENT OF HEALTH
CHAPTER II. ADMINISTRATIVE RULES AND REGULATIONS
SUBCHAPTER D. LABORATORIES
PART 58. CLINICAL LABORATORIES AND BLOOD BANKS
SUBPART 58-1. CLINICAL LABORATORIES
10 CRR-NY 58-1.10
10 CRR-NY 58-1.10
58-1.10 Specimens: identification and examination.
(a) Every specimen received for testing shall be numbered or otherwise appropriately identified and listed in an accession book, or another system acceptable to the department.
(b) Every tissue specimen shall be examined and reported upon by a qualified pathologist who is certified or eligible for certification for pathologic anatomy by the American Board of Pathology or whose qualifications, in the opinion of the Public Health Council pursuant to Part 19 of this Title, are equivalent of such certification. Preliminary examination or “screening” of specimens for cytopathology may be made only by an individual who has had special training in cytology acceptable to the department.
(c) A clinical laboratory or blood bank shall at any time during its regular working hours permit the inspection of its premises and records by a representative of the department and shall examine and report promptly on all specimens submitted by the department for the purpose of determining the competency of the laboratory.
(d) If the component to be tested for in a specimen is perishable, labile, or otherwise subject to deterioration, such specimen shall be tested as promptly as possible after collection. If a specimen is transported or stored, it shall be properly preserved, refrigerated, frozen or otherwise appropriately treated to maintain it in as close to its original state as is possible by then current technics.
(e) A specimen received by a laboratory shall not be tested or reported on if:
(1) the apparent condition of the specimen indicates that it is unsatisfactory for testing or that it is inappropriate for the test requested;
(2) it has been collected, labeled, preserved or otherwise handled in such a manner that it has become unsatisfactory or unreliable as a test specimen;
(3) it is perishable and the time lapse between the collection of the specimen and its receipt by the laboratory is of such duration that the test finding may no longer be reliable; or
(4) the date and, in the case of tests specified by the department, the hour when the specimen was taken by the physician or other authorized person is not furnished with the specimen.
(f) When a specimen is not tested for any of the reasons specified in subdivision (e) of this section the laboratory shall promptly notify the sender and give the reason therefor.
(g) All technical procedures employed in a laboratory shall be of proven reliability and generally accepted by leading authorities in the specialties of laboratory medicine and/or approved by the department.
10 CRR-NY 58-1.10
Current through August 15, 2019
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