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Title: Section 360.4 - Clinical laboratory testing

Effective Date

08/06/2020

Section 360.4 Clinical laboratory testing

(a) In the event of a declared state disaster emergency, the Commissioner shall have all necessary authority to:

(1) Authorize clinical laboratories to operate temporary collecting stations to collect specimens from individuals.

(b) In addition, and to the extent consistent with any Executive Order issued by the Governor, the Commissioner shall have all necessary authority to:

(1) Waive permit requirements for clinical laboratories and establish minimum qualifications to allow non-permitted clinical laboratories to accept and test specimens from New York State, provided that such laboratories must meet any federal requirements.

(2) Establish minimum qualifications of individuals that may perform clinical laboratory tests, provided that such persons meet federal requirements.

(3) Allow clinical laboratories to accept specimens without an order, subject to a plan approved by Commissioner to ensure the result of any tests are reported to the patient or the patient’s personal representative and there will be appropriate follow up with the patient based on the results.

(4) Authorize licensed pharmacists to order clinical laboratory tests, consistent with federal law, including certificate of waiver requirements.

(5) Permit licensed pharmacists to be designated as qualified healthcare professionals for the purpose of directing a limited service laboratory, pursuant to Section 579 of the Public Health Law.

(6) Permit licensed pharmacists to order and administer clinical tests.

(c) Prioritization of clinical laboratory tests. In the event the declared state disaster emergency requires utilization of clinical laboratory testing at a rate that exceeds available capacity, no laboratory shall perform such test unless the test has been ordered consistent with the  testing prioritization published by the Commissioner.

(d) Reporting of results of any communicable disease during a Surge and Flex period shall be made immediately via the Electronic Clinical Laboratory Reporting system, if positive, and on a schedule as determined by the Commissioner if negative.

Statutory Authority

Public Health Law, Sections 225, 576, 2800, 2803 and 4662 & Social Services Law, Section 461

Volume

VOLUME C (Title 10)

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