Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants
Section 10.10.13.10 - General Supervisor Requirement, Qualifications, and Responsibilities

Universal Citation: MD Code Reg 10.10.13.10

Current through Register Vol. 51, No. 19, September 20, 2024

A. General Supervisor Requirement. A permittee that offers to perform or performs first-tier, supplemental, or second-tier tests shall employ a general supervisor.

B. General Supervisor Qualifications. The general supervisor shall:

(1) Meet the qualifications for a general supervisor set forth at COMAR 10.10.07.06B(1); and

(2) Have at least 6 months experience supervising the operation of applicable test systems, including:
(a) Tandem mass spectrophotometry (MS/MS);

(b) Time-resolved immunofluorometry;

(c) Enzyme-linked immunosorbent assay (ELISA) systems; and

(d) Isoelectric focusing and high-performance liquid chromatography.

C. General Supervisor Responsibilities. A general supervisor shall carry out the responsibilities set forth in 42 CFR § 493.1463, including:

(1) Supervising the:
(a) Day-to-day operation of the laboratory; and

(b) Personnel performing tests and reporting test results; and

(2) Being accessible to testing personnel at all times testing is performed to provide on-site, telephonic, or electronic consultation and resolve technical problems in accordance with policies and procedures established and approved by the director and technical supervisor.

Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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