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.
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