Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.02 - Medical Laboratories-General
Section 10.10.02.01 - Responsibilities of the Department
Universal Citation: MD Code Reg 10.10.02.01
Current through Register Vol. 51, No. 19, September 20, 2024
A. The OHCQ. The OHCQ shall conduct surveys, as set forth in this subtitle, of laboratories that obtain or retain a license.
B. Surveys. The OHCQ shall:
(1) Conduct or oversee an announced or
unannounced survey of a laboratory at any time during its hours of operation to
assess compliance with applicable sections of Health-General Article, Title 17,
Subtitles 2 and 5, Annotated Code of Maryland, and this chapter; and
(2) Examine, as part of a survey, a
laboratory's facilities, equipment, quality assurance records and procedures,
operating procedures, personnel and personnel records, proficiency testing,
patient reports, and other records and files pertinent and subject to this
subtitle.
C. Issuance of Licensing Documents. The OHCQ shall:
(1)
License a person to operate a laboratory by issuing a letter of exception or
permit when the laboratory is in compliance with the applicable standards set
forth in this subtitle;
(2) Issue a
license that includes the:
(a) Name of the
laboratory,
(b) Name of the
licensee or laboratory director,
(c) Name of the laboratory owner,
and
(d) Expiration date of the
license; and
(3) Issue a
license that designates:
(a) The classes of
services, that is, disciplines, provided,
(b) The tests or examinations offered,
or
(c) Both §C(3)(a) and (b)
of this regulation.
D. Administration and Information Management. The OHCQ shall:
(1) Maintain a list of
licensed laboratories;
(2) Document
information regarding denial, suspension, or revocation of a license and submit
this documentation to the Secretary;
(3) Monitor the proficiency testing
performance of a laboratory required to participate in proficiency
testing;
(4) Conduct a cytology
proficiency testing program for each cytotechnologist and pathologist who
performs gynecological examinations;
(5) Set and collect fees as set forth in
COMAR 10.10.04; and
(6) Impose
alternative sanctions and initiate actions leading to imposition of principal
sanctions against a laboratory under the appropriate provisions of this
subtitle.
E. Recommending Excepted Test Status.
(1) The
Secretary shall maintain a Laboratory Advisory Committee to advise the
Secretary on matters relating to medical laboratories as set forth in
Health-General Article, Title 17, Subtitle 2, Annotated Code of
Maryland.
(2) The Laboratory
Advisory Committee's responsibilities shall include making a recommendation to
the Secretary in favor of or against granting a test excepted status.
(3) The Laboratory Advisory Committee shall
consider a test for excepted test status and make a recommendation to the
Secretary if:
(a) The Laboratory Advisory
Committee is requested in writing by:
(i) The
Secretary;
(ii) A Maryland chapter
of a specialty medical society; or
(iii) The Medical and Chirurgical Faculty of
Maryland;
(b) The test
on which the request is based is waived under CLIA, by the CDC, or by the
federal Food and Drug Administration;
(c) The test employs a directly collected
specimen not subjected to post-collection manipulation or processing;
and
(d) The test is a manual test
or is a test system employing a single use test device for nonforensic testing
that tests for one or more analytes in a single specimen.
(4) The Laboratory Advisory Committee shall
make a recommendation to the Secretary concerning excepted test status based
on:
(a) Immediate patient need for the test
in order to:
(i) Provide rapid patient
follow-up;
(ii) Order additional
tests; or
(iii) Make an immediate
diagnostic or therapeutic decision;
(b) Whether the test is core to a physician's
practice, based on:
(i) Physician
specialty;
(ii) Usefulness of the
test in the specialty; and
(iii)
Who actually performs the test;
(c) Access, applicability, and ease of
performance by personnel in a POL and POC setting;
(d) Whether all analytes testable on a
multi-test, single-use test device are recommended for excepted
status;
(e) Consideration of the
known benefits and risks of the test or test system, especially those involving
an infectious disease; and
(f) The
potential harm to a patient if the test:
(i)
Is performed incorrectly; or
(ii)
Produces a false positive or false negative test result.
(5) In recommending a test for
excepted status, the Laboratory Advisory Committee may specify certain
conditions to be met based on factors set forth in §E(4) of this
regulation.
F. Authorizing Excepted Test Status.
(1) The
Secretary may authorize a test for excepted status if:
(a) The test is recommended for excepted test
status by the Laboratory Advisory Committee; or
(b) The Secretary:
(i) Determines that the test meets the
criteria of §E(3)(b)-(d) of this regulation; and
(ii) Bases the authorization for excepted
status on the factors set forth in §E(4) of this regulation.
(2) In authorizing a
test for excepted status, the Secretary may specify certain requirements to be
met based on factors set forth in §E(4) of this regulation.
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