.01 Responsibilities of the Department.

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.