1. A. The OHCQ. The OHCQ shall conduct surveys, as set forth in this subtitle, of laboratories that obtain or retain a license.

2. B. Surveys. The OHCQ shall:

   1. (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. (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.

3. C. Issuance of Licensing Documents. The OHCQ shall:

   1. (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. (2) Issue a license that includes the:

      1. (a) Name of the laboratory;
      2. (b) Name of the licensee or laboratory director; and
      3. (c) Name of the laboratory owner.

   3. (3) Issue a license that designates:

      1. (a) The classes of services, that is, disciplines, provided;
      2. (b) The tests or examinations offered; or
      3. (c) Both §C(3)(a) and (b) of this regulation.

4. D. Administration and Information Management. The OHCQ shall:

   1. (1) Maintain a list of licensed laboratories;
   2. (2) Document information regarding denial, suspension, or revocation of a license and submit this documentation to the Secretary;
   3. (3) Monitor the proficiency testing performance of a laboratory required to participate in proficiency testing; and
   4. (4) For tests that are not CLIA waived, impose alternative sanctions and initiate actions leading to imposition of principal sanctions against a laboratory under the appropriate provisions of this subtitle.
5. E. Recommending Excepted Test Status. 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.

Authority: Courts and Judicial Proceedings Article, §10-1001; Health General Article, §§17-201, 17-202, 17-205, 17-214, and 17-501, Annotated Code of Maryland

Effective date: December 13, 1999 (26:25 Md. R. 1897)

Regulation .01 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198)

Regulation .01E adopted effective January 21, 2002 (29:1 Md. R. 23)

Regulation .01E amended effective April 16, 2012 (39:7 Md. R. 492)

Regulation .01F adopted effective August 29, 2005 (32:17 Md. R. 1438)

Regulation .01F amended effective April 16, 2012 (39:7 Md. R. 492)

Regulation .02 amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .02C amended effective July 24, 2000 (27:14 Md. R. 1340)

Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787)