1. A. In this chapter, the following terms have the meanings indicated.

2. B. Terms Defined.

   1. (1) “Acquired immunodeficiency syndrome (AIDS)” has the meaning stated in Health-General Article, §§18-201.1(a) and 18-202.1(b), Annotated Code of Maryland.
   2. (2) “Anonymous” means that a patient does not use the patient's name as identification and can only be identified through use of a code.
   3. (3) “Assigned laboratory number” means a number assigned to a laboratory by the Department for use in filing reports of HIV infection or CD4+ count.

   4. (4) “Case” means an individual who has:

      1. (a) Been clinically diagnosed as having HIV or AIDS; or
      2. (b) Laboratory evidence of being infected by HIV.

   5. (5) “Clinical material” means:

      1. (a) An organism isolated from a clinical specimen;
      2. (b) Material derived or prepared from a clinical specimen in which evidence of a communicable disease has been identified or detected; or

      3. (c) If neither §B(5)(a) nor §B(5)(b) of this regulation is available, material from an individual already held by the medical laboratory, in the following order of preference:

         1. (i) A patient specimen;
         2. (ii) Nucleic acid; or
         3. (iii) Other laboratory material.
   6. (6) “Clinical or infection control practitioner” means a physician, infection control nurse, physician assistant, nurse practitioner, or other clinical staff designated by the administrative head of an institution to report under Health-General Article, §18-202.1, Annotated Code of Maryland.
   7. (7) “Department” means the Maryland Department of Health.
   8. (8) “Designated anonymous HIV test site” means an HIV counseling and testing site designated by the Department as a site where a patient may have an anonymous HIV test.

   9. (9) “Drug” means a drug that has been:

      1. (a) Licensed by the United States Food and Drug Administration (FDA); or
      2. (b) Approved by the FDA as an investigational new drug.
   10. (10) “Exemption” means a research project meeting certain criteria, with the result that no reporting is required under this chapter.
   11. (11) “Health officer” means the health officer in each of the 23 counties and the Commissioner of Health in Baltimore City or the duly designated representative of the health officer.
   12. (12) “Human immunodeficiency virus (HIV)” has the meaning stated in Health-General Article, §§18-201.1(a) and 18-202.1(b), Annotated Code of Maryland.
   13. (13) “Institution” means an entity that employs an individual licensed to practice osteopathy or medicine by the State.
   14. (14) “Institutional review board” means a group of individuals designated by an institution in compliance with 45 CFR Part 46 to review the use of human subjects in proposed research.
   15. (15) “Laboratory examination order” means the written document signed by a physician or other authorized individual that specifies one or more laboratory examinations to be performed in regard to a specified patient.
   16. (16) “Newborn HIV exposure” means a newborn infant whose mother has tested positive for HIV infection.
   17. (17) “Physician” means an individual licensed to practice osteopathy or medicine by the State or the physician's designee working under the supervision of the physician.
   18. (18) “Secretary” means the Secretary of Health or the Secretary's designee.

Authority: Health-General Article, §§2-104(b), 4-101, 4-102, 18-102, 18-103, 18-201.1, 18-202.1, 18-205, 18-207, and 18-215;
State Government Article, §10-617; Annotated Code of Maryland

Effective date: February 18, 2002 (29:3 Md. R. 220)

Chapter revised effective September 8, 2008 (35:18 Md. R. 1600)

Regulation .01 amended effective May 18, 2020 (47:10 Md. R. 518

Regulation .02 amended effective May 18, 2020 (47:10 Md. R. 518)

Regulation .02B, C amended effective March 14, 2016 (43:5 Md. R. 385)

Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385); May 18, 2020 (47:10 Md. R. 518)

Regulation .06A amended effective May 18, 2020 (47:10 Md. R. 518)

Regulation .07 amended effective May 18, 2020 (47:10 Md. R. 518)

Regulation .08 amended effective May 18, 2020 (47:10 Md. R. 518)

Regulation .08C amended effective March 14, 2016 (43:5 Md. R. 385)

Regulation .09B amended effective May 18, 2020 (47:10 Md. R. 518)

Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385)