# COMAR Title 10 — Maryland Department of Health

## Subtitle 18 — Human Immunodeficiency Virus (HIV) Infection and Acquired Immunodeficiency Syndrome (AIDS)

### Chapter 02 — HIV and CD4+ Investigations and Case Reporting

#### Regulation .01 Scope.

*COMAR 10.18.02.01*

A. This chapter establishes the requirements for:

  (1) Physician reporting of a:

    (a) Case of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); and

    (b) Birth of an infant whose mother has tested positive for HIV;

  (2) Institution reporting of a case of HIV or AIDS;

  (3) Laboratory reporting of a test result for:

    (a) HIV detection;

    (b) HIV viral load;

    (c) CD4+ cell count or percentage; or

    (d) HIV genotype sequence; and

  (4) Follow-up of:

    (a) A physician's report of HIV or AIDS;

    (b) A physician's report of an infant whose mother has tested positive for HIV;

    (c) An institution's report of HIV or AIDS; and

    (d) A laboratory’s report of a test result for:

      (i) HIV detection;

      (ii) HIV viral load;

      (iii) CD4+ cell count or percentage; or

      (iv) HIV genotype sequence infection or CD4+ count.

B. Except as noted in §C of this regulation, this chapter applies to all instances of laboratory testing of specimens from a human body for:

  (1) HIV detection;

  (2) HIV viral load;

  (3) CD4+ cell count or percentage; or

  (4) HIV genotype sequence.

C. This chapter does not apply if the specimen from a human body is:

  (1) Not tested for:

    (a) HIV detection;

    (b) HIV viral load;

    (c) CD4+ cell count or percentage; or

    (d) HIV genotype sequence;

  (2) Tested for HIV detection solely for the purpose of determining the suitability of the source individual as a prospective donor of blood, semen, or tissue;

  (3) Taken from a patient at a designated anonymous HIV test site solely for the purpose of performing an anonymous HIV test;

  (4) Tested for HIV detection as part of research conducted by an institution within Maryland under the following conditions:

    (a) All personal identifiers are removed from the specimen before testing;

    (b) The specimen cannot be linked to the individual from whom the specimen was taken;

    (c) The result cannot be linked to the individual from whom the specimen was taken; and

    (d) The research protocol has been approved by an institutional review board;

  (5) Tested for HIV detection as part of research conducted under a research protocol approved by an institutional review board of an institution located outside of Maryland;

  (6) Taken from a patient known to reside outside of the United States; or

  (7) Tested for HIV detection as part of a research project that has been approved under Regulation .02 of this chapter for an exemption.