Sec. 10.18.08.01. Scope

A. Except as provided in §§C-F of this regulation, this chapter governs:

(1) Pretest and post-test information;

(2) Requirements for reporting and control efforts;

(3) Requirements for informed consent; and

(4) Specific counseling for patients, including when HIV testing is performed on pregnant women as part of a prenatal care program.

B. In cases exempt from the requirements for consent throughout this chapter, as specified in §§C-F of this regulation, it is not necessary to obtain written informed consent for HIV testing on the form approved by the Secretary.

C. If an HIV test is performed on an individual solely for the purpose of determining the suitability of that individual as a prospective donor of blood, semen, or tissue, the requirements for information and consent are addressed in:

(1) Health-General Article, §18-334, Annotated Code of Maryland; and

(2) COMAR 10.50.01.

D. If an HIV test is performed on an individual as a result of a court order issued under the provisions of the Criminal Procedure Article, §§11-107-11-117, Annotated Code of Maryland:

(1) The requirements for HIV testing are addressed in COMAR 10.52.10; and

(2) Informed consent does not apply.

E. HIV testing undertaken under provisions of Health-General Article, §§18-338, 18-338.1, and 18-338.3, Annotated Code of Maryland, is not governed by this chapter.

F. HIV testing of specimens for research is not governed by this chapter if:

(1) All personal identifiers have been removed from the specimen;

(2) The specimen cannot be linked to the patient from whom the specimen was taken;

(3) The test result cannot be linked to the patient from whom the specimen was taken; and

(4) The research protocol has been approved by an institutional review board.

G. This chapter pertains to all patients for whom a diagnostic test for the presence of HIV infection is conducted, including minors and pregnant women receiving prenatal care.