Md. Code Regs. 10.18.02.01

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Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.18.02.01 - Scope

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.

Md. Code Regs. 10.18.02.01

Regulation .01 amended effective 47:10 Md. R. 515, eff. 5/18/2020