Regulation .01 Scope.
Regulation .01 Scope.LinkCopy Citation
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.