Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 18 - HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION AND ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)
Chapter 10.18.02 - HIV and CD4+ Investigations and Case Reporting
Section 10.18.02.03 - Definitions
Universal Citation: MD Code Reg 10.18.02.03
Current through Register Vol. 51, No. 19, September 20, 2024
A. In this chapter, the following terms have the meanings indicated.
B. Terms Defined.
(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) "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) "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) "Case" means an individual who has:
(a) Been clinically diagnosed as having HIV
or AIDS; or
(b) Laboratory evidence
of being infected by HIV.
(5) "Clinical material" means:
(a) An organism isolated from a clinical
specimen;
(b) Material derived or
prepared from a clinical specimen in which evidence of a communicable disease
has been identified or detected; or
(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:
(i) A patient specimen;
(ii) Nucleic acid; or
(iii) Other laboratory material.
(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) "Department" means the Department of
Health and Mental Hygiene.
(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) "Drug" means a drug
that has been:
(a) Licensed by the United
States Food and Drug Administration (FDA); or
(b) Approved by the FDA as an investigational
new drug.
(10)
"Exemption" means a research project meeting certain criteria, with the result
that no reporting is required under this chapter.
(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) "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) "Institution" means an entity that
employs an individual licensed to practice osteopathy or medicine by the
State.
(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) "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) "Newborn HIV exposure" means a newborn
infant whose mother has tested positive for HIV infection.
(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) "Secretary" means the Secretary of
Health and Mental Hygiene or the Secretary's designee.
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