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

Current through Register Vol. 51, No. 14, July 12, 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.