Md. Code Regs. 10.18.08.02

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.18.08.02 - Definitions

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) "Acquired immunodeficiency syndrome (AIDS) " means the medical condition caused by the human immunodeficiency virus.

(2) "Anonymous" means that:

(a) A patient's name is not used for identification; and

(b) The patient can be identified only through use of an assigned code.

(3) 'Applicant" means a community based organization or other similar agency that seeks approval to become a designated human immunodeficiency virus testing site.

(4) "Appropriate entity" means the Maryland Department of Health or the Baltimore City Health Department, which designate HIV testing sites in the State per Regulations .03 and .04 of this chapter.

(5) "Centers for Disease Control and Prevention (CDC)" means the federal Centers for Disease Control and Prevention of the federal Department of Health and Human Services.

(6) "Confidential" means that a patient's name is used as identification and that the patient's medical records contain the patient's name but are protected against disclosure as provided by statute.

(7) "Counseling" means providing education to pregnant women on:

(a) The effect of a positive HIV test result on the pregnant woman and fetus concerning the risk of transmission of HIV to the fetus; and

(b) Recognized methods of reducing the risk of transmission of HIV to the fetus during pregnancy.

(8) "Department" means the Department of Health and Mental Hygiene.

(9) "Designated anonymous testing site" means a human immunodeficiency virus testing site approved by the Department or the Baltimore City Health Department as a site where a patient may have an anonymous human immunodeficiency virus test using a code rather than a name for identification.

(10) "Health care facility" means a facility or office where health or medical care is provided to patients by a health care provider including:

(a) A hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland;

(b) A freestanding medical facility as defined in Health-General Article, §19-3A-01, Annotated Code of Maryland;

(c) A health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland;

(d) The Department of Public Safety and Correctional Services;

(e) A program approved by the Department to provide human immunodeficiency virus testing services, according to Regulations .03 and .04 of this chapter;

(f) A facility operated by the Department or a local health officer; or

(g) The office of a health care provider.

(11) "Health care provider" means a:

(a) Physician;

(b) Nurse;

(c) Licensed direct-entry midwife; or

(d) Designee of a health care facility.

(12) "Human immunodeficiency virus (HIV)" means a virus that causes AIDS.

(13) "Indeterminate HIV test result" means that a test did not establish either the presence or absence of HIV infection as defined by the CDC's laboratory criteria.

(14) "Informed consent" means the voluntary permission by the patient to be tested for HIV, after the patient receives pretest information as specified in Regulations .06 and .08 of this chapter.

(15) "Institutional review board" means a group of individuals designated by an institution in compliance with 45 CFR 46, to review the use of human subjects in proposed research.

(16) "Negative HIV test result" means the test result failed to document the presence of HIV as defined by the CDC's laboratory criteria.

(17) Nonclinical Settings.

(a) "Nonclinical settings " means locations:

(i) That are not health care settings;

(ii) Where medical or treatment services are not provided; and

(iii) Where selected diagnostic services and selected prevention services may be provided.

(b) "Nonclinical settings " may include:

(i) Community based organizations;

(ii) Outreach settings; or

(iii) Mobile vans.

(18) Partner.

(a) 'Partner" means an individual with whom one has:

(i) Had or will have, oral, anal, or vaginal sexual contact; or

(ii) Shared hypodermic needles or other similar drug paraphernalia.

(b) 'Partner" includes any individual who:

(i) Is the marriage partner of an HIV-infected patient; or

(ii) Has been the marriage partner of the HIV-infected patient at any time within the 10-year period before the diagnosis of HIV infection.

(19) "Patient" means any individual who has presented for an HIV test, whether or not the individual chooses to be tested for HIV.

(20) "Positive HIV test result" means the test result has documented the presence of HIV as defined by the CDC's laboratory criteria.

(21) "Post-test information" means notifying a patient about HIV test results and providing a patient with other relevant information after an HIV test has been performed, as required by Regulations .09 and .10 of this chapter.

(22) "Prenatal care " means obstetric and gynecologic services performed as part of a medical care program for a pregnant woman and her unborn child, and may include:

(a) Screening;

(b) Physical examination;

(c) Laboratory and diagnostic testing procedures and interpretation; or

(d) Counseling.

(23) "Pretest information" means providing a patient with information before a specimen is tested for the presence of HIV infection, as required by Regulations .06 and .05 of this chapter.

(24) "Research" means an investigation carried out according to a protocol approved by an institutional review board.

(25) "Secretary" means the Secretary of Health and Mental Hygiene.

(26) "Seropositive" means that a positive HIV test result has been obtained from the test of a patient's specimen.

(27) "Specimen" means a sample of:

(a) Blood;

(b) Other body fluid; or

(c) Body tissue.

(28) " Surrogate consent" means consent given by an individual who is not the patient, as permitted under Health-General Article, §5-605, Annotated Code of Maryland, and other provisions of Maryland law.

Md. Code Regs. 10.18.08.02

Regulation .02B amended effective September 8, 2008 (35:18 Md. R. 1600); December 14, 2009 (36:25 Md. R. 1954); amended effective 43:6 Md. R. 408, eff.3/28/2016; amended effective 45:9 Md. R. 462, eff. 5/7/2018