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10.18.08.07

.07 Requirement to Obtain Written Informed Consent.

A. In this regulation, "health care facility" means:

(1) A facility operated by the Department;

(2) A local health department;

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

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

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

(6) A licensed medical facility operated within the Department of Public Safety and Correctional Services or the Department of Juvenile Services; or

(7) The office of a health care provider where medical treatment is delivered and medical records are maintained.

B. A health care practitioner who orders the HIV test shall ensure that voluntary informed consent is obtained from the individual to be tested for HIV in accordance with this regulation.

C. Before obtaining an individual's consent, the health care provider shall provide the individual with pretest counseling according to Regulation .06 of this chapter.

D. If substitute consent is to be given as permitted under Health-General Article, §5-605, Annotated Code of Maryland, or other provisions of Maryland law, the health care provider shall provide the individual giving substitute consent with pretest counseling before obtaining voluntary informed consent.

E. A health care provider shall obtain voluntary informed consent from the individual to be tested for HIV before a specimen is obtained for the purpose of HIV testing or before an HIV test is performed on a specimen obtained for another purpose, except that:

(1) An individual tested at a designated anonymous test site may indicate consent by placing that individual's assigned code in lieu of the individual's signature on the signature line of the form approved by the Secretary to obtain written informed consent for HIV testing;

(2) If an individual is unable to give informed consent, substitute consent may be given as permitted under Health-General Article, §5-605, Annotated Code of Maryland, or other provisions of Maryland law; and

(3) In cases exempt from the requirements of this chapter, as specified in Regulation .01C—E of this chapter, it is not necessary to obtain written informed consent on the form approved by the Secretary.

F. A health care provider administering an HIV test under the authority of a health care facility shall document the provision of informed consent in the medical record of the individual to be tested.

G. If an HIV test is administered in or under the authority of an institution other than a health care facility, the individual or entity administering the HIV test shall:

(1) Utilize an HIV informed consent form approved by the Secretary to obtain and document the provision of informed consent and keep the HIV informed consent form separate and distinct from all other forms;

(2) Read and explain the form, through an interpreter if necessary, to anyone who cannot read or understand the form's contents; and

(3) Allow the individual to be tested an opportunity to sign the informed consent form voluntarily.

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