Md. Code Regs. 10.18.08.08

Current through Register Vol. 51, No. 19, September 20, 2024

Section 10.18.08.08 - Consent and Pretest Requirements for HTV Testing in Nonclinical Settings

A. For HIV tests administered in nonclinical settings, as permitted in Regulations .03 and .04 of this chapter, the individual administering the HIV test shall:

(1) Utilize the HIV informed consent form approved by the Secretary to document the obtainment of informed consent;

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

(3) Obtain voluntary written informed consent from the patient before an HIV test is performed on a specimen.

B. A patient tested at a designated anonymous nonclinical test site, as permitted in Regulation .03 of this chapter, may indicate consent by placing their assigned code on the signature line of the form approved by the Secretary to indicate written informed consent.

C. Pretest information shall be provided to the patient being tested before each specimen is tested.

D. An individual providing pretest information shall:

(1) Provide HIV-specific information:

(a) Verbally;

(b) In writing;

(c) Through video; or

(d) Through any combination of §D(l)(a)-(c) of this regulation based on the testing history and information needs of the patient;

(2) Provide HIV information in a manner that protects the confidentiality of the patient;

(3) Using layman's terms, provide, at a minimum, the following information to the patient:

(a) That the patient is being tested for HIV;

(b) That the patient has the right to:

(i) Ask questions; and

(ii) Decline the test without penalty;

(c) The primary modes of HIV transmission including:

(i) Sexual contact without the use of condoms, other barriers, or other biomedical interventions;

(ii) Injection drug use; and

(iii) Mother-to-child transmission;

(d) Counseling as defined in Regulation .02 of this chapter to pregnant women;

(e) That a negative test result means that:

(i) A patient is not infected with HIV or that the test was unable to detect the presence of HIV because a patient is in the early stage of infection and has not yet developed detectable evidence of HIV infection; and

(ii) If the patient has had any potential recent exposures, that the patient should be retested within an appropriate time frame based on the type of testing used;

(f) That a positive test result means the patient:

(i) Is infected with HIV;

(ii) Will be linked with medical treatment and other supportive services; and

(iii) May need a confirmatory test if the preliminary positive was based on an HIV rapid test; and

(g) Inform the patient being tested at a designated anonymous HIV test site that an assigned code will be used instead of a name;

(4) Include an opportunity for the patient to:

(a) Ask questions and receive answers about HIV infection and other topics described in this regulation ; and

(b) Decline HIV testing; and

(5) Make necessary accommodation with respect to language or disability to ensure that the patient understands the information presented.

Md. Code Regs. 10.18.08.08

Regulation .08 amended effective December 14, 2009 (36:25 Md. R. 1954); adopted effective 43:6 Md. R. 408, eff.3/28/2016; recodified from .07 amended effective 45:9 Md. R. 462, eff. 5/7/2018