10.18.08.07

.07 Consent and Pretest Requirements for HIV 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 formís contents; and

(3) Obtain voluntary written informed consent from the individual to be tested for HIV before an HIV test is performed on a specimen.

B. An individual 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 individual 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) By video; or

(d) By any combination of §D(1)(a)—(c) of this regulation based on the testing history and information needs of the individual being tested;

(2) Provide HIV information in a manner that protects the confidentiality of the individual being tested;

(3) Using laymanís terms, provide, at a minimum, the following information to the individual being tested:

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

(b) That the individual has the right to:

(i) Ask questions; or

(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) That a negative test result means that:

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

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

(e) That a positive test result means the individual:

(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

(f) Inform the individual 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 individual being tested to:

(a) Ask questions about HIV infection and other topics described in this regulation and have those questions answered; and

(b) Decline HIV testing; and

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