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Legal Considerations
Most states have enacted statutory and other legal requirements pertaining to HIV/AIDS testing and reporting. Areas that states may choose to regulate are: pre- and posttest HIV counseling, use of rapid HIV tests, confirmatory testing of preliminary positive test results, informed consent, laboratory requirements, confidentiality, and training and authorization of health care personnel who may administer the HIV test and provide HIV counseling.
It is important that HIV screening program planners are familiar with how HIV/AIDS laws and regulations in their states are being interpreted, applied, and amended. In some jurisdictions, existing laws may bar or impede implementation of certain elements of the CDC's universal HIV screening recommendations in health care settings. In others, however, the National Alliance of State and Territorial AIDS Directors (NASTAD), found that statutes that appear to be restrictive have minimal effect on the CDC's new recommendations. (In June, 2007, NASTAD published a report on its survey of state and local health departments on state HIV/AIDS laws and screening practices in health care settings.)
The CDC commissioned a legal analysis of state HIV laws in 2004. This analysis (PDF), categorizes state HIV statutes into four major areas: personnel; pre-test requirements; testing; and posttest requirements. The following information is a summary of the report's analysis and is intended to provide general context for considering the legal issues. Please note that in states with no statutory requirements for various aspects of HIV testing, the requirements may have been established by case law, agency regulation, or custom. These required elements may nullify or impose additional requirements in one or more of the four major areas regulated by state HIV statutes.
Personnel
The personnel area concerns the regulation of who can offer HIV counseling and testing. Such laws are unlikely to be an impediment to HIV testing by physicians and nurses in hospital ED departments. With respect to counseling, most states regulate individuals who provide pre and posttest HIV counseling, many have legislated specific training requirements, and some require certification for all health care workers and social workers who function as HIV counselors.
top of this pagePretest Requirements
Almost all states have enacted statutes concerning pretest HIV requirements. Relevant statutes govern mandatory pretest counseling, which usually entails disclosure of the risks associated with HIV/AIDS, a description of the HIV test, the risks and benefits of testing, the implications of test results, and how test results will be communicated. Twenty-four states require pretest counseling and the provision of specific information. Only one-third of states mandate risk assessment and risk reduction as components of pretest counseling. The required disclosures under most pretest counseling laws are not time-prohibitive and can be performed by health care providers in a routine medical setting.
Thirty-two states require prior informed consent to HIV testing, posing a potential conflict with the CDC's new recommendation that consent is inferred unless the individual opts out of testing. In addition, the CDC's recommendation that a general consent form for all medical care replace a specific consent form for HIV testing may be problematic under state HIV test informed consent statutes. To the extent that those who perform HIV testing are trained to comply with a state's informed consent requirements, such laws may not pose a problem for opt-out screening. However, compliance may be time-consuming, defeating one of the purposes of opt-out screening. Ultimately, interpretation of these statutes may vary across jurisdictions. In one state, an informed consent statute may be found to bar opt-out screening and the general consent form, but in another state a similar statute may pose no legal impediment at all to the new CDC screening method. Currently, one-third of states are contemplating changing their laws to allow opt-out testing.
Testing
Testing requirements set forth in state laws may regulate the specific type of HIV test that is used such as ELISA or Western Blot, mandate confirmatory testing of positive HIV test results, and dictate when positive test results can be released. A few states specifically authorize the use of rapid HIV tests either by statute or by regulation. Some states impose additional requirements on clinical laboratories that perform HIV tests beyond federal CLIA requirements. Testing protocols in some states may interfere with HIV rapid testing.
top of this pagePosttest Requirements
Posttest legislation concerns confirmatory testing, where it may be performed, which confirmatory tests may be used, and the delivery of test results. A number of states require posttest counseling regardless of the test result. Many states mandate that test results be given face-to-face by trained HIV counselors. It is believed that state statutes requiring posttest counseling will be the most problematic type of state HIV laws for implementing the new CDC HIV screening recommendations and guidelines.
top of this pageResources
- Map to HIV Testing Laws for all U.S. States
National HIV/AIDS Clinicians' Consultation Center - Advancing HIV Prevention Initiative - A Limited Legal Analysis of State HIV Statutes (PDF)
Hodge, Jr. James G. at The Center for Law & the Public's Health at Georgetown & Johns Hopkins Universities - Report on Findings from an Assessment of Health Department Efforts to Implement HIV Screening in Health Care Settings (PDF)
National Alliance of State and Territorial AIDS Directors, June 26, 2007
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