Model Protocol for HIV Counseling and Testing Conducted Outside County Health Departments and Registered Testing Programs

This model protocol provides guidelines on performing confidential HIV counseling and testing in accordance with statutory requirements and established public health policy. Florida law carefully structures the manner in which health care providers may perform HIV tests. The law requires those who perform HIV tests to obtain the informed consent of the test subject, confirm positive preliminary results with a supplemental test before informing the test subject of the result, except as provided for in s. 381.004(3)(d)2., F.S., and make a reasonable attempt to notify the test subject of his or her test result.

Evaluating an individual’s risk for HIV infection and offering HIV testing on a voluntary basis should be a routine part of primary health care. Risk assessment should take place without regard to age, religion, sexual orientation, gender, race/ethnicity, marital status, economic status, social or other cultural factors.

1.    Risk Assessment

Risk assessment involves asking the individual a series of open-ended questions to determine behaviors that may put them at risk for HIV infection. When conducting the risk assessment, it is important to assure the client that all information is confidential under Florida law. Questions should be asked in a professional, culturally sensitive, non-judgmental manner.

The following criteria should be used to help the test subject determine his or her level of risk:

• Sexual behavior
• Substance use/abuse
• Needle sharing
• Occupational exposure
• Blood/blood products/transplants
• Partners at risk for HIV
• History of sexually transmitted disease(s)
• Child of woman with HIV/AIDS
• History of sexual assault/domestic violence
• Sex for drugs/money

Appropriate referrals should be made based on information obtained in the risk assessment. The Florida Domestic Violence Hotline (1-800-500-1119) provides information and referrals in English, Spanish and Creole.

2.    Pre-Test Counseling

Florida law no longer requires pre-test counseling, except in the case of a provider who attends a pregnant woman for conditions related to her pregnancy (see item 6); however, it is recommended that HIV testing be preceded by a pre-test counseling session consisting of the following elements:

• Purpose of the HIV test;
• Indications for testing (medical indication and/or information obtained from the risk assessment);
• The possible need for retesting;
• Information on how to avoid contracting and transmitting HIV infection;
• Potential social, medical, and economic effects of a positive test result;
• Options for eliminating and/or reducing risk behavior;
• The availability of support services for those awaiting test results (e.g., hotlines, health care professional's name and telephone number, county health department number); and,
• Scheduling a specific date for receiving test results. (It is recommended that positive results always be disclosed during a face-to-face post-test counseling session.)

If the health care provider chooses to release negative HIV test results without face-to-face post-test counseling, a system should be in place to ensure the confidentiality of this information. This system might include giving the results over the telephone after test subjects identify themselves with a previously agreed upon code word or number. This process should be explained to clients prior to administering the HIV test. Florida law imposes strict penalties for breaches of confidentiality.

3.    Informed Consent

• No person shall perform an HIV test without first obtaining the informed consent of the test subject or his or her legal representative. The limited exceptions to obtaining informed consent can be found in s. 381.004 (3)(h), F.S.
• When obtaining informed consent, explain the right to confidential treatment of information identifying the subject of the test and the results of the test to the extent provided by law. Persons with knowledge of an individual's HIV test result have legal obligations to protect this information from unauthorized disclosure. Special provisions for hospitals are listed in s. 381.004(3)(g), F.S.
• Consent need not be in writing provided that documentation is included in the medical record indicating that the test was explained and informed consent was obtained. (A few limited exceptions are included in Rule 64D-2.004(4), F.A.C.).
• In accordance with Administrative Rule 64D-2.004, Testing Requirements, an explanation of the following information represents a sound and reasonable standard for obtaining informed consent:

1. An HIV test is a test to determine if an individual is infected with the virus which causes AIDS;
2. The potential uses and limitations of the test (the reliability of the results and what positive, negative or indeterminate results do and do not mean);
3. The procedures to be followed; and,
4. HIV testing is voluntary and consent to be tested can be withdrawn at any time prior to testing.

• Persons who volunteer to be tested confidentially for HIV should be informed that positive test results will be reported to the local county health department so that health department staff may contact persons who test positive to offer follow-up activities. Examples of voluntary follow-up activities are post-test counseling for persons who do not return for test results, referrals for medical evaluation, case management services and voluntary partner notification. (Exemptions from HIV reporting include persons tested anonymously at a registered anonymous test site, testing in the event of a significant exposure or university-based medical research protocols approved by the Department of Health.)
• The test subject must also be given information on the availability and location of anonymous test sites. Each county health department maintains a list of available anonymous test sites to be disseminated to all persons and programs offering HIV testing within their service area.

4.    Post-Test Counseling

The person ordering the test or that person’s designee shall ensure that all reasonable efforts are made to notify the test subject of his or her test result. In the case of a hospital emergency department, detention facility, or other facility where the test subject has been released before being notified of positive test results, informing the county health department for the department to notify the test subject fulfills this responsibility. When test subjects are given their test results, Florida law requires that, at a minimum, the following information be provided:

• For positives, information on preventing transmission of HIV, the availability of appropriate medical and support services and on the importance of notifying sex and/or needle-sharing partners who may have been exposed. Providers must make a good faith effort to ensure that spouses and former spouses (from the past ten years) of HIV-infected persons are notified that they may have been exposed to HIV infection.
• For negatives, information on preventing the transmission of HIV, if appropriate.

Although Florida law no longer requires a face-to-face post-test counseling session, it is recommended that providers conduct such a session when the individual tests positive or is a high-risk negative. A post-test counseling session should consist of the following elements:

• The meaning of the test results;
• The potential social, medical and economic effects of a positive test result;
• The possible need for retesting;
• A reassessment of risk;
• Availability of health care, mental health, social and support services for those testing negative;
• Options for eliminating and/or reducing the transmission of HIV infection to the individual and/or partners;
• A discussion of the increased risk for TB and appropriate referrals for TB testing and treatment; and,
• Other appropriate referrals (e.g., STD, primary care, psychosocial).

5.    Release of Preliminary HIV Test Results

Pursuant to s. 381.004(3)(d), F.S., preliminary test results may be released to health care providers and to the person tested when decisions about medical care or treatment cannot await the results of confirmatory testing. Positive preliminary HIV test results shall not be characterized to the patient as a diagnosis of HIV infection. Justification for the use of preliminary test results must be documented in the medical record by the health care provider who ordered the test. This does not authorize the release of preliminary test results for the purpose of routine identification of HIV-infected individuals or when HIV testing is incidental to the preliminary diagnosis or care of a patient. Corroborating or confirmatory testing must be conducted as follow up to a positive preliminary test. Results shall be communicated to the patient according to statute regardless of outcome.

6.    Pregnant Women/Special Provisions (This requirement was effective October 1, 1996)

Florida law (s. 384.31, F.S.) requires a health care provider who attends a pregnant woman for conditions relating to her pregnancy to offer testing for HIV and counsel her on the availability of treatment if she tests positive.

If the pregnant woman objects to HIV testing, a reasonable attempt must be made to obtain a written statement of objection, signed by the patient, which shall be placed in her medical record. (If a pregnant woman tests HIV negative, consideration should be given to offering the test again at a later date during her pregnancy because of the window period of up to 6 months between exposure to HIV and testing positive for antibodies and the risk of exposure during pregnancy through sex or needle sharing.)

When a pregnant woman tests HIV positive, in addition to the medical and support services listed above, she should also be referred to the Healthy Start Care Coordination System. For more information on the availability of services, contact the Family Health Line at 1-800-451-BABY or the Florida AIDS Hotline at 1-800-FLA-AIDS.