Effective Date: 02/22/2012
Title: Section 63.3 - HIV-related testing
63.3 HIV-related testing. (a) Except as noted in subdivision (d) of this section, no physician or other person authorized pursuant to law may order an HIV-related test without first having obtained written or, where authorized by this section, oral informed consent. When the test being ordered is a rapid HIV test, such informed consent may be obtained orally, and shall be documented in the subject of the test's record including where a confirmatory test was performed. Oral consent cannot be obtained in facilities operated under the Correction Law. A physician or other person authorized pursuant to law to order an HIV-related test to be used for patient care shall provide to the laboratory the name and address of the person who is the source of the specimen and other such information as specified by the commissioner except in the case of anonymous testing as provided for in this Part. Certification of consent does not have to be provided to the laboratory.
(b) Informed consent shall include providing information to the person to be tested or, if such person lacks capacity to consent, to the person lawfully authorized to consent to health care for such person. In situations in which a person other than the test subject consents for the test, information shall also be provided to the test subject to the extent that the person responsible for ordering the test deems that the test subject will benefit from the information. Information necessary to obtain informed consent may be provided through electronic, written or oral means and shall include:
(1) HIV causes AIDS and can be transmitted through sexual activities and by needle-sharing, by pregnant women to their fetuses, and through breastfeeding infants;
(2) there is treatment for HIV that can help an individual stay healthy;
(3) individuals with HIV or AIDS can adopt safe practices to protect infected and uninfected people in their lives from becoming infected or multiply infected with HIV;
(4) testing is voluntary and can be done anonymously at a public testing center;
(5) the law protects the confidentiality of HIV-related test results;
(6) the law prohibits discrimination based on an individual's HIV status and services are available to help with such consequences; and
(7) the law allows an individual's informed consent for HIV-related testing to be valid for such testing until such consent is revoked by the subject of the HIV test or expires by its terms.
(c) In situations where written consent is being obtained, it must be executed on a form that contains information consistent with standardized model forms approved by the department. Such forms based on department models do not require departmental review. General consent forms for medical care may be used to obtain consent, provided that they include information consistent with the state’s model forms and a clearly marked place adjacent to the signature where the subject of the HIV-related test, or when the subject lacks the capacity to consent, a person authorized pursuant to law to consent to the health care for such individual, shall be given an opportunity to decline in writing such testing. Consent may be for a single test, for a period of time determined by the subject of the test, or be open-ended, so long as the subject of the test may revoke consent for future tests at any time. Each additional time that an HIV test is being ordered, the physician or other person authorized to order an HIV test shall orally notify the subject of the test or, if the subject is not able to consent, the person authorized to consent for the subject that the test will be conducted and this notification will be noted in the subject's medical record.
(d) Informed consent is not required in the following situations:
(1) for court-ordered testing pursuant to Civil Practice Law and Rules, section 3121;
(2) when testing without informed consent is otherwise specifically authorized or required by State or Federal law, including under Public Health Law section 2994-g;
(3) for testing related to procuring, processing, distributing or use of a human body or human body part, including organs, tissues, eyes, bones, arteries, blood, semen or other body fluids for use in medical education, medical research or therapy, or for transplantation to persons, provided that if the test results are communicated to the tested person, post-test information for negative results or counseling for positive, indeterminate/inconclusive and preliminary positive results is required;
(4) for research if the testing is performed in a manner by which the identity of the test subject is not known and may not be retrieved by the researcher;
(5) for testing of a deceased person to determine cause of death or for epidemiological purposes;
(6) for comprehensive newborn testing pursuant to PHL section 2500-f; and
(7) for anonymous testing of a person who is the source of an occupational exposure under Section 63.8(n) of this Part, who is deceased, comatose, or otherwise unable to provide consent, and no person authorized to consent on behalf of the source patient is immediately available, as provided in Public Health Law section 2781(6)(e).
(e) With respect to positive and indeterminate/inconclusive results, and for preliminary positive results obtained pursuant to Subpart 58-8 of this Title, in addition to explaining the test result to the person who consented to the test, the person who orders the test shall be responsible, directly or through a representative, for ensuring post-test counseling, referrals and linkage to care as appropriate. Blood banks and tissue banks may report results as specified in Subparts 58-2 and 52-3 of this Title, respectively. When confirmed positive results are being provided, with the consent of a person who tests positive, or if such person lacks the capacity to consent, with the consent of the person authorized to consent to health care for such person, the person ordering the test or his or her representative shall provide or arrange for an appointment for follow-up care for HIV. In situations in which a person other than the test subject consents for the test, results, post-test counseling and referrals should also be provided to the test subject, to the extent the person responsible for ordering the test deems that the test subject will benefit from counseling. For persons who test positive, post-test counseling shall address:
(1) strategies for coping emotionally with the test results;
(2) discrimination issues relating to employment, housing, public accommodations, health care and social services;
(3) the importance of taking precautions to prevent HIV transmission to others;
(4) the ability to release or revoke the release of confidential HIV-related information;
(5) HIV reporting requirements for the purposes of epidemiologic monitoring of the HIV/AIDS epidemic;
(6) the importance of contacts' being notified to prevent transmission, and allowing early access of exposed persons to HIV testing, health care, and prevention services, and a description of notification options and assistance available to the protected individual;
(7) an assessment of the risk of domestic violence in conformance with a domestic violence screening protocol developed by the commissioner pursuant to law;
(8) the requirement that known contacts, including a known spouse, will be reported and that protected persons will also be requested to cooperate in contact notification efforts of known contacts and may name additional contacts they wish to have notified with the assistance of the provider or authorized public health officials;
(9) non-disclosure of the protected individual's name or other information about them during the contact notification process;
(10) the provider's responsibility for making an appointment for newly diagnosed persons to receive follow-up HIV medical care;
(11) the availability of medical services and the location and telephone numbers of treatment sites, information on the use of HIV chemotherapeutics for propyhlaxis and treatment and peer group support, access to prevention, education and support services and assistance, if needed, in obtaining any of these services; and
(12) prevention of perinatal transmission.
(f) In the case of a test not indicating evidence of HIV infection, the person who orders the test shall be responsible, directly or though a representative, for providing the result to the subject of the test, or for a person lacking capacity to consent, the person authorized to consent for the health care for the subject. The person ordering the test or his or her representative must also provide, in a manner that may consist of oral or written reference to materials previously provided, information concerning the risks of participating in high risk sexual or needle-sharing behavior. The negative result and required information may be provided in-person, by mail, electronic messaging, or telephone provided that patient confidentiality is reasonably protected.
(g) Every individual between the ages of thirteen and sixty-four years (or younger or older if there is evidence or indication of risk activity) who receives health services as an inpatient or in the emergency department of a general hospital defined in subdivision ten of section twenty-eight hundred one of the Public Health Law or who receives primary care services in an outpatient department of such hospital or in a diagnostic and treatment center licensed under article twenty-eight of the Public Health Law or from a physician, physician assistant, nurse practitioner, or midwife providing primary care in any office, clinic, facility or other setting shall be offered an HIV-related test unless the health care practitioner providing such services reasonably believes that:
(1) the individual is being treated for a life threatening emergency; or
(2) the individual has previously been offered or has been the subject of an HIV-related test (except that a test shall be offered if otherwise indicated); or
(3) the individual lacks capacity to consent to an HIV-related test.
(h) Nothing in this Part or Part 58 of this Title shall be construed to prohibit a person from directly ordering an HIV test on a specimen taken from his/her own body and directly receiving the results of such HIV test. The test must be performed by a New York State licensed laboratory using a specimen collection kit which has been approved for home HIV specimen collection by the U.S. Food and Drug Administration and which is available without a prescription, or as provided by Section 576-b of the Public Health Law.