Subchapter I. HIV-Related Tests
TITLE 16
Health and Safety
Regulatory Provisions Concerning Public Health
CHAPTER 12. INFORMED CONSENT AND CONFIDENTIALITY
Subchapter I. HIV-Related Tests
§ 1201. Definitions.
For purposes of this subchapter the following definitions shall apply:
(1) "Aids" shall mean Acquired Immunodeficiency Syndrome.
(2) "Health care provider" shall mean any nurse, physician, dentist or other dental worker, optometrist, podiatrist, chiropractor, laboratory and blood bank technologist and technician, phlebotomist, dialysis personnel, emergency health care provider (including any paramedic, emergency medical technician, law enforcement personnel or firefighter) or others whose activities involve contact with patients, their blood or corpses.
(3) "Health facility" shall mean a hospital, nursing home, clinic, blood bank, blood center, sperm bank, laboratory or other health care institution.
(4) "HIV" shall mean the human immunodeficiency virus identified as the causative agent of AIDS.
(5) "HIV-related test" shall mean a test for the antibody or antigen to HIV.
(6) "Legal guardian" shall mean a person appointed by a court to assume legal authority for another who has been found incompetent or, in the case of a minor, a person who has legal custody of the child.
(7) "Manner known to transmit HIV" shall mean parenteral exposure to blood or blood products including but not limited to injection through the skin; or as otherwise determined by the Division of Public Health.
(8) "Person" shall mean any natural person, partnership, association, joint venture, trust, public or private corporation or health facility.
(9) "Release of test results" shall mean a written authorization for disclosure of HIV-related test results which is signed, dated and which specifies to whom disclosure is authorized and the time period during which the release is to be effective.
66 Del. Laws, c. 336, § 1; 71 Del. Laws, c. 458, § 1.;
§ 1202. Informed consent.
(a) No health facility, health care provider or other person shall test or shall cause by any means to have tested, any specimen of any patient for HIV-related tests, without the informed consent of the subject of the test or the subject's legal guardian. A health care provider shall ensure that informed consent has been received prior to ordering testing by a laboratory or other facility.
(b) Informed consent to an HIV-related test shall consist of a voluntary agreement executed by the subject of the test or the subject's legal guardian. If the agreement is oral, the facts pertaining thereto must be documented by customary practice. Informed consent shall consist of at least the following:
(1) An explanation of the test, including its purpose, potential uses, limitations and the meaning of its results;
(2) An explanation of the procedure to be followed, including that the test is voluntary, that consent may be withdrawn and the extent and limitations of the manner in which the results will be confidential;
(3) An explanation of the nature of AIDS and other manifestations of HIV infection and the relationship between the test result and those diseases; and
(4) Information about behaviors known to pose risks for transmission of HIV infection.
(c) Notwithstanding subsection (a) of this section the provisions of subsections (a) and (b) of this section do not apply when:
(1) Knowledge of such test results are necessary for medical diagnostic purposes to provide appropriate emergency care or treatment and the subject of the test is unable to grant or withhold consent.
(2) The testing is done for the purposes of research; provided that the test is performed in a manner by which the identity of the test subject is not known and may not be retrieved by the researcher.
(3) A health care provider or health care facility procures, processes, distributes or uses (i) blood, (ii) a human body part donated for a purpose specified under the Uniform Anatomical Gift Act [Chapter 27 of this title] or (iii) semen provided prior to July 11, 1988, for the purpose of artificial insemination, and such test is necessary to assure the medical acceptability of such gift or semen for the purposes intended.
(4) The health of a health care worker has been threatened during the course of a health care worker's duties, as a result of exposure to blood or body fluids of the patient in a manner known to transmit HIV.
(5) Necessary to control the transmission of HIV infection as may be allowed pursuant to Chapter 7 of this title as it relates to sexually transmitted diseases, or § 6523(b) of Title 11 as it relates to the Department of Correction.
(6) Testing is ordered by a court of competent jurisdiction within the confines of civil or criminal litigation where the results of an HIV-related test of a party, or a person in the custody or under the legal control of another party, is relevant to the ultimate issue of culpability and/or liability. Said order must be issued in compliance with the following provisions:
a. No court of this State shall issue such order unless the court finds that there is a compelling need for such test results which cannot be accommodated by other means. In assessing compelling need, the court shall weigh the need for testing and disclosure of the test results against the privacy interest of the test subject and the public interest which may be disserved by disclosure which deters future testing or which may lead to discrimination.
b. Pleadings pertaining to ordering of an HIV-related test shall substitute a pseudonym for the true name of the subject of the test. The true name shall be communicated confidentially, in documents not filed with the court.
c. Before granting any such order, the court shall provide the individual whose test result is in question with notice and a reasonable opportunity to participate in the proceedings if the individual is not already a party.
d. Court proceedings as to disclosure of test results so ordered shall be conducted in camera unless the subject of the test agrees to a hearing in open court or unless the court determines that a public hearing is necessary to the public interest and the proper administration of justice.
(7) The testing is done on a pregnant woman as defined in § 1204 of this title.
(d) Any person on whom an HIV-related test was performed without first having obtained informed consent pursuant to subsections (c)(1), (4) and (5) of this section shall be given notice promptly, personally and confidentially that a test sample was taken and the results of such test may be obtained upon request.
(e) At the time of learning the test result, the subject of the test or the subject's legal guardian shall be provided with counseling for coping with the emotional consequences of learning the result, for understanding the interpretation of the test result, for understanding measures for preventing infection to others and to urge the voluntary notification of sexual and needle-sharing partners of the risk of infection.
(f) Notwithstanding any other provision of law, a minor 12 years of age or older may consent or refuse consent to be a subject of HIV-related testing and to counseling relevant to the test. The consent or refusal of the minor shall be valid and binding as if the minor had achieved majority, and shall not be voidable, nor subject to later disaffirmance, because of minority.
66 Del. Laws, c. 336, § 1; 70 Del. Laws, c. 186, § 1; 77 Del. Laws, c. 109, § 1.;
§ 1203. Confidentiality.
(a) No person may disclose or be compelled to disclose the identity of any person upon whom an HIV-related test is performed, or the results of such test in a manner which permits identification of the subject of the test, except to the following person:
(1) The subject of the test or the subject's legal guardian.
(2) Any person who secures a legally effective release of test results executed by the subject of the test or the subject's legal guardian.
(3) An authorized agent or employee of a health facility or health care provider if the health facility or health care provider itself is authorized to obtain the test results, the agent or employee provides patient care or handles or processes specimens of body fluids or tissues, and the agent or employee has a medical need to know such information to provide health care to the patient.
(4) Health care providers providing medical care to the subject of the test, when knowledge of the test results is necessary to provide appropriate emergency care or treatment.
(5) When part of an official report to the Division of Public Health as may be required by regulation.
(6) A health facility or health care provider which procures, processes, distributes or uses: (i) blood; (ii) a human body part from a deceased person donated for a purpose specified under the Uniform Anatomical Gift Act; or (iii) semen provided prior to July 11, 1988, for the purpose of artificial insemination.
(7) Health facility staff committees or accreditation or oversight review organizations which are conducting program monitoring, program evaluation or service reviews, including the Child Death, Near Death and Still Birth Commission conducting reviews pursuant to Title 31.
(8) Pursuant to Chapter 9 of this title as it relates to investigation of child abuse.
(9) Pursuant to Chapter 7 of this title as it relates to sexually transmitted diseases and their control.
(10) A person allowed access to said record by a court order which is issued in compliance with the following provisions:
a. No court of this State shall issue such order unless the court finds that the person seeking the test results has demonstrated a compelling need for the test results which cannot be accommodated by other means. In assessing compelling need, the court shall weigh the need for disclosure against the privacy interest of the test subject and the public interest which may be disserved by disclosure which deters future testing or which may lead to discrimination.
b. Pleadings pertaining to disclosure of test results shall substitute a pseudonym for the true name of the subject of the test. The disclosure to the parties of the subject's true name shall be communicated confidentially, in documents not filed with the court.
c. Before granting any such order, the court shall provide the individual whose test result is in question with notice and a reasonable opportunity to participate in the proceedings if the individual is not already a party.
d. Court proceedings as to disclosure of test results shall be conducted in camera unless the subject of the test agrees to a hearing in open court or unless the court determines that a public hearing is necessary to the public interest and the proper administration of justice.
e. Upon the issuance of an order to disclose test results, the court shall impose appropriate safeguards against unauthorized disclosure, which shall specify the persons who may have access to the information, the purposes for which the information shall be used and appropriate prohibitions on future disclosures.
(11) Pursuant to Chapter 12A of this title as it relates to notification of emergency medical care providers.
(b) No person to whom the results of an HIV-related test have been disclosed pursuant to subsection (a) of this section shall disclose the test results to another person except as authorized by subsection (a) of this section.
(c) The provisions in this section shall not interfere with the transmission of information as may be necessary to obtain 3rd-party payment for medical care related to HIV infection or with the documentation of cause of death on death certificates.
66 Del. Laws, c. 336, § 1; 68 Del. Laws, c. 415, § 2; 70 Del. Laws, c. 186, § 1; 75 Del. Laws, c. 361, § 3.;
§ 1204. Counseling of all pregnant women.
(a) As a routine component of prenatal care, every licensed health care provider who renders the primary prenatal care, regardless of the site of such practice, shall advise every pregnant woman who is that provider's patient of the value of testing for Human Immunodeficiency Virus (HIV) infection and shall include a test for HIV infection among the standard battery of prenatal tests administered to each such pregnant woman, unless such pregnant woman opts out. Practitioners shall also counsel all pregnant women who are found to be HIV positive about the dangers to her fetus and the advisability of receiving treatment in accordance with the then current Centers for Disease Control and Prevention recommendations for HIV positive pregnant women.
(b) In addition to the provisions of subsection (a) of this section, a licensed health care provider who renders the primary prenatal care for a pregnant woman must offer HIV testing in the third trimester if she is at high risk for acquiring HIV. A woman is at high risk if 1 or more of the following applies:
(1) A history of a sexually transmitted disease; or
(2) During the pregnancy:
a. Illicit drug use or the exchange of sex for money or drugs;
b. Multiple sex partners or a sex partner known to be HIV-positive or at high risk of acquiring HIV; or
c. Signs or symptoms suggestive of acute HIV infection.
(c) Any pregnant woman shall have the right to refuse consent to testing HIV infection and any recommended treatment. Documentation of such refusal shall be maintained in the patient's medical record. All other provisions of this subchapter shall apply to such counseling, testing and disclosure which takes places pursuant to this section.
70 Del. Laws, c. 520, § 1; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 458, § 1; 75 Del. Laws, c. 434, § 1; 77 Del. Laws, c. 109, § 2.;
§ 1205. Enforcement of subchapter.
(a) Any person aggrieved by a violation of this subchapter shall have a right of action in the Superior Court and may recover for each violation:
(1) Against any person who negligently violates a provision of this subchapter, damages of $1,000 or actual damages, whichever is greater.
(2) Against any person who intentionally or recklessly violates a provision of this subchapter, damages of $5,000 or actual damages, whichever is greater.
(3) Reasonable attorneys' fees.
(4) Such other relief, including an injunction, as the court may deem appropriate.
(5) Any action under this subchapter is barred unless the action is commenced within 3 years after the cause of action accrues. A cause of action will accrue when the injured party becomes aware of an unauthorized disclosure pursuant to § 1203 of this title, or that an HIV-related test has been conducted without informed consent pursuant to § 1202 of this title.
(b) The Attorney General may maintain a civil action to enforce this subchapter in which the court may order any relief authorized by subsection (a) of this section.
(c) Nothing in this subchapter shall be construed to impose civil liability or criminal sanction for disclosure of an HIV-related test result in accordance with any reporting requirement by the Division of Public Health.
66 Del. Laws, c. 336, § 1; 70 Del. Laws, c. 520, § 1; 71 Del. Laws, c. 458, § 1.;