TITLE 16

Health and Safety

Regulatory Provisions Concerning Public Health

CHAPTER 7. SEXUALLY TRANSMITTED DISEASES

Subchapter II. HIV Testing and Counseling


For purposes of this subchapter the following definitions shall apply:

(1) "AIDS" shall mean Acquired Immunodeficiency Syndrome, a stage of HIV illness.

(2) "Approved laboratory" shall mean a laboratory approved by the Department for the purpose of performing standard tests for HIV as recognized as such by the Department.

(3) "Clinical setting" shall mean prenatal clinics, hospital emergency departments, urgent care clinics, inpatient services, substance abuse treatment clinics, public health clinics, nursing homes, community clinics, correctional healthcare facilities, blood banks, blood centers, sperm banks, primary care settings, and other public or private settings as defined by the Division.

(4) "Healthcare provider" shall mean any nurse, physician, dentist or other dental worker, optometrist, podiatrist, chiropractor, laboratory or blood bank technologist or technician, phlebotomist, dialysis personnel, emergency healthcare provider (including any paramedic, emergency medical technician, law-enforcement personnel or firefighter), others whose activities involve contact with patients, their blood or corpses, and other public or private providers as defined by the Division.

(5) "Health facility" shall mean a hospital, nursing home, clinic, blood bank, blood center, sperm bank, laboratory, or other healthcare institution.

(6) "HIV" shall mean the Human Immunodeficiency Virus, a virus that can be transmitted sexually and that is identified as the causative agent of AIDS.

(7) "HIV-related tests" shall mean HIV tests, CD4 cell count tests, viral load tests, or any other tests related to HIV.

(8) "HIV test" shall mean a test to detect HIV infection.

(9) "Informed consent" means consent of the subject of the test or subject's legal guardian to the performance of HIV testing by a healthcare provider who has informed the subject or the subject's legal guardian both verbally and in writing, to an extent reasonably comprehensive to general lay understanding, of the nature of the proposed testing and of the risks and alternatives to testing which a reasonable person would consider material to the decision whether or not to undergo testing.

(10) "Invasive medical procedure" shall mean any procedure involving surgical entry into tissues, cavities, or organs.

(11) "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 minor.

(12) "Manner known to transmit HIV" shall mean parenteral exposure to blood or blood products including but not limited to injection through the skin, sexual exposure, or exposure as otherwise determined by the Division.

(13) "Nonclinical setting" shall mean community-based organizations (CBO), outreach and education settings, mobile vans, and other settings as defined by the Division.

(14) "Person" shall mean any natural person, partnership, association, joint venture, trust, public, or private corporation, or health facility.

(15) "Prevention counseling" shall mean an interactive process of assessing risk, recognizing specific behaviors that increase the risk for acquiring or transmitting HIV, and developing a plan to take specific steps to reduce risks.

(16) "Release of test results" shall mean a written authorization for disclosure of test results, which is signed, dated and specifies to whom disclosure is authorized and the time period during which the release is to be effective.

(17) "Routine/opt-out testing" shall mean that the general consent for medical care shall encompass testing for HIV and that testing may be performed as a part of routine care unless it is declined and that declination is noted in the medical record. A separate consent for HIV testing is not required.

(18) "Test counseling" shall include information that includes an explanation of the testing process/procedure, the meaning of possible test results, and provision of resources for additional information about relevant infections. The information may be provided orally or in writing and the subject of the counseling given the opportunity to ask questions.

66 Del. Laws, c. 336, § 1; 71 Del. Laws, c. 458, § 1; 78 Del. Laws, c. 277, § 2.;

(a) A healthcare provider or other person who performs HIV testing services in a clinical setting may provide routine/opt-out testing provided that the following occurs:

(1) The subject is informed, orally or in writing, that routine/opt-out HIV testing is encompassed by the general consent for medical services.

(2) The subject is given the opportunity to refuse consent to HIV testing at each instance of testing. Documentation of such refusal shall be noted in the subject's medical record.

(3) The subject is provided HIV test counseling, orally or in writing, at the first instance of testing and by request thereafter.

(b) The healthcare provider or other person who performs HIV testing services in a nonclinical setting must obtain written documentation of informed consent at each instance of HIV screening.

(1) Informed consent to an HIV test in a nonclinical setting shall consist of a voluntary agreement executed by the subject of the test or the subject's legal guardian.

(2) At each instance of testing, the subject of the test must be offered HIV test counseling and prevention counseling prior to consent for HIV testing.

(c) 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.

(d) Notwithstanding subsection (a) of this section the provisions of subsections (b), (c) and of this section do not apply when:

(1) Knowledge of such test results is 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 healthcare provider or healthcare facility procures, processes, distributes or uses:

a. Blood;

b. A human body part donated for a purpose specified under the Uniform Anatomical Gift Act (Chapter 27 of this title); or

c. 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 healthcare worker has been threatened during the course of a healthcare worker's duties, as a result of exposure to blood or body fluids of the patient in a manner known to transmit HIV.

(5) It is necessary to control the transmission of HIV infection as may be allowed pursuant to this chapter 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 subject of the test 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.

(e) Any person on whom an HIV-related test was performed without first having obtained informed consent pursuant to paragraphs (d)(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.

(f) 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, to urge the voluntary notification of sexual and needle-sharing partners of the risk of infection and the availability of any appropriate healthcare services, including mental healthcare and appropriate social and supportive services.

66 Del. Laws, c. 336, § 1; 70 Del. Laws, c. 186, § 1; 77 Del. Laws, c. 109, § 1; 78 Del. Laws, c. 277, § 2.;

(a) A perinatal care provider may provide routine/opt-out testing pursuant to § 715(a) of this title.

(1) In addition to the provisions of this subsection, a licensed healthcare provider who renders the primary prenatal care for a pregnant woman must offer HIV testing upon intake to perinatal services, during the third trimester, and at intake into labor and delivery if the result of previous test are not available or documented in the patient's chart.

(2) In addition to the provisions this subsection, a licensed healthcare provider who renders the primary prenatal care for a pregnant woman must also counsel a pregnant woman that is found to be HIV-infected, orally or in writing, about the dangers to her fetus and about the treatment options for maintaining her health and reducing chances of transmission of HIV to her fetus.

(b) A pregnant woman shall have the right to refuse consent to testing HIV infection at any instance of testing and to refuse 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 take place 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; 78 Del. Laws, c. 277, § 2.;

(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 healthcare provider if the health facility or healthcare 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 healthcare to the patient.

(4) Healthcare 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 as may be required by law or regulation.

(6) A health facility or healthcare provider which procures, processes, distributes or uses:

a. Blood;

b. A human body part from a deceased person donated for a purpose specified under the Uniform Anatomical Gift Act [Chapter 27 of this title]; or

c. 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 subchapter I of this chapter 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 § 715(d)(6) of this title. 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 third-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; 78 Del. Laws, c. 277, § 2.;

(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 a Court may deem appropriate.

(b) 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 § 717 of this title, or that an HIV-related test has been conducted without informed consent pursuant to § 715 of this title.

(c) The Attorney General may maintain a civil action to enforce this subchapter in which a Court may order any relief authorized by subsection (a) of this section.

(d) 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.

66 Del. Laws, c. 336, § 1; 70 Del. Laws, c. 520, § 1; 71 Del. Laws, c. 458, § 1; 78 Del. Laws, c. 277, § 2.;