CHAPTER 336

FORMERLY

HOUSE BILL NO. 559

AS AMENDED BY HOUSE AMENDMENT NOS. 4 AND 6

AN ACT TO AMEND TITLE 16 OF THE DELAWARE CODE RELATING TO INFORMED CONSENT AND CONFIDENTIALITY REGARDING HIV RELATED TESTS.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE (Two-thirds of all members elected to each House thereof concurring therein):

Section 1. Amend Title 16, Delaware Code by adding a new chapter to read as follows:

"Chapter 12. Informed Consent and Confidentiality Regarding HIV Related Tests.

§1202. Definitions.

For purpose of this Chapter the following definition shall apply;

(a) 'AIDS' shall mean Acquired Immunodeficiency Syndrome

(b) 'HIV' shall mean the human immunodeficiency virus identified as the causative agent of AIDS.

(c) 'HIV related test' shall mean a test for the antibody or antigen to HIV.

(d) 'Health facility' shall mean a hospital, nursing home, clinic, blood bank, blood center, sperm bank, laboratory, or other health care Institution.

(e) 'Health care provider' shall mean any nurse, physician, dentist and 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), and others whose activities Involve contact with patients, their blood or corpses.

(f) '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.

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

(a) '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.

(I) '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.

§I202. 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'

(I) 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

(1) information about behaviors known to pose risks for transmission of HIV infection.

(c) Notwithstanding Section 1202(a) the provisions of Sections 1202(a) and 1202(b) 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 (1) blood, (ii) a human body part donated for a purpose specified under the Uniform Anatomical Gift Act, or (ill) semen provided prior to the effective date of this Act for the purpnc of artificial insemination, and such test is necessary to assure the medical acceptability of such gift or semen for the purposes intended.

(1) 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.

(2) necessary to control the transmission of HIV infection as may be allowed pursuant to 16 Del.C. Chapter 7 et. seq. as it relates to sexually transmitted diseases, or 11 Del.C. Section 6523 (b) as it relates to the Department of

Corrections.

(1) 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 following provisions:

(I) 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.

(II) 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.

(ill) 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 he or she is not already a party.

(iv) 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.

(d) Any person on whom an HIV related test was performed without first having obtained informed consent pursuant to Section 1202(c)(1), 1202(c)(4) and 1202(c)(5) 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 his or her majority, and shall not be voidable, nor subject to later disaffirmance, because of minority.

§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:

(I) 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.

(1) 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.

(2) When part of official report to the Division of Public Health as may be
required by regulation.

(3) 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 the effective date of this Act for the purpose of artificial insemination.

(4) Health facility staff committees or accreditation or oversight review
organizations which are conducting program monitoring, program evaluation or service reviews.

(1) Pursuant to 16 Del. C. Section 901 et. seq. as it relates to investigation
of child abuse.

(1) Pursuant to 16 Del. C. Chapter 7 et. seq. as it relates to sexually
transmitted diseases and their control.

(1) A person allowed access to said record by a court order which is issued
In compliance with the following provisions:

(t) 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.

(II) 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.

(IiI) 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 he or she Is not already a party.

(Iv} Court proceedings as to disclosure of test results shall be conducted to 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.

(v) 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.

(b) No person to whom the results of an HIV related test have been disclosed

pursuant to Section 1203(a) shall disclose the test results to another person except as authorized by Section 1203(a).

(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.

(b) Any person aggrieved by a violation of this Act 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 Act,

damages of $1 ,000 or actual damages, whichever is greater.

(1) Against any person who intentionally or recklessly violates a provision of this Act, damages of $5 000_ or actual damages, whichever is greater.

(1) Reasonable attorney fee.

(2) Such other relief, including an injunction, as the court may deem
appropriate.

(1) Any action under this Act is barred unless the action Is commenced within three 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 Section 1203, or that an HIV related test has been conducted without Informed consent pursuant to Section 1202.

(d) The Attorney General may maintain a civil action to enforce this Act In which the court may order any relief authorized by Section 1204(b).

(e) Nothing In this Act 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."

Approved July 11, 1988.