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    PROPOSAL
    Issue Date:  January 19, 2018
    Volume 45 • Issue 2 • Pages 90—94
     
    Title 10
    MARYLAND DEPARTMENT OF HEALTH
    Subtitle 18 HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION AND ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)
    Notice of Proposed Action
    [18-013-P]
    The Secretary of Health proposes to:
    (1) Amend Regulations .01, .02, .05, and .06, adopt new Regulations .07 and .09—.11, amend and recodify existing Regulations .07 and .11 to be Regulations .08 and .13, respectively, repeal existing Regulations .08 and .09, and recodify existing Regulation .10 to be Regulation .12 under COMAR 10.18.08 HIV Testing Procedures; and
    (2) Repeal Regulations .01—.06 in their entirety under COMAR 10.18.09 HIV Testing for Pregnant Women Receiving Prenatal Care.
     
    Statement of Purpose
    The purpose of this action is to combine COMAR 10.18.08 and 10.18.09 into one chapter and to include and clarify all testing requirements for HIV during pregnancy in regulations per Ch. 668 (H.B. 518), Acts of 2017.
    Comparison to Federal Standards
    There is no corresponding federal standard to this proposed action.
    Estimate of Economic Impact
    The proposed action has no economic impact.
    Economic Impact on Small Businesses
    The proposed action has minimal or no economic impact on small businesses.
    Impact on Individuals with Disabilities
    The proposed action has no impact on individuals with disabilities.
    Opportunity for Public Comment
    Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 W. Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through February 20, 2018. A public hearing has not been scheduled.
     
    10.18.08 HIV Testing Procedures
    Authority: Criminal Procedure Article, §§11-107—11-117; Health-General Article, §§2-104(b) and (i), 2-105(a) and (b), 18-102, 18-201.1, 18-202.1, 18-205, 18-207, 18-208, 18-334, 18-336—18-338, 18-338.2, 18-338.3, and 20-102; Annotated Code of Maryland
    .01 Scope.
    A. Except as provided in §§C—F of this regulation, this chapter governs [pretest]:
    (1) Pretest and post-test information [and requirements];
    (2) Requirements for reporting and control efforts;
    (3) Requirements for informed consent; and
    (4) Specific counseling for patients, including when HIV testing is performed on pregnant women as part of a prenatal care program.
    B.—D. (text unchanged)
    E. HIV testing undertaken under provisions of Health-General Article, [§18-338,] §§18-338, 18-338.1, and 18-338.3, Annotated Code of Maryland, is not governed by this chapter.
    F. HIV testing of specimens for research is not governed by this chapter if:
    (1) (text unchanged)
    (2) The specimen cannot be linked to the [individual] patient from whom the specimen was taken;
    (3) The test result cannot be linked to the [individual] patient from whom the specimen was taken; and
    (4) (text unchanged)
    G. This chapter pertains to all [individuals] patients for whom a diagnostic test for the presence of HIV infection is conducted, including minors and pregnant women receiving prenatal care.
    .02 Definitions.
    A. (text unchanged)
    B. Terms Defined.
    (1) (text unchanged)
    (2) “Anonymous” means that:
    (a) [An individual’s] A patient’s name is not used for identification; and
    (b) The [individual] patient can be identified only through use of an assigned code.
    (3) (text unchanged)
    (4) “Appropriate entity” means the Maryland Department of Health or the Baltimore City Health Department, which designate [anonymous] HIV testing sites in the State per Regulations .03 and .04 of this chapter.
    (5) (text unchanged)
    (6) “Confidential” means that [an individual’s] a patient’s name is used as identification and that the [individual’s] patient’s medical records contain the [individual’s] patient’s name but are protected against disclosure as provided by statute.
    (7) “Counseling” means providing education to pregnant women on:
    (a) The effect of a positive HIV test result on the pregnant woman and fetus concerning the risk of transmission of HIV to the fetus; and
    (b) Recognized methods of reducing the risk of transmission of HIV to the fetus during pregnancy.
    [(7)] (8) (text unchanged)
    [(8)] (9) “Designated anonymous testing site” means a human immunodeficiency virus testing site approved by the Department or the Baltimore City Health Department as a site where [an individual] a patient may have an anonymous human immunodeficiency virus test using a code rather than a name for identification.
    [(9)] (10) “Health care facility” means a facility or office where health or medical care is provided to patients by a health care provider including:
    (a) [Hospital] A hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland;
    (b) [Freestanding] A freestanding medical facility as defined in Health-General Article, §19-3A-01, Annotated Code of Maryland;
    (c) [Health] A health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland;
    (d) The Department of Public Safety and Correctional Services; [or]
    (e) A program approved by the Department to provide human immunodeficiency virus testing services, according to Regulations .03 and .04 of this chapter[.];
    (f) A facility operated by the Department or a local health officer; or
    (g) The office of a health care provider.
    [(10)] (11) “Health care provider” means a [physician, nurse, or designee of a health care facility.]:
    (a) Physician;
    (b) Nurse;
    (c) Licensed direct-entry midwife; or
    (d) Designee of a health care facility.
    [(11)] (12)—[(12)] (13) (text unchanged)
    [(13)] (14) “Informed consent” means the voluntary permission by the [individual] patient to be tested for HIV, after the [individual] patient receives pretest information as specified in Regulations .06 and [.07] .08 of this chapter.
    [(14)] (15)—[(16)] (17) (text unchanged)
    [(17) Partner.
    (a) “Partner” means:
    (i) An individual with whom one has, or has had, oral, anal, or vaginal sexual contact; or
    (ii) An individual with whom one has shared hypodermic needles or other similar drug paraphernalia.
    (b) “Partner” includes any individual who is the marriage partner of an HIV-infected patient, or who has been the marriage partner of that patient at any time within the 10-year period before the diagnosis of HIV infection.]
    (18) Partner.
    (a) “Partner” means an individual with whom one has:
    (i) Had or will have, oral, anal, or vaginal sexual contact; or
    (ii) Shared hypodermic needles or other similar drug paraphernalia.
    (b) “Partner” includes any individual who:
    (i) Is the marriage partner of an HIV-infected patient; or
    (ii) Has been the marriage partner of the HIV-infected patient at any time within the 10-year period before the diagnosis of HIV infection.
    (19) “Patient” means any individual who has presented for an HIV test, whether or not the individual chooses to be tested for HIV.
    [(18)] (20) (text unchanged)
    [(19)] (21) “Post-test information” means notifying [an individual] a patient about HIV test results and providing [an individual] a patient with other relevant information after an HIV test has been performed, as required by Regulations [.08 and .09] .09 and .10 of this chapter.
    (22) “Prenatal care” means obstetric and gynecologic services performed as part of a medical care program for a pregnant woman and her unborn child, and may include:
    (a) Screening;
    (b) Physical examination;
    (c) Laboratory and diagnostic testing procedures and interpretation; or
    (d) Counseling.
    [(20)] (23) “Pretest information” means providing [an individual] a patient with information before a specimen is tested for the presence of HIV infection, as required by Regulations .06 and [.07] .08 of this chapter.
    [(21)] (24)—[(22)] (25) (text unchanged)
    [(23)] (26) “Seropositive” means that a positive HIV test result has been obtained from the test of [an individual’s] a patient’s specimen.
    [(24)] (27) (text unchanged)
    [(25)] (28)[Substitute] Surrogate consent” means consent given by an individual who is not the patient, as permitted under Health-General Article, §5-605, Annotated Code of Maryland, and other provisions of Maryland law.
    .05 Denial and Reconsideration.
    A. An applicant under Regulation .03 or .04 of this chapter that has a written request denied by the appropriate entity may request reconsideration of the decision:
    (1) (text unchanged)
    (2) Within 30 calendar days of the date [postmarked] on the notice of denial.
    B. If an applicant requests a reconsideration according to §A of this regulation, the appropriate entity shall:
    (1) Review the request for reconsideration and any supplemental documentation submitted by the applicant within 45 calendar days of the [postmarked] date on the letter requesting reconsideration; and
    (2) (text unchanged)
    .06 Consent and Pretest Requirements for HIV Testing by Health Care Providers.
    A. General medical consent is[:
    (1) Required to be obtained only once during a patient’s visit; and
    (2) Sufficient] sufficient to perform HIV testing.
    [B. Before performing HIV testing, a health care provider who has received consent as described in §A of this regulation shall:
    (1) Inform the individual verbally or in writing that HIV testing will be performed unless the individual refuses; and
    (2) Document all declinations of an HIV test in the medical record of the patient.
    C. The general informed consent for medical care may specify that an HIV test will be performed.
    D. Except as provided under Regulation .07 of this chapter, a health care provider may not be required to obtain consent for HIV testing on a separate consent form.
    E. Pretest information shall be provided to the patient to be tested for HIV before each specimen is tested.]
    B. Consent for HIV testing is only required to be obtained one time during a patient’s visit.
    C. A health care provider who obtains consent for HIV testing shall:
    (1) Obtain consent as a part of a patient’s general consent for medical care in the same manner as for other screening and diagnostic tests;
    (2) Document all declinations of an HIV test in the medical record of the patient; and
    (3) When needed, obtain:
    (a) Consent from a health care agent designated per Health-General Article, §5-602, Annotated Code of Maryland; or
    (b) Surrogate consent per Health-General Article, §5-605 Annotated Code of Maryland.
    D. The general informed consent form for medical care may specify that an HIV test will be performed.
    E. Except as provided under Regulation .08 of this chapter, a health care provider may not be required to obtain consent for HIV testing on a separate consent form.
    F. Pretest information, including counseling for pregnant women, shall be provided to the patient to be tested for HIV before each specimen is tested.
    [F.] G. A health care provider providing pretest information, including counseling for pregnant women, shall:
    (1) Provide HIV-specific information:
    (a)—(b) (text unchanged)
    (c) [By] Through video; or
    (d) [By] Through any combination of [§F(1)(a)—(c)] §G(1)(a)—(c) of this regulation;
    (2) (text unchanged)
    (3) Using layman’s terms, provide, at minimum, the following information to the patient being tested:
    (a) (text unchanged)
    (b) That the patient has the right to:
    (i) Ask questions; [or] and
    (ii) (text unchanged)
    (c)—(e) (text unchanged)
    (4) Provide counseling as defined in Regulation .02 of this chapter to pregnant women;
    [(4)] (5) Include an opportunity for the [individual being tested] patient to:
    (a) Ask questions and receive answers about HIV [infection] and other topics described in this regulation [and have those questions answered]; and
    (b) Decline [HIV testing] an HIV test; and
    [(5)] (6) (text unchanged)
    .07 Testing Requirements for Pregnant Women Receiving Prenatal Care.
    A. As part of a health care provider’s patient acceptance procedures or protocol, a health care provider shall give a pregnant woman information on being tested for the presence of HIV as part of the woman’s prenatal care program.
    B. In addition to §§C—E of this regulation, a health care provider testing a pregnant woman shall follow all requirements for pretest and post-test information as set forth in Regulations .06 and .08—.10 of this chapter as appropriate.
    C. Unless a patient declines, a health care provider shall test a pregnant woman under the health care provider’s care:
    (1) During the first trimester of pregnancy or the first prenatal visit; and
    (2) In the third trimester of pregnancy.
    D. A health care provider who provides labor and delivery services to a pregnant woman shall offer:
    (1) A rapid HIV test to a pregnant woman with unknown or undocumented HIV status during labor and delivery; and
    (2) Antiretroviral prophylaxis before receiving the results of the confirmatory test if a rapid HIV test performed during labor and delivery is positive.
    E. Confidentiality.
    (1) HIV test results for pregnant women shall be maintained pursuant to Health-General Article, §18-338.2, Annotated Code of Maryland.
    (2) Except as otherwise provided in §E(3) of this regulation, the record of an HIV test performed under this section is confidential and not discoverable or admissible in evidence in any criminal, civil, or administrative action.
    (3) Provided that the identity or any other information that could readily be associated with the identity of the pregnant woman is not disclosed, the results of an HIV test performed under this section may be introduced into evidence in a criminal, civil, or administrative action, including the adjudication of a workers’ compensation claim.
    [.07] .08 Consent and Pretest Requirements for HIV Testing in Nonclinical Settings.
    A. For HIV tests administered in nonclinical settings, as permitted in Regulations .03 and .04 of this chapter, the individual administering the HIV test shall:
    (1)—(2) (text unchanged)
    (3) Obtain voluntary written informed consent from the [individual to be tested for HIV] patient before an HIV test is performed on a specimen.
    B. [An individual] A patient tested at a designated anonymous nonclinical test site, as permitted in Regulation .03 of this chapter, may indicate consent by placing their assigned code on the signature line of the form approved by the Secretary to indicate written informed consent.
    C. Pretest information shall be provided to the [individual] patient being tested before each specimen is tested.
    D. An individual providing pretest information shall:
    (1) Provide HIV-specific information:
    (a)—(b) (text unchanged)
    (c) [By] Through video; or
    (d) [By] Through any combination of §D(1)(a)—(c) of this regulation based on the testing history and information needs of the [individual being tested] patient;
    (2) Provide HIV information in a manner that protects the confidentiality of the [individual being tested] patient;
    (3) Using layman’s terms, provide, at a minimum, the following information to the [individual being tested] patient:
    (a) That the [individual] patient is being tested for HIV;
    (b) That the [individual] patient has the right to:
    (i) Ask questions; [or] and
    (ii) (text unchanged)
    (c) The primary modes of HIV transmission including:
    (i)—(ii) (text unchanged)
    (iii) Mother-to-child transmission[.];
    (d) Counseling as defined in Regulation .02 of this chapter to pregnant women;
    [(d)] (e) That a negative test result means that:
    (i) [An individual] A patient is not infected with HIV or that the test was unable to detect the presence of HIV because [an individual] a patient is in the early stage of infection and has not yet developed detectable evidence of HIV infection; and
    (ii) If the [individual] patient has had any potential recent exposures, that the [individual] patient should be retested within an appropriate time frame based on the type of testing used;
    [(e)] (f) That a positive test result means the [individual] patient:
    (i)—(iii) (text unchanged)
    [(f)] (g) Inform the [individual] patient being tested at a designated anonymous HIV test site that an assigned code will be used instead of a name;
    (4) Include an opportunity for the [individual being tested] patient to:
    (a) Ask questions and receive answers about HIV infection and other topics described in this regulation [and have those questions answered]; and
    (b) (text unchanged)
    (5) Make necessary accommodation with respect to language or disability to ensure that the [individual being tested] patient understands the information presented.
    .09 Post-Test Requirements for HIV Testing by Health Care Providers.
    A. If a patient’s HIV test result is negative, the individual providing testing shall provide post-test information to the patient tested that includes:
    (1) That the HIV test result is negative; and
    (2) The meaning of a negative result.
    B. If a patient’s HIV test result is indeterminate, the individual providing testing shall provide post-test information to the patient in person that includes:
    (1) That the HIV test result is indeterminate;
    (2) The meaning of an indeterminate HIV test result; and
    (3) A recommendation that the patient:
    (a) Return in a medically appropriate time frame for another HIV test; and
    (b) Take precautions as if the patient’s HIV test result had been positive until the patient is retested.
    C. If a patient’s HIV test result is positive:
    (1) The individual providing testing shall provide post-test information to the patient in person that includes:
    (a) That the HIV test result is positive;
    (b) The meaning of a positive HIV test result;
    (c) If the patient is pregnant:
    (i) How HIV infection may affect a pregnancy, fetus, or newborn;
    (ii) That there is a potential that the newborn will have HIV infection; and
    (iii) Information regarding recognized methods of reducing the risk of transmission of HIV to the fetus; and
    (d) Information regarding the patient’s responsibility to:
    (i) Notify all known sexual and needle-sharing partners of possible exposure; or
    (ii) Request assistance from the health officer in the jurisdiction to notify all known sexual and needle-sharing partners of possible exposure;
    (2) The health care provider shall:
    (a) Ensure the patient is linked to an appropriate source of HIV medical care and support services; and
    (b) If necessary, provide the patient with information about mental health services for HIV-infected individuals;
    (3) For contact control, the health care provider shall:
    (a) Endeavor to bring an individual with whom the patient has had potentially infectious contact to examination and, as appropriate, prophylaxis by:
    (i) Requesting the health officer to conduct a contact investigation of any case of HIV; or
    (ii) Interviewing the patient in order to ascertain the names, descriptions, addresses, telephone numbers, and email addresses of those with whom the patient has had potentially infectious contact; and
    (b) Report immediately to the health officer an individual identified as having had potentially infectious contact with a patient with a positive HIV test result;
    (4) A health officer shall:
    (a) Investigate and notify immediately an individual reported under the provisions of §C(3)(b) of this regulation, who is within the health officer’s jurisdiction of the individual’s exposure and advise the individual to undergo a medical examination to ascertain whether the individual is infected with HIV; and
    (b) Immediately forward to the Secretary all reports of individuals who are outside the health officer’s territorial jurisdiction for referral to the health officer of the proper jurisdiction; and
    (5) A reported individual shall, within 1 week of notification, be examined to ascertain whether the individual has been infected with HIV.
    .10 Post-Test Requirements for HIV Testing in Nonclinical Settings.
    A. If a patient’s HIV test result is negative, the individual providing testing shall provide post-test information to the patient tested that includes:
    (1) That the HIV test result is negative;
    (2) The meaning of a negative result; and
    (3) A recommendation about whether a repeat test is advisable based on potential recent exposures and the type of test technology used.
    B. If a patient’s HIV test result is indeterminate, the individual providing testing shall provide post-test information to the patient tested in person that includes:
    (1) That the HIV test result is indeterminate;
    (2) The meaning of an indeterminate HIV test result;
    (3) Information regarding transmission of HIV and means of preventing transmission of HIV; and
    (4) A recommendation that the patient:
    (a) Return in a medically appropriate time frame for another HIV test; and
    (b) Take precautions as if the patient’s HIV test result had been positive until the patient is retested.
    C. If a patient’s HIV test result is positive:
    (1) The individual providing testing shall provide post-test information to the patient tested in person that includes:
    (a) That the HIV test result is positive;
    (b) The meaning of a positive HIV test result;
    (c) Information regarding transmission of HIV and means of preventing transmission of HIV;
    (d) If the patient is pregnant;
    (i) How HIV infection may affect a pregnancy, fetus, or newborn;
    (ii) That there is a potential that the newborn would have HIV infection; and
    (iii) Information regarding recognized methods of reducing the risk of transmission of HIV to the fetus;
    (e) That the patient should have a medical evaluation by a physician or physician’s designee who knows that the patient is HIV positive;
    (f) That the patient should receive ongoing health care appropriate for an HIV seropositive individual; and
    (g) Information regarding the patient’s responsibility to:
    (i) Notify all known sexual and needle-sharing partners of possible exposure; or
    (ii) Request assistance from the health officer in the jurisdiction to notify all known sexual and needle-sharing partners of possible exposure;
    (2) The individual performing the HIV test shall:
    (a) Ensure the patient is linked to an appropriate source of HIV medical care and support services including evaluation and treatment for:
    (i) Tuberculosis;
    (ii) Hepatitis;
    (iii) Pregnancy; and
    (iv) Sexually transmitted infections; and
    (b) If necessary, provide the patient with information about mental health services for HIV-infected individuals;
    (3) For contact control, the individual providing the testing shall:
    (a) Request the health officer from the patient’s home jurisdiction conduct a contact investigation of any case of HIV; and
    (b) Report immediately to the health officer from the patient’s home jurisdiction any known individual identified as having had potentially infectious contact with a patient with a positive HIV test result;
    (4) A health officer shall:
    (a) Investigate and notify immediately an individual reported under the provisions of §C(3)(b) of this regulation, who is within the health officer’s jurisdiction, of the individual’s exposure and advise the individual to undergo a medical examination to ascertain whether the individual is infected with HIV; and
    (b) Immediately forward to the Secretary all reports of individuals who are outside the health officer’s jurisdiction for referral to the health officer of the proper jurisdiction; and
    (5) A reported individual shall, within 1 week of notification, be examined to ascertain whether the individual has been infected with HIV.
    .11 Immunity for Health Care Providers Working with Pregnant Women.
    A health care provider may not be subject to disciplinary action by the professional licensing board that licenses the health care provider for following the requirements for prenatal HIV testing established by the Department.
    [.11] .13 Information on Exposures.
    A. A hospital where an exposure occurred shall:
    (1) Maintain a confidential record or incident report for an HIV test conducted under Regulation [.10] .12 of this chapter;
    (2) Adopt procedures for the confidential HIV testing of blood samples or other body fluids used or collected for purposes of Regulation [.10] .12 of this chapter;
    (3) (text unchanged)
    B. Nothing in Regulation [.10] .12 of this chapter or this regulation shall be construed to exempt any individual or entity required to report infectious diseases from reporting the infectious diseases as required in Health-General Article, Title 18, Annotated Code of Maryland.
    DENNIS SCHRADER
    Secretary of Health