Except as provided in §§C—F of this regulation, this chapter governs: Pretest and post-test information; Requirements for reporting and control efforts; Requirements for informed consent; and Specific counseling for patients, including when HIV testing is performed on pregnant women as part of a prenatal care program. In cases exempt from the requirements for consent throughout this chapter, as specified in §§C—F of this regulation, it is not necessary to obtain written informed consent for HIV testing on the form approved by the Secretary. If an HIV test is performed on an individual solely for the purpose of determining the suitability of that individual as a prospective donor of blood, semen, or tissue, the requirements for information and consent are addressed in: Health-General Article, §18-334, Annotated Code of Maryland; and COMAR 10.50.01. If an HIV test is performed on an individual as a result of a court order issued under the provisions of the Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland: The requirements for HIV testing are addressed in COMAR 10.52.10; and Informed consent does not apply. HIV testing undertaken under provisions of Health-General Article, §§18-338, 18-338.1, and 18-338.3, Annotated Code of Maryland, is not governed by this chapter. HIV testing of specimens for research is not governed by this chapter if: All personal identifiers have been removed from the specimen; The specimen cannot be linked to the patient from whom the specimen was taken; The test result cannot be linked to the patient from whom the specimen was taken; and The research protocol has been approved by an institutional review board. This chapter pertains to all patients for whom a diagnostic test for the presence of HIV infection is conducted, including minors and pregnant women receiving prenatal care. In this chapter, the following terms have the meanings indicated. Terms Defined. “Acquired immunodeficiency syndrome (AIDS)” means the medical condition caused by the human immunodeficiency virus. “Anonymous” means that: A patient’s name is not used for identification; and The patient can be identified only through use of an assigned code. “Applicant” means a community based organization or other similar agency that seeks approval to become a designated human immunodeficiency virus testing site. “Appropriate entity” means the Maryland Department of Health or the Baltimore City Health Department, which designate HIV testing sites in the State per Regulations .03 and .04 of this chapter. “Centers for Disease Control and Prevention (CDC)” means the federal Centers for Disease Control and Prevention of the federal Department of Health and Human Services. “Confidential” means that a patient’s name is used as identification and that the patient’s medical records contain the patient’s name but are protected against disclosure as provided by statute. “Counseling” means providing education to pregnant women on: 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 Recognized methods of reducing the risk of transmission of HIV to the fetus during pregnancy. “Department” means the Maryland Department of Health. “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 a patient may have an anonymous human immunodeficiency virus test using a code rather than a name for identification. “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 or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland; A freestanding medical facility as defined in Health-General Article, §19-3A-01, Annotated Code of Maryland; A health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland; The Department of Public Safety and Correctional Services; A program approved by the Department to provide human immunodeficiency virus testing services, according to Regulations .03 and .04 of this chapter; A facility operated by the Department or a local health officer; or The office of a health care provider. “Health care provider” means a: Physician; Nurse; Licensed direct-entry midwife; or Designee of a health care facility. “Human immunodeficiency virus (HIV)” means a virus that causes AIDS. “Indeterminate HIV test result” means that a test did not establish either the presence or absence of HIV infection as defined by the CDC’s laboratory criteria. “Informed consent” means the voluntary permission by the patient to be tested for HIV, after the patient receives pretest information as specified in Regulations .06 and .08 of this chapter. “Institutional review board” means a group of individuals designated by an institution in compliance with 45 CFR 46, to review the use of human subjects in proposed research. “Negative HIV test result” means the test result failed to document the presence of HIV as defined by the CDC’s laboratory criteria. Nonclinical Settings. “Nonclinical settings” means locations: That are not health care settings; Where medical or treatment services are not provided; and Where selected diagnostic services and selected prevention services may be provided. “Nonclinical settings” may include: Community based organizations; Outreach settings; or Mobile vans. Partner. “Partner” means an individual with whom one has: Had or will have, oral, anal, or vaginal sexual contact; or Shared hypodermic needles or other similar drug paraphernalia. “Partner” includes any individual who: Is the marriage partner of an HIV-infected patient; or Has been the marriage partner of the HIV-infected patient at any time within the 10-year period before the diagnosis of HIV infection. “Patient” means any individual who has presented for an HIV test, whether or not the individual chooses to be tested for HIV. “Positive HIV test result” means the test result has documented the presence of HIV as defined by the CDC’s laboratory criteria. “Post-test information” means notifying a patient about HIV test results and providing a patient with other relevant information after an HIV test has been performed, as required by Regulations .09 and .10 of this chapter. “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: Screening; Physical examination; Laboratory and diagnostic testing procedures and interpretation; or Counseling. “Pretest information” means providing a patient with information before a specimen is tested for the presence of HIV infection, as required by Regulations .06 and .08 of this chapter. “Research” means an investigation carried out according to a protocol approved by an institutional review board. “Secretary” means the Secretary of Health. “Seropositive” means that a positive HIV test result has been obtained from the test of a patient’s specimen. “Specimen” means a sample of: Blood; Other body fluid; or Body tissue. “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. An applicant shall seek approval from an appropriate entity to become a designated anonymous testing site from the: Baltimore City Health Department for an applicant offering services in Baltimore City; or Department for an applicant offering services outside of Baltimore City. An applicant that seeks approval to become a designated anonymous testing site shall request an application from the appropriate entity and submit a completed application in writing to the appropriate entity. The Department or the Baltimore City Health Department shall: Review a written request that is submitted for approval; and Respond in writing to the written request: Indicating approval or disapproval to become a designated anonymous testing site; or Soliciting for revision and resubmission of the written request. An applicant shall seek approval from an appropriate entity to become a designated confidential testing site from the: Baltimore City Health Department for an applicant offering services in Baltimore City; or Department for an applicant offering services outside of Baltimore City. An applicant that seeks approval to become a designated confidential testing site shall request an application from the appropriate entity and submit a completed application in writing to the appropriate entity. The Department or the Baltimore City Health Department shall: Review a written request that is submitted for approval; and Respond in writing to the written request: Indicating approval or disapproval to become a designated confidential testing site; or Soliciting for revision and resubmission of the written request. 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: By submitting the request in writing to the appropriate entity; and Within 30 calendar days of the date on the notice of denial. If an applicant requests a reconsideration according to §A of this regulation, the appropriate entity shall: Review the request for reconsideration and any supplemental documentation submitted by the applicant within 45 calendar days of the date on the letter requesting reconsideration; and Issue a decision in writing to the applicant. General medical consent is sufficient to perform HIV testing. Consent for HIV testing is only required to be obtained one time during a patient’s visit. A health care provider who obtains consent for HIV testing shall: 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; Document all declinations of an HIV test in the medical record of the patient; and When needed, obtain: Consent from a health care agent designated per Health-General Article, §5-602, Annotated Code of Maryland; or Surrogate consent per Health-General Article, §5-605 Annotated Code of Maryland. The general informed consent form for medical care may specify that an HIV test will be performed. 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. Pretest information, including counseling for pregnant women, shall be provided to the patient to be tested for HIV before each specimen is tested. A health care provider providing pretest information, including counseling for pregnant women, shall: Provide HIV-specific information: Verbally; In writing; Through video; or Through any combination of §G(1)(a)—(c) of this regulation; Provide HIV information in a manner that protects the confidentiality of the patient being tested; Using layman’s terms, provide, at minimum, the following information to the patient being tested: That the patient is being tested for HIV; That the patient has the right to: Ask questions; and Decline the test without penalty; An explanation of HIV infection; That a negative HIV test result means that: A patient is not infected with HIV or that the test was unable to detect the presence of HIV because a patient is in the early stage of infection and has not yet developed detectable evidence of HIV infection; and If the patient has had any potential recent exposures, the patient should be retested within an appropriate time frame based on the type of testing used; and That a positive HIV test result means the patient: Is infected with HIV; and Will be linked with medical treatment and other supportive services; Provide counseling as defined in Regulation .02 of this chapter to pregnant women; Include an opportunity for the patient to: Ask questions and receive answers about HIV and other topics described in this regulation; and Decline an HIV test; and Make necessary accommodation with respect to language or disability to ensure that the patient being tested understands the information presented. 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. 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. Unless a patient declines, a health care provider shall test a pregnant woman under the health care provider’s care: During the first trimester of pregnancy or the first prenatal visit; and In the third trimester of pregnancy. A health care provider who provides labor and delivery services to a pregnant woman shall offer: A rapid HIV test to a pregnant woman with unknown or undocumented HIV status during labor and delivery; and Antiretroviral prophylaxis before receiving the results of the confirmatory test if a rapid HIV test performed during labor and delivery is positive. Confidentiality. HIV test results for pregnant women shall be maintained pursuant to Health-General Article, §18-338.2, Annotated Code of Maryland. 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. 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. For HIV tests administered in nonclinical settings, as permitted in Regulations .03 and .04 of this chapter, the individual administering the HIV test shall: Utilize the HIV informed consent form approved by the Secretary to document the obtainment of informed consent; Read and explain the HIV informed consent form, through an interpreter if necessary, to anyone who cannot read or understand the form’s contents; and Obtain voluntary written informed consent from the patient before an HIV test is performed on a specimen. 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. Pretest information shall be provided to the patient being tested before each specimen is tested. An individual providing pretest information shall: Provide HIV-specific information: Verbally; In writing; Through video; or Through any combination of §D(1)(a)—(c) of this regulation based on the testing history and information needs of the patient; Provide HIV information in a manner that protects the confidentiality of the patient; Using layman’s terms, provide, at a minimum, the following information to the patient: That the patient is being tested for HIV; That the patient has the right to: Ask questions; and Decline the test without penalty; The primary modes of HIV transmission including: Sexual contact without the use of condoms, other barriers, or other biomedical interventions; Injection drug use; and Mother-to-child transmission; Counseling as defined in Regulation .02 of this chapter to pregnant women; That a negative test result means that: A patient is not infected with HIV or that the test was unable to detect the presence of HIV because a patient is in the early stage of infection and has not yet developed detectable evidence of HIV infection; and If the patient has had any potential recent exposures, that the patient should be retested within an appropriate time frame based on the type of testing used; That a positive test result means the patient: Is infected with HIV; Will be linked with medical treatment and other supportive services; and May need a confirmatory test if the preliminary positive was based on an HIV rapid test; and Inform the patient being tested at a designated anonymous HIV test site that an assigned code will be used instead of a name; Include an opportunity for the patient to: Ask questions and receive answers about HIV infection and other topics described in this regulation; and Decline HIV testing; and Make necessary accommodation with respect to language or disability to ensure that the patient understands the information presented. If a patient’s HIV test result is negative, the individual providing testing shall provide post-test information to the patient tested that includes: That the HIV test result is negative; and The meaning of a negative result. 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: That the HIV test result is indeterminate; The meaning of an indeterminate HIV test result; and A recommendation that the patient: Return in a medically appropriate time frame for another HIV test; and Take precautions as if the patient’s HIV test result had been positive until the patient is retested. If a patient’s HIV test result is positive: The individual providing testing shall provide post-test information to the patient in person that includes: That the HIV test result is positive; The meaning of a positive HIV test result; If the patient is pregnant: How HIV infection may affect a pregnancy, fetus, or newborn; That there is a potential that the newborn will have HIV infection; and Information regarding recognized methods of reducing the risk of transmission of HIV to the fetus; and Information regarding the patient’s responsibility to: Notify all known sexual and needle-sharing partners of possible exposure; or Request assistance from the health officer in the jurisdiction to notify all known sexual and needle-sharing partners of possible exposure; The health care provider shall: Ensure the patient is linked to an appropriate source of HIV medical care and support services; and If necessary, provide the patient with information about mental health services for HIV-infected individuals; For contact control, the health care provider shall: Endeavor to bring an individual with whom the patient has had potentially infectious contact to examination and, as appropriate, prophylaxis by: Requesting the health officer to conduct a contact investigation of any case of HIV; or 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 Report immediately to the health officer an individual identified as having had potentially infectious contact with a patient with a positive HIV test result; A health officer shall: 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 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 A reported individual shall, within 1 week of notification, be examined to ascertain whether the individual has been infected with HIV. If a patient’s HIV test result is negative, the individual providing testing shall provide post-test information to the patient tested that includes: That the HIV test result is negative; The meaning of a negative result; and A recommendation about whether a repeat test is advisable based on potential recent exposures and the type of test technology used. 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: That the HIV test result is indeterminate; The meaning of an indeterminate HIV test result; Information regarding transmission of HIV and means of preventing transmission of HIV; and A recommendation that the patient: Return in a medically appropriate time frame for another HIV test; and Take precautions as if the patient’s HIV test result had been positive until the patient is retested. If a patient’s HIV test result is positive: The individual providing testing shall provide post-test information to the patient tested in person that includes: That the HIV test result is positive; The meaning of a positive HIV test result; Information regarding transmission of HIV and means of preventing transmission of HIV; If the patient is pregnant; How HIV infection may affect a pregnancy, fetus, or newborn; That there is a potential that the newborn would have HIV infection; and Information regarding recognized methods of reducing the risk of transmission of HIV to the fetus; That the patient should have a medical evaluation by a physician or physician’s designee who knows that the patient is HIV positive; That the patient should receive ongoing health care appropriate for an HIV seropositive individual; and Information regarding the patient’s responsibility to: Notify all known sexual and needle-sharing partners of possible exposure; or Request assistance from the health officer in the jurisdiction to notify all known sexual and needle-sharing partners of possible exposure; The individual performing the HIV test shall: Ensure the patient is linked to an appropriate source of HIV medical care and support services including evaluation and treatment for: Tuberculosis; Hepatitis; Pregnancy; and Sexually transmitted infections; and If necessary, provide the patient with information about mental health services for HIV-infected individuals; For contact control, the individual providing the testing shall: Request the health officer from the patient’s home jurisdiction conduct a contact investigation of any case of HIV; and 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; A health officer shall: 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 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 A reported individual shall, within 1 week of notification, be examined to ascertain whether the individual has been infected with HIV. 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. Definition. In this regulation, the following term has the meaning indicated. “Infection preventionist or employee health provider” means the designated infectious disease/communicable disease officer of a hospital. A health care provider, first responder, or public safety worker involved in an exposure as defined in Health-General Article, §18-338.3, Annotated Code of Maryland, shall comply with the provisions of Health-General Article, §18-338.3, Annotated Code of Maryland. A hospital’s designated infection preventionist or employee health provider or its designee shall follow the requirements in Health-General Article, §18-338.3, Annotated Code of Maryland, if an exposure, as defined in Health-General Article, §18-338.3, Annotated Code of Maryland: Occurs: In a hospital, between a patient and a health care provider; or Before admission of the patient to a hospital, between a patient and a: First responder; or Public safety worker; and Is such that, in accordance with the CDC’s recommendations, warrants recommending or offering chemoprophylaxis treatment for the health care provider, first responder, or public safety worker. A hospital where an exposure occurred shall: Maintain a confidential record or incident report for an HIV test conducted under Regulation .12 of this chapter; Adopt procedures for the confidential HIV testing of blood samples or other body fluids used or collected for purposes of Regulation .12 of this chapter; Maintain a record of: An exposure as defined by Health-General Article, §18-338.3(a), Annotated Code of Maryland; and A refusal to consent by a patient as described in the Health-General Article, §18-338.3(b)(2)(ii), Annotated Code of Maryland; and Provide records as specified in §A(3)of this regulation or information from the records to the Department when and as requested by the Secretary. Nothing in Regulation .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. 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 Effective date: February 3, 2003 (30:2 Md. R. 76) Regulation .01A amended effective December 14, 2009 (36:25 Md. R. 1954) Regulation .01F adopted effective December 14, 2009 (36:25 Md. R. 1954) Regulation .02B amended effective September 8, 2008 (35:18 Md. R. 1600); December 14, 2009 (36:25 Md. R. 1954) Regulation .03 amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .04 amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .05 amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .06 amended effective December 14, 2009 (36:25 Md. R. 1954) Regulation .06B amended effective September 8, 2008 (35:18 Md. R. 1600) Regulation .07 amended effective December 14, 2009 (36:25 Md. R. 1954) Regulation .08 amended effective December 14, 2009 (36:25 Md. R. 1954) Regulation .10A, C amended effective December 14, 2009 (36:25 Md. R. 1954) Regulation .11 adopted effective June 11, 2012 (39:11 Md. R. 687) Regulation .12 adopted effective June 11, 2012 (39:11 Md. R. 687) Chapter revised effective March 28, 2016 (43:6 Md. R. 408) Chapter revised effective May 7, 2018 (45:9 Md. R. 462)