Chapter 08. HIV Testing Procedures

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.

Health-General Article, §18-334, Annotated Code of Maryland; and

COMAR 10.50.01.

The requirements for HIV testing are addressed in COMAR 10.52.10; and

Informed consent does not apply.

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.

“Acquired immunodeficiency syndrome (AIDS)” means the medical condition caused by the human immunodeficiency virus.

“Anonymous” means that:

“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:

“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:

“Health care provider” means a:

“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.

Partner.

“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:

“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:

“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.

Baltimore City Health Department for an applicant offering services in Baltimore City; or

Department for an applicant offering services outside of Baltimore City.

Review a written request that is submitted for approval; and

Respond in writing to the written request:

Baltimore City Health Department for an applicant offering services in Baltimore City; or

Department for an applicant offering services outside of Baltimore City.

Review a written request that is submitted for approval; and

Respond in writing to the written request:

By submitting the request in writing to the appropriate entity; and

Within 30 calendar days of the date on the notice of denial.

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.

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:

Provide HIV-specific information:

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:

Provide counseling as defined in Regulation .02 of this chapter to pregnant women;

Include an opportunity for the patient to:

Make necessary accommodation with respect to language or disability to ensure that the patient being tested understands the information presented.

During the first trimester of pregnancy or the first prenatal visit; and

In the third trimester of pregnancy.

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.

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.

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.

Provide HIV-specific information:

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:

Include an opportunity for the patient to:

Make necessary accommodation with respect to language or disability to ensure that the patient understands the information presented.

That the HIV test result is negative; and

The meaning of a negative result.

That the HIV test result is indeterminate;

The meaning of an indeterminate HIV test result; and

A recommendation that the patient:

The individual providing testing shall provide post-test information to the patient in person that includes:

The health care provider shall:

For contact control, the health care provider shall:

A health officer shall:

A reported individual shall, within 1 week of notification, be examined to ascertain whether the individual has been infected with HIV.

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.

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:

The individual providing testing shall provide post-test information to the patient tested in person that includes:

The individual performing the HIV test shall:

For contact control, the individual providing the testing shall:

A health officer shall:

A reported individual shall, within 1 week of notification, be examined to ascertain whether the individual has been infected with HIV.

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.

Occurs:

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.

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:

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.