This chapter establishes the requirements for: Physician reporting of a: Case of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); and Birth of an infant whose mother has tested positive for HIV; Institution reporting of a case of HIV or AIDS; Laboratory reporting of a test result for: HIV detection; HIV viral load; CD4+ cell count or percentage; or HIV genotype sequence; and Follow-up of: A physician's report of HIV or AIDS; A physician's report of an infant whose mother has tested positive for HIV; An institution's report of HIV or AIDS; and A laboratory’s report of a test result for: HIV detection; HIV viral load; CD4+ cell count or percentage; or HIV genotype sequence infection or CD4+ count. Except as noted in §C of this regulation, this chapter applies to all instances of laboratory testing of specimens from a human body for: HIV detection; HIV viral load; CD4+ cell count or percentage; or HIV genotype sequence. This chapter does not apply if the specimen from a human body is: Not tested for: HIV detection; HIV viral load; CD4+ cell count or percentage; or HIV genotype sequence; Tested for HIV detection solely for the purpose of determining the suitability of the source individual as a prospective donor of blood, semen, or tissue; Taken from a patient at a designated anonymous HIV test site solely for the purpose of performing an anonymous HIV test; Tested for HIV detection as part of research conducted by an institution within Maryland under the following conditions: All personal identifiers are removed from the specimen before testing; The specimen cannot be linked to the individual from whom the specimen was taken; The result cannot be linked to the individual from whom the specimen was taken; and The research protocol has been approved by an institutional review board; Tested for HIV detection as part of research conducted under a research protocol approved by an institutional review board of an institution located outside of Maryland; Taken from a patient known to reside outside of the United States; or Tested for HIV detection as part of a research project that has been approved under Regulation .02 of this chapter for an exemption. Qualifications for Exemption. A research project that meets both of the following criteria may be eligible for exemption from the HIV reporting requirements of Regulation .06 of this chapter: The research project has been approved by an institutional review board; and The research: Is intended to determine the safety or effectiveness of a vaccine that would produce immunity against HIV; or Is not primarily intended to provide medical treatment to participants. Application for Exemption. The principal investigator of a research project shall submit all of the following documents to the Department in order to apply for an exemption: A copy of the research protocol approved by the institutional review board of the institution conducting the research; and A copy of the notice stating that the protocol has been approved by the institutional review board of the institution conducting the research. Approval. The Director of the Infectious Disease Prevention and Health Services Bureau or the Director’s designee shall review the application submitted under §B of this regulation to determine whether the: Application is complete; and Research protocol meets the criteria specified in §A of this regulation. If the application is complete and the research protocol meets the specified criteria, the Director shall grant an exemption from the requirements set forth in Regulation .06 of this chapter for any specimen tested for HIV detection under the research project approved for exemption. The Director shall mail written notification to the applicant of an exemption under this regulation within 30 days of receipt of the application, stating whether the exemption: Has been approved; Has been denied and the reason for the denial; or Cannot be processed until further information is provided to the Department. Responsibilities of the Principal Investigator. If a research project is granted an exemption under §C of this regulation, the principal investigator of the research project shall send to each laboratory to which specimens collected under the research protocol will be sent to be tested for HIV detection a copy of the notification from the Director issued pursuant to §C(3)(a) of this regulation to verify that the project has been exempted from the reporting requirements of Regulation .06 of this chapter. Scope of Exemption. Except as indicated in §E(2) of this regulation, an exemption approved under §C of this regulation does not relieve the principal investigator, a laboratory director, or another individual from a reporting requirement contained in Health-General Article, §18-201.1, 18-202.1, 18-205, or 18-207, Annotated Code of Maryland, or Regulation .06 of this chapter. A principal investigator, laboratory director, or other individual is not required to report HIV detection test results if the test is done as part of the research project and the individual tested: Meets the criteria for participation in the research project set forth in the research protocol submitted under §B(1) of this regulation; and Has signed an informed consent form agreeing to participate in the research project. In this chapter, the following terms have the meanings indicated. Terms Defined. “Acquired immunodeficiency syndrome (AIDS)” has the meaning stated in Health-General Article, §§18-201.1(a) and 18-202.1(b), Annotated Code of Maryland. “Anonymous” means that a patient does not use the patient's name as identification and can only be identified through use of a code. “Assigned laboratory number” means a number assigned to a laboratory by the Department for use in filing reports of HIV infection or CD4+ count. “Case” means an individual who has: Been clinically diagnosed as having HIV or AIDS; or Laboratory evidence of being infected by HIV. “Clinical material” means: An organism isolated from a clinical specimen; Material derived or prepared from a clinical specimen in which evidence of a communicable disease has been identified or detected; or If neither §B(5)(a) nor §B(5)(b) of this regulation is available, material from an individual already held by the medical laboratory, in the following order of preference: A patient specimen; Nucleic acid; or Other laboratory material. “Clinical or infection control practitioner” means a physician, infection control nurse, physician assistant, nurse practitioner, or other clinical staff designated by the administrative head of an institution to report under Health-General Article, §18-202.1, Annotated Code of Maryland. “Department” means the Maryland Department of Health. “Designated anonymous HIV test site” means an HIV counseling and testing site designated by the Department as a site where a patient may have an anonymous HIV test. “Drug” means a drug that has been: Licensed by the United States Food and Drug Administration (FDA); or Approved by the FDA as an investigational new drug. “Exemption” means a research project meeting certain criteria, with the result that no reporting is required under this chapter. “Health officer” means the health officer in each of the 23 counties and the Commissioner of Health in Baltimore City or the duly designated representative of the health officer. “Human immunodeficiency virus (HIV)” has the meaning stated in Health-General Article, §§18-201.1(a) and 18-202.1(b), Annotated Code of Maryland. “Institution” means an entity that employs an individual licensed to practice osteopathy or medicine by the State. “Institutional review board” means a group of individuals designated by an institution in compliance with 45 CFR Part 46 to review the use of human subjects in proposed research. “Laboratory examination order” means the written document signed by a physician or other authorized individual that specifies one or more laboratory examinations to be performed in regard to a specified patient. “Newborn HIV exposure” means a newborn infant whose mother has tested positive for HIV infection. “Physician” means an individual licensed to practice osteopathy or medicine by the State or the physician's designee working under the supervision of the physician. “Secretary” means the Secretary of Health or the Secretary's designee. A physician shall: Report a case of HIV or AIDS or newborn HIV exposure for a patient under the physician's care to the health officer within 48 hours, by phone or in writing on a form provided by the Secretary; and Include the information requested on the form. A physician may not transmit information to the health officer or the Secretary about a case of HIV or AIDS or newborn HIV exposure by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method. A physician authorized to order laboratory examinations shall include all of the following information on the written laboratory examination order for a test covered by this chapter: Name, date of birth, race, ethnicity, and gender of the patient; Street address, city, state, and zip code of the patient's residence; and Name, address, and telephone number of the physician ordering the test. A physician who reports a case of HIV or AIDS or a newborn HIV exposure or orders a laboratory examination for a test covered by this chapter shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report as set forth in Health-General Article, §18-207, Annotated Code of Maryland. A physician working in an institution required to report as set forth in Health-General Article, §18-202.1, Annotated Code of Maryland, is not required to report an HIV or AIDS case if the administrative head of the institution has designated an individual clinical or infection control practitioner or a specific set of clinical or infection control practitioners other than the physician to be responsible for reporting on behalf of all clinical and infection control practitioners in the facility, as set forth in Regulation .05 of this chapter. A clinical or infection control practitioner working in an institution required to report as set forth in Health-General Article, §18-202.1, Annotated Code of Maryland, shall: Report a case of HIV or AIDS under the care of the institution to the health officer within 48 hours, by phone or in writing on a form provided by the Secretary; and Include the information requested on the form. A clinical or infection control practitioner may not transmit to the health officer or the Secretary information about a case of HIV or AIDS by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method. A clinical or infection control practitioner who reports a case of HIV or AIDS shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report as defined in Health-General Article, §18-207, Annotated Code of Maryland. The administrative head of an institution required to report as set forth in Health-General Article, §18-202.1, Annotated Code of Maryland, may designate an individual clinical or infection control practitioner or a specific set of clinical or infection control practitioners who shall be responsible for reporting on behalf of all clinical and infection control practitioners in the facility. A clinical or infection control practitioner working in an institution required to report as defined in Health-General Article, §18-202.1, Annotated Code of Maryland, is not required to report HIV or AIDS cases if the administrative head of the institution has designated a different individual clinical or infection control practitioner or specific set of clinical or infection control practitioners who shall be responsible for reporting on behalf of all clinical practitioners in the facility. Except as provided in Regulations .01C and .02 of this chapter, the director of a medical laboratory shall: Submit a report to the health officer for the jurisdiction where the laboratory is located, within 48 hours after an examination of a specimen from a human body shows one of the following: A result on a test designed to detect in a sample the presence of HIV in accordance with Health-General Article, §18-207(b)(1), Annotated Code of Maryland, including negative results; A quantitative or qualitative HIV viral load test result, including undetectable; A CD4+ cell test result, count, or percentage in an individual not known to be HIV negative; or An HIV genotype sequence test result; Use the form provided by the Department in making the report required under §A(1) of this regulation; Include all of the following information in the report required under §A(1) of this regulation: Name and address of laboratory or assigned laboratory number; Date the specimen was obtained from the patient; Type and result of laboratory test, that is, HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence; Name, date of birth, race, ethnicity, and gender of the patient; Street address, city, state, and zip code of the patient's residence; Name of the physician authorizing the laboratory examination; and Address and telephone number of the physician authorizing the laboratory examination; and Contact the physician authorizing the laboratory examination to obtain any of the information, as required by §A(3) of this regulation, that is not provided on the laboratory examination order. A laboratory director may not transmit to the health officer or the Secretary information about a case of HIV or AIDS by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method. The laboratory director shall, at the request of the Secretary, make available to the Secretary any remaining clinical material from tested individuals. This regulation does not relieve a physician of the duty to report as set forth in Health-General Article, §§18-201.1 and 18-202.1, Annotated Code of Maryland. An out-of-State laboratory that holds a permit to operate issued by Maryland and performs HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence tests shall submit the report required under Regulation .06 of this chapter to the Secretary. This regulation establishes requirements for follow-up by the health officer of a report of HIV or AIDS or newborn HIV exposure or laboratory report of HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence. This regulation does not supplant or otherwise modify the: Physician's obligation to report a case of HIV or AIDS or newborn HIV exposure under Health-General Article, §18-201.1, Annotated Code of Maryland, and Regulation .04 of this chapter; Clinical or infection control practitioner's obligation to report a case of HIV or AIDS under Health-General Article, §18-202.1, Annotated Code of Maryland, and Regulation .05 of this chapter; and Laboratory director’s obligation to report a test result of HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence under Health-General Article, §18-205, Annotated Code of Maryland, and Regulation .06 of this chapter. Upon receipt of a report from a physician pursuant to Regulation .04 of this chapter, a clinical or infection control practitioner pursuant to Regulation .05 of this chapter, the health officer shall: Determine whether the case of HIV, the case of AIDS, or the newborn HIV exposure has been reported previously; Complete the case investigation if the patient has HIV or AIDS or is a newborn HIV exposure and the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously; and Submit the HIV/AIDS case report as set forth in Health-General Article, §18-207, Annotated Code of Maryland, to the Department if the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously. Upon receipt of a test result report from a laboratory director pursuant to Regulation .06 of this chapter, the health officer shall: Determine whether the report matches to a case of HIV, a case of AIDS, or a newborn HIV exposure that has been reported previously, and submit the report to the Department if the report matches; Complete a case investigation if the report indicates the patient has HIV or AIDS or is a newborn HIV exposure and the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously; Submit the case report, as set forth in Health-General Article, §18-207, Annotated Code of Maryland, to the Department if the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously; and Retain a nonmatching report for up to 4 years, rematching the report, not less than annually, to test result reports and to cases of HIV or cases of AIDS or newborn HIV exposures that had not been reported previously, to identify new matches, and submit the report to the Department if the report matches. A health officer may not transmit to the Secretary information about a case of HIV or AIDS by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method. A person that submitted a report of HIV or AIDS or newborn HIV exposure shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report, according to Regulations .04—.06 of this chapter. Except for a designated anonymous HIV test site, a person that ordered the laboratory examination shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report, according to Regulations .04 and .05 of this chapter, upon receipt of one of the following: A result on a test designed to detect in a sample the presence of HIV in accordance with Health-General Article, §18-207(b)(1), Annotated Code of Maryland, including negative results; A qualitative or quantitative HIV viral load test result, including undetectable; A CD4+ cell test result, count, or percentage in an individual not known to be HIV negative; or An HIV genotype sequence test result. Confidentiality. A report required under this chapter is: Confidential; Not open to public inspection; Not a medical record under Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and Subject to the confidentiality requirements of Health-General Article, Title 4, Subtitle 1, Annotated Code of Maryland. The reports and any proceedings, records, or files relating to the reports required under this chapter are not discoverable and are not admissible in evidence in any civil action. Section C(1) of this regulation does not apply to a disclosure by the Secretary to another governmental agency performing its lawful duties pursuant to State or federal law where the Secretary determines that the agency to whom the information is disclosed will maintain the confidentiality of the disclosure. Health-General Article, §§2-104(b), 4-101, 4-102, 18-102, 18-103, 18-201.1, 18-202.1, 18-205, 18-207, and 18-215;State Government Article, §10-617; Annotated Code of Maryland Effective date: February 18, 2002 (29:3 Md. R. 220) Chapter revised effective September 8, 2008 (35:18 Md. R. 1600) Regulation .01 amended effective May 18, 2020 (47:10 Md. R. 518 Regulation .02 amended effective May 18, 2020 (47:10 Md. R. 518) Regulation .02B, C amended effective March 14, 2016 (43:5 Md. R. 385) Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385); May 18, 2020 (47:10 Md. R. 518) Regulation .06A amended effective May 18, 2020 (47:10 Md. R. 518) Regulation .07 amended effective May 18, 2020 (47:10 Md. R. 518) Regulation .08 amended effective May 18, 2020 (47:10 Md. R. 518) Regulation .08C amended effective March 14, 2016 (43:5 Md. R. 385) Regulation .09B amended effective May 18, 2020 (47:10 Md. R. 518) Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385)