Section 27.32a. Reporting AIDS, HIV, CD4 T-lymphocyte counts and perinatal exposure of newborns to HIV

(a) Reporting by clinical laboratories.

(1) A person in charge of a clinical laboratory shall report CD4 T-lymphocyte test results as defined in § 27.22(b) (relating to reporting of cases by clinical laboratories) electronically to the HIV/AIDS Epidemiology Section, Division of Infectious Disease Epidemiology, Bureau of Epidemiology, within 5 days of obtaining the test results.

(2) A person in charge of a clinical laboratory shall report positive test results of any test approved by the FDA to establish the presence of HIV, including a serologic, virologic, nucleic acid (DNA or RNA) or any other type of test the FDA approves to establish the presence of HIV. The report shall be made to the HIV/AIDS Epidemiology Section, Division of Infectious Disease Epidemiology, Bureau of Epidemiology, within 5 days of obtaining the test results.

(3) The report shall include the following information:

(i) The individual’s name and the address, city, county, and zip code of the individual’s residence.

(ii) The patient identifying number assigned to the individual by the physician or at the facility requesting the laboratory test.

(iii) The individual’s date of birth (month, day, year).

(iv) The individual’s sex.

(v) The individual’s race/ethnicity.

(vi) The date of each test performed.

(vii) The type of tests performed.

(viii) The results of the tests.

(ix) The name of the person or entity submitting the specimen for testing.

(x) The address of the person or entity submitting the specimen for testing, including the zip code, physical address and telephone number of the submitter.

(4) To enable the laboratory to complete the report it is required to file with the Department, a person or entity that requests a laboratory test for HIV or a CD4 T-lymphocyte count shall provide to the laboratory the information in subsection (a)(3), with the exception of subparagraphs (vi)—(ix). In addition to the information included in subsection (a)(3), a person or entity that requests a laboratory test for HIV or a CD4 T-lymphocyte count shall provide to the laboratory the date each test was requested and the type of test or tests requested.

(b) Reporting by physicians, hospitals, persons or entities, who diagnose AIDS or who receive or provide HIV and CD4 T-lymphocyte test results.

(1) A physician, hospital, person providing HIV services or person in charge of an entity providing HIV services, who makes a diagnosis of AIDS or who receives HIV or CD4 T-lymphocyte test results or provides HIV or CD4 T-lymphocyte test results to patients, shall report the following to the LMRO responsible for the geographic area in which the person is tested or diagnosed within 5 business days of the diagnosis of AIDS or the receipt of the results of the test:

(i) A diagnosis of AIDS.

(ii) A positive result of any test approved by the FDA to establish the presence of HIV, including a serologic, virologic, nucleic acid (DNA or RNA) or any other type of test the FDA approves to establish the presence of HIV (effective October 18, 2002).

(iii) A CD4 T-lymphocyte test result with a count of less than 200 cells/µL or a CD4 T-lymphocyte percentage of less than 14% of total lymphocytes (effective October 18, 2002).

(iv) A perinatal exposure of a newborn to HIV (effective October 18, 2002).

(2) A report of an HIV test result, CD4 T-lymphocyte count, AIDS case based on the CDC case definition, or perinatal exposure of a newborn to HIV shall include the following information:

(i) The individual’s name and the address, city, county and zip code of the individual’s residence.

(ii) The patient identifying number assigned to the individual by the physician or at the facility requesting the laboratory test.

(iii) The individual’s date of birth.

(iv) The individual’s sex.

(v) The individual’s race or ethnicity.

(vi) The date of each test performed.

(vii) The type of tests performed.

(viii) The test results.

(ix) The patient’s history on probable modes of transmission.

(x) The treatment provided.

(xi) The name, address and telephone number of the physician, hospital, or other person or entity that secured a specimen from the individual and submitted it for laboratory testing.

(xii) The name, address and telephone number of the entity in which the diagnosis was made or that received the HIV test result or CD4 T-lymphocyte count.

(3) In addition to reporting the AIDS diagnosis or the receipt of test results, the reporter shall maintain the data required in paragraph (2) in the patient file on the Department’s HIV/AIDS report form.

(4) An LMRO receiving reports of diagnoses of AIDS, positive HIV test results, reportable CD4 T-lymphocyte counts, and perinatal exposures to HIV shall forward completed case reports containing the information included in paragraph (2) electronically to the Department’s Bureau of Epidemiology through a secure electronic mechanism specified by the Department.

The provisions of this § 27.32a adopted July 19, 2002, effective July 20, 2002, 32 Pa.B. 3597.

Notation

Authority

The provisions of this § 27.32a adopted under section 16(b) of the Disease Prevention and Control Law of 1955 (35 P. S. § 521.16(b)); sections 2102(g), 2106(a) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g), 536(a) and 541(b)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).