28 Pa. Code § 27.32a. Reporting AIDS, HIV, CD4 T-lymphocyte counts and percentages, HIV viral load test results, including detectable and undetectable viral load results and HIV genotype test results, and perinatal exposure of newborns to HIV.

§ 27.32a. Reporting AIDS, HIV, CD4 T-lymphocyte counts and percentages, HIV viral load test results, including detectable and undetectable viral load results and HIV genotype test results, 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 counts and percentages electronically to the Department through the appropriate electronic disease surveillance system within 5 work 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 appropriate electronic disease surveillance system within 5 work days of obtaining the test results.
   (3)  A person in charge of a clinical laboratory shall report HIV viral load test results, including detectable and undetectable viral load results, and HIV genotyping results, to the Department through the appropriate electronic disease surveillance system, within 5 work days of obtaining the test results.
   (4)  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.
   (5)  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, a CD4 T-lymphocyte count or percentage, or HIV viral load test results, including detectable or undetectable test results, and HIV genotype test results shall provide to the laboratory the information in subsection (a)(4), with the exception of subparagraphs (vi)—(ix). In addition to the information included in subsection (a)(4), a person or entity that requests a laboratory test for HIV, a CD4 T-lymphocyte count or percentage, an HIV viral load test result, including detectable or undetectable test results, and HIV genotype test results shall provide to the laboratory the date each test was requested and the type of test or tests requested.
(b)  Reporting by health care practitioners, hospitals, and other persons or entities, who diagnose AIDS or who receive or provide HIV test results, CD4 T-lymphocyte counts and percentages, or HIV viral load test results, including detectable and undetectable results, and HIV genotype test results.
   (1)  A health care practitioner, 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 test results, CD4 T-lymphocyte counts and percentages, HIV viral load test results, including detectable and undetectable results, or HIV genotype test results, or who provides an AIDS diagnosis, HIV test results, CD4 T-lymphocyte counts and percentages, HIV viral load test results, including detectable and undetectable test results, and HIV genotype test results to patients, shall report the following to the Department through the appropriate electronic disease surveillance system within 5 work 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.
     (iii)   CD4 T-lymphocyte counts and percentages.
     (iv)   A perinatal exposure of a newborn to HIV.
     (v)   HIV viral load results, including detectable and undetectable viral load results, and HIV genotype test results.
   (2)  A report of an HIV test result, CD4 T-lymphocyte count and percentage, HIV viral load test result, including detectable and undetectable test results, and HIV genotype test result, 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 health care practitioner, 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 AIDS diagnosis was made or that received the HIV test result, CD4 T-lymphocyte count and percentage, HIV viral load test results, including detectable and undetectable test results, or HIV genotype test results.
   (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)  A local health department receiving reports of diagnoses of AIDS, positive HIV test results, CD4 T-lymphocyte counts and percentages, HIV viral load test results, including detectable and undetectable test results, and HIV genotype test results, and perinatal exposures to HIV shall forward completed case reports containing the information included in paragraph (2) to the Department through the Department’s electronic disease surveillance system.

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); amended under section 16(a) and (b) of the Disease Prevention and Control Law of 1955 (35 P.S. §  521.16(a) and (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).

Source

   The provisions of this §  27.32a adopted July 19, 2002, effective July 20, 2002, 32 Pa.B. 3597; amended October 30, 2020, effective October 31, 2020, 50 Pa.B. 5981. Immediately preceding text appears at serial pages (290026) to (290028).

Cross References

   This section cited in 28 Pa. Code §  27.32b (relating to confidential and anonymous testing).

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