Last Updated: Oct 1, 2020
The Pennsylvania Department of Health (DOH) has announced final-form regulations that amend the Department’s mandatory reporting requirements for Human Immunodeficiency Virus (HIV) infection. These updated regulations require the complete reporting of CD4 T-lymphocyte, viral load and genotyping test results relating to HIV infection.
The final-form regulations can be accessed here.
The Independent Regulatory Review Commission (IRRC) approved the final-form regulations at it September 2020 meeting. The regulations will take effect upon publication in the Pennsylvania Bulletin.
In 2002, DOH added the mandatory reporting of cases of HIV infection and CD4 T-lymphocyte test results to its communicable and noncommunicable disease reporting regulations. Under the 2002 regulations, the reporting of CD4 T-lymphocyte test results with a count of equal to or less than 200 cells/pL or a CD4 T-lymphocyte percentage of less than 14% of total lymphocytes are required to be reported.
The Centers for Disease Control and Prevention (CDC) has strongly recommended the reporting of all CD4 T-lymphocyte cell counts, viral loads, and genotyping test results related to HIV. The CDC has made it clear that it believes such reporting is essential to early and appropriate treatment. DOH reports that 46 other states already require all CD4 counts to be reported and 48 states require the reporting of all viral load results.
What Do the Amended Regulations Require?
The new amended regulations require the reporting of all CD4 T—Lymphocyte cell counts and percentages relating to HIV infection as well as the reporting of all viral load test results, including detectable and undetectable viral loads, and genotyping results related to HIV.
Under these new regulations, an individual/entity who makes a diagnosis of AIDS or who receives HIV tests results, CD4 T-lymphocyte counts and percentages, HIV viral load test results including detectable and nondetectable results, or HIV genotype test results; or an individual/ entity who provides an AIDS diagnosis, HIV tests results, CD4 T-lymphocyte counts and percentages, HIV viral load test results, including detectable and nondetectable results, or HIV genotype test results must report certain information to DOH within five (5) business days of the diagnosis of AIDS or the receipt of the test results.
The information that must be reported to DOH is as follows:
- A diagnosis of AIDS.
- 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.
- CD4 T-lymphocyte counts and percentages.
- HIV viral load results, including detectable and undetectable viral load results, and HIV genotype test results.
Who Is Subject to These Regulations?
All healthcare practitioners, healthcare facilities, and laboratories statewide, and all persons who make diagnoses of HIV or AIDS or who receive or provide HIV test results and CD4 T-lymphocyte test results were required to comply with the regulations relating to the reporting of AIDS and HIV disease, including specified CD4 T-lymphocyte test results promulgated in 2002.
These same types of providers, facilities, and laboratories would be required to comply with these new amended regulations to HIV reporting requirements.
The Pennsylvania Medical Society (PAMED) will continue to monitor the implementation of these regulations and provide updates accordingly.