New Jersey Administrative Code 8:65 establishes the standards, procedures, and forms by which:

1. Health care facilities and health care providers report HIV infection diagnoses to the New Jersey Department of Health (hereafter called ‘Department’); and
2. Clinical laboratories - national, state, federal, hospital, commercial, independent, public (including blood banks and plasma centers), and Department-funded HIV counseling and rapid HIV testing sites (officially called CLIA-waived limited purpose laboratories) report HIV-related laboratory test results, to the Department.

The N.J.A.C. 8:65  HIV case reporting rule serves multiple purposes, chief among them:

• Facilitating the identification of persons at risk for HIV to whom various preventive, clinical and social support services may be offered;
• Enabling the Department to count the persons living with HIV statewide, in local communities, and among various socioeconomic and demographic populations;
• Permits the state to quantify and plan its resources to address needs of communities, identify emerging trends and best practices in prevention, mitigate and respond, and comply with data collection and reporting responsibilities in accordance with the National HIV Surveillance System (NHSS) led by the Centers for Disease Control and Prevention (CDC).

To download a full copy of the newly codified regulations guiding the reporting of HIV infection in New Jersey, please visit:

casetext.com/regulation/new-jersey-administrative-code/title-8-law-and-public-safety/chapter-65-hiv-infection-reporting

Laboratory data are an essential component of the national and state HIV surveillance system. HIV-related laboratory test result-reporting provides timely and accurate identification of all patients with suspected or confirmed HIV.  Laboratory data is used to measure progress toward the National HIV/AIDS Strategy (NHAS).

The standards, procedures, and forms by which health care facilities, including clinical laboratories and Department-funded HIV counseling and rapid HIV testing sites (officially called CLIA-waived limited purpose laboratories) report HIV-related laboratory test results are defined here.  

Laboratories reporting to New Jersey are required by rule to meet three critically important metrics.

1. They require clinical laboratories to report test results that are consistent with the APHL Algorithm and thereby meet “complete” reporting standards; and
2. They prevent potential new cases of infection from being “lost to follow-up”, ensuring that the Division remains compliant with grant requirements by providing robust and reliable data to guide programs by detecting populations that have poor care outcomes;  and lastly
3. They emphasize the Division’s enforcement jurisdiction over deficient reporting.

The HIV testing algorithm defines laboratory criteria for defining a confirmed case. To download a full copy of the recommended HIV testing algorithm, visit:

cdc.gov/hiv/pdf/guidelines_testing_recommendedlabtestingalgorithm.pdf

Updated recommendations for the laboratory diagnosis of HIV-1 and HIV-2 infection now accommodate new multitask algorithms, including criteria for differentiating between HIV-1 and HIV-2 infection and for recognizing early HIV infection.

To download a full copy of the updated HIV diagnostic algorithm, visit:

cdc.gov/hiv/guidelines/recommendations/technical-update-for-hiv.html

To standardize mapping and reporting of HIV test results, Logical Observation Identifiers Names and Codes (LOINC) have been developed by the CDC Division of HIV Prevention, HIV Surveillance Branch along with the Association of Public Health Laboratories, the Regenstrief Institute, Inc., and the CDC Division of Laboratory Systems.

To download a full copy of the updated LOINC mapping tool, visit:

cdc.gov/hiv/guidelines/reporting.html

To download a copy of the most updated LOINC codes, click here: [XLSX]

Incomplete reporting obstructs the State’s ability to obtain its full share of available Federal funding. Incomplete and untimely reporting also impede linkages to care and other elements of the care continuum, such as receipt of and retention in care, and viral suppression. Laboratory test results for CD4, viral load or genotype tests are indicative of a patient who is receiving care. As such, incomplete reporting of laboratory test results makes it hard to identify cases who are in care from those who need care, and to whom the Department's services should be targeted. The Division’s inability to collect the results of genotype tests, which analyze molecular sequence data, could result in a failure to detect groups of infection among HIV clusters or transmission networks within the State.

N.J.A.C 8:65 mandates reporting all HIV test results with positive findings or markers of HIV infection, such as:

• Confirmed positive HIV antibody test results
• Reactive nucleic acid tests
• Positive HIV detection tests
• All HIV nucleic acid (RNA and DNA) detection tests (qualitative and quantitative), including undetectable results for persons with a positive diagnosis
• All CD4 lymphocyte counts and percentages, unless known to be ordered for a condition other than HIV illness
• HIV subtype and antiviral resistance testing
• Result of an HIV-related laboratory test conducted as part of the testing algorithm, including negative and indeterminate results, when any HIV-related test conducted as part of the testing algorithm contains a positive or reactive result
• The mandated reporting fields by the lab that collects and analyzes the specimen are:
  • About The Laboratory:
    • Full Name
    • Address
    • Specimen Collection Date
    • Valid Results
    • Prescribing Provider
    • CLIA
    • Accession Numbers
•  
• • About Patient:
    • Full Name
    • Full Address
    • Sex At Birth
    • Date Of Birth
    • Alive/Deceased
    • Gender Identity
    • Race/Ethnicity
    • Pregnancy