Toolkit: HIV Diagnostic Algorithm Laboratory Testing

The intent of this toolkit is to provide helpful resources to laboratory directors, administrators, and other decision makers for implementing the 4th Generation HIV-1/2 Ag/Ab combo immunoassay and the recommended HIV diagnostic algorithm. This compilation of resources includes fiscal, technical, and procedural information needed to nagivate this process and is organized into two sections:

• Planning
• Implementing

Planning

Recommended HIV Diagnostic Algorithm for Laboratories

• 2018 Updated Guidelines for Laboratories for HIV Diagnostic Testing (PDF)
• CDC Updated Recommendations
  • CDC Dear Colleague Letter on updated laboratory testing recommendations (June 26, 2014)
  • Laboratory Testing for the Diagnosis of HIV Infection (June 27, 2014)
• CDC HIV Diagnostic Algorithm Quick Reference
• Regulations
  • NYS Laboratory Standards
    • Diagnostic Immunology
  • Communicable Disease Reporting
    • Communicable Disease Reporting Guidelines 2016
    • 2016 Changes in Reporting Communicable Diseases

Billing/Reimbursement

• Reimbursement
  • Medicaid Fee Schedule
  • Procedure Codes
  • Laboratory Billing Guidelines

As it becomes available, additional information and guidance on the new HIV Diagnostic Testing algorithm will be posted on the NYSDOH website under “HIV Testing”.  Questions may be directed to hivtesting@health.ny.gov

Implementing

Clinical Laboratory Evaluation Program (CLEP)

• Obtain a Permit
• Change a Permit
• Re-apply for a Permit
• Laboratory Fees
• Proficiency Testing

Laboratory Reporting to the NYSDOH

• Preferred LOINCS (Logical Observation Identifiers Names and Codes) (PDF)
• NYSDOH Guidance for HIV Public Health Reporting (PDF)
• ECLRS (Electronic Clinical Laboratory Reporting System)
  • Questions regarding ECLRS reporting of HIV-related results should be directed to the Bureau of HIV/AIDS Epidemiology at (518) 474-4284 or by email tobhaelab@health.ny.gov

Reporting to Providers

• Guidance for Reporting Results of the HIV Diagnostic Algorithm (PDF)
• APHL Suggested Reporting Language for the HIV Laboratory Diagnostic Testing Algorithm (November 2013)

Billing/Reimbursement

• Reimbursement
  • Medicaid Fee Schedule
  • Procedure Codes
  • Laboratory Billing Guidelines

Wadsworth Center

• Clinical Testing
  • HIV-1/HIV-2 Diagnostic Testing
  • HIV-2 Nucleic Acid Testing
  • Collection, Shipping and Reporting

FDA-Approved Diagnostic Tests/Devices Not Included in the Recommended HIV Diagnostic Algorithm

• HIV Rapid Testing
  • Alere Determine™ HIV-1/2 Ag/Ab Combo
  • CLIA-Waived Tests
• HIV-1 Western Blot
  • NYSDOH Dear Colleague Letter - Indeterminate WB (October 31, 2014)
  • APHL/CDC Fact Sheet: "Limitations for the Use of HIV-1 Western Blot in Plasma/Serum"

As it becomes available, additional information and guidance on the new HIV Diagnostic Testing algorithm will be posted on the NYSDOH website under “HIV Testing”.  Questions may be directed to hivtesting@health.ny.gov