Guidelines for HIV testing in a clinical laboratory

Requirements for conducting HIV testing in Massachusetts clinical laboratories

Laboratories that wish to perform HIV testing must receive approval from the Department of Public Health (DPH) prior to beginning testing. The following information must be submitted to DPH for review:

  • Evidence of Proficiency Testing Enrollment
  • Written request for the addition of the specialty, Immunology and the sub-specialty, Viral Serology (HIV Testing)
  • Sample of laboratory request and final report
  • Documentation of arrangement for re-examination of positive patient specimens
  • Documentation of arrangement for a confirmatory test for a positive specimen
  • Written policies to assure confidentiality of test results and other patient information
  • Written policies which ensure patient consent for the test prior to the test being performed, including voluntary nature of tests for non-blood donors; purpose of the test; interpretation of the test including significance and limitations; availability of confirmatory tests; and availability of additional information and counseling
  • Documentation that the test has been approved by an internal review mechanism within the hospital or clinic, if applicable

All hospital and clinic laboratories must submit evidence that the HIV testing policies have been approved by an internal review mechanism. This mechanism can be an already established committee at the hospital or clinic, such as the Infectious Disease Committee, or a newly established ad hoc committee. Evidence of review can be satisfied by:

  • A letter from the chairman of the committee
  • A copy of the minutes of a meeting held by the committee

Rapid (Waived) HIV Test Requirements

Facilities wishing to perform Waived HIV Testing must be licensed and/or approved by DPH to perform clinical laboratory testing in the sub-specialty area of “Viral/HIV” Serology. The Massachusetts state regulations, 105 CMR 180.000: The Operation, Approval and Licensing of Clinical Laboratories, allow DPH to consider proposals for special projects for the innovative delivery of clinical laboratory services. Under this provision, DPH will consider granting an HIV Special Projects Waiver to facilities that:

Applicants must respond to all questions within this document in order to be considered for approval. The Clinical Laboratory Program works in conjunction with the Bureau of Infectious Disease and Laboratory Sciences, Office of HIV/AIDS to review HIV Special Projects Waiver applications.

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