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Responding to Incidents

An incident is an unexpected result that might indicate a concern about the performance of test kits or about the testing procedures at an HIV testing site. One of the key responsibilities of the quality assurance lead is to lead the local investigation into an incident.

Any incident, even if its cause is readily understood, should be recorded in the Incident Log. (Templates for this log are available.) Incidents include:

  • A damaged kit that impairs its use
  • Any invalid test (either a client test or a QC test)
  • An unexpected outcome of quality control testing
  • A discrepancy between the results of POC testing and standard laboratory-based testing
  • A discrepancy between the outcomes of a proficiency test at your site and the expected result

The following incidents should be reported to the AIDS and Hepatitis C Programs immediately:

  • Two invalid tests (or greater than 1% in a one month period)
  • Two unexpected quality control results
  • Any negative POC test, followed by a positive laboratory test (even if the client was in the window period; the AIDS and Hepatitis C Programs needs to alert the manufacturer promptly)
  • More than one false reactive POC test (or >1% of tests done in a month)
  • Damage to a significant number of newly shipped kits (>5% of the order)

The Incident Log

The incident log (Excel, Word and PDF) includes the following sections:

  • The date of the incident
  • The lot number of all products involved (POC kits but also quality controls, if applicable)
  • The type of products involved (test kits, quality controls, proficiency testing panels, etc.)
  • The type of incident (invalid test, false positive, etc).
  • A brief description of what happened, what the likely reasons might be (“no control dot, perhaps not enough specimen was added”)
  • Action taken (Repeated the test producing an appropriate result)
  • Date resolved (the same day if the test was repeated)

Other tips for handling incidents:

  • Use your phone to take a picture and document the incident as soon as possible
  • Report to the supervisor or QA lead, as soon as possible
  • Do not throw out the test membrane
  • If a test will be repeated to clarify the incident, try to have the QA lead or a second test counsellor present

 More detailed instructions are available here to help you deal with invalid test results or unexpected positive/negative quality control results. The information on the monthly summary report includes a discussion of false positive and false negative test results.