Laboratory Test Results Auto-verification
Autoverification is the process by which patient results are generated from interfaced instruments and sent to the LIS, where they are compared against laboratory-defined acceptance parameters before the release.
When the results are within the parameters set, the results are automatically released to patient reporting formats without any additional laboratory staff intervention.
All data outside of the defined parameters are checked by a professional in the laboratory before the release. The quality of the final result will allow making correct clinical decisions.
Autoverification has been conceived as a process that includes setting decision rules aimed at identifying the error. The concept has, however, become much broader until turning into a high-precision and accuracy computer tool, able to hold patient’s available information, detect analytical error, sample quality, quality control, and lab policy, and release results in real time.
The group responsible for the auto-verification process must analyze the results release algorithms in order to define the rules and criteria commonly used for the validation process, and determine which filters will subsequently remain included in the final auto-verification algorithm
Auto-verification improves operational efficiency by eliminating the need for a medical laboratory scientist to approve each test result before they are released to the laboratory information system for reporting. Improves turnaround time and reduces reporting errors.
Software rules for verification, reside in the Laboratory Information System. Several parameters are included e.g. instrument flags, serum interference indices, delta check, need for manual dilution, analytical measurement range and of course reference range, and critical range.
The following criteria must be met before a result is autoverified:
• Quality control is acceptable
• Results fall within the specified auto-verification range
• Results pass delta check limits
• No instrument flags are present
• No errors have been arised during any step of the process.
Common reasons that a result is not auto-verified include specimen error (clot, bubble), need for dilution, instrument error, interference index flag etc.
One issue that complicates chemistry auto-verification is the presence of method interferences. The LIS must be able to capture all instrument error flags and use them to prevent automatic verification.
Auto-verification procedures requires that Laboratory has established a policy for automatic verification, signed properly from the medical director, approving the use of automation.
Policy for Auto-Verification procedure
• Results must be within normal ranges and must not exceed panic or absurd ranges and/or must not be accompanied by any abnormal instrument flags.
• A selection of any of these criteria can be made on an individual instrument basis.
• Normal ranges, unique to the instrument and methodology used, are determined by the medical professional staff and based on literature review.
• Results once auto-verified are ready to be released to the referring physicians.
• The LIS administrator is responsible for ensuring that the mechanism for the accuracy of auto-verification is tested annually.
• Documentation for annual testing of auto-verification will be kept on file.
• The auto-verification policy must be reviewed, approved and documented annually by the proper in-Chief Personnel of both Pathology and Laboratory.
• If changes are made to the auto-verification rules after initial testing and documentation, the process is re-verified as to its accuracy.
• Upon notification of a problem with either test method, analytic instrument or the auto-verification program, an LIS administrator may immediately suspend the auto-verification program.