Auto-verification of test results
‘Auto-verification’ is a software module of ‘MediLab LIS’ that permits the automatic release of those results that are in a proper range. The LIS systems collects the patients results from the analysers and the medical instruments via the instrument interfacing. Then the software compares each one against laboratory acceptance parameters, before the release.
All data outside of the range of parameters stay waiting for a manual check and acceptance by a laboratory scientist. An automatic release of the rest of the results that are within acceptance range sends the results to the reffering physicians. Therefore the software archives in proper patient reporting formats without any additional laboratory staff intervention.
Automatic verification is a process that includes sets of decision rules aiming at identifying the error. However, the concept has become much broader until turning into a high-precision and accuracy computer tool. This tool holds patient’s available information, detects analytical error, sample quality, quality control, and lab policy, and releases results in real time.
Rules and algorithms
The group responsible for the auto-verification process must analyze the results release algorithms. The group must define the rules and common criteria for the validation process, and determine which filters will subsequently remain in the final auto-verification algorithm.
Software rules for verification, reside in the MediLab’s tables. there are several parameters e.g. instrument flags, serum interference indices, delta check, need for manual dilution, analytical measurement range and of course reference range, and critical range.
Moreover, auto-verification improves operational efficiency by eliminating the need for a medical laboratory scientist to approve each test result. In such a case the software releases automatically the results to the laboratory information system, ready for reporting. Therefore this improves turnaround time and reduces reporting errors.
The following criteria must be met before a result is auto-verified:
- Quality control is acceptable
- Results fall within the specified auto-verification range
- There is not a pass of the delta check limit on the result
- Instrument flags are not present
- None step of the process is in error.
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 capture all instrument error flags and use them to prevent automatic verification.
Auto-verification procedures requires Laboratory policy for automatic verification. However, an approval of the automation rules, by the medical laboratory director is absolutely necessary.
Policy for Auto-Verification procedure
- Results must be within normal ranges and must not exceed panic or absurd ranges. Abnormal instrument flags must not appear.
- Selection of any of these criteria can be on an individual instrument basis.
- The medical professional staff set the normal ranges, unique to the instrument and methodology, based on literature review.
- Release of the results to the referring physicians happens once auto-verification has succeed.
- There is an annual test mechanism for the accuracy of auto-verification.
- Documentation for annual testing of auto-verification is a must.
- Both the Pathology and Laboratory in-Chief Personnel must review, approve and document annually the auto-verification policy.
- A new verification of the process is necessary on any change, as to its accuracy.
- After that, upon notification of a problem with either test method, analytic instrument or the auto-verification program, an administrator may immediately suspend the auto-verification program.
Auto-verification: A sophisticated approval of Lab results based on a set of Laboratory rules.
In conclusion, the current climate for reimbursements for laboratory testing has only increased the importance of automation, with further reductions. That push laboratories to optimize laboratory throughput and quality, to keep up with the increasing demands. The Laboratory Information System ‘MediLab LIS’ is an advanced information System that includes all the necessary tools to help lab personnel to increase the automation level of the Lab. It also includes procedure for the automatic verification of the results, supporting the minimazation of Turn Around Time and advancing the total laboratory’s performance.