Use of Auto-verification Rules for COVID-19 IL-6: Testing is Mission-Critical

In a recent COVID-19 LIVE! Briefing put on by The Dark Intelligence Group , Norton Healthcare’s head of laboratory informatics, Angela Martin, BS MT(ASCP) shared the importance of software auto-verification rules to control result quality and accuracy for newly introduced assays in their fight against the coronavirus. Joining her on the call, Norton’s chief of chemistry, Dr. Joshua Hayden, Ph.D. DABCC, discussed the use of Interleukin-6 (IL-6) testing for COVID-19 patient risk stratification and patient management. Dr. Hayden focused on the utility of the IL-6 assay for triaging patients by disease severity including the use of novel therapies to abate the disease process.

Auto-Verification Rules – Mission Critical to Accurate Data Reporting

Norton identified a high probability of reporting inaccurate IL-6 results if they depended on manual result review and manual result entry practices. The IL-6 assay has a range of results formats with variable decimal points to results reported in the thousands (< 2.5, > 30,000). Relying on manual result review and entry for such a wide range of possible results, introduces a high risk of a technologist adding or leaving off a digit, incorrectly rounding or entering the result using the wrong decimal place. The unpredictability of the COVID-19 disease process combined with scant data supporting this patient population has not allowed for extensive validation studies to identify other biological or instrument conditions that could impact the IL-6 result assay.

As the medical and lab community gets a handle on the prevalence of COVID-19 and gains an understanding of the range of expected results, more scrutiny needs to be applied to IL-6 test results. Like Norton Healthcare, it is imperative that labs add increased controls that can identify unexpected, unusual, or absurd results that could be human or instrument generated. An incorrectly reported result could lead to wrong treatment protocols, lack of treatment or worse, patient harm. Norton wanted to eliminate the most obvious source of result inaccuracy by automating and standardizing the result review process with software auto-verification rules logic

Auto-verification Rules Can Support COVID-19 Patient Care

The Norton team implemented software auto-verification rules into their Data Innovations Instrument Manager® system based on critical factors that influence the quality of the IL-6 results for COVID-19 patients.

Impact on You. Make setting up software auto-verification rules as important as implementing the test itself. These 7 Critical Factors highlight why no lab should be without software auto-verification rules. It’s not just about saving lab processing time, it’s about saving lives.

Critical Factor 1. Eliminate result transcription errors due to manual entry actions. IL-6 results are reported in several different formats depending on the result value ranging from a low of < 2.5 with one decimal point to a high of > 30,000 with no decimal points. Leaving off a digit or adding a digit in the wrong direction could be catastrophic to patient care.

Critical Factor 2. Prevent misinterpretation issues from instrument read-outs or paper reports. To err is human. Manual entering of results into a host system from a report print-out or paper report is error-prone no matter how many human-based checks you apply to the process.

Critical Factor 3. Hold results for technologist’s review for instrument reporting notifications. Specimen integrity and instrument operational statuses can influence the quality of the result. Even the trained eye can miss an instrument generated non-numeric character or symbol that indicates an error malfunction that can impact the result. Auto-verification rules can identify these result reporting alerts consistently each time.

Critical Factor 4: Ensure critical results are reported on a priority basis. Results that are within a high critical range for IL-6 should be quickly identified and escalated for reporting by the laboratory. The Il-6 test result is an early indicator of acute inflammation for COVID-19 and faster reporting of critical results can positively accelerate patient care.

Critical Factor 5. Direct the technologist to perform sample processing actions. Results are suspect if they fall below or above the read-able range of the instrument. It is easy to disregard results that are out of these ranges and report them without following the correct lab protocols. Rules logic enforces and re-enforces sample processing best practices to ensure predictable outcomes.

Critical Factor 6. A fail-safe check on new assay performance.  The deployment of any new analytical test and method has inherent risks of missing reporting issues or clinical conditions that cannot be replicated in the verification process. All analytical testing has ‘gray areas’ for result reporting that requires technologist intervention to resolve. Adding rules that can immediately identify unknown instrument or specimen functional abnormalities is a fail-safe tool that can hold up the testing process until the issue has been identified and remedied.

Critical Factor 7. Speed up IL-6 test result availability.  Time to result or turnaround time is on the life-saving critical path. Reviewing hundreds of negative results takes time and can never be optimized as volume grows. Removing manual review practices using software auto-verification rules shortens turnaround time for all ranges of results (positive, negative, gray zones).

Software Auto-verification rules and risk management

Results of any analytical test are influenced by the instrument & method, reagents, specimen integrity and the biology of the individual patient. The added risk of manually entering compromised results into the LIS or other system of record increases with the lack of verifiable and reproducible controls. The Norton clinical laboratory leadership and their IT stakeholders recognized that the use of auto-verification rules was important for them to manage the accuracy of result reporting for IL-6 for COVID-19 patients. The elimination of human-induced errors has allowed Norton to concentrate on other variables that could impact the IL-6 assay performance and veracity. Adding a layer of control by using software auto-verification rules to identify any influences not uncovered in the assay validation process reduces the impact of human error enabling Norton to concentrate on other analytical issues that can be quickly identified and corrected to improve the test result accuracy.

Inspire you.

We are reminded during this pandemic time and at any time we introduce new testing, simple manual result review and manual entry errors can and should be avoided by the routine practice of simultaneously introducing quality software auto-verification rules.

Check out Angela’s rules here.