General Laboratory: Introduction to Autoverification Online Training
Compare autoverification with the traditional manual approach to releasing results. Explain ways autoverification impacts the laboratory. Outline the steps for implementing autoverification. Identify key lessons learned in the success of autoverification. This clinical laboratory training qualifies for continuing education units (CEU).
Rules LIS Manual Review Select Next to continue. Upon successful completion of this course, you will be able to: Compare Autoverifcation to current manual process List ways Autoverification impacts the laboratory Outline the steps to implement Autoverifcation Identify key points for Autoverification success Select Next to continue. What is it? Impact for Laboratory Keys to Success What is it? Impact for Laboratory Keys to Success Is the QC acceptable ? Is it consistent with previous results ? Should it be repeated ? Are there any instrument flags ? Which results are we supposed to always call to Dr. House ? Is the result medically improbable ? LIS Chemistry Urinalysis IA Hematology Quality Labor Chemistry Urinalysis IA Hematology LIS Quality Labor Quality Labor Assay ranges Quality Control Delta checks Instrument flags Autovalidated Autoverification screens all results for the things we know are important Each rule is a simple yes/no question Series of simple rules builds powerful screening tool If all rules pass, result is released If any rule fails, result held for review Decisions Based on Pre-Analytical Data Patient-specific criteria: age, gender, location, etc. Physician-specific criteria Location specific criteria (e.g. Dialysis units) Decisions Based on Analytical Data Test results Sample information (Serum Indices, clots, etc.) QC status Instrument status Decisions Based on Post-Analytical Data Delta checks based on previous results Results of other tests associated with the sample Critical Value checks Calculate results Add comments or interpretations Electronic Sticky Notes What is it? Keys to Success Impact for Laboratory AACC Survey April 2009 Lab Information Systems 63% Middleware 34% Lab Information Systems Middleware Trend for the future... Auto verify chemistry 58% AACC Survey April 2009 80% of labs auto verify > 50% 20% of labs auto verify 80% or more 48% Auto verify hematology 50% Use complex rules Reduced Error Rate Consistent TAT Workflow impact... STAT TAT 13% Quality improvement: Consistently detecting contaminated samples and similar issues. Staff has time for thorough follow up After: ⇒Support other work areas ⇒Bring in high volume send outs: Vit. D, PTH Before: 2 FTE almost full time manual result review What is it? Impact for Laboratory Keys to Success Assemble a team Create the rules Test the rules Validate the rules Go live Maintain the process All stakeholders represented Commitment to the project Develop goals Develop project plan Document what happens now Write out the rules in detail Use the tools to create rules Document the rules Siemens can assist here Trace the logic on paper Create and test “dummy” results Be sure to check at decision points Document the testing Use samples tested on instrument Use test samples / environment Verify rules execute correctly Document the validation Be sure everyone knows how it works Document process for rule failures Have process in place to follow up Ensure regulatory compliance Keep current process in parallel at first Example: CAP Laboratory General Checklist — June 2009 Results released by Autoverification identified as such for audit purposes Results from tests with QC failures or instrument flags cannot be autoverified All current manual review process must be incorporated into Autoverification Delta checks (if used) Screening for medically improbable results Reportable range checks Must have process in place to turn rule processing off if there is a problem Often referred to as Selective Suppression of rules Have process in place for annual review of rule function Rules can do more; they cannot do less CAP Laboratory General Checklist – June 15, 2009 GEN.43875 Phase II Is there documentation that the autoverification process was validated initially, and is tested at least annually and whenever there is a change to the system that could affect the autoverification logic? Changes to: Rule code or logic Instrument / middleware software that may impact rules LIS, if the change can impact rule execution One way to validate: From patient samples already run, select those with results that will trigger rules Using the results, manually follow the correct logic path Compare manual execution with autoverification outcome; if they match, rule is verified Start Small Use Familiar Instruments Focus on High Volume Tests Make Sure Lab Staff Understands Don’t try to implement for all tests right away If the instrument is new, get familiar with it first before attempting autoverification (e.g. BMP, CBC) Get most impact for the effort Autoverification will not replace jobs Helps staff focus on exceptional results Improves patient safety Autoverification is a powerful and flexible tool It is not a “turnkey” process with a completely developed vendor provided package Setting up Autoverification is a complex, time consuming process Responsibility for validating, implementing, and maintaining rules belongs to the laboratory To be successful, it should be implemented in stages after the laboratory is comfortable with the instrument systems