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AUTOVERIFICATION:The HOW
Michael W. Fowler, Ph.D.
Distinguished Professor of Chemistry and Biology
Oklahoma Christian UniversityOklahoma City, OK
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Brainstorming Data EvaluationData Gathering
Autoverification Ruleand Retain-For-Review Process
Definitions
Autoverification Rule and
Retain-For-Review ProcessMonitoring
Autoverification Rule andRetain-For-Review Process
Implementation
Autoverification Rule andRetain-For-Review Pre-
Implementation Testing
Periodic Autoverification
Rule and Retain-For-ReviewProcess Verification IF PROBLEMS
IF PROBLEMS
Aut ove r i fi c a t i on Ru le And Re t a in -Fo r-Rev iewPr o c e s s Im p l e m e n t a t i o n
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BRAINSTORMING
• Involve Staff – Bench Technologists
– Lead Technologists/Technical Specialists– Managers/Coordinators– Scientific/Technical and Medical Directors
– IS&T
• Make list of all necessary information – specimen
types, instrument error messages, etc.
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DATA GATHERING
• Specimen Parameters• Instrument Flags• Analytical Performance and Quality Control Information• Reference Range Considerations• Reference Change Values and Delta Checks• Look-back Interval• Clinical Practice Guidelines and Information• Concurrent Test Information
Instrument
Manual
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Specimen Parameters
• Specimen Type, Acceptability and AnalysisBias– Serum– Plasma ( EDTA, heparin, other)– Whole Blood
• Specimen Stability
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Instrument Parameters• Specimen Validity Flags, Indices Flags and/or
Quantification– Hemolysis– Lipemia
– Icterus– Others
• Performance Flags– Abnormal Absorbance– Range Limits– Insufficient Sampling– Clots
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Analytical and Quality ControlInformation
• Method Imprecision
• Method Interferences
• Method Bias
• Automated QC monitoring
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Reference Range Considerations
• Age-related Issues - ALKP• Gender-related issues – hormones, tumor markers• Ethnic-related issues• Collection Issues
– AM vs PM - hormones
– Recumbant vs ambulatory – albumin– Concurrent therapy (e.g. IV, K +)
• Inpatient vs outpatient
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Clinical Practice Guidelines
• Published– Thyroid (2002)– Diabetes Mellitus (2002)– Cardiac Markers (1999)– Hepatic Injury (2000)
• Interviews with client physicians
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Delta Checks: How to Determine?
• Technologist Experience• Data Review
• Clinician Input• Literature
• Reference Change Values
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Delta Checks and Reference Change Values
• Assumptions– Pre-analytical Variation is minimized and
constant– Analytical Variation is less than ½ of
Biological Variation
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Calculation of Reference Change Values
• RCV = 21/2
x Z x (CV A2
+CV I2
)1/2
Z – Probability or Degree of Significance
Z= 2.58 at 99% Probability (Highly Significant)Z = 1.96 at 95% Probability (Significant)*Other Z values available in statistics tables
CV A – Analytical VariationCV I – Biological Variation (within-subject)
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Calculation of Reference Change Values
• Significant Change
• RCV sig(95%) = 21/2
x 1.96 (CV A2
+CV I2
)1/2
• Highly Significant Change• RCV high sig(99%) = 2 1/2 x 2.58 (CV A
2 +CV I2)1/2
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Reference Change Values and Delta Checks
• Example #1 – Cholesterol• CV A=2.0%• CV I=6.0%
• RCV sig(95%) = 2 1/2 x 1.96 (2.0 2 +6.0 2)1/2 = 17.2%
• RCV high sig(99%) = 2 1/2 x 2.58 (2.0 2 +6.0 2)1/2 = 22.6%
• Recommended Delta Check Value – At least 23 % from previous result– At 250mg/dl +58 mg/dl– At 300 mg/dl +69 mg/dl
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Reference Change Values and Delta
Checks• Example #2 – TSH
• CV A = 5.5% at 0.36 mU/L• CV I= 19.7%
• RCV sig(95%) = 2 1/2 x 1.96 (5.5 2 +19.7 2)1/2 = 57%
• RCV high sig(99%) = 2 1/2 x 2.58 (5.5 2 +19.7 2)1/2 = 75%
• Recommended Delta Check Value – At least 75 % change from previous result– At 0.3 uU/ml +0.23 uIU/ml
– At 5.0 uU/ml +3.75 uIU/ml– NACB Thyroid Testing Guidelines +0.75 mIU/L
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Other Uses of Reference Change Values
• Setting Quality Specifications for Tests
• Enhance Clinical Information– Use RCV information to Flag Computer-Reported Results as Significant or Highly
Significant Change
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Delta Checks and Look-Back Interval• Acute Care vs Chronic Care vs Preventive Care
– Example – K+
• Hopitalized – hours or days• Health Maintenance Profile – months
– Example TSH• Interval between Physician visits?
• Screening vs Monitoring– Example – PSA
• Screening – annually or more• Monitoring after detection (>4.0) – 6 mo to 1 yr• Monitoring after Surgery - ?3 to 6 months• Monitoring after Radiation Therapy - ?
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Concurrent Test Information• Comparison to same-order/requisition results
– Na + to Cl - or Anion Gap– TSH to FT4(3) or T4(3)
– BUN to Creatinine– ALT to AST, Bilirubin– Total Protein to Albumin
– Hemolysis Index and Troponin– Hemolysis Index and K +
Aut ove r i fi c a t i on Ru le And Re t a in -Fo r-Rev iew
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Brainstorming Data EvaluationData Gathering
Autoverification Ruleand Retain-For-Review Process
Definitions
Autoverification Rule and
Retain-For-Review ProcessMonitoring
Autoverification Rule andRetain-For-Review Process
Implementation
Autoverification Rule andRetain-For-Review Pre-
Implementation Testing
Periodic Autoverification
Rule and Retain-For-ReviewProcess Verification IF PROBLEMS
IF PROBLEMS
Aut ove r i fi c a t i on Ru le And Re t a in For Rev iewPr o c e s s Im p l e m e n t a t i o n
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DATA EVALUATION
• Use acquired data and workgroup experience toformulate rule
• Decide where to implement each part of the rule– Instrument System
– Middleware
– LIS
– HIS
Aut ove r i fi c a t i on Ru le And Re t a in -Fo r-Rev iew
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Brainstorming Data EvaluationData Gathering
Autoverification Ruleand Retain-For-Review Process
Definitions
Autoverification Rule and
Retain-For-Review ProcessMonitoring
Autoverification Rule andRetain-For-Review Process
Implementation
Autoverification Rule andRetain-For-Review Pre-
Implementation Testing
Periodic Autoverification
Rule and Retain-For-ReviewProcess Verification IF PROBLEMS
IF PROBLEMS
Pr o c e s s Im p l e m e n t a t i o n
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AUTOVERIFY RULE DEFINITION
• Define Autoverify Rules in proper form
– IF statements e.g. IF result > or < Ref Range• Evaluate True or False or Then
– Multiple IF statements linked• IF result > or < Ref Range and IF Delta Value > X%• Evaluate True or False or Then
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RETAIN-FOR-REVIEW PROCESS
• Clearly define what to do when AutoverificationRule Fails (Retain-for –Review Process)
• Use Brainstorming Group to Formulate Retain-for-Review Process– Example: If K + > 5.5-6.0 mEq/L check for hemolysis; if
not hemolyzed report; if hemolyzed report withcomment or redraw
• Do while developing Autoverification Rule(Linked Process)
Aut ove r i fi c a t i on Ru le And Re t a in -Fo r-Rev iew
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Brainstorming Data EvaluationData Gathering
Autoverification Ruleand Retain-For-Review Process
Definitions
Autoverification Rule andRetain-For-Review Process
Monitoring
Autoverification Rule andRetain-For-Review Process
Implementation
Autoverification Rule andRetain-For-Review Pre-
Implementation Testing
Periodic AutoverificationRule and Retain-For-Review
Process VerificationIF PROBLEMS
IF PROBLEMS
Pr o c e s s Im p l e m e n t a t i o n
AUTOVERIFY RULE
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AUTOVERIFY RULEand
RETAIN-FOR-REVIEWPRE-IMPLEMENTATION TESTING
• Use computer test system to test Autoverify Rule
against database
• Use database downloaded to spreadsheet to testAutoverify Rule
• Use manual testing of recently processed data
Aut ove r i fi c a t i on Ru le And Re t a in -Fo r-Rev iew
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Brainstorming Data EvaluationData Gathering
Autoverification Ruleand Retain-For-Review Process
Definitions
Autoverification Rule andRetain-For-Review Process
Monitoring
Autoverification Rule andRetain-For-Review Process
Implementation
Autoverification Rule andRetain-For-Review Pre-
Implementation Testing
Periodic AutoverificationRule and Retain-For-Review
Process VerificationIF PROBLEMS
IF PROBLEMS
Pr o c e s s Im p l e m e n t a t i o n
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AUTOVERIFY RULEand
RETAIN-FOR-REVIEW PROCESS
REVISION• Make necessary changes in the Autoverify Rule
and Retain-for-Review Processes based on resultsof pre-implementation testing
• Retest modified Rule and Retain-for-ReviewProcess
Aut ove r i fi c a t i on Ru le And Re t a in -Fo r-Rev iew
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Brainstorming Data EvaluationData Gathering
Autoverification Ruleand Retain-For-Review Process
Definitions
Autoverification Rule andRetain-For-Review Process
Monitoring
Autoverification Rule andRetain-For-Review Process
Implementation
Autoverification Rule andRetain-For-Review Pre-
Implementation Testing
Periodic AutoverificationRule and Retain-For-Review
Process VerificationIF PROBLEMS
IF PROBLEMS
Pr o c e s s Im p l e m e n t a t i o n
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AUTOVERIFY RULEand
RETAIN-FOR-REVIEW PROCESS
IMPLEMENTATION
Just Do It!
Aut ove r i fi c a t i on Ru le And Re t a in -Fo r-Rev iewP I l i
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Brainstorming Data EvaluationData Gathering
Autoverification Ruleand Retain-For-Review Process
Definitions
Autoverification Rule and
Retain-For-Review ProcessMonitoring
Autoverification Rule andRetain-For-Review Process
Implementation
Autoverification Rule andRetain-For-Review Pre-
Implementation Testing
Periodic AutoverificationRule and Retain-For-Review
Process VerificationIF PROBLEMS
IF PROBLEMS
Pr o c e s s Im p l e m e n t a t i o n
AUTOVERIFY RULE
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AUTOVERIFY RULE
and
RETAIN-FOR-REVIEW PROCESS MONITORING
• Have Back Out Plan to remove rule
• Monitor intensely for 24 – 48 hours!!
• Monitor carefully for 1 – 2 weeks!
• Monitor for 1 month
Aut ove r i fi c a t i on Ru le And Re t a in -Fo r-Rev iewP I l t t i
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Brainstorming Data EvaluationData Gathering
Autoverification Ruleand Retain-For-Review Process
Definitions
Autoverification Rule andRetain-For-Review Process
Monitoring
Autoverification Rule andRetain-For-Review Process
Implementation
Autoverification Rule andRetain-For-Review Pre-
Implementation Testing
Periodic AutoverificationRule and Retain-For-Review
Process Verification IF PROBLEMS
IF PROBLEMS
Pr o c e s s Im p l e m e n t a t i o n
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AUTOVERIFY RULEand
RETAIN-FOR-REVIEW PROCESS REVISION
• Make necessary changes in the Autoverify
Rule and Retain-for-Review Processesbased on results of monitoring
• Retest• Implement• Monitor
Aut ove r i fi c a t i on Ru le And Re t a in -Fo r-Rev iewPr o c e s s Im p l e m e n t a t i o n
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Brainstorming Data EvaluationData Gathering
Autoverification Ruleand Retain-For-Review Process
Definitions
Autoverification Rule andRetain-For-Review Process
Monitoring
Autoverification Rule andRetain-For-Review Process
Implementation
Autoverification Rule andRetain-For-Review Pre-
Implementation Testing
Periodic AutoverificationRule and Retain-For-Review
Process VerificationIF PROBLEMS
IF PROBLEMS
Pr o c e s s Im p l e m e n t a t i o n
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PERIODIC AUTOVERIFY RULE
and
RETAIN-FOR-REVIEW PROCESS
VERIFICATION
• Include Autoverify Rule Description,Retain-for-Review Process and PeriodicVerification Process in SOP
• Design Periodic Verification Process to
meet regulatory requirements
Aut ove r i f ic a t i on Ru le And Re t a in -Fo r-Rev iewPr o c e s s I m p l em e n t a t i o n
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Brainstorming Data EvaluationData Gathering
Autoverification Ruleand Retain-For-Review Process
Definitions
Autoverification Rule andRetain-For-Review Process
Monitoring
Autoverification Rule andRetain-For-Review Process
Implementation
Autoverification Rule andRetain-For-Review Pre-
Implementation Testing
Periodic AutoverificationRule and Retain-For-Review
Process VerificationIF PROBLEMS
IF PROBLEMS
Pr o c e s s I m p l em e n t a t i o n