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AUTOVERIFICATION:The HOW

Michael W. Fowler, Ph.D.

Distinguished Professor of Chemistry and Biology

Oklahoma Christian UniversityOklahoma City, OK



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



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.



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



Specimen Parameters

• Specimen Type, Acceptability and AnalysisBias– Serum– Plasma ( EDTA, heparin, other)– Whole Blood

• Specimen Stability



Instrument Parameters• Specimen Validity Flags, Indices Flags and/or

Quantification– Hemolysis– Lipemia

– Icterus– Others

• Performance Flags– Abnormal Absorbance– Range Limits– Insufficient Sampling– Clots



Analytical and Quality ControlInformation

• Method Imprecision

• Method Interferences

• Method Bias

• Automated QC monitoring



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



Clinical Practice Guidelines

• Published– Thyroid (2002)– Diabetes Mellitus (2002)– Cardiac Markers (1999)– Hepatic Injury (2000)

• Interviews with client physicians



Delta Checks: How to Determine?

• Technologist Experience• Data Review

• Clinician Input• Literature

• Reference Change Values





Delta Checks and Reference Change Values

• Assumptions– Pre-analytical Variation is minimized and

constant– Analytical Variation is less than ½ of

Biological Variation



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)



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



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



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



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



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 - ?



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





Definitions




Implementation





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



DATA EVALUATION

• Use acquired data and workgroup experience toformulate rule

• Decide where to implement each part of the rule– Instrument System

– Middleware

– LIS

– HIS






Definitions




Implementation





IF PROBLEMS

Pr o c e s s Im p l e m e n t a t i o n



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



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)






Definitions


Monitoring


Implementation



Periodic AutoverificationRule and Retain-For-Review

Process VerificationIF PROBLEMS

IF PROBLEMS


AUTOVERIFY RULE



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






Definitions


Monitoring


Implementation





IF PROBLEMS




AUTOVERIFY RULEand


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






Definitions


Monitoring


Implementation





IF PROBLEMS




AUTOVERIFY RULEand


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





Definitions




Implementation





IF PROBLEMS


AUTOVERIFY RULE



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





Definitions


Monitoring


Implementation




Process Verification IF PROBLEMS

IF PROBLEMS




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





Definitions


Monitoring


Implementation





IF PROBLEMS




PERIODIC AUTOVERIFY RULE

and


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





Definitions


Monitoring


Implementation





IF PROBLEMS

Pr o c e s s I m p l em e n t a t i o n

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C User Sh Elder App Data Local Microsoft Windows Temporary Internet Files Content Outlook221R84SMTheHow[1]