Why Data Auditing is Important Arizona State Public Health Laboratory April 2019
Objectives • Define data auditing • Explain the importance of data auditing
Data Auditing • What does data mean to you? • What is data auditing? • When should you perform data auditing?
Data Auditing Defined The process by which the inspector (internal or external) reviews the information associated with the production of the final results.
Associated References • ISO/IEC 17025:2017 • 7.5 Technical records • “…shall ensure that technical records for each laboratory activity contain the results, report and sufficient information to facilitate, if possible, identification of factors affecting the measurement result …” • 7.7 Ensuring the validity of results • The resulting data shall be recorded in such a way that trends are detectable…”
Associated References • EPA Drinking Water Manual • Chapter IV, Section 8.5, “ Adequate information should be available to allow the auditor to reconstruct the final results for compliance samples and PT samples .” • Chapters IV & VI, Section 8.6, “Computer programs should be verified initially and periodically by manual calculations and the calculations should be available for inspection. Access to computer programs and electronic data should be limited to appropriate personnel.”
Associated References • CLIA §493.1289 Analytic systems quality assessment • “The laboratory must establish … an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems…” • GLP Guidance: Providing scientific confidence (quality) through: • Quality standards (personnel, maintenance, etc.) • Fundamental scientific practices • Accountability
Overview of Data Auditing • Obtain a list of samples prior to performing the review and select a few to inspect • Different tests, different analysts, new methods, around holidays or rush samples • Pull appropriate SOPs, methods, and other supporting documents
Overview of Data Auditing • Pull checklists, if available, to perform review • Consistency in review • Ensure cover key elements • Review of hand calculations or spreadsheets • Mint Miner review for organic analysis
Overview of Data Auditing • Quality Control • Quality control for the test • Does this match what is required by test, package insert, or regulations? • Does it match what is in the SOP? • Acceptance criteria clearly located and understood • Are the results being monitored for shifts and trends? • Correct organisms or standards being used
Example - Microbiology • Data auditing • Inventory • Quality control • Temperatures • Molecular review • Use of the above • What else needs to be considered
Reviewing inventory • Checking logs (or LIS) where inventory information is stored • Is enough reagent or media being ordered for volume of testing? • Are lot numbers and expiration dates clearly documented (traceability back to samples analyzed)?
Temperature • Reviewing temperature logs • Are the temperatures within specifications and clearly documented? • Is the thermometer in use verified to be accurate? • Is there a correction factor? • Are temperatures being taken each day of operation? • If not, why not?
Example - Inorganic • A small sampling of reviewing information • Calibration of instruments • Verifying calculations • Verifying maintenance/set up
Calibration Examples
Calibration Examples
Verifying calculations
Maintenance and Set up
Example - Organic • A small sampling of reviewing information • Use of Mint Miner tool • Review of calibration and quality control samples
Mint Miner • Mint Miner allows for the review of data quickly • Chemstation (Enviroquant) • Thru-Put Systems Target • Perkin-Elmer TurboChrom • Only one tool in toolkit but can be powerful
Mint Miner View
ChemStation QEdit
10/20/2017 552.3 PQL 5.0 ppb
10/20/2017 552.3 PQL 5.0 ppb 19 Manual Ints Starting at 10.5489 ppb
Professionalism is Key • When performing a review avoid being condescending – everyone is a professional • Cooperation is the key to performing any assessment whether internal, external or even investigatory
Conclusion • Data auditing defined • Importance of data auditing
Thank you Arizona State Public Health Laboratory Team Steve Baker, Office Chief of Laboratory Licensure and Certification Mary Cornell, State/Federal Laboratory Licensure Surveyor Barbara Baker, Quality Assurance Officer Miranda Schaab, Quality Assurance Officer
Contact Kathryn Wangsness, MHA Quality Assurance Manager and Office Chief of Laboratory Services Kathryn.wangsness@azdhs.gov 602.364.0724 Steve Baker, MS Office Chief of Laboratory Licensure and Certification Steve.baker@azdhs.gov 602.364.0735
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