Why Data Auditing is Important Arizona State Public Health - - PowerPoint PPT Presentation

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
• r 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