Laboratory Ethics - NEMC

National Environmental Monitoring Conference

San Antonio, TX

Thursday, August 8, 2013

Gary P. Yakub

Environmental Standards, Inc.

Laboratory Ethics:

An Auditor’s Perspective

“Let’s begin with an interesting little story…”

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Questions

What does an auditor look for to identify

potential ethics violation?

What could have helped

the QA Manager

recognize potential

ethics violation?

Can we develop a list of tools that can help us

evaluate our laboratories?

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Data Surveillance

Internal Surveillance

External Surveillance

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What Does an Auditor Look for?

Evaluation Starts in the Pre-Audit Meeting

Strong Ethics Program

Does the Laboratory have:

Ethics Policy – Written Program?

Ethics Agreement – Signed by Everyone?

Ethics Support – Upper Management?

Ethics Training – Employee Understanding?

Ethics Audits – Specifically Target Ethics?

Corrective Actions – Ethics Violations?

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What Does an Auditor Look for? (Cont.)

Uniformity

Perfection

Following Written Procedures & SOPs

Gaps in Continuity

Trained, Knowledgeable Personnel

Adequate Equipment, Glassware

Adequate Amount of Consumables

Preparation of Standards and Reagents

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What Does an Auditor Look for? (Cont.)

Raw Data Evaluations

Timelines, Sample Through-Put

Calibration Records and Responses

Instrument Output

Manual Data Management

Related Analytical Results

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What Can Management Do?

Assign Someone to Perform Surveillance

Someone separate from laboratory operations

Develop an Internal Audit Schedule

Specifically Target Data

Integrity/Ethics

Think Like an Auditor

Develop and Utilize Tools to

Detect Issues

Practice What You Preach

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Data Surveillance Tools

Data Audit

Records Audit

Purchase Order Audit

Double-Blind Studies

Split Samples

Confidential Reporting Mechanism

Frequent Training and Discussions

Knowing Right from Wrong

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“The rest of the story…”

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Positive Factors

Strong Ethics Program

Dedicated, Educated Analysts & Managers

Strong Performance

Isolated Incident

Acceptable, Prompt Corrective Action Discipline

Re-training

Sample Qualification & Client Notification

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BONUS SLIDES!

Don’t tell anyone that you heard it from me, but

here are some things I commonly see when I audit

a laboratory…

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“Guess We Weren’t Paying Attention…”

Expired Standards and

Reagents

Solids Oven Temperatures

Thermometer Calibrations

Application of Correction

Factors

BOD – Chlorine Removal

& Sample Pretreatment

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“Close, But No Cigar”

QC Tests Analyzed, Results Ignored

Balance Calibration Verifications

Incomplete Records

Indirect Traceability vs. Direct Traceability

Incomplete or Ineffective Corrective Actions

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“That’s Just Wrong”

Metals PE Study Samples

Assorted Ethics Violations

Undertrained/Inexperienced Analysts

Incomplete Demonstrations of Capability

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Contact

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Gary Yakub

gyakub@envstd.com | 610.935.5577

Environmental Standards, Inc. “Setting the Standards for Innovative Environmental Solutions”

Headquarters 1140 Valley Forge Road | PO Box 810 | Valley Forge, PA 19482 | 610.935.5577

Virginia 1208 East Market Street | Charlottesville, VA 22902 | 434.293.4039

Tennessee 8331 East Walker Springs Lane, Suite 402 | Knoxville, TN 37923 | 865.376.7590

Texas 11200 Richmond Avenue, Suite 350 | Houston, TX 77082 | 281.752.9782

Web www.envstd.com | E-mail solutions@envstd.com