1. LABORATORY CERTIFICATION & DATA QUALITY MICHAEL W. MILLER, Ph.D. NJ-DEP Office of Quality Assurance 609-292-3950 mmiller1@dep.state.nj.us

2. Outline Introduction Laboratory Paper Audit Laboratory On-site Audit Complaint About Laboratory Data

3. OFFICE OF QUALITY ASSURANCE (OQA) Certify ~900 labs. worldwide who do environmental chemical and biological analyses in NJ; 25 Radiochem. Labs Perform management and technical audits of DEP programs Review DEP project and program plans Provide technical assistance to DEP programs on data issues Conduct training

4. Laboratory certification ensures that the laboratory is capable of analyzing the sample and obtaining quality data. Certification does not ensure that a laboratory will obtain quality data on a specific sample.

5. NJ Has Two Certification Programs NJ Environmental Laboratory Certification Program (ELCP) –Laboratory analyzes NJ samples –Laboratory follows N.J.A.C. 7:18 National Environmental Laboratory Accreditation Program (NELAP) –Laboratory analyzes NJ samples –Laboratory follows NELAC standards –Accreditation recognized in eleven states

6. DEP Certified Radiological Labs

7. Laboratory Paper Audit Review of Documents at OQA Personnel Qualifications Quality Systems Manual (QSM) Method SOPs Review of Performance Testing Results (PTs) Review of Demonstration of Capability Review of Minimum Detectable Activity (MDA)

8. Quality Systems Manual ELCP-Lab must have a QA/QC manual that describes procedures to implement QA. –From sample receipt to data report NELAP- A document stating the management policies, objectives, principles, organizational structure and authority, responsibilities, accountability, and implementation of an organization, to ensure the quality of its product and the utility of its product to its user.

9. Method SOPs Method SOP must detail all the steps needed to successfully complete the analysis. The SOP applies to the specific Lab. If a published method has choices the Lab must specify the choice used. Dated, numbered, revision, and signed by manager &/or QA person EPA guidance for Preparing SOPs EPA QA/G-6: www.epa.gov/quality/qs_docs/g6.final.pdf

10. Performance Testing Results ECLP-Lab successfully analyzes one PT per program/analyte/year NELAP- Lab successfully analyzes two PT per program/analyte/year In addition; SDW One PT per method per year At this time ERA only Rad. PT provider

11. Demonstration of Capability (DOC) DOC- NELAC term for Precision and Accuracy Study LAB Control Sample (LCS)- Lab Spiked Blanks –Initial Four Samples per analyte per method –Determine RSD and %R NELAC requires DOC for each analyst ELCP requires only one set of P & A for lab Establishes the performance of the method & analyst

12. Laboratory On-site Audit Review records for QSM Sample Receiving (Track a sample) Check analytical method used vs. SOP Check Method QC Interview Analyst Review bench records Review raw data PT results Corrective actions from previous audit

13. Quality System Manual NELAC 29 page checklist to validate the implementation of the QSM ELCP systematic review of Labs operational procedures Staff implements QSM

14. The Bench Audit Interview Analyst Compare operation to the official SOP QC used vs. Method QC Bench Records Actual sample data –Look at the data system –NJDEP data or PT data

15. Complaints About Laboratory Data Type Laboratory Not Certified for Analyte or Method Wrong Method Data Does Not Meet Regulatory Level Not following the method Incomplete QC Holding Times

16. Complaints About Laboratory Data Investigation Request documents from Lab. for OQA review –Chain of Custody –Customer data report –Data, Calibration and QC summaries –Full Data package after preliminary review Conduct On-site Audit –Need to interview analyst –Problem may be larger than one sample set