Why Lab. Certification?

Laboratory certification tries to insure that the laboratory is qualified and capable of analyzing the sample and obtaining quality data.

Certification cannot guarantee that a laboratory will obtain quality data on a specific sample.

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

Laboratory Paper AuditReview 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 MDLs

Categories of OQA Lab. Certification

DW WP SHW CLP Air Radon Radiochemistry

Types of Test Methods

Inorganics

Metals

Organics

Biologicals

Sources of Test Methods

EPA (SM, SW-846)

ASTM

USGS

DSAMs

Personnel Qualifications

ELCP- Supervisors and bench operators must have specific experience and education; listed in 7:18.

NELAP- Technical Directors (supervisors) must have specific experience and BS.

When staff change instruments, they must re-qualify on new instrument before generating data

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.”

Method SOPs

Method SOP must detail all the steps needed to successfully complete the analysis.

The SOP must state what that lab. actually does 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-

www.epa.gov/quality/qs_docs/g6.final.pdf

Performance Testing (PT) Samples

ECLP-Lab successfully analyzes one PT per program/analyte/year– Separate programs for DW, WP and SHW

NELAP- Lab successfully analyzes two PT per program/analyte/year

In addition; SDW One PT per method per year

Demonstration of Capability (DOC)

DOC- NELAC term for Precision and Accuracy (P&A) 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

Method Detection Level (MDL)

MDL based on the 40 CFR 136 app. B Evaluated against the method values Must be generated for each certified method

annually Labs. Must evaluate their reporting level (RLs)

against their calculated MDLs DEP auditors look at this information while

conducting on-site audits

Laboratory On-site Audit

NELAC labs. are looked at every 2 years

ELCP Labs. every 3-5 years, or when a DEP program asks us to review specific information

OQA staff have expertise in every area of analytical testing; multiple staff participate in most audits

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

Sample Receiving and Custody

Must show that the lab. follows the SOP Proper use of sample containers Proper sample entry log Complete chain of custody Sample preservation documented (pH, Temp.) Internal sample tracking system (analysts

cannot check out samples themselves) Select samples to track through the lab.

The Bench Audit

Interview Analyst Compare operation to the official SOP Question analyst about their knowledge of

the method Evaluate QC used vs. Method-required QC Examine laboratory data Check appropriate use of all reagents Verify data reporting and review

Recordkeeping

Examine how data is reviewed and reported

Insure that records (paper & electronic) are securely stored and can be retrieved if needed

Laboratories must demonstrate capability to produce specific reports and/or forms (e.g., CLP)

Typical Complaints About Laboratory Data

Not Certified for Analyte or Method Wrong Method Reporting Level of Data Does Not Meet

Regulatory Level Not following the method Incomplete or Wrong QC Sample Custody Violated Holding Times Exceeded

Complaints About Laboratory Data:Investigation and Follow-Up

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 & QA Officer

– Problem may be larger than one sample set

Investigation and Follow-Up: Next Steps

OQA will issue a Letter of Deficiency that can be shared with interested DEP program(s)

Lab. has 60 days to perform required remedial action

Enforcement actions (fines, loss of cert.) can result if remedies are not made

For repeat offenders, subsequent follow-up audits, often unannounced, can be scheduled

How to Choose a Laboratory

NJDEP Certified? Is Lab. certified for required methods? Review laboratory quality systems What is OQAs history with this lab.? Will lab. provide all requested documentation? Can lab.

– Meet project data quality objectives?

– Provide required data deliverable?

– Provide timely results?

Provide all information on the nature of the samples to be analyzed

If there are specific DQOs, tell the lab. in advance of sample collection

Be specific on what your data reporting needs are

Find a lab. contact you are comfortable with and maintain open communication

If you have any issues, let the lab. know ASAP!

How to Communicate With Your Lab.