Why Lab. Certification?

1
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.

2
NJ Has Two Certification Programs

• NJ Environmental Laboratory Certification Program
  (ELCP)
• Laboratory analyzes NJ samples
• Laboratory follows N.J.A.C. 718
• National Environmental Laboratory Accreditation
  Program (NELAP)
• Laboratory analyzes NJ samples
• Laboratory follows NELAC standards
• Accreditation recognized in eleven states

3
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

4
Categories of OQA Lab. Certification

• DW
• WP
• SHW
• CLP
• Air
• Radon
• Radiochemistry

5
Types of Test Methods

• Inorganics
• Metals
• Organics
• Biologicals

6
Sources of Test Methods

• EPA (SM, SW-846)
• ASTM
• USGS
• DSAMs

7
Personnel Qualifications

• ELCP- Supervisors and bench operators must have
  specific experience and education listed in
  718.
• NELAP- Technical Directors (supervisors) must
  have specific experience and BS.
• When staff change instruments, they must
  re-qualify on new instrument before generating
  data

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 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

10
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

11
Demonstration of Capability (DOC)

• DOC- NELAC term for Precision and Accuracy (PA)
  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
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

13
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

14
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

15
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.

16
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

17
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)

18
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

19
Complaints About Laboratory DataInvestigation
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

20
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

21
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?

22
How to Communicate With Your Lab.

• 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!