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. 7:18
National Environmental Laboratory Accreditation Program (NELAP)
Laboratory follows NELAC standards
Accreditation recognized in eleven states
ELCP This program was established in the early 80’s. It has evolved into a program that emphasizes:
EPA promulgated analytical methods
QC Defined by the Method and NJAC 7:18
Lab SOPs
Actual data review
Lab successfully analyzes one PT per program/analyte/year
NELAP national standards set by about 42 states & 5 Federal programs. Major input by private sector ((NELAC conference)
Based on Quality System Approach
International ISO standards ISO1725
Quality System entails extensive record keeping
Lab successfully analyzes two PT per program/analyte/year
Program is an advantage to a Lab that analyzes samples from several states
Data Quality of NJ labs should be the same INDEPENDENT OF THE PROGRAM

3. 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 MDLs
Performed for new labs coming into the Program, Labs requesting new methods.
For a new lab an onsite audit is scheduled after the successful paper audit.

4. Categories of OQA Lab. CertificationDW WP
SHW
CLP
Air
Radon
Radiochemistry
Performed for new labs coming into the Program, Labs requesting new methods.
For a new lab an onsite audit is scheduled after the successful paper audit.

5. Types of Test Methods Inorganics Metals Organics Biologicals
Performed for new labs coming into the Program, Labs requesting new methods.
For a new lab an onsite audit is scheduled after the successful paper audit.

6. Sources of Test Methods
EPA (SM, SW-846)
ASTM
USGS
DSAMs
Performed for new labs coming into the Program, Labs requesting new methods.
For a new lab an onsite audit is scheduled after the successful paper audit.

7. 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
Need qualified staff to obtain quality 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.”
ELCP- Program does not list the detailed requirements
NELAC standards have very detailed requirements, 29 page check list

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-
ELCP- does not have any detailed instructions for SOPs
NELAC QA chapter 5 has some instructions

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
PTs are an indication of the Lab ability to analyze the parameter, single blind.
Should be analyzed as a sample.
EPA DW requires One PT per method. ICP + GFAA
PT failures are investigated at the onsite.

11. 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
Evaluated against the method values.
Used to establish initial Lab QC values for LCS and MS

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
Every two years
New lab in the program
Lab wants to add a technology to Certification. i.e. ICP, GC/MS, ICP/MS
Lab adds a new code, microbiology,
Complaint

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
Every two years
New lab in the program
Lab wants to add a technology to Certification. i.e. ICP, GC/MS, ICP/MS
Lab adds a new code, microbiology,
Complaint

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.
Entry log- book or computer, Contains Key sample information:
client ID, Lab ID, sampling time & date, Analysis needed, preservation
COC check several for completeness:
Preservation Checks recorded. Includes bottles if provided by lab.
Internal Tracking:
sample custodian must sign sample release. Location and analyst of sample must be documented.
Formal internal COC available by contract or request of customer.

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
This is where you find out what is happening
Analyst my not have current SOP or may have made changes
Does the lab have current control charts
Bench records very important for classical chem. Not computerized
Sample Data:
Methods On GC/MS, check manual intergrations

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)
This is where you find out what is happening
Analyst my not have current SOP or may have made changes
Does the lab have current control charts
Bench records very important for classical chem. Not computerized
Sample Data:
Methods On GC/MS, check manual intergrations

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
Under most circumstances data is reviewed at OQA.
Check methods requested vs OQA data base and method actually used by looking at data summaries.

19. 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

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!