In
Reply Refer To:
Mail
Stop 412 January 9, 2002
Subject: Approval
of Laboratories with existing National Environmental Laboratory Accreditation
Conference (NELAC) accreditation.
Office
of Water Quality Technical Memorandum 98.03 discusses the approval process and
responsibilities for accepting analytical work from an outside laboratory. When a U.S. Geological Survey (USGS)
District chooses to use a laboratory other than our national laboratories, the
laboratory must prove that they can provide comparable data to those in our
national database.
The
process to ascertain that data are acceptable for the USGS is two-fold. The first involves the Laboratory Evaluation
Project (LEP), which reviews the Quality System of a laboratory. Proper documentation, along with identified
and quantifiable quality-control (QC) and quality-assurance (QA) practices
provide the formula for acceptable data generation. Secondly, the Standard
Reference Sample (SRS) project provides biannual reference materials to
laboratories to assure that specific analyses are operating within an
acceptable range. Together, the laboratory QA processes and the laboratory
analytical results (QC) provide the USGS with an overall assurance of quality
data.
Previously,
environmental laboratories had to prove analytical proficiency to multiple
customers with differing criteria for acceptance. It was not uncommon that a laboratory had to participate in three
or four different complete laboratory audits per year, all with slightly
different requirements. The National Environmental Laboratory Accreditation
Conference (NELAC) was formed to try to establish mutually acceptable
performance standards for the inspection and operation of environmental
laboratories.
USGS
would like to benefit from this consolidation of effort, and to minimize
redundancy in the laboratory approval process. Therefore, USGS will recognize
NELAC accreditation of laboratories for their quality-systems assessment and no
longer require an independent USGS review. NELAC accreditation will suffice for
USGS laboratory quality systems approval. Specific analyte performance
proficiency is tested separately from laboratory quality system approval, and is
still required for USGS.
The NELAC proficiency test sample results can be used to supplement USGS analyte performance evaluation. However, analysis of USGS standard reference samples (SRS) will remain a necessary prerequisite for USGS approval. This is because proficiency test samples are aimed at satisfying specific regulatory program data quality objectives, and are not geared towards USGS ambient monitoring or in real matrices (they are usually spiked in laboratory reagent grade water). .
For
a LABORATORY to be approved by USGS:
1.
If a laboratory is NELAC certified, the USGS requirements for general
documentation are satisfied and the laboratory is approved providing:
a.
The
laboratory is certified for similar analyses as those of interest to the USGS;
b.
The
list of deficiencies found by the NELAP accrediting authority is either
resolved or in an acceptable state to the USGS; and
c.
There
have been no significant changes in performance or operation that would change
any previous findings.
2. To verify that the laboratory of interest is acceptable to USGS, we will require an amended list of documents for laboratory approval.
a.
The
complete NELAC deficiency log from the NELAC on-site laboratory inspection.
Include the laboratory response and corrective actions report.
b.
The
NELAC proficiency sample results for at least two consecutive test periods.
c.
The
requested analytes and concentrations ranges that need to be covered for the
USGS project.
d.
SOPs
of analyses for which the laboratory is NOT NELAC accredited.
For
approval of SPECIFIC ANALYTES from a USGS approved Laboratory:
1. Approval for specific
analytes are USGS approved if they are NELAC accredited under the correct
program.
a.
NELAC
accreditation can be under either the Clean Water Act (CWA) or the Safe
Drinking Water Act (SDWA) for USGS approval.
b.
USGS
cannot accept accreditation under the CAA (Clean Air Act) for water
samples.
c.
USGS
cannot accept accreditation under the Resource Conservation and Recovery Act
(RCRA) and Comprehensive Environmental Response, Compensation, and Liability
Act (CERCLA - commonly known as Superfund) for USGS analyses at ambient
concentrations unless the ability to provide appropriate results in the
expected concentration range and the appropriate matrix is proven.
2. For NELAC accredited Inorganic
analyses, participation in the USGS standard reference (SRS) project is still
required.
3. For NELAC accredited
Organic, Radiochemical, Physical Measurements, and Biological analyses,
participation in the USGS standard reference (SRS) project is not required if
proficiency test samples are acceptably analyzed.
4. If a laboratory has NELAC
accreditation and USGS requires proof of proficiency for analytes that are not
within the scope of its NELAC accreditation, the laboratory must provide
appropriate SOPs to the USGS, and prove that these other analyses remain under
the general Quality System accredited by NELAC audit.
Once
a laboratory is approved by USGS, the specific analytes of interest must remain
in an acceptable status as determined by performance on SRS and/or appropriate
proficiency test samples. NELAC laboratory approvals are based on a 12-month
period, and must be maintained in order to extend beyond 12 months. USGS approvals are good for three years or
until NELAC accreditation is revoked or performance is unacceptable and deemed
irreparable in an appropriate time frame.
Stephen K. Sorenson
Acting Chief, Office of Water Quality
Distribution: A, B, FO, PO
District
and Regional Water Quality Specialists
This
memorandum is an amendment to Office of Water Quality Technical Memorandum
98.03.