Approval of Laboratories with existing National Environmental Laboratory Accreditation Conference (NELAC) accreditation

In Reply Refer To:
Mail Stop 412                                 January 9, 2002


Office of Water Quality Technical Memorandum 2002.05

Subject:  Approval of Laboratories with existing National Environmental
          Laboratory Accreditation Conference (NELAC) accreditation

Background

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.

Approach

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 /s/
                         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.

(See attached file: tech.nelac.0205.htm)
********************************************
Stephen K. Sorenson
Acting Chief, Office of Water Quality
US Geological Survey
412 National Center
Reston, VA  20192
703/648-6864
sorenson@usgs.go