Methods and Data Comparability Board

1
Methods and Data Comparability Board

• Accreditation of Federal Laboratories for Water
  Quality Monitoring
• Advisory Committee on
• Water Information
• April 3, 2002

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Accreditation Workgroup Presentation

• Herb Brass -- USEPA
• Bart Simmons -- CA Department of Toxic Substances
  Control (Workgroup Co-Chair)
• Cliff Annis -- Merck Co., Inc.
• Jerry Parr -- Catalyst Information Resources,
  Inc.
• Jerry Diamond -- Tetra Tech

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Organizations Represented in Accreditation
Workgroup

• USGS
• USEPA
• US DOD (Corps of Engineers and Navy)
• CA Dept of Toxic Substances
• Association of Public Health Laboratories
• ME Health and Env. Testing Laboratory
• AZ Dept. of Health

• VA DEQ
• American Chemistry Council
• Merck and Co., Inc.
• Catalyst Information Resources
• Standard Methods
• Montgomery Watson Harza
• IDEXX Laboratories
• Tetra Tech

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Mission of the Accreditation Workgroup

• Develop and promote a Board position on
  laboratory accreditation and field certification.
  Coordinate with external accreditation
  standard-setting organizations (e.g., NELAC).

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Why Accreditation?

• There has been the notion that following the
  method ensures accurate data. A method is
  simply one key component of generating reliable
  data. Consider an analogytwo chefs, in two
  kitchens, using the same recipe

In the hands of a skilled, experienced cook,
using fresh ingredients and with all the right
equipment, a wonderful outcome will result.

• The same recipe in the hands of an inexperienced
  cook with less-than-terrific equipment is a
  riskier proposition.

Both cooks, however, may be following the same
method.
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Accreditation Workgroup accomplishments

• White Paper on the value of accreditation
• Issue Paper on the need for federal lab
  accreditation
• Coordination with NELAC and ELAB
• Diverse representation on the workgroup was key
  to achieving consensus on recommendations

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Revised Recommendations for Federal Laboratories
(2002)
1
All federal agencies (and commercial laboratories
employed by federal agencies) performing
analytical water testing, as part of compliance
or ambient monitoring programs, be accredited
under a recognized program, in order to better
establish comparability of data and to meet the
needs of specific federal agency programs. Each
agency should evaluate the cost of implementing
this recommendation as it applies to their
individual situation.
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Revised Recommendations for
Federal Laboratories (2002)
2
The National Environmental Laboratory
Accreditation Program (NELAP -- full program) is
the Boards recommended program, because NELAP
adequately meets (or is taking measures to that
meet) the broad needs of the majority of federal
laboratories performing water testing.
Specifically, it is focused on uniform
accreditation requirements across states (and
therefore, potentially reduces accreditation
costs for labs operating in several states), and
allows Federal as well as state accrediting
authorities.
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Revised Recommendations for
Federal Laboratories (2002)
2

• For NELAP to serve as a satisfactory
• accrediting program for federal laboratories,
• NELAP needs to continue its efforts to
• Obtain more state participation and reciprocity
• Address standards for ambient monitoring,
• field sample collection, and field
  measurements
• Promote the development of PBMS implementation

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Revised Recommendations for Federal Laboratories
(2002)
New 3

• The MDCB (and its parent organization, the
  NWQMC) will periodically re-evaluate NELAPs
  suitability to serve as a national accreditation
  program in order (1) to review the status of
  their progress in the aforementioned efforts, and
  (2) to encourage state, federal, and private
  participation in NELAP

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Revised Recommendations for Federal Laboratories
(2002)
4
Federal agencies should consider seeking to
become an accrediting authority for their own
laboratories under NELAP Recommendation deleted
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Accreditation of Federal Laboratories for Water
Quality MonitoringComments Received

• ACWI -- May 2001
• EPA -- August 2001
• ACWI March 2002

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ACWI Comments May, 2001

• Concern about federal agencies becoming
  accrediting authorities for their own
  laboratories -- conflict of interest.
• Response -- Delete recommendation 4 and add
  text stating that Council and Board will track
  progress by EPA and other agencies.

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ACWI Comments-- May, 2001

• Concern about recommending a specific
  accrediting program
• Response -- Further explanation added in text
  to strengthen NELAP as recommended accreditation
  program. Added recommendation that MDCB and NWQMC
  will periodically review NELAP progress.
  Combined original recommendations 2 and 3

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Major EPA Comments

• Costs of implementing recommendations not
  specified
• Response -- Recommendation 1 modified to state
  that federal organizations should consider cost
  impact. Comments added in text including results
  of an analysis that suggests that cost should be
  reduced under a national accreditation program

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Major EPA Comments

• Need to note that recommendations are to be
  adopted on a voluntary basis.
• Response Text of position paper changed to
  reflect this point.

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Major EPA Comments

• Concern about accreditation of research
  laboratories performing projects, such as methods
  development
• Response -- Text changed to reflect that
  research labs need not be accredited under such
  circumstances

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Major EPA Comments
Needs to be a better presentation of the problem
(including relevant history) and background to
the paper in the Introduction section. Those
unfamiliar with the word accreditation and its
benefits will have difficulty grasping the issues
and ideas expressed in the paper. Need to define
reciprocity. Response -- Introductory section
added that defines accreditation, its benefits,
its importance in monitoring, and relevant
discussion of the problem being addressed in the
paper. Taken from Value of Accreditation
write-up. Reciprocity defined.
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Major EPA Comments

• Definition of terms needs to be added for
  clarity
• Response -- a table was added early in the
  text to define terms

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Major EPA Comments
The paper needs to present more supportive
materials for NELAP justifying it as the
recommended program Response -- More information
was added that brings out several advantages or
Merits of NELAP including their relatively
comprehensive accreditation standards, open-forum
approach to participation, and focus on state
reciprocity issues. Relevant information
concerning NELAC has also been incorporated in
this section. Text has been added explaining
recent improvements in state and laboratory
participation in NELAP, which further
demonstrates NELAP as a feasible and preferred
option
21
ACWI Comments-- March, 2002

• Smaller labs may find accreditation to be
  resource prohibitive (NOAA)
• Response -- Cost studies show that national
  accreditation is cost effective, if laboratories
  have quality systems in place. Under NELAP,
  options are available for tiering, so that some
  requirements are reduced for smaller laboratories.

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ACWI Comments-- March, 2002

• Research laboratories must be required to meet
  accreditation standards, because their data may
  be used to establish baseline contamination
  levels, and should be of suitable quality to
  compare to compliance and other monitoring data.
  (LWVUS)
• Response -- Opinions regarding accreditation of
  research laboratories varied from full
  accreditation to none. Position taken is a
  compromise that recommends that laboratories not
  gathering monitoring data have documented
  quality systems in place to ensure that
  appropriate data are collected.

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ACWI Comments-- March, 2002

• The Quality Assurance Officer for Illinois
  EPA-Bureau of Water and I whole-heartedly agree
  with the position expressed. Illinois and many
  other states labs are NELAP accredited and also
  provide NELAP accreditation to other private and
  government labs. NELAP is now the most wide
  spread accreditation program in the USA, and it
  allows reciprocity between states and other
  entities. NELAP accreditation provides a basic
  level of quality assurance for analytical
  laboratories. (Gregg Good, Mike Henebry)

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ACWI Comments-- March, 2002

• NELAP is not recognized on an international basis
  as is A2LA. If we have federally recognized
  accreditation, it should operate on a global
  basis.
• Response -- There is a fundamental difference
  between the US and other countries.
  Environmental laboratory accreditation is viewed
  by states (and EPA) as an inherently governmental
  function. This comes from the delegation of the
  SDWA program to the states by EPA. However,
  integration with international standards is
  important. Note -- while A2LA is recognized
  internationally, it has not been embraced by the
  states.

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Status of NELAP

• Most accredited labs are wastewater, drinking
  water, or commercial labs
• Over 1,200 accredited labs in 45 states, Puerto
  Rico and three foreign countries
• New York Dept of Health accredits the most labs

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Current NELAP Issues

• Re-restructuring to satisfy legal concerns and to
  potentially to use a non-profit organization
• Revising standards to comply with ISO 17025
• Revising standards to incorporate
  performance-based testing

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Future Methods Board Accreditation Tasks

• Transmit public version of NEMI to the NELAC
  Board, ELAB, and NELAC Quality Systems Committee
• Review proposed language on performance-based
  standards and recommend changes to NELAC Quality
  Systems Committee
• Recommend changes to NELAC standards to conform
  with Water Quality Data Elements
• Pursue the option of taxonomy standards with NELAC

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