Transcript Louisiana Environmental Laboratory Accreditation Program

Louisiana Environmental
Laboratory Accreditation
Program (LELAP)
Paul Bergeron
LELAP Supervisor
Joint Emergency Services
Training Center
Zachary LA
April 29, 2010
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Why Accreditation?
•Many state agencies, not just LDEQ, make
policies based on data from laboratories.
•Consequently, objections to policies are
pursued by challenging the quality of the data.
•Accreditation is a mechanism for establishing
that a laboratory has a system for producing
data of known and documented quality.
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Scope of Accreditation
•EPA and DEQ have policies concerning how
different media or matrices are affected by
human activity.
•Laboratories specialize in the ability to
measure compounds and parameters in the
matrices according to recognized methods.
•Accredited laboratories receive a scope of
accreditation which identifies the matrix,
method, and analyte on which the
accreditation is based.
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Accreditation and
Certification—what’s the
difference?
•Accreditation is used to verify that
laboratories have an appropriate quality
management system and can properly perform
test methods and calibration parameters
according to their scopes of accreditation.
•Certification is reserved for personnel and
products as having adequate credentials or
meeting certain requirements.
•Accredited laboratories do receive and must
display a certificate.
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Accreditation in Louisiana
•The only state in the US with two
NELAP Recognized Accrediting Bodies
(Louisiana Department of
Environmental Quality and Louisiana
Department of Health and Hospitals)
•The only state in the US offering full
accreditation for stack testers
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
LDEQ Overview
•LELAP was created in 1994 by
legislation
•Program began accepting
applications in 1998; since then,
number of applications has leveled
off to 5-10 year
•Interim accreditation ended in 2001
•Program officially became a NELAP
accrediting authority in 2001 and a
NELAP accrediting body in 2008
following the formation of TNI
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
NELAP v. LELAP
•NELAP does not fully accredit
stack testers; LELAP accredits stack
testers
•NELAP requires records to be
retained for 5 years; LELAP
requires records to be retained for
10 years
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
NELAP v LELAP
•NELAP requires two rounds of passing
proficiency test results for the addition of
a method to the scope of accreditation;
LELAP requires one round
•NELAP gives laboratories the option to
perform supplemental proficiency tests;
LELAP requires remedial proficiency tests
for failed routine proficiency tests
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
NELAP v LELAP
•If proficiency test samples are not
available, NELAP requires the
maintenance of a total quality
management system; LELAP requires an
analytical data package
•NELAP addresses the use of
experimental proficiency tests; LELAP
does not address experimental
proficiency tests
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
NELAP v LELAP
•NELAP requires the technical director of a
chemistry laboratory to have 24 semester
hours of chemistry in addition to a
bachelor of science degree; LELAP requires
a bachelor of science degree or 4 years of
equivalent experience in a related field
•NELAP requires all containers of prepared,
standards, and reference materials to bear
an identifier and expiration date; LELAP
requires all purchased chemicals, solutions,
and standards to be labeled with the date
of receipt, expiration date, and date the
container is opened.
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
NELAP v LELAP
•NELAP requires a laboratory to state that the
final report shall not be reproduced except in full
without the written approval of the laboratory;
LELAP requires a laboratory to state that the
report shall not be reproduced in full or in part
without the written approval of the customer
•NELAP does not require quality assurance data
to be included with final reports; LELAP requires
that the report include appropriate quality
assurance documents.
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
At Present…
•185 accredited facilities
•10 applicants are pending, 7 are first-time
•1 facility was suspended in 2009
•92 facilities accredited by primary
accreditation, 74 facilities by secondary
accreditation (recognition), 19 have both
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Primary and Secondary
Accreditation
Laboratories Accredited by the State Regulations and
the National Standard
Primary Accreditation
(92)
Secondary Accreditation
(74)
Both (19)
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Instate versus Out-ofState
Laboratories (185)
In-State (48)
Out-of-State
(137)
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Accreditation by Program
Programs Which are Accredited Directly by
LDEQ or Recognized
NELAP (97)
LELAP (State
Regulations) (58)
AASHTO (1)
AIHA or NVLAP (17)
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
NELAP Accreditation
Laboratories
In-State (17)
Out-of-State
(Primary) (16)
Out-of-State
(Secondary) (66)
Out-of-State
(Both) (9)
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Accreditation Application
•Electronic copy available on
website
•Must include application fee
•Must include copy of Quality
Assurance Manual and list of SOPs
•Must include proficiency test
results
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Proficiency Testing
•List of approved providers is available at
website
•LELAP no longer approves providers for
gas proficiency tests
•The requirement for gas proficiency
tests is suspended until such providers
are accredited by the American
Association for Laboratory Accreditation
(A2LA)
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Analytical Data Packages
• Submitted in lieu of proficiency test results when there
are no approved proficiency test samples
• Defined as including all analytical method, technical
information, and quality assurance results
• If facility is not performing the method, it must provide
data as specified by the reference method calibration
or quality control requirements at a minimum
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Confidential Business
Information
• See LAC 33:I.503
• Must be declared before an assessment begins
• Materials granted CBI status will be locked with
restricted access
• Request must be renewed every two years
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Test Categories
•Metals
•Microbiology
•Biomonitoring
•Classical Wet Chemistry
(nutrients, minerals, ions,
demands, and coliforms)
oMinor conventional
parameters
•Organics (semi-volatiles,
volatiles, pesticides,
herbicides, and PCB’s)
•Dioxins and Furans
•Radiochemistry
•Asbestos
•Geotechnical Soil Testing
•Air Pollutants
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Minor Conventional
Parameters
BOD5, HexaneExtractable Material, TSS,
Fecal & Total Coliform,
and Residual Chlorine
ONLY
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Accreditation by Test
Categories
All Accredited Laboratories
With 1 category
(77)
With 2
categories (31)
With 3
categories (55)
With 4
categories (17)
With 5
categories (5)
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Accreditation by Category
and Location
60
50
40
30
20
10
0
In-State
Laboratories
(48)
Out-of-State
Laboratories
(137)
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
NELAP Accreditation by
Category and Location
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45
40
35
30
25
20
15
10
5
0
In-State Laboratories
(17)
Out-of-State
Laboratories (93)
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
NELAP Primary and Secondary
Accreditation by Category for
Out-of-State Laboratories
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30
25
20
15
10
5
0
Primary (92)
Secondary (74)
Both (19)
With 1
With 2
With 3
With 4
With 5
category categories categories categories categories
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
ASSESSMENT TEAMS
• Assessment teams are
comprised of assessors from
LELAP.
•Most assessments require at
least two assessors.
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Pre-Assessment Materials
• Includes checklists, standard operating
procedures, and data packages
• Facilities are requested to complete and
return the checklist prior to assessment
• Offsite reviews reduce travel time to
assessor and visiting time for laboratory
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Scope Amendments
• Request must be submitted in
hard copy, accompanied by
one round of proficiency test
results (state) or two (NELAP)
• No addition amendments are
allowed during the
assessment process
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Schedules
•Renewal Application—every 3 years
•Assessments—every two years
Stack tester assessments include home base and field
assessments
Field assessments may be static (demonstration only)
and combined with home base.
•Proficiency Tests and Analytical Data
Packages—Twice a year~6 months apart
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Schedules
•Assessment Reports due 30 days after the
NELAP assessment; due 60 days after the
state assessment
•Corrective Action Plans—due 30 days after
receipt of the assessment report
•Responses to the Corrective Action Plan –
due 30 days after receipt of the NELAP
Corrective Action Plan
•Correction of Findings Identified During
Assessment—6 months after receipt of the
assessment report
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Schedules
•Test Category Fee after Initial
Assessment—due 30 days from receipt of
invoice
•Decision on NELAP accreditation for initial
applicant—due 9 months after application
is received
•Re-application to Obtain NELAP
accreditation—laboratory must wait 6
months
•Regain Full NELAP Accreditation after
Suspension—6 months to correct cause
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Schedules
•Regain Full NELAP or State Accreditation
after Revocation---laboratory may reapply
after cause is corrected
•Notice to LELAP of change of key
accreditation criteria—due 30 days after
change is effective
•Notice to laboratory clients of change of
accreditation status—due 10 days from
official notice of the action
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Questions?
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
LELAP Location within LDEQ
Headquarters
•Office of Environmental
Services
•Permit Support Services
Division
•Notifications and
Accreditations Section
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
LELAP physical location…
602 North Fifth Street
Baton Rouge LA 70802
Paul Bergeron, Supervisor
Phone 225-219-1244
Email [email protected]
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
LELAP has the following staff…
Paul Bergeron
Supervisor
Beverly Cupit
Administrative
Coordinator
Cindy Gagnon
Assessor
Dr. Jacqueline
Prudente
Assessor
Dr. Alicia Ryan
Assessor
Elizabeth West
Assessor
(Shreveport)
Charles Leonard,
CIH
Assessor
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
LELAP has implemented
“regionalization”
An assessor is based in the Northwest
Regional Office to conduct assessments
for laboratories located in
north and central Louisiana, the
Texarkana area, and northern
Mississippi
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
LELAP is implementing other
aspects of the Ten Point Plan
•Ethics and Integrity—assessors receive annual
training
•Transparency—LELAP FAQs are posted on
website
•Front-loading—a/k/a “Accreditation 101”
•Investment in Small Business—LELAP
encourages small laboratories to participate
on the TNI small laboratory sub-committee
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
LELAP is implementing other
aspects of the Ten Point Plan
•Investment in Community Organizations and Local
Governments—LELAP continues to support LWEA and
its members
•Investment in Green Government and Applied
Research—documents will be accepted and sent
electronically; method modification will continue to be
approved according to regulations
•Investment in Technology and e-Commerce—LELAP is
making improvements to its database; fees can be paid
electronically, contact the LDEQ Financial Services
Division
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
LELAP is implementing
“Streamlining for Efficiency”
•Records are being transferred to the
Electronic Data Management System
(EDMS)
•Scopes are available on EDMS and will
be available on the website
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
“Streamlining for Efficiency”
• The LELAP Quality Assurance Plan and
the standard operating procedures are
being revised to increase efficiency of
accreditation activities
• Regulation changes will be proposed to
reduce or combine assessments
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Benefits of “Streamlining for Efficiency”
Assessment time in laboratory will be
reduced if the laboratories provide the
documentation upfront
•Provide requested documents such as
checklists to the assessor prior to the
assessment
•Have training records, internal audits
and annual management reviews ready
for the assessor to review
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Benefits of “Streamlining for Efficiency”
Costs to Laboratories and Overtime Will be
Reduced
• Contractor assessors have been
eliminated
• Streamlining with the use of checklists
•Limiting the scope of the assessment
• Rotating/target certain areas for
assessment
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Benefits of “Streamlining for Efficiency”
Exit Debrief will be Reduced by Limiting
Extraneous Discussion
•Submitting copy of the assessor’s checklist
with previously noted and discussed findings,
seriousness, and lab objections
• A hard copy of the post assessment
requirements may be presented to labs
•A teleconference may also be conducted
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Assessment Cycle Focus
• First Assessment—Overview to
determine if compliant quality system
has been implemented
• Second Assessment—Focus on
methods
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Assessment Cycle Focus
• Third Assessment—Focus on data
review
• Fourth Assessment—Back to
overview, determine if quality system
is functioning in laboratory
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Assessment Cycle Focus
• Minimum Quantitation Levels (MQLs)—
assessors are looking for implementation
of new MQLs in EPA Region 6-based
work
• New technologies—LELAP will address
nanotechnology, metals speciation, etc.
as the need arises
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Assessment Cycle Focus
Other assessments will be conducted
as needed
• Laboratory relocations
• Complaints received by LELAP
• Addition of new test category or
technology to scope
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Other items…
•LELAP Recognition by the NELAP Board
was finalized by November 2009
•The application for accreditation has
been revised
•Checklists have been posted on the
website
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Reminders…
•Use accredited laboratories for
subcontracted work
•Submit analytical data packages if
there are no proficiency test
samples available
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Reminders…
•Notify LELAP of changes affecting the
condition of your laboratory
accreditation (new name, address, etc.)
•Fees are due by July 1 of each year or as
stated on invoice
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Reminders…
•Provide requested documents such as
checklists to the assessor prior to the
assessment
•Have training records, internal audits
and annual management reviews
ready for the assessor to review
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Reminders…
•Submit a satisfactory corrective
action plan for findings identified
during the assessment
•Expect a teleconference or meeting if
the plan is predominantly “not
approved”
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Reminders…
•Implement the corrective action plan
when it is approved! Monitor the
implementation to establish its
effectiveness
•Be prepared to provide documentation
of implementation by the next
assessment
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Questions…
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS
Laboratory Issues and
Challenges
An Open Forum
Paul Bergeron, LDEQ
Joint Emergency Services
Training Center
Zachary, LA
April 29, 2010
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LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY
:FOR ALL YOUR ENVIRONMENTS