Environmental Laboratory
Accreditation
Richard H. Sheibley, Chief
Laboratory Accreditation Program
Department of
Environmental Protection
1
Act of June 29, 2002
P.L. 596, No. 90
Title 27 Sections 4101-4113
Environmental Laboratory Accreditation Act
2
Key Provisions Act 90
Section 4103 – Laboratory Requirements
• An environmental laboratory must be
accredited under this act
• All testing and analysis of environmental
samples shall be performed by an
accredited environmental laboratory
• Testing shall be performed pursuant to
the act, the environmental statutes and
departmental conditions
3
Key Provisions Act 90
Who is Affected?
“Environmental Laboratory”
A facility engaged in the testing
or analysis of environmental
samples.
4
Key Provisions Act 90
Who is Affected?
“Environmental sample”
A solid, liquid, gas or other
specimen taken for the purpose of
testing or analysis as required by
an environmental statute.
5
Key Provisions Act 90
Who is Affected?
“Environmental statute”
A statute administered by the
Department relating to the
protection of the environment or of
public health, safety, and welfare.
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Laboratory Accreditation
Advisory Committee
Eleven Members
Provide Technical Assistance
Public Meetings
7
Regulation Development
Process
Preliminary Draft – October 2002
LAAC Review – October through
February
10/17, 12/16, 2/13
Ad Hoc Work Group
11/26, 1/9, 3/5
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Regulation Development
Process
(continued)
Advisory Committees
•
•
•
SRBC Water Quality Advisory Committee
State Board for Certification of Water and
Wastewater Systems Operators
Certification Program Advisory Committee
for Water and Wastewater Systems
Operators (CPAC)
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Regulation Development
Process
(continued)
Advisory Committees
•
•
Small Business Compliance Advisory
Committee
Small Water Systems Technical
Assistance Center Advisory Board
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Regulation Development
Process
(continued)
DEP Program Input
Water Supply
Water Quality
Underground Storage Tanks
Land Recycling
Mining
Oil and Gas
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Dual Accreditation Program
State Accreditation
• Created by Regulation Chapter 252
NELAP – VOLUNTARY
• NELAC standards incorporated by
reference
12
Chapter 252
Environmental Laboratory
Accreditation Regulations
13
General Provisions
• Definitions
– Batch
– Drinking water, non-potable water, solid
and chemical materials
– Laboratory notebook
– Laboratory control sample
– Quality manual
14
General Provisions
• Definitions (continued)
– Analyst
– Laboratory Supervisor
– Technical staff
– Standard operating procedure
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General Provisions
• Purpose
• Scope
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General Requirements
• NELAP Equivalency
• Accreditation by Rule
– Drinking Water
– Field measurements
• Dissolved Oxygen
• Residual disinfectant concentration
• Alkalinity
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General Requirements
• Accreditation by Rule (continued)
– Field measurements
•
•
•
•
Temperature, flow
Settleable solids
Field radioactivity
Total halogen – waste oil
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Application, Fees,
Supporting Documentation
• Application
– Initial
– Ownership transfer
– Renewal
19
Out-of-State Laboratories
• Primary Accreditation
• Secondary Accreditation
• Same Fees As In-State Laboratories
20
General Standards for
Accreditation
• Laboratory Supervisor
– Responsibilities
– Qualifications
– Grandparent Provision
• Personnel Requirements
– Demonstrate Capability
– Documentation
21
General Standards for
Accreditation
• Physical Facilities
– Adequate for Testing & Analysis
– No Affect on Testing & Analysis
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General Standards for
Accreditation
• Equipment, Supplies, Reference
Materials
– Maintain Records
– Properly Maintained
– Calibrated
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pH Meter
•
•
•
•
Electrode
Scale Graduations
Thermometer or Probe
Standardize
– 3 buffers, 4, 7, & 10
– 2 buffers 4 & 7 OR 7 & 10
– Maintain Records
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Methodology
•
•
•
•
ID Method
Effective Date
Scope
Equipment &
Supplies
• Reagents &
Standards
• Quality Control
•
•
•
•
•
Calibration
Analytical Procedure
Calculations
Corrective Action
Reporting Results
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QUALITY ASSURANCE
AND
QUALITY CONTROL
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Basic Requirements
Quality Manual
•
•
•
•
Document Control
Ethics
Sample Handling
Sample Acceptance
• Departures from
SOP
• Quality Control
• Reporting Results
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Essential Quality Control
•
•
•
•
Chemistry
Toxicity Testing
Microbiology
Radiochemistry
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Chemistry & Radiochemistry
•
•
•
•
•
Initial Calibration
Continuing Calibration Verification
Sample Duplicates
Detection Limits
Selectivity
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Toxicity Testing
•
•
•
•
•
Positive & Negative Controls
Sensitivity
Test Organisms
Equipment
Test Conditions
30
Microbiology
•
•
•
•
•
•
Positive & Negative Controls
Autoclaves & Ovens
Miscellaneous Equipment
Reagent Water
Media
Test Variablilty
31
Proficiency Test Studies
ONE
SUCCESSFUL
PROFICIENCY TEST STUDY
PER
YEAR
32
On-Site Assessments
•
•
•
•
•
•
Sample Receipt to Final Report
Data & Procedural Review
Learning Process
Confirmation Doing It RIGHT
Correct Deficiencies
Continuous Improvement
33
Miscellaneous Provisions
•
•
•
•
•
•
Expiration of Application
Denial, Revocation, Suspension
Use of Accreditation
Record Keeping
Subcontracting
Reporting & Notification
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QUESTIONS
?
35
USEFUL INFORMATION
• www.dep.state.pa.us
Choose Subjects / Lab Certification
• Rsheibley@state.pa.us 717-705-2425
Bureau of Laboratories
Evan Press Building – Room 100
P. O. Box 1467
Harrisburg, PA 17105-1467
Phone 717-787-4669
FAX 717-783-1502
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