Environmental Laboratory Accreditation

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Environmental Laboratory Accreditation

Richard H. Sheibley, Chief Laboratory Accreditation Program

Department of Environmental Protection

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Act of June 29, 2002

P.L. 596, No. 90

Title 27 Sections 4101-4113 Environmental Laboratory Accreditation Act

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Key Provisions Act 90Section 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

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Key Provisions Act 90Who is Affected?

“Environmental Laboratory”A facility engaged in the testing

or analysis of environmental samples.

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Key Provisions Act 90Who 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.

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Key Provisions Act 90Who 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

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Regulation Development Process

Preliminary Draft – October 2002

LAAC Review – October through February

10/17, 12/16, 2/13Ad 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 InputWater SupplyWater QualityUnderground Storage TanksLand RecyclingMiningOil and Gas

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Dual Accreditation Program

State Accreditation• Created by Regulation Chapter 252

NELAP – VOLUNTARY• NELAC standards incorporated by

reference

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Chapter 252Environmental Laboratory Accreditation Regulations

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General Provisions

• Definitions– Batch– Drinking water, non-potable water, solid

and chemical materials– Laboratory notebook– Laboratory control sample– Quality manual

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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

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Out-of-State Laboratories

• Primary Accreditation• Secondary Accreditation• Same Fees As In-State Laboratories

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General Standards for Accreditation

• Laboratory Supervisor– Responsibilities– Qualifications– Grandparent Provision

• Personnel Requirements– Demonstrate Capability– Documentation

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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 ASSURANCEAND

QUALITY CONTROL

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Basic RequirementsQuality 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

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Microbiology

• Positive & Negative Controls• Autoclaves & Ovens• Miscellaneous Equipment• Reagent Water• Media• Test Variablilty

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Proficiency Test Studies

ONESUCCESSFUL

PROFICIENCY TEST STUDYPER

YEAR

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On-Site Assessments

• Sample Receipt to Final Report• Data & Procedural Review• Learning Process• Confirmation Doing It RIGHT• Correct Deficiencies• Continuous Improvement

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Miscellaneous Provisions

• Expiration of Application• Denial, Revocation, Suspension• Use of Accreditation• Record Keeping• Subcontracting• Reporting & Notification

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QUESTIONS?

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USEFUL INFORMATION• www.dep.state.pa.us

Choose Subjects / Lab Certification• Rsheibley@state.pa.us 717-705-2425

Bureau of LaboratoriesEvan Press Building – Room 100

P. O. Box 1467Harrisburg, PA 17105-1467

Phone 717-787-4669FAX 717-783-1502