department of environmental protection - PA DEP

DEPARTMENT OF ENVIRONMENTAL PROTECTION
Bureau of Laboratories |Document Number:|150-2302-006 |
| | |
|Title: |Environmental Laboratory Accreditation Manual for |
| |Laboratories Seeking Accreditation under the Pennsylvania|
| |Program |
| | |
|Effective Date: |Publication in the PA Bulletin - Effective Date of |
| |Chapter 252 |
| | |
|Authority: |27 Pa. C.S. §§ 4101 - 4113 (act) (relating to |
| |environmental laboratory accreditation) |
| |Pennsylvania Safe Drinking Water Act, Act of May 1, 1984,|
| |P.L. No. 206, as amended, 35 P.S. §§ 721.1 - 721.17 |
| |Safe Drinking Water Regulations, 25 Pa. Code Chapter 109,|
| |Subchapter H |
| |Oil and Gas Regulations, 25 Pa. Code Chapter 78 |
| |Environmental Laboratory Accreditation Regulations, 25 |
| |Pa. Code Chapter 252 |
| | |
|Policy: |It is the policy of the Department of Environmental |
| |Protection (DEP) to provide laboratory management |
| |personnel with the information necessary to either obtain|
| |or maintain accreditation to perform and report |
| |environmental analyses on compliance samples in |
| |Pennsylvania. |
| | |
|Purpose: |The purpose of this document is to assist environmental |
| |laboratories in obtaining and maintaining accreditation |
| |under the Pennsylvania program by explaining the |
| |requirements of 25 Pa. Code Chapter 252. |
| | |
|Applicability: |This guidance will apply to all laboratories desiring to |
| |obtain and maintain accreditation under 25 Pa. Code |
| |Chapter 252. Additional guidance is contained in the |
| |most current edition of the EPA's Manual for the |
| |Certification of Laboratories Analyzing Drinking Water. |
| |Accreditation using the National Environmental Laboratory|
| |Accreditation Conference (NELAC) Standard is also |
| |available as an alternate to accreditation using these |
| |guidelines. The procedures for accreditation using the |
| |NELAC Standard are described in Procedures for the |
| |Approval and Accreditation of Laboratories in the |
| |Commonwealth of Pennsylvania Utilizing the NELAC |
| |Standard, 150-2302-007. |
| | |
|Disclaimer: |The policies and procedures outlined in this guidance |
| |document are intended to supplement existing |
| |requirements. Nothing in the policies or procedures shall|
| |affect regulatory requirements. |
| |The policies and procedures herein are not an |
| |adjudication or a regulation. There is no intent on the |
| |part of DEP to give these rules that weight or deference.|
| |This document establishes the framework, within which DEP|
| |will exercise its administrative discretion in the |
| |future. DEP reserves the discretion to deviate from this |
| |policy statement if circumstances warrant. |
| | |
|Page Length: |19 |
| | |
|Location: | | Environmental Laboratory Accreditation Manual for Laboratories Seeking
Accreditation under the Pennsylvania Program TABLE OF CONTENTS
|1.0 INTRODUCTION |1 |
|2.0 APPLICATION AND APPROVAL PROCEDURE |2 |
|2.1 Application Materials |2 |
|2.2 Submission of Application |2 |
|2.3 Review of Application |2 |
|2.3.1 Completeness |2 |
|2.3.2 Quality Manual |3 |
|2.3.3 Laboratory Supervisor |7 |
|2.4 Demonstration of Capability |7 |
|2.5 Fee Schedule |8 |
|2.6 Proficiency Test Studies |9 |
|2.7 On-site Assessment |11 |
|2.8 Awarding of Accreditation |12 |
|2.9 Notification and Reporting Requirements |13 |
| 2.9.1 General Requirements |13 |
|2.9.2 Safe Drinking Water Program Requirements |13 |
|2.10 Change in Ownership |13 |
|2.11 Record Keeping and Retention |14 |
|3.0 ACCREDITATION STATUS |14 |
|3.1 Types of Accreditation |14 |
| 3.1.1 Accredited |14 |
| 3.1.2 Interim Accreditation |14 |
| 3.1.3 Not Accredited |14 |
|3.1.4 Suspension |14 |
| 3.1.5 Applied |14 |
|3.2 Maintaining Accreditation |14 |
|3.3 Denial, Suspension, and Revocation of Accreditation|15 |
| 3.3.1 Denial |15 |
| 3.3.2 Suspension |16 |
|3.3.3 Revocation |16 |
| 3.3.4 Upgrading of Status |17 |
|3.3.5 Voluntary Relinquishment |18 |
|3.4 Subcontracting Analyses |18 |
|4.0 OUT-OF-STATE LABORATORIES |18 |
|5.0 USE OF ACCREDITATION BY ACCREDITED LABORATORIES |19 | DISCLAIMER This document is a preliminary draft for discussion. The requirements
stated in this preliminary draft include requirements from both State and
Federal regulations. The specific citations of these State and Federal
regulations will be identified in the later drafts of this document. 1.0 INTRODUCTION
In the Commonwealth of Pennsylvania, numerous decisions are made daily by
the public, the regulated community and the government that are based upon
data generated by environmental laboratories, and valid and accurate data
is essential to determine compliance with State and Federal laws. However,
in the past, little has been known about the quality of data generated.
Therefore, in order to protect the health, safety and welfare of the
citizens of the Commonwealth, the Commonwealth of Pennsylvania has been
directed to establish, administer and enforce an environmental laboratory
accreditation program under the Environmental Laboratory Accreditation Act,
27 Pa. C.S. §§ 4101 - 4113. The Department of Environmental Protection
("Department"), therefore developed the accreditation requirements set
forth in 25 Pa Code Chapter 252 ("Chapter 252"), which enables the
Department to assure the quality of data used to make environmental
decisions. In order to ensure that Pennsylvania laboratories are continuing to report
the most accurate information according to the most reliable standards, the
Department is offering a dual system of laboratory accreditation,
Pennsylvania State Laboratory Accreditation and optional NELAP
Accreditation. Pennsylvania State Laboratory Accreditation is based upon
compliance with Departmental guidelines, including this document,
Procedures for the Approval and Accreditation of Laboratories in the
Commonwealth of Pennsylvania, the Chapter 252 Regulations, and the current
edition of the EPA's Manual for the Certification of Laboratories Analyzing
Drinking Water. For requirements specific to the analysis of drinking
water see, 25 Pa. Code Chapter 109. The Pennsylvania Oil and Gas Program
also mandates specific requirements that are located in 25 Pa. Code Chapter
78. The requirements delineated in Chapters 78 and 109 are in addition to
those requirements