DEPARTMENT OF ENVIRONMENTAL PROTECTION Bureau of Laboratories

Transcription

1 DEPARTMENT OF ENVIRONMENTAL PROTECTION Bureau of Laboratories Document Number: 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: Policy: Purpose: Applicability: Disclaimer: 27 Pa. C.S (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 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 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. 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. 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, 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: Effective Date of Chapter 252 Page i

2 Environmental Laboratory Accreditation Manual for Laboratories Seeking Accreditation under the Pennsylvania Program TABLE OF CONTENTS 1.0 INTRODUCTION APPLICATION AND APPROVAL PROCEDURE Application Materials Submission of Application Review of Application Completeness Quality Manual Laboratory Supervisor Demonstration of Capability Fee Schedule Proficiency Test Studies On-site Assessment Awarding of Accreditation Notification and Reporting Requirements General Requirements Safe Drinking Water Program Requirements Change in Ownership Record Keeping and Retention ACCREDITATION STATUS Types of Accreditation Accredited Interim Accreditation Not Accredited Suspension Applied Maintaining Accreditation Denial, Suspension, and Revocation of Accreditation Denial Suspension Revocation Upgrading of Status Voluntary Relinquishment Subcontracting Analyses OUT-OF-STATE LABORATORIES USE OF ACCREDITATION BY ACCREDITED LABORATORIES 19 Effective Date of Chapter 252 Page ii

3 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 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 of Chapter 252. Under the dual system, accreditation of Pennsylvania environmental laboratories will be based upon the most current aforementioned Departmental guidelines or Departmental guidelines incorporating the most current NELAC standard. Requirements for the use of specific methodology or quality control practices may be contained in the Drinking Water Regulations (25 Pa. Code Chapter 109), Oil and Gas Program Regulations (25 Pa. Code Chapter 78), the most recent revision of the Code of Federal Regulations (40 CFR), or in a permit issued by the Department. These requirements must also be met. This document contains specific requirements that must be met in order for a laboratory to obtain and maintain Pennsylvania State accreditation as an Environmental Laboratory performing testing or analysis of drinking water, non-potable water or solid and chemical materials as required by any of the following statutes: 1. The Oil and Gas Act (58 P.S ). 2. The Clean Streams Law (35 P.S ). 3. The Hazardous Sites Cleanup Act (35 P.S ). 4. The Land Recycling and Environmental Remediation Standards Act (35 P.S ). 5. The Pennsylvania Safe Drinking Water Act (35 P.S ). 6. The Solid Waste Management Act (35 P.S ). 7. The Storage Tank and Spill Prevention Act (35 P.S ). 8. The Pennsylvania Bituminous Coal Mine Act (52 P.S ). 9. The Surface Mining Conservation and Reclamation Act (52 P.S ). 10. The Coal Refuse Disposal Control Act (52 P.S ). 11. The Bituminous Mine Subsidence and Land Conservation Act (52 P.S ). 12. The Noncoal Surface Mining Conservation and Reclamation Act (52 P.S ). Page 1

4 The Department s Bureau of Laboratories Laboratory Accreditation Program administers its accreditation programs in a manner that will ensure the protection of the environment and the health of the citizens of the Commonwealth of Pennsylvania. All accreditation activities are conducted in an impartial and nondiscriminatory manner. 2.0 APPLICATION AND APPROVAL PROCEDURE 2.1 Application Materials. NOTE: Any sub-facilities or remote laboratory sites (including mobile laboratories) are considered separate facilities and must submit a separate application. Application forms and instructions may be downloaded from Type in keyword labs. Upon request, a laboratory will be sent an application packet consisting of: (a) (b) (c) Application forms. Instructions. Any other pertinent information including a copy of this guidance. Note: Copies of 25 Pa. Code Chapter 252 are available to download from click Search, select Volume, select Volume, Number,. Copies may also be requested by mail. 2.2 Submission of Application. A complete application package must contain: (a) (b) (c) (d) Completed application. 2.3 Review of Application. Quality Manual (See Section 2.3.2) (with the initial application, and thereafter with subsequent renewal applications, when changes have been made to the laboratory s quality manual, and upon request by the Department). Appropriate fee in the form of a check made payable to "Commonwealth of Pennsylvania." Waste Water Treatment Plant laboratories must submit a copy of their current discharge permit (NPDES or Water Quality Management Part II Permit). This must be submitted initially and upon renewal, update or reissue of the permit. The laboratory shall submit the completed application package by US mail to: Pennsylvania Department of Environmental Protection Attn: Laboratory Accreditation Program P.O. Box 1467 Harrisburg, PA All modes of delivery other than US mail shall be made to: Laboratory Accreditation Program Pennsylvania Department of Environmental Protection Bureau of Laboratories 2575 Interstate Drive Harrisburg, PA Completeness. Page 2

5 All appropriate sections of the application must be completed for the requested fields of accreditation. Incomplete applications will be returned to the laboratory, or the missing information will be requested before the application can be processed Quality Manual. All laboratories analyzing drinking water, non-potable water or solid and chemical materials for compliance purposes must adhere to the quality control ( QC ) procedures specified in the methods of analysis, 40 CFR Parts 136 and 141 and Chapter 252. This is to ensure that routinely generated analytical data are scientifically valid and legally defensible and are of known and acceptable precision and accuracy. To accomplish these goals, each laboratory must prepare a Quality Manual, which is a written description of its policies, operational procedures, protocols, and practices established to meet the requirements of Chapter 252. The Quality Manual must be appropriate to the type, range and volume of testing and analysis of environmental samples performed by the laboratory, and it must be available to and used by all laboratory personnel. The laboratory management is responsible for keeping the Quality Manual up to date. All laboratory personnel must agree to have read, understood and implement the most recent version of the laboratory s Quality Manual. The Quality Manual must be submitted to the Department for review with an initial application for accreditation and prior to the on-site assessment. The laboratory Quality Manual must be a separately prepared text. However, many of the items required in the Quality Manual may be made by reference to appropriate sections of the laboratory's standard operating procedures (SOPs) or other literature (e.g., promulgated methods, Standard Methods for the Examination of Water and Wastewater, etc.). For example, Chapter 252 requires that a laboratory document in writing how analysts shall treat the results of testing that is associated with failed QC measures. If this information is detailed in all of the laboratory s method specific SOPs, then the Quality Manual may simply state that analysts must refer to the specific method SOP for information on how to deal with these types of situations. The laboratory management must regularly review the Quality Manual at a frequency defined by the laboratory in its Quality Manual. At a minimum, the following items should be addressed in each Quality Manual: Laboratory organization and responsibility: Include a chart or table showing the laboratory organization and lines of responsibility, including laboratory management and supervisors. List the key individuals who are responsible for ensuring the production of valid measurements, the routine assessment of laboratory operations for improper practices and departures from reference methods or laboratory policies and procedures, and for monitoring the quality of analysis (e.g., who is responsible for internal audits, data reviews, initiating corrective actions, and reviewing laboratory policies and procedures, including the effectiveness and success of the implementation of the Quality Manual and its requirements). Reference the job descriptions of all laboratory personnel, including the minimal level of qualification, experience and skills Page 3

6 necessary for all positions, as these requirements were defined by the laboratory management Ethics Policy The laboratory must develop and maintain an ethics policy that describes the code of conduct maintained by the laboratory and its staff. This policy must include procedures for educating and training personnel in their ethical and legal responsibilities and the potential punishments and penalties for improper, unethical or illegal actions. All laboratory employees must sign a statement indicating they have read, understood, and acknowledge their ethical and legal responsibilities and the consequences of improper, unethical or illegal actions. Such statements must be kept in the employee s training file, and reference to the location of these statements should be made in this section of the Quality Manual Document Control System The laboratory must develop and maintain a system of tracking and controlling documents that ensures all SOPs, reference methods, manuals and/or any other laboratory documents, clearly indicate the time period during which the procedure or document was in effect. The laboratory must reference the location and/or unique identification of equipment maintenance logbooks and reagent and standard preparation logbooks. The laboratory must describe its record keeping procedures, including how corrections are made to records, the length of storage time and media type (electronic or hard copy), and describe the security policy of electronic databases Laboratory sample acceptance and handling procedures. The sample acceptance policy must outline how information on the samples analyzed by the laboratory must be maintained. The laboratory must describe the procedures it follows to accept and analyze samples and ensure that all the necessary information is maintained for all samples accepted by the laboratory. The laboratory s sample acceptance policy must include sample identification, location, date and time of collection, collector s name, preservation type, and sample type. The policy must describe how samples are labeled in the laboratory and how the laboratory determines if it is using the appropriate containers and sample preservation methods. The laboratory must describe how it adheres to holding times specified in regulation or the method. The laboratory must describe its procedures for ensuring that the volume of sample collected is sufficient for all analyses performed on the sample, and what course of action it takes in instances where a sufficient sample size is not or cannot be collected. It must also define its procedures followed when samples show signs of damage, contamination or that the sample was preserved inadequately. Bound laboratory notebooks, if used, shall be filled out in ink and the entries dated and analyst identification included (A secure, password protected, electronic data base is acceptable). Page 4

7 The laboratory must ensure that all unprocessed and processed samples are stored at the proper temperature, isolated from laboratory contaminants, standards and highly contaminated samples, and that holding times are not exceeded. The integrity of all samples must be maintained (e.g., by tracking samples from receipt by the laboratory through analysis to disposal). The laboratory must specify criteria for rejection of samples which do not meet shipping, holding time and/or preservation requirements and procedures for notification of sample collectors and data users that samples were not collected, stored or handled in an appropriate manner Training and Review of Personnel Qualifications The laboratory must ensure and document the training and competency of each member of its technical staff by keeping training records on all laboratory employees. The records kept for each laboratory employee must include the dates of employment; signatures and initials; list of persons authorized to approve or release data; initial and continued demonstrations of capability; statements indicating that each employee has read, understood and is using the latest version of the laboratory s Quality Manual and SOPs; statements indicating all employees have read, understood and acknowledged their ethical and legal responsibilities; and documentation of any technical and ethical training courses in which employees have participated Procedures for detecting departures from reference methods or the laboratory s Quality Manual. The laboratory must implement procedures to detect when its standard protocols have not been followed. These procedures must at least include the identification of the individuals responsible for assessing each quality control type and initiating and recommending corrective actions; a procedure describing how the analyst(s) must treat the results of testing if the associated quality control measures fail to meet the requirements of the method (may reference the SOPs); specification for how outof-control data situations and subsequent corrective actions are to be documented; and a procedure for the laboratory supervisor to review corrective action reports Proactive program for the prevention and detection of improper, unethical or illegal actions. The laboratory must develop and implement procedures to detect and prevent improper activities in the laboratory. Components of this program may, but are not required to, include internal proficiency testing (single and double blind), post analysis data audits and reviews, and separate SOPs identifying appropriate and inappropriate laboratory and instrument manipulation practices Procedures for permitting departures from documented policies and procedures. Page 5

8 The laboratory must document the laboratory management s processes and procedures for permitting departures from the method, quality manual, established policies and procedures, or SOPs. These types of situations may arise when it is not possible to follow the method, quality manual, SOPs, or laboratory policies exactly as they are written. The laboratory must decide how it will determine instances where a departure from standard procedures is appropriate, and how these departures will be documented Procedures for monitoring the quality of analysis (may reference SOP) Examples of such procedures include internal quality control procedures (e.g. blanks, fortified blanks, duplicates, and matrix spike samples), participation in PT studies, analysis of split samples, etc Essential Quality Control Requirements (may reference SOP): Laboratories must follow the Essential Quality Control Requirements in , which specify specific quality control requirements based on the type of analysis the laboratory is performing (i.e. Chemistry, Toxicity, Microbiology, Radiochemistry). Sample results must be determined from an initial instrument calibration, which has been verified by a second source standard. A calibration verification standard must be analyzed at the beginning and end of each analysis day and after every 10 samples, unless the method states an alternate frequency. A method blank, laboratory control sample, and sample duplicate must be processed with each batch of samples and carried through all steps of the analytical procedure. Surrogate compounds representing all chemistries of the target analytes must be added to all samples, standards and QC samples for all organic chromatography test methods. A detection limit study must be determined for each analyte and in the matrix of interest for each method where spiking solutions are available. The laboratory must relate detection limits to quantitation limits, and the quantitation limit must be above the detection limit. The laboratory must develop and document acceptance criteria for retention time windows for methods where retention times are used for identification of an analyte Laboratories must also follow all QA and QC measures and practices required by State and/or Federal laws, regulations, promulgated methods, orders and permit conditions. For example, a laboratory testing non-potable water must adhere to any QC requirements published in 40 CFR Procedures for reporting of results Page 6

9 The laboratory must develop procedures for reporting the results of samples that are in compliance with all applicable sections of Chapter 252 and State and/or Federal laws, regulations, promulgated methods, orders and permit conditions. For example, if the laboratory is performing analysis for compliance with a NPDES discharge permit, then the results must be reported to the laboratory s regulatory agency according to any reporting requirements written into the permit, as well as those of Chapter PT Testing Laboratories must describe the frequency with which they participate in the PT program, and how it handles PT samples in the laboratory. For example, Chapter 252 directs laboratories to handle PT samples exactly like routine samples, including personnel, exposure to reagents, glassware and number of replicate analyses. If a particular item is not relevant or not applicable to the laboratory s operations, the Quality Manual should state this and provide a brief explanation. A laboratory Quality Manual should be responsive to the above items while remaining brief and easy to follow. Minimizing paperwork, while improving dependability and quality of data, are the intended goals Laboratory Supervisor. The laboratory supervisor shall be a qualified professional with the technical education, experience and managerial capability commensurate with the size and type of the laboratory. The laboratory supervisor must meet the minimum requirements outlined in 35 Pa. Code Chapter 252, (relating to the laboratory supervisor and (relating to qualifications of the laboratory supervisor). The laboratory supervisor is ultimately responsible for ensuring that all laboratory personnel have demonstrated proficiency for their assigned functions and that all data reported by the laboratory meet the required quality assurance (QA) criteria and regulatory requirements. The laboratory supervisor exercises actual day-to-day supervision of laboratory procedures and reporting of results. The title of such persons may include, but is not limited to technical director, laboratory director, laboratory supervisor, or laboratory manager. A laboratory may appoint one or more laboratory supervisors for the appropriate fields of testing for which they are seeking accreditation. This person s duties shall include, but not be limited to, monitoring standards of performance in quality control and quality assurance; monitoring the validity of the analyses performed and data generated in the laboratory to assure reliable data; ensuring that sufficient numbers of qualified personnel are employed to supervise and perform the work of the laboratory; and providing educational direction to laboratory staff. An individual may not be the laboratory supervisor of more than one accredited environmental laboratory without authorization from the Department. In cases where the laboratory supervisor is absent for a period of time exceeding 16 consecutive calendar days, the environmental laboratory shall designate another staff member meeting the qualifications of the laboratory supervisor to temporarily perform this function. If this absence exceeds 30 consecutive calendar days, the Department must be notified in writing in accordance with (relating to reporting and notification requirements). 2.4 Demonstration of Capability. Page 7

10 Prior to the acceptance and institution of any test method, and each time there is a change in instrument type, personnel or method, a satisfactory initial demonstration of capability ( IDC ) is required. An IDC must include all of the sample preparation and analytical steps contained in the method and must be performed according to the procedure specified in the method or State and/or Federal regulations. If no procedure is specified, then the demonstration must be performed according to j. A demonstration of continued proficiency (DOC) must be performed every 12 months thereafter for each method that relates to an employee s job responsibilities. The DOC requirement may be fulfilled by performing any of the procedures listed in b.3.vii (relating to demonstrations of continued proficiency) (i.e., another IDC or acceptable performance of a blind performance sample, successful analysis of blind proficiency test (PT) samples). For some methods, the laboratory must be able to achieve published method detection limits ( MDLs ). These published MDLs are usually located in the applicable parts of 40 CFR or in the referenced method. In all cases, the environmental laboratory must demonstrate the capability to meet any reporting limits required by the Department. Data associated with all Demonstrations of Capability and any required MDLs or reporting limits must be retained and sufficient to reconstruct all laboratory and analytical activities. This data must be made available to the Department upon request and/or during the on-site assessment. 2.5 Fee Schedule. Laboratories applying for Accreditation or renewal of Accreditation shall submit the appropriate annual fee along with the required application. Fees are in accordance with the Environmental Laboratory Accreditation Regulations, 25 Pa. Code, Chapter 252, Subchapter B, Checks must be made payable to the "Commonwealth of Pennsylvania". FEES ARE NONREFUNDABLE. Application Fees Drinking Water Fees Accreditation Category Fee (1) Application Fee Initial Application $ 600 Application Fee - Renewal Application $ 500 Application Fee Ownership Transfer $ 150 Application Fee Addition of Fields of Accreditation $ 250 Basic Drinking Water Category includes 1 method for each of the following: Total Coliform Bacteria, Fecal Coliform Bacteria, E. coli Bacteria, Heterotrophic Bacteria, Nitrate, Nitrite, Fluoride, Cyanide $ 600 Asbestos $ 350 Microbiology $ 450 Trace Metal Category $ 450 Inorganic Non-metal Category $ 500 Trace Metal & Inorganic Non-metal Categories $ 800 Volatile Organic Chemicals $ 500 Extractable and Semi-volatile Organic Chemicals $ 750 Dioxin $ 600 Radiochemical Category $ 700 Page 8

11 Drinking Water & Non- Solid and Chemical Non-potable Water Fees potable Water Fees Materials Basic Non-potable Water Category includes 1 method for each of the following: Fecal Coliform Bacteria, BOD, CBOD, Nitrate, Ammonia, Total Nitrogen, Total Kjeldahl Nitrogen, Nitrite, Phosphorus, and 1 method for each type of residue $ 700 Asbestos $ 350 Microbiology $ 400 Trace Metal Category $ 450 Inorganic Non-metal Category $ 550 Trace Metal and Inorganic Non-metal Categories $ 900 Volatile Organic Chemicals $ 500 Extractable and Semi-volatile Organic Chemicals $ 950 Dioxin $ 600 Radiochemical Category $ 600 Whole Effluent Toxicity Testing Category $ 600 Microbiology $ 750 Trace Metal Category $ 800 Inorganic Non-metal Category $1,000 Trace Metal and Inorganic Non-metal Categories $1,550 Volatile Organic Chemicals $ 900 Extractable and Semi-volatile Organic Chemicals $1,650 Dioxin $1,050 Radiochemical Category $1,050 Asbestos $ 350 Microbiology $ 450 Trace Metal Category $ 450 Inorganic Non-metal Category $ 550 Volatile Organic Chemicals $ 550 Extractable and Semi-volatile Organic Chemicals $1,200 Dioxin $ 600 Radiochemical Category $ 600 (1) In addition to the appropriate fee, out-of-state laboratories shall reimburse the Department for out-or-state travel related expenses necessitated by the accreditation. Accreditation fees should be calculated by adding the appropriate application fee to the appropriate category fee. For example, if a laboratory wishes to apply for initial accreditation for the basic drinking water category, the fee for initial application would be $1,200 ($600 initial application fee + $600 basic drinking water category fee). Upon renewal of their accreditation, this same laboratory would submit a $1,100 fee with their renewal application ($500 renewal application fee + $600 basic drinking water category). Page 9

12 The Department will re-evaluate the fees at least every three years for any disparity between program income generated by the fees and the cost of administering the program. 2.6 Proficiency Test Studies. The Pennsylvania Environmental Laboratory Accreditation Regulations (25 Pa. Code Chapter 252, ) require that laboratories successfully complete at least one set of proficiency test ( PT ) studies for each of the parameters for which accreditation is sought. Laboratories seeking to obtain or retain existing accreditation under Chapter 252 shall analyze PT studies according to the following criteria: Initially, a laboratory must successfully complete 1 single blind, single concentration PT study for each field of accreditation for which the laboratory is seeking accreditation, where a PT study is available for the field(s) of accreditation. To maintain on-going certification, a laboratory must successfully complete 1 single blind, single concentration PT study, where available, for each field of accreditation for which the laboratory is currently accredited at least once every 12 months. Laboratories are encouraged to participate in more than one PT study per year PT studies must be purchased at the laboratory s expense directly from suppliers approved by the Department as a Proficiency Test Provider. A list of approved PT providers is available on the DEP website or from the Laboratory Accreditation Program The Department will revoke a laboratory s accreditation for a field of accreditation for failure to participate in a required proficiency test study or failure to obtain acceptable results on 2 consecutive PT studies for a particular field of accreditation Accreditation for Polychlorinated Biphenyls ( PCB ) analysis by US EPA Method 508A which reports PCBs as the decachlorobiphenyl is contingent upon successful completion of a PT study for PCBs which require reporting as the decachlorobiphenyl Accreditation for PCB screening methods, US EPA 505, 508, 508.1, and 525.2, require analysis of a PCB PT study that requires identification and quantification of the specific aroclor Total trihalomethanes (drinking water matrix) is a calculated value based upon the analytical results of 4 individual parameters. Accreditation for total trihalomethanes requires successful performance on each of the 4 individual parameters. Analysis of all 4 parameters in the same PT study is required in order to meet the PT study requirement for total trihalomethanes Successful performance in the regulated volatile organic chemicals ( VOCs ) group (drinking water) is defined as correctly analyzing at least 80% of the parameters. Failure to report a compound that is present shall constitute an incorrect result and will be included in the calculations for determining successful performance. Incorrectly analyzing the same parameter on 2 consecutive PT studies while maintaining an overall 80% correct rating will result in the laboratory being downgraded to NOT accredited for the regulated VOCs subcategory Accreditation for vinyl chloride (drinking water) requires current accreditation in the regulated VOCs subcategory and a successful PT study for vinyl chloride Successful performance in the Haloacetic Acids ( HAA5 ) group (drinking water) is defined as correctly analyzing at least 80% of the parameters. Failure to Page 10

13 report a compound that is present shall constitute an incorrect result and will be included in the calculations for determining successful performance. Incorrectly analyzing the same parameter on 2 consecutive PT studies while maintaining an overall 80% correct rating will result in the laboratory being downgraded to NOT accredited for the HAA5 subcategory A PT study for microbiology analysis of drinking water is defined as ten 100-mL samples analyzed to determine the presence or absence of bacterial organisms. A PT study may be supplied as full volume 100-mL samples or as samples requiring reconstitution to 100-mL. Successful completion of a microbiology PT study for drinking water is defined as 9 out of 10 samples correct with no false negatives reported. For non-potable water, the laboratory must report an acceptable result for each sample Accreditation for the radiochemistry parameter group gamma emitters requires successful analysis of Barium 133, Copper 60, Cesium 134, Cesium 137, and Zinc The laboratory s management and all analysts shall ensure that all PT samples are handled (i.e. managed, analyzed, and reported) in the same manner as real environmental samples utilizing the same staff, procedures, equipment, facilities, number of replicates, and methods as used for routine analysis of the analyte Laboratories shall not send any PT study, or portion of a PT study, to another laboratory for any analysis for which it seeks accreditation or is accredited prior to the time the results of the study are released by the proficiency test study provider Laboratories shall not knowingly receive any PT study, or portion of a PT study, from another laboratory for any analysis for which the sending laboratory seeks accreditation or is accredited prior to the time the results of the study are released by the proficiency test study provider An environmental laboratory shall not communicate with another environmental laboratory, including other laboratories under common ownership, concerning the PT study prior to the time the results of the study are released by the proficiency test study provider An environmental laboratory shall not attempt to obtain the prepared value of a PT study from the PT provider prior to the time the results of the study are released by the PT provider If a laboratory fails a PT study for an individual field of accreditation, it shall determine the cause for the failure and take any necessary corrective action. It shall then document in its own records both the investigation and the action taken. If a laboratory fails two consecutive PT studies for a parameter or subcategory, its performance is considered unacceptable for that parameter or subcategory. The laboratory must then meet the requirements of initial accreditation The laboratory shall direct the PT Provider to report laboratory PT performance results directly to the Department at the same time that it reports the results to the laboratory Laboratories shall maintain copies of all raw data associated with PT studies for at least 5 years. 2.7 On-site Assessment. Prior to accrediting an environmental laboratory, the Department will perform an on-site assessment of the laboratory. In addition, prior to granting accreditation for an additional Page 11

14 field of accreditation, the Department may perform an on-site assessment. The Department may conduct announced or unannounced on-site assessments to ensure compliance with the conditions of accreditation, Chapter 252 and all other orders issued by the Department. All accredited laboratories will be reassessed approximately once every 2 years. Additional on-site assessments may be performed at the Department s discretion. Procedures for conducting on-site assessments are contained in internal Department Procedures. The assessment may be general to determine the capability of the laboratory to perform environmental testing or a specific examination of a certain area of testing. The assessment will include both an appraisal of the laboratory s operations and a review of the appropriate records. The assessment will cover all of the fields of accreditation for which the laboratory seeks accreditation. Upon completion of the on-site assessment, the assessment team will prepare a formal written report. Reports are normally issued within approximately 45 calendar days following completion of the assessment. The assessment report will contain all information pertinent to the assessment and all findings that need to be addressed by the laboratory. The on-site assessment report will also contain comments and recommendations made by the assessors based upon their observations during the onsite. Within 60 calendar days of the receipt of the report, the laboratory shall prepare and submit a corrective action report to the Department, in response to areas where the Department has cited deficiencies. The corrective action report must document the corrective action taken by the laboratory to correct each deficiency. The Department will review and respond to the written corrective action report. If any portion of the corrective action report is not acceptable, the laboratory shall submit a revised written corrective action report within 30 calendar days from receipt of the Department s response. If the second corrective action report is not acceptable, the Department may revoke the laboratory s accreditation. Unless otherwise approved by the Department, deficiencies must be corrected within 120 calendar days of receipt of the on-site assessment report. The Department may extend the period of implementing corrective actions, for specific deviations, for a maximum of 30 calendar days upon receipt of the laboratory s written petition and corrective action report, when the laboratory must purchase new equipment, revise its quality manual and/or replace significant laboratory personnel. If the laboratory fails to implement the corrective actions as stated in their corrective action report, accreditation for those fields of testing, specific methods, or analytes within those fields of testing shall be revoked. Decisions regarding a laboratory s accreditation will only be made after the resolution of the on-site assessment process, and the laboratory has submitted corrective actions that the Department deems to be acceptable and in compliance with all applicable regulations. 2.8 Awarding of Accreditation. When a participating laboratory has met the requirements specified for obtaining accreditation, the laboratory will receive a Certificate of Accreditation awarded by the Department. The certificate will provide the following information: the name of the laboratory, address of the laboratory, and the specifications of the accreditation action. The Certificate of Accreditation will contain a Scope of Accreditation, as an attachment, listing the specific contaminants and methods for which the laboratory has obtained accreditation. A new and revised Scope of Accreditation will be issued with each change in Accreditation status. Additional terms and conditions may be specified in an addendum Page 12

15 to the Certificate. Addenda or attachments to the certificate shall be considered to be official documents and a part of the Certificate of Accreditation. Even though a parent laboratory is accredited, the sub-facilities (laboratories operating under the same parent organization, analytical procedures, and quality assurance system) are inspected or processed separately and shall obtain their own Certificate of Accreditation. A separate application, including appropriate fees, is required for each subfacility. Any sub-facilities or remote laboratory sites are considered separate sites and subject to separate announced and unannounced assessments. 2.9 Notification and Reporting Requirements General Requirements An accredited laboratory shall notify the Department of a change in laboratory supervisor, a change in the legal name of the laboratory and/or any item contained on the application for accreditation within 30 calendar days of the change. All such updates are public records Out-of-State laboratories with either primary or secondary accreditation from the Department must notify the Department in writing, within 48 hours of any changes in the laboratory s accreditation status from any other primary accrediting authority. Failure to provide timely notification to the Department of the termination of accreditation may result in revocation of accreditation for all parameters The Department may require an on-site assessment and/or additional information or proof of continued capability to perform the testing or analysis for affected fields of accreditation upon receipt of notification of the above or under Safe Drinking Water Program Requirements A laboratory accredited by the Department shall submit to the Department, in a manner approved by the Department, the results of all test measurements or analyses performed by the laboratory on behalf of a regulated public water system in accordance with the provisions of 25 Pa. Code Chapter 109. The time limits for routine reporting of those results are located in 25 Pa. Code (a) A laboratory accredited by the Department that performs tests and analyses on behalf of a regulated public water system, shall follow the reporting procedures set forth in 25 Pa. Code (b) whenever an MCL, MRDL, or a treatment technique performance requirement under 25 Pa. Code (relating to State MCLs, MRDLs and treatment technique requirements) is violated or a sample result requires the collection of check samples under 25 Pa. Code (relating to general monitoring requirements) A laboratory accredited by the Department that performs tests and analyses on behalf of a regulated public water system under 25 Pa. Code Chapter 109 shall notify each public water supplier served by the laboratory within 48 hours of the following: A failure to renew or Department denial of renewal of existing accreditation for a category of accreditation Revocation of accreditation by the Department or voluntary relinquishment by the laboratory. Page 13

16 2.10 Change in Ownership. Accreditation may be transferred when the legal status or ownership of an accredited laboratory changes without affecting its staff, equipment, and organization. The accredited laboratory shall notify the Department in writing of any changes in ownership within 30 calendar days of the change and submit the appropriate application and application fees. The Department may conduct an on-site assessment to verify effects of such changes on laboratory performance. All of the previous terms and conditions in the Certificate of Accreditation apply to the new ownership and/or the new location of a laboratory Record Keeping and Retention. An environmental laboratory must maintain records in a manner accessible by the Department, and the records, including original handwritten data, must allow reconstruction of all laboratory activities associated with the testing or analysis of environmental samples. All generated data, except that generated by automated data collection systems, must be recorded promptly and legibly in permanent ink or in an electronic format. When the laboratory must make changes to its records, the changes must be made such that the original entry remains visible (i.e. a single line drawn through the changed material), and the individual making the change must sign or initial and date the correction. The requirements for making changes to records also applies to records maintained in electronic formats. All records required under Chapter 252 must be maintained for a minimum of 5 years, unless otherwise specified. The laboratory must also develop and implement a written plan that specifies how records will be maintained or transferred if the laboratory transfers ownership or terminates operations. 3.0 ACCREDITATION STATUS 3.1 Types of Accreditation. After review of PT study results and completion of an on-site assessment, the Department will classify the laboratory for all fields of accreditation according to the following rating scheme: Accredited: A laboratory that meets the minimum applicable regulatory requirements. "Accredited status may not be granted to any laboratory that has not met performance criteria specified in the Department s regulations Interim Accreditation: Interim accreditation will be granted to laboratories that have submitted a complete application within 6 months from the effective date of the Laboratory Accreditation Regulations. Interim accreditation shall be effective until the Department makes a final determination of the laboratory s accreditation status. Interim accreditation will allow a laboratory to perform analyses and report results with the same status as an accredited laboratory Not Accredited: A laboratory that possesses major deficiencies and, in the opinion of the Department, cannot produce valid data within the acceptance limits specified in the applicable regulations and within the policies of the Department. A laboratory with Not Accredited status may not analyze or report the results of compliance samples Suspension: A laboratory that posses deficiencies and, in the opinion of the Department, cannot produce valid data within the acceptance limits specified in the applicable regulations and within the policies of the Department. Suspension is the temporary removal of a laboratory s accreditation for a defined Page 14

17 period of time not to exceed 6 months. A suspended laboratory may not analyze or report the results of compliance samples Applied: A laboratory that has initially requested accreditation for a field of testing, but does not meet the requirements of all applicable regulations and/or policies of the Department. The Department has not determined a final action on the request. An applied laboratory may not analyze or report results of compliance samples. 3.2 Maintaining Accreditation. Accreditation shall remain in effect until revoked by the Department, voluntarily relinquished at the written request of the accredited laboratory, or until the expiration of the accreditation period. The accreditation period will not exceed 12 months, and the expiration date of the accreditation period will be printed on the laboratory s Certificate of Accreditation. To maintain accreditation, the accredited laboratory shall complete or comply with all Department regulations and guidance. Failure to complete or comply with these standards or regulations shall be cause for suspending or revoking accreditation as specified in Department regulations or in this guidance. Accredited laboratories shall submit a renewal application and the appropriate fee to the Department at least 60 calendar days prior to the expiration of the current accreditation period. Failure of the laboratory to submit a renewal application in a timely manner may result in the loss of accreditation during the processing of the application. 3.3 Denial, Suspension, and Revocation of Accreditation Denial The Department will deny an application for accreditation, transfer of accreditation or application for renewal of accreditation under one or more of the following circumstances: a) The laboratory is in continuing violation of or demonstrates an inability or lack of intention to comply with Chapter 252 or other laws administered by the Department. b) The Department revoked the laboratory s Certificate of Accreditation for all fields of accreditation for failure to correct deficiencies identified in an on-site assessment report within the previous 6 months The Department may deny an application for accreditation, transfer of accreditation or application for renewal of accreditation for one or more of the following reasons: a) Falsifying analyses. b) Failure to comply with the reporting and notification requirements as specified in (relating to reporting and notification requirements). c) Making misrepresentations to the Department. d) Engaging in unethical or fraudulent practices. e) Analysis of proficiency test studies by personnel other than the analysts associated with the routine analysis of environmental samples in the laboratory. Page 15

18 f) Failure to submit a completed application. g) Failure to pay required fees. h) Failure of laboratory staff to meet the personnel qualifications of education, training and experience. i) Failure to successfully analyze and report proficiency test studies as required by Chapter 252. j) Failure to respond to an on-site assessment report with a corrective action report within the required timeframes. k) Failure to implement the corrective actions detailed in the laboratory s corrective action report within a timeframe approved by the Department. l) Failure to implement a quality assurance program. m) Denial of entry to the Department during normal business hours for an on-site assessment. n) Violation of a statute, Chapter 252 or an order by the Department. o) Failure to meet the requirements of Chapter Upon reapplication, the laboratory again will be responsible for all of the fees applicable as part of the initial application for accreditation Suspension The Department will suspend an environmental laboratory s accreditation for all fields of accreditation when the Department is denied access to the laboratory during normal business hours. Upon notice from the Department, the laboratory must immediately cease analysis of environmental samples The Department will suspend a laboratory s accreditation in full or in part for one or more of the following reasons: a) If the Department finds that protection of public health, safety or welfare requires emergency action. b) If the laboratory fails to successfully complete a PT study within the previous 12 months. c) The laboratory fails two consecutive PT studies for a particular field of accreditation The Department may suspend a laboratory s accreditation in total or in part for one or more of the following reasons: a) Failure to comply with the reporting and notification requirements as specified in (relating to reporting and notification requirements). b) Failure to implement a quality assurance program. c) Failure to employ staff that meets the personnel qualifications for education, training and experience A laboratory may continue to analyze environmental samples for those fields of accreditation not affected by the suspension. Page 16