DEPARTMENT OF ENVIRONMENTAL PROTECTION Bureau of Laboratories

Transcription

1 DEPARTMENT OF ENVIRONMENTAL PROTECTION Bureau of Laboratories Document Number: Title: Procedures for the Approval and Accreditation of Drinking Water Laboratories In the Commonwealth of Pennsylvania Effective Date: PRELIMINARY DRAFT FOR DISCUSSION PURPOSES ONLY Authority: 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. Policy: Purpose: Applicability: Disclaimer: It is the policy of the Department of Environmental Protection (DEP) to provide laboratory directors with the information necessary to either obtain or maintain accreditation to perform and report environmental analyses on samples from public drinking water supplies in Pennsylvania. The purpose of this document is to establish minimum criteria that laboratories must meet in order to obtain and maintain accreditation. The guidance will apply to all laboratories desiring to obtain and maintain accreditation under the Pennsylvania drinking water program. Additional guidance is contained in Critical Elements documents, , , and , in addition to 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 Standards is also available as an alternate to accreditation using these guidelines. The procedures for accreditation using the NELAC standards is described in Procedures for the Approval and Accreditation of Laboratories In the Commonwealth of Pennsylvania Utilizing NELAC Standards, 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: 17 Location: Volume 3, Tab 7 January 21, 2004 Page i FOR DISCUSSION PURPOSES ONLY

2 Procedures for the Approval and Accreditation of Drinking Water Laboratories In the Commonwealth of Pennsylvania TABLE OF CONTENTS INTRODUCTION BACKGROUND APPLICATION AND APPROVAL PROCEDURE Application Materials Submission of Application Review of Application Completeness Quality Manual Laboratory Supervisor Quality Manager Demonstration of Capability Fee Schedule Proficiency Test Studies On-site Assessment Awarding of Accreditation Notification and Reporting 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 Withdrawal Subcontracting Analyses OUT-OF-STATE LABORATORIES USE OF ACCREDITATION BY ACCREDITED LABORATORIES 15 January 21, 2004 Page ii FOR DISCUSSION PURPOSES ONLY

3 INTRODUCTION The Commonwealth of Pennsylvania is granted primacy under the Federal Safe Drinking Water Act, 42 U.S.C. 300(f) et seq. Laboratory certification or accreditation is required by the Pennsylvania Safe Drinking Water Act, Act of May 1, 1984, P.L. No. 206, as amended, 35 P.S et seq. The regulations implementing the Safe Drinking Water Act are contained in the Pennsylvania Code at Title 25, Chapter 109 (25 Pa. Code 109). The requirements for Laboratory Certification are in Subchapter H. 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 Drinking Water Accreditation and optional NELAP Accreditation. Current Pennsylvania safe drinking water laboratory certification is based upon compliance with Departmental guidelines, including this document, Procedures for the Approval and Certification of Drinking Water Laboratories, and the Critical Elements documents, and the current edition of the EPA s Manual for the Certification of Laboratories Analyzing Drinking Water. See 25 Pa. Code Pennsylvania oil and gas laboratory certification is based upon compliance with Departmental guidelines and specific regulatory requirements. See 25 Pa. Code 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 standards. Requirements for the use of specific methodology or quality control practices may be contained in the Drinking Water Regulations (25 Pa. Code Chapter 109) 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 accreditation as an Environmental Laboratory performing testing or analysis of Drinking Water on Public water supplies in Pennsylvania. 1.0 BACKGROUND The Department s Bureau of Laboratories Laboratory Accreditation Program has been delegated the right, responsibility and authority to administer Drinking Water Laboratory Certification. This document provides information and guidance to laboratories seeking to obtain and maintain accreditation as an environmental laboratory from Pennsylvania under the standards contained in Departmental guidelines. Accreditation programs are administered in a manner that will insure the protection of the environment and the public health of the citizens of the Commonwealth of Pennsylvania. All accreditation activities are conducted in an impartial and non-discriminatory manner. 2.0 APPLICATION AND APPROVAL PROCEDURE 2.1 Application Materials NOTE: Sub-facilities or remote laboratory sites are considered separate and must submit a separate application. Upon request, a laboratory will be sent an application packet consisting of: (a) (b) (c) (d) Application forms. Pennsylvania Safe Drinking Water Regulations. Applicable Critical Elements documents. Any other pertinent information. 2.2 Submission of Application January 21, 2004 Page 1 FOR DISCUSSION PURPOSES ONLY

4 A complete application package must contain: (a) (b) (c) Completed application. Quality Manual (See Section 2.3.2) (Initial Application and upon request by the Department). Appropriate fee in the form of a check made payable to "Commonwealth of Pennsylvania." The laboratory shall submit the completed application to: 2.3 Review of Application. Pennsylvania Department of Environmental Protection Laboratory Accreditation Program P.O. Box 1467 Harrisburg, PA Completeness. 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 Quality Manual. All laboratories analyzing drinking water compliance samples must adhere to the quality control ( QC ) procedures specified in the methods. This is to ensure that routinely generated analytical data are scientifically valid and defensible, and are of known and acceptable precision and accuracy. To accomplish these goals, each laboratory must prepare Quality Manual, which is a written description of its QC and quality assurance ( QA ) activities. It is the responsibility of the quality manager to keep the Quality Manual up to date. All laboratory personnel must be familiar with the contents of the 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, documentation for many of the listed Quality Manual items 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.). The Quality Manual must be reviewed by the Quality Manager at least annually. 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 QA managers. List the key individuals who are responsible for ensuring the production of valid measurements and the routine assessment of measurement systems for precision and accuracy (e.g., who is responsible for internal audits and reviews of the implementation of the plan and its requirements). Reference the job descriptions of the personnel and describe training to keep personnel updated on regulations and January 21, 2004 Page 2 FOR DISCUSSION PURPOSES ONLY

5 methodology, and document that laboratory personnel have demonstrated proficiency for the methods they perform Process used to identify clients' Data Quality Objectives SOPs with dates of last revision. Keep a list of SOPs. Ensure that current copies of SOPs are in the laboratory and in the QA Managers files. Ensure that SOPs are reviewed annually and revised as changes are made. Ensure that SOPs have signature pages and revision dates Field sampling procedures. Describe the process used to identify sample collectors, sampling procedures and locations, required preservation, proper containers, correct sample container cleaning procedures, sample holding times from collection to analysis, and sample shipping and storage conditions. Ensure that appropriate forms are legibly filled out in indelible ink or hard copies of electronic data are available. (See Chapters IV, V, and VI for specific items to be included.) Describe how samples are checked upon arrival for proper containers and temperature and how samples are checked for proper preservation (e.g., ph, chlorine residual) before analysis. Ensure that sampling protocol is written and available to samplers Laboratory sample receipt and handling procedures. Bound laboratory note books, if used, should be filled out in ink; entries dated and signed (A secure, password protected, electronic data base is acceptable). Store unprocessed and processed samples at the proper temperature, isolated from laboratory contaminants, standards and highly contaminated samples and, sometimes, each other; holding times may not be exceeded. Maintain integrity of all samples, (e.g., by tracking samples from receipt by laboratory through analysis to disposal). Require Chain-of-Custody procedures for samples likely to be the basis for an enforcement action (see Appendix A). Specify criteria for rejection of samples which do not meet shipping, holding time and/or preservation requirements and procedures for notification of sample originators Instrument calibration procedures (may reference SOP). Specify type of calibration used for each method and frequency of use. Describe calibration standards' source, age, storage, labeling; Perform data comparability checks. Use control charts and for radiochemistry, report counting errors with their confidence levels Analytical procedures (may reference SOP). Cite complete method manual. January 21, 2004 Page 3 FOR DISCUSSION PURPOSES ONLY

6 Describe quality control procedures required by the methods that must be followed Data reduction, validation, reporting and verification (may reference SOP). Describe data reduction process: method of conversion of raw data to mg/l, picocuries/l, coliforms/100 ml, etc. Describe data validation process. Describe reporting procedures; include procedures and format. Describe data verification process. For radiochemistry, describe reporting of counting uncertainties and confidence levels. Describe procedure for data corrections Type of quality control (QC) checks and the frequency of their use (may reference SOP) Parameters for chemistry and radiochemistry should include or reference: Instrument performance check standards. Frequency and acceptability of method detection limit (MDL) calculations. Frequency and acceptability of demonstration of low level capability. Calibration, internal and surrogate standards. Laboratory reagent blank, field reagent blank and trip blank. Field and laboratory matrix replicates. Quality control and proficiency testing samples. Laboratory fortified blank and laboratory fortified sample matrix replicates. Initial demonstration of method capability Use of control charts. Qualitative identification/confirmation of contaminants Parameters for microbiology should include or reference: Positive and negative culture controls. Confirmation/verification of presumptive total coliform positive samples. Sterility controls. Proficiency testing and quality control samples. Instrument performance checks List schedules of internal and external system and data quality audits and inter laboratory comparisons (may reference SOP) Preventive maintenance procedures and schedules. Describe location of instrument manuals and schedules and documentation of routine equipment maintenance. Describe availability of instrument spare parts in the laboratory. List any maintenance contracts in place Corrective action contingencies. January 21, 2004 Page 4 FOR DISCUSSION PURPOSES ONLY

7 Describe response to obtaining unacceptable results from analysis of PT samples and from internal QC checks. Name persons responsible for the various corrective actions. Describe how corrective actions taken are documented Record keeping procedures. Describe procedures and documentation of those procedures. List length of storage, media type (electronic or hard copy). Describe security policy of electronic databases. All electronic data must have software support so it may be regenerated. If a particular item is not relevant, 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 and experience, and managerial capability commensurate with the size/type of the laboratory. 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 person 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. Circumstances to be considered in the decision to grant such authorization shall include, but not be limited to, the extent to which operating hours of the laboratories to be directed overlap, adequacy of supervision in each laboratory, and the availability of environmental laboratory services in the area served. In case the laboratory supervisor is absent for a period of time exceeding 15 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 65 consecutive calendar days, the Department shall be notified in writing Quality Manager. The laboratory shall have a designated quality manager. The quality manager (however named) has responsibility for the quality manual and its implementation. The quality manager shall have direct access to the highest level of management at which decisions are made on laboratory policy or January 21, 2004 Page 5 FOR DISCUSSION PURPOSES ONLY

8 resources, and to the laboratory supervisor. Where staffing is limited, the quality manager may also be the laboratory supervisor or deputy laboratory supervisor. The quality manager should have a bachelor's degree in science, training in quality assurance principles commensurate with the size and sophistication of the laboratory, and at least one year of experience in quality assurance. The quality manager should have at least a working knowledge of the statistics involved in quality control of laboratory analysis and a basic understanding of the methods which the laboratory employs. 2.4 Demonstration of Capability. Prior to the acceptance and institution of any test method, satisfactory demonstration of method capability is required. For some methods, the laboratory must be able to achieve published method detection limits ( MDLs ). In all cases, the environmental laboratory must demonstrate capability to meet any reporting limits required by the Department. Data supporting the Demonstration of Capability and any required MDLs or reporting limits must be available to the Department on 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 Safe Drinking Water Regulations, 25 Pa. Code, Chapter 109, Subchapter H. Checks must be made payable to the "Commonwealth of Pennsylvania". FEES ARE NONREFUNDABLE. Accreditation Category Fee Drinking Water (Potable) Inorganic chemicals $ 800(1) Drinking Water (Potable) Organic chemicals $ 1000(1) Drinking Water (Potable) Inorganic and organic chemicals $ 1350(1) Drinking Water (Potable) Microbiological contaminants $ 800(1) Drinking Water (Potable) Radionuclides $ 1300(1) (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. 2.6 Proficiency Test Studies. The Pennsylvania Safe Drinking Water Regulations (26 Pa. Code Chapter (b)) require that laboratories successfully complete at least one set of proficiency test ( PT ) studies for the parameters in the category for which certification is sought. Laboratories seeking to obtain or retain existing certifications under the Pennsylvania Safe Drinking Water Act shall analyze performance evaluation studies according to the following criteria: Initially, a laboratory must successfully complete 1 single blind, single concentration PT study where available, for each method and contaminant for which the laboratory is seeking certification. To maintain certification, a laboratory must successfully complete 1 single blind, single concentration PT study, where available, for each method and contaminant for which they are 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 NIST as a Proficiency Test Provider or approved as PT provider in January 21, 2004 Page 6 FOR DISCUSSION PURPOSES ONLY

9 accordance with the current National Environmental Laboratory Accreditation Conference Standards (NELAC) Laboratories must maintain a history of at least 2 acceptable studies out of the 3 most recent rounds attempted to retain certification If a parameter is not successfully analyzed at least once every 12 calendar months or incorrectly analyzed on 2 out of the most recent 3 PT studies, the laboratory will be decertified or certification will not be renewed for that method and contaminant Certification for Polychlorinated Biphenyls ( PCB ) analysis by US EPA Method 508A which reports PCBs as the decachlorbiphenyl is contingent upon successful completion of a PT study for PCBs which require reporting as the decachlorobiphenyl Certification for PCBs 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 Corrosivity is a calculated parameter based upon the analytical results of 4 individual parameters. Certification for corrosivity requires successful performance on each of the 4 individual parameters. Analysis of all 4 parameters is required in order to meet the PT study requirements for corrosivity Total trihalomethanes is a calculated value based upon the analytical results of 4 individual parameters. Certification for total trihalomethanes requires successful performance on each of the 4 individual parameters and the calculated value as defined above. Analysis of all 4 parameters is required in a PT study in order to meet the PT study requirements for total trihalomethanes Successful performance in the regulated volatile organic chemicals ( VOC1 ) subcategory 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 be included in the calculations of the required 80% correct results. 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 certified for the VOC1 subcategory Certification for vinyl chloride requires current certification in the VOC1 subcategory and a successful PT study for vinyl chloride Certification for unregulated or non-regulated volatile organic chemicals group requires current certification in VOC1 subcategory and a successful PT study for unregulated volatiles. Since not all parameters contained in the this grouping may be contained in every PT study, successful performance for these compounds will be defined as correctly analyzing at least 80% of the parameters. Failure to report a compound that is present shall constitute an incorrect result and be included in the calculations of the required 80% correct results. Incorrectly analyzing the same parameter on 2 consecutive studies while maintaining an overall 80% correct rating will result in the laboratory being downgraded to NOT certified for all unregulated or non-regulated volatiles A PT study for microbiology analysis is defined as ten 100-mL samples analyzed to determine the presence or absence of total coliforms and fecal coliforms (or E.coli). 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 is defined as 9 out of 10 samples correct with no false negatives reported Certification for the radiochemistry parameter group gamma emitters requires successful analysis of Barium 133, Copper 60, Cesium 134, Cesium 137, and Zinc The PT studies shall be analyzed and the results returned to the PT study provider no later than 45 calendar days from the scheduled study shipment date 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 January 21, 2004 Page 7 FOR DISCUSSION PURPOSES ONLY

10 environmental samples unitizing 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 certification or is certified 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 certification or is certified Laboratory management or staff shall not communicate with any individual at another laboratory, including intra-company communication, concerning the PT study Laboratory management or staff shall not attempt to obtain the prepared value of a PT study from the PT provider Whenever a laboratory fails a PT study, it shall determine the cause for the failure and take any necessary corrective action. It shall then document in its own records and provide to the Department within 15 days both the investigation and the action taken. If a laboratory fails two out of the three most recent 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 certification 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 for at least 5 years. 2.7 On-site Assessment. An initial on-site assessment is required of all laboratories seeking accreditation. All accredited laboratories must be reassessed at least once every 3 years. Additional onsite 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 a general one 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 tests for which the laboratory seeks accreditation. Upon completion of the on-site assessment, the on-site assessor will prepare a formal written report. Reports are normally issued within 45 calendar days following completion of the assessment. The assessment report will contain all information pertinent to the assessment. Within 60 calendar days of the receipt of the report, the laboratory shall prepare and submit a corrective action report. The Department will review and respond to the written corrective action report within 30 calendar days after receipt of the corrective action report. If any portion of the corrective action report is not acceptable, the laboratory shall submit within 30 calendar days a revised written corrective action report. If the corrective action report is not acceptable, the Department may revoke Accreditation at any time in accordance with Department procedures. If the laboratory fails to implement the corrective actions as stated in their corrective action report, accreditation for fields of testing, specific methods, or analytes within those fields of testing shall be revoked. 2.8 Awarding of Accreditation. January 21, 2004 Page 8 FOR DISCUSSION PURPOSES ONLY

11 When a participating laboratory has met the requirements specified for obtaining accreditation, including all of the requirements in the appropriate Critical Elements guidance, the laboratory will receive a certificate awarded on behalf of 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 (for example, the laboratory may be accredited for the analysis of water or for use of a specific analytical methodology, etc.). The Certificate of Accreditation will contain a Scope of Accreditation as an attachment. 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 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 subfacilities (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. The accredited laboratory shall notify the Department of any changes in key accreditation criteria within 30 calendar days of the change. This written notification is required for, but is not limited to, changes in the laboratory ownership, location, key personnel, and major instrumentation. All such updates are public record. Out-of-State laboratories must notify the Department in writing, within 48 hours of the termination of the laboratory accreditation from the US EPA or another agency with primary enforcement authority. Failure to provide timely notification to the Department of the termination of accreditation may result in revocation of accreditation for all parameters A laboratory accredited under 25 Pa. Code Chapter 109, Subchapter H shall submit to the Department, on forms provided by the Department, the results of test measurements or analyses performed by the laboratory under 25 Pa. Code Chapter 109. These results shall be reported within either the first 10 days following the month in which the result is determined or the first 10 days following the end of the required monitoring period as stipulated by the Department, whichever is shorter. A laboratory accredited under 25 Pa. Code Chapter 109, Subchapter H shall 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): (1) Notify the public water supplier by telephone within 1 hour of the laboratory s determination. If the supplier cannot be reached within that time, notify the Department by telephone within 2 hours of the determination. If it is necessary for the laboratory to contact the Department after the Department s routine business hours, the laboratory shall contact the appropriate Department regional office s after-hours emergency response telephone number and provide information regarding the occurrence, the name of a contact person and the telephone number where that individual may be reached in the event further information is needed. If the Department s appropriate emergency number cannot be reached, the laboratory shall notify the appropriate Department regional office by telephone within 1 hour of the beginning of the January 21, 2004 Page 9 FOR DISCUSSION PURPOSES ONLY

12 next business day. Each certified laboratory shall be responsible for the following: a. Obtaining and then maintaining the Department s current after-hours emergency response telephone numbers for each applicable regional office. b. Establishing or updating a standard operating procedure, and at least annually thereafter to provide the information needed to report the occurrences to the Department. The information regarding the public water system shall include, but is not limited to, the PWSID number of the system, the system s name, the contaminant involved in the occurrence, the level of the contaminant found, where the sample was collected, the dates and times that the sample was collected and analyzed, the name and identification number of the certified laboratory, the name and telephone number of a contact person at the laboratory and what steps the laboratory took to contact the public water system before calling the Department. (2) Notify the appropriate Department district office in writing within 24 hours of the determination. For the purpose of determining compliance with this requirement, the postmark, if the notice is mailed, or the date the notice is received by the Department, whichever is earlier, will be used. Upon approval by the Department, the notice may be made electronically to the Department as long as the information is received within the 24-hour deadline. A laboratory accredited under 25 Pa. Code Chapter 109, Subchapter H shall notify the public water supplier served by the laboratory within 48 hours of the following: (1) A failure to renew or Department denial of renewal of existing certification for a category of certification. (2) Revocation of certification by the Department under this Subchapter H 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. 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. All laboratory records associated with accreditation parameters shall meet the requirements of the Safe Drinking Water Act and the accompanying regulations and shall be maintained for a minimum of five years unless otherwise designated for a longer period in regulation. In the case of data used in litigation, the laboratory is required to store such records for a longer period upon written notification from the Department. 3.0 ACCREDITATION STATUS 3.1 Types of Accreditation. After review of PT study results and an on-site assessment, the Department will provide a written report generally within 45 calendar days and classify the laboratory for each contaminant or group of contaminants according to the following rating scheme: January 21, 2004 Page 10 FOR DISCUSSION PURPOSES ONLY

13 3.1.1 Accredited: A laboratory that meets the minimum requirements of this guidance document and all applicable regulatory requirements. "Accredited status may not be granted to any laboratory that has not met performance criteria specified in the Department s regulations or guidance Interim Accreditation: Interim accreditation may be granted to laboratories that have completed all of the requirements for accreditation except that of an on-site assessment. Interim accreditation shall allow a laboratory to perform analyses and report results with the same status as an accredited laboratory until the onsite assessment requirements have been completed. Interim accreditation status shall not exceed twelve months. Interim accreditation status may be granted only when the Department judges that the laboratory has the appropriate instrumentation, is using approved methods, has adequately trained personnel to perform the analyses, and has satisfactorily analyzed a PT study, if available, for the contaminants in question 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 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, withdrawn at the written request of the accredited laboratory, or until the expiration of the accreditation period. The accreditation period will not exceed 12 months. 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. January 21, 2004 Page 11 FOR DISCUSSION PURPOSES ONLY

14 Reasons to deny an initial application shall include, but are not limited to the following: a) Failure to submit a completed application. b) Violation of a condition of the certification. c) Violation of a statute, 25 PA. Code 109 or an order of the Department or its agent. d) Misrepresentation made to the Department or its agent. e) Falsifying analyses, selectively reporting data or engaging in other unethical or fraudulent practices. f) Failure to notify the Department under 25 P. Code (e)(1) (relating to certification procedure) of substantial change in personnel, facilities or equipment. g) Failure to participate in the analysis of proficiency test studies. h) Failure to arrange for timely onsite laboratory inspection at the designated intervals. i) Failure to provide a satisfactory response to an on-site assessment within the required time frames. j) Failure to implement the corrective actions detailed in the corrective action report within the time frames specified by the Department. k) Unacceptable Proficiency Test Study results in two consecutive series of tests for the same parameter, which will result in decertification for that category until the laboratory analyzes at least one Proficiency Test Study with acceptable results and submits an explanation for the previous unsatisfactory performance. l) Analysis of Proficiency Test Studies by personnel other than the analysts associated with the routine analysis of monitoring samples in the laboratory. m) Failure of laboratory supervisor to meet the personnel qualifications, including the education, training and experience requirements. n) Denial of entry during normal business hours for an on-site assessment If the laboratory is not successful in correcting the deficiencies, the laboratory must wait six months before reapplying for accreditation Upon reapplication, the laboratory again will be responsible for all of the fees applicable as part of the initial application for accreditation Suspension A laboratory's accreditation may be suspended in total or in part. The laboratory may retain accreditation for the fields of testing, methods and analytes where it continues to meet the requirements of the Department Reasons for suspension shall include: a) If the Department finds during the on-site assessment that the public interest, safety or welfare imperatively requires emergency action. b) Failure to complete proficiency testing studies and maintain a history of at least two successful proficiency testing studies for each affected accredited field of testing out of the three most recent proficiency testing studies. c) Failure to notify the Department of any changes in key accreditation criteria as set forth in this guidance. January 21, 2004 Page 12 FOR DISCUSSION PURPOSES ONLY

15 A suspended laboratory may not continue to analyze samples for the affected fields of testing The laboratory's suspended accreditation status will change to accredited when the laboratory demonstrates to Department that the laboratory complies with Department requirements A suspended laboratory does not have to reapply for accreditation if the cause/causes for suspension are corrected within six months and the original period of accreditation has not expired If the laboratory fails to correct the causes of suspension within six months after the effective date of the suspension, the Department shall revoke in total or part of the laboratory's accreditation Revocation. The Department shall revoke a laboratory's accreditation, in part or in total, for failure to correct the deficiencies as set forth in this guidance, the NELAC standards, and Department regulations and for failure to correct the reasons for being suspended. The laboratory may retain accreditation for the fields of testing, methods and analytes where it continues to meet the requirements of the Department Reasons for revocation in part or in total include: a) Failure to submit an acceptable corrective action response to an onsite assessment report. b) Failure to implement corrective action(s) related to any deficiencies found during a laboratory assessment. c) After being suspended due to failure of proficiency testing samples, if the laboratory s analysis of the next proficiency testing study results in three consecutively failed proficiency testing studies, the laboratory s accreditation shall be revoked for each affected accredited field of testing Reasons for total revocation include a laboratory s: a) Failure to submit a completed application. b) Violation of a condition of the certification. c) Violation of a statute, 25 PA. Code 109 or an order of the Department or its agent. d) Misrepresentation made to the Department or its agent. e) Falsifying analyses, selectively reporting data or engaging in other unethical or fraudulent practices. f) Failure to notify the Department under 25 P. Code (e)(1) (relating to certification procedure) of substantial change in personnel, facilities or equipment. g) Failure to participate in the analysis of proficiency test studies. h) Failure to arrange for timely onsite laboratory inspection at the designated intervals. i) Failure to provide a satisfactory response to an on-site assessment within the required time frames. j) Failure to implement the corrective actions detailed in the corrective action report within the time frames specified by the Department. January 21, 2004 Page 13 FOR DISCUSSION PURPOSES ONLY

16 k) Unacceptable Proficiency Test Study results in two consecutive series of tests for the same parameter, which will result in decertification for that category until the laboratory analyzes at least one Proficiency Test Study with acceptable results and submits an explanation for the previous unsatisfactory performance. l) Analysis of Proficiency Test Studies by personnel other than the analysts associated with the routine analysis of monitoring samples in the laboratory. m) Failure of laboratory supervisor to meet the personnel qualifications, including the education, training and experience requirements. n) Denial of entry during normal business hours for an on-site assessment After correcting the reason/cause for total revocation, the laboratory may reapply for accreditation no sooner than 6 months from the official date of revocation. This reapplication shall include the payment of any applicable fees Upgrading of Status. Laboratories are only considered for upgrade to Accredited status after identified deviation(s) have been eliminated or rectified. Laboratories whose accreditation has been revoked, shall not be considered until all bases for revocation have been eliminated or rectified, and until a period of not less than six (6) months from the date of revocation has elapsed, except in the following instances: A laboratory which lost accreditation for failure to correctly analyze PT studies is eligible for upgrade of status after meeting the PT study requirements A laboratory which lost accreditation because of false statements on documents or falsified analytical results is eligible for consideration for accreditation one year after revocation A laboratory which lost accreditation because of conviction of any violation of the laws of Pennsylvania is not eligible for Accreditation. Any application for accreditation shall be made in the same manner as an application for initial Accreditation and shall be accompanied by the appropriate fee Voluntary Withdrawal. If an environmental laboratory wishes to withdraw its accreditation, in total or in part, it must notify the Department no later than 30 calendar days before the end of the accreditation year or the effective date, whichever is earlier. Fees are nonrefundable. 3.4 Subcontracting Analyses. If a laboratory subcontracts one or more analyses, it may only subcontract to a laboratory accredited by the Department for that analyte. A laboratory acting as an agent of a Public Water System (PWS) that subcontracts the sample to a certified laboratory must insure that the PWS receives all information required by 25 PA. Code Chapter 109. The agent laboratory must notify the subcontracted laboratory that the sample is from a PWS so the subcontracted laboratory uses appropriate methodology and quality control and is aware of the reporting and notification requirements of 25 Pa. Code (b). The laboratory that subcontracts analyses must follow all required reporting procedures. January 21, 2004 Page 14 FOR DISCUSSION PURPOSES ONLY

17 Identification of the laboratory that performs the subcontracted analyses must appear on all report forms. 4.0 OUT-OF-STATE LABORATORIES To obtain and retain accreditation in Pennsylvania, out-of-state laboratories must meet the same requirements as laboratories located within the State. In addition to the appropriate fee, out-of- State laboratories shall reimburse the Department for out-of-state travel-related expenses necessitated by accreditation. Separate on-site inspections are performed for Microbiology, Chemistry, and Radionuclide accreditation. 5.0 USE OF ACCREDITATION BY ACCREDITED LABORATORIES Laboratories accredited by the Department shall: 1) Post or display their most recent accreditation certificate including their accredited fields of testing in a prominent place in the laboratory facility. 2) Make accurate statements concerning their accreditation fields of testing and accreditation status. 3) Not use their certificate of accreditation and Department accreditation status to imply endorsement by the Department. Laboratories choosing to use the Department s name and/or making reference to its accreditation status in any catalogs, advertising, business solicitations, proposals, quotations, laboratory analytical reports, or other materials, shall: 1) Distinguish between proposed testing for which the accredited laboratory is accredited and the proposed testing for which the accredited laboratory is not accredited. 2) Include the accredited laboratory s accreditation number or other identifier. Accredited laboratories upon suspension, revocation, or withdrawal of their accreditation shall: 1) Discontinue use of all catalogs, advertising, business solicitations, proposals, quotations, laboratory analytical results, or other materials that contain reference to their past accreditation status. 2) Return any certificates of accreditation and fields of testing to the Department within 48 hours. January 21, 2004 Page 15 FOR DISCUSSION PURPOSES ONLY