The laboratory should be able to provide documentation to the certification authority that the person(s)analyzing any PT sample is a laboratory employee who routinely analyzes drinking water compliance samples l3.2 Laboratories must use the methods specified in the drinking water regulations at 40 CFR part 141 These methods are listed in Chapters IV,V, VI, and Appendix G 13.3 On-Site Evaluation The Ca should be satisfied that a laboratory is maintaining the required standard of quality for certification. normally this should be based on a recommendation from a triennial on-site evaluation. However, if the laboratory undergoes a major change or repeatedly fails a PT sample, the Ca should consider conducting an evaluation before the usual three ear period has expired 13. 4 Notification of Certifying Authority(CA)of Major Changes Certified laboratories should notify the appropriate CA(Regional Administrator or designee or the Chief, Tsc OGWDW)in writing, within 30 days of major changes in personnel, equipment, or laboratory location. A major change in personnel is defined as the loss or replacement of the laboratory supervisor or a situation in which a trained and experienced analyst is no longer available to analyze a particular parameter for which certification has been granted The Ca should discuss the situation with the laboratory supervisor and establish a schedule for the laboratory to address major changes. If the Ca determines that the laboratory can no longer produce valid data, the Ca should follow the procedure for revocation of certification. 14. Criteria and Procedures for Downgrading/Revoking Certification Status 14.1 Criteria for Downgrading Certification Status A laboratory should be downgraded to"provisionally certified "status for a contaminant or group of contaminants for any of the following reasons Failure to analyze a pt sample at least annually within the acceptance limits specified in the regulations, or if there are no requirements specified in the regulations, within policy described by their certifying authority; Failure of a certified laboratory to notify the Ca within 30 days of major changes(e.g, in personnel, equipment, or laboratory location); Failure to satisfy the Ca that the laboratory is maintaining the required standard of quality, based upon a EPa on-site evaluation: Failure to report compliance data to the public water system or the state drinking water program in a timely manner, thereby preventing compliance with Federal or State regulations and endangering public health. Data which may cause the system to exceed an MCl should be reported as soon as possible 14.2 Procedures for Downgrading to " Provisionally Certified "Status If a laboratory is subject to do wngrading on the basis of the above indicated criteria, the Ca should notify the laboratory director or owner(by registered or certified mail) of its intent to downgrade within 14 days from becoming aware of the situation warranting downgrading. The laboratory director should review the problems cited, and within 30 days receipt of the letter, send a letter to the Ca specifying what immediate corrective actions are being taken and any proposed actions that need the concurrence of the CA. The Ca should consider the adequacy of the response and notify the laboratory in writing(by registered or certified mail) of its cert 14 days of receipt of its response. The Ca should follow up to ensure that corrective actions have been taken If a laboratory fails to analyze a Pt or other unknown sample within the acceptance limits, the Ca should not downgrade certification if the laboratory identifies and corrects the problem to the Ca's satisfaction within 30 days of being notified of the failure. If, after a review of the submitted information, the ca determines that the laboratory need not be downgraded, then within 30 days of this decision, the Ca should notify the laboratory that it is required to analyze III-7
III-7 The laboratory should be able to provide documentation to the certification authority that the person(s) analyzing any PT sample is a laboratory employee who routinely analyzes drinking water compliance samples. 13.2 Methodology Laboratories must use the methods specified in the drinking water regulations at 40 CFR part 141 These methods are listed in Chapters IV, V, VI, and Appendix G. 13.3 On-Site Evaluation The CA should be satisfied that a laboratory is maintaining the required standard of quality for certification. Normally, this should be based on a recommendation from a triennial on-site evaluation. However, if the laboratory undergoes a major change or repeatedly fails a PT sample, the CA should consider conducting an evaluation before the usual three year period has expired. 13.4 Notification of Certifying Authority (CA) of Major Changes Certified laboratories should notify the appropriate CA (Regional Administrator or designee or the Chief, TSCOGWDW) in writing, within 30 days of major changes in personnel, equipment, or laboratory location. A major change in personnel is defined as the loss or replacement of the laboratory supervisor or a situation in which a trained and experienced analyst is no longer available to analyze a particular parameter for which certification has been granted. The CA should discuss the situation with the laboratory supervisor and establish a schedule for the laboratory to address major changes. If the CA determines that the laboratory can no longer produce valid data, the CA should follow the procedure for revocation of certification. 14. Criteria and Procedures for Downgrading/Revoking Certification Status 14.1 Criteria for Downgrading Certification Status A laboratory should be downgraded to "provisionally certified" status for a contaminant or group of contaminants for any of the following reasons: • Failure to analyze a PT sample at least annually within the acceptance limits specified in the regulations, or, if there are no requirements specified in the regulations, within policy described by their certifying authority; • Failure of a certified laboratory to notify the CA within 30 days of major changes (e.g., in personnel, equipment, or laboratory location); • Failure to satisfy the CA that the laboratory is maintaining the required standard of quality, based upon a EPA on-site evaluation; • Failure to report compliance data to the public water system or the State drinking water program in a timely manner, thereby preventing compliance with Federal or State regulations and endangering public health. Data which may cause the system to exceed an MCL should be reported as soon as possible. 14.2 Procedures for Downgrading to "Provisionally Certified" Status If a laboratory is subject to downgrading on the basis of the above indicated criteria, the CA should notify the laboratory director or owner (by registered or certified mail) of its intent to downgrade within 14 days from becoming aware of the situation warranting downgrading. The laboratory director should review the problems cited, and within 30 days of receipt of the letter, send a letter to the CA specifying what immediate corrective actions are being taken and any proposed actions that need the concurrence of the CA. The CA should consider the adequacy of the response and notify the laboratory in writing (by registered or certified mail) of its certification status within 14 days of receipt of its response. The CA should follow up to ensure that corrective actions have been taken. If a laboratory fails to analyze a PT or other unknown sample within the acceptance limits, the CA should not downgrade certification if the laboratory identifies and corrects the problem to the CA's satisfaction within 30 days of being notified of the failure. If, after a review of the submitted information, the CA determines that the laboratory need not be downgraded, then within 30 days of this decision, the CA should notify the laboratory that it is required to analyze
another PT. If the laboratory analyzes this second unknown sample within the acceptance limits established by the epa or State, the laboratory should not be downgraded. If the laboratory fails to analyze this second unknown sample within its, the Ca should downgrade the laboratory to "provisionally certified"status and notify the laboratory within 14 days(by registered or certified mail). Laboratories should be downgraded only for the analyte failed, except where EP A/State certifies a group of related analytes based on a limited number of analytes in the group. See Chapter 4, Section 7.2.1 for additional information. During any phase of this procedure, a laboratory may request that the EPa or State provide technical assistance to hely identify and resolve any problem After the CA notifies a laboratory, in writing, that it has been downgraded to "provisionally certified"status for procedural, administrative, equipment or personnel deficiency, the laboratory should correct its problem within three months. If the laboratory was downgraded to"provisionally certified"status because of a failure to analyze a PT sample (or other unknown test sample)within the acceptance limits specified in the regulations, or within policy required by their certifying authority, the laboratory should correct its problems and satisfactorily analyze another PT sample (or other unknown sample) within one month of receipt of the second PT sample. a provisionally certified laboratory may continue to analyze samples for compliance purposes, but should notify its clients of its downgraded status and provide that information, in writing, on any report 14.3 Criteria for Revoking Certification Status A laboratory should be downgraded from certified, provisionally certified or interim certified status to"not certified for a particular contaminant analysis for the following reasons: Reporting Pt data from another laboratory as its own; Falsification of data or other deceptive practic Failure to use the analytical methodology specified in the regulations For provisionally certified laboratories, failure to successfully analyze a PT sample or any other unknown test sample for a particular contaminant within the acceptance limits specified For provisionally certified laboratories, failure to satisfy the Ca that the laboratory has corrected deviations identified during an on-site evaluations; For provisionally certified laboratories, persistent failure to report compliance data to the public water system or the State drinking water program in a timely manner thereby preventing compliance with Federal and/or State regulations and endangering public health. Data which may cause the system to exceed an MCL should be reported as soon as possible Refusal to participate in an on-site evaluation conducted by the Ca 14.4 Procedures for Revocation The Ca should notify the laboratory, in writing(by registered or certified mail) of the intent to revoke certification. If the laboratory wishes to challenge this decision, a notice of appeal should be submitted in writing to the Ca within 30 days of receipt of the notice of intent to revoke certification. If no notice of appeal is filed, certification should be The notice of appeal should be supported with an explanation of the reasons for the challenge and should be signed by supervisor in the case of a municipal laboratory or the laboratory director for a State or Regional laborator oratory a responsible official from the laboratory such as the president/owner for a commercial laboratory, or the laboratory Within 30 days of receipt of the appeal, the Ca should make a decision and notify the laboratory in writing(by registered or certified mail). Denial of the appeal should result in immediate revocation of the laboratory's certification. Once certification is revoked, a laboratory may not analyze drinking water samples for compliance until its certification has been reinstated If the appeal is determined to be valid, the ca should take appropriate measures to reevaluate the facility and notify the laboratory, in writing(by registered or certified mail), of its decision within 30 days of the reevaluation. I 8
III-8 another PT. If the laboratory analyzes this second unknown sample within the acceptance limits established by the EPA or State, the laboratory should not be downgraded. If the laboratory fails to analyze this second unknown sample within the established limits, the CA should downgrade the laboratory to "provisionally certified" status and notify the laboratory within 14 days (by registered or certified mail). Laboratories should be downgraded only for the analyte failed, except where EPA/State certifies a group of related analytes based on a limited number of analytes in the group. (See Chapter 4, Section 7.2.1 for additional information.) During any phase of this procedure, a laboratory may request that the EPA or State provide technical assistance to help identify and resolve any problem. After the CA notifies a laboratory, in writing, that it has been downgraded to "provisionally certified" status for procedural, administrative, equipment or personnel deficiency, the laboratory should correct its problem within three months. If the laboratory was downgraded to "provisionally certified" status because of a failure to analyze a PT sample (or other unknown test sample) within the acceptance limits specified in the regulations, or within policy required by their certifying authority, the laboratory should correct its problems and satisfactorily analyze another PT sample (or other unknown sample) within one month of receipt of the second PT sample. A provisionally certified laboratory may continue to analyze samples for compliance purposes, but should notify its clients of its downgraded status and provide that information, in writing, on any report. 14.3 Criteria for Revoking Certification Status A laboratory should be downgraded from certified, provisionally certified or interim certified status to "not certified" for a particular contaminant analysis for the following reasons: • Reporting PT data from another laboratory as its own; • Falsification of data or other deceptive practices; • Failure to use the analytical methodology specified in the regulations; • For provisionally certified laboratories, failure to successfully analyze a PT sample or any other unknown test sample for a particular contaminant within the acceptance limits specified; • For provisionally certified laboratories, failure to satisfy the CA that the laboratory has corrected deviations identified during an on-site evaluations; • For provisionally certified laboratories, persistent failure to report compliance data to the public water system or the State drinking water program in a timely manner thereby preventing compliance with Federal and/or State regulations and endangering public health. Data which may cause the system to exceed an MCL should be reported as soon as possible. • Refusal to participate in an on-site evaluation conducted by the CA 14.4 Procedures for Revocation The CA should notify the laboratory, in writing (by registered or certified mail) of the intent to revoke certification. If the laboratory wishes to challenge this decision, a notice of appeal should be submitted in writing to the CA within 30 days of receipt of the notice of intent to revoke certification. If no notice of appeal is filed, certification should be revoked. The notice of appeal should be supported with an explanation of the reasons for the challenge and should be signed by a responsible official from the laboratory such as the president/owner for a commercial laboratory, or the laboratory supervisor in the case of a municipal laboratory or the laboratory director for a State or Regional laboratory. Within 30 days of receipt of the appeal, the CA should make a decision and notify the laboratory in writing (by registered or certified mail). Denial of the appeal should result in immediate revocation of the laboratory's certification. Once certification is revoked, a laboratory may not analyze drinking water samples for compliance until its certification has been reinstated. If the appeal is determined to be valid, the CA should take appropriate measures to reevaluate the facility and notify the laboratory, in writing (by registered or certified mail), of its decision within 30 days of the reevaluation
14.5 Upgrading or Reinstatement of Certification Through a written request, a laboratory may seek upgrading or reinstatement of certification, when and if the laboratory can demonstrate to the Ca's satisfaction that the deficiencies which produced provisionally certified status or revocation have been corrected. This may include an on-site evaluation, successful analysis of unknown samples or any other measure the Ca deems appropriate 15. Record Keeping The certification program manager should ensure that records for on-site laboratory assessments and certification program reviews be maintained in an easily accessible central location for a period of 6 years to include the last two on- site audits, or longer if required by specific State regulations. This includes records/correspondence used to determine compliance with the requirements in this manual. Records may include checklists, corrective action reports, final reports, certificates. pt study results and related documents 16. Reciprocit Reciprocity(mutually acceptable certification among Regions and/or primacy States) is strongly endorsed by Epa as a highly desirable element in the certification program for drinking water laboratories responsibility for reciprocal certification resides with the Regions ando perm it reciprocity. Even though ultimate States are encouraged to adopt provisions in their laws and regulations te rimacy States, the States may ask for the assistance of EPA in cases involving clarification of what should be considered in a reciprocal agreement. Such requests should be submitted to the region or oGwdw through the Region 17. Trainin Training is an integral part of the laboratory certification process for personnel conducting on-site evaluations of laboratories on behalf of either the regional office or a primacy State EPA policy requires that all Regional Certification Officers initially pass the appropriate EPA laboratory certification training courses for the discipline for which they certify(chemistry or microbiology). All laboratory auditors should be experienced professionals, and have at least a bachelor's degree or equivalent education/experience in the discipline for which they certify and recent laboratory experience in the field for which they audit laboratories. Third party auditors (see Appendix D)also need to pass the EPa certification training course. Outside experts, retained for their knowledge in a limited area(e.g, asbestos )are not required to pass the laboratory certification course if they are used as part of an on-site audit team which includes a certification officer. Periodic training for both laboratory auditors and analysts should be provided by the Regions. Certification officers should attend refresher training programs at least every five years to keep their knowledge of the methods and the drinking water program current. It is highly recommended that certification officers have recent bench experience in the methods for which they certify. oGWDw will notify certification officers of major updates/changes to EPAs certification program. It is recommended that the states use these same criteria in their certification programs 18. Alternate Test Procedures(ATPs) EPA promulgates analytical methods for all regulated drinking water contaminants. A regulation for a particular contaminant will include one or more methods that must be used to determine that contaminant. Subsequently, the dditional methods or modifications of EPA approved methods in another rule. EPA may also authorize the use of alternate analytical methods as provided in 40 CFR 141. 27, With the written permission of the State concurred by the Administrator of the EPA, an alternate analytical technique may be employed. An alternate technique be accepted only if it is substantially equivalent to the prescribed test in both precision and y as it relates to the determination of compliance with any MCL. Anyone can request that EPA approve a new method or modification of a method already approved by Epa, by submitting EPA-specified data and other information to the Director, Analytical Methods Staff, (MS 4303T)Office of Science and Technology, Office of Water, EPA, 1200 Pennsylvania Ave, Nw, Washington DC 20460. EPA will evaluate the material to determine whether the method or method modification meets ePa criteria Im-9
III-9 14.5 Upgrading or Reinstatement of Certification Through a written request, a laboratory may seek upgrading or reinstatement of certification, when and if the laboratory can demonstrate to the CA's satisfaction that the deficiencies which produced provisionally certified status or revocation have been corrected. This may include an on-site evaluation, successful analysis of unknown samples or any other measure the CA deems appropriate. 15. Record Keeping The certification program manager should ensure that records for on-site laboratory assessments and certification program reviews be maintained in an easily accessible central location for a period of 6 years to include the last two onsite audits, or longer if required by specific State regulations. This includes records/correspondence used to determine compliance with the requirements in this manual. Records may include checklists, corrective action reports, final reports, certificates, PT study results and related documents 16. Reciprocity Reciprocity (mutually acceptable certification among Regions and/or primacy States) is strongly endorsed by EPA as a highly desirable element in the certification program for drinking water laboratories. States are encouraged to adopt provisions in their laws and regulations to permit reciprocity. Even though ultimate responsibility for reciprocal certification resides with the Regions and primacy States, the States may ask for the assistance of EPA in cases involving clarification of what should be considered in a reciprocal agreement. Such requests should be submitted to the Region or OGWDW through the Region. 17. Training Training is an integral part of the laboratory certification process for personnel conducting on-site evaluations of laboratories on behalf of either the Regional Office or a primacy State. EPA policy requires that all Regional Certification Officers initially pass the appropriate EPA laboratory certification training courses for the discipline for which they certify (chemistry or microbiology). All laboratory auditors should be experienced professionals, and have at least a bachelor's degree or equivalent education/experience in the discipline for which they certify and recent laboratory experience in the field for which they audit laboratories. Third party auditors (see Appendix D) also need to pass the EPA certification training course. Outside experts, retained for their knowledge in a limited area (e.g., asbestos) are not required to pass the laboratory certification course if they are used as part of an on-site audit team which includes a certification officer. Periodic training for both laboratory auditors and analysts should be provided by the Regions. Certification officers should attend refresher training programs at least every five years to keep their knowledge of the methods and the drinking water program current. It is highly recommended that certification officers have recent bench experience in the methods for which they certify. OGWDW will notify certification officers of major updates/changes to EPA's certification program. It is recommended that the States use these same criteria in their certification programs. 18. Alternate Test Procedures (ATPs) EPA promulgates analytical methods for all regulated drinking water contaminants. A regulation for a particular contaminant will include one or more methods that must be used to determine that contaminant. Subsequently, the Agency may approve additional methods or modifications of EPA approved methods in another rule. EPA may also authorize the use of alternate analytical methods as provided in 40 CFR 141.27, "With the written permission of the State, concurred by the Administrator of the EPA, an alternate analytical technique may be employed. An alternate technique may be accepted only if it is substantially equivalent to the prescribed test in both precision and accuracy as it relates to the determination of compliance with any MCL." Anyone can request that EPA approve a new method or modification of a method already approved by EPA, by submitting EPA-specified data and other information to the Director, Analytical Methods Staff,(MS 4303T) Office of Science and Technology, Office of Water, EPA, 1200 Pennsylvania Ave., NW, Washington DC 20460. EPA will evaluate the material to determine whether the method or method modification meets EPA criteria
In the case ofacceptable versions"of methods, (minor modifications to approved methods ), a letter of approval will be issued by ow. A list of these approved minor modifications can be found on the ow website at http://www.epa.gov/ogwdw/methods II-10
III-10 In the case of “acceptable versions” of methods, (minor modifications to approved methods), a letter of approval will be issued by OW. A list of these approved minor modifications can be found on the OW website at http://www.epa.gov/OGWDW/methods
Chapter M Critical Elements for Chemistry 1. Personnel lI Laboratory Supervisor The laboratory supervisor should have at least a bachelor's degree with a major in chemistry or equivalent, and at least one year of experience in the analysis of drinking water. The laboratory supervisor should have at least a working know ledge of quality assurance principles. The laboratory supervisor has the responsibility to ensure that all laboratory personnel have demonstrated their ability to satisfactorily perform the analyses to which they are assigned and that all data reported by the laboratory meet the required quality assurance and regulatory criteria 1.2 Laboratory Analyst The laboratory analyst should have at least a bachelor's degree with a major in chemistry or equivalent, and at least one year of experience in the analysis of drinking water. If the analyst is responsible for the operation of analytical instrumentation, he or she should have completed specialized training offered by the manufacturer or another qualified training facility or served a period of apprenticeship under an experienced analyst. The duration of this apprenticeship should be proportional to the sophistication of the instrument Data produced by analysts and instrument operators while in the process ofobtaining the required training or experience are acceptable only when reviewed and validated by a fully led analyst or the lab Before beginning the analysis of compliance samples, the analyst must adhere to any required QC procedures specified in the methods for blanks, precision, accuracy, sensitivity, specificity and satisfactory analysis on unknown samples. This should be documented according to the laboratorys QA Plan. 13 Technician The laboratory technician should have at least a high school diploma or equivalent, complete a method training program under an experienced analyst and have six months bench experience in the analysis of drinking water samples Before beginning the analysis of compliance samples, the technician must adhere to any required Qc procedures specified in the methods for blanks, precision, accuracy, sensitivity, specificity and satisfactory analysis on unknown samples. This should be documented according to the laboratorys QA Plan 1.4 Sampling Personnel Personnel who collect samples should be trained in the proper collection technique for all types of samples which they collect. Their technique should be reviewed by experienced sampling or laboratory personnel. 1.5 Waiver of Academic Training Requirement The certification officer may waive the need for specified academic training, on a case-by-case basis, for highly experienced analysts 1.6 Training Records Training records should be maintained for all personnel. These should include all job-related formal education and training taken by the analyst which pertains to any aspect of his/her responsibilities, including but not limited to analytical ethodology, laboratory safety, sampling, quality assurance, data analysis, etc 2. Laboratory Facilities The analysis of compliance samples is to be conducted in a laboratory where the security and integrity of the samples and the data can be maintained. The laboratory facilities should be clean, have adequate temperature and humidity control, have adequate lighting at the bench top and should meet applicable OSHA standards. The laboratory must adhere to any required Qc procedures specified in the methods by having provisions for the proper storage and disposal of chemical wastes; secondary containment for hazardous waste storage is recommended. The appropriate type of exhaust hood ired where applicable
IV- 1 Chapter IV Critical Elements for Chemistry 1. Personnel 1.1 Laboratory Supervisor The laboratory supervisor should have at least a bachelor's degree with a major in chemistry or equivalent, and at least one year of experience in the analysis of drinking water. The laboratory supervisor should have at least a working knowledge of quality assurance principles. The laboratory supervisor has the responsibility to ensure that all laboratory personnel have demonstrated their ability to satisfactorily perform the analyses to which they are assigned and that all data reported by the laboratory meet the required quality assurance and regulatory criteria. 1.2 Laboratory Analyst The laboratory analyst should have at least a bachelor's degree with a major in chemistry or equivalent, and at least one year of experience in the analysis of drinking water. If the analyst is responsible for the operation of analytical instrumentation, he or she should have completed specialized training offered by the manufacturer or another qualified training facility or served a period of apprenticeship under an experienced analyst. The duration of this apprenticeship should be proportional to the sophistication of the instrument. Data produced by analysts and instrument operators while in the process of obtaining the required training or experience are acceptable only when reviewed and validated by a fully qualified analyst or the laboratory supervisor. Before beginning the analysis of compliance samples, the analyst must adhere to any required QC procedures specified in the methods for blanks, precision, accuracy, sensitivity, specificity and satisfactory analysis on unknown samples. This should be documented according to the laboratory’s QA Plan. 1.3 Technician The laboratory technician should have at least a high school diploma or equivalent, complete a method training program under an experienced analyst and have six months bench experience in the analysis of drinking water samples. Before beginning the analysis of compliance samples, the technician must adhere to any required QC procedures specified in the methods for blanks, precision, accuracy, sensitivity, specificity and satisfactory analysis on unknown samples. This should be documented according to the laboratory’s QA Plan. 1.4 Sampling Personnel Personnel who collect samples should be trained in the proper collection technique for all types of samples which they collect. Their technique should be reviewed by experienced sampling or laboratory personnel. 1.5 Waiver of Academic Training Requirement The certification officer may waive the need for specified academic training, on a case-by-case basis, for highly experienced analysts. 1.6 Training Records Training records should be maintained for all personnel. These should include all job-related formal education and training taken by the analyst which pertains to any aspect of his/her responsibilities, including but not limited to analytical methodology, laboratory safety, sampling, quality assurance, data analysis, etc. 2. Laboratory Facilities The analysis of compliance samples is to be conducted in a laboratory where the security and integrity of the samples and the data can be maintained. The laboratory facilities should be clean, have adequate temperature and humidity control, have adequate lighting at the bench top and should meet applicable OSHA standards. The laboratory must adhere to any required QC procedures specified in the methods by having provisions for the proper storage and disposal of chemical wastes; secondary containment for hazardous waste storage is recommended. The appropriate type of exhaust hood is required where applicable