01. AUTHORITY. These regulations establish requirements for laboratories to be certified to test drinking water compliance samples. The certification is specific to contaminants and methods used to test drinking water. The authority is found in Neb. Rev. Stat. §§ 71-5303, 71-5306, and 71-2619 to 71-2621.
02. DEFINITIONS. For purposes of these regulations, definitions in the Nebraska Safe Drinking Water Act and the following definitions are hereby adopted.
02.01 AGREEMENT. A binding contract between the Department and a laboratory.
02.02 CERTIFICATE. The document issued by the Department indicating that the laboratory has fulfilled the requirements for certification and is authorized to perform analyses for water intended for human consumption.
02.03 COMPLIANCE SAMPLES. Those water samples required under the Nebraska Safe Drinking Water Act and Title 179 Nebraska Administrative Code (NAC) to determine whether a public water system meets current drinking water standards.
02.04 DEFICIENCY. A failure to meet the established minimum standards.
02.05 DEPARTMENT. The Division of Public Health of the Department of Health and Human Services.
03. CERTIFICATION FOR LABORATORIES IN NEBRASKA.
03.01 APPLICATION. The owner of a laboratory must make an application for certification in writing. The application must be submitted to the Department and may be:
003.1(A) A request for first-time certification for microbiology, chemistry, or radiochemistry;
003.01(B) A request for certification to analyze additional or newly regulated contaminants;
003.01(C) A request to reapply for certification after correction of deficiencies which resulted in the revocation of certification status; or
003.01(D) A request for certification for microbiology, chemistry, or radiochemistry based on certification or accreditation from a nationally recognized accreditation program, or another state with a certification program approved by the Environmental Protection Agency.
03.02 FIRST-TIME CERTIFICATION. An applicant for first-time certification for microbiology, chemistry, or radiochemistry must submit the following information:
003.02(A) A completed Application (Attachment 1) which is incorporated herein by reference;
003.02(B) A signed Attestation of Compliance form (Attachment 2) which is incorporated herein by reference;
003.02(C) A completed Personnel for Certification form (Attachment 3) which is incorporated herein by reference, and a copy of certification of their academic training (diploma(s) or transcript(s));
003.02(D) A completed Quality Assurance Manual Checklist (Attachment 4) which is incorporated herein by reference;
003.02(E) A completed List of Matrix, Method and Analyte form (Attachment 5) which is incorporated herein by reference, indicating what certification is being requested;
003.02(F) A signed copy of the laboratory’s current analytical and administrative standard operating procedures, in the proper Environmental Protection Agency format, for each method, analyte, and matrix for which the laboratory is requesting certification;
00302(G) A copy of the laboratory’s current signed quality assurance manual in the proper Environmental Protection Agency format;
003.02(H) A checklist from the Environmental Protection Agency Manual for Certification of Laboratories Analyzing Drinking Water, Fifth Edition (January 2005) including Supplement 1 (June 2008) and Supplement 2 (November 2012) depending on the methods and analytes being requested. A completed chemistry checklist form is required when chemistry methods certification is being requested, a completed microbiology checklist form is required when microbiological methods certification is being requested, and a completed radiochemistry checklist form is required when radiochemistry methods certification is being requested; and
003.02(I) The proficiency testing provider must send the most current proficiency testing results for each method and analyte, to the Department. If the laboratory is applying for a new certification for a method and analyte it must have a proficiency testing provider send a copy of proficiency testing results performed within the last 60 days for each method and analyte. If the laboratory is applying for recertification, at least one acceptable proficiency testing result must be received for each method and analyte in every 12-month period.
03.03 ADDITIONAL OR NEWLY REGULATED CONTAMINANTS. An applicant wishing to analyze additional or newly regulated contaminants in microbiology, chemistry, or radiochemistry must submit the following information:
003.03(A) A completed Application (Attachment 1) which is incorporated herein by reference;
003.03(B) A signed Attestation of Compliance form (Attachment 2) which is incorporated herein by reference;
003.03(C) A completed Personnel for Certification form (Attachment 3) which is incorporated herein by reference, and a copy of certification of their academic training (diploma(s) or transcript(s));
003.03(D) A completed Quality Assurance Manual Checklist (Attachment 4) which is incorporated herein by reference;
003.03(E) A completed List of Matrix, Method and Analyte form (Attachment 5) which is incorporated herein by reference, indicating what certification is being requested;
003.03(F) A signed copy of the laboratory’s current analytical and administrative standard operating procedures, in the proper Environmental Protection Agency format, for each method, analyte, and matrix for which the laboratory is requesting certification;
003.03(G) A copy of the laboratory’s current signed quality assurance manual in the proper Environmental Protection Agency format;
003.03(H) A checklist from the Environmental Protection Agency Manual for Certification of Laboratories Analyzing Drinking Water, Fifth Edition (January 2005) including Supplement 1 (June 2008) and Supplement 2 (November 2012) depending on the methods and analytes being requested. A completed chemistry checklist form is required when chemistry methods certification is being requested, a completed microbiology checklist form is required when microbiological methods certification is being requested, and a completed radiochemistry checklist form is required when radiochemistry methods certification is being requested; and
003.03(I) The proficiency testing provider must send the most current proficiency testing results for each method and analyte, to the Department. If the laboratory is applying for a new certification for a method and analyte it must have a proficiency testing provider send a copy of proficiency testing results performed within the last 60 days for each method and analyte. If the laboratory is applying for recertification, at least one acceptable proficiency testing result must be received for each method and analyte in every 12-month period.
03.04 UPGRADING CERTIFICATION. An applicant requesting to reapply for certification after a downgrading of certification status. Through a written request, a laboratory may seek upgrading of certification, when and if the laboratory can demonstrate to the Department that the deficiencies that produced provisionally certified status have been corrected.
03.05 CERTIFICATION. After reviewing each application for certification, proficiency testing sample results, on-site visit results for applicable laboratories, and on-site visit reports for reciprocity applicants, the Department will classify the laboratory for each contaminant or group of contaminants according to the following rating scheme:
003.05(A) CERTIFIED. A laboratory that meets the requirements set out in 179 NAC 20- 005.
003.05(B) PROVISIONALLY CERTIFIED. A laboratory that has deficiencies but demonstrates its ability to consistently produce valid data within the acceptance limits specified in Title 179 NAC. A provisionally certified laboratory may analyze drinking water samples for compliance purposes, if its clients are notified of its downgraded status in writing, on any report. Provisional certification will not be given if the Department believes that the laboratory cannot perform an analysis within the acceptance limits specified in Title 179 NAC.
003.05(C) NOT CERTIFIED. A laboratory that possesses deficiencies and, in the opinion of the Department, cannot consistently produce valid data.
003.05(D) INTERIM CERTIFICATION. A laboratory may be granted interim certification in certain circumstances when a certified laboratory wants to add an analyte or analytes to their certification involving a method for which it already has certification and it is impossible or unnecessary to perform an on-site audit. Interim certification status may be granted if, for example, the Department determines that the laboratory has the appropriate instrumentation, is using the approved methods, has adequately trained personnel to perform the analyses, and has satisfactorily analyzed proficiency testing samples, if available, for the contaminants in question. The Department will perform an on-site audit as soon as possible but no later than three years after the application is received. The Department will review the laboratory’s quality control data and proficiency testing data before granting this type of certification.
003.05(E) RECIPROCITY. Certified by reciprocity as set out in 179 NAC 20-003.06.
03.06 CERTIFICATION BY RECIPROCITY.
003.06(A) A laboratory requesting Nebraska certification because they hold accreditation from a national accrediting body, another state that is Environmental Protection Agency certified, or Environmental Protection Agency or state certified laboratory located outside the State of Nebraska may be certified by:(i) Submitting a completed Application (Attachment 1);(ii) Submitting a signed Attestation of Compliance form (Attachment 2);
(iii) Submitting a copy of the laboratory’s certification and accreditation certificate, clearly showing the name of the laboratory, the certification or accreditation entity, the methods and analytes the certification covers, the beginning date and the expiration date of the certificate;
(iv) Submitting a copy of the laboratory’s current signed quality assurance manual;
(v) Having a proficiency testing provider send the most recent proficiency testing results for the method(s) and analyte(s) for which certification is requested directly to the Department; and
(vi) Submitting a copy of the laboratory’s latest on-site audit report.
04. APPROVED CERTIFICATION BODIES AND ACCREDITATION BODIES. The Department will accept certification or accreditation from the following organizations for the purposes of certification in Nebraska:(i) An Environmental Protection Agency Certified Laboratory.(ii) A state laboratory certified by the Environmental Protection Agency.
(iii) A laboratory certified by a state certification program.
(iv) A laboratory accredited by the National Environmental Laboratory Accreditation Program. 05. CERTIFICATION STANDARDS FOR LABORATORIES IN NEBRASKA. To be certified by the Department, a laboratory must meet the following requirements:
05.01 The regulatory performance criteria as explained in the Environmental Protection Agency Manual for the Certification of Laboratories Analyzing Drinking Water, Ffifth Eedition, (January 2005) including Supplement 1 (June 2008) and Supplement 2 (November 2012) and all other applicable regulatory requirements. The manual, Environmental Protection Agency 815-R-05-004, is incorporated herein by reference. It is available for viewing at the Department of Health and Human Services Division of Public Health, 301 Centennial Mall South, Lincoln, NE 68509. The manual may be obtained on-line at http://dhhs.ne.gov/publichealth/Pages/lab_certification.aspx. 05.02 Use the methods specified in Title 179 NAC incorporated herein by this reference. These documents are available for viewing at the Department of Health and Human Services Division of Public Health, 301 Centennial Mall South, Lincoln, NE 6850, or on-line at http://dhhs.ne.gov/publichealth/Pages/lab_certification.aspx. 05.03 Comply with a current laboratory quality assurance plan, as specified in the Environmental Protection Agency Manual for the Certification of Laboratories Analyzing Drinking Water, Fifth Edition, (January 2005) including Supplement 1 (June 2008) and Supplement 2 (November 2012).
05.04 Maintain current administrative and analytical standard operating procedures that follow the format set out in Guidance for the Preparation of Standard Operating Procedures (SOPs) for Quality Related Documents, April 2007, (Environmental Protection Agency QA/G- 6), published by the United States Environmental Protection Agency Quality Assurance Division, Washington, DC 20460, which is incorporated herein by this reference. This document may be viewed at the Office of the Department of Health and Human Services, Division of Public Health, 301 Centennial Mall South, Lincoln, NE 68509 or it may be obtained on-line at http://dhhs.ne.gov/publichealth/Pages/lab_certification.aspx. 05.05 Employ both a laboratory director and a quality assurance manager having the following qualifications:
005.05(A) The laboratory director must be a qualified professional with the technical education and experience, and managerial capability commensurate with the size and type of the laboratory. The laboratory director 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 criteria and regulatory requirements.
005.05(B) The quality assurance manager must be independent from the laboratory management, if possible, and have direct access to the highest level of management. The quality assurance manager must have a bachelor’s degree in science or the equivalent work experience, 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 assurance manager must 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.
05.06 Document the laboratory has analyzed a proficiency testing sample with acceptable results for each test method for which certification is requested within the past 60 calendar days. Proficiency testing samples must be purchased from a proficiency testing provider approved by National Environmental Laboratory Accreditation Program. The approved proficiency testing provider must send results of the proficiency testing samples directly to the Department.
05.07 Be able to provide documentation to the Department that the person(s) analyzing any proficiency testing sample(s) is a laboratory employee who routinely analyzes drinking water compliance samples.
05.08 Analyze the proficiency testing samples by each method for which the laboratory wishes to be certified.
05.09 Analyze proficiency testing samples in the same manner (including the same number of times) that the laboratory tests compliance samples.
05.10 For those laboratories that do compliance testing for a system(s) in which they may have a vested interest or by which they may be owned, agree to have a minimum of 10% of the minimum number of samples per month required in 179 NAC 3-004.01B, or a minimum of one sample per week of drinking water compliance testing, whichever is more, analyzed by the Department Laboratory or a certified laboratory which maintains an agreement with the Department for the specific compliance testing and which is not owned by and does not have a vested interest in the testing results. Compliance samples must be collected and analyzed at regular time intervals throughout the month.
05.11 The ability to submit results in an electronic format acceptable to the Department.
05.12 To maintain continued certification by the Department a laboratory must:
005.12(A) Notify the Department in writing within 30 days of any change to the following:
(i) The name and street address (not PO Box) of the laboratory;
(ii) The name of the laboratory director;
(iii) The name of the laboratory quality assurance manager;
(iv) Test methods used;
(v) Quality assurance plan;(vi) Standard operating procedures; or
(vii) The name of the primary analyst for certified methods.
005.12(B) Document that the laboratory has successfully analyzed a proficiency testing sample every 12 months for each test method for which certification is maintained.(i) Proficiency testing samples must be purchased from a National Environmental Laboratory Accreditation Program approved proficiency testing provider.
(ii) Results of the proficiency testing samples must be sent to the Department directly from the proficiency testing provider.
(iii) If the results of a proficiency testing sample are unacceptable, the laboratory has 30 calendar days to perform another test and obtain satisfactory results.
(iv) Proficiency testing samples must be analyzed in the same manner (including the same number of times) as routine samples.
05.13 All laboratory certifications will be valid for no more than 36 months, expiring on December 31 of the third year. Certifications based upon reciprocity will be valid based on the expiration date of the certifying body’s certificate. In no instance will the reciprocity certification exceed 36 months.
06. DISCIPLINARY ACTIONS.
06.01 A laboratory will be downgraded to provisionally certified status for a contaminant or group of contaminants for any of the following reasons:
006.01(A) Failure to analyze a proficiency testing sample at least every 12 months within the acceptance limits specified by the proficiency testing provider.
006.01(B) Failure of a certified laboratory to notify the Department within 30 days of major changes (e.g., in personnel, equipment, or laboratory location).
006.01(C) Failure to satisfy the Department that the laboratory is maintaining the required standard of quality, based upon an on-site evaluation.
006.01(D) Failure to report compliance data to the public water system or the Department drinking water program in a timely manner as set out in Title 179 NAC. Data which may cause the system to exceed a maximum contaminant level must be reported as soon as possible as set out in Title 179 NAC.
06.02 A laboratory certification or agreement may be denied, revoked, suspended, or refused renewal for any of the following reasons:
006.02(A) Violation of Neb. Rev. Stats. §§ 71-2619 to 2621, the Nebraska Safe Drinking Water Act, or these regulations;
006.02(B) Falsification of data or other deceptive practices;
006.02(C) Failure to maintain required staff;
006.02(D) Failure to comply with the reporting requirements;
006.02(E) Failure to use the analytical methodology for which the laboratory is certified;
006.02(F) Refusal or failure to participate in an on-site evaluation conducted by the Department or to provide information or documents requested by the Department;
006.02(G) Failure to successfully analyze a proficiency testing sample or any other unknown test sample for a particular contaminant within the acceptance limits specified;
006.02(H) Failure to demonstrate to the Department that the laboratory has corrected deviations identified during an on-site evaluation; or
006.02(I) Persistent failure to report compliance data to the public water system or the Department drinking water program in a timely manner as set out in Title 179 NAC. Data which may cause the system to exceed a maximum contaminant level must be reported as soon as possible as set out in Title 179 NAC.
06.03 In the event of any disciplinary action, the decision of the Department will be final 30 days after the mailing of the notice unless the director or other designated representative of the laboratory, within such period, gives written notice to the Department of a desire for hearing. Hearings before the Department will be conducted in accordance with Chapter 84, Article 9 and 184 NAC 1.
07. RECORD KEEPING. The laboratory must ensure that records for on-site laboratory assessments and certification program reviews are maintained in an easily accessible central location for a period of six years to include the last two on-site audits. This includes records and correspondence used to determine compliance with the requirements in 179 NAC 20 and checklists, corrective action reports, final reports, certificates, proficiency testing study results, and related documents.
08. FEES. The fees for inspection of a laboratory are as follows:
08.01 Bacteriological examination $150.
08.02 Inorganic chemical analyses $100.
08.03 Heavy metal analyses $200.
08.04 Organic chemical analyses $200.
08.05 Radiochemical analyses $200.