179 Neb. Admin. Code, ch. 20, § 003

Current through September 17, 2024
Section 179-20-003 - CERTIFICATION FOR LABORATORIES IN NEBRASKA

Applicants must submit a complete application provided by the Department and meet all requirements of the statutes and this chapter. All standards and documents referenced in this chapter can be obtained at Department of Health and Human Services, Public Health Environmental Laboratory, 3701 S. 14th Street, Lincoln NE 68502 or be viewed on the Department's website.

003.01FIRST-TIME CERTIFICATION OR ADDITIONAL OR NEWLY REGULATED CONTAMINANTS. An applicant for first-time certification for microbiology, chemistry, radiochemistry, or additional or newly regulated contaminants must submit a complete application and the following information:
(A) A copy of the diploma(s) or transcript(s) for the personnel listed on the application;
(B) A Quality Assurance Manual;
(C) A completed 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
(D) The most current proficiency testing results for each method and analyte, to the Department. The results must be sent directly from the proficiency testing provider. If the applicant 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 applicant is applying for recertification, at least one acceptable proficiency testing result must be received for each method and analyte in every 12-month period.
003.02UPGRADING CERTIFICATION. Through a written request, an applicant may seek upgrading of certification, when and if it can demonstrate to the Department that the deficiencies that produced provisionally certified status have been corrected.
003.03CERTIFICATION. Based on the 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 applicant for each contaminant or group of contaminants according to this section.
003.03(A)CERTIFIED. An applicant that meets the requirements set out in this chapter.
003.03(B)PROVISIONALLY CERTIFIED. Has deficiencies but demonstrates its ability to consistently produce valid data within the acceptance limits set out in the regulations adopted under the Nebraska Safe Drinking Water Act. A provisionally certified laboratory may analyze drinking water samples for compliance purposes providing a valid agreement is in place, and its clients are notified of its downgraded status in writing, on any report.
003.03(C)NOT CERTIFIED. An applicant that does not meet the requirements set out in this chapter.
003.03(D)INTERIM CERTIFICATION. An applicant may be granted interim certification in certain circumstances when it wants to add an analyte or analytes to its 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 the Department determines that the applicant 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 applicant's quality control data and proficiency testing data are to be reviewed by the Department before granting this type of certification is granted.
003.03(E)RECIPROCITY. Certified by reciprocity as set out in this chapter.
003.04CERTIFICATION BY RECIPROCITY. An applicant for first-time certification for microbiology, chemistry, or radiochemistry or additional or newly regulated contaminants based on accreditation from a national accrediting body, another state that is Environmental Protection Agency certified or by the environmental Protection Agency or is state certified laboratory located outside of Nebraska must submit a complete application and the following:
(A) A copy of the applicant'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;
(B) The most current proficiency testing results for each method and analyte, to the Department; The results must be sent directly from the proficiency testing provider. and
(C) A copy of the applicant's latest on-site audit report from the certifying body.

179 Neb. Admin. Code, ch. 20, § 003

Amended effective 6/14/2023