Lab Certification Requirements

 
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What you need to know

​​​​​​​​​​​​The Department of Health and Human Services, Division of Public Health, in accordance with Nebraska State Regulation, Title 179, Chapter 20, and Nebraska Statute Sections 71-5303, 71-5306, and 71-2619, manages a program to certify laboratories to perform testing for drinking water. Performing analyses to determine the quality of public drinking water systems must be performed by a certified laboratory.  Laboratory Certification is offered under the Safe Drinking Water Act (SDWA).  Any Laboratory that holds a valid Nebraska Certification may request to enter into an Agreement with the Department of Health and Human Services, Division of Public Health to perform compliance testing for Public Water Systems in Nebraska.

The EPA approved methodology for the Safe Drinking Water Act is referenced in 40 CFR Parts 141 and 142. Strict adherence to the approved methodology is a minimum requirement for certification under the Nebraska Laboratory Certification Program. ​

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Laboratory certification requirements

Laboratory certifications requirements include:

  1. Use methods specified in the EPA Drinking Water Regulations.
  2. Meet all Lab requirements, including a current Laboratory Quality Assurance Plan, specified in the EPA Manual for the Certification of Laboratories Analyzing Drinking Water.
  3. Maintain current administrative and analytical standard operating procedures that follow the format as set out for the preparation of Standard Operating Procedures for Quality Related Documents.
  4. Employ both a Laboratory Director/Manager and a Quality Assurance Officer with the following qualifications:
    1. ​Laboratory Director or Manager must have a bachelor's degree in science, managerial capability and experience, ability to analyze and interpret statistics involved in lab analysis, and a basic understanding of the methods that the lab employs.
    2. The Quality Assurance Officer must have a bachelor's degree in science, training in quality assurance principles, at least one year of laboratory experience, a working knowledge of statistics involved in quality control of laboratory analysis, and a basic understanding of the standard operating procedures that the laboratory employs.
  5. Document that the laboratory has analyzed a proficiency testing (PT) sample with acceptable results for each test method for which certification is requested within the last 60 days.  The PT's must be purchased from a PT provider approved by the National Institute of Standards and Technology.  The approved PT provider must send results of the PT samples directly to the DHHS Licensure Unit representative.
  6. The laboratory must submit a completed application and the required documentation as indicated on the instructions checklist.  Be sure to include all required documents with the application and checklist. 

Required forms

Required Forms

The following forms are required forms for Laboratory Certification.  You may print them and fill them out and mail them in with all other required documents.  If you are unable to print these documents you can request a Laboratory Certification Packet by calling (402) 471-2122. ​

  1. Application for Certification of Drinking Water Testing Laboratories for Nebraska
  2. Attestation of Compliance;
  3. Instructions and Checklist for Certification
  4. Personnel for Certification Matrix-Methods-Analytes;
  5. Quality Assurance Manual Checklist
  6. List of Matrix, Method, and Analyte Certification Requested 


The following manual may help you in your certification process.

  1. EPA - Manual for the Certification of Laboratories Analyzing Drinking Water (Criteria and Procedures Quality Assurance)
  2. EPA - Guidance for Preparing Standard Operating Procedures (SOPs) - EPA QA/G-6
  3. Reporting of Sample Analytical Results from Outside Laboratories to Nebraska's Safe Drinking Water Information System (SDWIS), (pdf format) (rtf format).

Certification through reciprocity​

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:

  1. A completed application for certification.
  2. A signed Attestation of Compliance form.
  3. A copy of the laboratory's certification and accreditation certificate by the State of the Laboratory's location, EPA, or NELAP authority, including the date of expiration.
  4. A list of the analytes and methods you are requesting certification for.
  5. Assigned copy of the laboratory's Quality Assurance Manual.
  6. The most recent proficiency testing results for the method(s) and analytes(s) for which certification is requested must be sent by the proficiency testing provider.
  7. Submit a copy of the laboratory's latest on-site audit report.

Continued certification​

To maintain certification by the Department a laboratory shall: notify the Department in writing within 30 days of any changes to the following:

  • The name and street address (not P.O. Box) of the Laboratory;
  • The name of the Laboratory Director/Manager;
  • The name of the Laboratory Quality Assurance Officer;
  • Test methods used for certification purposes;
  • Quality Assurance Plan; or
  • Standard Operating Procedures; and

Document that the Laboratory has successfully analyzed a proficiency testing (PT) sample annually for each test method certification is requested.  PT samples must be purchased from a National Institute of Standards and Technology approved PT provider.  If the results of a PT sample is unacceptable, the laboratory should submit corrective action taken to ensure accuracy of future results.  At least one PT per year must be acceptable for each test method and analyte in which certification is requested.

Renewal

The Department shall notify all primary certified laboratories and all laboratories that have entered into an agreement with the Department 60 days prior to the expiration date of the current certification or agreement that renewal is required and explain the process for renewal.  It is the responsibility of laboratories that are certified by reciprocity and that have not entered into an Agreement to initiate certificate renewal.

All laboratory certifications shall be valid for a period of time not to exceed 36 months, expiring on December 31 of the third year or when reciprocal certification expires or is revoked.  Certifications based upon reciprocity will be valid based on the expiration date of the certifying body's certificate.

All laboratory agreements shall expire each year on December 31.

Laboratory i​nspections

The following pertains to all laboratories located in Nebraska:

The Department shall conduct an inspection at least once every three years to determine if the laboratory is meeting the required standards for certification based on the requirements of Federal and State regulations.  The Department may recognize an on-site inspection conducted by EPA or National Environmental Laboratory Accreditation Program (NELAP), provided their standards are at least as stringent as those required by State of Nebraska regulations.

The Department can conduct an inspection of a certified laboratory or a laboratory applying for certification at any time during standard working hours.

The Department shall document any deficiencies from the standards and/or note any recommendations for the laboratory within 45 working days of the inspection.

The inspected laboratory shall respond in writing to each deficiency and/or recommendation noted in the onsite inspection report with an acceptable plan of correction and completion date within 30 working days.

There will be a charge for each inspection performed:

  • Bacteriological examination - $150
  • Inorganic chemical analyses - $100
  • Heavy metal analyses - $200
  • Organic chemical analyses - $200
  • Radiochemical analyses - $200 

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