Current through Register Vol. XLI, No. 50, December 13, 2024
Section 64-3-13 - Certification of Laboratories to Conduct Drinking Water Tests13.1. All laboratories providing drinking water testing results for purposes of this rule or the federal regulations adopted by this rule shall be certified by the commissioner or by the federal Environmental Protection Agency.13.2. A certified laboratory shall: 13.2.1. Comply with the requirements and criteria contained in the federal Environmental Protection Agency's Manual for the Certification of Laboratories Analyzing Drinking Water, Fifth Edition, EPA 815-R-05-004, January 2005, Supplement I to the Fifth Edition of the Manual to the Certification of Laboratories Analyzing Drinking Water, EPA 815-F-08-006, June 2008, Supplement II to the Fifth Edition of the Manual to the Certification of Laboratories Analyzing Drinking Water, EPA 815-F-12-006, November 2012. In addition, before an analyst is permitted to do any regulatory compliance samples for chemistry, the Demonstration of Capability (DOC) required by each method must be completed. If there are no DOC requirements in the method, the following are guidelines to be used: At a minimum, the DOC shall include four replicates of a quality control or reference sample which must be processed through all steps of the analytical procedure and evaluated against laboratory derived acceptance limits. In addition, precision and accuracy must be established if more than one sample preparation technique is used;13.2.2. Comply with the requirements of this rule and hold a certificate of recognition from the National Environmental Laboratory Accreditation Program (NELAP) for the analysis of drinking water; or13.2.3. Any other accreditation determined to be equivalent by the commissioner.13.3. An in-state laboratory shall submit an application form when seeking initial approval at least 60 days prior to the date certification is desired.13.4. A laboratory located outside the boundaries of this state shall be certified by the commissioner if: 13.4.1. It has been certified by the federal Environmental Protection Agency; or13.4.2. It has been certified by a program for the certification of laboratories equivalent to the program of this state as determined by the commissioner. If the program of the state in which the laboratory is located is not judged equivalent, the laboratory may request an on-site evaluation and full certification review by the commissioner. The commissioner may charge a fee for all expenses incurred for an on-site survey of an out-of-state laboratory.13.5. An out-of-state laboratory shall submit an application form when seeking initial approval and shall include with its application evidence of compliance with subdivision 13.4.1. or 13.4.2. of this section. The out-of-state laboratory shall notify the commissioner immediately of any change in its certification status under subdivision 13.4.1. or 13.4.2. of this section.13.6. The commissioner will conduct on-site inspections of in-state laboratories to determine compliance with this rule and the federal standards adopted in this rule initially prior to certification, and at least every three years thereafter. The bureau has the right of entry upon proper identification at any time considered necessary during operating hours in order to conduct the inspections.13.7. The commissioner will issue certificates of approval upon initial approval and will renew the certificates on an annual basis thereafter pursuant to the conditions listed in this rule. Certificates issued will contain the name and location of the laboratory, a laboratory code number, the signatures of the state's Office of Laboratory Services' director and certification officers, and the date of expiration of the certificate.13.7.1. Certified laboratories shall participate in a proficiency testing water study within the first three months of the calendar year. The study shall have a closing date no later than the last working day of March. If the commissioner does not receive proficiency testing water study results by the end of May of each calendar year, the commissioner will downgrade the laboratory to "provisionally certified" for each certified parameter not analyzed.13.7.2. For a drinking water laboratory to maintain certification, the commissioner must receive an acceptable proficiency testing water study result for each certifiable parameter and by each approved method for which the laboratory holds, or is seeking, certification between January 1 and September 30 of each year. The proficiency testing provider shall forward the water study results directly to the commissioner; photocopies from the laboratory will not be accepted.13.8. Certified laboratories shall notify the commissioner when there is a change in ownership, laboratory director, technical personnel or location of the laboratory.13.9. Certified laboratories shall submit to the commissioner all required or requested data, information and reports in a manner or form approved or provided by the Commissioner.13.10. Certified laboratories shall accept chemistry compliance monitoring samples only in containers that have been demonstrated and documented to be free of regulated or interfering contaminants. This demonstration shall be accomplished through testing using an approved drinking water method. The contaminants of interest must be shown to be below detectable levels on a representative container from any given lot after exposure to reagent water and any required preservatives.13.11. Certified laboratories shall reject any public water system compliance monitoring sample that has exceeded its holding time for the indicated testing parameters, has not been received at the required temperature or pH, or does not contain the required preservatives, or is not in an approved container. Upon a rejection, the certified laboratory shall then notify the submitting public water system and the sample originator in a timely manner to allow for resampling and resubmission to prevent noncompliance with federal regulations and state rules and endangerment of public health.13.12. The commissioner shall administer and use the criteria and procedures of the section titled "Criteria and Procedures for Downgrading/Revoking Certification Status" of the Manual for the Certification of Laboratories Analyzing Drinking Water referenced in subsection 13.2 of this section, when a laboratory's noncompliance with the Manual, the provisions of this rule, or both, is detected.13.13. For each parameter and method the laboratory holds certification and receives an unacceptable evaluation from the proficiency testing provider, shall submit a pre-placement proficiency testing study to the commissioner within 90 days of being notified of the unacceptable result. Failure to comply shall result in the parameter or method, or both, being downgraded.13.14. For each parameter and method the certified laboratory has two consecutive unacceptable evaluations from the proficiency testing provider shall have the aforementioned parameter or method, or both, downgraded to "provisionally certified." 13.15. A laboratory requesting reinstatement due to unacceptable proficiency testing water study performance must provide two consecutive proficiency testing water studies which have been evaluated to be acceptable by the proficiency testing provider.