Denial, Downgrading, and Revocation of Certification

(1) Denial. The Department may deny a laboratory's request for certification, including a request for renewed certification, if: (a) the application does not meet the requirements of 310 CMR 42.00; (b) the laboratory's current or prior certification has been downgraded or revoked; (c) the laboratory or one of its owners or employees has been or currently is subject to an order issued pursuant to 310 CMR 42.17(1); or (d) the laboratory or one of its owners or employees has been or is currently in violation of 310 CMR 42.00. (2) Provisional Certification. For minor deficiencies not affecting the laboratory's ability to produce Valid Data, the Department may downgrade a laboratory's certification status to provisional, in total or in part, for a period not to exceed 180 calendar days. If the Department determines that there are grounds for downgrading, the Department shall notify the laboratory in writing by certified mail. (a) The following may be grounds for downgrading if the Department determines that the infraction is minor in nature and does not affect the laboratory's ability to produce Valid Data: 1. Failure to pass an inspection; 2. Failure to report compliance data to a public water system, the Department, or other responsible party in a manner so as to meet prescribed reporting time deadlines, or interfering with the reporting of such data produced by other entities; 3. Careless or inaccurate reporting of analytical measurements and supporting documentation; 4. Failure to notify the Department in writing within the prescribed timelines listed in 310 CMR 42.13 regarding any change in ownership, laboratory name, laboratory location, personnel, equipment, or any other factor that could impair the analytic, reporting, or operational capability of the laboratory; 5. Reporting sample results without indicating whether or not the laboratory is certified for that analysis; 6. Reporting sample results for analyses for which the laboratory is certified without indicating whether or not the analyses were conducted in accordance with Department certification standards; 7. Failure to use an approved method or to follow the approved method for sample analysis where the report issued for the analysis indicates that the analysis was conducted in accordance with Department certification standards; 8. Handling samples in a manner so as to compromise sample integrity; and 9. Failure to comply with any other requirement of 310 CMR 42.00. (b) A laboratory that has had its certification downgraded to provisional may request reinstatement within the time period prescribed in the notification of downgrading and in accordance with the requirements of 310 CMR 42.12(4). If the laboratory fails to correct the deficiencies listed in the notice of downgrading and request reinstatement within the time specified by the Department in the notification, the Department may revoke, in total or in part, the laboratory's certification, pursuant to 310 CMR 42.12(3). (3) Revocation. The Department may revoke a laboratory's certification, in total or in part, if the Department determines that there are grounds for revocation. The Department shall notify the laboratory in writing via certified mail in the event of a revocation. (a) Grounds for revocation are: 1. Failure to pass an inspection; 2. Failure to report compliance data to a public water system, the Department, or other responsible party in a manner so as to meet prescribed reporting time deadlines or interfering with the reporting of such data produced by other entities: 3. Failure to participate in or analyze proficiency test samples, or to meet the requirements for successful performance of such tests; 4. Operating the laboratory in such a manner so as to endanger public health or safety; 5. Making an intentionally false oral statement or written statement on any document issued by the laboratory or on any document associated with certification; 6. Careless, inaccurate, or falsified reporting of analytical measurements and supporting documentation; 7. Failure to notify the Department in writing within the prescribed timelines pursuant to 310 CMR 42.13 regarding any change in ownership, laboratory name, laboratory location, personnel, equipment, or any other factor that could impair the analytic, reporting, or operational capability of the laboratory; 8. Unethical conduct in the operation of the laboratory; 9. Fraudulent or deceptive practices; 10. Reporting sample results without indicating whether or not the laboratory is certified for that analysis; 11. Failure to use an approved method or to follow the approved method for sample analysis where the report issued for the analysis indicates that the analysis was conducted in accordance with Department certification standards; 12. Reporting sample results for analyses for which the laboratory is certified without indicating whether or not the analyses were conducted in accordance with Department certification standards; 13. Performing, reporting, or failing to report drinking water analyses in a manner so as to threaten public health or welfare; 14. Failure to implement, report, or maintain corrective action related to any deficiencies found during a laboratory inspection or deficiencies otherwise identified by the Department; 15. Failure to correct the deficiencies cited in a notice of downgrading to provisional certification and apply for reinstatement during the time frame specified by the Department; 16. Handling samples in a manner so as to compromise sample integrity; and 17. Failure to comply with any other requirement of 310 CMR 42.00. (b) A laboratory that has had its certification revoked must not advertise itself as certified for those matrices, disciplines, or categories for which the laboratory's certification has been revoked and, to the extent possible, must remove or replace any advertisements that indicate that the laboratory is certified within 30 calendar days of the laboratory's receipt of a notice of revocation of its certification. (c) A laboratory that has had its certification revoked must not perform analyses in those disciplines and categories for which its certification was revoked where the Department or the laboratory's client requires that the analyses be performed by a Massachusetts-certified laboratory and/or that the Department's certification standards of analysis be used. (d) The Department may impose a waiting period of up to three years in its notice of revocation, during which time the laboratory may not apply for recertification. After the waiting period ends, the laboratory must submit a new application for certification, including payment of the application fee, if it wishes to become recertified. (e) A laboratory that has had its certification revoked, but no waiting period imposed, may request reinstatement within 180 days of the date of revocation in accordance with the requirements of 310 CMR 42.12(4). A laboratory that fails to request reinstatement within 180 days must submit a new application for certification, including payment of the application fee, if it wishes to become recertified. (4) Reinstatement. (a) A laboratory for which certification has been downgraded to provisional may request reinstatement within the time period prescribed in the notification of downgrading and in accordance with the requirements of 310 CMR 42.12(4)(c). (b) A laboratory for which certification has been revoked and no waiting period imposed may request reinstatement within 180 days of the date of revocation and in accordance with the requirements of 310 CMR 42.12(4)(c). (c) Laboratories seeking reinstatement shall submit a written report to the Department detailing corrective action that has been taken in regard to the deficiencies that resulted in the downgrading or revocation of the certification. At the same time, the laboratory shall submit a written request for reinstatement review by the Department. The corrective action report and the request for reinstatement must be submitted within the time frame specified in 310 CMR 42.12(4)(a) or (b), as applicable. (d) The Department may reinstate a certification that has been downgraded or revoked if the laboratory has corrected all the deficiencies identified in the notice of downgrading or revocation to the Department's satisfaction and if the laboratory has applied for reinstatement in accordance with 310 CMR 42.12(4). The reinstatement of a laboratory's certification status following a downgrading or revocation is not effective until the Department has issued its decision in writing to the laboratory. (e) If a laboratory's request for reinstatement after revocation is denied by the Department, the laboratory shall submit a new application for certification, including payment of the application fee, if it wishes to become recertified. (f) A laboratory that has had its certification revoked and a waiting period imposed may not request reinstatement. (5) Successor. The revocation of a laboratory's certification shall operate to prohibit any successor from applying for certification from the Department except in accordance with 310 CMR 42.12(4).