100851. (a) An application for TNI accreditation or renewal of TNI accreditation shall be denied by the accrediting body for any of the following reasons:
(1) Failure to submit all information necessary to determine the laboratory’s eligibility for its accreditation or continued compliance with this section or regulations adopted thereunder.
(2) Failure of the laboratory staff to meet TNI standards for personnel requirements. These qualifications may include education, training, and experience requirements.
(3) Failure to successfully analyze and report proficiency testing samples.
(4) Failure to respond to a deficiency report from the onsite assessment with a corrective action report within 30 calendar days of the receipt of the report.
(5) Failure to implement the corrective actions detailed in the corrective action report within the specified amount of time.
(6) Misrepresentation of any material fact pertinent to receiving or maintaining TNI accreditation.
(b) The TNI-recognized accrediting body may suspend the accreditation of a TNI-accredited laboratory, in whole or in part, for failure to correct the deficiencies, within a specified amount of time, as identified in the onsite assessment. The laboratory shall retain those areas of accreditation where it continues to meet the requirements of the accrediting body. A suspended TNI-accredited laboratory shall not be required to reapply for accreditation if the causes for suspension are corrected within six months.
(c) The TNI-approved accrediting body shall suspend a TNI accreditation, in whole or in part for the following reasons:
(1) Failure to complete proficiency testing studies.
(2) Failure to maintain a history of at least two successful, out of the most recent three, proficiency testing studies for each affected accreditation field of testing, subgroup, or analyte for which the laboratory is accredited.
(3) Failure to successfully analyze and report proficiency testing sample results pursuant to TNI standards.
(4) Failure to submit an acceptable corrective action report in response to a deficiency report and failure to implement corrective action related to deficiencies found during laboratory assessments within the required time period, as required by the TNI standards.
(5) Failure to notify the accrediting body of any changes in key accreditation criteria, as required by TNI standards.
(6) Failure to perform all accredited tests in accordance with TNI standards.
(7) Failure to meet all applicable quality system requirements in TNI standards.
(d) A suspended laboratory shall not be required to reapply for TNI accreditation if the causes for suspension are corrected within six months. A suspended laboratory shall not continue to analyze samples for the affected fields of testing for which it holds accreditation. A suspended laboratory shall remain suspended without a right to appeal if the suspension is caused by unacceptable proficiency testing sample results.
(e) If a laboratory is unable to correct the reason for suspension, the laboratory’s accreditation shall be revoked in whole or in part.
(f) A laboratory’s accreditation shall not be suspended without the right to due process, as set forth in TNI standards.
(Amended by Stats. 2018, Ch. 92, Sec. 146. (SB 1289) Effective January 1, 2019.)