Idaho Admin. Code r. 16.02.13.210

Current through September 2, 2024
Section 16.02.13.210 - CRITERIA AND PROCEDURES FOR DOWNGRADING OR REVOKING CERTIFICATION STATUS
01.Reasons a Laboratory May be Downgraded to Provisionally Certified Status. A laboratory may be downgraded to provisionally certified status for an analyte or method for any of the following reasons:
a. Failure to analyze a PT annually within acceptance limits specified in the regulations as demonstrated by a failure of a second PT;
b. Failure to submit an incident report after failing a PT or to analyze a second PT;
c. Failure to notify the CA within thirty (30) days of major changes;
d. Failure to maintain the required standard of quality based upon observations made by the CO during an on-site evaluation; or
e. Failure to report compliance data to the regulatory agency in a timely manner.
02.Procedure for Downgrading to Provisionally Certified Status.
a. The CA will notify the laboratory director or owner by certified mail of the intent to downgrade the laboratory to provisional certification per analyte per method within thirty (30) days of learning of any of the items listed under Subsection 210.01 of this rule. The laboratory will be given be given thirty (30) days from the date of receipt to develop a written corrective action plan and submit it with all supporting documentation to the CA. This information will be reviewed and evaluated for adequacy. The laboratory will be notified by certified mail if the response is acceptable or if additional corrective action must be taken. The CO will document that the corrective action plan has been implemented during the next on-site evaluation.
b. If a laboratory fails a second PT, the CA will downgrade the laboratory to provisionally certified status for that analyte or method and notify the laboratory by certified mail.
c. A provisionally certified laboratory has three (3) months to correct the problem in a manner that is acceptable to the CA. If the downgrading of certification is based on the results of PT testing, the reason for the error must be identified and corrected. A third PT must be successfully analyzed. A provisionally certified laboratory may continue to analyze samples for compliance purposes, but must notify its clients of the downgraded status of certification and provide that information in writing on all reports.
d. An out-of-state laboratory that has reciprocity with Idaho and is downgraded to provisional status by either the accreditation agency or certification authority of the home state must notify the CA of the change within thirty (30) days of the downgrade.
03.Criteria for Revoking Certification Status.
a. A laboratory must be downgraded from certified, provisionally certified, or interim certified status to "not certified" for a particular analyte or method for the following reasons:
i. Reporting PT data from another laboratory as its own;
ii. Falsification of data or other deceptive practices;
iii. Failure to use the analytical methodology specified in the regulations; and
iv. For provisionally certified laboratories, failure to correct the identified deficiencies that lead to the downgrading of certification status.
b. Reciprocity of out-of-state laboratories who do not notify the CA of any changes in the status of certification or accreditation will automatically be revoked.
04.Procedure for Revocation.
a. The CA will notify the laboratory in writing of the intent to revoke certification. The laboratory will have thirty (30) days from the time of the notification to provide a written response.
b. If the laboratory responds with an acceptable written corrective action plan, including documentation of implementation, the revocation will be suspended.
c. If the response is unacceptable, incomplete, or both, certification will be revoked. If the laboratory does not respond, certification will be revoked. The laboratory will be notified in writing of the revocation.
05.Upgrading or Reinstatement of Certification. A laboratory seeking an upgrade of certification must request this change in writing and provide documentation that the deficiencies that led to the provisional certification have been corrected. In addition, an on-site evaluation and successful completion of an additional PT may be required. A laboratory seeking certification after a revocation must follow the same procedure as a new laboratory seeking initial certification.

Idaho Admin. Code r. 16.02.13.210

Effective March 15, 2022