La. Admin. Code tit. 48 § V-8041
Current through Register Vol. 50, No. 9, September 20, 2024
Section V-8041 - Interim CertificationA. If a laboratory completes all of the requirements for certification except that of an on-site assessment because the department is unable to schedule the assessment in a timely manner, the department may issue an interim certification. Interim certification is not available for first time certification of a laboratory or after revocation of certification. Interim certification will allow a laboratory to perform analyses and report results with the same status as a fully certified laboratory until the on-site assessment requirements have been completed. Interim certification status may not exceed 12 months. The interim certification status is a matter of public record and will be noted on the certificate of the laboratory.B. Revocation of Interim Certification. Revocation of interim certification may be initiated for due cause in accord with the requirements of §8039 of this Chapter.C. The department may approve a laboratory application to add an analyte or method to its scope of certification by performing a data review without an on-site assessment. An addition to the scope of certification via a data review of PT performance (if available), quality control performance, and written standard operating procedure is at the discretion of the department. An addition of a new technology or test method requiring specific equipment may require an on-site assessment.La. Admin. Code tit. 48, § V-8041
Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 38:3223 (December 2012), Amended by the Louisiana Department of Health, Office of Public Health, LR 461096 (8/1/2020).AUTHORITY NOTE: Promulgated in accordance with R.S. 36:254(B)(7).