Purpose, type, and frequency

Purpose, type, and frequency. (1) The department shall perform on-site evaluations to determine a laboratory’s potential, actual, or continued ability to comply with the provisions of this chapter. (2) The department shall conduct announced on-site evaluations of laboratories once every three years and when any of the following occurs: (a) A laboratory applies to become certified or registered in any field of accreditation unless the department waives the requirement to perform an on-site evaluation. When the department does not waive an evaluation, the evaluation shall be performed within 90 days after the department determines that a received application is complete. (b) A laboratory changes its location, ownership or key personnel, unless the department waives the requirement to perform an on-site evaluation. When the department does not waive an evaluation, the evaluation shall be performed within 90 days after the department receives notification of these changes. (c) The department determines that an on-site evaluation is necessary to verify corrective action implemented by a laboratory to address deficiencies identified in a previous on-site evaluation. (d) The department has reason to believe that a laboratory is not in compliance with this chapter. (3) The department may conduct unannounced on-site evaluations of a laboratory to verify compliance with this chapter after a notice of violation has been issued to a laboratory.