(1) In addition to the requirements of s. 408.811, the agency shall ensure that each clinical laboratory subject to this part is inspected either onsite or offsite when deemed necessary by the agency, but at least every 2 years, for the purpose of evaluating the operation, supervision, and procedures of the facility to ensure compliance with this part. Collection stations and branch offices may be inspected either onsite or offsite, when deemed necessary by the agency. The agency may conduct or cause to be conducted the following inspections:
(a) An inspection conducted at the direction of the federal Centers for Medicare and Medicaid Services.
(b) A validation inspection.
(c) A complaint investigation, including a full licensure investigation with a review of all licensure standards as outlined in rule. Complaints received by the agency from individuals, organizations, or other sources are subject to review and investigation by the agency. If a complaint has been filed against a laboratory or if a laboratory has a substantial licensure deficiency, the agency may inspect the laboratory annually or as the agency considers necessary.
(2) For laboratories operated under s. 483.035, biennial licensure inspections shall be scheduled so as to cause the least disruption to the practitioner’s scheduled patients.
(3) The agency may inspect an out-of-state clinical laboratory under this section at the expense of the out-of-state clinical laboratory to determine whether the laboratory meets the requirements of this part and part II of chapter 408.
(4) The agency shall accept, in lieu of its own periodic inspections for licensure, the survey of or inspection by private accrediting organizations that perform inspections of clinical laboratories accredited by such organizations, including postinspection activities required by the agency.
(a) The agency shall accept inspections performed by such organizations if the accreditation is not provisional, if such organizations perform postinspection activities required by the agency and provide the agency with all necessary inspection and postinspection reports and information necessary for enforcement, if such organizations apply standards equal to or exceeding standards established and approved by the agency, and if such accrediting organizations are approved by the federal Health Care Financing Administration to perform such inspections.
(b) The agency may conduct complaint investigations made against laboratories inspected by accrediting organizations.
(c) The agency may conduct sample validation inspections of laboratories inspected by accrediting organizations to evaluate the accreditation process used by an accrediting organization.
(d) The agency may conduct a full inspection if an accrediting survey has not been conducted within the previous 24 months, and the laboratory must pay the appropriate license fee under s. 483.172(2).
(e) The agency shall develop, and adopt, by rule, criteria for accepting inspection and postinspection reports of accrediting organizations in lieu of conducting a state licensure inspection.