Section 144-256-ONE-10 - INSPECTIONS10.1Inspection of premises and operation. The department is authorized to inspect the premises and operation of all medical laboratories, subject to state licensure or any provisions of the Maine Medical Laboratory Act. See 22 M.R.S.A. §2024. 10.1.1Exempt from state inspection. Medical laboratories are exempt from state inspection if they possess a valid: 10.1.1.1 CLIA Certificate of Compliance; or10.1.1.2 CLIA Certificate of Accreditation.10.1.2State inspection required. Medical laboratories are subject to state inspection every three (3) years if they possess a valid: 10.1.2.1 CLIA Certificate of Waiver; or10.1.2.2 CLIA Provider-Performed Microscopy Procedures Certificate (PPM).10.1.3CLIA standards used for state inspections. CLIA standards for a Certificate of Waiver and a Certificate of Provider-Performed Microscopy Procedures (PPM) are used during state inspections to determine compliance with these rules, in accordance with Section 2.2 of these rules.10.2Notice of inspection. The department must notify medical laboratories in writing at least ten (10) business days prior to a state inspection, except as set out in Sections 10.2.1 and 10.2.2 of these rules. 10.2.1Complaints and suspected violations of rules. Without notice, medical laboratories may be inspected by the department in response to a complaint or suspected violation of these rules.10.2.2Code violations. Medical laboratories may be inspected without notice by the department, or another state agency, or a municipality for violations of building codes, fire codes, life safety codes or for other purposes unrelated to laboratory licensing or accreditation.10.3Statement of deficiency. The department, after inspection, shall issue a written statement of deficiency when the department determines that a violation of these rules has occurred and the laboratory shall be required to submit a plan of correction.10.4Plan of correction. Except as provided in Section 10.4.1 of these rules, the laboratory must submit a written plan of correction to the department within 10 business days of receipt of the statement of deficiency. 10.4.1Federal plan of correction: accepted by department. When a plan of correction is required, the department shall accept a CLIA-accepted federally required plan of correction when the federal plan of correction addresses the violations in the state-issued statement of deficiency.10.5Failure to implement plan of correction: directed plan of correction. When a medical laboratory fails to implement the plan of correction, the department is authorized to issue a directed plan of correction that must be implemented by the laboratory. The department may take additional enforcement actions in accordance with these rules.10-144 C.M.R. ch. 256, § ONE-10