Summary:
Summary Statement of Deficiencies D0000 A Revisit Survey was performed at Acadian Diagnostic Laboratories, LLC-CLIA # 19D2062876 on October 23, 2018 through October 25, 2018. Acadian Diagnostic Laboratories, LLC was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1420 CONDITION: Preanalytic Systems 42 CFR 493.1250 CONDITION:Analytic Systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing; Laboratory Director =================================================================== 36645 A Complaint Survey # LA00046831 was performed at Acadian Diagnostic Laboratories, LLC-CLIA # 19D2062876 on October 30, 2017 through November 3, 2017. Acadian Diagnostic Laboratories, LLC was found not in compliance with the following CONDITION LEVEL DEFICIENCIES which constitute an IMMEDIATE JEOPARDY to the patients serviced by the laboratory: 42 CFR 493.1420 CONDITION: Preanalytic Systems 42 CFR 493.1250 CONDITION:Analytic Systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing; Technical Consultant 42 CFR 493.1421 CONDITION: Laboratories performing moderate complexity testing; Testing personnel 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing; Laboratory Director 42 CFR 493.1447 CONDITION: Laboratories performing high complexity testing; Technical Supervisor 42 CFR 493.1459 CONDITION: Laboratories performing high complexity testing; General Supervisor 42 CFR 493.1487 CONDITION: Laboratories performing high complexity testing; Testing personnel 42 CFR 493.1771 CONDITION: Inspection Requirements Applicable to ALL CLIA-Certified and CLIA- Exempt Laboratories Instruments that are not classified by the Food and Drug Administration (FDA) are considered laboratory developed tests under CLIA. These instruments, as well as any FDA approved moderate complexity instrument that has been modified are considered high complexity and are subject to the CLIA regulations for Establishment and Verification of performance specifications (42 CFR 493.1253(b)(2) and all other high complexity CLIA requirements. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --