Summary:
Summary Statement of Deficiencies D0000 An unannounced revisit survey was performed on 08/17/2023. The laboratory was found to be in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). ---------------------------------------- An announced VALIDATION survey of the laboratory was conducted on June 27, 2023. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: D5300 - 42 C. F.R. 493.1240 Condition: Preanalytic systems D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. Noted deficiencies and allegations of compliance/plans of correction were discussed with the laboratory representative(s) at the exit conference. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the