Summary:
Summary Statement of Deficiencies D0000 An unannounced revisit of the laboratory was conducted on 09/11/2023. The laboratory remains out of compliance with the CLIA regulations. 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 Noted deficiencies and allegations of compliance/plans of correction were discussed with the laboratory re-presentative(s) at the exit conference. ------------------------------------ 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