Summary:
Summary Statement of Deficiencies D0000 An initial survey was performed on 4/27/21, 4/28/21 and 5/10/21 in response to complaint TX00377562 The laboratory was found out of compliance with the CLIA regulations. Immediate jeopardy findings were identified. The conditions not met were: D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems; D6000 - 42 C.F. R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director The laboratory voluntarily started to perform patient testing per the manufacturer's instructions on 5/18/21 as evidenced by a letter signed by the laboratory director on 5/17/21. The complaint TX00377562 was substantiated. Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the