Avanti Laboratories, Llc

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES resulting in a finding of IMMEDIATE JEOPARDY: D5300 - 42 C.F.R. 493.1240 Condition: Pre-Analytic Systems D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director; moderate complexity The immediate jeopardy was abated by the laboratory submitted a letter on 05/06/2021 that it would follow all manufacturer's instructions. Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was 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

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES resulting in a finding of IMMEDIATE JEOPARDY: D5300 - 42 C.F.R. 493.1240 Condition: Pre-Analytic Systems D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director; moderate complexity The immediate jeopardy was abated by the laboratory submitted a letter on 05/06/2021 that it would follow all manufacturer's instructions. Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was 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