M&M Clinical Group

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. Immediate jeopardy findings were identified. The conditions not met were: Fed - D - 5022 - 493.1213 - Toxicology Fed - D - 5300 - 493.1240 - Preanalytic Systems Fed - D - 6076 - 493.1441 - Laboratory Director Fed - D - 6108 - 493.1447 - Laboratory Technical Supervisor Fed - D - 6168 - 493.1487 - Testing Personnel The laboratory voluntarily suspended patient testing on 7/26/19 as evidenced by a letter signed my the laboratory owner on 7/26/19. 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