Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with laboratory representatives at the entrance and exit conferences. The facility representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. Based upon the onsite survey conducted 02/13/2020 - 02/14/2020, this facility was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493.1240 Pre-Analytic Systems 493.1250 Analytic Systems 493.1441 Laboratory Director, (high complexity) 493.1447 Technical Supervisor 493.1487 Testing Personnel (high complexity) The laboratory's failure to be in compliance with these regulations was found to pose IMMEDIATE JEOPARDY to the patients served by the laboratory. NOTE: The laboratory was asked to cease urine screen and confirmation toxicology testing. The laboratory voluntarily ceased urine toxicology screen and confirmation testing on patients. See letter dated 02/17/2020 and signed by the laboratory director. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the