Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 26, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) document review and staff interview, the laboratory failed to attain an overall testing event score of at least 80% for 4 of 5 testing events. Findings include: 1. Review of the 2018 and 2019 American Society of Internal Medicine (MLE) PT documents reveals the laboratory received unsatisfactory results for urine colony count culture 4 of 5 testing events: 2018 Event #2 (50%) and #3 (0%) and 2019 event #1 (50%) and #2 (0%) without documentation of