Summary:
Summary Statement of Deficiencies D0000 A recertification survey was performed on May 29, 2024. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) document review and testing personnel (TP) interview, the laboratory failed to ensure the QC was within range for the Polymerase Chain Reaction (PCR) bacteriology test(s) before patient results were released. Findings : 1. Review of PCR QC for Staphylococcus Aureus (Staph. Aureus) and Citrobacter Freundii on the date of June 21, 2024 revealed the PTC control (positive control) failed. 2 of 2 patients ran were resulted as positive for Staph. Aureus. 2. Interview with TP #5 (CMS 209 page 2) on 5/29/24 at 1:46 PM in the lab confirmed the aforementioned finding. D5783