Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on 05/13/2025. The facility was found to not be in compliance with the laboratory requirements of 42 CFR Part 493 with standard deficiencies cited. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on observation, review of laboratory policy, review of proficiency testing records, and confirmed in interview, the laboratory failed to have documentation of split sample testing for 4 of 4 months. During a tour of the laboratory area on 05/13 /2025 at 10:15 AM, a Sciex 4500 Triple Quad LC/MS analyzer, Serial Number BJ23711405, was observed. The laboratory policy titled "Standard Operating Procedure, LC-MS/MS Split Sample Testing" stated, "Split-sample testing is required for individual analytes within the confirmation test menu that are tested by the laboratory, which are not included in the Proficiency Testing menu. Appendix A indicates which analytes within the LC-MS/MS test menu require split-sample testing as they are not included within the CAP test menu for the Urine Toxicology (UT) module. Spiked samples containing the analytes of interest shall be sent to a CLIA accredited laboratory twice a year (April and October.) A review of the laboratory's proficiency test manual revealed the laboratory failed to perform split sample testing for October 2023, April 2024, October 2024, and April 2025. In an interview on 05/13 /2025 at 11:00 AM in the office area, the Technical Supervisor (TS) was asked if split sample testing had been performed for the laboratory. The TS confirmed split sample testing had not been performed for the laboratory. This confirmed the findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --