Summary:
Summary Statement of Deficiencies D0000 A recertification survey was performed on May 14, 2024. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on review of standard operations procedure manual (SOP) and interview with testing personnel (TP), the laboratory failed to have the proper procedure in place for the Sysmex XN-430 or the date of the initial use of the procedure. Findings: 1. Review of the SOP revealed the procedure in place was for the previous analyzer, the Beckman Coulter ACT Diff II, not the analyzer currently in use, the Sysmex XN-430. The initial date of use was also absent for the Sysmex XN-430. 2. Interview with TP #1 (CMS 209) on 5/14/24 at 12 Noon in the breakroom, confirmed the aforementioned finding(s). D6024 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(7) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) documents and testing personnel (TP) interview, the laboratory director failed to ensure