Summary:
Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on February 18, 2025. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following standard level deficiencies were cited: D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the laboratory validation documents on the Sysmex XN330 hematology analyzer and staff interview, the lab director failed to approve all of the validation documents before the analyzer was used for patient testing. Findings: 1. Review of the Sysmex XN330 validation documents provided, the lab director failed to approve, by signature, the carryover study performed or the reportable range study done upon istallation (4/17/23). 2. Interview with the practice administrator in the upstairs office area on 2/18/25 at 10:25 am confirmed the aforementioned finding. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on Sysmex XN330 maintenence document review and staff interview, the laboratory failed to document required daily and weekly maintenence. Findings: 1. Review of the Sysmex XN330 maintenence documents revealed the lack of documented daily and weekly maintenence for the period of May 2023 to 2025 to date. 2. Interview with the practice administrator, in the upstairs office area, on 2/18 /25 at 12:31 pm, confirmed the aforementioned finding. D5779