Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 03/06/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). 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 surveyor's observations, review of laboratory's analyzer verification studies and staff interview, the laboratory failed to document verification of normal/reference range for 2 of 2 analyzers used by the laboratory from November 2023 to March 2024, the VITROS XT 3400 chemistry analyzer, and the Sysmex XN-430 hematology analyzer. Findings included: 1. Surveyors observations on 03/06/2024 at 0905 hours in the laboratory revealed the laboratory used the following analyzers: One VITROS XT 3400 clinical chemistry analyzer, serial number (SN) J34500954 One Sysmex XN- 430 hematology analyzer, SN 11877 2. Review of laboratory's "VITROS XT 3400 Clinical Chemistry Analyzer (SN 3450954) Verification Summary Report - Springwood Village" (document VER-064.1, approved 11/03/2023) revealed: "6.4.1. Reference ranges were established by Kalsey-Seybold clinic multisite reference establishment study." 3. Review of laboratory's " Sysmex XN-430 (SN 11877) Verification Summary - Springwood Village" (document VER-061.1, approved 10/26 /2023) revealed: "6.4.1. Reference range was adopted from established KSC ranges." 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 -- 4. Laboratory was asked for documentation of verification of normal/reference range for the above instruments and no such documentation was available for review prior to survey exit. 5. In an interview of 03/06/2024 at 1010 hours in the conference room, the laboratory's Technical Consultant (as indicated on submitted Form CMS 209) confirmed the findings. Key: CMS - Centers for Medicare and Medicaid KSC - Kelsey Seybold Clinic -- 2 of 2 --