Mitchell Family Medicine, Llc

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: . Based on a review of laboratory policy and interviews with laboratory staff, it was determined the laboratory failed to document criteria for acceptable quality control for Chemistry. Survey findings include: A. Laboratory policy "Quality Control Protocol" states "..If one control level is outside the expected range (app 2SD ( sic approximately 2 Standard deviations)) for only one day but within 3SD the run may be accepted" and "New lots of control material are verified before use. This is accomplished by running at least one day of the old control with the new. The mean value for these runs must fall within the expected range of the manufacturer. The control ranges for the respective analytes are kept for two years." B. The surveyor reviewed chemistry quality control documentation for November 2025, February, 2026, and March 2026. Records documented a lot change for the "CHEM01" Lyphocheck Unassayed Chemistry Control (new lot 93401) occurred 11/11/25. Records documented one of ten runs for the level one CHEM01 control was omitted from the new lot validation, for all analytes. For Lipase, six of eight runs were omitted from the new lot mean calculation. C. Upon request, the lab was unable to provide documentation showing the mathematical criteria that led to the exclusion of certain Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- runs from the mean calculation for the new lot. D. Upon request, the laboratory was not able to provide methods or criteria for control range and mean adjustments outside of new lot introductions. C. In an interview, at 3:03pm on 5/12/26, the Technical Consultant confirmed that the policy did not clearly specify the mathematical thresholds and procedures for adjusting means and standard deviations for chemistry controls. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies 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: . Through a review of new instrument validation documentation for the Sysmex 300 XN Hematology Analyzer lack of documentation, as well as interviews with staff, it was determined the Laboratory failed to have the director approve verification procedures to ensure they are adequate to determine the accuracy, precision, and other pertinent performance characteristics as evidenced by: A. A review of the verification documentation for Sysmex 300 XN Hematology Analyzer revealed the signature page of the verification procedure was not approved or signed by the laboratory director. B. Upon request, the laboratory could not produce documentation that the laboratory director approved or signed the validation of the Sysmex 300 XN Hematology Analyzer. C. In an interview on 10/07/2020 at 1030, the technical consultant confirmed the validation procedure for the Sysmex 300 XN Hematology analyzer was not approved or signed by the Laboratory Director. 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 --