Community Medical Center

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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 review of new instrumentation list, list of tests performed, lack of documentation, and interview with the laboratory manager, the laboratory failed to verify precision on the laboratory's new sedimentation rate analyzer, Diesse Mini Cube. 1. Review of new instrumentation list revealed the laboratory started patient testing on August 2024 on the new sedimentation rate analyzer, Diesse Mini Cube. 2. Review of the laboratory's list of tests performed revealed the laboratory tested 299 patients using the new sedimentation rate analyzer. 3. Review of the validation of performance specifications for the new sedimentation rate analyzer revealed no run to run precision studies had been performed. 4. Interview with the laboratory manager on 4/29/2025 at 12:36 PM, confirmed run to run precision was not performed prior to patient testing. 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 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's list of tests performed, lack of documentation, and staff interview at 12:35 PM on 5/7/2019, the laboratory failed to verify the accuracy for histopathology. Findings are: 1. Review of the list of tests performed provided by the laboratory revealed histopathology performed at this laboratory with a volume of 2 tests for 2017. 2. No documentation could be presented through proficiency testing or laboratory comparison to verify the accuracy of histopathology testing for 2017. 3. Staff interview revealed the laboratory had not enrolled in proficiency testing or laboratory comparisons for 2017 for histopathology testing. 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 --