Kimball Health Services

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 verification records, and interview with laboratory manager the laboratory failed to have a system for verifying the accuracy of prostate specific antigen, vitamin D, and urine microalbumin testing at least twice annually for 2024. Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory performs prostate specific antigen, vitamin D, and urine microalbumin testing. 2. Interview with the laboratory manager on 6/18/2025 at 9:33 AM MTN, confirmed the laboratory did not perform twice annual accuracy verification for prostate specific antigen, vitamin D, and urine microalbumin 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 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 review of new instrumentation list, list of tests performed, lack of documentation, and interview with the technical consultant, the laboratory failed to verify precision on the laboratory's new sedimentation rate analyzer, Mini Cube. 1. Review of new instrumentation list revealed the laboratory started patient testing on December 20222 on the new sedimentation rate analyzer, Mini Cube . 2. Review of the laboratory's list of test performed revealed the laboratory had tested 177 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 technical consultant on 8/16/2023 at 9:43 AM 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 D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on surveyor review of instrument maintenance and an interview with general supervisor and facilities hospital staff member, the laboratory failed to calibrate the electronic thermometer used for blood bank fridge. Findings are: 1. Review of the electronic thermometer instruction label revealed calibration due date on January 10, 2018. 2. Interview with general supervisor and facilites hospital staff member at 11:30 AM on 7/24/2019 confirmed the laboratory had not performed calibration on the electronic thermometer. 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 --