Boone County Health 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 laboratory Hepatitis B Surface Antibody (HBsAb) patient results, review of HBsAb performance specifications, and interview with the laboratory manager the laboratory did not verify HBsAb reportable range high enough. 1. Review of HBsAb patient results from 4/16/2026 - 6/16/2026 revealed a patient result from 3/27/2026, resulted as 1600.67 mIU/mL. 2. Review of the laboratory's HBsAb performance specifications revealed the verified reportable range as 0.00 mIU/mL - 420.00 mIU/mL. 3. Interview with the laboratory manager on 6/16 /2026 at 2:20 PM, confirmed the laboratory verified 0.00 mIU/mL - 420.00 mIU/mL HBsAb reportable range and confirmed the laboratory did not verify the reportable range higher than 420.00 mIU/mL. 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 surveyor review of proficiency testing (PT) records, lack of any verification records, and an interview with the laboratory supervisor, the laboratory failed to have a system for verifying the accuracy of the testing for cerebrospinal fluid (CSF), glucose and CSF, protein at least twice yearly for the last two years. Findings are: 1. The laboratory's proficiency test results from 2022 and 2023 did not include testing for CSF, glucose and CSF, protein. 2. Interview on 6/11/2024 at 4:02 PM, the laboratory supervisor confirmed the laboratory had not enrolled in PT for CSF, glucose and CSF, protein nor had the laboratory performed accuracy verification for these analytes. 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 --