Southeast Clinical Laboratories

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 a review of the College of American Pathologists (CAP) proficiency test records and an interview with the Laboratory Director, the Laboratory failed to implement a mechanism to verify the accuracy of the viral markers Anti-HIV, Hepatitis (Anti-HBc), and Hepatitis (HBsAg). This was noted for one of thirty nine events reviewed in 2023. The findings include: 1. A review of the CAP proficiency records revealed the laboratory scored zero percent for Anti-HIV, Anti-HBc, and HBsAg on the 2023 VM-C Viral Marker proficiency test due to "failure to participate." 2. During an interview on 8/5/2025, at 10:13 AM, the Laboratory Director confirmed the above findings. 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 reviews of the installation and validation records for four new instruments in the specialty of Microbiology and interviews with the Microbiology General Supervisor and the Laboratory Director, the surveyor determined the laboratory failed to ensure an evaluation of the data generated during the initial installation procedures was documented, reviewed and approved as verification of the manufacturer's performance specifications for precision and accuracy before patient testing began. The laboratory further failed to ensure discrepant results generated during the validation were investigated to determine if further studies or other