Calhoun Liberty Hospital Association, Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Calhoun Liberty Hospital Clinical Laboratory on 05/29/2024 - 07/16/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing results and interview, the laboratory failed to evaluate the ungraded proficiency testing scores 1 (1st testing event in 2023) out of 4 testing events in Chemistry, 2 (1st and 2nd testing event in 2023)out of 4 testing events in Hematology, and 3 (2nd and 3rd testing event in 2023 and 1st testing event in 2024) in Microbiology. Findings Included: API test results were reviewed for the 1st, 2nd, and 3rd testing event in 2023 and the 1st testing event in 2024. In the 1st testing event in 2023 in Chemistry the laboratory received an ungraded result for ALT. In the 1st and 2nd testing event in 2023 for Hematology the laboratory received an ungraded result for Lymphocytes. In the 1st testing event in 2024 in Microbiology the laboratory received an ungraded result for Urine Culture Zone, CSF (Cerebral Spinal Fluid) cultures, and CSF susceptibility. In the 2nd testing event in 2023 in Microbiology the laboratory received an ungraded result for Urine culture zone, Blood culture and susceptibility. In the 3rd testing event in 2023 in Microbiology the laboratory received an ungraded result for Urine Culture Zone. Interview on 05/29/2024 at 5:00 PM the Laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Manager confirmed that there was no

Summary Statement of Deficiencies D0000 A recertification survey was conducted on April 25, 2022 and continued through July 5, 2022 to gather additional documentation. Calhoun Liberty Hospital Clinical Laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. D5781

Summary Statement of Deficiencies D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform quality control of PO2 tests for Arterial Blood Gas Analysis each day of patient testing in accordance with CLIA requirements on the month of July 2016. Findings included: Review of the quality control (QC) documentation for Arterial Blood Gas testing of PO2 on July of 2016 showed that monthly quality control was not performed. During an interview on 4/2/18 at 4:00 PM, testing personnel # 6 confirmed that there was no documentation to show that the laboratory had performed quality control on PO2 tests of Arterial Blood Gas analayzer for the whole month of July 2016. 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 --