Laboratory Corporation Of America Holdings

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) from the provider American Proficiency Institute (API) performed 8/01/19 to 10/26/21 and interview with Quality Manager revealed that the laboratory director (LD) or designee failed to attest on 1 of 19 events that proficiency testing samples were handled in the same manner as patient samples and laboratory testing personnel (TP) failed to attest on 3 of 19 events that proficiency testing samples were handled in the same manner as patient samples. Findings: 1. Review of the attestation pages for PT from API revealed no signature of the LD or designee was present on API 2020 Immunology/Immunohematology 2nd Event. 2. Review of the attestation pages for PT from API revealed that no TP signatures were present on: a. API 2019 Immunology/Immunohematology 2nd Event b. API 2021 Immunology/Immunohematology 2nd Event c. API 2021 Hematology/Coagulation 2nd Event 3. Interview with the Quality Manager on 10/26/21 at 11:40 a.m. confirmed, the laboratory director (LD) or designee failed to attest on 1 of 19 events that proficiency testing samples were handled in the same manner as patient samples and laboratory testing personnel (TP) failed to attest on 3 of 19 events that proficiency testing samples were handled in the same manner as patient samples. 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 D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Ictotest quality control (QC) and interview with test personnel #1, the laboratory failed to perform a positive QC each day of patient testing in June and July of 2019. Findings: 1. Review of Ictotest QC and patient log showed patient's results were documented on June 25, July 1,2,3,16,18,19,22,29 and no positive QC was documented. 2. Interview with Testing personnel #1 at 1:30 PM confirmed the laboratory failed to perform positive Ictotest QC each day of patient testing in June and July 2019. 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 D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)