Labcorp Kansas, Inc - Main Lab

Summary Statement of Deficiencies D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of manual cell counts test logs and interview, the laboratory failed to perform one control level in duplicate and failed to perform patient testing in duplicate for manual cell counts using a hemocytometer on one of one patients January 6, 2022. Findings: 1. Review of manual cell count test logs showed patient testing was not being performed in duplicate on one of one patients on January 6, 2022 at time of survey. 2. Quality Control (QC) records for manual cell counts were requested, there was no QC performed in duplicate on January 6, 2022. 3. GS #1 stated the QC performed on manual cell counts was a comparison of the automated hematology analyzer result to the manual result of one of one patients. 4. Interview with GS #1 at 2:15pm on January 25, 2022 confirmed, the laboratory failed to perform one control level in duplicate and failed to perform patient testing in duplicate for one of one patients on January 6, 2022 for manual cell counts using a hemocytometer at time of survey. 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 D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of instrument type and test settings, reagent package insert, and interview, the laboratory failed to follow manufacturer's instruction for the ISI setting in prothrombin time testing. Findings include: 1. Prothrombin time testing is performed on the ACL TOP 300 using RecombiPlasTin2G reagent. 2. ACL TOP 300 instrument setting for prothombin time testing showed lot #N0588147, ISI set to 1.020, and last modification date/time as 09/02/2018 11:45:17. 3. RecombiPlasTin2G reagent package insert for lot #N0588147 defines the ISI at 0.98 for ACL TOP Series instruments. 4. Interview with GS #1 September 18, 2019 at 10:50 AM confirmed the laboratory failed to follow manufacturer's instruction for the ISI setting in prothrombin time 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 --