Laboratory Corporation Of America

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review of maintenance logs and interview with the laboratory director on 11/19/20 the laboratory failed to perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. The findings include: 1. The laboratory performs estrodiol, progesterone, creatine kinase-MB (CK-MB) and N-terminal pro brain natriuretic peptide(NT proBNP) testing on the Cobas e411. A record review of maintenance logs from the Cobas e411 from 9/1/2018 to 11/19/20, revealed that weekly maintenance was missing in March 2020, April 2020, August 2020 and October 2020. Monthly maintenance was not completed in September 2020, and the two week maintenance was missed once in March and not done at the correct interval in April. Weekly maintenance of cleaning the incubator and aspiration station and cleaning of the sipper probe: March 2-7, 2020 Not performed April 7-11, 2020 Not performed August 3-7, 2020 Not performed September 28- October 2,2020 Not performed Two week maintenance of cleaning the rinse stations and performing the liquid flow cleaning: March 2020 only performed once April 2020 performed on 4/17 and 4/23 Monthly maintenance of replacing the pinch valve tubing: September 2020 not performed. 2. There were not

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory technologist, the laboratory failed to retain calibration reports and data, as well as manufacturer quality control assay reference sheets for the Sysmex pocH-100i hematology analyzer since August 2017 and failed to retain the manufacturer's quality control assay reference sheets and calibration and calibration verification data print-outs from the Medience PathFast immunoassay analyzer since October 2017. Findings: 1. A review of the Sysmex hematology analyzer quality control records revealed the laboratory failed to retain the manufacturer's quality control assay reference sheets for 3 out of 3 levels of external liquid quality control materials and failed to retain calibration records and instrument data print-outs from the time of installation in August 2017 to May 2018. 2. A review of the PathFast analyzer quality control records revealed the laboratory failed to retain the manufacturer's quality control assay reference sheets for 2 out of 2 levels of external liquid quality control materials for troponin and 1 out of 2 levels of quality control materials for the D-dimer assay since July 2018, and failed to retain calibration and calibration verification data print-outs between November 2017 and August 2018. 2. An interview on August 30, 2018 at 1:30 PM, with the laboratory technologist, confirmed the testing personnel failed to retain all quality control assay sheets and calibration data for the hematology and PathFast analyzer from the time of installation in August 2017. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and an interview with the laboratory technologist, the laboratory failed to document the evaluation of ungraded, unsatisfactory, and unacceptable PT results for hematology and chemistry analytes from the American Proficiency Institute (API) program 2018 events 2. Findings: 1. A review of PT results from API 2017 event 2, revealed the laboratory failed to document the review and