Summary:
Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of 2016, 2017 and 2018 calibration records 06/08/18 and review of Centers for Medicare & Medicaid Services (CMS) Statement of Deficiencies (SOD) and Plans of Correction (POC) dated 07/19/12 and 03/04/16, the laboratory has repeat deficiencies for failure to retain all required documentation for the performance of calibration on the Abbott Cell-Dyn Emerald hematology analyzer. Review of 2016, 2017 and 2018 calibration records revealed the laboratory failed to retain all required documentation for the performance of calibration on the Abbott Cell-Dyn Emerald hematology analyzer (see D3031). Review of CMS SOD and POC's dated 07/09/12 and 03/04/16 revealed the laboratory has repeat deficiencies for failure to retain all required documentation for the performance of calibration on the Abbott Cell-Dyn Emerald hematology analyzer. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 review of 2016, 2017, and 2018 hematology calibration records 06/08/18, the laboratory failed to retain all required documentation of calibration. The laboratory performs Complete Blood Cell Counts on the Abbott Cell-Dyn Emerald hematology analyzer. Review of 2016, 2017 and 2018 calibration records for Abbott Cell-Dyn Emerald analyzer revealed the laboratory failed to retain all documentation for the performance of calibration. 1. For the calibration performed 3/28/16, the laboratory failed to retain documentation of the pre-calibration factors, post calibration factors, and post calibration quality control records. 2. For the calibration performed 12/20/17, the laboratory failed to retain package insert for the Cell-Dyn 18 Plus Calibrator, Lot #7352C, used in the calibration, and failed to retain documentation of the pre-calibration factors and the calibration verification documentation. This deficiency was previously cited 7/19/12 and 3/04/16. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of 2016, 2017 and 2018 College of American Pathologists (CAP) proficiency testing record and testing personnel (TP) interview 06/08/18, the laboratory failed to review and evaluate all unacceptable results obtained for proficiency testing. Review of CAP testing event, FH1-C 2016 Hematology Auto Differentials, revealed the laboratory scored 80% for Red Blood Cell Count, specimen FH1-13 was graded as "unacceptable". There was no evidence the unacceptable result was reviewed and evaluated. Interview with TP #2 at approximately 12:30 p.m. confirmed the laboratory did not review or evaluate the unacceptable result. TP #2 stated she thought since the overall score was 80% and passing, that unacceptable results did not need review. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of manufacturer's operating manual, review of 2016, 2017, and 2018 hematology analyzer "Event Logs", maintenance logs, and calibration records, and interview with testing personnel (TP) 06/08/18 and review of Centers for Medicare & Medicaid Services (CMS) Statement of Deficiencies (SOD) and