Jefferson Regional Cancer Center

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Through a review of the manufacturer instructions for Coulter 4C-ES Cell Controls, Coulter 4C-ES table of expected results, observations made during a tour of laboratory, laboratory patient logs, as well as interview with staff, it was determined the laboratory performed patient testing for Complete Blood Counts (CBC) when the Hematology quality controls had exceeded their open vial expiration date. Survey findings follow: A. A review of manufacturer instructions for Coulter 4C-ES Control storage and stability requirements revealed "when stored at 2-8 degrees Celsius, sealed /unopened tubes are stable until the expiration date show on the vials. For opened vial stability, refer to the Table of Expected results." B. A review of the Table of Expected results for Coulter 4C-ES Controls revealed "open vials of Coulter 4C-ES Controls are stable for thirty-five days. C. During a tour of the laboratory on 9/9/20 at 1342, the surveyor observed three vials of Coulter 4C-ES quality control in the laboratory refrigerator. Low Control lot #068000, Normal control lot #078000, and High Control lot #88000 with an open date of 07/30/2020. The open vial expiration date for Low, Normal, and High Controls was 9/03/2020. D. A review of laboratory patient logs from 9/3/2020 to 9/9/2020 revealed fifteen patients had Complete Blood Counts (CBC) analyzed when the quality controls had expired. E. In an interview on 9/9/2020 at 14:00 technical consultant confirmed the quality controls had exceeded their expiration date and patients were tested for Complete Blood Counts. D5785

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Through a review of the AcT diff 2 Hematology Instrument start up results, patient test logs for January 2018, as well as interviews with laboratory staff, it was determined the laboratory failed to ensure function checks were within manufacturer's established limits before patient testing was conducted. As evidenced by: A. The laboratory uses the AcT diff 2 Hematology Instrument to perform Complete Blood Count (CBC) on patient blood samples. B. A review of the maintenance log for the AcT diff analyzer revealed the daily start-up report which includes the background results (pass or fail) for the measured parameters (White Blood Cells, Red Blood Cells, Hemoglobin, and Platelets). C. A review of the daily start-up report and patient testing logs for January 2018 revealed on 1/18/2018 the background result for Platelets was reported as "Failed". The laboratory reported twelve patient CBC results. D. In an interview, at 11:30 on 02/9/2018, the technical consultant (as listed on the form CMS-209) confirmed the laboratory reported patients on days when the background counts did not meet the manufacturer's acceptability requirements. 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 --