Summary:
Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the AcT Diff 2 hematology analyzer records including quality control, maintenance, and calibration records from 9/1/2021 through 6/14/2023 and confirmation with testing personnel (TP) #1 as listed on the Centers for Medicare and Medicaid Services 209 Personnel form at 10:00 a.m. on 6/14/2023, the laboratory failed to perform calibration on CBC (complete blood count) performed on the AcT Diff 2 every 6 months as required by the written laboratory procedure manual and instrument manufacturer for 2 of 4 calibrations due since the last survey 9/1/2021. Findings include: 1. Review of the AcT Diff 2 calibration records revealed calibration was performed on 9/18/2021 and 2/17/2023. 2. Interview with the TP #1 at 10:00 a.m. on 6/14/2023 confirmed CBC calibrations were not performed every 6 months for 2 of 4 calibrations required between 9/17/2021 and 2/17/2023. D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing records, Centers of Medicare and Medicaid Services (CMS) database proficiency testing CASPER report 0155D and confirmation with testing personnel (TP) #1 at 12:00 p.m. on 6/14/2023, the technical consultant (TC) failed to ensure the laboratory participated in an HHS approved proficiency testing (PT) program for CBC (complete blood count) performed on the Beckman Coulter AcT Diff 2 hematology analyzer for 1 of 5 testing events between 9/1/2021 and 6/14/2023. Findings include: 1. Based on review of the laboratory proficiency records from 9/1/2021 through 6/14/2023 and the CMS database CASPER Report 0155D proficiency report, the laboratory did not perform or report Proficiency testing for CBC's for the 1st event of 2023. The laboratory did not participate in 1 of 5 proficiency events since 9/2/2021. 2. TP #1 confirmed in an interview at 12:00 p.m. on 6/14/2023 that the laboratory did not participate in the 1st proficiency event of 2023 for hematology testing (CBC). -- 2 of 2 --