Summary:
Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Medonic M-series User's Manual, Medonic -M series CBC analyzer procedure, quality control summary log from the Medonic M-series, and interviews with laboratory Technical Consultant, it was determined the laboratory failed to document function checks as defined by the manufacturer. Survey findings include: A. A review of the Medonic M-series User's Manual revealed that Instrument Startup is required daily. The following sequence guides the operator through the beginning of the day startup routine for the analyzer. There are 2 simple steps to follow which takes the user through a background and control analysis sequence with detailed guidance at each step. It is recommended that the performance of the Medonic M-Series system is checked daily with certified blood controls authorized by Boule. B. The laboratory procedure Medonic-M series CBC analyzer states "three levels control material performed daily", and "two levels must pass prior to patient testing". C. During a review of quality control summary log for February 2023 it was determined on 2/27/2023 and morning of 2/28/2023, the laboratory had documentation of background counts but no documentation of the quality control for Medonic M-series CBC analyzer. The laboratory failed to document quality control on one of twenty-eight days in February 2023. D. In a review of patient test reports it was determined that eleven patients had complete blood counts reported from the Medonic M-Series CBC analyzer on 2/27/2023 and 2/28/2023. Patients #1398, #1399, #1403, #1406, #1409, #48448, #1414, #48462, and #900424000019 were reported on 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 -- 2/27/2023. Patients #1420, and #1424 were reported on 2/28/2023. E. In an interview at 2:07 p.m. on 10/17/2023 the technical consultant (TC) (TC listed on the form CMS- 209) confirmed the laboratory had no documentation of quality control counts on 2/27 /2023 and morning of 2/28/2023. -- 2 of 2 --