Summary:
Summary Statement of Deficiencies 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: Review of the laboratory's policy and procedure for hematology quality control (QC), acceptable range sheets for CDS Boule Con-Diff Multi-Parameter Assayed Hematology Controls, All Data Summary Reports provided by the Medonic M-Series analyzer, maintenance checkist for the Medonic M-Series Hematology Analyzer, lack of documentation and interview with laboratory staff determined the laboratory testing failed to meet the applicable analytic systems requirements as evidenced by: D5429: The laboratory failed to document and/or perform maintenance required for the proper operation of the Medonic M-Series Hematology Analyzer. D5445: The laboratory failed to perform daily QC prior to releasing patient results on July 23, 2024. D5783: The laboratory failed to document