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: Based on reviews of the Horiba ABx Micros 60 calibration guide, calibration and quality control records, and interviews with Testing Personnel #1 and the Laboratory Director, the surveyor determined the laboratory: (1) failed to follow the manufacturer's instructions to verify calibrations by running quality controls (QC) for one out of four calibrations of the Hematology analyzer performed in 2017 - 2019 (refer to D5437), and (2) failed to implement effective