Summary:
Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with Testing Personnel (TP) the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems from 11/28/22 to 5/12/25. The finding includes: 1. The laboratory failed to have a procedure to verify new lots of controls before they were put in use on the iStat analyzer. 2. The TP confirmed on 5/12/25 at 10:40 am that the laboratory failed to have a procedure to verify new lots of controls before they were put in use. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of