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. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on an audit of 5 patient reports as part of the quality assessment review (in the date range of 1/1/2019-9/1/2020) and the associated tissue slides, the laboratory failed to establish/monitor an ongoing mechanism to detect mistakes of slide labeling (analytic process). Findings include: 1. On 10/20/2020, an audit was conducted from 3: 00 p.m. to 4:30 p.m. with a review of 5 randomly selected MOHS patients 2. One of the audit cases demonstrated an inconsistency in the procedure anatomic patient location in the patient logbook vs. the patient report. The patient under review indicated a procedure logbook location of left nose on 9/13/19, and the associated laboratory report indicated a clinical location of left ear. 3. A representative of the laboratory (LP) confirmed on (10/20/2020 at 3:45 p.m. that the above descriptions were inconsistent. No