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 6 patient reports (in the date range of 1/1/2018-2/4/2020) and the associated tissue slides, the laboratory failed to establish/monitor an ongoing mechanism to detect mistakes of slide labeling (analytic process). Findings include: a. On 9/3/2020, an audit was conducted from 10 a.m. to 11:30 a.m. with a review of 6 randomly selected histology and MOHS patients b. Two of the audit cases demonstrated an inconsistency in the procedure date on the slide and logbook vs. the patient report. Patient 1 indicated a procedure date of 5/7/2019 and the MOHS report indicated 5/17/2019; Patient 2 indicated a procedure date of 10/1/2019 and a MOHS report indicated 10/11/2019. c. A representative of the laboratory (OM- office manager) confirmed on (9/3/2020 at 11:45 a.m.) that the above descriptions were inconsistent and that no