Summary:
Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on an audit of 6 patient reports (in the date range of 1/1/2018-11/30/2019) and the associated tissue slides, the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems. Findings include a. On 1/17/2020, an audit was conducted with a review of 6 randomly selected histology and MOHS patients. b.One patient report/slide set demonstrated an inconsistency with the slide label date and the associated report date- the slide indicated 12/17/19 and the report indicated 12/23/19. The laboratory failed to document a discrepancy on this patient and to generate a correction action report. c.Laboratory personnel (LP) confirmed (1 /17/2020 at 11:45 a.m.) that the above description was inconsistent and that no