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 record review and staff interview, the laboratory's quality assessment review of control records failed to identify histopathology control failure in November 2023. Findings include: 1. Review on 6/5/2024 of control records for histopathology slide quality from May 2022 through May 2024 revealed control slides were assessed at the beginning of each day of patient testing (1 day per week at this location). Further review revealed the control slide on 11/15/2023 was found to have unacceptable stain quality. There was no further documentation of