Summary:
Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on the surveyors' interviews with the laboratory's office manager (OM) and record review of pre-analytic, analytic, and postanalytic remedial action records on September 2, 2022; the laboratory failed to establish written policies and procedures for an ongoing quality assessment mechanism to monitor, assess, and when indicated, correct problems identified in the laboratory's systems. Findings included: 1. According to laboratory's OM, during preanalytic, analytic, and postanalytic review of patients' processed Mohs slides, if a patient specimen was received or a report was issued that did not meet the laboratory's criteria for acceptability, a description as to why the specimen or report did not meet the laboratory's criteria for acceptability would be documented, appropriate