Summary:
Summary Statement of Deficiencies D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy/procedure, quality assessment documentation, five patient testing records, and an interview with the administrative assistant (AM); the laboratory is herein cited for failure to retain the differential stain quality control (QC) slide for one out of five records reviewed. The findings include: 1. The laboratory worked with an external Mohs company to process patient samples and slides. According to the policy/procedure, at each patient day of testing, a differential stain QC slide was provided. 2. The QC slide on January 20, 2025, could not be located affecting one out of five patient records reviewed. No