Summary:
Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's quality assessment records, randomly chosen patient records for Mohs procedure and an interview with the laboratory director (LD), it was determined the laboratory failed to provide the quality control slide to assess the quality of staining materials on each day of Mohs. The findings include: 1. Based on the surveyor's review of 2022-2025 Mohs patient records, it was determined that one out of seven records was missing a quality control (QC) slide on October 14, 2022. 2. The LD affirmed by interview on August 6, 2025, at approximately 3:00 p.m., that the quality control slide for Mohs on October 14, 2022 was not found. No