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 quality control (QC) and patient log record review and interview with the histotechnician (HT), the laboratory failed to ensure that daily stain QC was consistently documented, recording the quality of the staining characteristics of the Hematoxylin and Eosin (H&E) stain each day of patient testing. Findings: 1. The laboratory performs H&E staining procedures to evaluate histopathology slides for Mohs surgery patients. Daily stain QC for the H&E stain is recorded on the "Quality Control Slide Log" (QC log). 2. A review of daily stain QC logs from December 2025 through June 2026 showed that the results of the stain QC was not documented on the QC log on 12/31/2025 and 05/22/2026; and 3. A review of patient logs for the same time period showed that there were 10 patients tested on 12/31/2025 (Mohs case # W25-1289 through W25-1298), and 10 patients tested on 05/22/2026 (Mohs case # W26-0607 through W26-0616). 4. During an interview on 08/13/2026 at 12:00 PM, the HT confirmed that daily stain QC was not consistently documented. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --