Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, CLIA requirements for laboratories as a result of an initial survey completed on July 06, 2026 and certification is recommended. Standard level deficiencies were cited. 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 review of laboratory policy, laboratory quality control records, patient test list, and confirmed in interview, the laboratory failed to ensure documentation of intended stain reactivity for hematoxylin and eosin (H&E) stain, and toluidine stain (T- Blue), for one of nine random days reviewed from August 2025 through June 2026, when patients slides had been made and stained for the assessment of MOHS surgical procedures. The findings included: 1. Review of the laboratory policy titled "Daily Control Slide for Mohs Surgery" included the following information: "A daily control slide for H&E and T-Blue stain is documented representing stain quality for each date- of-use. The first H&E / T-Blue stain slide of each date of surgery will serve as the control for that date. The control slide will be documented in "Daily Control Slide for Mohs Surgery" logbook, and with a red + mark in the daily accession log." 2. Review of the "Daily Control Slide for Mohs" did not include a daily stain quality assessment for acceptable staining characteristics of H&E or T-Blue staining on 9/26/2025 when patient testing occurred. 3. Review of the patient MOHS log included the following eleven patients with slides made and stain for the assessment of MOHS surgical procedures on 9/26/2025. T-Blue: M25-23, M25-24, M25-27, M25-28, M25-29 M25- 30, M25-31, M25-32, M25-33 H&E: M25-23, M25-26. 4. In an interview on 7/6/2026 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- at 14:20 hours, in the laboratory, testing personnel (TP) 6 confirmed stain quality control had not been documented for T-Blue and H&E staining on 9/26/2026. -- 2 of 2 --