Summary:
Summary Statement of Deficiencies D0000 An onsite survey conducted 07/22/2025 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 a review of patient test records, quality control records, and confirmed in an interview with facility personnel, the laboratory failed to provide documentation that it performed quality control testing each day of patient testing from July 2024 to December 2024. The findings included: 1. Review of patient test records records from July 1, 2024 to December 31, 2024 found the following 8 days when patients were tested for MOHS: 07-17-2024 07-24-2024 07-30-2024 07-31-2024 08-06-2024 08-21- 2024 08-28-2024 12-31-2024 See patient alias list (patient alias list is the MOHS testing log for each of the 8 patient testing days listed above) 2. Review of quality control records for each of the 8 patient testing days found no documentation of H & E quality control testing for intended reactivity to ensure predictable staining characteristics. The quality control log for each of the listed patient testing days had a dash on it. 3. The findings were confirmed in an interview with the MOHS technician on July 22, 2025 at 10:45 a.m. in the front office. Key: H & E - Hematoxylin and Eosin 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 --