Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing policy, lack of documentation and interview with the Mohs technician, the laboratory failed to verify at least twice annually the accuracy of microscopic histopathology examinations performed in 2024. Findings include: 1. The laboratory's Quality Assurance proficiency testing policy stated, "Slide will be reviewed and comments noted on a standard form two times a year (quality assurance proficiency testing form)". 2. On the day of survey, 11/21 /2025 at 12:40 pm, the laboratory could not provide documentation for the verification of accuracy performed at least twice annually for microscopic histopathology examinations performed in 2024. 3. The laboratory performed 1075 microscopic histopathology examinations in 2024. (CMS 116, estimated annual volume, dated 11 /25/2025). 4. The Mohs technician confirmed the above findings on 11/21/2025 at 1: 47 pm. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the Mohs technician, the 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 -- laboratory failed to ensure that 1 of 1 reagent used to perform hematoxylin and eosin (H&E) staining for microscopic histopathology slide examinations was not used beyond the expiration date from 09/30/2025 to date of survey. Findings include: 1. On the day of the survey 11/21/2025 at 1:14 pm, observation of the laboratory revealed the following 1 of 1 expired reagent used to perform H&E staining for microscopic histopathology slide examinations performed from 09/30/2025 to 11/21/2025: - 1 opened bottle of Avantik Gill 3 Hematoxylin Stain Solution (Lot #194713 expired 09 /30/2025) 2. Review of the laboratory's Mohs test logs revealed 158 histopathology slide examinations were performed from 09/30/2025 to 11/21/2025. 3. The Mohs technician confirmed the findings above on 11/21/2025 at 1:47 pm. -- 2 of 2 --