Tony Fu Dermatology

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 laboratory records, lack of documentation, and interview with laboratory director (LD); the laboratory failed to perform bi-annual evaluations for one of one high complexity test system: dermatopathology testing in 2024. Findings Include: 1. Review of laboratory records found no bi-annual method accuracy evaluations for dermatopathology testing in 2024. 2. Interview with the LD on 10-22- 25 at 10:09 am confirmed that no bi-annual method accuracy evaluation had been performed for Dermatopathology testing in 2024. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the laboratory director (LD), the laboratory failed to evaluate results of bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for two of two events from 2025. Findings include: 1. Review of laboratory records revealed no documented evaluations of results upon receipt of peer reviewed histopathology interpretations for two of two bi-annual method accuracy events in 2025. 2. Interview with the LD on 10/22/2025, at 10:10 am, confirmed the laboratory failed to document evaluation of results of peer reviewed histopathology interpretations in 2025. 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 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation and interview with the laboratory director (LD), the laboratory failed to make available a written procedures manual for one of one high complexity histopathology microscopic slide evaluation and interpretation with diagnostic reporting testing procedure in 2021, 2022 and 2023. Findings include: 1. Surveyor review of laboratory records and lack of documentation revealed the laboratory failed to provide laboratory personnel a written procedures manual for high complexity histopathology microscopic slide evaluation and interpretation with diagnostic reporting testing procedure in 2021, 2022 and 2023. 2. On 10/04/2023 at 09:14 a.m., the LD confirmed the above findings. 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 --