Collier Skin Cancer Center

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/24/2024. The laboratory was found in compliance with a standard-level deficiency cited. The finding was reviewed with the laboratory director, office manager, and laboratory technician at the conclusion of the survey. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 and interview with the laboratory manager, the laboratory failed to ensure an expired material was not available for use. Findings include: (1) Observation of the laboratory on 05/24/2024 at 09:45 am, identified one bottle of Polarstat Plus - Red Frozen Embedding Medium - lot #088368 with an expiration date of 10/31/2021; (2) Interview with the laboratory manager on 05/24/2024 at 09:47 am confirmed the expired material was available for use. 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 D0000 The recertification survey was performed on 06/17/2022. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the laboratory director, histotech/office manager, and histotech at the conclusion of the survey. 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 a review of records and interview with the laboratory director, the laboratory failed to verify the accuracy of slide interpretations at least twice annually. Findings include: (1) On 06/17/2022 at 09:15 am, the laboratory director stated the laboratory performed microscopic interpretations of H&E (Hematoxylin and Eosin) stained slides from vertical skin biopsies and tissues removed during Mohs surgery. The tissue would then be observed microscopically; (2) A review of records for testing performed from December 2020 through the day of the survey revealed the accuracy of the slide interpretations for vertical biopsies and Mohs surgical specimens had not been verified twice annually. The interpretations had not been verified for accuracy between: (a) 12/01/2020 and 08/05/2021 (b) 08/05/2021 and 04/13/2022 (3) The records were reviewed with the laboratory director who stated on 06/17/2022 at 11:10 am the slide interpretations had not been verified for accuracy twice during 2021. 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 --