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 laboratory observation, a review of laboratory Quality Assurance (QA) policy, patient test reports, lack of records, and staff interviews, the laboratory failed to verify the accuracy of Mohs micrographic surgery (Mohs) histopathology patient testing at least twice annually in 2024, 2025, and through the survey date in 2026 (05 /26/2026). The findings include: 1. Laboratory observation on 05/26/2026 at 11:00 a. m. revealed equipment used for processing and staining tissue for slide interpretation of Mohs surgical histopathology procedures. 2. A review of the laboratory Quality Assurance policy revealed the following requirement: "In order to verify reported Mohs Micrographic Surgery results, an exchange of Mohs Micrographic Surgery slides will be made twice annually. Three cases, one case every other month, representing three Mohs Micrographic Surgery cases will be randomly selected and exchanged with fellowship-trained Mohs colleague twice annually, a total of 6 cases per year." 3. A review of patient test reports revealed that Mohs patient histopathology slide interpretations had been performed as follows: -Patient 10242 on 10/26/2024 - Patient 10385 on 04/30/2025 -Patient 10815 on 07/22/2025 -Patient 11206 on 01/13 /2026 -Patient 11277 on 03/03/2026 4. A review of the laboratory Quality Assurance records revealed that no cases had been exchanged and reviewed in 2024, 2025, and 2026. 5. The laboratory director and the office manager confirmed the survey findings in an interview on 05/26/2026 at 12:30 p.m. . D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- (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 laboratory observation and staff interviews, the laboratory failed to ensure that it did not use five of five lots of tissue marking dyes beyond their expiration dates for Mohs surgical histopathology testing in 2026. The findings include: 1. Laboratory observation on 05/26/2026 at 11:00 a.m. revealed one grossing station used for gross examination of Mohs surgical tissue specimens. The station contained five different expired tissue-marking dyes with the following lot numbers and expiration dates used for patient testing on the day of the survey (05/26/2026): Color Lot Number Expiration Yellow 24099 04/30/26 Blue 24078 03/31/26 Green 24065 03/31/26 Red 24067 03/31/26 Black 24088 03/31/26 2. The Mohs technician confirmed the survey findings in an interview on 05/26/2026 at 11:00 a.m., and the office manager confirmed the survey findings in an interview on 05/26/26 at 1:15 p.m. -- 2 of 2 --