Abington Dermatology Associates

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the laboratory's temperature records, lack of documentation, and interview with the histotechnician, the laboratory failed to monitor and document cryostat operating temperature to ensure reliable test system operation and test result reporting for 32 of 32 days when histopathology slide examinations were performed from 2/5/2024 to 6/25/2024. Findings include: 1. On the day of survey, 11/17/2025 at 9:32 am, review of the laboratory's cryostat temperature log revealed the laboratory failed to document operating temperature (laboratory's acceptable range: -20 to -30 degrees Celsius) for 1 of 1 Thermo Scientific HM525 cryostat (s/n 54747) on the following days when histopathology slide examinations were performed from 2/5 /2024 to 6/25/2024: - 2/5/24, 2/6/24, 2/12/24, 2/13/24, 2/19/24, 2/20/24, 2/26/24, 2/27 /24. - 3/4/24, 3/5/24, 3/12/24, 3/18/24, 3/19/24, 3/26/24. - 4/1/24, 4/2/24, 4/9/24, 4/16 /24, 4/25/24, 4/29/24, 4/30/24. - 5/7/24, 5/13/24, 5/14/24, 5/21/24, 5/28/24. - 6/4/24, 6 /10/24, 6/11/24, 6/18/24, 6/24/24, 6/25/24. 2. Review of the laboratory's Mohs test logs revealed the laboratory performed 186 histopathology slide examinations from 2 /5/2024 to 6/25/2024. 3. The histotechnician confirmed the above findings on 11/17 /2025 at 11:20 am. 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 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 peer review records and interview with the Practice Manager (PM) and Histotechnologist, the laboratory failed to ensure that the verification of accuracy for MOHS micrographic surgery slide examinations was performed at least twice annually in 2022. Findings Include: 1. On the day of survey, 11/28/2023, the laboratory could not provide documentation that the verification of accuracy for MOHS micrographic surgery slide examinations was performed at least twice annually in 2022. 2. The PM and Histotechnologist confirmed the finding above on 11 /28/2023 around 10:24 a.m. 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 --