Pennsylvania Dermatology Specialists

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 laboratory records and interview with the Clinical Administrator (CA), the laboratory failed to monitor and document room temperature and humidity to ensure operating conditions were met for 1 of 1 Olympus BX41 Microscope used to perform dermatopathology slide examinations from 02/19/2025 to date of survey. Findings Include: 1. The operating environment listed in the manual for Olympus BX41 model microscopes stated: "ambient temperature 5 to 40 degree Celsius and Maximum relative humidity is 80% for temperature to 31 degrees Celsius." 2. On the date of the survey, 07/31/2026 at 08:40 am, the laboratory failed to provide documentation for monitoring room temperatures (acceptable range: 5-40 degrees Celsius) and humidity (acceptable ranges up to 80%) to ensure operating conditions were met for 1 of 1 Olympus BX41 microscope used for dermatopathology slide examinations from 02/19/2025 to 07/31/2026. 3. The laboratory performed 1500 dermtopathology examinations in 2025 (CMS 116, estimated annual volume dated 06 /26/2026). 4. The CA confirmed the findings above on 07/31/2026 at 08:50 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 the laboratory's Proficiency Testing policy, lack of documentation and interview with Testing Personnel #2 (TP#2), the laboratory failed to verify at least twice annually the accuracy of microscopic histopathology examinations performed for 2 of 2 years in 2023 and 2024. Findings: 1. The laboratory's Proficiency Testing policy states "semi-annually, the tech or Risk Manager will send two cases containing the original slides, label it with only the surgical case number, and send it our for a microscopic examination by a Board Certified Pathologist." 2. On the day of survey, 02/19/2025 at 10:00am, the laboratory failed to provide documentation for the verification of accuracy performed at least twice annually for microscopic histopathology examinations performed in 2023 and 2024. 3. The laboratory performed 1550 microscopic histopathology examinations in 2023. 4. The laboratory performed 1204 microscopic histopathology examinations in 2024. 5. TP#2 confirmed the above findings on 02/19/2025 at 10:09 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 --