Dermatology Southeast - Sunbeam

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Southside Dermatology Pa on 9/16/2026. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 record review and interview, the laboratory failed to verify the accuracy of Mohs histopathology testing at least twice annually for the calendar years 2024 and 2025. Findings include: 1. On 9/16/2026, review of the laboratory's peer review documentation showed one accuracy verification in 2024, dated 7/10/2024, and one in 2025, dated 9/29/2025. The record showed no second accuracy verification for either calendar year. 2. During the interview on 9/16/2026 at 3:00 PM, Staff #A (Mohs Technician) confirmed that peer review was not performed twice annually. 3. The facility policy titled "Proficiency Testing Mohs Micrographic Surgery Skin Specimens" 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 out for a microscopic examination by a Board Certified Dermatopathologist." 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 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 -- 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 record review and interview, the laboratory failed to document the cryostat operating temperature, room temperature, and relative humidity for the Mohs testing area on 1 of 26 days reviewed (10/27/2025) when patient testing was performed. Findings include: 1. Review of the laboratory's log titled "Hematoxylin & Eosin Quality Control & Maintenance Linistat Linear Stainer" showed no documented cryostat operating temperature, room temperature, or relative humidity on 10/27/2025. Review of the laboratory's Mohs accession log showed that 7 patient specimens were processed in the Mohs laboratory on that date. 2. During an interview on 9/16/2026 at 3:00 PM, Staff #A confirmed that temperatures were not documented. -- 2 of 2 --

Summary Statement of Deficiencies D0000 At the time of the announced, on-site recertification survey, Southside Dermatology was found to NOT be in compliance with the CLIA laboratory requirements of 42 CFR 493. . 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 record review and staff interview, the laboratory failed to verify the accuracy of KOH (potassium hydroxide) testing at least twice a year for 2 of 2 (2019 - 2020) years reviewed. Findings Included: Review of peer review records showed no documentation of twice annual verification of KOH testing. Interview with the Laboratory Director on 12/16/20 at 10:00am confirmed that no peer review was performed for KOH during the 2 year period (2019-2020) when patient testing was performed. 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 A recertification survey was conducted on November 1, 2018. Southside Dermatology clinical laboratory had one deficiency found at the time of the visit. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 record review and interview, it was determined that the humidity of the laboratory room to assure optimal operating conditions of the histopath equipments was not checked daily for 2 of the 2 years documents reviewed. Findings included: Review of the laboratory's procedure and logbook indicated that the humidty of the room needed to be recorded daily with a normal range of less than 60 %. There was no humidity record found on the logbook for 2 years from November 2016 to 2018. Interview on 11/1/18 at 11:30 AM, testing person # 1 confirmed that the humidity of the laboratory room was not checked and recorded daily. 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 --