Forefront Dermatology, S C

Summary Statement of Deficiencies D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: . Based on observation and interview with dermatology personnel #1 and #2, the laboratory failed to ensure histopathology tissue slides were coverslipped to ensure tissue preservation for nine (Patients 1-9) of 10 patient cases reviewed. Findings include: 1. A review of 10 patient cases revealed the following nine cases had slides with significant bubbling over the stained tissue sections: a. Patient 1 had histopathology testing performed on 02/13/2025. b. Patient 2 had histopathology testing performed on 12/04/2024. c. Patient 3 had histopathology testing performed on 09/19/2024. d. Patient 4 had histopathology testing performed on 09/19/2024. e. Patient 5 had histopathology testing performed on 06/20/2024. f. Patient 6 had histopathology testing performed on 04/17/2024. g. Patient 7 had histopathology testing performed on 01/25/2024. h. Patient 8 had histopathology testing performed on 10/10/2023. i. Patient 9 had histopathology testing performed on 04/18/2023. 2. An interview on 3/10/25 at 2:00 pm with dermatology personnel #1 and #2 confirmed the slides had significant bubbling over tissue sections. 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 D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with the Regional Clinic Manager, the laboratory failed to perform and document the room temperature and humidity readings each day of patient testing for 8 (January - July in 2019) of 24 months reviewed for the proper operation of the Leica CM 1520 Cryostat. Findings include: 1. Record review of the cryostat log for the room temperature and humidity readings revealed a lack of documentation for 8 months in 2019. 2. On July 22, 2019 at approximately 11:00 AM when interviewed, the Regional Clinic Manager confirmed the room temperature and humidity readings for January - July in 2019 were not performed and documented. ***Repeat Deficiency from 1/17/2017 survey*** 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 --