Forefront Dermatology, Sc Dba Skin Center,

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at FOREFRONT DERMATOLOGY, SC DBA SKIN CENTER on April 10, 2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 lack of documentation and interview with the laboratory technician, the laboratory did not maintain records of documentation for the Room Temperature and Humidity for 3 months (October, November and December) in 2023, out of the 24 months (April 2023 to April 2025) reviewed. Findings included: 1- Review of the ROOM TEMPERATURE/HUMIDITY LOG(s) revealed there was no temperature and humidity documented for October, November, and December of 2023. 2- Review of the Laboratory Procedure Manual for Mohs DAILY QUALITY CONTROL stated step "3 TEMPERATURE: ROOM TEMPERATURE, SLIDE OVEN, EMBEDDING CENTER, AND TISSUE PROCESSOR TEMPERATURE RECORDS MUST BE CHECKED DAILY TO ENSURE WITHIN PROPER LIMITS. THESE RECORDS 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 -- MUST BE KEPT FOR TWO YEARS." 3- Interview on 04/10/2025 at approximately 3:10 PM with the lead histology technician stated that the records were disposed of in error during a cleanup at end of 2024. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on July 30, 2019. Roger H Stewart MD PA was found not in compliance with 42 CFR 493, requirements for clinical laboratories. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have a negative control slides for recording the negative reactivity and failed to record the positive and negative reactivity for each for Immunohistochemical (IHC) stains from 7/30/17 to 7 /30/19. Findings: Only the microscopic examination of the IHC slides is performed at the laboratory. Review of patient slides showed that there was no negative control slides for 1 (#2) out of 5 (#1, 2, 3, 4, 5) patient slides reviewed. The laboratory was unable to provide a log showing the evaluation of the positive and negative reactive IHC control slides. The laboratory evaluates the following IHC stains: CK 903 ((34betaE12, High Molecular Weight Cytokeratin Squamous Epithelium Carcinoma IHC stain), Melan-A (Melanocytic IHC stain), S100 (Neural Tissue/Lesion and Melanoma IHC stain), and Sox-10 (Melanoma IHC stain). During an interview on 7 /30/19 at 11:23 AM, the Testing Personnel C confirmed they don't have separate negative control slides for IHC stained slides and that there was no log for recording the reactivity of positive and negative IHC control slides. D5609 HISTOPATHOLOGY 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 -- CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document and maintain a record of the open dates for reagents used in their Hematoxylin & Eosin (H&E), Periodic Acid Schiff (PAS) and Acid- Fast Bacilli (AFB) stains. Findings: Record review of the laboratory's logs titled "Laboratory Reagent Log" and "Laboratory Reagent Log Sheet" showed that the laboratory failed to record when the reagents where opened from 7/30/17 to 7/30/19. During an interview on 7/30/19 at 10:05 AM, the Testing Personnel C confirmed they didn't record the open date for their reagents on the logs. -- 2 of 2 --