Chicago Cosmetic Surgery & Dermatology

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 laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory representative (LR), the laboratory failed to perform Mohs bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for two of two events in 2024. Findings include: 1. Review of laboratory policies and procedures revealed the policy, "Protocol For Proficiency Testing (PT) or Method Accuracy Verification (MAV) for Unregulated Testing, as in the case for Mohs", which stated under the section "Proficiency Testing Procedures", "Twice yearly the dermatologist will examine approximately ten unknown pathology slides chose from a group of slides by the dermatologist or dermatopathologist and the test results scored". 2. Review of laboratory records and lack of documentation revealed no Mohs bi-annual method accuracy for two of two events in 2024. Event PT performed Event 1- 2024 No Event 2- 2024 No 3. Interview with the LR on 09/16/2025, at 1:01 pm, confirmed the laboratory failed to perform Mohs bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for two of two events in 2024. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: 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 -- Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory representative (LR), the laboratory failed to document evaluation of results for Mohs bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for one of one event in 2025. Findings include: 1. Review of laboratory policies and procedures revealed the policy, "Proficiency Testing Protocol", which stated under "Policy", "Quality assessment forms must be filled out and reviewed by the Medical Director upon receipt". 2. Review of laboratory records revealed a lack of documentation of review by the Medical Director for one of one Mohs histopathology bi-annual method accuracy event performed in 2025. 3. Interview with the LR on 09/16/2025, at 4:40 pm, confirmed the laboratory failed to document evaluation of results for Mohs bi- annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for one of one event in 2025. -- 2 of 2 --

Summary Statement of Deficiencies D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and an interview with the laboratory staff, the laboratory failed to document each lot number of commercially prepared reagents and stains, when opened, to perform Hematoxylin and Eosin (H&E) staining procedures. Findings include: 1. The laboratory procedures manual, patients test logs, and "Got Mohs" quality control (QC) and maintenance logs for the years of 2018 and 2019 were reviewed. 2. The "Got Mohs" and patients' test logs revealed the following: *Seven (7) Mohs procedures dates were selected for QC and maintenance logs review: 01/09/2018; 04/13/2018; 08/17/2018; 12/07/2018; 02/15/2019; 06/21/2019; and 09/20/2019. *The QC logs failed to include the documenting of the reagents and stains it brings to the laboratory for tissue processing for the above dates. 3. The laboratory failed to ensure the travel Mohs service provided the laboratory with the list of reagents, their lot numbers and expiration dates, when brought by the TP into the laboratory, to perform H & E staining. 4. On an Recertification survey conducted on 11/07/2019 at 1:50 PM, the laboratory staff confirmed the above findings. 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 --