Sanctuary Medical Aesthetic Center Of Boca Raton

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Sanctuary Medical Aesthetics Center of Boca Raton LLC on December 1, 2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited is as follows: 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. This STANDARD is not met as evidenced by: Based on review of the procedure manual, record review, and interview, the laboratory failed to document the acceptability of the Hematoxylin and Eosin (H&E) control slide for one day (07/12/2024) of the quality control (QC) worksheets reviewed from 01/04/2024 to 12/01/2025. Findings: 1. Review of the policy titled, Policy for Recording Daily Quality Control noted the quality control form is used to document and record "2. Modified H&E Stain Quality Control Slide." 2. Review of Daily QC Worksheet form showed the Mohs surgeon failed to document the acceptability of the H&E stain by checking the acceptability of the stain 07/12/2024. 3. Review of the Mohs Log showed there were 5 Mohs surgical procedure on 07/12 /2024. 4. During an interview on 12/01/2025 at 12:48 PM, the Risk Manager acknowledged the acceptability of the quality control slide was not checked by the Mohs surgeon on 07/12/2024. 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 January 3, 2024. Sanctuary Medical Aesthetic Center of Boca Raton clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of quality control (QC) and Mohs logs, and interview, the laboratory failed to maintain documentation of the H&E stain acceptability, stain maintenance, changing and rotation of reagents, cryostat temperature and maintenance, room temperature and humidity, and microscope maintenance for 5 (04/29/2022, 05/20 /2022, 02/24/2023, 03/10/2023, 03/14/2023) of 22 days (11/12/2021, 01/14/2022, 02 /18/2022, 03/25/2022, 04/29/2022, 05/20/2022, 06/24/2022, 07/29/2022, 09/23/2022, 10/28/2022, 02/17/2023, 02/24/2023, 03/10/2023, 03/14/2023, 05/05/2023, 06/02 /2023, 07/07/2023, 08/04/2023, 09/08/2023, 10/06/2023, 11/03/2023, 12/11/2023) Mohs surgical procedures were performed. Findings: The laboratory recorded the H&E stain acceptability, stain maintenance, changing and rotation of reagents, cryostat temperature and maintenance, room temperature and humidity, and microscope maintenance on their Daily QC Worksheet. Review of the Mohs Log listing the Mohs surgical procedures performed showed on 04/29/2022 there were six procedures, on 05/20/2022 there were nine procedures, on 02/24/2023 there were seven procedures, on 03/10/2023 there were two procedures, and on 03/14/2023 there were three procedures. Review of the Daily QC Worksheet showed worksheets for 04 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 -- /29/2022, 05/20/2022, 02/24/2023, 03/10/2023, and 03/14/2023 were missing. On 01 /03/2024 at 2:12 PM, the Mohs Tech stated he did not know where the missing worksheets were located. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the laboratory's test reports and interview, the laboratory failed to have the full address of the laboratory for three of three patients, (#1, #2, #3) on the laboratory's patient reports (surgical notes). Findings: Review of the surgical notes for patient's #1, #2, and #3, showed the address of the laboratory was not listed on the notes. On 01/03/2024 at 3:42 PM, the Medical Assistant stated they give the surgical notes to patients, if requested. The Medical Assistant acknowledged the address of the laboratory was not listed on the notes. -- 2 of 2 --