Brevard Skin & Cancer Center

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Brevard Skin and Cancer Center on August 5, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: 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 Mycology and Parasitology testing twice annually from 09/03/2024 to 08/05/2026. Findings Included: 1. Review of the Clinical Laboratory Improvement Amendments application, signed and dated on 08/05/2026 by the Laboratory Directory, noted the addition of the specialties of Mycology and Parasitology effective date was 09/03 /2024. 2. Review of the Laboratory Personnel Report, signed and dated on 08/05/2026 by the Laboratory Directory revealed Testing Personnel E - H performed moderate level KOH (Potassium Hydroxide) Testing. 3. Review of proficiency testing documentation revealed there was no documentation of proficiency testing for Mycology and Parasitology. 4. During an interview on 08/05/2026 at 4:58 PM, the Mohs Technician revealed, they thought the KOH testing was a waived test, and no proficiency testing was done. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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) and Special stains control slide for two days (02/17/2025, 04/04/2025) from 08/06 /2024 to 08/05/2026, and the laboratory failed to record the acceptability of the immunohistochemistry (IHC) slides from 08/01/2024 to 07/23/2026 Findings: A1. Review of the Histology Stains - Quality Control log revealed, it was used to document the acceptability of H&E stain and special stains. The log was not filled out indicating the control slides were acceptable and were not signed by the Laboratory Director on 02/17/2025 and 04/04/2025. A2. During an interview on 08/05/2026 at 2: 54 PM, the Mohs Technologist acknowledged the log was not filled out and signed on 02/17/2025 and 04/04/2025. B1. Review of the IHC/Special Stain Log showed the Laboratory Director failed to document the acceptability of the negative control IHC stained control slides form 08/01/2024 to 07/23/2026. B2. During an interview on 08 /05/2026 at 4:40 PM, the Mohs Technologist acknowledged the acceptability of the negative IHC control slides was not documented. D5805 TEST REPORT CFR(s): 493.1291(c) (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 histopathology reports and interview, the laboratory failed to list where the immunohistochemical (IHC) stains were performed for three (#1 - #3) of four (#1 - #4) patient reports with IHC stained slides reviewed. Finding Included: 1. Review of histopathology final reports showed patient reports listed results for the following IHC stains: 1A. Patient #1 - S100 (Neural Tissue/Lesion and Melanoma IHC stain), Melan-A (Melanocytic Marker IHC stain), and PRAME (Melanoma IHC stain). 1B. Patient #2 - S100, Melan-A, AE1/AE3 (Epithelial IHC stain), CK 5/6 (Cytokeratin 5/6 IHC stain), Desmin (Smooth Muscle Tumor IHC stain), and ERG (Endothelium; TMPRSS2-ERG IHC stain). 1C. Patient #3 - S100, Melan-A, and PRAME. 2. Review of the histopathology reports revealed the reports failed to list the name and address of the laboratory where the IHC staining was performed. 3. During an interview on 08/05/2026 at 4:00 PM, the Mohs Technician stated the laboratory stopped performing the staining of the IHC slides in mid September 2025. 4. During an interview on 08/05/2026 at 4:23 PM, the Mohs Technician acknowledged the name and address of the laboratory where the IHC staining was performed was not listed on the histopathology final report. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to evaluate the competency of four (E - H) of eight (A - H) Testing Personnel performing Mycology and Parasitology testing from 09/03/202 to 08/05/2026. Findings Included: 1. Review of the Clinical Laboratory Improvement Amendments application, signed and dated on 08/05/2026 by the Laboratory Directory, noted the addition of the specialties of Mycology and Parasitology effective date was 09/03/2024. 2. Review of the Laboratory Personnel Report, signed and dated on 08/05/2026 by the Laboratory Directory revealed Testing Personnel E - H performed moderate level KOH (Potassium Hydroxide) Testing. 3. Review of personnel documents revealed there was no documentation of competency evaluations on the personnel performing KOH testing. 4. During an interview on 08/05/2026 at 4:58 PM, the Mohs Technician revealed, they thought the KOH testing was a waived test, and no competency evaluation were done. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on April 12, 2022. Brevard Skin and Cancer Center 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 record review, and interview, the laboratory failed to retain quality control documents for nine (July, August, September, October, and November 2020, and February, March, April and May 2021) of 25 (April 2020 to April 2022) months reviewed. Findings: Review of the laboratory's quality control documents revealed the laboratory's "Reagent Control Sheet" for 07/1/2020 to 11/30/2020 and 02/01/2021 to 05/31/2021 were not available. On 04/12/2022 at 1:24 PM, the Laboratory Assistant stated she did not know where the logs were located. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing 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 2 -- This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the laboratory's quality assessment program failed to monitor and evaluate the overall quality of the analytic system and identify problems. Findings: Cross Reference D5433. Based on record review and interview, the laboratory failed to document all maintenance activities for 4 (September 2020, March 2021, July 2021, January 2022) of 5 months (September 2020, January 2021, March 2021, July 2021, January 2022) reviewed. This is a repeat deficiency from the recertification survey on 06/17/2020. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to document all maintenance activities for 4 (September 2020, March 2021, July 2021, January 2022) of 5 months (September 2020, January 2021, March 2021, July 2021, January 2022) reviewed. This is a repeat deficiency from the recertification survey on 06/17/2020. Findings: Review of the "Hematoxylin and Eosin Quality Control," the "Quality Control Maintenance Checklist," and "Monthly Log" showed that not all days in which testing was performed were documented. Review of the Frozen Section Worksheet" listed the dates and the patients who had Mohs surgical procedure. Documentation on the "Hematoxylin and Eosin Daily Maintenance" log was missing for the following dates when patient testing was performed: 09/01/2020 - 6 patients 03 /09/2021 - 9 patients 03/18/2021 - 6 patients 01/06/2021 - 10 patients Documentation on the "Quality Control Maintenance Checklist" log was missing for the following dates when patient testing was performed: 09/01/2020 - 6 patients 03/11/2021 - 10 patients 03/18/2021 - 6 patients 01/04/2021 - 9 patients 01/06/2021 - 10 patients 01/07 /2021 - 5 patients 01/11/2021 - 9 patients 01/13/2021 - 9 patients 01/16/2021 - 7 patients 01/18/2021 - 9 patients Documentation on the "Monthly Log" used to record temperature and humidity of the Mohs laboratory was missing for the following dates when patient testing was performed: 09/01/2020 - 6 patients 03/02/2021 - 10 patients 03/18/2021 - 6 patients 03/23/2021 - 10 patients 03/25/2021 - 9 patients 07/27/2021 - 12 patients 07/30/2021 - 6 patients On 04/12/2022 at 12:00 PM, the Office Manager acknowledged some of the documentation was not completed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on June 17, 2020. Brevard Skin & Cancer Center clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document all maintenance activities from 6/17/18 to 6/17/20. Review of the "Hematoxylin and Eosin Daily Maintenance" and "Quality Control Maintenance Checklist" showed that not all days in which testing was performed were documented. Documentation on the "Hematoxylin and Eosin Daily Maintenance" log was missing for the following dates that patient testing was performed: 6/26/18 - 7 patients 8/16/18 - 5 patients 3/29/19 - 8 patients 4/2/19 - 5 patients 4/4/19 - 6 patients 4/5/19 - 7 patients 4/9/19 - 6 patients 4 /25/19 - 5 patients 4/26/19 - 5 patients 4/30/19 - 5 patients 7/31/19 - 6 patients 3/5/20 - 7 patients 3/10/20 - 7 patients Documentation on the "Quality Control Maintenance Checklist" log was missing for the following dates that patient testing was performed: 4/2/19 - 5 patients 4/4/19 - 6 patients 4/5/19 - 7 patients 4/9/19 - 6 patients 4/11/19 - 8 patients 4/12/19 - 6 patients 4/16/19 - 6 patients 4/18/19 - 4 patients 4/23/19 - 6 patients 4/25/19 - 5 patients 4/26/19 - 5 patients 4/30/19 - 5 patients 5/28/19 - 5 patients 9/10/19 - 9 patients 11/14/19 - 9 patients 4/3/20 - 5 patients 4/24/20 - 6 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 -- patients During an interview on 6/17/20 at 12:00 PM, the General Supervisor stated that some of the maintenance was not recorded. -- 2 of 2 --

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory quality assessment program failed to establish and follow a written policy to identify discrepancies in their patient logs, Mohs maps and operative reports. Findings: Review of the laboratories "Monthly Quality Assurance Checklist" did not include any evidence that a review of patient reports were conducted from April 4, 2016 to April 4, 2018. Review of the "Frozen Section Worksheet", "Mohs Map" and "Mohs Operative Report" showed that one out of five Mohs patients that were reviewed the diagnosis for the patient was inconsistent. The "Frozen Section Worksheet" listed the diagnosis of SCC (Squamous Cell Carcinoma) for Mohs patient #1. The "Mohs Map" listed the tumor type as SCC for Mohs patient #1. The "Mohs Operative Report" listed the "Pre-operative Diagnosis" and "Post-operative Diagnosis" as BCC (Basal Cell Carcinoma) for Mohs patient #1. During an interview on 4/04/18 at approximately 4:30 PM, the Supervisor acknowledged that the diagnosis was not the same on all three forms and that they were not currently monitoring patient reports for errors. 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 --