Azalea Skin Treatment Center

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 review of the Avantik Q12 Cryostat instruction manual, review of 2022, 2023, and 2024 laboratory records, and interviews with the clinical supervisor and office manager on 2/22/2024, the laboratory failed to define an appropriate humidity range consistent with the manufacturer's instructions and monitor the humidity to ensure reliable test system operation. Findings: Review of the Avantik Q12 Cryostat instruction manual revealed in "Chapter 2: Environmental Specifications" that relative humidity cannot exceed 60%. Review of laboratory records revealed no documentation of humidity readings for 2022, 2023, and 2024. In interview at approximately 11:47 a.m., the clinical supervisor and office manager stated the following: 1. The clinical supervisor confirmed that humidity levels are not monitored or recorded in the laboratory. 2. The office manager stated that the laboratory was not aware of this requirement. 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 D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory procedure, review of 2017, 2018 and 2019 quality control (QC) logs, and review of 2017, 2018 and 2019 Mohs surgery patient logs 7/9 /19, revealed the laboratory failed to document quality control of the Hematoxlin and Eosin (H&E) staining performed by the laboratory. Review of laboratory procedure "Stain Maintenance" revealed, "10. A QC work sheet is documented daily on the stain quality and any corrections or changes made." Review of H&E "Quality Control Staining" logs and review of Mohs surgery patient logs revealed the laboratory failed to document H&E quality control on 11 days from 12/21/17 through 4/17/19. Approximately 87 patients were affected. The dates and number of patients are as follows: 1. 12/21/17 - 6 patients 2. 3/1/18 - 16 patients 3. 5/10/18 - 8 patients 4. 5/17 /18 - 8 patients 5. 5/30/18 - 7 patients 6. 6/7/18 - 6 patients 7. 8/22/18 - 7 patients 8. 8 /23/18 - 7 patients 9. 1/31/19 - 7 patients 10. 2/7/19 - 7 patients 11. 4/17/19 - 8 patients 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 --