Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Aqua Dermatology of Florida on 9/17/2026. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain the laboratory assigned specimen identification number consistently through completion of testing and reporting of results for 1 of 3 Mohs cases reviewed (Patient #2), when the Mohs case number documented on the surgical map and final report did not correspond with the case number assigned in the specimen accession log and documented on the corresponding tissue slides. Findings include: 1. On 09/17/2026, review of the laboratory records for Patient #2 showed inconsistent Mohs case numbers among the specimen accession log, corresponding tissue slides, Mohs surgical map, and final report documentation. Review of the "Mohs Frozen Specimen Log" showed Patient #2's specimen was accessioned as Mohs Case #26-642 Review of the tissue slides showed the slides were labeled #26-642, consistent with the accession log. Review of the corresponding Mohs surgical map showed the case as Mohs Case #26-692 Review of Patient #2's Mohs final report showed Mohs Case Number: 26-692 Further review of the Mohs Frozen Specimen Log showed that case #26-692 had not been assigned or accessioned in the laboratory log. 2. During an interview on 09/17/2026 at 9:30 AM, Staff #A (Mohs Technician) confirmed that the specimen was assigned case #26-642 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 -- in the accession log, and that the #26-692 documented on the Mohs surgical map and final report was not the assigned case number for the specimen. Staff #A further confirmed that case #26-692 had not been assigned to another specimen. . 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 record review and interview, the laboratory failed to document the cryostat operating temperature, room temperature, and humidity for the Mohs testing area on 1 of 60 days reviewed (12/12/2025) when patient testing was performed. Findings include: 1. Review of the laboratory's document titled "Cryostat Temperature log" showed no documented cryostat operating temperature on 12/12/2025. 2. Review of the laboratory's document titled "Laboratory Ambient Temperature Log and Humidity Log" showed room temperature and humidity was not documented on 12/12/2025. 3. Review of the laboratory document titled "Mohs Frozen Specimen Log" showed 21 patients were tested that day. 4. During an interview on 9/17/2026 at 9:30 AM, Staff #A confirmed that temperatures were not documented. . D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers 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 record review and interview, the laboratory failed to document the daily Hematoxylin and Eosin (H&E) stain quality control (QC) review for Mohs patient testing for 1 (12/12/2025) out of 60 patient testing days reviewed. Findings include: 1. On 09/17/2026, review of the laboratory's "Histology H&E Quality Control" log showed no entry for 12/12/2025 documenting the daily H&E quality control check or the acceptability of the stain. Review of the laboratory's Mohs accession log showed that 21 Mohs patient cases were tested on 12/12/2025. 2. During an interview on 09/17 /2026 at 9:30 AM, Staff #A (Mohs Technician) confirmed that the staining quality control review was not documented on 12/12/2025 and verified that quality control checks must be recorded for each day of patient testing. . -- 2 of 2 --