Aqua Dermatology Of Florida Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Aqua Dermatology of Florida dba Coastal Dermatology on 4/8/26. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: 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 observation, record review, and interview, the laboratory failed to monitor and document two of two cryostat temperatures for Histopathology testing. Finding included: 1. On 4/8/26 at 11:05 a.m. two cryostat (serial numbers 02.1999 and 04.2006) used for Histopathology testing were observed powered up in the laboratory with signage to not turn off the instruments. 2. The MOHS Manual was last reviewed by the Laboratory Director on 1/5/26. The MOHS Manual included a MOHS Cryotomy Procedure which directed under Quality Control #2-cryostat temperature to be between -20 to -30 degrees Celsius to be checked and logged every day of testing. 3. Three of three months (3/2026, 10/2025, and 7/2024) of Daily QC (Quality Control) worksheets reviewed included space to document temperature for one cryostat, there was no indication of which of two cryostats temperature was 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 -- documented daily. 4. The Clinical Supervisor on 4/8/2026 at 12:05 p.m. verified the laboratory used both cryostats but did not have documentation of monitoring temperatures for both each day used for testing. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the laboratory failed to document employee competency for 2 (Testing Person #B and #C) out of 3 testing people (#A, #B, and #C) reviewed for 2 out of 2 years (2016-2017) reviewed. Findings Included: Review of employee competency evaluations revealed Testing Person #B and #C did not have any competency evaluations. During an interview on 01/31/18 at 1:46 PM the Office Manager confirmed that there were no competency evaluations performed on Testing Person #B and #C. 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 record review and interview with the Office Manager, the laboratory failed 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 -- to record the room temperature and humidity in the laboratory for 2 out of 2 (2016- 2017) years. Findings Included: Review of temperature charts revealed no room temperature or humidity recorded in 2016 and 2017. During an interview on 01/31/18 at 1:20 PM the Office Manager confirmed that the room temperature and humidity in the laboratory was not recorded. -- 2 of 2 --