Aqua Dermatology Of Alabama Pc

Summary Statement of Deficiencies 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 a review of the Bi-Annual Quality Control (QC) Peer Review (PR) Proficiency Testing (PT) records, the Policy and Procedure Manual and an interview with the MOHS Laboratory Supervisor (LS), the laboratory failed to submit one of the two Bi-Annual QC PR PT due in 2024, as per laboratory policy. The findings include: 1. A review of the 2024 Bi-Annual QC PR PT records revealed no documentation of MOHS surgery accuracy verification the first six months of 2024. 2. A review of the PT Procedure revealed twice per year the laboratory will submit 1-2 cases per surgeon per location to Derm Pathology for accuracy verification of the MOHS surgeon's diagnoses. 3. The MOHS LS confirmed the above findings during the exit conference on 11-12-2025 at 11:59 PM. 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 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 a review of the Leica CM 1800 cryostat Operator's Manuals, a lack of room temperature and room humidity records, and an interview with the Histotechnician, the laboratory failed to monitor and document room temperature and humidity to ensure the Cryostat was operated within the environmental parameters specified by the manufacturer. The findings include: 1. A review of Leica CM 1800 cryostat Operator's Manual stated "Operating temperature range (ambient temperature): 18 degrees C to 40 degrees C. All specifications related to temperature are valid only up to an ambient temperature of 22 degrees C and an air humidity lower than 60%." 2. During an interview conducted on 12/03/2021 at 10:45 AM, the Histotechnician confirmed that the laboratory had not monitored and documented room temperature and humidity for this laboratory. 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 --