Skincare Physicians

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the SkinCare Physicians laboratory on 07/28/2026 pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . 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 with the Director of Clinical Operations (DCO) and the Histotechnician on 07/28/2026, the laboratory failed to define and correctly document temperature and humidity conditions for the proper operation of the Leica CM 1520 Cryostat as evidenced by the following: The surveyor reviewed the laboratory's Cryostat Temperature Logs and Lab Humidity Logs for calendar years 2025 and 2026. Findings were: A. The acceptable temperature range for the Cryostat listed on the logs is -23 to -28 degrees Celsius. The review revealed that the recorded temperatures from January 2025 through July 2026 were out of range for 352 out of 369 days when the Cryostat was in use for Mohs testing. B. The acceptable range for Lab Humidity listed on the logs is 30% to 50%. The review revealed that from January 2025 through December 2025 humidity values were not recorded for 230 out of 230 days and that the recorded humidity values from January 2026 through July 2026 were out of range for 81 out of 139 days when the Cryostat was in use for Mohs 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 -- testing. The DCO and the Histotechnician confirmed in an interview on 07/28/2026 at 9:58 A.M. that the recorded temperatures of the Cryostat from January 2025 through July 2026 were out of range for 352 of 369 days and that humidity values from January 2025 through December 2025 were not recorded for 230 out of 230 days and that the recorded humidity values from January 2026 through July 2026 were out of range for 81 out of 139 days when the Cryostat was in use for Mohs testing. The laboratory performs 1054 Histopathology Mohs slide examinations annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Skincare Physicians laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Based on proficiency testing (PT) review and interview with the Histotechnologist on 7/9/21, the laboratory failed to document and maintain a copy of all PT records as evidenced by the following: The surveyor reviewed American Proficiency Institute (API) PT records for calendar years 2019, 2020, and 2021 on 7/9/21. The review revealed that attestation statements provided by API were not signed by the analyst and laboratory director (LD) for the following events: Microbiology KOH Preparations: 2019 Event 2 2020 Events 2 & 3 2021 Event 1 The Histotechnologist confirmed in an interview on 7/9/21 at 10:30 AM that not all attestation statements were signed by the analyst and LD. . D6018 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require