Skin Solutions Dermatology

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of reagent logs, final patient test report, laboratory patient test logs, and staff interview, the laboratory failed to ensure that personnel did not use the Hematoxylin stain was not used beyond the manufacturer's expiration date for micrographically oriented histographic surgery (MOHS) histopathology patient testing for 19 days in 2024. The findings include: 1. Observation of the laboratory on 06/24/2025 at 9:30 a.m. revealed a Hematoxylin stain used to process patient tissue specimens for MOHS micrographic procedures. 2. A review of the laboratory's reagent log titled "Mohs Stain Expiration Log" for 2024, reviewed by the laboratory director on 12/30/2024, revealed the following: Hematoxylin lot number 2228732 was opened on 05/01/2023, expired on 01/25/2024, and was empty on 04/02/2024. Hematoxylin Lot number 2324408 was opened on 04 /02/2024. The expired lot 2228732 was used for patient testing from 01/26/2024 through 04/01/2024. 3. A review of final patient test reports revealed that patient number 211264 was reported by the laboratory on 03/21/2024 when the expired Hematoxylin lot number 2228732 was used. 4. A review of the laboratory's patient log titled "Mohs Patient Daily Log" from January 2024 through April 2024 revealed the laboratory tested 89 patient samples from 01/26/2025 through 04/01/2025. 5. An interview with the practice manager on 06/24/2025 at 12:00 p.m. confirmed the survey findings. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory records, patient test results, and staff interview, the laboratory failed to retain analytic system records including hematoxylin and eosin (H and E) stain quality control (QC) logs, daily patient logs, reagent logs, maintenance logs, temperature logs, and quality assurance (QA) for patient comparison records for MOHS testing for a period of two years in 2022 and 2023. The findings include: 1. Review of laboratory records including H and E control logs, daily patient logs, reagent logs, maintenance logs, temperature logs, QA logs (patient comparison with outside pathology) revealed the following: A. Lack of all records from January 2022 through September 2022 (last patient slide 09/08/2022). B. Lack of reagent logs, and maintenance logs, from 02/09/2023 through 04/12/2023. C. Lack of H and E quality control logs from 02/28/2023 through 04/12/2023. 2. Review of patient test results from randomly selected dates revealed MOHS testing was performed on patients in 2022 and 2023 as follows: 04/07/2022 patient MH22-092 05/19/2022 patient MH22- 122 06/16/2022 patient MH22-145 09/08/2022 patient MH22-207 02/09/2023 patient MH23-001 03/02/2023 patient MH23-033 3. Interview on 05/22/2023 at 1:00 pm with the Chief Clinical Officer and laboratory personnel (non-testing) confirmed the laboratory failed to maintain analytic system records for two years in 2022 and 2023. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory records, laboratory policy, and staff interview, the laboratory failed to verify accuracy of the histopathology MOHS testing procedure twice per year in 2022 (one of three years reviewed). The findings include: 1. Review of laboratory records revealed no documentation of verification of accuracy for the histopathology MOHS testing procedure performed in 2022. 2. Review of the laboratory policy titled " Quality Assurance Manual" revealed "Any test performed in the laboratory for which proficiency testing is not available will be verified at least twice a year, and the results will be reviewed by the Laboratory Director." 3. Interview on 05/22/2023 at 1:00 pm with the Chief Clinical Officer and laboratory personnel (non-testing) confirmed the laboratory did not verify the accuracy of histopathology MOHS testing procedure in 2022. D5603 HISTOPATHOLOGY CFR(s): 493.1273(b)(f) (b) The laboratory must retain stained slides, specimen blocks, and tissue remnants as specified in 493.1105. The remnants of tissue specimens must be maintained in a manner that ensures proper preservation of the tissue specimens until the portions submitted for microscopic examination have been examined and a diagnosis made by an individual qualified under 493.1449(b), (l), or (m). (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on random review of histopathology slides and staff interview the laboratory failed to retain stained histopathology daily quality control slides for 10 years (six of seven dates reviewed) for dates when MOHS patient testing was performed in 2021, 2022, and 2023. The findings include: 1. Random review of stained histopathology slides on 05/22/2023 of the following dates revealed daily quality control slides for 2021, 2022, and 2023 were not retained with patient slides. 11/16/2021 patient reported MH21-285 04/07/2022 patient reported MH22-092 05/19/2022 patient reported MH22-122 06/16/2022 patient reported MH22-145 09/08/2022 pateint reported MH22-207 02/09/2023 patient reported MH23-001 2. Interview with the Chief Clinical officer on 05/22/2023 at 1:00 pm confirmed the laboratory failed to retain the stained daily quality control slides for histopathology MOHS testing for 10 years. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review laboratory Quality Assurance (QA) policy, lack of records available, and staff interview, the laboratory failed to follow it's own QA policy in 2021, 2022, -- 2 of 3 -- and 2023 (19 of 21 total months reviewed) when patient testing for MOHS procedures were performed. The findings include: 1. Review of the laboratory policy titled "Quality Assurance Manual" revealed the following; "The Laboratory Director reviews quality control charts and logs on at least a monthly basis." "Any test performed in the laboratory for which proficiency testing is not available will be verified at least twice a year, and the results will be reviewed by the Laboratory Director." "...all quality assurance records be maintained for a period of two years.." 2. Request on 05/22/2023 for QA records revealed the documents were not available for 2021 (May through December), 2022 (January through September), February 2023, and March 2023. 3. Interview on 05/22/2023 at 1:00 pm with the Chief Clinical Officer and laboratory personnel (non-testing) confirmed the laboratory failed to follow it's own policy for Quality Assurance in 2021, 2022, and 2023. -- 3 of 3 --