Alabama Dermatology And Skin Specialists, Llc

Summary Statement of Deficiencies 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 a review of the temperature records, the Avantik QS12 cryostat user manual, and an interview with the Laboratory Director, the Laboratory failed to document humidity for the Avantik cryostat. This was noted for 10 months of 14 months reviewed from 2024 through 2025. The findings include: 1. A review of the temperature records revealed the laboratory failed to document humidity for the Avantik cryostat from May 2024 through February 2025. 2. A further review of the Avantik QS12 user manual page 14 revealed, "Relative Humidity: Max 60% RH..." 3. During an interview on March 28th, 2023, at 7:37 AM, the Laboratory Director did not realize that humidity was not documented with the room temperature. 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 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 accuracy verification ("Proficiency Testing") records and an interview with the Histotechnologist, the surveyor determined the laboratory failed to document accuracy verification of the results for Histopathology on MOHS Surgical procedures with the outside Dermatopathologist's findings on one of one 2022 events reviewed. The findings include: 1. A review of the accuracy verification ("Proficiency Testing") records revealed the laboratory sent Histopathology slides from four MOHS Surgical cases to a Dermatopathologist in New York City on December 21st 2022. The outside pathologist recorded his findings on the form with his signature and date, 1/23/23; however, there was no evidence the Laboratory Director had compared and attached the in-house results to the form with the pathologist's findings, with review documenting there were no discrepancies. 2. A review of the policy, "PROFICIENCY TESTING MOHS MICROGRAPHIC SURGERY SKIN SPECIMENS" revealed, "... Upon receipt of the pathology report from the Dermatopathologist, diagnosis of the slide specimen will be matched to the in-house diagnosis by the physician. If the diagnoses match, the reports are attached and placed in "Proficiency Testing"...". There was no evidence the laboratory had followed the policy to ensure the in-house results matched. 3. During an interview on 2/23/2023 at 10:45 AM, the Histotechnologist confirmed the above noted findings. . D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring 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 -- that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of the personnel files and an interview with the Histotechnologist, the surveyor determined the Technical Supervisor (also the Laboratory Director) failed to document on-site training and initial competency for Testing Personnel #1 (the Histotechnologist) before she began grossing and processing patient specimens in August 2022. This affected one of two testing personnel listed on the Form CMS-209 (Laboratory Personnel Report). The findings include: 1. A review of the personnel files revealed no documentation of on-site training and initial competency for Testing Personnel #1 (the Histotechnologist) before she began grossing and processing patient specimens in August 2022. 2. During an interview on 2/23/2023 at 9:15 AM, the Histotechnologist confirmed the above noted findings. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 2 of 2 --