Arizona Dermatology Specialists, Pllc

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 lack of accuracy verification documentation for the microscopic interpretation of Frozen Biopsy specimens and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the subspecialty of Histopathology at least twice annually during 2024. Findings include: 1. No documentation was presented for review to indicate the laboratory verified the accuracy of the microscopic interpretation of Frozen Biopsy specimens at least twice annually during 2024. 2. The facility personnel interviewed on 8/20/25 at 2:40 PM confirmed the laboratory failed to verify the accuracy of histopathology testing at least twice annually during 2024. 3. The laboratory performed 10 frozen biopsies in 2024. 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 D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review of policies and procedures, lack of test requisition documentation for review and interview with the facility personnel, the laboratory failed to have a written or electronic request for patient testing for two out of two patient records reviewed during the survey. Findings include: 1. The laboratory performs Frozen Biopsies (Sections) in conjunction with the Mohs procedure under the subspecialty of Histopathology. 2. The laboratory's "Frozen Section Procedure" reviewed during the survey states: "All specimens will be accompanied with a pathology requisition completed in the patient room." 3. No written or electronic request for Frozen Biopsy testing was presented for review for two out of two patient records reviewed during the survey (patient ID: FSS22-06 performed on 4/14/22, and patient ID: FSS23-12 performed on 6/15/23). 4. The facility personnel interviewed on 4/11/24 at 10:45 AM confirmed the laboratory failed to have an electronic or written test requisition for the Frozen Biopsies performed on the patients indicated above. 5. The laboratory performs approximately 20 Frozen Biopsies annually. 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 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 -- 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 lack of humidity records for review from 2022, 2023 and 2024, review of the manufacturer's specifications for the Linistat Linear Stainer and interview with the facility personnel, the laboratory failed to monitor and document the humidity of the room where the above instrumentation is utilized. Findings include: 1. The laboratory utilizes the Linistat Linear Stainer in conjunction with Mohs testing under the subspecialty of Histopathology with a reported annual test volume of 2,784. 2. The manufacturer's specifications for the Linistat Linear Stainer reviewed during the survey listed an operating relative humidity range of 0% - 80%. 3. On the survey date of 4/11/2024, no documentation was provided for review to indicate the laboratory monitored and documented the humidity of the room where the above instrumentation is utilized on each day of patient testing during 2022, 2023 and 2024 through the date of the survey. 4. The facility personnel interviewed on 4/11/2024 at 11:10 AM confirmed the laboratory failed to monitor and document the ambient humidity as indicated above. -- 2 of 2 --

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of patient test results maintained in the electronic health record (EHR), review of the laboratory log used to record patient test results and interview with the facility personnel, the laboratory failed to accurately report the Frozen Section Biopsy test result for one patient. Findings include: 1. The laboratory performs dermatopathology testing, including Frozen Section Biopsy testing, under the sub-specialty of Histopathology, with an approximate annual test volume of 8,314. It is the practice of the laboratory to manually document the Frozen Section Biopsy test result onto the laboratory log titled "Frozen Section Biopsy Log" and then to manually enter the test result into the EHR (Electronic Health Record) for each patient tested. The EHR is the final test report destination. 2. Review of the Frozen Section Biopsy diagnosis in the EHR for patient MR# 38802, FSS21-10 performed on 9/16/20 indicated the diagnosis as "Neoplasm of Uncertain Behavior - left shin, medial". 3. During the survey conducted on 12/01/2021, review of the Frozen Section Biopsy Log indicated the Final Diagnosis for the patient indicated above as "SCC" (Squamous Cell Carcinoma). 4. The facility personnel interviewed during the survey confirmed that the correct diagnosis was SCC, based on the subsequent Mohs surgery performed, 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 -- and the diagnosis documented in the EHR was incorrect. 5. No