Arizona Dermatology

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 Mohs 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 2023 and 2024. Findings include: 1. No documentation was presented for review to indicate the laboratory verified the accuracy of dermatopathology testing (performed in conjunction with the Mohs procedure) at least twice annually during 2023 and 2024. 2. The facility personnel interviewed on 1/14/25 at 11:45 AM confirmed the laboratory failed to verify the accuracy of dermatopathology testing at least twice annually during 2023 and 2024. 3. The laboratory's reported annual test volume in the subspecialty of histopathology is 704. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) documentation from 2023 and 2024 and interview with the facility personnel, the laboratory failed to follow established 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 -- policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493. 1291. Findings include: 1. Patient-specific data and the final test result information for Mohs is manually transcribed by laboratory personnel into the patient's Electronic Health Record (EHR). 2. The facility personnel interviewed on January 14, 2025 at 12: 00 PM stated that it is the practice of the laboratory to perform a "Quality Assurance Laboratory Mohs Audit" on at least 2 cases, twice annually, per Mohs physician. 3. No documentation from 2023 and 2024 was presented for review to indicate the laboratory followed the policy referenced above to ensure patient test results and patient-specific data were accurately and reliably transcribed into the patient's EHR. 4. The facility personnel interviewed on 1/14/25 at 12:00 PM confirmed the laboratory failed to perform a postanalytic QA audit for each physician on at least 2 cases twice annually during 2023 and 2024. 5. The laboratory performs a reported 704 tests annually under the subspecialty of Histopathology. The laboratory listed 3 physicians on the CMS-209, Laboratory Personnel Form presented for review during the survey who perform the Mohs procedure. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of established Quality Assessment policies and procedures and interview with the facility personnel, the laboratory failed to establish policies and procedures related to accuracy verification for histopathology testing performed by the laboratory. Findings include: 1. The laboratory performs the reading and diagnosis of Mohs specimens under the sub-specialty of Histopathology, with an approximate annual test volume of 500. 2. No documentation was presented for review during the survey to indicate the laboratory established policies and procedures related to the verification of accuracy process for the testing indicated above, including but not limited to, information specific to the frequency of the review, number of cases reviewed, individual or laboratory performing the review and a remedial action plan in the event of a noted discrepancy. 3. The facilty personnel interviewed during the survey on March 27, 2023 at approximately 1:50pm confirmed that the laboratory failed to have an established written policy specific to the verification of accuracy process for Mohs interpretations performed by the 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 --