Arizona Skin Buckeye

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) (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 final test result information for Mohs maintained in the Electronic Health Record (EHR) and interview with the facility personnel on November 19, 2025 at 10:22 AM, the laboratory failed to accurately report Mohs test site information in the patient's EHR for one out of four patient records reviewed during the survey. Findings include: 1. Patient-specific data and the final test result information for Mohs is manually transcribed by laboratory personnel into the patient's EHR. 2. One out of four Mohs cases reviewed (# S85-2025) failed to include the correct test site for Mohs in the patient's EHR. The Mohs test result information maintained in the EHR stated, "Location: left inferior central malar cheek." The Mohs map, patient's slides, original pathology report and the laboratory's Mohs log list the site as "right lateral malar cheek". 3. The facility personnel interviewed on 11/19/25 at 10:22 AM acknowledged the site information was incorrectly entered into the EHR by laboratory staff and confirmed that the correct site was the right lateral malar cheek for the Mohs case referenced above. 4. The laboratory performs testing in the subspecialty of Histopathology with a reported annual test volume of 360. 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 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 2022 and 2023. Findings include: 1. The laboratory began Mohs testing under the subspecialty of Histopathology on 6/17/21, with an annual reported test volume of 360. 2. No documentation was presented for review to indicate the laboratory verified the accuracy of the microscopic interpretation (reading/diagnosis) of Mohs specimens at least twice annually from 6/17/2021 through the date of the survey conducted on 12/06 /23. 3. The facility personnel interviewed on 12/06/23 at 11:05 AM confirmed the laboratory failed to verify the accuracy of Mohs testing at least twice annually since patient testing began. 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 lack of established Quality Assessment (QA) policies and procedures for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- review and interview with the facility personnel, the laboratory failed to establish QA policies and procedures for the general laboratory systems, including but not limited to, policies and procedures related to the accuracy verification process for dermatopathology testing performed by the laboratory. Findings include: 1. The laboratory performs the microscopic interpretation (reading/diagnosis) of dermatopathology specimens which are read during the Mohs procedure. 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 Mohs testing, 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 12/06/23 at 11:05 AM confirmed the laboratory failed to establish a written policy and procedure specific to the verification of accuracy process for the microscopic interpretation of Mohs specimens. 4. The laboratory's annual test volume is 360. 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 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 temperature records for review, lack of established temperature and humidity criteria defined by the laboratory and interview with the facility personnel, the laboratory failed to define criteria for the room temperature and humidity of the area where Mohs testing is performed and failed to monitor and document the room temperature and humidity of the area where dermatopathology stain reagents are stored and used for patient testing and where the cryostat is utilized. Findings include: 1. The laboratory began Mohs testing under the subspecialty of Histopathology on 6 /17/21, with an annual reported test volume of 360. 2. The laboratory failed to 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, including room temperature conditions where Mohs is performed and stain reagents are stored and humidity requirements for the cryostat as specified by the manufacturer. 3. The laboratory failed to monitor and document the room temperature of the area where Mohs specimens are processed and stain reagents are stored on each day of patient testing that occurred from 6/17/21 through the date of the survey conducted on 12/06/23. 4. The laboratory failed to monitor and document the humidity of the area where the cryostat is used to process Mohs specimens on each day of patient testing that occurred from 6/17/21 through the date of the survey conducted on 12/06/23. 5. The manufacturer's operating requirements for the Leica CM1510S cryostat reviewed during the survey listed an acceptable operating relative humidity range of 0 - 60%. 6. The facility personnel interviewed on 12/6/23 at 10:55 AM confirmed the laboratory failed to monitor and document the room temperature and humidity as indicated above, and failed to define room temperature and humidity criteria for the area where stain reagents are stored and the cryostat is utilized. -- 2 of 4 -- D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's microscope maintenance policy and interview with the facility personnel, the laboratory failed to perform and document the annual preventative maintenance of the microscope used for patient testing under the subspecialty of Histopathology. Findings include: 1. The laboratory began Mohs testing on patients under the subspecialty of Histopathology on 6/17/21 with an annual reported test volume of 360. 2. The laboratory failed to provide evidence of microscope maintenance documentation for the microscope that is used to read patient slides from 6/17/21 though 12/06/23, including annual preventative maintenance. 3. The facility personnel interviewed 12/6/2023 at 10:57 AM confirmed the laboratory failed to provide documentation of maintenance activities from 6/17/21 through 12/06 /23 for the microscope used by the laboratory to read patient slides. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on lack of patient test records for Mohs testing, review of the Mohs log and interview with the facility personnel, (A) the laboratory failed to maintain a copy of the Mohs map for one out of five patient records reviewed, and (B) one out of four Mohs maps reviewed failed to include the drawing of the specimen. Findings include: 1. The laboratory began Mohs testing on 6/17/21 under the subspecialty of Histopathology, with an annual reported test volume of 360. A1. The laboratory utilizes an Electronic Medical Record (EMR) system to maintain Mohs test results, including the Mohs map. A2. One out of five patient test records reviewed during the survey was missing the Mohs map. The map was not scanned into the patient's EMR and the facility personnel could not produce evidence of the map during the survey (Case # S210-2022 performed on 9/8/22). A3. The facility personnel interviewed on 12/6/23 at 10:20 AM confirmed the laboratory failed to maintain a copy of the Mohs map for the case indicated above. B1. One out of four Mohs maps reviewed during the survey failed to include the drawing of the specimen on the Mohs map (Case # S8- -- 3 of 4 -- 2021 performed on 7/29/21). B2. The facility personnel interviewed on 12/06/23 at 9: 55 AM confirmed the physical drawing of the specimen was missing on the Mohs map indicated above. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the facility personnel, five out of five test reports reviewed failed to include the correct facility name where the testing was performed. Findings include: 1. The laboratory began Mohs testing under the subspecialty of Histopathology on 6/17/21 with an annual reported test volume of 360. 2. Five out of five test reports reviewed during the survey failed to include the correct laboratory name where the testing was performed. The facility name listed on the test reports reviewed indicated 'Buckeye Dermatology' and the laboratory name listed in the CLIA Federal Database for CLIA# 03D2211783 is Arizona Mobile Dermatology and Wound Care, PLC. 3. The facilty personnel interviewed on 12/06/23 at 10:05 AM confirmed the name of the laboratory where the testing was performed was incorrect on the final test reports reviewed during the survey. -- 4 of 4 --