Saguaro Dermatology Ahwatukee

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 Frozen Biopsy testing 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. Findings include: 1. In 2023, the laboratory performed Frozen Biopsy testing on one patient. This testing was performed under the subspecialty of Histopathology. 2. No documentation was presented for review to indicate the laboratory verified the accuracy of Frozen Biopsy testing at least twice annually during 2023. 3. The facility personnel interviewed on 12/18/24 at 9:00 AM confirmed the laboratory failed to verify the accuracy of Frozen Biopsy testing at least twice annually during 2023. 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 review and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the sub-specialty of Histopathology at least twice annually during 2021. Findings include: 1. No documentation was presented for review during the survey conducted on January 25, 2023 to indicate the laboratory verified the accuracy of the microscopic interpretation of histopathology (Mohs) specimens at least twice annually during 2021. 2. The facility personnel interviewed on 1/25/23 at 1:15pm confirmed that the laboratory failed to verify the accuracy of histopathology testing at least twice annually during 2021. 3. The laboratory's approximate annual test volume under the sub-specialty of Histopathology is 125. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) documentation and interview with the facility 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 -- personnel, the laboratory failed to document the acceptability of staining materials used for Mohs testing performed in the sub-specialty of histopathology. Findings include: 1. The laboratory performs testing in the sub-specialty of Histopathology, with an approximate annual test volume of 125. 2. No documentation of the Hematoxylin & Eosin (H&E) stain acceptability was presented for review for testing that occurred on 12/03/2021. Approximately 6 patients were tested on that date. 3. The facility personnel interviewed on 1/25/23 at 1:00pm confirmed the laboratory failed to document the H&E stain acceptability on 12/03/2021, as indicated above. -- 2 of 2 --

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 review and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the sub-specialty of Histopathology at least twice annually during 2019. Findings include: 1. No documentation was presented for review during the survey to indicate that the laboratory verified the accuracy of Mohs testing at least twice annually during 2019. 2. The facility personnel confirmed that the laboratory failed to verify the accuracy of Mohs testing at least twice annually during 2019. 3. The laboratory's policy reviewed during the survey indicates that 5 cases selected at random are to be reviewed by an outside dermatopathologist biannually. 4. The laboratory's approximate annual test volume under the sub-specialty of Histopathology is 200. **This is a repeat deficiency from the previous survey conducted on 03/21/2018. 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. 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 -- 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 follow their policy in regards to performing annual microscope maintenance. Findings include: 1. No documentation was provided by the laboratory to indicate that the microscope was serviced in 2019 by a properly licensed company as established in the laboratory's microscope maintenance policy. 2. The facility personnel acknowledged that the microscope was not serviced in 2019. -- 2 of 2 --

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 review of accuracy verification documentation, laboratory policy review and interview with the facility personnel, the laboratory failed to verify the accuracy of dermatopathology testing at least twice annually in 2017. Findings include: 1. The laboratory performs patient testing under the sub-specialty of Histopathology, with an approximate annual test volume of 200. 2. The laboratory presented accuracy checks for Mohs cases that were reported in 2017, but were not reviewed by an outside dermatopathologist until March of 2018. There were no cases sent out for review in 2017. 3. The laboratory policy indicates that 5 cases selected at random are to be reviewed by an outside dermatopathologist biannually. 4. The facility personnel acknowledged that no cases were sent out for review in 2017. 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 --