Epiphany Dermatology Of Arizona, Llc

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 Biopsy Interpretations, review of laboratory policies 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, 2023 and 2024. Findings include: 1. No documentation was presented for review to indicate the laboratory verified the accuracy of Biopsy Interpretations at least twice annually during 2022, 2023 and 2024 (through the date of the survey conducted on 11/05/24). 2. The laboratory's established policy titled, "Laboratory: Quality Assessment, Proficiency Testing" states, "Proficiency shall be assessed at least semiannually." 3. The facility personnel interviewed on 11/05/24 at 2:50 PM confirmed the laboratory failed to verify the accuracy of histopathology testing at least twice annually during 2022, 2023 and 2024. 4. The laboratory's reported annual test volume in the subspecialty of histopathology is 12,100. 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. 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 lack of Quality Control (QC) documentation and interview with the facility personnel, the laboratory failed to document the acceptability of the Hematoxylin & Eosin (H&E) staining materials on 2 out of 4 testing days reviewed during the survey, for intended reactivity and to ensure predictable staining characteristics. Findings include: 1. The laboratory performs Biopsy Interpretations under the subspecialty of Histopathology with a reported annual test volume of 12,100. 2. Testing records reviewed during the survey indicated the laboratory failed to document the acceptability of the H&E stain on 2 out of 4 testing days, 12/01/22 and 6/08/24. 4. The number of patient specimens read and diagnosed on 12/01/22 and 6/08/24 could not be determined at the time of the survey. 5. The facility personnel interviewed on 11/05 /24 at 2:40 PM confirmed the laboratory failed to document the H&E stain acceptability each day of use for intended reactivity and to ensure predictable staining characteristics on the testing dates indicated above. -- 2 of 2 --

Summary Statement of Deficiencies 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 the laboratory's Mohs test reports and interview with the facility personnel, the Mohs test report for one patient failed to include a unique identification number. Findings include: 1. The laboratory reads and interprets slides in conjunction with the Mohs procedure in the sub-specialty of histopathology with an approximate annual test volume of 148. 2. It is the practice of the laboratory to maintain the Mohs test reports (Mohs operative report and Mohs map) in an electronic record system. Each Mohs case is given a unique accession number which is listed on the operative report, map and slide(s). 3. One out of four operative test reports (CF19-138) reviewed during the survey failed to include the unique accession number. 4. The facility personnel confirmed that the Mohs operative report for the patient indicated above failed to include the unique accession number. 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 --