Summary:
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 2022 and 2023. Findings include: 1. No documentation was presented for review to indicate the laboratory verified the accuracy of Frozen Biopsy testing at least twice annually during 2022 and 2023. 2. The facility personnel interviewed on 9 /20/24 at 1:25 PM confirmed the laboratory failed to verify the accuracy of the testing listed above at least twice annually during 2022 and 2023. 3. The laboratory performs 1,522 tests annually under the subspecialty of Histopathology. 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. 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 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 performs testing in conjunction with Mohs surgery and Frozen Biopsy testing under the subspecialty of Histopathology on with an annual reported test volume of 1,522. 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 'Advanced Dermatology and Cosmetic Surgery"' and the laboratory name listed in the CLIA Federal Database for CLIA# 03D2132603 is "Advanced Dermatology of Arizona." 3. The facilty personnel interviewed on 9/24/24 at 1:20 PM confirmed the name of the laboratory where the testing was performed was incorrect on the final test reports reviewed during the survey. -- 2 of 2 --