Skin Care Drs Pa

Summary Statement of Deficiencies D0000 The Skin Care Doctors PA laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on August 13, 2024. The following standard-level deficiency was cited: 493.1236 Evaluation of proficiency testing performance . 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 document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of the single Histopathology test performed in the laboratory at least twice annually in 2023. Findings are as follows: 1. The laboratory performed Mohs micrographic surgery under the specialty of Histopathology as confirmed by the Practice Administrator (PA) during a tour of the laboratory at 10:05 a.m. on 08/13/24. 2. Mohs case slide evaluation by an outside provider was required twice annually as established in the Quality Assurance Plan found in the Mohs Lab Policies and Procedure Manual. 3. 2023 Mohs case slide evaluations were not found in the Quality Assurance - Peer Slide Review folder on date of survey. The laboratory was unable to provide 2023 Mohs case evaluations upon request. 4. The laboratory performed 137 Mohs micrographic surgery procedures in February through March 2023, and June through December 2023, as indicated in the laboratory's Mohs Daily Log. 5. In an interview at 12:05 p.m. on 08/13/24, the PA confirmed the above finding. 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 document review and interview with laboratory personnel, the laboratory failed to perform and document activities used to verify the accuracy of the single Histopathology test performed in the laboratory at least twice annually in 2018, 2019, 2020. Findings are as follows: 1. The laboratory performed Mohs micrographic surgery with microscopic examination under the specialty of Histopathology as confirmed by the Histology Technician (HT) during a tour of the laboratory at 1:00 p. m. on 11/24/20. 2. A slide exchange with another Mohs surgeon was required twice annually as established in Section C. of the Quality Assurance Plan located in the Mohs Lab Policies and Procedures Manual. 3. Twice annual accuracy verification of Mohs testing performed at the Orono location was not found for 2018, 2019, and 2020 during review of laboratory records. The 2018, 2019, and 2020 Annual Quality Assurance Slide Review forms found in the Quality Assurance - Peer Slide Reviews Orono folder included Mohs cases not performed at the Orono location as determined by a comparison of case numbers listed on the quality assurance forms and those listed in the Mohs patient log. The laboratory was unable to provide Mohs accuracy verification documentation for testing performed at the Orono location in 2018, 2019, and 2020 upon request. 4. The laboratory performed approximately 357 Mohs micrographic surgery procedures annually as indicated in laboratory records and listed on Form CMS-116 Clinical Laboratory Improvement Amendments (CLIA) Application for Certification provided by the laboratory on date of survey. 5. In an interview at 2:10 p.m. on 11/24/20, the HT confirmed the above finding and indicated 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 -- the Mohs cases used for the twice annual accuracy verification were from other Skin Care Doctors PA locations. 2020 - Sartell location 2019 - Burnsville location 2018 - unknown location -- 2 of 2 --