Lakes Dermatology

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on May 17, 2023. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 a review of the 2021 and 2022 laboratory records for twice per year verification of accuracy and an interview with the Mohs technician, the laboratory failed to ensure that twice per year verification of accuracy was performed and documented during 2022 for Mohs testing and KOH preparations. Findings include: 1. There were no records of twice per year verification of accuracy during 2022 for Mohs testing and KOH preparations. 2. The findings were confirmed during an interview with the Mohs Technician on May 17, 2023 at approximately 11:30 AM. The laboratory performs approximately 80 histopathology tests and 10 mycology tests annually. 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 D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on December 5, 2018. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a random audit of patient histopathology records and slides from 1/05/17 through 11/08/18 and an interview with the facility nurse and the facility histotechnologist, the laboratory failed to ensure the positive identification of the patient's specimen from the time of collection through the completion of testing and reporting of results. Findings include: A random audit of six patients from 1/05/17 through 11/08/18 revealed one of the six patients who had a Mohs procedure performed on 7/15/18 had the source of the specimen to be the "right temple" on the requisition, the Mohs map and the final report. The four slides that were generated to be read by the provider, had "left temple" written on all four of the slides. This was confirmed by the facility nurse and the facility histotechnologist on 12/05/18 at approximately 3:30 pm. The laboratory performs approximately 80 patient histopathology tests annually. 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 --