Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site initial CLIA survey conducted at your facility on November 22, 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. 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 five random Mohs surgery cases between the dates of July 2023 and November 2023, a review of the director approved Quality Assurance Policy, and an interview with the office manager, the laboratory failed to ensure positive identification of the patient specimens was maintained from the time of collection of the specimen through completion of the testing and reporting of results. Findings include: 1. A review of mohs case MS23-18 performed on July 6, 2023, found that the mohs map failed to correctly identify the number of slides for the case. The map indicated five slides when there were six slides for this case. 2. A review of mohs case MS23-69 performed on October 23, 2023, found that the mohs map failed to correctly identify the date of surgery. The mohs logs and the patient's medical record indicated that the surgery was performed on October 23, 2023. The mohs map indicated the date of surgery was October 11, 2023. 3. A review of mohs case MS23- 70 performed on October 23, 2023, found that slides failed to correctly identify the date of the surgery. The mohs log, mohs map, and the patient's medical record 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 -- indicated that the surgery was performed on October 23, 2023. Slides 1-1 and 1-2 indicated that the date of surgery was October 10, 2023 and slide 1-3 indicated that the surgery date was October 23, 2023. 4. An interview with the office manager on November 22, 2023, at approximately 10:00 AM, confirmed these findings. The laboratory performs approximately 1200 histopathology tests per year. -- 2 of 2 --