Summary:
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 October 8, 2025. The findings and conclusions of any investigation by the Division of Health Care Purchasing and Compliance 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 review of six patient records, including slides, reports, and Mohs maps, and an interview with the office manager, the laboratory failed to maintain specimen identification and integrity throughout the testing and reporting process. Findings include: 1. A random review of six patient records from April 2024 through September 2025, including slides, reports, and Mohs maps, revealed that the patient with medical record number MM0000090151 had two Mohs procedures performed on July 11, 2024. a. The report indicated that Mohs case number 071124-02 was for the location of the right inferior crus of antihelix and the Mohs case number 071124-03 was for the location of the nasal supratip. b. The slides and Mohs maps indicated that Mohs case number 071124-02 was for the location of the nasal supratip and the Mohs case number 071124-03 was for the location of the right inferior crus of antihelix. 2. An interview with the office manager on October 8, 2025, at approximately 2:30 PM confirmed these findings. The laboratory performs approximately 200 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 2 -- 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 laboratory records from January 2024 through September 2025 and an interview with the office manager, the laboratory failed to perform twice per year accuracy checks for Mohs testing. Findings include: 1. A review of the laboratory records from January 2024 through September 2025 revealed that twice per year accuracy checks for Mohs testing had not performed. 2. An interview with the office manager on October 8, 2025, at approximately 2:30 PM confirmed these findings. The laboratory performs approximately 200 histopathology tests annually. -- 2 of 2 --