Keith Mark Gross Md Inc

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 January 15, 2025. 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 review of the laboratory accession logs, patient files, patient slides and an interview with the laboratory personnel, the laboratory failed to maintain accurate specimen identification throughout the pre-analytical, analytical, and post-analytical stages of testing. Findings include: 1. A random review of six Mohs patient files and the laboratory accession logs from 2023 and 2024, included patient number 19 on September 17, 2024. 2. The patient files for this patient indicated that the Mohs accession number was M09172419. 3. The accession log indicated that the Mohs accession number was M09132419. 4. A review of the first patient on September 17, 2024, found that the patient slide included Mohs accession number M09172401 and the Mohs accession number on the accession log was M09132401. 5. The accession log indicated that 19 of 19 patients tested on September 17, 2024 had an accession number beginning with M091324. 6. An interview on January 15, 2025, at 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 -- approximately 2:30 PM, with the laboratory personnel found that the slides and patient files were to have been numbered beginning with M091724. The laboratory performs approximately 200 Histopathology tests annually. -- 2 of 2 --

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 November 14, 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 review of the Mohs accession log, patients' medical records, Mohs maps, and histopathology slides, the laboratory failed to follow written policies and procedures to ensure positive identification and integrity of patients' specimens from the time of collection through completion and reporting of results. Findings include: 1. A sample survey of nine patients' specimens from collection through reporting of results from May 2017 through November 2018 showed that one of nine patients histopathology slides did not have the correct Mohs surgery location. 2. A review of the Mohs accession log, patient's medical records, Mohs map and histopathology slides for Mohs accession number M 08221706 revealed that the Mohs surgery location on the slides did not match the information on the accession log, medical records, and Mohs map. The slides indicated the location as "Lt Forearm" and the other records indicated "Rt Preauricular." The office manager confirmed the finding during the on-site survey on 11/14/18 at approximately 1:45 PM. 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 1 --