Great Basin Pathology

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 1/13/2022. 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 sample survey of 10 histopathology and four cytology samples from 2020 through 2021 and interviews with the laboratory staff and laboratory director, the laboratory failed to ensure positive identification of the samples through the testing and reporting process. Findings include: 1. Two of 10 histopathology patient names on the final report did not completely match the names on the accession log, slides and blocks. For sample S21-2021, the first name did not match. For sample S21-1934, the last name was misspelled. 2. The staff and laboratory director interviewed during the on-site survey on 1/13/2022 at approximately 11:00 AM confirmed the findings. The laboratory performs approximately 2095 pathology 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 May 2, 2019. 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. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of laboratory temperature records and interview with the laboratory director and histology technician, the laboratory failed to document daily room, embedding center, and slide oven temperatures. Findings include: 1. Review of a random selection of temperature records revealed the laboratory failed to document daily room, embedding center and slide oven temperatures. Temperatures were not recorded on five days in August 2018 and four days in September 2018. 2. The laboratory did not document the temperatures for the embedding center and slide oven. The laboratory documented that the temperatures were within range with a check mark. 3. The laboratory director and histology technician interviewed during the on-site survey on 5/02/19 at 10:00 AM confirmed the findings. The laboratory performs approximately 2,400 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 --