Yellowstone Pathology Institute-Cody Wyoming

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on patient test reports review, laboratory specimen log review, and interview with the director, the laboratory report failed to include the actual location where the histopathology frozen section and fine needle aspirate tests were performed for 7 of 7 test reports reviewed. The laboratory performed approximately 12 tests per year. Findings include: 1. Patient test reports review for cases logged into the pathology specimen log in Cody: 19-30224.S, 19-196415.S, 19-16967.S, 19-24754.S, 20-13007, 20-13007,and 20-14949.S stated the tests (frozen section and fine needle aspirate) were performed by the Yellowstone Pathology Institute lab in Billings, MT. One exception was case 20-481.S, that stated the frozen section specimen test was performed at the Yellowstone Pathology Institute, Cody. 2. The laboratory specimen log review failed to include documentation for specimens that were sent to the Billings laboratory and those that were tested in the lab in Cody. It could not be determined if the specimens were read on-site in Cody, or by telepathology in Billings. 3. In an interview conducted on 08/31/2020 at approximately 2:45 P.M., the laboratory director stated the process for Cody was changed to send all formalin biopsy specimens to Billings. Fine needle aspirates and frozen sections were primarily processed upon collection in the Cody laboratory then read via a microscope 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 -- connected to the Internet and read and reported from the Billings laboratory. The director also stated that on some occasions when the director was physically in Cody and upon appointment, slides were physically read and reported from the Cody laboratory. The director confirmed the laboratory reports failed to include the location where each portion of the test was actually performed. -- 2 of 2 --

Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on direct observation and interview with staff, the laboratory system failed to document the date and time pathology specimens were received into the laboratory for two years of testing reviewed. The laboratory performed approximately 3,000 gross analyses per year. Findings include: 1. The surveyor observed specimens being processed by the laboratory grossing technologist on 05/03/2018 at approximately 11: 45 A.M. that included entering into the laboratory information system the date and time specimens were accessioned by the laboratory and assigned a laboratory identification. 2. In in interview with staff on 05/03/2018 at approximately 12:20 P. M., staff stated specimens were retrieved from the operating room at approximately 10:00 A.M. each day of testing and then received into the laboratory and accessioned by the laboratory into the test system. Testing personnel stated the laboratory did not have a system or process established to record the date and time specimens that were dropped off by hospital staff members or for out patient specimens arriving during hours the grossing lab was not staffed were actually received into the laboratory location. 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 --