Las Vegas Gastroenterology

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 February 16, 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. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of the laboratory personnel training and competency assessment records for person number two listed on the CMS-209 form, the laboratory policy and procedure entitled, "Competency Testing," and an interview with the laboratory director, and person number two on the CMS-209 form, the director failed to ensure that initial training and competency assessment was completed for one of one testing personnel prior to performing gross analysis on patient histopathology specimens. Findings include: 1. Person number two listed on the CMS-209 form began performing gross analysis of histopathology specimens in the laboratory on October 12, 2021. The initial training and competency assessment form reviewed for person number two on the CMS-209 form was not completed until February 7, 2022. 2. The laboratory policy and procedure entitled, "Competency Testing" stated, "Competency testing is performed within 6 months of initial training and once a year thereafter." The policy and procedure further stated, "Competency testing is completed for each 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 -- employee. 3. During an interview conducted on February 16, 2022 at approximately 9: 30 AM, the laboratory director, and person number two listed on the CMS-209 form confirmed that no documentation of training and competency assessment for the gross analysis of histopathology specimens had been performed prior to patient testing on October 12, 2021. The laboratory performs approximately 139,000 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 March 8, 2021. 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. 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 a random audit of patient final test reports from 2/21/19 to 12/21/2020, and an interview with testing personnel #1 on the cms 209 form, the laboratory failed to ensure that the location of the laboratory where the technical component of the specimen processing and gross analysis was specified on the final test report. Findings include: 1) A random audit of patient final test reports between the dates of 2/21/19 and 12/21/20 revealed that the location of the laboratory where the technical component and gross analysis was performed was not correct on three of the seven reports reviewed. The final report indicated that the technical component was completed at the laboratory from which the case slides were distributed for the pathologist interpretation to be completed. 2) A random audit of patient reports 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 -- between the dates of 2/21/19 and 12/21/20 revealed that the location of the laboratory where the technical component and gross analysis was performed was incorrectly identified as two separate locations on two of seven reports reviewed. The location of the laboratory where the case slides were distributed from for the pathologist interpretation was identified as one of the locations of the performance of the technical component and gross analysis. The findings were confirmed during an interview with testing personnel #1 on the cms 209 form conducted on 3/8/21 at approximately 11:00 am. The laboratory performs 4,000 Histopathology tests annually. -- 2 of 2 --