West Dodge Imaging, Llc

Summary Statement of Deficiencies D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on surveyor review of patient testing logs from 1/3/2023 - 2/8/2024, review of CMS-209 laboratory personnel report, review of annual competencies, and interview with the technical consultant, the technical consultant failed to perform 2023 annual competencies on six out of sixteen testing personnel performing moderate complexity testing. Findings are: 1. Review of patient testing logs from 1/3/2023 - 2/8/2024 revealed testing personnel #1, #5, #10, #12, #13, and #16, as listed on the CMS-209, performed moderate complexity testing. 2. Review of 2022 and 2023 annual competencies presented at time of survey revealed testing personnel #1, #5, #10, #12, #13, and #16, as listed on the CMS-209, did not have 2023 annual competencies performed. 3. Interview with the technical consultant on 2/13/2024 at 11:57 AM, confirmed testing personnel #1, #5, #10, #12, #13, and #16, as listed on the CMS-209, did not have annual competencies performed. 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 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 surveyor review of two patient test reports and interview with the technical consultant the laboratory failed to have the test report date and laboratory address on the test reports. Findings are: 1. Surveyor review of two chemistry patient test reports revealed reports were missing the test report date and laboratory address. 2. Interview with the technical consultant on 9/20/2022 at 11:26 AM confirmed no test report date and laboratory address was included on the patient test reports. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on documentation provided the laboratory failed to have proper proof of 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 -- education on testing personnel #12, as listed on the CMS-209, performing moderate complexity testing. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on documentation provided and interview with the technical consultant the laboratory failed to have acceptable proof of education on testing personnel #12, as listed on the CMS-209 form. Findings are: 1. CMS-209 form listed sixteen testing personnel performing moderate complexity testing. 2. Surveyor reviewed twelve out of sixteen testing personnel qualifications. 3. One out of twelve testing personnel qualifications reviewed, revealed testing personnel #12, as listed on the CMS-209 form, had no acceptable proof of education. 4. Interview with the technical consultant on 9/20/2022 at 11:28 AM, confirmed no acceptable documentation was available at time of survey. -- 2 of 2 --