Summary:
Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) (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 review of the laboratory demographic information on the Centers for Medicare and Medicaid Services (CMS)-116 form, final patient test reports, and staff interviews, the laboratory failed to ensure the correct address for the performing laboratory location was on the final patient test report for five of five final patient test reports reviewed from 2024 and 2025. The findings include: 1. A review of the form CMS-116 revealed a physical laboratory address of 3325 Shores Rd, 3rd Floor, Murfreesboro, TN 37128. 2. A review of the following final patient test reports revealed the laboratory address listed as 1272 Garrison Drive, Murfreesboro, TN 37129, and no performing location was indicated. -Patient number 334925: Basic Metabolic Panel reported on 07/14/2024. -Patient number 821281: Complete Blood Count, Manual Differential and Rheumatoid Arthritis Panel reported on 11/19/2024. - Patient number 384001: Comprehensive Metabolic Panel reported on 04/24/2025. - Patient number 809016: Wet Prep reported on 07/10/2025. -Patient number 595060: Complete Blood Count reported on 09/03/2025. 3. An interview with the Laboratory Supervisor, the Chief Tech, and Testing Personnel #2 on 10/24/2025 at 1:30 p.m. confirmed the survey findings. . 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 -- D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the Medicare and Medicaid Services Laboratory Personnel Report CLIA (Form CMS-209), laboratory personnel records, lack of documentation, and staff interview, the technical consultants (TC) failed to perform competency assessments at least twice in the first year of testing for four of four testing personnel (TP) who performed moderately complex patient testing in 2023, 2024 and 2025. The findings include: 1. A review of Form CMS-209 revealed four TP and two TC for moderately complex patient testing. 2. A review of the laboratory personnel records revealed four TP performing moderately complex patient testing. TP 4 is a new employee since the previous survey. 3. A review of the laboratory competency assessment records revealed the following lack of documentation: -TP 1, no 6-month competency documentation -TP 2, no 6-month competency documentation -TP 3, no 6-month competency documentation -TP 4, no initial or 6-month competency documentation 5. An interview with the Laboratory Supervisor, the Chief Tech, and Testing Personnel #2 on 10/24/2025 at 1:30 p.m. confirmed the survey findings. -- 2 of 2 --