Tennessee Oncology, Pllc

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records, review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS-209), and staff interview, the laboratory failed to ensure PT testing was performed by personnel who routinely perform patient testing for Complete Blood Count (CBC) in 2022 and 2023. The findings include: 1. Review of the laboratory's PT attestation statements and PT testing records revealed that six of six PT events were performed by Testing Person #1. 2. Review of the Form CMS-209 revealed four testing personnel who perform patient testing for CBC. 3. Interview with the Laboratory Operations Manager on 3/21/24 at 12:00 p.m. confirmed that the laboratory did not rotate PT testing among all testing personnel who performed patient testing for CBC in 2022 and 2023. 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 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on Review of the Centers for Medicare and Medicaid Service (CMS) CASPER report 155 and the Medical Laboratory Evaluation(MLE) Performance Summary report the laboratory failed to achieve successful performance for the 2nd event 2019 and 1st event 2020 in the Cell I.D. or White Blood Cell Diff (WBC) resulting in 1st unsuccessful performance in 2020. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: 1. Review of the CMS Casper 155 report revealed White Blood Cell Differential (WBC DIFF) 2nd event 2019 with a score of 76% and 1st event 2020 with a score of 52% resulting in a 1st unsuccessful PT performance in 2020. 2. Review of the MLE performance evaluation report revealed the WBC Diff 2nd event 2019 with a score of 76% and 1st event 2020 with a score of 52%. -- 2 of 2 --