Tennessee Oncology Pllc

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 CASPER Report 155 (CMS 155) and the laboratory's proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory participation for two consecutive proficiency testing events in 2023 and 2024, resulting in initial unsuccessful participation for the automated white blood cell differential (WBC DIFF) analyte. (See 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: Based on desk review of the CMS 155 and the laboratory's PT evaluation reports, the laboratory failed to maintain satisfactory performance for two out of three test events for the automated white blood cell differential (WBC DIFF) analyte resulting in initial unsuccessful PT occurrence. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory WBC DIFF scores: - 2023 Event three: 0% - 2024 Event one: 24% 2. Review of the laboratory's PT evaluation report revealed the following unsatisfactory WBC DIFF scores: - 2023 Medical Laboratory Evaluation (AAB/MLE) PT Event three: 0% - 2024 American Proficiency Institute (API) PT Event one: 24% -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records, personnel policy, and staff interview, the laboratory personnel policy did not include assessing technical consultant (TC) competency, as required. The findings include: 1. Review of the laboratory personnel records revealed the following: Delegation of technical consultant duties by the lab director to one TC. There were no records for documentation of technical consultant competency by the director of the lab for 2021, 2022, and 2023. 2. Review of the laboratory personnel competency policy revealed no requirement for assessment of technical consultant competency. 3. Interview with the laboratory lead on 04/20/23 at 2:25 pm confirmed the laboratory personnel competency policy did not include a requirement for technical consultant competency assessment performed by the lab director. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; 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 -- This STANDARD is not met as evidenced by: Based on observation of the lab, review of patient test reports, instrument validation records and staff interview, the laboratory director failed to approve validation studies for Sysmex XN 430 serial number 11072 complete blood count instrument (CBC) prior to patient testing in 2018. The findings include: 1. Observation of laboratory on 4 /20/2023 at 8:45 a.m. revealed a Sysmex XN 430 instrument serial number 11072 on the counter in use for performing patient CBCs. 2. Review of the first patient reported (MRN #131649) revealed testing on the instrument began on 11/29/2018. 3. Review of the instrument validation records revealed an install date of 11/29/2018. Lab director approval was not performed until 10/29/2020. 4. Interview with the laboratory lead on 4/20/2023 at 2:15 p.m. confirmed that the laboratory began patient testing on the Sysmex XN 430 Serial number 11072 on 11/29/18 without lab director approval. -- 2 of 2 --

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 the Proficiency Testing Agency, Medical Laboratory Evaluation (MLE) performance summary and interview with the Technical Consultant determined the laboratory failed to maintain satisfactory performance for the specialty of Hematology for the Cell I.D. or White Blood cell Differential (WBC Diff) in the 2nd and 3rd event of 2017 resulting in the first unsuccessful occurrence. (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 3 -- 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: Based on record review of the MLE performance summary report and interview with the laboratory Technical Consultant the laboratory failed to achieve successful performance for the 2nd event with a score of 60% and 3rd event with a score of zero in 2017 for the specialty Hematology for Cell I.D. or WBC Diff resulting in the first unsuccessful performance in 2017. 1. Review of the MLE performance summary report revealed the laboratory failed to achieve successful performance for the 2nd event with a score of 60% and 3rd event with a score of zero for the specialty Hematology for Cell I.D. or WBC Diff in 2017. 2. Interview with the Technical Consultant on December 14, 2018 at 11:30 confirmed the laboratory failed to achieve successful performance for the 2nd event with a score of 60% and 3rd event with a score of zero for the specialty Hematology for Cell I.D. or WBC Diff in 2017. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on lack of quality control (QC) records from January 2017 through September 2017, calibration, maintenance and analyzer correlation records for the Coulter ACT-5 Complete Blood Count (CBC) analyzers and interview with the Technical Consultant the laboratory failed to retain analytic systems records for 2017. (See D3031) D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of quality control (QC) records from January 2017 through September 2017, calibration, maintenance and analyzer correlation records for the Coulter ACT-5 Complete Blood Count (CBC) analyzers and interview with the Technical Consultant the laboratory failed to retain analytic systems records for 2017. The findings include: 1. Lack of QC records from January 2017 through September 2017, calibration, maintenance and analyzer correlation records for the Coulter ACT-5 Diff CBC analyzers, revealed the laboratory failed to retain analytic system records for 2017. 2. -- 2 of 3 -- Interview with the Technical Consultant on December 14, at 11:30 confirmed the laboratory failed to retain QC records from January 2017 through September 2017, calibration maintenance and analyzer correlation records documenting all analytic systems activities for the Coulter ACT-5 Diff CBC analyzers in 2017. -- 3 of 3 --