Tennessee Oncology, Pllc

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 laboratory observation, a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), personnel records, American Proficiency Institute (API) proficiency testing (PT) records, and staff interviews, the laboratory failed to ensure that two of five testing personnel (TP) who performed hematology patient testing also participated in proficiency testing in 2023 and 2024. The findings include: 1. An observation of the laboratory on 02/05/2025 at 9:15 a.m. revealed that it used two Sysmex XN-530 hematology analyzers (ID: 12421 and 12412) for complete blood count (CBC) patient testing. 2. A review of the FORM CMS-209 revealed a total of five persons (TP1, TP2, TP3, TP4, and TP5) who perform moderately complex patient testing. 3. A review of the laboratory's personnel records revealed that all five testing persons performed CBC patient testing in 2023 and 2024. 4. A review of the laboratory's 2023 and 2024 API PT attestation statements revealed that TP1 and TP4 did not participate in any hematology PT events (0 of 6 reviewed). 5. An interview with the Regional Laboratory Operations Manager and Clinic Lab Manager on 02/05/2025 at 1:00 p.m. confirmed that all routine testing personnel did not participate in hematology PT testing. 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 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 -- activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on laboratory observation, a review of quality control (QC) records, laboratory policies, lack of documentation, and staff interviews, the laboratory failed to retain peer reporting and Levy-Jennings records for one of two QC lot numbers reviewed in 2024. The findings include: 1. An observation of the laboratory on 02/05/2025 at 9:15 a.m. revealed that it used an Abbott Alinity ci-series chemistry analyzer (ID: AC06855) to perform patient testing. The laboratory used three levels of Technopath Multichem S Plus and IA Plus QC material to verify the analyzer's acceptable performance. 2. A random review of the laboratory's 2024 daily QC records revealed that in May 2024, the laboratory used Technopath Multichem S Plus QC lot number 1205220 for performance verification of their chemistry analyzer. 3. A review of the laboratory's "Quality Assurance" policy revealed the laboratory reviews the "Levy- Jennings report and daily run to confirm all levels are sufficient for running patient samples." The policy further states, "Peer reporting of Monthly QC is sent in for review to the Laboratory Quality Review Supervisor and to be signed off by the Laboratory Technical Director." 4. The laboratory could not provide the Levy- Jennings charts or peer reporting of monthly QC for lot number 1205220. 5. An interview with the Regional Laboratory Operations Manager and Clinic Lab Manager on 02/05/2025 at 1:00 p.m. confirmed the findings. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and staff interviews, the laboratory failed to retain all records for three of twelve proficiency testing events in 2023 and 2024. The findings include: 1. A Review of the laboratory's API PT records revealed the following: - No records were available for the laboratory's 2023 Hematology Event 2. - No records were available for the laboratory's 2023 Chemistry Event 2. - No attestation page was available for the laboratory's 2024 Chemistry Event 1. 2. An interview with the Regional Laboratory Operations Manager and Clinic Lab Manager on 02/05/2025 at 1: 00 p.m. confirmed the findings. -- 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 CMS Laboratory Personnel Report (CLIA) (CMS 209), laboratory policy, testing personnel (TP) records, and interview with the technical consultant, the laboratory failed to follow the policy for personnel competency assessment for one of four testing personnel in 2022. The findings include: 1. Review of CMS 209 report revealed four testing personnel performing patient testing for complete blood counts and manual blood smear differentials. Testing personnel three was a new testing person since last survey with documented hire date of 01.10.2022. 2. Review of the laboratory's policy titled, "Competency Testing on Laboratory Personnel" stated, "During the first year of an individual's duties, competency must be assessed after initial training and semiannually". 3. Review of testing personnel competency assessment records revealed no documentation of semiannual competency assessment for testing personnel three in 2022. 4. Interview with the technical consultant on June 1, 2023 at 2:30 p.m. confirmed the laboratory failed to follow its policy for testing personnel competency assessment in 2022. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. 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 review of the laboratory's procedure manual, laboratory records, interview with lead testing person, and interview with the technical consultant, the laboratory failed to follow the procedure for annual pipette calibration 2021. The findings include: 1. Review of the laboratory procedure titled, "Equipment - Pipette Calibration" stated, "All multiuse pipettes must be calibrated annually to confirm proper volume delivery." 2. Review of laboratory pipette calibration records revealed calibration was not performed on the laboratory's two pipettes (serial numbers 300309 and MK945421) in 2021. 3. Interview with the lead testing person on June 1, 2023 at 2:00 p.m. confirmed, two pipettes (serial numbers 300309 and MK945421) were calibrated 11.17.2020 and 05.24.2022, and were not calibrated in November 2021 when due for annual calibration. 4. Interview with technical consultant on June 1, 2023 at 2:30 p.m. confirmed the laboratory failed to follow the procedure for annual pipette calibration in 2021. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interviews with the technical consultant, the laboratory failed to label three staining dishes used for manual blood smear differential patient testing in 2023. The findings include: 1. Observation of the laboratory on June 1, 2023 at 12:30 p.m. revealed a microscope on the counter and three staining dishes, one containing QuickLink I Wright's Stain and two containing deionized water in use for performing manual blood smear differential patient testing that were not labeled. 2. Interview with the technical consultant on June 1, 2023 at 12: 45 p.m. confirmed the QuickLink I Wright's stain had been poured from the original bottle into the staining dish and the other two dishes had been filled with dionized water. 3. Interview with the technical consultant on June 1, 2023 at 2:30 p.m. confirmed the laboratory failed to label the three dishes (one containing QuickLink I Wright's Stain and two containing deionized water) with content, lot number and expiration date on the date of the survey (06.01.2023). -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of 2016-2018 proficiency testing (PT) records and an interview with the general supervisor, the laboratory director (LD) failed to document signed eight of eight attestation statements for chemistry, immunolgy, endocrinology, and hematology PT Events (A, B, C) from 2016-2018. Findings include: 1. The laboratory director (LD) did not sign 8 of 8 PT attestation statements from 2016-2018 PT Events A, B, and/or C. 2. In an interview, on October 2, 2018, at 11:00 AM, the general supervisor confirmed she had signed all 8 of 8 PT attestation statements instead of the lab director for PT Events (A, B, C) in 2016-2018. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. 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 a review of records for 2018 personnel records, quality assurance plan, and an interview with the general supervisor, the laboratory director failed to ensure job descriptions with duties and responsibilities for the positions of Laboratory Director (LD), Clinical Consultant (CC), Technical Consultant/Supervisor (TC/TS), and Testing Personnel (TP). Findings include: 1. There were no job descriptions with duties and responsibilities available to review in personnel records during 2016-2018. 2. There were no job descriptions with duties and responsibilities available to review in the lab quality assurance plan during 2016-2018. 3. Interview with the general supervisor on October 2, 2018, at 10:00am, confirmed the laboratory director did not ensure job descriptions were available with duties and responsibilities for the LD, CC, TCTS, and TP during 2016-2018. -- 2 of 2 --