Tennessee Oncology, Pllc

Summary Statement of Deficiencies D6043 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(5) (b) The technical consultant is responsible for-- (b)(5) Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications; This STANDARD is not met as evidenced by: Based on laboratory observation, review of instrument validation records, quality control (QC) records, the laboratory's policies, monthly quality assurance (QA) reports, lack of documentation, and staff interviews, the technical consultant (TC) failed to identify, investigate, and follow-up on performance issues with one of four QC lots reviewed in 2023 and 2024. The findings include: 1. An observation of the laboratory on 09/07/2024 at 9:10 a.m. revealed that it used one Sysmex XN-430 (ID: 12002) and one Sysmex XN-550 (ID: 12419) to perform complete blood count (CBC) testing. The laboratory used three levels of Sysmex HN-L Check quality control material to verify each instrument's performance. 2. A review of instrument validation records revealed that the Sysmex XN-430 (ID: 12002) replaced a Sysmex XN-430 (ID: 11141) on 03/05/2024. 3. A review of the laboratory's 2023 and 2024 QC records revealed it used XN-L Check lots 4265, 4012, 3293, and 3209 to monitor test system performance. 4. A review of the laboratory's "Quality Assurance Program" (PolicyStat ID: 13180163) revealed the following: - Laboratory management will review quality assurance reports monthly for "quality outliers" and implement process improvement as needed. - The laboratory sends peer evaluations of monthly QC to the technical consultant for review and approval. 5. A review of the laboratory's monthly quality reports revealed that the laboratory used the Sysmex Insight report to monitor overall QC performance against peers. The January 2024 Insight report summary for Sysmex XN-430 (ID: 11141) using XN-L Check QC lot number 3293 stated there was an accuracy bias on the white blood cell (WBC) parameter. Further review revealed a "W" flag on the WBC parameter of the level two control due to a standard deviation 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 -- interval (SDI) of 2.4. The report states that the flag means the parameter is "outside the established SDI range." 6. The laboratory could not provide documentation that showed the QC outlier was identified or monitored. 7. An interview with the Clinical Lab Operations Manager and Regional Operations Manager on 09/07/2024 at 1:00 p. m. confirmed the findings. -- 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 review of the Centers for Medicare and Medicaid CASPER Report 155 (CMS 155) and the laboratory's American Proficiency Institute (API) 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 API 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: 72% - 2024 Event one: 28% 2. Review of the laboratory's API PT evaluation report revealed the following unsatisfactory WBC DIFF scores: - 2023 Event three: 72% - 2024 Event one: 28% -- 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 11:45 a.m. confirmed the laboratory failed to follow its policy for testing personnel competency assessment in 2022. 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 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 -- use. This STANDARD is not met as evidenced by: CITATION NUMBER ONE: Based on observation of the laboratory, review of manufacturer complete blood count (CBC) quality control package insert and interview with the technical consultant, the laboratory failed to label CBC quality control vials with corrected expiration date on the date of the survey (06.01.2023). The findings include: 1. Observation of the laboratory on June 1, 2023 at 8:50 a.m. revealed a Sysmex XN-430 CBC instrument (serial #11141) and a Sysmex XN-550 CBC instrument (serial # 16435) in use for patient testing. Also observed were three levels of Sysmex XN-L CBC controls (Lot 3125) that were not labeled with corrected expiration date. 2. Review of the manufacturer quality control package insert revealed the following statement: "Open vials and vials which have been sampled by cap piercing will retain stability for 15 days if stored at 2-8 degrees C after being re- capped." 3. Interview with the technical consultant on June 1, 2023 at 8:55 a.m. confirmed the laboratory had not labeled CBC quality control vials with corrected expiration date on the date of the survey (06.01.2023). Word Key C = Celsius CITATION NUMBER TWO: Based on observation of the laboratory and interviews with the technical consultant, the laboratory failed to label three coplin jars of QuickLink stains used in manual blood smear differential patient testing in 2023. The findings include: 1. Observation of the laboratory on June 1, 2023 at 8:45 a.m. revealed a microscope on the counter and three coplin jars of QuickLink Stains (QuickLink III Fixative Solution, QuickLink III Solution I, and QuickLink III Solution II) that were not labeled in use for performing manual blood smear differential patient testing. 2. Interview with the technical consultant on June 1, 2023 at 8:55 a.m. confirmed the QuickLink stains (QuickLink III Fixative Solution, QuickLink III Solution I, and QuickLink III Solution II) had been poured from the original bottles into the coplin jars. 3. Interview with the technical consultant on June 1, 2023 at 11:45 a.m. confirmed the laboratory failed to label the three coplin jars containing QuickLink III Fixative Solution, QuickLink III Solution I, and QuickLink III Solution II with content, lot number and expiration date on the date of the survey (06.01.2023). -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) record's attestation statements for 2017- 18 and an interview with the general supervisor, the laboratory director failed to ensure in signing nine of nine attestation statements in 2017-18. Findings include: 1. Attestation statements failed to reveal the laboratory director's (LD) signature and attestation in 6 of 6 testing events for 2 hematology instruments in 2017 and attestation in 3 of 3 testing events for 2018. 2. In an interview, January 9, 2019, at 10: 30am, the general supervisor confirmed the missing LD signature and attestation on the attestation statements for 6 of 6 testing events for 2 hematology instruments in 2017 and attestation in 3 of 3 testing events for 2018. 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 --