Tennessee Oncology, Pllc

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 a review of the laboratory procedure manual, review of testing personnel records, a review of a patient activity log, and staff interview, the laboratory failed to follow the policy for technical consultant approval of testing personnel training and competency prior to patient testing for one of one new testing persons since the last survey date. The findings include: 1. A review of the laboratory's policy titled "Competency Testing on Laboratory Personnel" revealed the following statement: The competency of each person who performs the duties of a defined test system must be assessed by the Technical Consultant following training before the person performs testing if the person is a new hire or is learning a new test system. 2. A review of one of one new testing persons (TP 3) since the last survey date revealed an initial competency assessment signed by the technical consultant on 05/20/25. 3. A review of a patient activity log revealed that TP 3 performed six patient CBC w/Diff tests prior to the technical consultant's competency assessment approval (patient sample identification numbers 25293892, 25294383, 25295571, 25295947, 25296080- performed on 05/12/25, sample identification number 25308415 performed on 05/16 /25). 4. Technical consultant two confirmed the survey findings during an interview on 07/09/25 at 3:30 p.m. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by 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 -- 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. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the laboratory procedure manual, review of instrument maintenance logs, review of validation records, review of a patient activity report and staff interview, the laboratory failed to follow the procedure for technical consultant review and approval of new test systems prior to patient testing for two of two new Complete Blood Count with Automated White Blood Cell Differential (CBC w/Diff) instruments implemented in April 2024 with approximately 2,757 patient CBC w/Diff results released prior to approval of validation records. The findings include: 1. Laboratory observation on 07/09/25 at 9:15 a.m. revealed the Sysmex XN 430 (serial number 12047 ) and the Sysmex XN 530 (serial number 12533) used for patient testing for CBC w/Diff. During observations, the lead testing person stated the instruments were new since the last survey date. 2. A review of the laboratory procedure titled "Qualification of Laboratory Equipment" revealed the following statement: "Under no circumstances is it acceptable to result patient testing prior to Medical Director or Technical Consultant (Moderate Complexity) signature release and demonstration of training competency of testing personnel." 3. A review of the instrument maintenance logs revealed that both instruments were put into use for patient testing on approximately 04/24/24. The exact date could not be determined. 4. A review of the validation records for both instruments revealed that they were not approved for use until after patient testing had begun. The approval date for both instruments was 06/11/24. 5. A review of a patient activity report revealed that approximately 2,757 patients were reported after the instruments were used for patient testing, but before the technical consultant and laboratory director approved the validations. 6. Technical consultant number two confirmed the survey findings during an interview on 07/09/25 at 3:30 p.m. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the laboratory document titled "Hematology Auto-Verification Rules and Actions", review of the laboratory information system auto-verification validation documents, and staff interview, the laboratory failed to provide documentation that supported the validation of auto- verification of CBC w/Diff results into the laboratory information system. The use of auto-verification began in March 2024 and continued until the survey date on July 9, 2025. 1. Laboratory observation on 07/09/25 at 9:15 a.m. revealed the Sysmex XN 430 (serial number 12047 ) and the Sysmex XN 530 (serial number 12533) used for patient testing for CBC w/Diff. During observations, the lead testing person was -- 2 of 3 -- asked to describe how the results from the instruments are released to the patient's chart. She stated that the laboratory uses auto-verification for many of the results. Certain results are held for review by the testing person before release to the chart. She stated that the use of auto-verification began sometime last year. 2. A review of the document titled "Hematology Auto-Verification Rules and Actions" detailed which results would be excluded from auto-verification and what actions the testing person would take for those results that did not auto-verify. 3. A review of the laboratory information system auto-verification validation documents, with a date of 03/22/24, revealed no approval signatures or dates of the laboratory director, no raw data supporting the verification activity, and no evidence that each criterion for results excluded from auto-verification had been tested. 4. Technical consultant two confirmed the survey findings during an interview on 07/09/25 at 3:30 p.m. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (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. This STANDARD is not met as evidenced by: Based on laboratory observation, document review, lack of documentation, and staff interview, the laboratory director failed to delegate technical consultant duties to two of three persons performing technical consultant duties (technical consultants two and three). The findings include: 1. Laboratory observation on 07/09/25 at 9:00 a.m. revealed two Sysmex CBC w/Diff instruments used for patient testing. 2. A review of laboratory documents revealed that two persons (new since the last survey date) performed technical consultant duties, which included reviewing quality control, reviewing maintenance, and conducting competency assessments of testing personnel. 3. The laboratory director had not delegated the technical consultant duties in writing to technical consultant two or technical consultant three. 4. Technical consultant two confirmed the survey findings during an interview on 07/09/25 at 3:30 p.m. -- 3 of 3 --

Summary Statement of Deficiencies D0000 During a recertification survey performed on 03/11/24, the laboratory was found out of compliance with the following condition: 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of instrument comparison records, and staff interview, the laboratory failed to compare results for the automated white blood cell count performed on the two Sysmex Complete Blood Count (CBC) instruments twice a year in 2022, 2023, and 2024. The findings include: 1. Observation of the laboratory on March 11, 2024, at 8:45 am revealed two Sysmex Complete Blood Count (CBC) instruments in use for performing patient testing for CBC with automated White Blood Cell (WBC) differential (serial numbers 11125 and 16001). 2. Review of instrument comparison records revealed the laboratory did not compare results for automated WBC differential between the two instruments in 2022, 2023, or 2024. 3. The laboratory liaison confirmed the survey findings during interview on 03 /16/24 at 12:45 pm. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the 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 -- qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of patient test reports, personnel qualifications, and staff interview, testing person number three did not meet the regulatory education requirements for moderately complex testing personnel (Refer to D6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of patient test reports, review of testing personnel records, and staff interview, testing person number three failed to qualify as a testing person due to lack of documentation. The findings include: 1. Observation of the laboratory on March 11, 2024, at 8:45 am revealed two Sysmex Complete Blood Count (CBC) instruments used for performing patient testing for CBC with automated White Blood Cell differential (CBC w/Diff). 2. Testing person three reported two patients for CBC w/Diff on 12/21/23 (Sample ID 23704541 and Sample ID 23706150). 3. Qualifications for testing person three were reviewed. The diploma on file did not indicate the degree. 4. The laboratory liaison stated the following during an interview on 03/11/24 at 12:00 pm: Testing person three graduated from a certificate degree Medical Laboratory Technician program. The high school diploma was not maintained as part of the employee file. This confirmed the survey findings. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the procedure manual, patient number one report and interview with the laboratory liaison, the laboratory failed to provide a procedure for the sodium citrate platelet aggregation testing. The findings include: 1) Observation of the laboratory on April 16, 2019 at 1:30 p.m. revealed the Sysmex XN-430 complete blood count (CBC) instrument serial number 11125 and the Sysmex XN-550 CBC instrument serial number 16001, in use for patient testing. 2) Review of the laboratory procedure manual revealed no procedure for the sodium citrate platelet aggregation testing. 3) Review of patient number one report and CBC instrument printout revealed the following:the final reported as Platelet Count, Sodium Citrate Tube, dated 01-10-19, result L 96 K/uL; the CBC instrument printout is 88 K/uL. 4) Interview on April 16, 2019 at 2: 30 p.m. with the laboratory liaison confirmed the laboratory collects patient samples using the sodium citrate tubes, performs testing on the CBC instruments and multiplies the answer by 1.1. The laboratory procedure and manufacturer's instructions for sodium citrate could not be located. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it 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 -- can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the verification of performance specification records and interview with the laboratory liaison, the laboratory failed to verify the sodium citrate platelet aggregation procedure, prior to testing in 2018. The findings include: 1) Observation of the laboratory on April 16, 2019 at 1:30 p.m. revealed the Sysmex XN-430 complete blood count (CBC) instrument serial number 11125 and the Sysmex XN-550 CBC instrument serial number 16001, in use for patient testing. 2) Review of the verification of performance specification records revealed the sodium citrate platelet aggregation procedure was not included in the verification process, signed by the laboratory director on 12-24-18. 3) Interview on April 16, 2019 at 3:45 p.m. with the laboratory liaison confirmed the sodium citrate platelet aggregation procedure was not included in the verification procedure, with continued patient testing. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the 2018 and 2019 laboratory records and interview with the laboratory liaison, the laboratory failed to compare the two CBC instruments for the sodium citrate platelet aggregation procedure at least two times per year, in 2018 and 2019. The findings include: 1) Observation of the laboratory on April 16, 2019 at 1:30 p.m. revealed the Sysmex XN-430 complete blood count (CBC) instrument serial number 11125 and the Sysmex XN-550 CBC instrument serial number 16001, in use for patient testing. 2) Review of the 2018 and 2019 laboratory records revealed no comparison between the two instruments for the sodium citrate platelet aggregation procedure in 2018 and 2019. 3) Interview on April 16, 2019 at 4:30 p.m. with the laboratory liaison confirmed the sodium citrate platelet aggregation procedure was in use for patient testing in 2018 and 2019. The laboratory did not evaluate and define the relationship between the two instruments performing the sodium citrate platelet aggregation procedure in 2018 and 2019. D6011 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) 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 -- 2 of 3 -- director must-- (e)(2) and provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the laboratory liaison, the laboratory director failed to provide a safe environment from biological hazards. The findings include: 1) Observation of the laboratory on April 16, 2019 at 1:30 p.m. revealed no biohazard signs in the laboratory where patient testing is performed. 2) Interview on April 16, 2019 at 1: 35 p.m. with the laboratory liaison confirmed there are no biohazard signs in the laboratory. -- 3 of 3 --