Tennessee Oncology, Pllc

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of laboratory policy, review of temperature records, and staff interview, the laboratory failed to follow its own policy for maintaining proper freezer temperatures for storage of referral specimens on 12 of 27 days in September 2023 and March 2024. The findings include: 1. Observation of the laboratory on November 13, 2024, at 10:15 a.m. revealed an American BioTech Supply (Serial Number- ABS5222033023038) refrigerator/freezer in use for storage of patient specimens. 2. A review of the laboratory policy titled "Laboratory Maintenance" revealed the following requirement: -"7. TEMPERATURE CHECK - 3. Check and record freezer temperature if separate from refrigerator daily: - A. Daily temperature will be taken at the beginning of each day for every freezer that is external from the refrigerator and recorded on the Temperature and Humidity Log. - a. Freezer temperature range: -15C to -25C (5 to -13F) - b. All out of range temperatures will be documented as such on the log. - c. All

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of patient test reports, laboratory procedures and staff interview, the laboratory failed to ensure procedures for Complete Blood Count (CBC) testing were approved by the laboratory director prior to patient reporting which began on 01/20/23. The findings include: 1. Observation of the laboratory on 05/26/23 at 9:00 am revealed a Sysmex XN 430 instrument (SN: 11748) in use for performing CBC patient testing. 2. Review of patient test reports revealed patient reporting for CBC began on 01/20/23 (patient: 379726). 3. Review of the Laboratory Standard Operating Procedure and Policy Guide revealed the procedure titled "Sysmex Hematology Analyzer" was approved on 02/10/23 by the current laboratory director. 4. Interview with the laboratory clinical operations manager on 05/26/23 at 12:00 pm confirmed the laboratory began CBC patient testing prior to laboratory director approval of procedures. 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 --