Southwest Cancer Center

Summary Statement of Deficiencies D0000 Recertification survey was conducted from August 11-18, 2022. Southwest Cancer Center clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to use certified thermometers to record the temperatures of the refrigerator and the freezer used to store reagents from 04/19/2021 to 08/11/2022. Findings: On 08/11/2022 at 9:24 AM, the following flow cytometry reagents were observed in the refrigerator: Flow-Check Pro Fluorospheres, Flow-Set Pro Fluorospheres, ClearLLab Control Cells Normal and Abnormal, ClearLLab Compensation Beads, IO Test 3 Lysing Solution, and IO Test 3 Fixation Solution. On 08/11/2022 at 9:24 AM, Fetal Bovine Serum was observed in the freezer. Review of the package insert for the Digital Fridge/Freezer Thermometer showed there was no date listed on the thermometer of when it was calibrated and no indication of when the calibrations were due. On 08/11/2022 at 10:27 AM, the Technical Supervisor stated the thermometers were not certified. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain daily Quality Control (QC) log on the Beckman Coulter Navios Flow Cytometer from 03/19/2021 to 04/04/2022. Findings: The laboratory performed daily controls consisting of Flow- Check Pro Fluorospheres, Flow-Set Pro Fluorospheres, ClearLLab Controls Cells Normal and ClearLLab Controls Cells Abnormal. Documentation of the controls were kept on the flow cytometer and in the form of paper in Levey-Jennings (L-J) charts. The records on the flow cytometer were corrupted between 03/19/2021 to 04/04/2022 and could not be viewed using the protocols of the lot numbers used for the daily controls. The laboratory did not provide the paper L-J charts from 03/19/2021 to 04/04 /2022. According to the Clinical Laboratory Improvement Amendment (CLIA) Application for Certification, signed and dated by the Laboratory Director on 08/16 /2022, the laboratory had an annual test volume of 10,800 tests. On 08/11/2022 at 11: 25 AM, the Technical Supervisor stated a previous testing personnel employee corrupted the files on the flow cytometer and she was working to recreate the charts. On 08/18/2022 at 5:16 PM, the Technical Supervisor stated the last day in 2021 they had the L-J charts for was 03/18/2021 and the first day in 2022 they had the L-J charts was 04/05/2022. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to monitor and evaluate the overall quality of the general laboratory system and correct identified problems. Cross Reference D5217. Based on record review and interview, the laboratory failed to verify the accuracy (proficiency testing - PT) of 29 analytes (antibodies) at least twice annually in 2021. This is a repeat deficiency from the initial survey on 01/12 /2021. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to verify the accuracy (proficiency testing - PT) of 29 analytes (antibodies) at least twice annually in 2021. This is a repeat deficiency from the initial survey on 01/12/2021. Findings: The laboratory chose to perform PT with the College of American Pathologists (CAP). Review of the CAP PT records showed the attestation, instrument printouts, and performance review for two of two events in 2021 were not available for review. The -- 2 of 5 -- Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed and dated by the Laboratory Director on 08/21/2022, noted the laboratory performed flow cytometry using 29 different antibodies. The laboratory evaluated the following antibodies: CD8 (T cells marker), CD10 (follicle center cells marker), CD11b (granulocytes and monocytes marker), CD13 (myeloid cells marker), CD14 (monocytes and macrophages marker), CD15 (granulocytes and Hodgkin's lymphoma marker), CD16 (granulocytes and natural killer cell marker), CD19 (B cell marker), CD20 (B cell marker), CD30 (B cell and Hodgkin's lymphoma marker), CD33 (monocytes and macrophages marker), CD34 (hematopoetic stem cells marker), CD38 (plasma cells and activated T and B cells marker), CD45 (leukocyte marker), CD56 (natural killer cells marker), CD64 (monocytes and macrophages marker), CD117 (stem cell and plasma cells marker), CD123 (progenitor cell marker), CD200 (myeloid cell marker), HLA-DR (Human Leukocyte Antigen - DR isotype T cell marker), Light chains (kappa and lambda, B cell marker), and TCR-gd (T cell receptor - gamma delta marker). According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 08/16/2022, the laboratory had an estimated annual test volume of 10,800. On 08/11/2022 at 10:18 AM, the Technical Supervisor stated the testing personnel who worked in 2021 did not perform proficiency testing. D5785

Summary Statement of Deficiencies D0000 An initial certification survey was conducted on January 12, 2021. Southwest Cancer Center clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to monitor and evaluate the overall quality of the general laboratory system and correct identified problems. Findings: Cross Reference D5201: Based on observation and interview, the laboratory failed to ensure that confidential patient information was securely (encrypted) emailed to and from the pathologist from 11/21/19 to 1/12/21. Cross Reference D5209: Based on record review and interview, the laboratory failed to establish and follow a written procedure to access the training and competency of 1 out of 1 (Testing Personnel A). Cross Reference D5217: Based on record review and interview, the laboratory failed to verify the accuracy (proficiency testing - PT) of 29 analytes (antibodies) at least twice annually from 11/21/19 to 1/12/21. D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to ensure confidential patient information was securely (encrypted) emailed to and from the pathologist from 11/21/19 to 1/12/21. Findings: During an observation on 1/12/21 at 11:40 AM, the Technical Supervisor emailed Patient #1's flow cytometry reports with confidential information to the pathologist for interpretation. The email was not encrypted and the patient's name was typed in the subject line. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 1/21/21, the laboratory had an estimated annual test volume of 11,000. During an interview on 1/12/21 at 11:40 AM, and 3:14 PM, the Technical Supervisor stated she put the patient's name in the subject line of the email and had not encrypted the email. 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 procedure manual and interview, the laboratory failed to establish and follow a written procedure to access the training and competency of 1 out of 1 staff, (Testing Personnel A). Findings: Review of the laboratory's procedure manual, signed by the Laboratory Director on 1/12/21, showed that there was no procedure on training and competency. Review of the laboratory's records showed the laboratory failed to have documentation of the initial training on the Beckman Coulter Navios Flow Cytometer and a competency evaluation after six months. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 1/21/21, the laboratory had an estimated annual test volume of 11,000. During an interview on 1/12/21 at 2: 22 PM, the Technical Supervisor stated there was no procedure on training and competency. During an interview on 1/12/21 at 1:30 PM, the Technical Supervisor stated she did not have the documentation on her training and no competency evaluation was performed on her. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to verify the accuracy (proficiency testing - PT) of 29 analytes (antibodies) at least twice annually from 11/21 /19 to 1/12/21. Findings: Review of the procedure manual showed there was no procedure on PT. No documentation was available that showed the laboratory performed PT. The Clinical Laboratory Improvement Amendments (CLIA) -- 2 of 7 -- Application for Certification, signed and dated by the Laboratory Director on 1/21/21, noted the laboratory performed flow cytometry using 29 different antibodies. The laboratory evaluated the following antibodies: CD8 (T cells marker), CD10 (follicle center cells marker), CD11b (granulocytes and monocytes marker), CD13 (myeloid cells marker), CD14 (monocytes and macrophages marker), CD15 (granulocytes and Hodgkin's lymphoma marker), CD16 (granulocytes and natural killer cell marker), CD19 (B cell marker), CD20 (B cell marker), CD30 (B cell and Hodgkin's lymphoma marker), CD33 (monocytes and macrophages marker), CD34 (hematopoetic stem cells marker), CD38 (plasma cells and activated T and B cells marker), CD45 (leukocyte marker), CD56 (natural killer cells marker), CD64 (monocytes and macrophages marker), CD117 (stem cell and plasma cells marker), CD123 (progenitor cell marker), CD200 (myeloid cell marker), HLA-DR (Human Leukocyte Antigen - DR isotype T cell marker), Light chains (kappa and lambda) B cell marker), and TCR- gd (T cell receptor - gamma delta marker). According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 1/21/21, the laboratory had an estimated annual test volume of 11,000. During an interview on 1/12/21 at 2:26 PM, the Technical Supervisor stated the laboratory did not have a procedure on PT. During an interview on 1/12/21 at 1:21 PM, the Technical Supervisor stated the laboratory had not performed any PT. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory's quality assessment program failed to monitor and evaluate the overall quality of the analytic system and correct identified problems. Findings: Cross Reference D5403. Based on record review and interview, the laboratory procedure manual failed to include a procedure on specimen labeling. Cross Reference D5413. Based on observation, record review and interview, the laboratory failed to record the temperature of the refrigerator, freezer, and the room and humidity of the room where the testing was performed from 11/21/19 to 1 /12/21.. Cross Reference D5429. Based on record review and interview, the laboratory failed to document the maintenance performed on Beckman Coulter Navios Flow Cytometer from 11/21/19 to 1/12/21. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. -- 3 of 7 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)