St Louis Cancer Care

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 review of proficiency testing (PT) policy, PT records for 2024, 2025 and to date 2026, patient hematology results and interview with the laboratory personnel manager, the laboratory failed to provide attestation documentation for seven of seven PT testing events. Findings: 1. Review of "Proficiency Testing Policy Revised 3/29 /10" states "All attestation sheets will be signed and dated with the nurse or nurses who performed the test". 2. Review of PT records for 2024, 2025, and to date 2026 showed the laboratory could not provide attestation records for testing personnel to show routine integration of samples into the patient workload for the following proficiency testing events: 2024 American Association of Bioanalysts (AAB)-Medical Laboratory Evaluation (MLE) Hematology M1 Event 2024 AAB-MLE Hematology M2 Event 2024 AAB-MLE Hematology M3 Event 2025 AAB-MLE Hematology M1 Event 2025 AAB-MLE Hematology M2 Event 2025 AAB-MLE Hematology M3 Event 2026 AAB-MLE Hematology M1 Event 3. Review of patient hematology results showed the laboratory performs approximately 3,641 CBC's annually. 4. Interview with the laboratory personnel manager on June 2, 2026 at 1:30 PM confirmed the laboratory could not provide attestation records for seven PT testing events in 2024, 2025 and to date 2026. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for 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 -- proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of Abacus 3CP User Manual, laboratory humidity records, and patient hematology results and interview with the laboratory personnel manager, the laboratory failed to ensure the humidity was maintained for 71 of 251 days. Findings: 1. Review of the Abacus 3CP User Manual states "Operate Abacus 3CP analyzer within a relative humidity range of 10-80%". 2. Review of the laboratory humidity records shows that the humidity in the laboratory where the Abacus 3CP is located was out of range for 71 of 251 days from January 2025 to December 2025. 3. Review of patient's hematology results showed the laboratory performs approximately 3,641 CBC's annually. 4. Interview with the laboratory personnel manager on June 2, 2026 at 1:00 PM confirmed the laboratory failed to ensure the humidity was maintained. -- 2 of 2 --

Summary Statement of Deficiencies D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the 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 review of personnel records and interview with the laboratory staff, the laboratory did not have academic credentials required to qualify one of six testing personnel for the speciality of hematology for moderate complexity testing (refer to tag #6065). 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: 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 -- Based on review of personnel records and interview with the laboratory staff, the laboratory failed to have documentation of academic credentials to qualify one of six testing personnel for moderate complexity testing. Findings: 1. Review of the personnel records for testing personnel #6 for the speciality of hematology revealed the laboratory failed to have academic credentials to qualify this individual. 2. Interview with the laboratory staff on April 26, 2018 at 9:00AM confirmed, the laboratory failed to have the required documentation to qualify testing personnel #6 of moderate complexity. -- 2 of 2 --