St Louis Cancer Care

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 a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and review of AAB Medical Laboratory Evaluation (AAB) 2024 and 2025 proficiency records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of hematology for the analytes red blood cell (RBC) and hemoglobin. Refer to D2130. D2130 HEMATOLOGY 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 -- CFR(s): 493.851(f) (f) 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 a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, review of AAB Medical Laboratory Evaluation (AAB) 2024 and 2025 proficiency records and email correspondence with testing personnel #2 on May 5, 2025, at 3:52 PM, the laboratory failed to achieve satisfactory performance for the same analytes for two out of three consecutive testing events in the specialty of hematology for the analytes red blood cell (RBC), and hemoglobin. Findings: 1. Review of the CASPER 0155 report showed the following results: Hematology 2024-2nd event the laboratory received an unsatisfactory score of 0 percent for red blood cell (RBC). Hematology 2024-2nd event the laboratory received an unsatisfactory score of 0 percent for hemoglobin. Hematology 2025-1st event the laboratory received an unsatisfactory score of 60 percent for red blood cell (RBC). Hematology 2025-1st event the laboratory received an unsatisfactory score of 60 percent for hemoglobin. 2. Review of the AAB Medical Laboratory Evaluation (AAB) 2024 and 2025 proficiency records confirmed the CASPER 0155 report results. 3. Email correspondence with testing personnel #2 on May 5, 2025, at 3:52 PM confirmed the laboratory failed to achieve satisfactory performance for red blood cell and hemoglobin in two out of three consecutive testing events. -- 2 of 2 --

Summary Statement of Deficiencies D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on review of quality control and interviews, the technical consultant failed to provide technical and scientific oversight (refer to D6036) and; failed to ensure acceptable levels of analytic performance are maintained throughout the entire testing process and to identify problems (refer to D6042). D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records and interview with technical consultant, the technical consultant failed to provide technical and scientific oversight of the laboratory for 2018, 2019 and to date February 4, 2020. Findings: 1. Review of the QC records for the Abacus 3CP analyzer for complete blood cell counts (CBC) for 2018, 2019 and to date January 4, 2020 revealed the technical consultant failed to review QC records and failed to provide documentation of technical and scientific oversight of the laboratory. 2. Interview with technical consultant on February 4, 2020 at 1:30 PM confirmed the technical consultant failed to provide documentation of technical and scientific oversight of the laboratory. 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 -- D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of quality control (QC) records and interview with technical consultant, the technical consultant failed to review QC for hematology testing performed on the Abacus 3CP for 2018, 2019 and to date February 4, 2020. Findings: 1. Review of the QC records for the Abacus 3CP analyzer for complete blood cell counts (CBC) for 2018, 2019 and to date January 4, 2020 revealed the technical consultant failed to review QC records to verify instrument accuracy. 2. Interview with technical consultant on February 4, 2020 at 1:30 PM confirmed the technical consultant failed to review quality control records for complete blood cell counts. This is a previously cited deficiency from March 1, 2018. -- 2 of 2 --

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with testing personnel #3, the laboratory failed to ensure test results and patient specific data was reliably sent from the Abacus 3CP hematology analyzer to the laboratory information system(LIS). Findings: 1. Review of documentation revealed the laboratory failed to check patient data and test results sent from the new hematology analyzer, Abacus 3CP, to the LIS. The new instrument was put into use on November 10, 2017. 2. Interview with testing personnel #3 on March 1, 2018 at 10:30 AM confirmed the laboratory failed to check patient test results and patient specific data electronically transmitted from the Abacus 3CP hematology analyzer to the LIS for accuracy. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of 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 -- specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of quality control(QC) records and interview with the testing personnel #3, the technical consultant failed to review QC for hematology testing performed on the Abacus 3CP. Findings: 1. Review of the QC records for the Abacus 3CP analyzer for complete blood cell counts(CBC) for April - December 2017 and January 2018 revealed the technical consultant failed to review the records to verify instrument accuracy. 2. Interview with the testing personnel #3 on March 1, 2018 at 10:30AM confirmed the technical consultant failed to review quality control records for complete cell counts. -- 2 of 2 --