Jennie Stuart Medical Oncology

Summary Statement of Deficiencies D0000 A recertification survey was initiated on 07/09/2026 and concluded on 07/09/2026. The facility was found to not be in compliance with the laboratory requirements of 42 CFR Part 493 with standard deficiencies cited. D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) events for year 2024,2025, and 2026, review of Laboratory Policy, and confirmed in staff interview, the laboratory failed to have signed attestation forms for 6 of 6 events. Findings include: Review of the laboratory API Proficiency Testing (PT) events revealed the following: a. 2024 Hematology/Coagulation 2nd Event - No Laboratory director/designee signature b. 2024 Hematology/Coagulation 3rd Event - No Laboratory director /designee signature c. 2025 Hematology/Coagulation 1st Event - No Laboratory director/designee signature d. 2025 Hematology/Coagulation 2nd Event - No Laboratory director/designee signature e. 2025 Hematology/Coagulation 3rd Event - No Laboratory director/designee signature f. 2026 Hematology/Coagulation 1st Event - No Laboratory director/designee signature Review of E.C. Green Cancer Center General Laboratory Manual (director signature review 7/7/2026) titled "Proficiency Testing Policy" stated: "14. The Medical Director shall then sign the attestation statement." In an interview on 07/09/2026 at 12:45 PM in the office area, 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 -- Laboratory Director (LD) was asked if the attestation forms were signed for the PT events. The LD confirmed the attestation results were not signed for the PT events. This confirmed the findings. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on direct observation, policy review, document review, and confirmed in staff interview, the laboratory director failed to review and approve two of two Performance Verification Studies for a new Hematology analyzer for patient testing, effective October 2025. Findings include: During a laboratory tour on 07/09/2026 at 11:20 PM, a Sysmex XN530 Hematology Analyzer, Serial Number 12411, was observed in operation for testing patient samples. A review of E.C. Green Cancer Center General Laboratory Manual (laboratory director reviewed on 07/07/2026) titled " Laboratory Delegation of Duties", section Laboratory Medical Director, stated: "8. Ensure that the performance specifications for new tests, instruments, and methods introduced to the laboratory have been properly validated or verified prior to being used for patient testing." A review of XN-Series Automated Hematology Systems/XN- L Automated Hematology Analyzers Method Verification Manual revealed: a. Certificate of Certification - Studies Reviewed By: - No Laboratory Director Signature b. Hematology Method Comparison - Accepted by: - No Laboratory Director Signature In an interniew on 07/09/2026 at 12:50 PM in the office area, the Technical Supervisor (TS) was asked for documentation for Laboratory Director review of the two verification studies. The TS confirmed no signatures for the studies. This confirmed the findings. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on staff interview and record review of proficiency testing (PT) results from American Proficiency Institute (API) on 11/29/2021, the laboratory director failed to ensure proficiency test results were reviewed for one (1) out of three (3) events for 2020, and one (1) out of two (2) events for 2021. Findings include: 1. The laboratory scored an eighty percent (80%) for the analyte Hematocrit (Hct) for the API PT 3rd event of 2020 and an eighty percent (80%) for the analyte Hct for API PT 1st Event of 2021. Record review revealed that the laboratory failed to document a