Advanced Care Oncology &

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), and interview with the Testing Personnel (TP), the laboratory failed toto follow the the procedure "Viewing and printing the levy-Jennings (LJ) Control Charts (Monthly)" from 7/23/24 to 9/2/26. The findings include: 1. The PM stated "6. The LJ chart for each level of quality control is reviewed monthly by the laboratory director and/or designee to ensure that the QC data falls within the ranges of the QC insert sheet". 2. There was no documented evidence that aforementioned procedure was followed. 3. The TP confirmed on 9/2/26 at 11:00 am that the aforementioned procedure was no performed. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control 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 -- materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on lack of of Quality Control Verification (QCV) records and interview with the Testing Personnel (TP), the laboratory failed to verify QC material before use for Sysmex XN-550 from 8/1/26 to 9/2/26. The findings include. 1) There was no documented evidenced that the QCV was performed on lot # 62061401 of XN-Check control material currently in use. 2) The TP confirmed 9/1/26 at 11:15 am that QC material was not verified before putting in use. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT), interview with Testing Personnel (TP), the laboratory failed to ensure that all TP who routinely perform Hematology testing participated in the American Proficiency Institute (API) PT in the calendar years 2019, 2020, 2021 and first and second events of 2022. The findings include: 1. A review of PT attestation records showed that two out of seven TP performed PT in the aforementioned time frame. 2. The TP confirmed on 9/13/22 at 2: 30 pm that PT events were not rotated between TP. 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. (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)

Summary Statement of Deficiencies D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require