Cattail River Hematology & Oncology

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 proficiency testing (PT) record review and interview with the laboratory director (LD), the laboratory failed to ensure that the individual testing or examining the PT samples signed the PT attestation statements, attesting that hematology PT specimens were run in the same manner as patient samples. Findings: 1. The laboratory currently has one testing person (TP) listed on the "Laboratory Personnel Report" (CMS-209). 2. A review of hematology instrument printouts from PT run between 2023 and 2025 showed that TP #1 ran the PT for five out of five PT events, however the attestation statements for these five PT events were signed by only the LD and not the TP who performed the PT testing. 3. During an interview on 05/02 /2025 at 12:30 PM, the LD confirmed that the attestation statements were not signed by the individual who performed the PT. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on procedure manual review and interview with the laboratory director (LD), the laboratory failed to update its procedure manual to include the implementation of a new hematology analyzer. Findings: 1. The laboratory validated and began testing with a new hematology analyzer, the "Medonic M-Series" on 06/29/2023. 2. A review of the approved procedure manual showed that it contained outdated information related to the previous "Beckman Coulter AcT Diff" hematology analyzer. This included a sheet titled, "Blood Value Limits: Beckman Coulter AcT Diff" which listed "Hematology Reportable Ranges Verified with Lin C Linearity Control" and "Patient Limits (Normal)," a "Coulter AcT Diff Maintenance Log," and a "Coulter AcT Maintenance Schedule." 3. The procedure manual also included generic procedures ("Patient Test Management [Record Keeping]" and "Quality Control") provided by Beckman Coulter. These generic procedures had blanks/gaps to allow the laboratory to "personalize" the procedure by writing in information specific to the laboratory ' s policies. The procedures had not been completed or filled out by the laboratory, to provide accurate information to testing personnel. 4. The laboratory had a copy of the "Medonic M-Series User ' s Manual" which was not approved (signed and dated) by the LD. 5. During an interview on 05/02/2025 at 12:30 PM the LD confirmed that the approved procedure manual had not been updated to reflect the testing currently performed in the laboratory. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the manufacturer's certificate of accuracy, review of the laboratory's procedure, and interview with the testing person (TP), the laboratory failed to verify the accuracy of the Streck Temp-Chex thermometers. Findings: 1. The laboratory monitored refrigerator and freezer temperatures using Streck Temp-Check thermometers. 2. The Streck Temp-Chex thermometer Instructional Information and Certificate of Accuracy stated "Due to use in diverse applications and handling, there is no precise way to predict how long calibration will be maintained. As with any thermometer, drift is a possibility and accuracy can be affected by shock, aging, temperature and contamination through daily use. Periodic recalibration or verification should be scheduled by each laboratory in accordance with its accrediting agency and/or established procedure. At a minimum, annual recalibration or verification from the date the thermometer is put 'in use' is good lab practice." 3. The laboratory did not have a procedure defining the frequency with which to verify the accuracy of the Streck Temp-Chex thermometers. 4. During the survey on 10/06/2023 at 1:15 PM, the TP confirmed that the Streck Temp-Chex thermometers have not been recalibrated/verified since put into use and the laboratory did not have a procedure for verifying the accuracy of the thermometers. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory (lab) director, the director did not document his review of the proficiency test providers evaluation for events the lab participated in 2019 and 2018. Findings: 1. The lab receives unknown proficiency samples from the proficiency test provider, for three separate events a year. The lab tests the samples and submits the results of the test to the provider. The proficiency test provider evaluates (scores) the test results and reports these results to the lab; 2. The lab director did not document that he reviewed the proficiency test providers evaluations for event 1 in 2019, event 3 in 2018, event 2 in 2018 and event 1 in 2018; and 3. This was confirmed during interview with the lab director upon exit on the day of survey. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory (lab) director, the lab Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- director did not ensure that hematology quality control programs are maintained to ensure quality control failures are identified and corrected prior to testing patient samples. Findings: 1. The lab performs automated hematology testing on patient samples using an analyzer that reports the patient complete blood count and white blood cell differential; 2. The laboratory written procedure stated that the lab test three levels of control reagent (low, normal and high), evaluate the results of each quality control test and take