Wildflower Pediatrics

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiency was cited. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the proficiency testing records, data logs, manufacturer's instructions, maintenance logs, and interview, the laboratory failed to test proficiency samples in the same manner as patient testing when it performed a monthly cleaning prior to five of five proficiency testing (PT) events on the Medonic M-series for the Complete Blood Count (CBC). Findings follow. A. Review of the American Proficiency Institute (API) Hematology testing events from the 1st, 2nd and 3rd events of 2023, and 1st and 2nd events from 2024 against the Medonic All Sample Summary Report (data logs) showed for each event a monthly cleaning was performed on the analyzer prior to the performance of PT. Review of the PT instrument print-outs showed PT was performed on the following dates: 03/16/2023, 07/12/2023, 11/14/2023, 03/14/2024, 07/16/2024. B. Review of the Medonic M-series User's Manual, Art no 1504472 02/2016, Section 8: Cleaning, Maintenance & Transport at 8.2 Monthly Cleaning stated, "This section describes the cleaning 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 -- procedure to be used to secure the correct function of the instrument on a monthly basis. The Monthly Cleaning procedure takes approximately 10 minutes, instructions are follows: 1. Clean the aspiration probes using an alcohol wipe. 2. Fill a cup with 10 ml 2% hypochlorite (Bottle #2 from Boule Cleaning Kit) and one cup with 18 ml diluent. (Recommend use of dispense function for obtaining diluent, see Section 5.5: Dispense Function.) 3. Aspirate the hypochlorite as a pre-dilute sample. 4. Run 2 blank samples by aspirating diluent as a pre-diluted sample. 5. Perform a background check, in pre-dilute mode, to verify all values are within range. See Section 5.3 for more details. Clot Prevention: This process will decrease the risk of debris material building up in the instrument system. This should be performed at least once a month or every 1000 samples. This procedure will take 15 minutes to complete." C. Review of the Medonic M Series Maintenance Log showed the monthly cleaning was performed on the following dates as PT: 03/16/2023, 07/12/2023, 11/14/2023, 03/14 /2024, 07/16/2024. D. Interview with testing personnel #1 on November 19, 2024 at 1520 hours stated she performed the monthly cleaning prior to performing PT. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory policy and procedures, test reports, and interview, the laboratory failed to redact the Complete Blood Count (CBC) indicies with flags on 2 of 2 test reports reviewed with flags. Findings follow. 1. Review of the Medonic M Series user manual, under Chapter 9: Parameter and System Information Messages, section 9.2 System Information Messages starting on page 71 stated, "The system software monitors a number of analytical and system functions and will display information that indicates the possible attention of the operator. This information will alert the operator to check the system or sample or institute selected troubleshooting procedures." Multiple error flags were listed, including BD which stated under "Action:" Blood sample too old or pathological sample. Follow laboratory's protocol for verification of results." 2. Review of the laboratory's policy and procedure titled CBC Medonic M-series, effective 6/22/2017, on page 2 under Patient Testing stated, "See the User's manual (pages 71-76 for system information message descriptions. The diff flags (BD, NM, OM and TM) indicate a possible problem with the accuracy of the results and should not be reported. Collect a new sample and repeat the testing. If the flag is still present, then the flagged results must be marked through on the printed report and the results should not be entered in the EMR." 3. Review of instrument printouts from the patient's chart showed a. ID # 1822, at sequence 6928, tested on 11/16/2020, and b. ID # 2338, at sequence 7355, tested on 02/01/2021, reported the White Blood Cell Differential results including Granulocytes %, Mids %, Lymphocytes %, absolute 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 -- Granulocytes, absolute Mids, and absolute Lymphocytes with the BD flag. 4. Review of the EMR showed 1 of 2 reports with flags were reported into the EMR. a. ID #2338 reported the Lymphocytes and Neutrophils. 5. Interview with the technical consultant on March 16, 2021 at 1130 hours in the office confirmed the testing person should have marked thru the results with the flags, and acknowledged she reviewed this with the staff on March 4, 2021. Interview with testing personnel #3 on March 16, 2021 at 1135 hours in the office confirmed the flagged results were not marked thru, and #2338 had been reported in the EMR. KEY EMR= Electronic Medical Record -- 2 of 2 --