Apex Pediatrics

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) 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 do the following: This STANDARD is not met as evidenced by: Based on review of operator's manual, review of 2023, 2024 and 2025 maintenance logs, and interview with testing personnel (TP) #5, 04/10/25, the laboratory failed to perform semi-annual maintenance on the Cell-Dyn Emerald hematology analyzer since time of last survey, 02/23/23, a period of approximately 25 months. Findings: Review of operator's manual for the Cell-Dyn Emerald hematology analyzer revealed under Section 9 "Semi-Annual Maintenance...Lubricating the Pistons....For optimal operation, the Syringe Pistons should be lubricated every six months as described below.". Review of 2023, 2024, and 2025 maintenance logs for the Cell-Dyn Emerald hematology analyzer revealed no documentation of the performance of the semi- annual maintenance. Interview with TP #5 at approximately 11:00 a.m. confirmed the laboratory had not performed the semi-annual maintenance. TP #5 stated the service representative told them it was not required. 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 D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 review of review of 2020, 2021 and 2022 American Proficiency Institute (API) proficiency testing (PT) records and interview with clinical manger 2/23/23, the laboratory director (LD) and/or testing personnel (TP) failed to sign attestation statements for 8 of 18 PT events reviewed. Findings: Review of 2020 and 2021 API PT events revealed the LD did not sign the following attestation statements. 1. 2020 API Hematology/Coagulation (HEM/COAG) - 2nd event. 2. 2020 API Microbiology (MICRO) - 3rd event. 3. 2020 API HEM/COAG - 3rd event. 4. 2021 API MICRO - 1st event. Review of 2020, 2021 and 2022 API PT MICRO events revealed the attestation statements were signed by the TP that plated the MICRO PT samples. The attestation statements were not signed by the TP (provider) that read and reported the PT results. 1. 2020 API MICRO - 1st event. 2. 2021 API MICRO - 2nd event. 3. 2021 API MICRO - 3rd event. 4. 2022 API MICRO - 1st event. Interview with clinical manager at approximately 2:00 p.m. confirmed attestation statements were not signed as required. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: A. Based on review of laboratory policy, review of 2021 and 2022 API PT records and lack of documentation 2/23/23, the laboratory failed to retain API PT comparative evaluation reports for 5 of 12 PT events reviewed. Findings: Laboratory policy "Quality Assurance Program" revealed "Record Retention...All routine laboratory records are kept for at least 2 years.". Review of 2021 and 2022 API PT records revealed the following API PT events failed to include the comparative evaluation reports used to determine if

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of hematology quality control (QC) records, review of hematology analyzer maintenance records and interview with testing personnel (TP) 12/06/19, the laboratory failed to retain QC and maintenance records for the hematology analyzer in use. Findings: Review of QC records revealed the laboratory failed to retain QC documentation for the Beckman Coulter Act Diff 2 hematology analyzer from 8/28/18 through 9/21/18, a period of approximately 25 days. Review of maintenance records for the Cell Dyn Emerald hematology analyzer revealed the laboratory failed to retain maintenance records from 10/18 through 8/19, a period of approximately 10 months. Exit interview with TP #4 at approximately 2:00 p.m. confirmed the laboratory could not locate the QC records for the Beckman Coulter Act Diff 2 analyzer and stated the maintenance records for the Cell Dyn Emerald analyzer were not retained as needed. 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 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 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)