Healthcare Express-Edmond

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/06/2023. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the technical consultant and director of laboratory operations at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) 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. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant and director of laboratory operations, the laboratory failed to ensure all proficiency testing records had been maintained for a minimum of two years for one of six Hematology events reviewed. Findings include: (1) A review of Hematology API (American Proficiency Institute) proficiency testing records for 2021 and 2022 identifed copies of the Sysmex XP-300 instrument printouts could not be located for one of six events reviewed (First 2021 event); (2) The records were reviewed with the technical consultant and director of laboratory operations. Both stated on 01/06/2023 at 09:50 am, the laboratory had not maintained the instrument printouts for the First 2021 Hematology event. 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 D0000 The initial survey was performed on 10/23/2020. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the technical consultant and director of laboratory operations at the conclusion of the survey. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant and director of laboratory operations, the laboratory failed to ensure the demonstrated reportable ranges were utilized for CKMB and Troponin I testing on the Triage Meter Pro; and failed to provide evidence the verification data had been evaluated prior to implementing the Sysmex XP-300 analyzer. Findings include: QUIDEL TRIAGE METER PRO (1) At the beginning of the survey, the director of laboratory operations stated to the surveyor the laboratory began using the Quidel Triage Meter Pro to perform CKMB and Troponin I testing on 10/15/2018; (2) The surveyor reviewed the performance specification records for the analyzer and identified the following: (a) CKMB - The laboratory had demonstrated a reportable range of 2.0-67.7 ng/ml; (b) Troponin I - The laboratory had demonstrated a reportable range of 0.09-28.1 ng/ml. (3) The surveyor then requested documentation to verify the reportable ranges that were being utilized by the laboratory for CKMB and Troponin I. The following was 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 -- identified: (a) CKMB - The laboratory was using the manufacturer's reportable range of 1.0-80 ng/ml; (b) Troponin I - The laboratory was using the manufacturer's reportable range of 0.05-30 ng/ml. (4) The surveyor reviewed the findings with the technical consultant and director of laboratory operations. Both stated the laboratory was not using the reportable ranges that had been demonstrated by the laboratory. SYSMEX XP-300 ANALYZER (1) At the beginning of the survey, the technical consultant stated to the surveyor the laboratory began using the Sysmex XN-330 analyzer to perform CBC (Complete Blood Count) testing on 10/11/2018; (2) The surveyor reviewed the performance specification records for the test system. There was no evidence the data had been reviewed and evaluated by the laboratory until 11 /13/2018; (3) The surveyor reviewed the records with the technical consultant and director of laboratory operations. The director of laboratory operations stated the data had not been signed and dated as approved until 11/13/2018. (NOTE: The interpretive guidelines at 493.1253(b)(1) state, "The laboratory is responsible for verifying the performance specifications of each nonwaived unmodified FDA-cleared or approved test system that it introduces, prior to reporting patient test results." In addition, the interpretive guidelines state, "Prior to introducing a test for routine patient testing, the laboratory must review and evaluate the verification data.") -- 2 of 2 --