Summary:
Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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 review of patient test reports from March 2025, review of the laboratory's verification studies for the Medonic M-series hematology analyzer, the laboratory failed to have documentation of verifying 16 of 16 reference ranges. The findings included: 1. A review of the patient test records from March 2025 identified the following reference ranges were in use: WBC: 3.5 - 10.0 GRA%: 35.0 - 80.0 MID%: 2.0 - 15.0 LYM%: 15.0 - 50.0 GRAN: 1.0 - 8.0 MID: 0.1 - 1.5 LYM: 0.5 - 5.0 RBC: 3.50 - 5.50 HGB: 11.5 - 16.5 MCV: 75.0 - 100.0 HCT: 35.0 - 55.0 MCH: 25.0 - 35.0 MCHC: 31.0 - 38.0 RDW%: 11.0 - 16.0 PLT: 100 - 400 MPV: 8.0 - 11.0 2. A review of the laboratory's verification studies for the Medonic M-series hematology analyzer determined the laboratory failed to have documentation of verifying the reference ranges in use. 3. The technical consultant confirmed the findings in a phone call conducted on 04/07/2024 at 1700 hours. Key WBC: white blood cell GRA%: percent granulocytes MID%: percent monocytes LYM%: percent lymphocytes GRAN: granulocyte count MID: monocyte count LYM: lymphocyte count RBC: red blood cell HGB: hemoglobin MCV: mean corpuscular volume HCT: hematocrit MCH: mean corpuscular hemoglobin MCHC: mean corpuscular hemoglobin concentration RDW%: red cell distribution width PLT: platelet MPV: mean platelet volume 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 -- D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of 10 patient test reports from March 2025 and staff interview, the laboratory failed to ensure the facility's correct address was provided on 10 of 10 test reports. The findings included: 1. A review of 10 patient test reports from March 2025 identified 10 of 10 reports did not have the correct address for the facility. The reports had the address: 900 West Sam Houston Pharr, Texas 78577 2. The facility's correct address was: 926 West Sam Houston Pharr, Texas 78577 3. The technical consultant confirmed the findings in a phone call conducted on 04/07/2025 at 1700 hours. -- 2 of 2 --