Summary:
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 instrument type, manufacturer instructions, analyzer test settings, normal range evaluation data for prothrombin time, lack of normal range evaluation data for activated partial thromboplastin time (PTT), patient test volumes and interview with the general supervisor (GS), the laboratory failed to perform both a normal range for the new lot of Innovin reagent for prothrombin time testing before use in patient testing, and failed to perform a normal range evaluation for PTT for the Actin FSL reagent lot change before use in patient testing. Findings: 1. Prothrombin time testing is performed on the Sysmex CA-660 analyzer using Innovin reagent (thromboplastin). 2. Review of the package insert for Innovin reagent revealed the statement: "The mean normal PT (MNPT) is defined as the mean value of the normal range. It must be determined specifically for each thromboplastin lot using the method used to analyze the patient samples and, where appropriate, using the coagulation analyzer used for the analysis." 3. Review of the CA660 analyzer settings for Prothrombin time testing revealed Innovin lot number 564628 with a normal mean value of 10.4 seconds entered 4/10/2023. 4. Review of the "Normal Patients study for Coag." does not include the reagent lot number and is dated "Sept 2023." The geometric mean is listed as 10.34 seconds. 5. Review of the package insert for Actin FSL reagent used for PTT testing revealed the statement: Reference intervals vary from laboratory to laboratory depending on the population served and the technique, method, equipment and reagent lot used. Therefore, each laboratory must establish its own reference intervals or verify them whenever one or more of the aforementioned 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 -- variables are changed." 6. Request was made for the PTT normal range (reference interval) study on the new lot of Actin FSL reagent 562728A entered into the CA-660 analyzer on 3/7/23. No documentation was provided at the time of survey. 7. Review of patient test records revealed that 96 prothrombin time results were reported using incorrect instrument setting for the international normalized ratio (INR) from 4/10/23 to 9/27/23 and 78 PTT results were reported without a verification of the normal range (reference interval) values used on the patient report. 8. Interview with the GS on 9/27 /23 at 12:15 p.m. confirmed, the laboratory failed to perform both a normal range for the new lot of Innovin reagent for prothrombin time testing before use in patient testing and failed to perform a normal range evaluation for PTT for the Actin FSL reagent lot change before use in patient testing. -- 2 of 2 --