Summary:
Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of determined reference ranges in the laboratory coagulation lot to lot rollover study and interview with the General Supervisor (GS)#1, the laboratory failed to ensure the test report included pertinent normal ranges as determined by the laboratory. Findings: 1. Review of the Sysmex CA620 Coagulation analyzer reagent lot roll over data revealed new patient normal ranges had been determined for: a. Prothombin time (PT) normal range of 9.11 - 11.79 seconds b. partial thromboplastin time (PTT) normal range of 21.92 - 30.66 seconds 2. New lot reagents were used for patient testing as of 9/15/2020. No documentation of review by Lab Director, Clinical Consultant, General Supervisor, or Technical Consultant was made availible at the time of survey. 3. Review of the patient reports dated 9/22/2020 from the LIS system revealed both PT and PTT reference ranges on the LIS report did not match the new lot ranges. LIS report continued to reflect the previous lot number refernce values. LIS normal New lot normal PT 9.30 -11.40 sec 9.11 - 11.79 sec PTT 24.5 - 32.80 sec 21.92 - 30.66 sec 4. Interview with the GS #1 on October 6, 2020 at 1:40 p.m. confirmed, the laboratory failed to ensure the test report included pertinent normal ranges as determined by the laboratory. 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 --