Summary:
Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant (TC) #2, the laboratory failed to establish a system to ensure the Laboratory Information System (LIS) calculated hematology tests were manually checked prior to reporting out patient results for 12 (March 2020 to March 2021) of 12 months in use and routinely thereafter. Findings include: 1. A record review revealed for 12 (March 2020 to March 20201) of 12 months, the surveyor identified a test called Absolute Neutrophil Count (ANC) on the final hematology report that requires a LIS calculation (white blood cell count x the % granulocytes). There was no documentation to show the calculations had been manually checked against the LIS computer system calculation prior to reporting out patient results or routinely thereafter. 2. A interview on 3/3/2021 at 10:33 am, TC2 confirmed the ANC calculation was not manually checked prior to patient reporting and routinely thereafter. 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 --