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: Through a review of ten randomly selected patient test reports, a review of the instrument data log for 7/31/2019, and interviews with laboratory staff, it was determined the laboratory reported Red Blood Cell (RBC) count inaccurately on one of ten patients reviewed: Survey findings follow: A. Ten patient laboratory reports were reviewed by the surveyor. Patient #1289476 who had a complete blood count performed on 7/31/2019 had an RBC reported as 7.9 which was flagged as critically high. With the Mean Cell Volume (MCV) reported as normal and the hematocrit reported as low the 7.9 RBC was an impossibility but was not identified as an error and was reported in the electronic medical record. B. Through a review of the data log from the hematology analyzer it was determine the actual result for RBC on Patient #1289476 was 4.48 instead of 7.9. C. In an interview at 11:26 on 10/23/2019, the laboratory director confirmed the 7.9 RBC reported in the medical record of patient #1289476 on 7/31/2019 was a transcription error and was actually the result for White Blood Cell (WBC) which was entered for both WBC and RBC. 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 --