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 review of patient test logs, patient test reports, and confirmed by laboratory personnel identifier #5 (refer to the Laboratory Personnel Report) at approximately 8: 30 am on 03/09/2021, the laboratory failed to have a system in place to ensure the accuracy and reliability of potassium hydroxide (KOH) examination test results manually transcribed into patient electronic health records (EHR) for one out of two patients (Patient A) tested in September 2020. The findings include: 1. Patient A had a KOH examination performed on 09/17/2020. The Laboratory Test Requisition and Report Log documented a negative result. The EHR test report documented clustered spores and short wide hyphae. 2. At the time of the survey, personnel identifier #5 confirmed that Patient A's KOH examination results did not match on the Laboratory Test Requisition and Report Log and in the patient's EHR. 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 --