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 surveyor review of the Patient Query (PQ), Staining Log (SL) and interview with the Laboratory Consultant (LC), the laboratory failed to ensure that Histopathology results were reported in a timely manner from May 2018 to the date of survey. The findings include: 1. A review of the PQ revealed Histopathology slides from 5/18/18 to 6/11/18 numbered 18-194 - 18-226 were prepared. 2. The SL revealed the last slide read and resulted was 18-193 on 5/17/18. 3. The LC stated the slides were held at the laboratory performing the Technical Component. 4. The LC confirmed on 6/18/18 at 12:45 pm that the laboratory did not ensure test results were reported in a timely manner. 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 --