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 for one (1) of eight (8) patients' histopathology slides from 01/08 /2016 to 05/25/2017, patients medical records, and an interview with a laboratory personnel, it was determined that the laboratory failed to ensure that a histopathology final report (medical record) result was accurately entered onto the patient's final report (medical record). 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. The findings included: a. Review on 01 /18/2018 (survey date 12:00) of the laboratory's test records, slide identifiers and final test report (medical report) for the patient's histopathology slide ID KAR17-204 A2 (06/27/2017), it was determined that the electronic patient's final report was missing from the patient's electronic medical record (EMR). The laboratory's practice is to scan the final patient report into the electronic medical record (EMR). b. On 01/18 /2018 the laboratory personnel affirmed that the patient's medical record final report result could not be retrieved in the EMR. c. The laboratory testing declaration (01/15 /2018) estimated a total annual of 1,853 histopathology testing performed and reported. 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 --