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 two (2) of eight (8) randomly selected patients from 04/15/2016 to 12/08/2017, quality control records, patients medical records and an interview with a laboratory technical supervisor, it was determined that the laboratory failed to ensure that the bacteriology final report result were accurately entered onto the patient's final report (electronic medical record (EMR)). 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 04/03/2018 (survey date 12:00 AM) of the laboratory's test records and final test report (electronic medical report (EMR)) for the patient ID S. L. (D.O.B 12/24/2014) for urine bacteriology testing performed on 08 /08/2016 and patient ID M. P (D.O.B. 06/12/2003) for urine bacteriology testing performed on 12/08/2017, it was determined that the patients' final reports were missing from the patients' electronic medical records (EMR). b. On 04/03/2018 the laboratory personnel affirmed that the patients' final test report could not be retrieved from the EMR. c. The laboratory testing declaration (04/02/2018) estimated a total annual of 900 bacteriology 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 --