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 laboratory records and interview with the Technical Consultant, the laboratory's quality assurance policy for evaluation of the accuracy of manually entered data into the electronic medical record is not followed. Findings include: 1. Review of the policy titled "Quality Assessment" states " ...a monthly evaluation of selected tests will be performed to evaluate the accurate reporting of patient test results". Patient Chart Review Log for 2017 and 2016 showed patient test results manually entered into the electronic medical record were evaluated for accuracy once each year. 2. Interview with Technical Consultant (Staff A) on May 9, 2018 at 11:50 AM, confirmed the evaluation was performed once per year and not monthly as stated in the laboratory policy. 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 --