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 laboratory records and interview with a laboratory representative; the laboratory failed to have a reliable system to ensure that test results are accurately transferred to the final report destination. Findings include: 1. Review of patient test results for vaginal wet preps found 2 of 6 patients identified on the "PPIL Wet Prep and KOH test log" failed to have test results for vaginal wet preps in their patient chart. a. Patient ID: P8 tested on 02-28-2018 b. Patient ID: P10 tested on 05-08-2019 2. On survey date 7-11-2019, at 1:50 pm the above findings were confirmed by the laboratory representative. 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 --