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 record review and an interview with the office manager; the laboratory failed to accurately and reliably manually transcribe test results into the patient's electronic medical records (EMR), for 1 (Patient-Pq5) out of 4 patients. Findings include: 1. The laboratory's standard operating procedures (SOP) manual, patients' electronic records, and test logs were reviewed. 2. The laboratory performs Potassium Oxide (KOH) and Wet Mounts procedures to test for the presence of Hyphae /Candida, bacterial, and parasitic organisms. 3. The review of 4 patients' test log results and their EMR final reports showed the following: Test log: Patient-Pq5 - KOH -"NO" (Hyphae/Candida not present); Wet Mount - boxes marked "Yes" for yeast Buds present, "Yes" for Trichomonas present; and "Yes" for Clue cells present. EMR report: Patient-Pq5 - Hyphae/Candida: no; Budding yeast: no; Trich: no; Clue cells: no; and WBCs (White Blood Cell): "Yes" (few). 4. The laboratory failed to ensure microscopic results were accurately transcribed from the test log into patient's EMR for 1 out of 4 patients. 5. On 09/25/2020 at 12:15 PM, the office manager confirmed the above findings. 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 --