Summary:
Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) (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 policy and procedures, test reports, and interviews with the laboratory representative; the laboratory failed to ensure that manually transcribed test results are accurately transferred to the final electronic medical record for one of two potassium hydroxide (KOH) wet mount patient test reports reviewed. Findings include: 1. Upon review of the laboratory's "KOH examination and QC" policy and procedure, under "Documentation", it stated, "The orders and results of the KOH prep are documented in the patient's electronic medical record and a positive or negative test result including elements seen is recorded, as well as any additional pertinent findings on microscopic exam." 2. Review of KOH wet mount patient reports revealed one of two manually transcribed patient test results reviewed were not accurately transferred to the patient's electronic medical record from the microscopic exam log. Patient MRN: 5247205 Date of Testing: 02/14/2024 Microscope exam result: Positive Patient electronic record: Negative 3. Interview with the laboratory representative at 10:40 am on 01/31/2024, confirmed the laboratory failed to ensure that manually transcribed test results were accurately transferred to the final report destination for one of two KOH test reports reviewed. 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 --