Waived Testing Logs and Documentation of Quality Control Checks

Waived Point-of-Care Testing is a simple, low-risk laboratory test approved for use near the patient (such as a medical unit, doctor’s office, or pharmacy) rather than in a lab. Regulated by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration(FDA), they require a Certificate of Waiver and have an insignificant risk of error. Common examples include pregnancy, blood glucose, strep, and influenza tests.

Documentation is often digitized, including patient information, user information, and test results. However, our teams have identified opportunities to improve the use of paper-based logs for documenting testing results, including Quality Control (QC) checks performed on devices, testing strips, and reagents.

Specifically, at one organization, QC checks were performed for blood glucose testing; however, there were no acceptable ranges for the test strips being checked in the designated space on the log. After reviewing the instructions for use for the testing strips, the acceptable range limits were located. Compared with documented QC values over the past 2 months, multiple values were outside acceptable ranges, which may indicate that the testing strips were invalid and that subsequent patient testing may not be accurate. Directions for staff to re-test and notify the Waived Testing coordinator in the lab were not documented as
being completed.

Organizations must ensure that waived testing practices, including QC checks, are followed. Additionally, staff must know and follow procedures when performing waived testing, including processes for handling variations in quality testing. Furthermore, waived testing coordinators must round on waived testing to ensure adequate oversight of the program and address opportunities as needed.

Please contact us for questions or more information at 704-573-4535 or info@courtemanche-assocs.com.

Courtemanche & Associates specializes in Healthcare Accreditation and Regulatory Compliance Consulting Services. With over 30 years of being in business and 100+ years of healthcare experience amongst our consulting team, we are ready to assist with your accreditation and regulatory compliance needs.