I think by now it is safe to say that we are truly living in unprecedented times with the current Coronavirus pandemic. The majority of us have never experienced anything even remotely similar to this in our lives before. If you are currently a front-line worker in one of our medical fields, first and foremost – thank you! Secondly, we know you face a lot of challenges and uncertainties, wondering how to proceed when staff and resources are at a premium. With so much demand placed on diagnostics and routine QC, what about proficiency testing? In this blog post, I address three major points around proficiency testing and the current pandemic:
1. Are hospitals and clinics still required to conduct their proficiency tests during this crisis?
- Yes. If you are running lab tests and reporting patient results, you are still required to take your periodic proficiency tests for whatever tests you’re performing.
- If your lab has elected to temporarily suspend a particular test (due to staff shortages, supply chain issues, or unavailable testing reagents) you must notify your PT provider, as well as your inspection agency. Before the testing cycle closes, document on your PT results form/portal that the test is not currently being conducted at your facility.
2. What if my PT provider has notified me that one or more of their programs is postponed or canceled?
- PT providers are required to immediately inform CMS or other regulatory bodies, as well as all enrolled laboratories, if they anticipate their program will experience delays or cancellations. Be sure to keep all documentation and notifications from your PT provider for your audit records.
- Labs will not be penalized for skipping a PT cycle due to provider complications but are still encouraged to run their own internal assessments to ensure the expected performance of instruments and test processes.
3. I see my PT provider is offering SARS-CoV-2 modules available for new enrollment, but none of the tests have been FDA approved yet!?
- Now may be one of the most critical times to participate in COVID-19 PT testing! Current tests released by the FDA under EUA (Emergency Use Authorization) have limited information regarding the sensitivity and specificity of test performance. Additionally, labs are also submitting their own internal assays for FDA review, as well as there being multiple reported incidents of fraudulent tests being sold in the market.
- To ensure the most accurate results for patients, routine PT evaluations are key and should be conducted by all labs running COVID-19 laboratory tests. Although it is technically not required, including CLIA waved COVID tests in your PT cycle is critical for maintaining reliable, accurate COVID-19 diagnostics.
- During the current pandemic, PT testing plays a crucial role in assessing the accuracy of assays, removing flawed tests from the market, and ultimately ensuring public safety is upheld.
Despite the current pandemic, proficiency testing still remains a critical part of routine clinic activity. Especially now, it is crucial to incorporate the new PT modules that target the various SARS-CoV-2 diagnostic instruments and processes. Monitoring test accuracy in the field can only help with curbing the spread of the virus and maintaining a healthy local community.
Microbiologics Proficiency Solutions
To learn how we can support your PT program, visit our Proficiency Solutions page.