COVID-19 Participation Notification

Dear Participant,

We understand that many facilities will be closed and not performing testing or performing a reduced menu of testing. CMS recently published clarification of the rules regarding Proficiency Testing during the COVID-19 epidemic. Generally, the statement is that CLIA rules regarding PT are still in full effect. The need to communicate to us in writing prior to the end of an event that you cannot participate will not change. We strongly encourage you to take a moment and let us know if your facilities are currently closed or will be closing during the upcoming event. This does not apply to laboratories that only perform waived testing. The notification of not testing needs to be in writing, but an e-mail to techsupport@aab-pts.org is sufficient. The key wording is that you are not performing patient testing at this time. We obviously hope that everyone will be back to normal before too long, so if you resume partial or full operations simply submit your results and grading will proceed as normal. If you only resume partial testing, it would be best to submit a statement of which tests you are and are not performing. We will do our best to understand your intent, but a clear statement will help immeasurably in insuring that our reporting to regulatory agencies matches your current situation.

For laboratories that expect to be closed during the 2nd Event May 5 – 20, you will need to let us know in writing, no later than Friday April 10. If you notify us you are closed, we will assume that you want us to hold your kit for later testing, unless you tell us you have made arrangement to receive the specimens. We will ship held kits as soon as you notify us you are resuming testing and will advise you as to the suitability of held specimens for testing at that point.

Per the Centers for Medicare & Medicaid Services’ (CMS) Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency document, “in the event where a laboratory temporarily suspends performing a specific test due to staffing shortage, supply shortage, or reagent shortage:
• The laboratory must document the timeframe during which the test is not being performed, and the reason therefore.
• The laboratory must notify the inspecting agency and PT program within the timeframe of submitting PT results that it has ceased testing, and the reason therefore.
• If the laboratory is still performing, or resumes such testing, and providing patient results, PT is still required and must be performed, as required by the CLIA regulations.”
If your laboratory is currently unable to perform testing, hold the material and use it for alternative assessment when routine testing circumstances resume.

Also, we ask that you strongly consider switching to the website; https://www.aab-pts.org/, for all reports and written communications. Phones will be manned as usual, but to minimize contact we are only staffing the office as necessary. We have no indication of delivery interruptions at this time, but that will be a possibility for the near future.

If we do not have an e-mail address for your laboratory, please go to our website and you can enter it there, or feel free to call our Technical Support group and they will take care of entering one or more for your account. This will ensure that you receive important information and routine communications throughout any periods of interruption.

As always, please feel free to call our Technical Support group at 800.234.5315 at anytime if you have questions.

Sincerely,
Eric Vanderslice, Ph.D.
Technical Director AAB Proficiency Testing
11931 Wickchester Lane, Suite 200
Houston, Texas 77043