Dear API Abby

Dear API Abby,

I received a notice from my accreditation agency that I am not enrolled in all the proficiency testing I need. I am enrolled for all the tests we perform in the lab. Why would they be asking me to enroll in more?

- Dazed and Confused

Dear Dazed,

If you are confident about your PT enrollment, I can see why a notice about missing PT would be confusing. Some regulatory agencies keep a list of tests you perform and verify your PT enrollment against that list before the year starts. The main goal is to prevent you from missing required PT, but it is also a helpful quality control check of both organizations’ records.

The most common reason for receiving such a notice is that your laboratory test menu has changed slightly, and the regulatory agency does not know it. Maybe you switched to a waived method and changed your PT enrollment to only two samples per event. Until you notify your regulatory agency, they would still expect you to enroll in five samples per event.

In this case, telling them you now use a waived method would reduce your PT requirements and likely resolve the matter. Notifying your regulatory agency any time you make a change will help to ensure you are meeting your requirements. Don’t be afraid to contact them. They are your partners in laboratory quality and want to help! 

Dear API Abby,

We failed two of our last three proficiency events for chloride. This has never happened to us before and we are at a loss for what to do. We were notified that we need to perform reinstatement testing to be able to continue reporting this analyte for patients. What is reinstatement testing and when can I start testing again?

- Is All Lost?

Dear Lost,

Not all those whose proficiency results wander are lost! There are routes you can take to bring you back to the required path.

Reinstatement testing is when two graded events are performed successfully on blind samples. It is used to show your regulator that you have corrected the cause of your two failed events. Reinstatement may be taken as regular PT events or as off-schedule testing from any HHS-approved PT provider. You may start testing patients again after your regulator reviews your corrective action and the reinstatement scores, and approves your request to resume patient testing.

However, since you received a notification, you may also be required to wait for six months before resuming testing. Read your notification carefully for the details that apply to your situation. A cease testing sanction is not always issued; it depends on your PT history and other factors. For next time, note that laboratories with two failed events who contact their regulator before a cease testing is issued can often avoid the six-month pause in patient testing and potential suspension of Medicare and Medicaid reimbursement.

Before performing your two reinstatement events, ensure you have identified and corrected the root cause of the unsuccessful performance. To confirm that your corrective action was successful, retest your original samples, or get “troubleshooting” samples from your PT provider. Then, reach out to your PT provider or others, if needed, about how soon you can test two sets of blind samples. Usually turnaround is shorter for off-schedule samples than for a regular PT event. Any reinstatement samples should be tested and documented just like PT samples, and you will receive a formal evaluation.

Keep detailed documentation along the way, and you’ll soon be back on track!