You have gotten the approval to bring on a new test that will reduce costs and improve testing turnaround time. Your training/validation kits have arrived, and you have been through training on the new assay. Now upper management wants to know when the tentative go live date will be.
There are many things that all need to come together before you go live with a new assay. In order to be most efficient, there are many things that must happen simultaneously. Have you ever run into some of the following roadblocks in your lab when trying to bring on a new assay?
- “Oops! We don’t have any kits to start on Monday…” Do you have the supply of kits, controls, consumables to get you through the first month after your target go-live date? Do you have to worry about anything being on backorder?
- “We’re starting tomorrow! Wait, what do you mean the clients can’t order it?” It will take the IT department some time to make the test orderable by the clients. They will need to build the test in the computer system and may need to work with client interfaces. These things take time and may be out of your control. The sooner you think about them and work with IT, the better.
- “We’re starting tomorrow! The validations are done! Oops, no I didn’t realize the validations and procedures needed to be officially approved and signed by Dr. Science…” Who needs to approve your validations and procedures? Will they be going out of town around the go-live date? Will they have the time to review everything before you go-live? Communication on what they expect to see in your validations/procedures and a timeline for when things should be done will help.
- “We went live on Monday, but nobody is sending specimens…” Did you remember to send a letter to the clients/physicians promoting the new test? Do they know the go-live date? Do they know how to order it and what the specimen requirements are?
- “Our CAP inspection window opens next week…you did update the activity list and you are doing proficiency testing, right?” Did you remember to update the CAP activity list with your new test? Did you order PT specimens? If PT specimens are not available, how will you handle alternate PT?
Do you relate to any of these common problems? Download our handy [download id=”1″ format=”1″] to help you keep track of where you are in the process, and help get your lab going live!