Project Board- Reagent Tasks

Reagent Tasks

Welcome to the first section of my Card Bank- Reagent Tasks.

Many of my projects are the validation of new assays, or the implementation of new processes, and these really should be thought out before they are started.  Typically, one person is tasked with such projects but as long as you can share and collaborate there are many reasons to include others on a project such as this.

Your Kan-Ban board allows for collaboration, assignment of tasks, and everyone can see what needs to be done.  Including others assures a well-trained staff, maximizes productivity and efficiency, and fosters the Team production.  New ideas can be shared, and you assure succession for your absence.

In my experience of bringing in new tests for the laboratory it has been evident that some of the longer delays relate to not having all the material on-hand to get a good start.  It may sound easy to place an order for a new reagent and have it delivered but it is not always so.  Remember the point of the Kan-ban board and your own card bank.  At this time, we are looking at the whole project to decide which cards we will be using and move them to the In Development area (a sort of pre-start).  AFTER all the cards needed for a project have been moved to this area, it will be easy to write a validation plan to get signed by your medical director.

So, starting with the Reagents, this is what the tasks of each entail:

Obtain Source of Reagent- this may be from your primary vendor which may require an amendment to your contract, or it may require finding a distributor you can work with as you may not have a purchasing agreement with the manufacturer of a third-party assay.  I cannot buy my Randox reagent from Randox but Cardinal does the job.  I have found my Account Executive from my analyzer vendor very helpful in this matter.  Even if it is not their reagent then they have people who support them to ask around.  You will need the reagent, calibrator, and other accessories that may come from multiple vendors.  Think ahead and you may be solving tasks in your QC task list.

Add to Special Order List?- We have a materials management system that should have items regularly purchased with prices.  New items will need to go through a process to add them.  In some cases it will always be "special order".  You should have a well-organized list somewhere so others on your team can order supplies in your absence.  Add items as needed.

Place validation order- No much can happen without your first supplies coming in.  Never hesitate to ask for free validation supplies.  This may come with a Field Application Specialist (or equivalent) from the vendor who can install the assay.  Keep in mind that this may not be enough for all your validation so be prepared to order more so you maintain the same lot number and there is no delay when reagent is used up in the first week of validation.

Place Initial Order for Go Live- Here is what I mentioned previously about enough reagent after the possible "freebies".  I like to see the first order before I place another to complete the validation and enough to 'Go live" with.  I don't want a lot number to change a day before and have a shift in QC.  I have been burned by not having enough and burned by buying more but the validation was not satisfactory, and we did not Go live with the new assay.

Roche FAS (or equivalent) to install assay- If I will get the assistance of the vendor for installing the assay and some validation this will need to be scheduled and I won't want my project delayed because I did not get on their schedule.  Get on their schedule no later than the day you get the validation plan signed.  If the vendor will not be coming (i.e. third-party) find out who you can contact for technical issues.  Put that as a note in your validation plan and on your project board.

Build 3rd Party in CDC File Creator- applies only to third-party assays and since I have a Roche Cobas Pro, all third-party applications are built on their website.  This is a real improvement over stopping an analyzer and typing assay parameters into the analyzer while patient samples wait, or another analyzer takes the full volume of samples.  This is actually a very large task that takes a lot of recourses and time to complete.  Look for a posting of mine at later date regarding my presentation at ADLN (formerly AACC) for Third Party Applications.

Load CDC File on Analyzer- related to the above.  It is a task that requires an analyzer to be in standby and should only take a few minutes.  Depending on many factors it may or may not be an easy process.  It does imply that afterward may be a good time to build calibrator and QC files and assign positions and test targets and anything else your system needs.

Load Reagent and Initial CAL/QC- Here is where we can have a very satisfying feeling when we see our assay comes to life.  Especially if we have put the time to building a third-party assay.  This will be a milestone in your project and your validation studies can be started after this.

Remember, your task list will be unique and may include more or less items.  Preferably each card will be a single task.