A Recipe For Success: Kit Substitution

kit-best-practicesThis article originally appeared in late 2014. However, the information is still relevant and may help sites when faced with the need to substitute a kit, especially given the recent K2 EDTA tube recall.  Please see this notice which was shared with impacted sites.

Substituting kits is a lot like substituting ingredients in a recipe: you have to find the item that is closest to what you are missing. Of course, It’s best to not have to substitute one kit for another, or with our example above, one ingredient for another, but sometimes a situation develops where you have no choice and have to find the best match.

To avoid that last minute scramble, it is important to monitor all site supplies and expiration dates. This should be done routinely and well in advance of any patient visits. Kits can be ordered on our resupply website at:www.covance.com/kitordering. It’s important to be aware of the number of days required for resupply as it varies by region. This information is also available on the website.

Our eLearning goes through the best practice for substituting a kit. Most of the time this will be an easy fix with an exact match of another kit (example one in the eLearning) being available, but sometimes there isn’t an exact match (example two in the eLearning). In both instances, sites need to first consult the Visit Test Schedule in their Covance Laboratory Manual and always remember to only use one accession number per kit. The accession number is scanned upon arrival at Covance and prepopulates the visit and protocol associated with that kit. We all know what happens when you substitute salt for sugar – a ruined dish. Similar results happen when multiple accession numbers are used for one patient’s study visit: Tests can be cancelled, reports delayed and sample shipments missed to referral labs.

Follow these steps for successful kit substitution:

When an Exact Match is Found with Another Kit:

  1. Preparation is key – stay on top of site supplies and expiration dates.
  2. Use one accession number per kit.
  3. Consult the Visit Test Schedule in the Covance Laboratory Manual, and kits you have on site, to find the kit that most closely matches the kit you are missing.
  4. Mark through the kit name at the top of the requisition and write the new name of the kit underneath it. Date and initial this correction.
  5. Note the testing on the bottom of the requisition that is required for this visit. If no testing is marked a query will be issued and testing will be held.
  6. Answer all relevant Administrative Questions.

When NO Exact Match is Found with Another Kit:

  1. Preparation is key – stay on top of site supplies and expiration dates.
  2. Use one accession number per kit.
  3. Consult the Visit Test Schedule in the Covance Laboratory Manual, and kits you have on site, to find the kit that most closely matches the kit you are missing.
  4. This substitute kit may not have everything you need to complete the visit and a replacement tube (from yet another kit) may still be needed in order to complete all required testing. Re-label this tube and properly dispose of the rest of the donor kit.
  5. If not all the tubes can be replicated from the kits you have on hand, you can use tubes from your local supply. The replacement tube must match the tube as described in the collection instructions. Do not deviate from the volume or chemical additive to the tube as this could lead to erroneous results or canceled testing.
  6. Always re-label any added tubes using the extra barcoded labels found in your kit. Write the test name of the sample in addition to the patient ID. Once the barcode label is prepared, completely cover up the previous label with the new one.
  7. Discard the requisition found in the originating kit and use in its place the requisition for the correct visit copied from the Covance Laboratory Manual. Using the correct visit’s requisition ensures all information for that visit is collected. Complete the requisition as required and be sure you have indicated the accession number of the kit being used at the top of the copied requisition.
  8. Answer all relevant Administrative Questions.
  9. Do not forget to contact Covance to replace any kits.

These tips will help you successfully avoid and confidently manage kit substitutions. Our Investigator support staff is always available for any questions you may have regarding this process. You can find the toll-free number for your region listed in your Covance Laboratory Manual.