“It was a busy day in a cell processing facility, all biosafety cabinets are busy with cellular products. Things were moving well with products being processed in separate work stations by different personnel. Processing was almost complete and staff were getting the cryopreservation bags ready for cells dispensing. A staff member completed their processing and offered to help their colleagues by labeling the cryopreservation bags and getting them ready. Processing was complete and products were cryopreserved. When the staff were moving the cryopreserved products from the controlled rate freezer to the liquid nitrogen storage, they were verifying the storage spot of each bag only to realize few THAT bags had labeling error; the final label and the partial label were mismatched”
This story happened for real, and the consequences were so painful. The response to such error may vary a little from one institution to another, but it can cover any or all of the following:
Filing a protocol deviation
Investigating the deviation at all involved levels
Identifying and implementing corrective and preventative actions
Potential loss of one or more products
Potential delay of patient transplant
So, what had happened here?
It would be very difficult to know exactly what had happened; there are multiple potential scenarios to describe what happened, but they are all assumptions. The only solid fact is: we have 2 products that were processed simultaneously and one of them displays the information of both products. Which raises doubts about what product was dispensed in what bags, and puts both products under query.
Even when there are indicators that xy bags are for ab patient, the slim chance that this assumption is wrong makes it unsafe to utilize this product without proper verification. The number 1 issue here is the loss of identity; if you can’t verify the product identity then it is unsafe to administer the product.
How to avoid such mistakes?
There are few practices that although simple but can prevent this from happening:
a. Segregate: keep products of different patients separate at all times during processing, this includes the product and the material. By keeping all paperwork, samples, bags, and labels in their designated work station you reduce the chances of mix ups.
b. Cross-verify: you probably relate to the fact that most of cell processing facilities are stretched thin in terms of staffing. Therefore, personnel are allowed to verify each other’s work. This verification though should be limited to paperwork, all processing-related work should be completed by the person in charge of that product, including the labeling.
c. Verify, verify, verify: as the person in charge of a product, you should always verify the product identity before every manipulation step. There are critical times where mix ups become more probable such as, spinning, labeling, and dispensing. Verify to ensure you are working on the right product using the right material.
Errors happen, but you can reduce their chances. By identifying, implementing, and sticking to error prevention practices, you almost eliminate the major mistakes and greatly reduce the chances of other mistakes.
Let us know if we missed anything, or if you would like a specific subject to be discussed, write to us.
About the author
Naseem Almezel, earned his MSc degree in Cellular Therapies in 2010, since then his career focus is to support Bone Marrow Transplant and Oncology programs. Naseem likes to work in the lab doing translational research, or in the cleanroom doing GMP production. When he is not working, Naseem likes to read and to spend time outdoors. Find more about Naseem here
