Fixation on Histology

Strategies for Validating a Tissue Processor

  

You’re excited. You’ve just received your brand new tissue processor and, like a kid unwrapping a present on Christmas morning, you can’t wait to dive in and play with your shiny new toy. After all, your lab may not have gotten a new tissue processor for ten years, so you’re really eager to find out what your new equipment can do.

But not so fast.

According to Heather Renko-Breed, Director of Product Marketing-Tissue Processing at Epredia, the last thing you want to do is just start using a new tissue processor before understanding how it works. “You cannot just move your protocols from your old tissue processor to your next,” said Renko-Breed during the NSH webinar, Validating Your Tissue Processor. “In order to produce the highest quality standardized and reproducible test results for our patients, we have to perform validation in the laboratory on each piece of equipment that we have, which is ultimately going to provide your pathologist with diagnostic confidence.”

Now that you’ve tempered your enthusiasm, just how do you go about validating your new tissue processor so you can ensure that diagnostic confidence? During the webinar, Renko-Breed offered several suggestions.

Educate Yourself on Methodology

The methodology you’ve utilized for years with your old tissue processor may not be useful when you use your new one. Since factors like temperature, time, agitation, and fluid exchange are not going to be handled the exact same way with different pieces of equipment, Renko-Breed stresses the importance of learning as much as possible about the new processor so you can employ methodologies that make the most sense. “Make sure that you understand any differences or changes from one instrument to the next,” she explained. “Make sure you do your homework and understand the considerations and the factors of the way that the instrument works.” Reading through the operator’s manual of your new processor is the foundation of this homework, says Renko-Breed. Additionally, you may enlist the help of your vendor, who can explain the best methodologies for using the product.

Learn Your Vendor’s Protocols

Just as a methodology will vary from one tissue processor to the next, Renko-Breed says you should also expect the protocols to be different. This is because vendors create protocols specifically with the needs of their customers in mind—whether they require protocols for biopsies, large specimens, or fatty specimens. “A lot of work goes into the development of this, and essentially your vendor should have an instrument delivered on your doormat with some hardwired protocols you can utilize as a jumping off point,” said Renko-Breed. “From one vendor to the next, you’ll typically get a routine protocol and they will tell you everything you need to have on that instrument, and every step you need to take for that routine protocol.”

The good news is, thanks to the work your vendor has done, you don’t have to reinvent the wheel. However, this doesn’t mean you’re wedded to that wheel either. Renko-Breed says that while a manufacturer’s protocol can be a solid starting point for using your new tissue processor, you can make various adjustments as needed. From temperature to time to vacuum, she says you can tweak the protocol to fit the needs of your lab, and you can work with your vendor to determine the best solutions as you make these changes.

Have Your Tissue Processor Revalidated

Renko-Breed says that validating your tissue processor should not just be a one-and-done affair, so she recommends having equipment revalidated by quality assessment programs, such as HistoQIP. By participating in these programs, labs can have their tissue processor evaluated and receive a report detailing its performance and how it measures up in peer comparisons—all of which will ensure the lab can perform tests with confidence.

“It’s really important to continuously look at ongoing proficiency testing programs,” she said. “They will do peer scoring and peer grading to know that ‘Yes, my tests are still meeting the expectations and are still high quality tests that my pathologist can use for diagnostic confidence,’ because a lot of times we validate our tissue processor and then kind of put that information in a drawer and forget about it.”

To hear more advice that Renko-Breed shared during the Validating Your Tissue Processor  webinar, click here.

Written By: Kenya McCullum


#2023
#Blog
#LaboratoryOperations
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12-22-2023 14:21

Hello Kenya McCullum,

Thank you for your interesting article. It reminded memories of the time when our laboratory acquired a new tissue processing machine and discarded the old one without showing any appreciation. Regrettably, we encountered a defect in one of the wax beakers of the newly installed machine. This incident caused everyone to laugh and feel ashamed about discarding the old machine prematurely. Surprisingly, the old machine stepped up and resumed its duties as if nothing had changed.

To validate the new machine, one feasible method is to process the same tissue samples on both machines and blindly present them to the pathologists for quality evaluation. This would require a dedicated form exclusively designed for this purpose.

Additionally, we should not overlook the importance of providing the laboratory staff using the new machine with brief training on "Change Management." This training would enable them to adapt and acclimate themselves to the new environment effectively.

Lastly, I have a question that I did not know of the statement at the end of the article: "The equipment is revalidated by quality assessment programs, such as HistoQIP." How frequently should such "revalidation" be conducted?