Fixation on Histology

Understanding the Spectrum of Patient Risk

  
Everyone in your lab knows the risks they face whenever they come to work. Whether the risks are from toxic chemicals, managing fresh tissues, or using sharp knives to cut samples, we have a daily reminder of what can go wrong in our histology labs every day. 
 
Unfortunately, we are a little bit removed from other lab risks that can be every bit as serious if something goes wrong—the risks to patients.
 
Trung Nguyen of Peter MacCallum Cancer Centre in Melbourne, Australia reminds us of those risks in the NSH webinar A Risk Matrix Approach to Validation/Verification of Antibodies for IHC
 
“We don't get to see the interaction face-to-face like nurses and clinicians and doctors do. We just see the sample come in—hopefully with adequate formula for fixation—but we don't get to see the human face behind the specimen much,” Nguyen explained. “We really need to start thinking about the risk to the patient if we get things wrong in the lab. You only get one shot at diagnosing someone's breast lesion for instance. You really can't come back after a blood test and ask for a rebleed. So there's a big deal of responsibility there with the sample that's been entrusted to the lab for you to do the right thing all day, every day, to get the diagnosis correct. There are really good treatments available for specific tumors, so it’s very important, down to the subtype of the tumor, to get the diagnosis right.” 
 

Putting a Human Face on Risk

 
To ensure that patient risk stays top of mind, the Peter MacCallum Cancer Centre designed a risk matrix so everyone in the histology lab understands the impact a false result may have on patients, as well as the likelihood of a false result from a test. These levels of risk are categorized as minor, moderate, major, and catastrophic, and Nguyen explains them in these ways:
 

Minor. This type of risk could potentially impact the subtype of a diagnosis but would have little or no impact on patient management.

 

Moderate. Moderate risk could lead to a less definite diagnosis if testing errors are made, so further investigation would be needed to determine what the actual diagnosis is.

 
Major. A major risk may result in an incorrect diagnosis, a false impression of prognosis, or unnecessary investigations. Also, a mistake made at this level can affect the type of treatment, so patients may undergo lengthy and intensive treatments that are not necessarily appropriate. 
 
Catastrophic. This level of risk could mean that a patient receives the wrong type of treatment entirely, or even no treatment at all. 
 
By assessing these risks, Nguyen says a lab can determine the level of validation required for antibodies, so the higher the risk level is, the higher the validation needs to be.
 
“Not all antibodies are created equally in how we use them and interpret them. There’s a spectrum of risk there from minor to catastrophic, but that's just one part of the puzzle,” said Nguyen.
 
Understanding the spectrum of patient risk in histology labs is crucial for ensuring accurate diagnoses and appropriate treatments. While lab professionals might be acutely aware of the immediate physical risks they face, it is essential to also recognize the profound impact their work has on patient outcomes. Trung Nguyen's insights from the Peter MacCallum Cancer Centre highlight the importance of maintaining a rigorous approach to validation and verification processes to mitigate these risks. To learn more about this including how to determine an error during validation and evaluate the level of internal controls needed to avoid risk, check out NSH’s A Risk Matrix Approach to Validation/Verification of Antibodies for IHC webinar here.


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