Specimen Safety at Risk: Real-World Threats of Misidentification and Cross-Contamination in Histology Labs—And How Process Improvements and Technology Can Help

Dec 1 / J. Greenlee
In the world of histology, where accurate diagnoses hinge on the precision of specimen handling, the importance of maintaining stringent specimen identification protocols and minimizing cross-contamination cannot be overstated. A LinkedIn post a few months back demonstrated a perfect example of this. The post came from Dr. Beri Ridgeway, the Chief of Staff at Cleveland Clinic. In the post, Dr. Ridgeway recognizes Dr. J Jordi Rowe, a dedicated staff pathologist at Cleveland Clinic.

A patient seeking a second opinion for a breast cancer diagnosis had their surgical pathology specimens carefully reviewed by Dr. Rowe. Her keen observation revealed inconsistencies that led to a suspicion that the biopsy and surgical pathology samples seemed to belong to different patients. After a DNA comparison, her suspicions were confirmed that there was, indeed, a mix-up, and the patient did not have breast cancer as initially diagnosed.

This incident highlights the pivotal role of meticulous specimen handling and identification in preventing misdiagnoses and ensuring patient safety. Dr. Rowe's actions spared the patient from unnecessary treatment and brought to light the potential consequences of lapses in specimen management.

There is a mantra for those who work in histology that is often repeated: remember and consider that each sample that arrives in the laboratory could be from a family member, a friend, or even our own. I remember the multiple doctor visits, procedures, and treatments my own mother dealt with during her battles with breast cancer. I remember the stress that weighed not only on her as she personally dealt with being told she had cancer but also the stress of family and friends. I could not even imagine going through all of that only to find out that it was completely unnecessary because the original diagnosis was a mistake.

Dr. Rowe did a fantastic job, and she rightfully deserves every bit of kudos and celebration that she receives for it. However, she should have never even been in that position.  If not for her keen eye, training, and a bit of luck that the slides landed on her desk and not someone else’s, the patient may have remained misdiagnosed.  The original misdiagnosis should never have happened, either. Unfortunately, as someone who has worked for decades in a laboratory, I know this is a real and legitimate risk based on many current processes, especially the manual processes used in histology.

This blog post is not about blame. Blame is irrelevant. There is no malicious intent when mistakes like this one happen. They do not occur because of a lack of caring or because the laboratory is filled with monsters.  They are often the result of process deficiencies and, in some cases, a confluence of variables and events that lead to a higher probability of mistakes. The solution is not to find someone to blame. Instead, the solution involves taking a realistic look at current scenarios and processes and identifying areas where improvements can be made to reduce risks.

As we delve deeper into the significance of maintaining specimen identification and reducing cross-contamination in histology, this case is a powerful reminder of the impact that vigilance and accuracy in pathology can have on patient outcomes.  This blog post will identify potential process causes that increase the risk of tissue mix-ups and cross-contamination and provide some best practices and possible process improvements and technologies to help mitigate these risks.

Potential Causes of Specimen Identification Mistakes and Cross-Contamination

Errors in specimen identification and cross-contamination in histology can stem from several factors. This reality is why it can be so difficult to prevent and catch every mistake that can lead to the outcome discussed in the LinkedIn post. This blog post could quickly become a novel if I included every potential risk.  Instead, I will focus on some of the key areas related to histology. Let’s start by looking at errors in specimen identification.

Errors in specimen identification can occur at multiple stages in the process, from specimen collection to the final labeling and delivery of the slides to the pathologist. One significant source of risk is the use of handwritten labels and identification. Although it is getting better, there are still many laboratories that rely on the use of handwritten identification on specimen containers, cassettes, and slides. Not only is readability an issue, but because we are human, it is quite easy to transpose numbers, misspell names, and make other potential errors.  Printing materials like cassettes offer a safer alternative by providing precise and consistent labeling. Printing also enables barcoding, which helps mitigate risks in later processes like slide label generation and provides the opportunity to track and trace materials using technology and software. As laboratories have grown and consolidated where samples are more often sent from one facility to another, sometimes even across the country, proper specimen identification and tracking are necessary.

Incorporating a cassette printer alone is not the solution to all potential misidentification risks, however. The process of how laboratories print cassettes is also important. For example, laboratories that batch print cassettes before grossing are still vulnerable to critical mistakes. Pre-printed cassettes can end up mixed with containers from another patient. When preprinting, there is an increased probability of an incorrect number of cassettes printed as well. When too many cassettes are printed, the laboratory is at an increased risk that those additional unused cassettes get mixed up instead of thrown away.  When not enough cassettes are printed, the laboratory is at an increased risk that incorrect information will be printed on the cassettes when additional cassettes are made. These risks are exacerbated when the grosser must stop what he or she is doing to go to a printer or back to accessioning to have other cassettes printed. There is not only a risk of identification errors in this situation but also of tissue drying or something happening while sitting or unattended at the grossing station.

Unfortunately, misidentifications and cross-contamination mix-ups are also at a higher risk in histology laboratories because manual processes in histology are prone to variations and inconsistencies that increase the risk of errors. Varying levels of experience and technical skills of staff can impact risk. Certain processes, like manual embedding, carry a significant risk for cross-contamination. During the manual embedding process, each and every cassette is re-opened after tissue processing, and a human being manually manipulates every tissue.  That tissue also touches multiple surfaces before ultimately finishing in the block.  Those surfaces include the forceps, the embedding module, the cassette and cassette lid, the base mold, the tamper, and potentially more. Each point of contact is an area of risk of cross-contamination if each surface is not diligently and repeatedly cleaned. Even at that, if one were to randomly examine any embedding module at any point at any histology laboratory in the country, there is a veritable guarantee that at least some tiny bit of tissue would be found somewhere on that embedding station.  Other manual processes like grossing and microtomy carry similar types of risks.

We also must recognize the elephant in the room regarding histology laboratories, which is staffing shortages. Short-staffing and employee burnout significantly increase the risk of dangerous mistakes. Overworked staff members may be more prone to errors due to fatigue and stress, especially when performing manual tasks. Ensuring adequate staffing levels and addressing burnout are crucial to maintaining specimen handling and identification accuracy.

Best Practices and Opportunities to Reduce Risks for Specimen Identification


Now that we have identified some risks for specimen misidentification, let’s examine some opportunities for improvement that can help significantly reduce these risks.

Label and Cassette Printing:
Various cassette printers are available on the market, ranging from thermal transfer printing to laser printers using laser-activated resin cassettes or UV etching. Each has pros and cons regarding technology, price, and reliability. Still, they all share one thing in common. They are all significantly better than handwriting in reducing the risk of misidentification. Cassette and slide printers should be mandatory equipment for every histology laboratory today. Yes, cassette printers cost money, but the value of decreasing the risk of misidentifications and the time saved on troubleshooting and re-work on incorrectly labeled cassettes and slides far outweighs the cost of the printers. Laboratories cannot afford NOT to have printers because just a single mistake that could result in a situation like the one described in the LinkedIn post could result in costs or loss of business that far outweighs the cost of printers.

For laboratories that have moved to printing but are still doing batch printing of cassettes and/or slides, the next important step in mitigating errors is to move to point-of-generation printing of cassettes and slides where cassettes are created at the grossing station only at the time when the specimen is grossed and that slides are created at the microtomy bench only when the block is being cut.  I can almost hear the collective moans and groans of the pathology assistants and grossing techs saying, “You are telling me that you want me to print my own cassettes? You are out of your mind! It will slow me down, and printing cassettes is not my job!”  The microtomists may be saying something similar about slides. At the same time, I can hear the collective moans and groans of laboratory supervisors and managers saying, “You are telling me you want us to buy a printer for every grossing and microtomy station? We don’t have that kind of money, and we don’t have the space!”

Yes. I am saying exactly that in both cases. Part of the grosser's job is to submit the correct tissue in the correct cassette. That is arguably one of THE most important jobs of the grosser.  The current batch printing process increases the risk of errors, making the grosser’s job more difficult. Printing the cassette for the sample only when it is actively grossed eliminates the risk of cassette mix-ups. It significantly reduces or eliminates the risk of printing too many or not enough cassettes, along with the distractions involved in correcting those issues. It gives the grosser autonomy to ensure the proper tissue goes into the appropriate cassette through a simple process that eliminates risk instead of relying on redundant checks to catch mistakes after they have already occurred. This actually saves time for the grossers overall.  There are significantly fewer mistakes, re-work, distractions, and redundant checks to eat into the grosser’s time. Grossers who have never done it any other way may not fully realize the time wasted in the current process, but it is understood fairly quickly once they convert.  I know because I have lived through that conversion. Like most, I was skeptical at first, but within a few days, the benefits were clear, and the almost instantaneous error reduction was amazing. No grosser wants to be responsible for an error that can lead to a misdiagnosis. Eliminating batch pre-printing brings with it an incredible level of safety and peace of mind. Grossers quickly learn how to work the printing into their bench process to where it is practically unnoticeable.

Laboratory supervisors and managers typically have two primary concerns: cost and space. Both are legitimate concerns. Money doesn’t grow on trees, and histology laboratories are not notoriously spacious places. However, both obstacles are not insurmountable. Reducing risk and lowering cost are two ongoing goals of the laboratory, and point-of-generation printing, although the printers themselves are an investment, achieve both.

What is the cost of risk? Risk can be very costly, especially for a situation like the one the patient went through in the LinkedIn post. There’s also the potential loss of reputation and business. Hopefully, these types of risks are rare, but when they occur, they can be very costly.

There is also the cost-savings of reducing rework and waste.  I’m not talking about just how many cassettes are thrown away each year that were printed in excess and were not needed, although some laboratories may be shocked to find out how many are actually wasted.  I am talking about the time and resources spent making the pre-printing process happen. Someone spends time collecting and re-sorting all the pre-printed cassettes or slides. I’ve seen laboratories use rubber bands, tape, plastic bags, and all sorts of “clever” ways to keep pre-printed cassettes together.  That is time staff could spend accessioning more cases or other value-added activities. Instead, we are paying people to rubber-band cassettes together only for them to be unbound, possibly moments later.   Some may think, “Well, it only takes a few minutes per day, so it isn’t a big deal.”  Often, it is not realized how much time we waste in laboratories on things that “only take a few minutes” every day.  There is time spent switching between activities like accessioning to grouping and back to accessioning. Time is spent redundantly checking to attempt to catch mistakes. Then there is additional time spent by the grosser removing the rubber bands, organizing the cassettes, and rechecking the cassettes AGAIN to make sure that a mistake hasn’t happened.  Multiple redundant checks exist in the process because, as much as we hope the cassettes are being checked, we all know that mistakes still occur because of the nature of the process. W. Edwards Deming, whom some call the grandfather of lean, has two quotes that I particularly appreciate related to these circumstances. The first is, “Defects are not free. Somebody makes them and gets paid for making them.”  The other is “Cease dependence on inspection to achieve quality.”  Point-of-generation printing helps eliminate defects and, thus, redundant inspections. When the laboratory keeps an open mind and evaluates the potential risk reduction and cost savings, the justification for buying additional printers is not too difficult.

“What about space? Even if we justify the money, we can’t just create space out of thin air.”  Space in histology laboratories is a limiting factor, but we must be careful not to use it as an excuse to prevent us from improving either. Manufacturers of printers know space is an issue, and printers have gotten smaller. A handful of cassette printers are available that only need approximately 1.5 square feet of space in total, some even less. There are also typically several ways to free up space that the laboratory never knew existed. Performing a simple 5S of the grossing station and surrounding areas can often free up significant chunks of space by eliminating clutter. Laboratories are notorious for having stuff hanging around “just in case,” even though it may not have been touched for months. “Well, that isn’t us!  We only have and use what we need!”  Don’t forget that changing the process to printing on-demand, as a consequence, changes other things around it as well.  For example, laboratories often find that their staging area for grossing does not have to be as big anymore because they no longer need to make room for the pre-printed cassettes grouped with the specimen containers. These are just some simple examples, but the point is, typically, where there is a will, there is a way. Histotechs are great at finding ways to make things work. This is no different.

Barcoding and tracking, which cassette and slide printing enable, is another great way to help eliminate misidentifications and mix-ups. Instead of typing in case numbers or identifications by hand, scanning and printing via barcoding cuts much of the risk of human error out of the equation. It can also help automate process steps to further reduce risk and save time.  Point-of-generation printing is not just useful at grossing, and barcoding of cassettes helps the implementation of the same process with slide printers at microtomy.  The microtomist only prints and creates the slide for the block he or she is currently cutting and creating slides.  The laboratory will experience similar benefits as described above with saving time, cutting costs, and reducing risks when implementing slide printing for each microtomy station and eliminating batch printing.

Standardization and Automation:

Standardization and automation in histology are important in mitigating risks of misidentification or cross-contamination by ensuring uniformity and reducing human error. Automated systems that currently exist, especially for notoriously manual processes in histology, like labeling, grossing, embedding, microtomy, and tracking, can enhance process efficiency and reliability. Standardized protocols and procedures for automation ensure that every specimen is handled consistently, minimizing the potential for mistakes.  Printers and barcoding have already been covered, but below are some examples of other existing technologies that can help reduce the risk of misidentifications and cross-contamination:

  • Automated Grossing Imaging Systems: Cameras at the grossing station are not new, but some new technologies are not just your everyday cameras.  Systems from companies like Spot Imaging (Spot Imaging) can be used to help capture information at grossing, including images, to monitor for mistakes. Newer technologies like the Sentinel from Vistapath (Vistapath) take it a step further and use AI and camera systems to continuously verify that the sample, vial, and cassette IDs match to reduce mislabeling and specimen mix-ups.


  • Automated Embedding Systems: Few options currently available for histology can exceed the risk reduction and cross-contamination benefits of automated embedding.  Technology like the Tissue-Tek AutoTEC a120 uses specialized cassettes called Tissue-Tek Paraform Sectionable Cassettes to protect and preserve tissue samples starting from grossing (Sakura Finetek USA). The combined systems eliminate the manual handling of specimens and the significant risk of cross-contamination present with typical manual embedding​. Automated embedding is not scary or unvetted technology either.  There have been publications and reports talking about how the standardization of automation can help workflow and reduce risk for almost 20 years ​​ (Labnews)​.


  • Automated Microtomy Systems: Embedding is not the only notoriously labor- and risk-intensive area in histology that can be automated.  Microtomy technology has advanced as well.  Semi-automated microtomes have been available for years and can help reduce the risk of repetitive motion disorders.  Various levels of semi-automated microtomes exist, ranging from those that simply provide automation for turning the handwheel to those like the Tissue-Tek AutoSection Automated Microtome (Sakura Finetek USA) that can also automate alignment of the chuck, reducing the risk of tissue loss from poor alignment.  Microtomy automation does not stop there either.  Newer, fully robotic, systems, like the AS-410M from Axlab (Axlab) act essentially like a microtomist in a box, capable of automating slide labeling, sectioning, and section placement on the slide.  This technology is newer to the histology world than some of the other types of automation, but there have already been laboratories using this technology to help standardize microtomy and reduce risk for several years.  The technology will only grow from here.


These are not the only automated systems that exist in histology that can help standardize processes and reduce risk. Still, they were highlighted because many laboratories may not be very familiar with them as options, even though some have been available for several years.  These systems are also not silver-bullet solutions.  There are pros and cons to each one, but the one thing they all have in common is that they are moving the laboratory forward regarding improvements, especially in the case of risk reduction.  Many manual traditional processes still commonly used in histology laboratories are not sustainable, and with staffing shortages a significant concern for many laboratories, automation is unique in its ability to often combine standardization and risk reduction with workflow and resource improvements.

Conclusion

Accurate specimen identification and reduced tissue cross-contamination are essential for ensuring the quality and reliability of histological diagnostics. Although it would be nice to say that the case mentioned in the LinkedIn post where Dr. Rowe saved the day for a patient was some rare outlier, the reality is that the processes that resulted in the risk and error described are unfortunately looming every day in many histology laboratories.  Implementing best practices, following standardized protocols, and adopting new technologies can significantly mitigate these risks. By prioritizing these measures, histology labs can enhance patient safety, improve diagnostic accuracy, and maintain high standards of care.

Check out the following link to see the LinkedIn post and if you would like to congratulate Dr. J Jordi Rowe on a job well done (
LinkedIn).
Created with