What is the optimum length of time to “Fix” tissue samples with Formalin in the routine Histology lab, before proceeding to tissue processing? I know we have all been taught that we must “complete fixation” first, but what does that really mean and why don’t we need a better standard? I think we can all agree that the most common fixative used in the Histology laboratory is 10% Formalin (rapidly penetrates, denatures proteins, stops enzymatic degradation and cross-links proteins), but can do not agree on an optimal fixation time? There is too much variation in practice and the CAP/ASCO guidelines for breast tissue (what about other tissue types?) does not really help to set a standard that we can use an acceptable variation range. Breast tissue must be fixed for a minimum of 6 hours and no more than 48 hours with needle cores (are they not breast tissue?) being are exempt and have only a suggestion of a minimum of 1 hour, but testing is discouraged on specimens that have been fixed for 1 or 2 hours. I don’t know about you, but I continue to be confused and again ask, what is the optimum Formalin fixation time for tissue samples?

Let’s reopen the fixation discussion and I have several questions for you to consider. What are we really trying to accomplish with our fixation techniques? What is the minimum and maximum time in Formalin, with an acceptable variation range, before proceeding to an alcoholic solution? I propose that we are creating a process that stabilizes tissue samples and produces a consistent artifact for the reviewing pathologist. If you agree with me, then what would be the minimum time in Formalin, 4 hours, 6 hours, 12 hours or 24 hours? And what would be the maximum time? What is the acceptable variation?

Fixation is a process, a process that should be standardized, of stabilization anatomical features in biological tissue that allows us to produce consistent results in a controlled manner. That’s what I think, what do you think?

It is way past time for all Histology labs to step out of the dark and embrace a standardized Test Method Validation Protocol: Standardized documentation and process control is an integral part of Good Laboratory Practices. This standard must be used anytime a test or protocol is introduced or changed to ensure the final test result will remain in compliance throughout the lifetime of the procedure.

Have you ever uncrated an instrument, plugged it in and started using it? How about receive a new shipment of stain reagents, place them right on the instrument and start using them? Why is it that in the Histology Lab we make procedure and process changes every day and assume that the change will produce the same result without validating the material, instrument or process?

I hear it everyday that this is JUST histology and we NEVER have a problem and besides we have done it this way for EVER without problems. I do not think CAP, JCAHO, the State and certainly not ISO 15189 standards require or allow us to function this way. What about the patient and what if you were the patient? Would you hire someone that worked in this manner?

Validation procedures in Histology must be reliable, stable and include a wide range of quality parameters. Every test or protocol may not use all basic quality parameters, but each test or protocol must be evaluated and reviewed to determine the suitability and application of the appropriate quality parameters:

Accuracy          Precision          Specificity         System Suitability          Reproducibility

What is your procedure and documentation for test and protocol change? What must we do to consistently provide the best quality results for the patient, the Lab and ourselves?

“Tell me and I will forget, show me and I will remember, involve me and I’ll understand.” – Confucius

We have all encountered the difficulties in educating, training and re-training employees to work in a Quality and efficient way in the Histology Lab. I think we can agree that there are many obstacles and reasons why this continues to be a struggle. I believe one of the biggest hurdles is our diversity. Now, do not misunderstand me, I think diversity is important and I am a supporter, but Histology is not staffed with classically trained employees that have the same education path or a standardized procedure, protocol and technique education or training. This type of diversity creates many challenges and it will take all of our efforts to overcome them. That said what can we do today to assist in the advancement and promotion of the science of Histotechnology and most importantly, provide the needed replacements for the baby boomers (I happen to be one)?

With the advent of healthcare changes looming, laboratory testing and Histological preparation and technique will become ever more important in providing the increasing amounts of data that will allow our pathologist partners to provide a diagnosis. So, what needs to be done to train and produce the Histotechnician and Histotechnologist for the next 20 years? How do we first convince and then train the new millennial generation to work in the field of Histotechnology, while constantly trying to meet their demands for input, interaction and stimulation?

With the trend by all our companies to reduce the education dollars for us to access traditional continuing opportunities, what do you see as the alternatives? Who do you see as the primary providers of this essential information? How interactive will the material need to be? Is the internet the answer? I think time is running out and we must rethink, redesign and reconsider our education requirements and needs. Where do you get you continuing education?

There is a technology that has been used in the Histotechnology for many years that is preparing to explode and promises to change all our lives - Digital Imaging. This technology will transform the Pathologists daily workload functions and remove the need for glass slides and the microscope. Is anyone considering the lives of the Histotechnologist? Doesn’t the Imager need a slide to image? Has this really been thought out from the process side?

I think the advancement of this technology is another example of the industry ignoring what really happens in a Histology lab and is assuming a slide is a slide. A “slide” is not the same from lab to lab, not even from day to day in some labs. And how many labs use the exact same equipment and reagents? How is this digital imaging going to transform the Histology process if we continue to ignore the basic principle of Standardization?

If we are going to be asked to provide digital images for diagnosis, would it not be better to produce an image that could be reviewed by multiple sites and Pathologists and provide a basis for collaboration, concordance and consultation? We continue to have “advances” pushed into Histology that do not advance the science of Anatomic Pathology.  Would it not be better for the patient and health care if this technological advance actually reduced costs while providing another valuable link in the electronic record?

I see great uses for this technology in Histotechnology. I would not start with the routine H&E, but with the re-cuts, special stains and IHC.  Once the basic H&E is reviewed, the aforementioned procedures most often produce a qualitative result that could be easily reviewed using the digital image. I know that breast tissue testing (i.e. ER/PR, Her2) are now used in a quantitative way, with the aid of complex software, but wouldn’t it be a great improvement to patient care and process flow to be able to provide the Pathologist with his re-cuts and all staining, post H&E, digitally? Think of the cost and time savings if there were a way to incorporate an imager into the staining instrument. Think of the advantages if the slide could be shared with multiple Pathologists, across multiple sites for instantaneous consultation. Histology results would truly travel at the speed of the Internet.

But wait, do you think a Pathologist outside of your lab will accept the stain quality produced in your lab and make the diagnosis? What do you see as the advantages or disadvantages of digital imaging expanding? How would you use the technology?

The Histology Lab, as we know it today, is rapidly being transformed and consolidated to create the new Integrated Histology Lab. In this new Integrated Lab, Routine Histology (tissue processing, cutting and staining) will be but one piece of the diagnosis puzzle and a small  part of the information collected and conveyed in the Surgical Pathology Report. The Histotechnologist will need to learn a whole new set of skills and will be competing with Medical Technologists for the control and management of this new Lab.

No, routine Histology is not being replaced, but for cases that provide a diagnostic or differential diagnosis, one or more technologies now residing in the Clinical Lab will be integrated into the Surgical Pathology Report and a Pathologists will use the information provided by these technologies to develop the final diagnosis.  That means Cytogenetics, Flow Cytometry, Molecular Biology and Radiology will be sharing and competing for samples normally used only for Routine Histology.

This transformation means there will be many new issues and challenges to workflow, workload, quality control and quality assurance. This is not a time for Pathologists or Histotechnologists to sit back and allow anyone else to step in and try to manage this process. Who else is better qualified or has the necessary background and knowledge to drive the efficient use of small irreplaceable specimens to realize maximum information? Shouldn’t we demand to strengthen our relationship witht the the doctors, surgeons, clinicians and patients instead of distancing ourselves through the management of others? What do you think we should do or how do you see this change taking place?

The Histology Automation Revolution is coming! the Histology Automation Revolution is coming!

For the past ten years, we in the field have been told to watch for the technology rider to gallop to our labs and announce that new automation is here. The rider has come to our labs several times, but it seems to me he is at a slow walk and the lamp of true technology change has not yet been lit. I do not think we will wait much longer.

I know what you are saying to yourself, hasn’t he seen all the new instruments that we can buy?! There are automated slide stainer/cover-slipper  combos and rapid and microwave tissue processors, technology is all around us. Yeah, but those are only the advance guard and I see “upgrades” to many of the same old processes and instrument platforms. When will the army of innovative automation arrive to truly reduce the workflow bottlenecks and create a giant leap in quality? Sure technicians can walk away from existing processes at many steps and we can use management tools to clean up, but we are fighting the battle with old technology. I say it is time to consider creating a new process, it’s time for a new method!

There are four major bottleneck in the existing Histotechnology process and they are not being adequately addressed by automation; grossing of tissues, embedding blocks, cutting slides and now a rapid decline in trained technical staff. To date there is only one automation advance that has tackled one of the bottlenecks - embedding blocks, and that is the AutoTEC automated embedding instrument. This advance is met with push back because people are resistant to change.

To help address the increasing workload, I say we need a revolutionary change in tissue sampling, such as one that recently came to Cytology or has been used for many years in Flow Cytometry. We need a new sample collection process that will allow for true standardization and automation of the diagnostic biopsy and continue to provide the Pathologists “cells” to stain and attach antibodies and probes.

Histotechnicians/Histotechnologists need time to redirect their efforts to add value to the existing process and help produce new diagnostic tools for our Pathologist partners and results for our patients.

I continue to look for the new technology rider and a bright signal for change. What have you seen or what are you waiting for?

I recently had the opportunity to visit the wonderful country of South Africa and found that it does not matter whether you are in Phoenix, Pittsburgh, Johannesburg or for that matter, any part of this great big world, the issues and problems in the Histology laboratory are the same - more work, less people and a directive to do it cheaper and faster while always improving the quality! The struggles to improve the Histology processes are common, but most often they stay in the Histology lab. Why is that?

What did suprise me was the fact that a Laboratory Manager, halfway around the world, approached and solved similar problems using the same techniques and instruments as I did four years ago.  As I listened to a presentation about his successes and his difficulties, I realized his process has stalled at the same roadblock that has probably hampered many attempts to develop a new workflow - scheduling. To affect real change in the Histology lab, we must look at all aspects of the process and develop a workflow that addreses the voice of the customer (VOC) and in this case, the customer must be part of a simple equation; surgeon/clinician=patient=Pathologist=employee=company.  How can we answer the customer’s needs with the resources we have?

You tell me how we can increase efficiency, reduce errors and increase quality and not appreciably change the turnaround time (TAT) without rethinking the work schedule of all affected parties in Histology. Delivering slides the next morning in large batches can no longer be acceptable. We can do better than that for the customer,  but it will take real teamwork and a willingness to change.

What do you think it will take to create the new lean and mean Histology lab?

The first step of Standardization in Histology, not just in a single lab, was taken when it was decided to use one fixative for routine specimens, 10% Neutral Buffered Formalin (NBF). Now we all know that there are other fixatives for special procedures and tissue types and we use them accordingly, but overall, 10% NBF is the standard fixative for routine tissue samples. Who made that decision? Look what standardization of tissue sampling has done for Cytotechnology. The Pap smear and the fine needle aspiration used to be “smeared” on a slide and the quality of the sample and the technologist review time varied greatly from sample to sample. The development of single layer, liquid preparation provided a consistent sample that can now be screened by image analysis, resulting in greatly improved quality, reduced review time and improved patient care. So, why did this process change catch on so fast? The Pathologists were the driving force behind this improvement and demand for improved quality.

Why are the Pathologists and their surrogates, the Pathology Assistant, not championing standardization of Surgical Pathology tissue samples? Is it so unthinkable to use a set of tools that assist in attaining the precise sample? Isn’t it obvious that standardized sample size and thickness will control fixation, reduce processing time, optimize automation and improve the quality of stained tissue samples? Is it worth spending a small increase in time at the grossing bench to realize exponential gains, improvements and cost reduction in the remaining technical tasks in the Histology process? What can we do to convince the Pathologists and the Pathology Assistants that we must partner together to change and standardize tissue sampling?

There were more workshops on process improvement than ever before. New instruments with LEAN principles in mind were presented and systems addressing rapid results were featured. Digital pathology took one step closer to reality and, for the first time, manufacturers introduced systems to manage Histology workflow. It certainly seemed to me that the meeting was telling me NOW is the time to CHANGE our approach to managing Histology. Did you get the same message?

It is my opinion that we, Technical Leadership in Histology, have to acknowledge that the vendors and manufacturers understand it’s time to standardize our processes to support continual process improvement and provide the products we need to become an efficient part of the whole Laboratory. I am not talking about the Histology labs that are involved in research, I talking about the Hospital, private and commercial labs where the majority of the patient tissue sampling takes place. We can no longer afford to continue to work in the same ways. If a product will not reduce cost, eliminate waste, save time, shorten turnaround time or free up our technical staff, then we MUST say NO! We need to demand SMART TECHNOLOGY and implement it now. What new instrument or technology do you need?

I also heard many stories of Histology labs consolidating, workloads increasing, continued labor shortages and many of my peers searching for ways to address these issues. Add to this the mix of multigenerational staff problems developing in Histology with the explosion of Molecular testing and we could just have a major catastrophe on our hands.

Now that I have your attention, here’s my question; how can we bridge the gap created by increased workload, diminishing qualified staff and limited resources from our companies? I feel that a combination of LEAN Six Sigma, the right team and the best equipment is the mix and the real answer. We MUST embrace this mix of strategic tools. Do you see any other way?