Anatomic Pathology’s Coming Revolution: Same Day Diagnoses

Microwave technology for real time processing

CEO SUMMARY: Anatomic pathology has been conducted the same way for 100 years—but no longer at the University of Miami. Pathologists there are using microwave technology to cut processing speed by 90% and improve workflow. By producing faster diagnoses, the lab can report results on 80% of samples the same day that specimens are received. Seeing these improvements, the hospital has added histology labs in other clinical areas to support the goal of point-of-care anatomic pathology.

IF THERE IS TO BE A REVOLUTION in the long-standing operations model of hospital-based anatomic pathology, then one early revolutionary is Azorides Morales, M.D., and his pathology department at the University of Miami/Jackson Memorial Hospital in Miami, Florida.

In recent years, Dr. Morales, who is Chairman of the Department of Pathology, and his colleagues have created a “real time” anatomic pathology (AP) service that delivers pathology reports on the same day for more than 80% of the specimens received! This reduction in turnaround time from receipt of specimen to delivery of the pathology report is contributing to a higher level of care. It has also dramatically eliminated the need for the histology laboratory to operate in the early morning hours.

Rapid Processing Approach

Two strategies underpin this revolution in anatomic pathology laboratory operations. One is the use of rapid processing technology (invented by Dr. Morales and his team), which has cut specimen processing time from 12 hours to 75 minutes (a reduction of 90%). The second is to move away from batching large volumes of specimens in favor of single piece and small batch work flow.

There are other benefits from this revolutionary approach to operating a pathology laboratory. Unlike many AP labs today that struggle with long hours and not enough staff, the lab at University of Miami/Jackson Memorial Hospital offers regular hours for the staff and family-friendly scheduling.

The new system has also contributed to a significant increase in productivity in the histology laboratory. This increased productivity has allowed the lab to absorb and process an increased volume of work with fewer histologists than were in the laboratory prior to implementation of microwave processing and the new work flow.

Another innovation that resulted from “real time” delivery of pathology reports is the location of pathology laboratories in other areas of the hospital, including a rapid response pathology laboratory connected to the operating suites by a pass-through window. That’s a direct result of clinicians asking for the more accurate and faster diagnoses produced by the University of Miami pathologists.

Recognizing that anatomic pathology histology laboratories have conducted tissue processing the same way for 100 years, Morales, along with co-inventors Drs. Nadji, Nassiri, Vincek, and Harold and Ervin Essenfeld, launched research in 1996 to automate AP with microwave processing. Professor and Chairman of the Department of Pathology at the Miller School of Medicine at the University of Miami, Morales is also the Director of Pathology Services at Jackson Memorial Hospital, Miami. Jackson Memorial has 1,500 beds and each year does 10 million clinical tests, 28,000 surgical cases, 6,000 cancer cases, and 300 autopsies. Other than a few rare exceptions, all tissue specimens go through the microwave tissue processing procedure.

Molecular Testing

Morales has been perfecting his microwave processing techniques for the past 10 years. Not only did he invent a way to reduce the time required to process AP specimens, but his process retains the molecular structure of the tissue samples. This allows processed specimens to be used for follow-on molecular testing.

“All the trends point to increased demand by physicians for faster delivery of laboratory test results,” predicted Morales. “This type of specimen processing technology is likely to play a significant role in the future of anatomic pathology. The cornerstone of this process is the Sakura Finetek TissueTek Xpress Rapid Tissue Processor, which incorporates the microwave technology developed here.

Morales explained the process, saying, “The tissue is submerged in mineral oil, acetone-and alcohol-based reagents,” he noted. “It is then exposed to controlled microwaves at a low level energy, averaging less than 100 watts. By contrast, a home microwave operates at 700 watts and produces uneven levels of energy. While exposed to the microwaves, the tissue is agitated at 51°C.

“Next, the tissue is heated to 65°C in paraffin while subjected to vacuum for infiltration,” he continued. “Unlike traditional processing with formalin, this process preserves the DNA, RNA, and proteins in the tissue, thus allowing us to conduct molecular testing on the same block of tissue.”

Lack of Cellular Distortion

“During the development stage, we conducted numerous blind studies to compare microwave technology with conventional methods,” Morales said. “The histological slides are not completely identical, but when conducting blind studies, a cross section of pathologists (both from our team and other facilities) could not differentiate which method was used to process the specimens.

“Cellular differentiation and stain uptake was not compromised with our new technology for microwave processing,” he added. “This is the reason it took a long time to develop: The end result had to show no cellular changes or distortion.

“Our goal was to develop a rapid tissue process that produced an end result that was identical to traditional, formalin-based processing,” stated Morales. “A pathologist has years of training and experience in the interpretation of cellular structure. It was imperative to maintain a high level of excellence in processing so that the end product—the processed tissue—contained no cellular changes that might influence interpretation and diagnosis.”

After testing and improving the processes, Morales found increased demand for AP services across the hospital. “In the medical center we have three histology labs (HL),” he explained. “Two are at Jackson Memorial. One is the main histology lab. The other lab is next to the operating room (OR) where each day we do 10 to 15 frozen sections and about 100 surgical cases. The proximity of this histology laboratory to surgery has increased our interaction with the surgical teams.

“In fact, the histology laboratory located next to the OR was so successful that we were next asked to establish a histology lab at the cancer center,” he recalled. “Although it was more expensive to have another processing instrument on site at the cancer center, it brought point-of-care histology services to the patients, surgeons, and surgical pathology. This improvement is significant for cancer patients because it reduces their anxiety. It also enables physicians to develop and implement treatment plans more expeditiously. For example, we can consistently provide pathology results within two hours of surgery, rather than having the patient waiting anxiously for days.”

Improved Processes

Using the new rapid microwave technology has been an undeniable hit with clinicians. But it has also delivered important benefits across the entire pathology department. Productivity improved by a substantial amount, with significant benefits in budgets, schedules, grossing, processing, and slide reading.

“These have all been worthwhile and practical benefits,” said Carmen Duboue, HLT(ASCP), Supervisor of Microwave Processing. “There is much less stress in the lab. It is much easier for the technical staff. For example, we no longer must deal with large batches of cassettes.

“Instead, we have what we call ‘rapid process flow.’ Specimens are immediately prepared and put into the processors,” she explained. “With our multiple processors, about every 15 minutes we have up to 40 cassettes in a basket ready for embedding and cutting.

“That means histologists work at a steady pace throughout the day,” observed Duboue. “We’ve eliminated that big race that would start at 3:00 a.m. in the morning when the overnight processors were unloaded and we would work to finish up all the specimens from the previous day and have those slides ready at the start of the day for our pathologists.”

The shift to rapid processing of small batches of tissues throughout the day has also altered the work habits of the pathologists. “Now, instead of starting the day with a big stack of folders containing slides, our pathologists get one or two cases at a time throughout the day,” noted Duboue.

“In our histology laboratory, rapid processing has dramatically altered the start and end times for shifts,” she continued. “Working hours are now so much better that we call it ‘family friendly’ and we don’t work weekends.

“For example, our staggered shifts start at 5:30 a.m. and finish at 7:30 p.m.,” explained Duboue. “Our last specimens go through processing at 4:00 p.m. Specimens received after 4:00 p.m. are put into molecular processing fixative. They are the first tissues we process the next day and they are generally ready for the pathologists to read by 9 a.m. the next morning.

“For histologists, our rapid processing technology has the advantage that the tissue cuts easier after processing,” Duboue continued. “It is not dried out. And, we can get our sections for immunohistochemistry out on the same day that the specimen is received.

“Since instituting rapid processing and small batch work flow, our specimen volumes have increased each year, by an average of 4%,” she noted. “Yet, not only have we not added staff since 2003, we perform all the work with fewer people. The productivity increase from the new work flow has been substantial.

“The business advantages are significant,” Morales added. “These work flow changes can give labs a competitive edge in the anatomic pathology marketplace.”

Duboue also mentioned that the rapid processing technology has made it easier for the staff to process tissue for molecular testing. “The same tissue block serves as a platform for molecular testing and the microwave process reduces the opportunity for mistakes,” she said.

“As a result, it is easier on the technical staff, not the least because there is less stress,” added Duboue. “Instead of being confronted with 500 blocks at one time (all of the previous day’s specimens batched and processed overnight), they now deal with just 10 or 20 blocks at a time. Also, rapid processing uses less reagents. That reduces the volume of reagents for disposal, which means there is less lifting. We can process 1,000 to 2,000 blocks with one gallon of each solution.

Lower Toxicity

“The rapid microwave process also reduces the volume and toxicity of reagents,” Duboue explained. “Because we no longer use formalin or xylene, we work in a safer environment. Since the processor is a closed machine, there are no fumes. It requires only two reagents, which is 80% less reagent volume than the traditional tissue processing machines.”

Duboue added that there is minimal maintenance to the machine. “It is very stable and if something goes wrong, it is very easy to troubleshoot,” she said. “We have fewer problems than with the traditional processing machines.”

When Morales tells pathologists of the remarkable processes in his lab, they are generally stunned. “Typically, most pathologists get their daily share of slides (yesterday’s specimens) in one big batch,” he said. “They must then work steadily to read them all and finish the reports. But due to the radical change in work flow with this system, our pathologists read slides throughout the day, as specimens come into the laboratory and are processed in real time. This enables the pathologists to have closer interaction with the surgeons and to provide faster results to the physicians and patients.

“Because the specimen processing is done sooner, the dictation is completed earlier too,” Morales said. “That means reports can be sent electronically or delivered via courier the same day. Getting results out the same day has reduced the number of phone calls we get. Plus, there is another benefit: Getting reports out faster means billing statements go out sooner.

“The business advantages are significant,” Morales added. “These work flow changes can give labs a competitive edge in the anatomic pathology marketplace. Combining processing technology with a small batch work flow can be particularly useful for hospital outreach programs that compete with the big national labs. After all, giving referring clinicians a faster turn-around time to results is a benefit to both physicians and patients.”

“In fact, as word gets out about the organization and performance of our pathology department, we now get site visits by people from all over the world,” Morales said. “We love to show visitors how the system works and what improvements they can make in their own labs.

Benefits Of A Site Visit

“I encourage anyone thinking about changing to microwave technology to come to our lab and see the process in action,” he continued. “Talk with our pathologists and technologists. Gain valuable insight and develop ideas on how to implement changes at your own laboratory. We recommend pathologists and staff spend at least a day with us to see the benefits of our approach, as well as to learn the challenges of evolving to this kind of work flow approach.

“When you see the Tissue Tek Xpress in action, you realize that the most important outcomes of microwave processing are improved patient care,” Morales continued. “By improving expediency of surgical reports, the patient waits less time for a diagnosis. It improves patient management for surgeons and other physicians.

“One way to see how successful we’ve been is to consider that the plans for a new Miami University hospital call for a histology laboratory in the midst of the operating room suites,” Morales explained. “It is expected that the new University hospital will be operational in 2010 and, by that time, microwave processing will already be routine, helping pathology to develop even closer relationships with surgeons, and helping to create higher recognition for the contribution that pathology provides to the healthcare team.

“This technology means we are poised for the next wave of innovation in molecular pathology: proteomics and genomics at the tissue level,” continued Morales. “More will be expected of anatomic pathology to provide diagnostic answers in real time to keep the cost of healthcare down.

“The instruments in histology now come with information technology support, much like the clinical chemistry instruments,” he observed. “This will put some labs in a battle with other departments for capital dollars, as AP becomes more capital-intensive. However, automation brings better work conditions for the staff and pathologists, and this is welcome at a time when, in some areas, it is increasingly difficult to recruit skilled laboratory staff.”

Boosting Pathology Quality

THE DARK REPORT observes that Morales and his colleagues are indeed on the cusp of a revolution. Their work to create a rapid processing technology that preserves the tissue for molecular testing is an impressive accomplishment. But, as Morales notes, the most significant advantage is improved patient care. Because microwave processing speeds workflow and allows labs to get work out the same day with less stress, it is likely that other labs will choose to implement this same approach.

But the most striking insight from these innovations may be how the pathology department at the University of Miami has increased its value as a clinical consulting resource to physicians while at the same time improving its visibility. Putting pathology at the point-of-care is a winning strategy for the entire pathology profession. The integration of pathology services at this medical center demonstrate that fact.

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Plenty of Advantages To Microwave Technology

AMONG THE MANY ADVANTAGES of microwave technology are the following, according to pathologists at University of Miami/Jackson Memorial Hospital in Miami, Florida:

  • Standard grossing technique
  • Consistent tissue handling
  • Lack of denaturation of tissue sample, leaving DNA, RNA proteins intact
  • 80% of specimens resulted within same day
  • Molecular testing on same tissue block
  • Complete results within 2 hours
  • Introduction of Point-Of-Care to surgical pathology
  • Improved turnaround time reduces patient anxiety
  • No overnight processing
  • Family-friendly work schedules and no weekends
  • Less stress for technical staff and pathologists
  • Improved working conditions
  • Overall management of laboratory is easier
  • Fumes and toxins eliminated: formalin and xylene no longer used
  • Easier disposal of reagents, less volume of reagents used
  • Reduction in processing time from 24 hours to 75 minutes
  • No overnight processing
  • Reduced repetitive manual procedures
  • Instrumentation very simple, easy to use, simple to troubleshoot

 

Gaining Better Quality In Histology Processing

ONE ASPECT OF MICROWAVE TECHNOLOGY that helps improve pathology test results is a different approach to standardizing how specimens are grossed, according to Azorides Morales, the Director of Pathology Services at University of Miami/ Jackson Memorial Hospital in Miami, Florida.

“One major change for pathologists using microwave technology comes when grossing specimens,” Morales said. “Currently, traditional gross practices do not require uniformity in the grossing process. With microwave processing the thickness of the tissue cannot be more than 2 mm thick. Yet, we can get 300 to 600 sections from the block with this size tissue. We developed specific tools to ensure uniformity in our grossing.”

There is another impressive aspect to the microwave processing and AP work flow developed by Morales. “We have an extraordinary level of confidence with microwave processing,” he said. “Since October 1996, we have never spoiled a patient’s sample. We have processed over 1.5 million samples through December 2006. We could not say the same for the traditional overnight processing, as it can breakdown in the middle of the night and problems occur. Now all our processing is done during the day and someone is always there should anything happen.”

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