Pathology puts the wheels of healthcare in motion. It detects the potential for disease, provides definitive diagnoses, and monitors both disease progression and the effects of prescribed treatments. All of this is done as it’s been done for more than 100 years, by looking at tissue samples through a microscope in a lab.
While technology is transforming healthcare it’s left pathology relatively untouched. The dated approach to examining tissue to detect disease is riddled with operational and quality challenges. It’s inconsistent and subjective, prone to human error, manual (slow!), and dependent on a shrinking number of histologists. The practice is long overdue for modernization that could solve these challenges by innovating, standardizing and digitally transforming the quality, safety, cost and throughput of the science.
Let’s take a closer look:
The Current Way of Analyzing Tissue Samples
For more than a century, doctors examine a patient and take a biopsy of tissue to determine the presence of disease. That tissue is sent to a lab where it is processed by a histologist. He or she embeds the sample into a paraffin block, uses a microtome to cut it into extremely thin slices, floats the slices on the surface of a water bath, and lifts them onto glass slides. The slides are then baked in an oven and processed through dyes before being analyzed by a pathologist. It’s a tedious process, often taking up to three hours per sample.
This manual tissue processing has been working for ages, so why mess with the status quo? The growing prevalence of chronic diseases including cancer, increased awareness and interest in early disease detection, the occurrence of epidemics and pandemics like COVID-19, and several other factors are increasing demands on labs. Their workforce—histologists— are reliant on manual processes to perform their work, day in and day out. Like all professionals, they have limited work capacity and varying skill levels. The manual and subjective nature of their work of sectioning tissue samples opens up several challenges for labs, which in turn affect patients.
Operational Challenges for Labs:
Inconsistency. Not all histologists are created equal. It takes years of training and experience to master the craft and be able to discern a 4 micron cut tissue sample, which is a sliver of the diameter of a human hair. Inconsistent, manual cuts often miss tissue and epidermis, leading to the need for recuts, which costs labs both time and money, and causes delays in diagnosis and in turn care.
Inefficiency. A histologist can only prepare so many samples in a day. With increasing workloads, labs often struggle to keep up with demand and as a result, biopsy turnaround times are delayed. Patients are forced to wait for answers and care is potentially delayed.
Expense. Skilled human labor is a major expense for labs and the histologist workforce is rapidly shrinking. A study found that by 2030, the number of active pathologists may decrease by approximately 30 percent compared to 2010 levels. Adding to the challenge is the growth of precision medicine, which relies heavily on diagnostics.
Quality Challenges That Impact Patients:
Error prone processes. Tissue sample slices are extremely thin and brittle and can easily fold during the water bath process. They are also prone to cells coming loose and attaching to another patient’s slide, which could lead to erroneous diagnoses.
Highly subjective. Sample quality is heavily influenced by the technician, and by nature, no two technicians are the same. There is no gold standard for the profession.
Possibility of harm. Histology is the central element of diagnoses. While it’s often difficult to detect errors in the process, 6 percent of detected errors lead to patient harm through inaccurate diagnoses.
Modernizing Pathology Practices
Technology, specifically automation, modernizes the practice of pathology by providing standardization and consistency. It provides both operational benefits and improved quality, leading to better care for patients and more efficient labs.
Automation helps to balance supply and demand issues and address the growing labor shortage facing pathology. This helps labs operate more efficiently, delivering profitability without subsidization while providing high quality care for patients.
Automating pathology and providing standardized, consistent samples and digital imaging provides more accurate lab outputs. It removes subjectivity and reduces the potential for human error, partially by removing manual cuts and water baths from the process, in turn reducing risks of patient harm. With consistent, uniform samples, pathologists can accurately diagnose without the need for repeat biopsies, helping to get patients quicker test results and more immediate access to care.
Standardized, consistent samples and digital imaging also enable telepathology, 3D reconstruction, and can open possibilities for matching genomic data with pathology data, leading to remarkable advances in medicine.
Transforming Pathology with Clarapath
Healthcare is rapidly evolving, improving the experience for both patients and providers, thanks to advances in technology. It’s time for pathology to be a part of the evolution. Working with leading academic medical center laboratories, Clarapath is leading the way with an automated and robotic device that consolidates nine labor intensive microtomy steps into one piece of equipment, resulting in better quality slides, faster turnaround times and lower costs for labs.