Below is an article I recently wrote for ADVANCE for Administrators of the Laboratory. There is also some other articles under “related content” that are good reads on the topic.
There is hesitation in the healthcare community to adopt digital pathology for clinical use. But why? Digital pathology is an innovation designed to reduce laboratory expenses, boost operational efficiency, enhance productivity, aid in better treatment decisions and improve patient care. It is used today throughout the world for diagnostic consultations, primary and intraoperative diagnosis, medical student education, resident training, diagnostic decision support, peer review, manual and semi quantitative review of immunohistochemistry (IHC), and tumor boards. Digital pathology is our future, however, forging this vision has not been easy and realization of the vision is a constant work in progress. Likely the hesitation to adopt is due to some common misconceptions about digital pathology. Addressing these misconceptions head on is required if the industry is going to advance.
Misconception #1: The FDA has not approved digital pathology therefore it must not be safe. The FDA does not regulate laboratories and it does not issue blanket approvals for specific applications like digital pathology. The reality is that the FDA approves the digital pathology hardware and software produced by a manufacturer for a specific intended use (e.g., primary diagnosis of H&E slides). Digital pathology manufacturers are required to go through a premarket approval (PMA) process to have their systems approved as a Class III medical device; this process takes time and is very costly for manufacturers. These hurdles have made it difficult for manufacturers to apply for FDA approval, but they are working on it. However, several digital pathology manufacturers have received FDA 510(k) clearances for specific manual and semi-quantitative analysis of specific IHC assays including HER2, ER/PR, Ki-67, and p53.
Misconception #2: My lab will not pass a CLIA or CAP inspection if we use digital pathology. The College of American Pathologists (CAP) is a Clinical Laboratory Improvement Amendments (CLIA) accredited organization that offers laboratory checklists which support the accreditation process and are designed to be a roadmap for a successful inspection. The Anatomic Pathology, Laboratory General and Cytopathology checklists all have items that apply to digital pathology. In 2011, a CAP Center working group created thirteen guidelines for validating digital pathology for clinical diagnostic use. CAP is expected to issue a final version of these guidelines soon. The Centers for Medicare and Medicaid Services (CMS) oversees CLIA and approves all CAP laboratory checklists. Therefore, if you use the available resources above then digital pathology will not become a risk to the accreditation of your lab.
Misconception #3: I cannot be reimbursed for digital pathology. Laboratories across the country are being reimbursed when they use digital pathology today. The most common reimbursements are for CPT codes 88360 and 88361, the manual and semi-quantitative analysis of IHC; 88321 and 88323 for consultations; and 88329, 88331, and 88332 for frozen section interoperative diagnosis.
Misconception #4: My lab cannot afford digital pathology, it is too expensive. Digital pathology is an investment but any lab can afford it and make a smart business decision. The implementation of digital pathology in your lab needs attention and must be thoroughly thought out. To be financially successful with digital pathology, create a business plan, establish a return on investment strategy and gain support within your organization. A business plan is the foundation for financial success. It will explain and illustrate why digital pathology is worth doing now and will identify the consequences of not doing it now. An ROI strategy is an attempt to determine the profitability of an investment and a time frame of when it will occur. Sadly, there is no perfect formula. However a good way to attempt an ROI plan is to preform a cost benefit analysis (CBA). With a CBA you analyze the benefits of a given situation or business-related action, sum them up, and then subtract all associated costs with putting that action into place. Do not overlook the value of improvements, including gains in efficiency or cost savings for reduced rework. This is extremely important especially when considering your laboratory workflow.
Misconception #5: Digital pathology disrupts my laboratory workflow. How do you break something that is already broken? Many laboratories have a workflow that is manual, fragmented and extremely inefficient. Digital pathology will not be disruptive, instead digital pathology will make these workflow inefficiencies more apparent. These inefficiencies will need to be addressed to be a more productive and progressive laboratory. Digital pathology is often described as the scanning of a glass slide into a whole slide image; yet, it is much more. The pieces of digital pathology include acquisition, integration, data management and interpretation. If all of these pieces interlock together, then laboratory efficiency and the pathologists satisfaction with the technology will improve. Traditionally, when glass slides are prepared they are manually matched with the patient paperwork including patient history, requisition and gross review; then the slides and information are delivered to the pathologist. With digital pathology, the process starts to look a lot different. Now you have whole slide images that can be reconciled to the digital patient paperwork; this information is then electronically delivered to the pathologist. The only way to do this effectively is with a laboratory information system (LIS), electronic medical record (EMR) integration and barcodes. Barcodes will reduce human error, save time on the constant need for verification and rechecks, and improve quality assurance by clear tracking of all specimens throughout the histology process.
Government demands and consumer expectations are growing for transparency in medicine, improvements in patient safety and identification, electronic medical records, and more personalized treatment plans. Digital pathology supports this healthcare evolution, and enables the digital transformation of pathology. Change is hard; however, if we become complacent with how pathology is practiced today we will underestimate the significance of what the practice of pathology could become tomorrow.