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The Digital Pathology Association’s FDA Task Force prepared four questions for the Regulatory Panel session held at the Pathology Visions conference last week. The third, two part question was:
The regulatory panel consisted of representatives from the FDA, CAP, and CMS/CLIA and was moderated by Dr. Stephen Hewitt of NCI. The questions above are very important but the answers have different implications on the audience. Digital pathology manufacturers are overseen by the FDA, and laboratories are overseen by CMS and CLIA guidelines. However, the only clear answer given to these questions was by FDA representative Tremel Faison. She announced,
WSI are systems and are not considered, by definition, as Laboratory Developed Tests (LDT).
To date, the FDA’s oversight of LDTs has been very limited and LDTs have been enforced at the discretion of the Centers for Medicare and Medicaid Services (CMS) which governs CLIA. Although it is very clear the FDA plans to play a bigger role in the oversight of LDTs based on the public hearing held in July of 2010, and the fact that they tabled their final guideline on IVDMIAs to address the broader issue of LDT oversight. Dr. Bruce Friedman discusses this further and provides a very good background in his blog post, “FDA Shelves IVDMIA Regulatory Initiative; Will Focus on Laboratory Developed Tests” at Labsoftnews.com.
Also present at the regulatory panel last week was CLIA/CMS representative Debra Sydnor and Dr. Walter Hendricks who represented CAP as a CMS approved accreditation organization under CLIA. These two presentations were very important to pathologists and laboratories professionals and they should have provided a clear understanding of what is or is not available to them for clinical use of digital pathology for patient care.
Dr. Hendricks provided an overview of what CAP initiatives are currently underway to assist pathologists and laboratories with validation of digital pathology. For example, he discussed the soon to be issued CAP guidelines for Validation of WSI and Dr. Anil Parwani gave a presentation earlier in the week about the guidelines. The guidelines were created by the CAP Center Working Group as,
13 STATEMENTS developed to assist the pathology community with validating WSI for clinical diagnostic use.
based on an:
Down the road (although no plan is currently in place) some of these guidelines may become a CAP Checklist Requirement. However currently there are several CAP Checklists items that are applicable today to digital pathology. Dr. Hendricks outlined all of these in his other Visions CAP presentation titled “The CAP Laboratory Accreditation Program Practical World View on Digital Pathology from a CLIA Accreditation Provider.” Based on all of this it would be easy for pathologists and laboratories to assume that CAP is trying to provide guidance on self-validation of digital pathology/WSI systems.
What does CMS/CLIA have to say about all this? Honestly, I’m not too sure. I found the regulatory panel presentation by Ms. Sydnor to be very confusing. I reviewed my notes and her presentation again this morning but could not make any more sense of it. It appears by her powerpoint that she gave some background on CLIA and then highlighted CLIA requirements that are applicable to digital pathology. Ms. Sydnor never said that WSI was not an LDT like the FDA, but in an attempt to answer a question about the components of a digital pathology system she stated,
CLIA supports the FDA.
But was this statement made based on her (or CMS/CLIA’s) unfamiliarity with digital pathology? I did not come away with any confidence that CMS/CLIA have any real understanding of what laboratories currently face regarding digital pathology.
NOW WHAT? That’s really the big question for laboratories to try and answer. My best advice is to proceed with caution but PROCEED! There are a lot of ways to use digital pathology that will not impact compliancy with CLIA; remember the only major intended use up for debate right now is primary diagnosis. Examples include tumor boards, consultations, intra-operative, education, archival, decision support, peer review, quality assurance, and manual or automated image analysis. In a previous post on my blog about the regulation of digital pathology I stated,
Are you even ready for primary diagnosis with digital pathology? There are a TON of other areas that need to be addressed to make primary diagnosis with digital pathology work. Barcodes, laboratory workflow (before and after the scanner), data storage and management, and integration with your LIS, PACS, and EMR. Just to name a few. If you are serious about our digital pathology future then stop worrying about what the FDA is saying (or not saying) and get to work! Prepare the labs for change and start using digital pathology for all those applications you are sick of hearing about.
Are you even ready for primary diagnosis with digital pathology? There are a TON of other areas that need to be addressed to make primary diagnosis with digital pathology work. Barcodes, laboratory workflow (before and after the scanner), data storage and management, and integration with your LIS, PACS, and EMR. Just to name a few.
If you are serious about our digital pathology future then stop worrying about what the FDA is saying (or not saying) and get to work! Prepare the labs for change and start using digital pathology for all those applications you are sick of hearing about.
If you are one of those rare labs that has everything worked out and are ready for primary diagnosis, then set up a clinical trial collaboration with a manufacturer or use your own discretion on self-validation of digital pathology. As discussed above several resources are available for self validation of digital pathology. Use the CAP guidelines, CAP accreditation checklists, applicable CLIA requirements, and the newly release DPA white paper on validation to guide you. Ultimately the decision is up to you and what you are comfortable with.
In post USCAP Part 1: The BIG Players In Digital Pathology I said, “A shift in the mindset of pathologists could be felt throughout the meeting and left the digital pathology industry energized about what 2011 will bring. No more just looking and talking about digital pathology, pathologists were truly starting to plan and think about how to adapt to their digital future.” This is a big step toward the “tipping point” of digital pathology, however, we still have several barriers to work through including cost, regulatory, technical, and psychological.
COST
Cost justification is difficult in digital pathology, however, there are several options to help deal with this barrier. At USCAP two companies, MikroScan and Motic, showcased small, affordable, high-quality scanners for only $35,000.
Mikroscan's D2 Desktop Scanner
Mikroscan’s Victor Casas said “we are here to disrupt the workflow” by creating an affordable system that is outside the lab and on the pathologists desk. Mikroscan believes that they do not compete against the high-throughput systems created by other manufacturers, instead their systems are positioned to work with them. Mikroscan wants to focus on intra-operative/frozen section scanning; small, remote labs in rural areas; and the personal scanning needs of pathologists. The D2 scanner’s has a very nice “desktop” look and the paddle (aka slide holder) can load four 1×3 slides, two 2×3 slides, or one 2×3 and two 1×3 slides. Objectives include a 2.5x for the macro scan, 20x, and 40x for high resolution scanning.
Motic’s microscope based system can be configured for 1 or 25 slides, and offers microscope-like flexibility with slide acquisition up to 100x and of the z-axis. Scans average around 4 minutes for a 15 mm2 area (scan time only). Their system supports a server software and viewer, and has the capability for real-time remote telepathlogy of the microscope.
However, if your digital pathology needs include mid or high-throughput scanning the cost barrier will not be overcome simply with low cost equipment. Instead you need a business plan and strategy. My company, Digital Pathology Consultants, helps organizations of all sizes create a business plan that will ”cost justify” digital pathology and set you up for digital success now and in the future. Our 5WH program provides clients with a cost-effective, unbiased business case for digital pathology. The 5WH program is based on a common methodology for information gathering and the goal is simply to answer the who, what, where, when, why and how of digital pathology. Although the methodology is simple, discovering the best answers to these questions is not easy and that is why you need help.
REGULATORY
Some day (hopefully within the next 10 years…) I’ll be able to blog about the FDA’s plan on how to regulate digital pathology manufacturers. Until that day comes pathologists, and their labs, must determine ways to safe guard themselves but still move forward with the use of digital pathology. Remember the FDA regulates what digital pathology manufacturers can claim or say their technology is used for, not what a pathologist or a hospital does with digital pathology. CLIA is who regulates laboratory use of digital pathology. At USCAP, CAP announced that the Pathology and Laboratory Quality Center were developing guidelines for digital pathology titled “CAP Validation Principles for Whole Slide Imaging in Digital Pathology.” The goal of this document is to develop principles to assist pathologists in properly validation WSI digital imaging systems. The draft recommendations will be available for public review in Sring 2011.
TECHNICAL
In post USCAP Part 2: Innovation Trends in Digital Pathology I discussed technology trends and how these are helping to address technical barriers of adoption. However, our biggest initiative must be to educate others in the HIT world and share what we learn, and to not shy away from this very real component of digital pathology. Two white papers were published by the Digital Pathology Association in 2010 and are good examples of what we must do to prepare for the data wave and the level of integration necessary to ensure pathology departments are successful with digital pathology now and in the future.
PSYCHOLOGICAL
Psychological barriers is a “hot topic” for me. I firmly believe this is an area the digital pathology industry must have a plan to address or adoption may never truly succeed. At Digital Pathology Consultants we have developed a coaching program to help departments or individual pathologists overcome the psychological impacts of digital pathology. I also know this is a point of interest for Aperio, and their CMO Jared Schwartz, MD PhD. Dr. Schwartz recently did a webinar on the Psychological Barriers and how Aperio is working to address them.
Overall, USCAP 2011 was an amazing meeting with lots to see and discuss about digital pathology. What do you think- take the poll below:
Digital Pathology is innovation. Digital Pathology make changes to something established (ie. pathology) by introducing new methods, ideas, and products. At USCAP last week there were examples all over the exhibit hall of digital pathology being used with other types of innovation including mobile devices, cloud computing, Software As A Service (SAAS), and methods to improve the pathologists workstation experience.
iPads, iPads, and more iPads!
Nikon Live Remote Viewing
I recently blogged about the iPad trend in healthcare (see post iPad Deployment In Healthcare to Reach 70% In 2011). This trend was reinforced by the number of iPads in use at USCAP. The Information Week article stated that 1/3rd of the 950 respondents listed lab order visualization and results, clinical decision support, and medical image viewing applications as “top priorities” for the use of the iPad in healthcare. All great reasons for digital pathology too!
New Olympus VS800 viewer on an iPad
At USCAP Nikon demonstrated live image sharing (aka telepathology) on an iPad with their digital site camera system, Aperio was showing the mobile site of the Juan Rosai Collection on one, Aurora’s mScope really was “anytime, anywhere” on an iPad, and Olympus was demonstrating the new VS800 software on an iPad too!
WSI’s & more in the Cloud
Aurora's mScope
Software (and/or Storage) As A Service (SAAS) are catching on to help overcome the IT barriers of digital pathology. I blogged on the storage element of this over a year ago (see post SAAS- Cloud 9 For Digital Pathology?) and firmly believe that SAAS has it’s place in healthcare and for digital pathology. At USCAP, several digital pathology providers were showing examples of SAAS with support for cloud based storage and secure web-enabled software solutions to ease the strain on IT. Aurora is “building communication networks” and overcoming IT barriers through their SAAS model; Aperio’s SecondSlide & Ventana’sPathXchange are cloud based; Apollo launched a collaboration with Hitachi to offer their Enterprise Patient Media Manager in the cloud, and Mikroscan offers a cloud based solution through a collaboration with Simagis. Why is this becoming more popular? SAAS solutions are accessible from anywhere with an internet connection, do not require installation on a local server or client, can be up and running quickly, and can be rapidly scaled as needed. Another example of SAAS is as an adjunct to a client-based solution. Omnyx developed a web-enabled version of their pathology workstation viewer to work with their client based Pathology workstation software. This will give the pathologist access to cases remotely (home, vacation, etc) and allow for safe, secure sharing of slides outside the hospital network for consultations.
The Pathologist Workstation
The Pathologists workstation experience has become a hot spot of innovation. Barco (see post Diagnostic Color Displays for Digital Pathology) was beta testing software that could improve the “viewing experience” and provide the speed, image quality, and intuitive interaction needed to diagnosis off of a WSI. It was amazing, and they were only using simple input devices bought at Best Buy. The Diagnostic Intelligence and Health Information Technology (DIHIT), a department of CAP STS, were again advocating for and demonstrating their prototype of a pathology diagnostic workstation. Also a few digital pathology manufacturers, like Aperio and 3DHistech, were showing new and/or compatible input devices.
A beta tester at Barco trying out the speed and ease of viewing
Aperio's Innovation Station w/Compatible Input Devices
3DHistech "Microscope like" Input Device
Digital pathology continues to be at the forefront of innovation. It was wonderful to see so many digital pathology solutions leveraging other key innovations!
Look for my final post on Monday, USCAP Part 3: Breaking Down The Barriers Of Digital Pathology.
Steve Potts, PhD CEO of Flagship Biosciences gave a great webinar last week on the right time to use image analysis in regulated pathology. Steve was faced with the challenge of trying to convey a meaningful message to a diverse audience from both the biopharma and clinical markets. He kept everyone engaged on this detailed, ever evolving topic which provided information on FDA, CLIA, CAP/ASCO, and GLP regulatory guidelines. Steve did this well, and kept us laughing throughout the presentation.
Navigating regulatory guidelines for image analysis and digital pathology will never be easy, however there are several ways you can effectively use these technologies today while safe guarding yourself. Steve provides a lot of information and resources in his powerpoint that can help organizations work through and understand just how to do this.
As for when is the “right time”? Well, you’ll have to download the recorded webinar and Steve’s powerpoint slides to find out! Thank you Steve for your time and for presenting on this important topic!
Download the Video
Download the presentation
Stay tuned to this blog and/or register for my newsletter to find out about our future webinars.
It is time; time to change how you give a diagnosis.
Participatory Medicine, defined by the Society for Participatory Medicine, is a cooperative model of health care that encourages and expects active involvement by all connected parties (patients, caregivers, healthcare professionals, etc.) as integral to the full continuum of care. The patient role has evolved, therefore the role of a pathologist must evolve too. Pathologists must start to go above and beyond the diagnosis and become a key advisor to physicians and patients on the prevention of disease, therapeutic treatments, and the progression of disease within patients.
I have written a post before about my dad, a resident of Colorado, who had a liver transplant in August 2009 at Cleveland Clinic (CC). As soon as he returned home to Colorado, he had to have bi-weekly blood draws for review by his clinical care team at CC. The initial plan was for my dad’s family medicine office to do the blood draw with kits that were shipped from the Cleveland Clinic’s lab, and package them up in a pre-paid envelope (also provided by CC ) and ship them back to CC’s lab for analysis. The turnaround time would be about 36-48 hours for the result, plus the cost and risk of shipping the blood to CC.
After trying this out and realizing it was a logistical nightmare, my parents decided to have all the blood work done by the University of Colorado lab, which would post the results within 8 hours to their hepatology patient care system. My parents could then simply access the results securely online, print and fax them to Cleveland Clinic. This new process brought the turnaround time to 8-12 hours; saving 24-36 hours over the original method. Overall, a great example of participatory medicine!
In Pathology, the use of a participatory model is a greater challenge since pathologists rarely interact with the growing numbers of patients they diagnosis everyday. However transformation to a new model of care must be accepted, and the College of American Pathologists (CAP) has two programs “Transforming Pathologists” and ”Every Number Is A Life” where the evolving role of pathologists and value of pathology are being advocated for. CAP says on the transformation website,
…As health care changes quickly and on all fronts, Pathologists must step up and embrace transformation, pursue new roles in the workplace, and re-position themselves as the center of the clinical care team. This is an urgent call to action and we must take action now. If Pathologists are to survive, we must adapt….Pathologists must have an understanding of their changing role – they must NOT be defined by the tools they use. We have a bright future as researchers/innovators, test providers, interpreters, clinical data integrators, clinical consultants, business developers and practice leaders.
However, pathologists often do not know where to begin. Try these steps:
Proponents of the participatory model of care believe that adoption can increase patient satisfaction, save time, reduce costs, improve care, and lower liability risks for physicians. Although change is difficult, pathologists must seize the opportunity they have been given! It is time, time to go above and beyond the diagnosis.
In the middle of difficulty lies opportunity. ~Albert Einstein
In the middle of difficulty lies opportunity.
~Albert Einstein
Are you a patient who has a great story about a pathologist? Share your story today! Click here
Want to learn how to become an organ donor? Click here
A great read on participatory medicine by American Medical News- Participatory medicine: A high-tech alliance with patients
No excuses! CAP has made it free, easy and convenient.
In an effort to educate pathologists about their digital future, The College of American Pathologists (CAP), under the CAP Institute has launched a free educational series about digital pathology and the effects that this digital future will have on the practice of pathology. The first session, titled “The New Pathology Paradigm – Digital Pathology”, will be delivered by Dr. Richard Friedberg the Chairman of Pathology at Baystate Health. The session will discuss how this emerging technology may allow pathologists to:
In addition, the learning session is available 24/7 to everyone at no cost. You can stop it and come back later, skip sections, or only focus on content that you want to learn more about. The fact is, you have no excuse! Get involved, learn about digital pathology today!
To register for the course click here
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