Tag Archive for CAP

Debunked: Digital Pathology Misconceptions

August 29, 2012 Business Case, CAP, CLIA, Digital Pathology, EMR, FDA, Laboratory Automation, LIS, Pathology Comments Off

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.

Debunked: Digital Pathology Misconceptions

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.

Part 2: Digital Pathology is Not an LDT! Now What?

November 11, 2011 CAP, CLIA, Clinical Trials, Digital Pathology, FDA, Validation Comments Off

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:

  • Does WSI fit within the paradigm of a Laboratory Developed Test?
  • What would be required for Self- Validation?

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:

  • Increasing interest in using whole slide imaging(WSI) for diagnostic purposes in pathology.
  • Increasing questions about what needs to be done to ‘validate’ a WSI system for clinical service and if validation is necessary.
  • Lack of current standardized guidelines regarding validation of WSI for diagnostic use.

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.

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.

Go Above And Beyond the Dx: Participatory Medicine

May 26, 2010 CAP, Digital Pathology, Organ Donor, Participatory Medicine, Pathology, Patient Advocacy, Personalized Medicine, Transformation One comment

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:

  1. Identify two or three cases where your role as diagnostician is crucial to the patients care and outcome
  2. Arrange a meeting with the primary physician for that patient
  3. Discuss your involvement with the clinical team and how you would like to engage with the patient directly
  4. Follow through! Do what you say you are going to do. Build credibility with the clinical team and your patients
  5. Document your successes and struggles and think about ways to make the process better
  6. Share your successes! Click here to share
  7. Repeat the process

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

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

Get Involved! Learn About Digital Pathology

December 9, 2009 CAP, Digital Pathology, Education Comments Off

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:

  • Review images from outside locations
  • Provide real time support for consultation cases
  • Easily archive images sent for consultation
  • Use image analysis tools, computer assisted diagnostic algorithms and other advanced analytic tools
  • Enhance your presentations for tumor boards

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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