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.