Integrated Diagnostics: The Perspective of a Pathologist

1. Integrated Diagnostics: The Perspective of a Pathologist Bruce A. Friedman, M.D. Emeritus Professor of Pathology University of Michigan Medical School Ann Arbor, MI Email: friedman@labinfotech.com Blog: www.labsoftnews.com Twitter: @labsoftnews

2. Lecture Outline • Defining current role of specialized diagnosticians in the healthcare enterprise; relationship with clinicians • The integration challenge across the wide array of diagnostic studies; errors caused by lack of integration • Defining integrated diagnostics; what gains can be achieved by closer collaboration in the dx enterprise? • Healthcare reimbursement as major driver for integrated diagnostics; “cheaper, faster, better” as new goal? • Deploying the integrated dx report; taking advantage of a multidisciplinary team in dx; similar to rx teams

3. The Genesis of an Idea for Revamping the Diagnostic Process • On 10/23/2006, I posted a blog note on Lab Soft News: Ten Reasons to Merge Pathology & Radiology • Idea struck me as reasonable in an era of increasing specialization and “silo-ization”; return to “big picture” • Clearly, this is a change that will not take place overnight, if ever; too much resistance to change • Also, current environment evolved for a reason; most of the incumbents have large stake in the current system • Following are the ten reasons as originally published in Lab Soft News but with some editing for brevity/clarity

4. Ten Reasons for Merging Pathology, Lab Medicine, and Radiology • Substantial overlap between current missions of the diagnostic specialties (pathology, radiology, lab med) • Enhanced clinical and research value if the LIS, RIS, and PACS databases were merged/analyzed • Integrated [diagnostic] reports would achieve higher levels of quality; pursuit of the “super-diagnosis” for pts. • Merger of medical imaging, molecular imaging, and molecular dx is already taking place at rapid pace • Science & research agendas of molecular imaging & molecular dx already demonstrate extensive overlap

5. Ten Reasons for Merging Pathology, Lab Medicine, and Radiology (cont.) • Dx medicine would form the basis for a cohesive, cohesive, and competitive new medical specialty • Dx medicine would benefit from a critical mass of trainees who would carve out a professional identity • Core dx technologies would benefit from infusion of the new science & technology currently used in imaging • Pathology & lab medicine need a new influx of capital investment in the form of corporate R&D funds • Radiology, pathology, & lab medicine are similarly dependent on IT, molecular dx, & imaging technology

6. Arriving at a Diagnosis for a Patient: A Collaborative Exercise • Diagnosis: identifying a disease on basis of signs, symptoms, and results of various diagnostic procedures • In modern medicine, clinicians order various dx tests & procedures as means to arrive at a correct diagnosis • Clinicians interact directly with patients; specialized diagnosticians act as consultants in this dx process • Because clinicians control dx ordering, it falls to them to integrate the results/reports into the final diagnosis • Integration becoming more difficult because of increasing sophistication of tests/procedures offered

7. How Do Specialized Diagnosticians Communicate with Clinicians? • In theory and in past, diagnosticians were available to clinicians for face-to-face discussions about patients • Because of workload & physical separation, communication accomplished via LIS/RIS/EMR reports • Radiology totally converted to digital; these images now available on-line for review by clinicians via the PACS • Only minority of clinicians (e.g., ortho/neuro surgeons) attempt to routinely interpret their own ordered studies • One group of clinicians, cardiologists, has maintained some degree of control over their own dx studies

8. Diagnoses Versus Impressions Versus Numerical/Narrative Data • Surgical pathologists, render dx’s; when tissue surgically removed, falls to them to be serve as final arbiter • Radiologists renders impressions, dx’s, conclusions; answer questions posed by the clinicians in their orders • Because radiology can be less precise than surgical pathology, a differential diagnosis is often included • A suggestion often included in radiology report about the next imaging study to narrow the differential diagnosis • In clinical pathology & molecular dx, report frequently provides numerical results with occasional analysis

9. The Integration Challenge Across the Array of Diagnostic Studies • Little integration across CP & AP; also little integration across the various radiology imaging modalities • Surgical pathology, various clinical labs, imaging modalities (e.g., CT, MRI) each generate their own reports • It falls to the clinicians to integrate each of these individual reports released across time to arrive at the correct dx • Hard to fault this approach historically because clinicians has the best knowledge of the progression of dx workup • Due to complexity of modern medicine, diagnosticians need to provide more integrated reporting to clinicians

10. Inefficiencies/Errors Associated with Lack of Integrated Diagnostics • By working inside their silos, diagnosticians turning a blind eye to inefficiencies/errors promoted by system • Different vocabularies have evolved in rad/ path over time to describe same pathologic changes • Surgical pathology dx’s could be focused/ improved with parallel ordering/interp. of molecular dx studies • Scheduling of dx studies often turfed to clinicians; dx services could use scheduling algorithms • Diagnosticians best qualified to eliminate down-time & waste form their own internal processes/systems

11. What is Integrated Diagnostics? • Integrated-Dx: collaborative efforts by dx services to present clinicians with final, integrated dx for patients • In the short-run, efforts will focus on low-lying fruit; wring out waste & facilitate generation of common dx’s • In the long-run, I envision merging of current dx specialties into new discipline – Diagnostic Medicine • Early efforts will be laborious because initiative is novel; existing specialties will resist radical change • These efforts will result in computer-managed diagnostic algorithms to optimize tests & procedures

12. Multidisciplinary Teams in Therapeutics & Diagnostics • Highest quality care being delivered in cancer centers staffed by multidisciplinary [clinical] teams (MDTs) • MDTs generate optimal treatment recommendations but inhibit natural instincts of individual physician specialists • Also need to decouple clinical decision-making from reimbursement stream where procedures yield income • Multidisciplinary [diagnostic] teams achieve same end; integration of “silo diagnoses” into a “super” diagnosis • Because of volume of diagnostic tests/procedures; such teams can only work effectively on virtual basis (see later)

13. How to Best Pursue Integrated Dx; Need for Successful Pilot Projects • Pessimistic that pathology/radiology would pursue integrated diagnostics independently & spontaneously • Current silos evolved on basis of greater productivity & specialty ethos of silos; incumbents will fight to keep • Error reduction studies via integration could provide incentives, but will never be performed on large-scale • Only significant driver will be integrated-dx pilot studies that produce “cheaper-faster-better” results • Logical place for such pilot studies will be in existing radiology-managed, screening-driven breast clinics

14. Accountable Care Organizations and the Pursuit of Cheaper-Better-Faster • An ACO is a clinically integrated group of providers who improve the health of a defined population and share resulting savings. • PPACA (2010): A group of providers of services and suppliers meeting criteria specified by [HHS] may work together to manage and coordinate care for Medicare fee-for-service beneficiaries. • Comparative effectiveness research (CER) is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in “real world” settings. The purpose of this research is to improve health outcomes …[and determine] which interventions are most effective for which patients under specific circumstances.

15. Relevance of Digital Pathology to Integrated Diagnostics • Recall that the goal of integrated dx is cheaper, faster, better and the need to wring out waste from systems • Digital pathology facilitates tissue diagnoses; portability of whole-slide-images creates new options • Hospital pathologists can “read images” anywhere; WSI also enables e-consultations for small groups • Digital pathology has also ushered in era of algorithms for analyzing IHC/FISH stained breast tumors • Digital pathology major step in conversion of surgical pathology to more of a quantitative medical specialty

16. Example of Optimized Integrated Work-Flow in a Breast Center • Patients with new breast masses discovered at screening & referred patients moved to dx side • Additional imaging studies & FNA or core biopsy when indicated; tissues specimens transferred to histo lab • Tissue samples processed/embedded; glass slides scanned with WSI to path PACS; pathologists alerted • Case interpreted by pathologist; relevant serum/tissue biomarkers ordered on basis of approved protocol • “Virtual” conferencing by panel of diagnosticians to assign “super” dx on basis of specialized dx’s

17. Specialized Dashboard/Console for Support of Integrated Diagnostics • Unlikely in the near-term that we will see integrated diagnostic systems (LIS+RIS+PACS); little demand • As substitute and to support integrated dx, development of web-based dx dashboards/consoles • Interfaced to legacy LIS, RIS, PACSs, EMR • Will display all relevant diagnostic images and data including all relevant IP/OP clinical data • Critical integrative tool for pathologists/radiologists who will participate in the virtual dx “panels” • Some of these devices are already on market; more to follow event absent interest in integrated diagnostics

18. More Details About the Integrated Diagnostic Report • Current process is to release imaging studies, surgical path reports, molecular dx sequentially, each with dx’s • Proposal: convene “virtual” panels of diagnosticians to review individual dx’s & generate “super” diagnosis • Analogous to MDTs in Cancer Centers that discuss cases & recommend integrated therapeutic regimens • Each member of “virtual” panel would simultaneously review case using dx console for access to all data • Connectivity using video conferencing would be time-saver; necessary because of the volume of cases

19. The Future Pursuit of the Integrated Diagnostic Center (IDC) • I envision that early integrated diagnostic initiatives will eventually morph into both physical/virtual IDCs • PCPs/internists/surgeons would refer patients with undiagnosed masses; pts. would exit with diagnoses • During diagnostic process, all ordering & patient management would be managed by diagnosticians • Oncologists are in the therapeutic & not diagnostic “business”; only want referrals of diagnosed patients • Other types of organ masses after breast that would be suitable for referral: lung, thyroid, kidney, liver

20. Wrap-up of Major Take-Home Points • Call for modification of “silo-ed” dx processes; collaboration of pathology, radiology, lab medicine • Integrated diagnostics analogous to emergence of multi-disciplinary therapeutic teams in cancer centers • Goal would be “cheaper, faster, better” diagnoses; digital pathology key TAT element from pathology side • “Virtual” panels, using specialized diagnostic dashboards would generate “super” dx’s from myriad dx reports • Current breast clinics, used mainly for screening, would be valuable/logical sites for pilot projects to test TAT • Success will not come easily with entrenched interests; drive toward ACOs could serve as stimulus for change