Courtesy of Wall Street Journal

According to the Dark Daily, acquisition of digital pathology technologies still remains in earliest stages:

"Anatomic pathology laboratories continue to purchase and deploy digital pathology systems at a brisk rate. It is confirmation that ever more pathologists are ready to adopt and use digital pathology systems."

The story goes on to say:

"It should be pointed out that, at this time, total worldwide sales of digital pathology systems do not exceed much more than 1,000 to 1,500 systems, exclusive of digital slide scanners. This number represents only a small percentage of the developed world’s clinical pathology laboratories. But the number is a useful benchmark that pathologists can use to track the adoption of digital pathology."

Full story from Dark Daily

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Here is just some of what you will take away…

Table of Contents

Introduction

Chapter 1. Current Status of Managed Care Requirements for Coding, Claim Submission and Reimbursement of Molecular Tests

Chapter 2. Why Payer Pre-Authorization and/or Notification for Genetic Molecular Tests Will Become Widespread 

Chapter 3. Existing Differences Among Payers in Pre-Authorization of Genetic and Molecular Tests  

Chapter 4. Advantages of Automated Payer Communication

Chapter 5. A Systematic Approach to Evaluating Genetic and Molecular Test Claims

Chapter 6. Case Study: Improving Clinical, Operational and Financial Performance in the Laboratory

Chapter 7. Conclusion 

A-1 About Matthew Zubiller
A-2 About McKesson
A-3 About DARK DAILY
A-4 About The Dark Intelligence Group, Inc., and The Dark Report
A-5 About Executive War College on Laboratory and Pathology Management
A-6 About Karen Appold

Terms of Use — Page 36

1x3 & 2x3 slide scanning services for brightfield & fluorescence applications.

• Illumination: Transmitted light LED and metal halide reflected light fluorescence.
• Optics: plan fluorite 10x 0.25NA, 20x 0.46NA, and 40x 0.75NA as standard.
• Other optics available upon request.
• High resolution cooled color digital camera, meets Nyquist Theorem requirements.
• XYZ automated platform with high resolution motorized stage.
• Autofocus capability - several autofocus applications available.
• Custom integrated PC / imaging software platform for a variety of applications.

The Services: What We Provide

• You decide - we acquire high resolution images per your determined methodology.
• Single images are in standard single TIFF image format for ease of use on a variety of analysis platforms.
• Custom software is included in the scanning service for our customers to navigate and view the full macro image at lower resolution and then expand to the single full resolution image for detailed viewing.
• All scanned image sets and folders will be stored on a USB digital hard drive, included with the return of your samples. We will store copies of these images at Micro Optical until you confirm that your hard drive and data has been received. You can choose to return the hard drive to Micro Optical or keep it as a backup copy of your original data.

Shipping

Interesting perspective from Dr. Paul Chang on digital pathology and workflow processes published in Health Imaging and IT.  

With vendors inking partnerships and developing new tools to bring pathology out of the dark ages and experts pegging the integration of radiology and pathology as one of the top opportunities for imaging, digital pathology may be imaging’s next frontier. This month, Health Imaging & IT chatted with Paul Chang, MD, professor and vice chair of radiology informatics and medical director of pathology informatics at University of Chicago, who offers insights into pathology workflow.

How does digital pathology workflow compare to radiology workflow?

Chang: I’ve been struck by a few assumptions that have been made about pathology workflow. The first is the belief that the pathology imaging task is similar to radiology. People see the success of digital image management in radiology and believe we should apply the same paradigm to pathology. However, pathology workflow differs in fundamental ways which I believe change the direction of digital pathology. 

Can you describe these differences?

Chang: As a radiologist, the most important part of my interpretation is whether or not there has been a change from the previous images. I need a high-quality representation of current and prior studies. This is not how pathologists use prior studies.
When evaluating prior studies, pathologists typically refer to a few key selected regions—the fields that represent the prior histology. The pathologist’s job is to tell if the current cells represent the same or different histology. Accordingly, the pathologist almost never is required to review every prior slide.

What are the image management implications of this pathology workflow process?

Chang:The consequences are significant. I don’t have to replicate digital radiology image management, which requires a large, complex and costly archive. It’s hard to justify an archive that is write once, read almost never. Wouldn’t it be better to just capture and store the key regions from the slides? Those selected images would be far easier to store and would be more cost-effective.

That addresses the image storage process, the PACS component. What about the RIS side of imaging informatics?

Chang: This is another fundamental difference between radiology and pathology workflow. In radiology, we acquire the digital image of the patient as one of the first steps in our workflow. From an informatics perspective, we transform the “analog” patient into digital data at the beginning and maintain that digital representation throughout the workflow process, which makes it easier to leverage digital technology to realize quality and efficiency.
In pathology the transformation from physical to digital is not done until near the end of the workflow.  The pathology workflow process requires the handling, tracking and processing of physical specimens throughout. In many labs, specimens are identified with patient demographics by the use of rubber bands binding the specimen container with a paper requisition form. A lot of things can go wrong. The real need here is not digital imaging but specimen tracking.
This very important part of pathology workflow doesn’t need PACS; it needs Fed Ex. Fed Ex manages the handling of physical packages by embracing digital workflow. They use barcoding to make sure packages don’t fall through the cracks. In anatomic pathology, barcoding and similar digital approaches could link the physical specimen to the patient and help manage specimen handling to avoid lost or misidentified specimens.

Can you provide an example?

Chang: At the University of Chicago, we are building a workflow solution that attempts to leverage digital technology appropriately. Barcoding will be used to unambiguously associate specimens with patient demographics and to track these specimens throughout the process. This specimen tracking system will provide the ability to launch contextually relevant decision support tools for users. For example, at the grossing station, scanning the specimen barcode will automatically show the pathologist the patient information and the relevant radiology images to help guide the specimen sampling. 
This is good news. We don’t have to wait for PACS archive technology to get significantly cheaper before we can embrace digital pathology. We can leverage existing enterprise PACS to store the much more modest representative images and then apply appropriate digital solutions such as specimen tracking to orchestrate more efficient and safer workflow. We can do this now.

Social networking and Pathology 2.0 are giving young pathologists unique opportunities to advance their careers and their clinical expertise. If you're a pathology resident or fellow, smart use of these tools can help you identify the perfect job, with ample salary and benefits to match.

If you're preparing to enter the professional arena, you'll want to use Pathology 2.0 and social networking to build valuable collaborations within the pathology profession. In the clinical area, it's a great way to open doors and interact with nationally prominent sub-specialist pathologists and professional leaders. 

Keith J. Kaplan, MD, FCAP is an up-and-coming young pathologist who is recognized as an early master of social networking-and is credited with coining the term "Pathology 2.0." Now he's ready to share what he's learned with you.

If you're a pathology resident or fellow, this is your chance to understand the essentials of Pathology 2.0 and social networking. Find out how the effective use of these resources can boost your career-both clinically and financially when you register to attend "Finding Your Perfect Pathology Job: How to Use Pathology 2.0 and Social Networking to Advance Your Career" on Thursday, February 10, 2011.

"Web 2.0" refers to an Internet that is both personalized and interactive. It incorporates technologies that allow websites to recognize the individual and deliver information and content tailored specifically to each user's interests and needs. It's about instant communication and collaboration across large numbers of like-minded individuals, enabled by the Internet.

Take all those Web 2.0 capabilities, add digital pathology images and you have the basis of Pathology 2.0, which represents a disruptive change agent in today's practice of anatomic pathology. 

Pathology 2.0 is the convergence of digital imaging, digital pathology systems, and integrated healthcare informatics. This combination of digital pathology images with social networking collaborations gives you the ability to discuss or diagnose a case across an ever-expanding network.

During this webinar, you'll learn how Pathology 2.0 is already beginning to change the daily practice of surgical pathology. Find out how digitized whole slide images, combined with different web-based technologies, can change case referral patterns. It all starts with a physician treating a patient and extends to the pathologist who may want a sub-specialist to review the images.

It is easy to see why Pathology 2.0 is likely to transform the current anatomic pathology practice into a different, more vibrant, and more collaborative profession. It will be today's pathology residents-already familiar with computers, email, and video games-who will be more likely to use the Internet to support their surgical pathology practices. 

As a pathology resident or fellow today, you have incredible new tools to advance your clinical skills and increase your professional compensation. Pathology 2.0 and social networking are valuable resources that can help you identify and secure the perfect job this spring. Find out how when you register to attend this very special webinar. 

And don't forget the question-and-answer session at the end of this 75-minute conference. It's your opportunity to get answers to specific questions about how to put Pathology 2.0 to work for you. 

For one low price—just $249—you and your entire team can take part in this fast-paced, insightful webinar. Best of all, you'll be able to connect personally with either of the panelists when we open up the phone lines for live Q&A.

Here's just some of what you’ll learn during this in-depth 75-minute webinar:

• Why digital imaging and digital pathology change everything.

• How Pathology 2.0 increases your professional capabilities.

• How you can use both social networking and Pathology 2.0 to market yourself to referring physicians.

• Avoiding the biggest mistakes pathologists make with their Facebook and MySpace pages.

• Steps pathology residents can take with social networking to increase recognition of their skills and sub-specialty competencies.

• Dangers and benefits of communicating with patients and physicians via social networking methods.

  …and much more!
  

Individuals who benefit from this webinar:

• Pathology chief residents, residents and fellows 
  
• Academic pathology chairs 
  
• Residency program directors 
  
• Pathology department administrators 
  
• Undergraduate and graduate medical educators 
  
• Pathology and laboratory professionals
  

How to Register:
1. Online
2. Call toll free: 800-560-6363

Your webinar registration includes:

• A site license to attend the webinar (invite as many people as you can fit around your computer at no extra charge)
• Downloadable PowerPoint presentations from our speakers
• A full transcript emailed to you soon after the conference
• The opportunity to connect directly with our speaker during the audience Q&A session

  Register Now! Or for more information, call us toll-free at 800-560-6363.
  

Distinguished Expert:

Keith J. Kaplan, MD is a pathologist and Chief Information Officer (CIO) of Carolinas Pathology Group, Celligent Diagnostics and Diligent Billing and Management. As CIO, he is responsible for all aspects of informatics strategies, operations, and projects and processes that encompass laboratory, healthcare and research information systems for Carolinas Pathology Group. Dr. Kaplan is board certified in anatomic and clinical pathology. His subspecialty interests include gastrointestinal and hepatic pathology, cytopathology and pathology informatics as well as research interests in gastrointestinal and hepatobiliary pathology, hyperspectral imaging, image analysis and the use of Web 2.0 tools in pathology. Prior to joining Carolinas Pathology Group, Dr. Kaplan was a surgical pathologist at Mayo Clinic and held the academic post of associate professor of pathology of Mayo Medical School. Dr. Kaplan is a graduate of Northwestern University Feinberg School of Medicine and completed residency training in anatomic and clinical pathology at Walter Reed Army Medical Center. While at Walter Reed, he was named Resident of the Year, and in conjunction with the Armed Forces Institute of Pathology, founded and directed the Army Telepathology Program. This program connected 25 hospitals internationally for consultation using telepathology. Dr. Kaplan is a member of the College of American Pathologists, American Society of Clinical Pathology and the American Society of Cytopathology as well as the American Pathology Foundation. He is also an executive board member of the Digital Pathology Association. 
 

In the fourth installment of my series entitled “Where do pathologists fit into Accountable Care Organizations (ACOs)?, I mentioned that I personally had not come across much information on oncology and ACOs.  In this post, I highlight some information about the potential plans of a large, single-specialty integrated oncology practice. Ben Calhoun MD PhD. 

As a surgical pathologist specializing in breast pathology, I assume that oncology will be a major area in of intersection between tumor pathology and ACOs (and the rest of oncology care delivery) in my daily practice.  How will ACOs affect those of us who spend most of our time looking at biopsies and resections for cancer?  That question is difficult to answer right now, but another way to approach the question could be to ask: What do we know about ACOs and oncology in general?

The short answer is: not much.  But, I ran across a recent (January, 2011) article by Judy Packer-Tursman on AISHealth.com about US Oncology and it’s potential as a single-specialty Medicare ACO (reprinted from ACO Business News).  Dr. Leonard Kalman, one the Medical Directors for US Oncology (recently purchased by McKesson), discusses an ACO-like arrangement involving US Oncology and the likely initial scope of ACOs in oncology (most likely limited to states or regions, with the possibility of a national approach later).

Dr. Kalman envisions some exclusivity to ACOs designed to deliver cancer care: “When cancer becomes the primary diagnosis, the oncologist basically handles the patient’s primary care, Kalman explains. ‘Remember, the majority of an oncology patient’s care is cancer care,’ he says. So while ACO patients may require occasional care from other sources, including primary care physicians or specialists such as cardiologists or rheumatologists, only oncologists would be affiliated with a Medicare oncology ACO as he envisions it.”  I guess if primary care physicians and specialists are excluded, that takes some of the mystery out of where pathologists would fit in…hospitals aren’t mentioned, either.

Two other points are worth noting:

1.  US Oncology is already involved in an ACO-like venture in Texas that involves Aetna, Inc. and a subsidiary of US Oncology.  “Meanwhile, Kalman says a seven-month-old ACO-type project in Texas — involving Aetna Inc., Texas Oncology (an affiliated US Oncology practice of 300-odd oncologists); and Innovent Oncology, a subsidiary of US Oncology — is expanding and has ‘the potential to go national.’”

2.  US Oncology is in the process of identifying large hospitals and commercial insurance carriers as potential partners for ACOs after the rules are written and released in January 2012. Dr. Kalman tells ACO Business News that “…..a major hospital in Miami has approached his 40-physician practice about handling cancer care in such a way. ‘Our ACO partner is a dominant hospital system where we put basically all of our patients,’ he says, declining to name it.”  Dr. Kalman adds that “the time is ripe for oncology practices to approach commercial managed care organizations and begin ACO discussions, setting the fee schedule and expenditure targets and a shared-savings arrangement. ‘We’ve picked out a commercial insurance plan as a potential partner,’ he notes.”

Another article in the Oncology Business Review (OBR) on Oncbiz.com discusses oncology and ACOs.  In the January 2011 issue of OBR, Allison Shimooka lists 5 key areas for investment in developing oncology ACOs: physician alignment, payer contracting, knowledge management (this means IT), facility strategy (integrating providers and healthcare systems), and patient engagement/activation.  She refers to plans recently announced by US Oncology and Milliman, a Seattle-based actuarial and consulting firm, to “develop a model for physician-led oncology organizations to contract around risk, either through episode rates, bundled payments, or capitation.”  She also mentions that United HealthCare is “piloting a new episode-based payment methodology with 5 private practice medical oncology groups.”

So, it’s clear that regional and perhaps national oncology ACOs are being contemplated by major players.  What, if any, developments should we expect with regional and national pathology groups and ACOs in general and oncology ACOs specifically (assuming such ACOs eventually exist)? 

By Rachel Smith 

http://www.businessreviewcanada.ca/sectors/medical-devices-products/toronto-set-become-world-class-medical-r-d-centre

GE Healthcare’s first global Pathology Imaging Centre of Excellence to advance digital imaging pathology solutions worldwide

Methods: Using a previously reported virtual microscopy platform and an open source image processing tool, ImageJ, a method for assessment of immunohistochemically (IHC) stained area and intensity was created. A tissue microarray (TMA) series of breast cancer specimens from 1931 patients was immunostained for Ki-67, digitized with a whole slide scanner and uploaded to an image web server.

The extent of Ki-67 staining in the tumour specimens was assessed both visually and with the image analysis algorithm. The prognostic value of the computer vision assessment of Ki-67 was evaluated by comparison of distant disease-free survival in patients with low, moderate or high expression of the protein. 

Results: 1648 evaluable image files from 1334 patients were analysed in less than two hours.

Visual and automated Ki-67 extent of staining assessments showed a percentage agreement of 87% and weighted kappa value of 0.57. The hazard ratio for distant recurrence for patients with a computer determined moderate Ki-67 extent of staining was 1.77 (95% CI 1.31-2.37) and for high extent 2.34 (95% CI 1.76-3.10), compared to patients with a low extent.

In multivariate survival analyses, automated assessment of Ki-67 extent of staining was retained as a significant prognostic factor. 

Conclusions: Running high-throughput automated IHC algorithms on a virtual microscopy platform is feasible. Comparison of visual and automated assessments of Ki-67 expression shows moderate agreement.

In multivariate survival analysis, the automated assessment of Ki-67 extent of staining is a significant and independent predictor of outcome in breast cancer.

Author: Juho KonstiMikael LundinHeikki JoensuuTiina LehtimakiHarri SihtoKaija HolliTaina Turpeenniemi-HujanenVesa KatajaLiisa SailasJorma IsolaJohan Lundin

Credits/Source: BMC Clinical Pathology 2011,11:3

The following post was submitted by Dr. Holger Lange, CTO of Flagship Biosciences, who is working with a number of pharmaceutical partners on regulatory companion diagnostics development.

Digital Pathology is a new technology, a new industry, where organizations like CLIA, CAP and the FDA provide limited guidance, and the manufacturers still have to learn what it means to provide instruments into a clinical laboratory.

With Digital Pathology now entering the clinical laboratories, it is crucial for physicians and laboratory professionals to understand the regulatory requirements and how to best implement Digital Pathology in their clinical laboratories.

For the past 4-5 years I have worked for a leading Digital Pathology manufacturer. I was responsible for their first product in the clinical market – a digital IHC workflow solution, and their portfolio of FDA clearances. Now I have put together a presentation that summarizes my experience in the clinical market. I hope it will help many physicians and laboratory professionals to quickly get up to speed on how to deal with the implementation of Digital Pathology in their clinical laboratories.

These are the subjects that are covered in the presentation:

Clinical Laboratory Regulations

A discussion on how the CLIA standard and the CAP checklist apply to Digital Pathology. A review of the new ASCO/CAP guidelines for HER2 and ER/PgR for the latest thoughts on standardization and validation in clinical laboratories.

Medical Device Manufacturer Regulations

An overview of the existing US Food and Drug Administration (FDA) clearances for Digital Pathology with an example of a successful study design. A discussion on the FDA advisory panel meeting on Digital Pathology Whole Slide Imaging (WSI) for the latest thoughts on what it takes to validate Digital Pathology systems for primary diagnosis.

Digital Pathology Systems

Practical tips on how to implement a digital pathology system in a clinical laboratory and how digital pathology manufacturers could make it easier. A demo of how a digital pathology system can help with the logistics of its own validation. A discussion on how going digital could be a game changer for the standardization of pathology, looking at the example of the automatic standardization of staining, using standard controls and automatic image analysis.

Go to the Flagship Biosciences product page for digital pathology regulatory products.

You get an 1½ hour video presentation on a DVD and the presentation transcript.

Save yourself many hours of research and reading! Get the insights you need by viewing this video presentation. Get access to material that cannot be found anywhere else.

Our telephone numbers are now: 

 
 

The American Society for Clinical Pathology (ASCP) is pleased to announce that it has learned that the Centers for Medicare and Medicaid Services (CMS) is planning to rescind its recent rule requiring a physician's signature on requisitions for laboratory tests reimbursed under the Medicare clinical laboratory fee schedule. The CMS rule proved very controversial and prompted not only the collective opposition of the entire laboratory coalition but also the American Medical Association and a number of other medical specialty societies.

ASCP, in tandem with its partners in the Clinical Laboratory Coalition, mounted an aggressive campaign to protest the proposal. ASCP launched two separate advocacy campaigns on the rule. The first campaign let CMS know directly the concerns of ASCP members, while the second campaign was intended to encourage members of Congress to contact CMS in opposition to the rule. In total, ASCP members wrote more than 2,000 letters in opposition to the rule. CMS received a loud and clear message from Congress today as the agency received a letter from 89 members of the U.S. House of Representatives and another letter from more than 30 U.S. Senators.

In announcing the agency's intent to withdraw the rule, it was mentioned that the agency would officially withdraw the rule well in advance of the April 1 date that the rule was supposed to go into effect. For more information on the rule, click here.

Where is the digital pathology interest in dermatopathology buried?

With the increased adoption of both brightfield and whole slide fluorescence scanning, the accessibility of skin samples seems ripe for digital pathology applications.  But there are good reasons for going slow in this clinic area:

1) Questions of dermatology diagnostic equivalency of glass versus image. While the whole slide imaging technology keeps improving, Jonhan Ho et al (University of Pittsburg, 2008) rightly mentions concerns with the whole slide image in clinical dermatology usage. A recent publication by Bjarne Nielsen et al (Aarhus University in Denmark, 2010), is positive on skin tumor virtual microscopy provided pathologists have completed a period of digital pathology training. The good news overall is scanning technology keeps getting better, especially in reducing poorly scanned areas that are unacceptable in a clinical practice. 

2) Complexity of dermatopathology. The skin may be the only place where the surface really is the most complex. There are an estimated 1500 different rashes and skin tumors, including variants, making dermatology and dermatopathology among the most complex specialties of medicine. How exactly does one approach an equivalency study design with this much disease complexity? It would challenge even a Dr. Holger Lange to device an adequate regulatory digital pathology study design for dermatology. 🙂

3) Complexity of image analysis approaches. One needs to first be able to have the computer identify layers of the derm, prior to looking at feature-level analysis (e.g. cell and object counting, or geometry measurements in a given layer). Layer analysis requires a white-box or rules-based programming that combines geographic knowledge ("Which layer am I in?") with textual feature recognition ("Hey computer, this layer's texture looks like this..."). In this sense it is similar to layer-based ophthalmology image analysis. It takes substantial time to write these layer-based detection algorithms and one has to constantly verify that the assumptions made in the algorithm match the tissue being analyzed (e.g as a superficial example, an algorithm looking to identify five stratum layers may work in thick skin epidermis, but will fall apart when working in thin skin with a missing stratum lucidum and only three or four of the five layers).

4) Economics of clinical dermatopathology. Most dermatology practices do not send out many of their dermatapathology cases, and cannot afford the hundreds of thousands of dollars for digital pathology scanners and software, which would not change how they would practice their discipline (at least not yet). 

Despite these limits in clinical dermatology digital pathology adoption, we are excited about the possibilities that whole slide imaging brings to dermatology research and pharmaceutical clinical trials. Quantitative data on both efficacy and toxicology is key to all stages of pharmaceutical product development, and skin is no exception. To be successful, the dermatology trained pathologist must work closely with an image analysis expert. Particularly in skin, the specific image analysis design must be discussed beforehand with a pathologist, and a pathologist needs to review and sign off on each result. This is true whether the study approach is simple, like increased collagen or dermal thickness measurements, or complex, like multiplexed IHC melanoma proliferation studies.

Interestingly enough, thanks to the efforts of some remarkable pathologist pioneers in dermatopathology, the dermatology field has historically been described in algorithmic terms. Dr. Ackerman's book in 1978 is the classic work, and written in a rules-based approach. There have been multiple new editions, but the original 1978 textbook, if you can find one, costs thousands of dollars, and is worth far more in the contribution he provided to this field.  

As a digital pathology CRO, we do a lot of work in the area of skin samples, whether the sample is for implanted device material evaluation, cosmetics studies, or dermatopathology product development. This seems an opportunity for comparative pathology approaches, and the opportunity to participate in dialogs between veterinary and MD pathologists in developing dermatology image analysis applications is truly a privilege. However, finding MD dermatopathologists who have the interest, time, and training to be involved in dermatology product development is not easy. 

Of all the various organs where digital pathology will have a major impact, the complexity of dermatopathology is perhaps the most humbling to image analysis experts. We are just scratching the surface. 

P.S. Speaking of humility and history, I need to remind Keith Kaplan that the last time the Chicago Bears won a Super Bowl was around when Dr. Ackerman's first edition was gaining fame. I don't mind the Bears, it is the Bears fans I can't stand. At least Jay Cutler doesn't like Bears fans either.

Humbly submitted by Steve Potts, of Flagship Biosciences, a digital pathology CRO.