This makes perfect sense for the LIS space.  McKesson needed an AP solution to add to their portfolio and increases NovoPath's presence in laboratories under McKesson's corporate strategy.

Princeton, NJ (PRWEB) August 30, 2012

NovoPath, a market-leading provider of anatomic pathology software solutions, today announced a strategic partnership with McKesson, a healthcare services and information technology leader. As part of the new agreement, McKesson plans to propose the NovoPath Anatomic Pathology Solution in conjunction with its advanced laboratory offering and its integrated health information system. The partnership is expected to benefit providers by offering the market an alternative solution that combines NovoPath’s deep expertise in anatomic pathology with McKesson’s best-of-breed laboratory solutions.

In addition to further extending NovoPath’s considerable presence in the anatomic pathology market, this agreement also supports McKesson’s Better Health 2020 strategy to enable better business, care and connectivity across the healthcare continuum including laboratories throughout the country.

Delivering enhanced communications, productivity and accuracy to pathology lab professionals nationwide, NovoPath is a comprehensive workflow and reporting lab information software system specifically designed to support the unique needs of the anatomic pathology laboratory. The NovoPath solution has been installed in small, medium and large hospitals, as well as specialty practice anatomic pathology laboratories, and local, regional and national reference labs.

“We are excited about this new relationship with NovoPath, which has a track record of exceptional service and product offerings for the anatomic pathology laboratory market,” said John Yount, vice president, Lab Solutions.

Both companies look forward to providing a comprehensive anatomic pathology solution that complements McKesson’s suite of laboratory solutions.

“This partnership enables NovoPath to provide McKesson customers and the larger market with a tightly integrated anatomic pathology solution,” commented Rick Callahan, NovoPath’s vice president of sales and marketing. “This integration offers laboratories the best of both worlds; a seamless integration of a best-of-breed with an outstanding enterprise-wide solution.”

About NovoPath, Inc. NovoPath, Inc. develops and markets software solutions for the Anatomic Pathology Laboratory market segment that includes local, regional, national, in-house laboratories as well as community and university teaching hospitals and medical centers. Since the release of its flagship product in 1999, NovoPath, Inc. has focused exclusively on Anatomic Pathology. NovoPath's mission is to provide unique and unparalleled solutions and services to all aspects of the Anatomic Pathology sector in a way that improves workflow, reduces the probability of human error, ensures results accuracy for greater patient safety, protects patient confidentiality, and above all, produces more precise and informative diagnostic outcomes. More information is available at http://www.NovoPath.com.

About McKesson McKesson Corporation, currently ranked 14th on the FORTUNE 500, is a healthcare services and information technology company dedicated to helping its customers deliver high-quality healthcare by reducing costs, streamlining processes, and improving the quality and safety of patient care. Over the course of its 178-year history, McKesson has grown by providing pharmaceutical and medical-surgical supply management across the spectrum of care; healthcare information technology for hospitals, physicians, homecare and payers; hospital and retail pharmacy automation; and services for manufacturers and payers designed to improve outcomes for patients.

Read the full story. 

Amande Lowe, president of Digital Pathology Consultants, LLC has a great article for practicing pathologists about common misconceptions regarding the use of digital pathology in the practice of pathology and how and what the technology means in clinical practice under the current framework of government demands, regulations and consumer expectations. 

Debunked: Digital Pathology Misconceptions

Yes, you can be reimbursed, and no, it won't slow you down.

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. 

 

Related Content

• Advances in Digital Pathology

• Digital Pathology Chess

• Histology Process Improvement

Source: Advance for Administrators of the Laboratory

 

 

There has to be an app for that!  

 Actually there is one now from informatics folks at the Centers for Diease Control (CDC).

Downloaded this yesterday and everything a (medical) app should be -- Low cost (free), intuitive, easy to use, practical, educational and informative. Not hard to use, navigate or get infrormation from.

iTunes preview

CDC's PTT Advisor offers clinicians a tool to quickly select the appropriate follow-up tests to evaluate patients with a prolonged partial thromboplastin time (PTT) laboratory result and a normal prothrombin time (PT) laboratory result. PTT Advisor will run on your iPhone, iPod touch or iPad. PTT Advisor has been created by CDC in collaboration with experts in diagnostic coagulation with a collective experience of more than 50 years in the field. 

CDC works 24/7 keeping America safe from health, safety and security threats, both foreign and domestic. Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights it and supports communities and citizens to prevent it. CDC is the nation's health protection agency — saving lives, protecting people from health threats, and saving money through prevention. 

iTunes preview

FEATURES:

• Simple and easy-to-use interface
  
• Quickly navigate through the decision tree
• Additional information/footnotes provided at key decision points
• Quickly modify your answers and review all your selections at any point
• Can be used for both pediatric and adult populations
• No registration or login required
• No data is collected or stored

Contact e-mail:  InformaticsLab@cdc.gov

Q: How do I get PTT Advisor? 
A: You can download PTT Advisor for your iPhone, iPod touch, or iPad from Apple's App Store — free of charge. 

FAQs:

Q: How do I navigate through the application?
A: The toolbar at the bottom of the screen has three navigation buttons: 
 
(1) Back: Go back one step. 
(2) Next: Go forward one step. 
(3) Go to Last: Go to the last step you were presented, but haven't yet responded to. 

Q: Each screen is labeled at the bottom with Step #. How many total steps are in an evaluation?
A: The number of steps per evaluation is determined by your responses. Certain responses will lead to additional steps, so there is no fixed total number of steps. 

Q: How do I change my response to a question?
A: You can either: 

(1) tap the Back button  to navigate to the desired question, then change your response -OR- 

(2) tap the Evaluation Review button , then tap the desired question listed under Completed Steps.
You will be returned to the selected question, where you can change your response. 

Q: When I navigate back to previous steps, why are some buttons green with a checkmark?
A: The button that you tapped as your response will be green with a white checkmark. 

Q: I changed a response, and a Change Decision Warning alert appears. What does this mean?
A: If you change your response to a previously answered question, all the responses you gave at steps beyond the question will be discarded. You will receive new questions and information from that point forward. For example, if you are at Step 5, but change the response for Step 2, your responses for Steps 3 through 5 will be discarded. You will get new questions/information at Step 3 and onward. 

Q: What does the Footnotes button  do?
A: The Footnotes button will be enabled on a step if footnotes are associated with the information presented. This will be indicated by a note at the end of the question/information that reads: [see footnotes]. Touching the Footnotes button launches the Footnotes screen, where any associated footnotes will be listed. 

Q: What is the Evaluation Review screen?
A: The Evaluation Review screen is launched by touching the Evaluation Review button  on the toolbar. This screen lists the steps you have completed thus far, as well as the current step (or recommendation, if you've reached the Recommendation step). From here, you can tap any step and return to it (to change your answer, for example), or just review the steps and responses thus far in the evaluation. 

Q: If I restart the patient evaluation with the Restart button , will my previous responses be lost?
A: Yes, when you restart the patient evaluation, any previously entered responses will be discarded. 

Q: I've made it to the Recommendation screen. What do I do now? 
A: Once you have reached the Recommendation screen and read the recommendation, you can: 
(1) start a new patient evaluation by tapping the Done button  or the Restart button . 
(2) review the evaluation and your responses by navigating backward with the Back button , or launching the 
Evaluation Review screen with the Evaluation Review button . 
(3) suspend or close PTT Advisor. 

Q: Is the response data collected or stored?
A: No, your responses are discarded once you either (1) close the application, or (2) start a new patient evaluation. 

CDC convened seven Institutes from 1984 to 2007 on critical issues in clinical laboratory practice (http://www.cdc.gov/dls/institutes/). National and international experts focused on the role of the clinical laboratory in providing quality testing to improve patient outcomes. The Clinical Laboratory Integration into Healthcare Collaborative (CLIHC)™,  CDC’s Division of Laboratory Science and Standards (DLSS), is addressing some of the recommendations from these institutes by focusing on important “gaps” that must be filled to optimize the ability of practicing clinicians to effectively utilize laboratory services for better patient care. 
The PPT Advisor was developed through CDC’s Office of Surveillance, Epidemiology and Laboratory Services by the DLSS’s CLIHC™, in partnership with the OSELS Informatics R&D Activity.

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We may not be top 10 worldwide in academic performance measured by math and science scores but this can't possibly accurate.  DarkDaily has a story today about another high school student developing some great laboratory advances.  The future is bright for the specialty of pathology!

Courtesy of DarkDaily:

Pathologists take heed! Teenagers are taking off-the-self technology and creating useful new clinical laboratory tests for cancer and other diseases

For the second time in recent weeks, a teenager has made national news for developing a medical laboratory test that can more accurately diagnose disease when compared to methodologies currently used by clinical laboratories and pathology groups. Pathologists and clinical chemists have good reason to ask what is different about the science taught in today’s high school compared to recent years.

Read more: DARK Daily Laboratory and Pathology News http://www.darkdaily.com/#ixzz24wgwvS00

Teen-ager Brittany Wenger of Sarasota, Florida, developed a software program that was able to more accurately diagnose breast cancer from specimens collected by fine needle aspiration (FNA). Her effort won second place at the Google Science Fair, along with national news coverage of her accomplishment. (Photo by Andrew Federman of Google.)

From the ANZ Journal of Surgery

Article first published online: 24 AUG 2012

DOI: 10.1111/j.1445-2197.2012.06191.x

© 2012 The Authors. ANZ Journal of Surgery © 2012 Royal Australasian College of Surgeons

Courtesy of FierceMobileHealthcare

The Pathology Blawg has a nice piece and comments on the ridiculous notion that pathologists (and radiologists and anesthesiologists), given the nature of their clinical practices (non-direct, non-patient care, non-outcomes focused for payment) could and would be penalized for not meeting EHR meaningful use criteria like "real" doctors; those who are on the front lines, in the trenches, managing smoking cessation, weight control, diabetes, hypertension, hyperlipidemia, COPD, etc...

On Friday August 24, 2012, the CAP released a STATLINE special alert detailing how the Centers for Medicare and Medicaid Services (CMS) granted a temporary “stay” in penalizing pathologists, anesthesiologists and radiologists from the MU benchmarks.  In addition, HR 4066 now has 38 co-sponsors.

Read more here.

Dear Aperio
Customer,

On behalf of everyone at Aperio, I want to take
this opportunity to tell you about a new and exciting development. I am pleased
to announce that Leica Biosystems is acquiring Aperio. Aperio began as a
start-up business 12 years ago and today has grown into the leader of
ePathology solutions. By integrating with Leica Biosystems, we will improve our
global reach and provide the broadest portfolio of pathology solutions to serve
this growing and changing market.

At Aperio, we believe pathology plays a vital
role in patient care and research, with an ever-increasing importance due to
advances in diagnostic testing, more targeted drug therapy options, and
advances in personalized medicine. Leica Biosystems shares that belief.

Leica Biosystems’ goal is to provide solutions
that meet all your anatomical pathology needs and help advance cancer
diagnostics. They are represented in over 100 countries, with manufacturing
facilities in 7 countries, sales and service organizations in 19 countries, and
an international network of dealers. Leica Biosystems provides end-to-end
solutions that help customers improve workflow efficiency and diagnostic
confidence.

Leica Biosystems is acquiring Aperio because of
our leadership in ePathology solutions, our great products, and our dedicated
team. We believe that together we can advance our product portfolio more
effectively, expand our global reach, and continue to improve our customer
service. The Aperio ePathology solutions are complementary to Leica’s own broad
portfolio of pathology solutions. The integrated business will enhance both
solutions going forward. For the foreseeable future we expect business to
remain as usual.

The transaction is subject to various closing
conditions, including customary regulatory approvals, and we will continue to
operate independently until the closing.

Please do not hesitate to contact me if you have any
questions. We look forward to continuing to serve you in the years
to come as Leica Biosystems and Aperio embark on this exciting new journey
together.

Best regards, ???

David Schlotterbeck ?

CEO, Aperio

There are many angles and points to this news and one post on the matter will not do the implications for us users, consumers, clients, customers, prospects and technophlies justice.  I hope this will the first installment of many as more details emerge about the deal.

Perhaps not too surprising would be that the story on Tuesday mentioning Leica buying Aperio turned out to be only a slightly more popular post than a recent post about a 10-year old with Asperger's giving a personal medal to the Canadian Olympic team, confirming again that everyone likes a story with a happy ending (pending SEC clearance and the deal closing).

In April of last year I wrote a post entitled "Leica and Slidepath got it right" about seeing their SCN400 device along with SlidePath Digital Image Hub viewer and image analysis tools. 

Also of note was the large laboratory presence in staining, instrumentation and clinical microscopy Leica brought to the table with great optics and solid software applications. 

What was missing then as it was until a few days ago was a scanner of their own, the ability to support multiple sites on a common database, a portfolio of FDA 510K cleared image analysis applications that Aperio has in its portfolio and a polished sales and marketing staff.

A perfect fit for both companies.  Leica gains a product that can network, cleared IHC algorithms, a larger sales and marketing force very familiar with clinical, educational and research markets as well as instant major market share purchasing the leader in the space with 1100 systems deployed worldwide.

2 years ago today, Roche announced it was buying BioImagene, the sale came approximately 2 years after Dr. Ajit Singh joined the company as CEO.  When he joined the company, clearly his job was to get the company sold.

Fast forward to November of last year when Aperio appointed healthcare veteran David Schlotterbeck as CEO of Aperio following an appointment on the board and replacing founder Dirk Soeksen as CEO. Clearly his job was to get Aperio sold.  Mission accomplished.  In less than a year.

For the past couple of years and more recently in the past several months it was known that Aperio was having difficulty with cash flow evidenced by the number of times it raised money. Early this year Aperio shifted its focus to selling and promoting its newly branded ePathology solutions and partnered with Dell to create a cloud computing partnership and a global consultation network.  They were making advances in the market and needed capital to execute.  

Customers appeared to be choosing Aperio over Leica on most head-to-head deals based on proven experience and ability to define customer needs and match products and services. Leica did hot have as broad a product offering or enough boots on the ground to compete, particularly in North America. 

Some questions come to mind:

Did Aperio's market prowess impact Leica's ability to win new digital pathology business? Did a lack of IHC image analysis with FDA clearance hurt them considering reads of ER/PR/HER2 appear to be solid use cases for digital pathology? And if you can't beat 'em, buy 'em?

In the end, Leica combines a long history of laboratory products and manufacturing processes to go head-to-head with Roche for a combined solution for staining/scanning/analysis for cancer diagnostics and prognostics and Aperio gets a suitor.

Many questions remain I do not know the answer to:

How much?

Is there/Will there be measurable culture clash in this acquisition?

What will the new combined branding look like i.e. "Leica Biosystems ePathology Solutions Powered by Aperio" much like Roche/Ventana's "Powered by BioImagene" byline?

Here is where I think are now with market segments in the digital pathology space:

1.  IHC image analysis (Roche and Leica) - groups with in-house IHC, independent labs, reference labs, consultation capabilities across a network.

2.  PACS integration (Philips and GE) - large integrated health care delivery systems, hopspital owned groups and perhaps virtual IHC offerings or large consultation/referral combined networks through PACS integration.

3.  Small volume, low cost (DigiPath and Mikroscan) - coverage for remote frozen sections, FNAs, ad hoc intramural/extramural consults (low volume of slides and transactions), in-office laboratories, low cost solution for risk mitigation in low volume circumstances.