I am in the process of accomplishing one of my new years resolutions to become Black Belt certified in Lean Six Sigma. I am two thirds of the way done. I became certified as a Six Sigma Green Belt in April and Lean certified in June; both with a focus in healthcare.  I am currently in the process of taking my black belt course and working on a project for certification.  These days Lean Six Sigma methods are constantly running through my head and I have applied several methods to my consulting work.

The power of Post-It's and moveable whiteboards!

One of my favorite tools are Post-its and take anywhere, disposable white boards.  I use them on-site with clients and I also use them in my office, ALL over my office.  So in an ongoing effort to immerse myself more in Lean Six Sigma for the lab I turned to one the leaders of Lean Six Sigma in pathology, Henry Ford Hospital.

Dr. Mark Tuthill, Division Head of Pathology Informatics, was kind enough to give me a tour and WOW was I impressed.  Yes.. it was a big WOW! My last blog post was about creating WOWs instead of waiting for them to happen.  This is exactly what Henry Ford’s department for Pathology and Laboratory Medicine has done and continues to do, because striving to improve is never complete!  You know from the moment you enter the department you have walked into a remarkable place.  Placards are prominently displayed with powerful messages including:

Every Life Deserves World-Class Laboratory Service”

Lean Six Sigma is a management philosophy and their department is lead by prominent pathologist Dr. Richard Zarbo, who clearly embraces the power of Lean Six Sigma.  The entire department is involved and committed to continuous improvement; a fact that would make their founder, and the father of Lean, Henry Ford proud.

Here are some of my take-aways from my visit.

• Silence is golden! Dr. Tuthill brought to my attention, while standing in the gross lab, how quiet everything was. This quite and calm environment continued throughout the AP lab too.  The department has moved away from transcription and voice dictation and developed templates that integrate into their LIS.
• Process improvement takes time and really is continuous. This is a fundamental of Lean Six Sigma but was reinforced throughout my department tour.  White boards are all over to illustrate how new processes are mapped, monitored, and certain boards engage employees to document defects on an ongoing basis.  Defects, as defined in their publication “Effective Reduction of Process Defects and Waste In Surgical Pathology,” are forms of waste including flaws, imperfections, or deficiencies in specimen processing that required work to be delayed, stopped, or returned to the sender.  Here are some pictures of their whiteboards and process flow charts:

Gross Room: Process Flow Chart

Defect Tracking

• A very visual environment. Everything, and I mean EVERYTHING was labeled- even gauze.  The department loves 5S and Kanbans and you can tell.  You never have to question where something is, where it should go, or if there is more available.  It’s a straight forward concept but is your lab like that?
• A foundation for success! Henry Ford has been working hard to prepare their lab and department for their digital future over the past few years (while also reducing costs, improving patient safety, and laboratory efficiency). Their entire process is barcoded from accession to sign-out.  The laboratory uses barcode technology from General Data, and even assigns barcodes to requisition forms that are scanned to eliminate paper in the lab.  The gross lab is set up with a Milestone gross imaging system,  digital cameras are mounted on grossing tables and pathologists microscopes.  The cameras are then connected via a TWAIN interface to PathPacs, their middleware software by Apollo.  PathPacs is integrated with their Sunquest CoPath Plus LIS and allows the pathologist to choose and select images to be in the LIS and reports.

Can you guess their next step for their digital future? Digital Pathology!   With the foundation described above, a Lean Six Sigma culture, and a management team with vision I have no doubt that they will be successful.  Thank you Henry Ford Hospital for your level of excellence, you truly are a gold standard.

Tis the season for fireworks and a celebration of independence! Fireworks are spectacular and have an amazing WOW (or ooooohhhh aaaaahhhh) factor.  Digital pathology use to have a big WOW factor but the industry has lost that over the past couple of years.  This has to change!  We need to shake things up and create new WOWs! We need to make digital pathology spectacular!

Stop waiting for the ultimate WOW to come from a digital pathology manufacturer.  This mindset has to change– it’s time to create your own WOW with digital pathology and become independent of the manufacturers.  The technology is very good and it can do what you want it to do today.  It just takes work, lots of work to make your digital pathology vision a reality.   Work…..ugh, I know.  The good things in life are never easy but we need more success stories, more spectacular outcomes with digital pathology!  I know we can do it!!

Stressed about the work it will take to make digital pathology spectacular? Need help? Give me a call.

There have been situations in my career when I wish I knew less and when I wish I knew more about pathology and laboratory medicine.  Typically both of those emotions arise when a personal situation collides with my professional world.

A very close friend of mine just had a miscarriage when she was 13 weeks pregnant.  During this sad and emotional time she was faced with a tough decision.  Did she want to have the fetal tissue tested after her D&C for chromosomal abnormalities? Her OB said the fetal tissue would be sent to pathology either way but further testing could possibly answer the question as to “why” she miscarried.  The word “pathology” stuck with my friend and since she knows what I do she called me for advice and for my opinion on whether she should have the testing done.

I was deeply concerned and sad for my friend.  Although I wanted to help her I knew there was no way I could (or should) answer this for her- it had to be her decision.  But one thing that was obvious was my friend needed more information and a medical professional she could talk to.

I believe that medical professional should of been a geneticist, pathologist, or someone affiliated with the lab.  Lab tests are often just ordered, or if presented to the patients as an option, the ordering physician typically do not know enough of the facts on the test to answer questions beyond generalities.  In the case of my friend I think the answers to the following questions may of helped her:

• What exactly is cytogenetic testing and what exactly will the test tell me?
• How is the test preformed?
• Who does the testing? Is it done in a lab here at the hospital or sent out?
• Who reads/diagnoses the test results?
• How accurate are the results? Are false positives or inaccurate results possible? If so, how possible?
• Does insurance cover this test?

I am going to guess her OB would not have known the answer to these questions, but someone in the lab would or should! The day before my friends D&C she received a telephone call from her OB and an Anesthesiologist to prepare her for the procedure.  What if someone from the lab had called too to go over the pathology and testing options?  Would that have helped? I’m guessing so!

We need to transform the model of care in the lab to include a proactive approach to diagnosis and testing rather than just reactive.  From a business perspective I’m guessing the lab would prefer patients to order cytogenetic testing.   To increase orders for the right lab tests and to decrease the blind useless ordering of other tests, labs and their physicians must step up!

In the end my friend decided against the cytogenetic testing.  Her lack of understanding of the tests and fear of a gigantic bill when insurance denied the claim caused her to decline the testing. Yet the tissue was still sent to pathology.  So somewhere in some lab there are glass slides with fetal tissue from my friends baby.  Will she ever know the pathologists findings? Probably not, but she should.

Digital Pathology Consultants LLC (DPC) and BioInformatics LLC announced today a partnership to provide digital pathology companies unprecedented market insight about their customers, products, and brand.

BioInformatics LLC has served the life science, medical device, and pharmaceutical industries for the past 17 years as a leading market research and advisory firm.  Digital Pathology Consultants, a premier consulting firm, is a trusted advisor to the digital pathology industry, healthcare, and pharmaceutical markets.  The collaboration between DPC and BioInformatics LLC combines extensive industry knowledge with an accomplished team of market research experts to provide digital pathology companies with the vital market information necessary to grow their business and remain competitive.

Amanda Lowe, President of Digital Pathology Consultants said, “We are excited to work with BioInformatics LLC, an excellent firm with an outstanding track record.  Their skilled staff of experts will provide my clients with the right information to make good business decisions.”

Bill Kelly, President of BioInformatics LLC, said, “In order to provide comprehensive solutions to leading medical technology companies, advisory firms must respond in a collaborative, innovative way.  We are excited to join forces with Digital Pathology Consultants, an organization that brings a deep knowledge of the digital pathology industry and an understanding of best practices to each engagement.”

In 1997, BioInformatics LLC established a professional online community, The Science Advisory Board, which has grown in number to over 60,000 scientific consumers. Members network on this social media platform to voice opinions, share protocols and collaborate with colleagues around the world. According to Kelly, “Over the past year, we have been actively recruiting scientists in the pathology and molecular diagnostics fields to our online panel in anticipation of continued growth in these markets.”  Members agree to participate in market research surveys and focus groups, which will be a valuable resource to Digital Pathology Consultants and will support our collaborative efforts to reach out to scientists in the digital pathology industry.

About Digital Pathology Consultants

Digital Pathology Consultants, founded by Amanda Lowe, is a leading provider of digital pathology consultation services. Our services assist businesses, and medical and biopharma professionals with market research, business planning, and step-by-step through the selection, implementation, and validation of digital pathology solutions.  Knowledge, trust, and an open exchange forum shape the foundation of Digital Pathology Consultants. Delivering results is our promise, exceeding your expectations is our guarantee.

About BioInformatics LLC

BioInformatics LLC, is the premier research and advisory firm serving the life science industry.  By leveraging our professional social network of more than 60,000 life scientists, we have supported more than 300 companies and provided insights that lead to better business decisions.  Our assignments include assessing the size and attractiveness of markets, optimizing product configurations and pricing, validating corporate acquisitions, measuring customer loyalty, and evaluating brand strength and positioning.

Read press release here at http://www.prweb.com/releases/2011/5/prweb8472899.htm

Seven years ago hardly anyone knew what digital pathology (or virtual microscopy) was. I thought we had overcome much of this, yet it turns out we still have a lot of work to do to get the message beyond the pathologists.

Last week I delivered a presentation on digital pathology, sponsored by Nikon Instruments, to an audience of laboratory and diagnostic imaging professionals at the Amerinet (GPO) Member Conference.  It was an excellent and eye opening experience (hopefully for my audience too).  My presentation began with asking the audience “What is digital pathology?”  Some people shock there heads, I had lots of blank stares, and one person who finally said…

You scan a glass slide and share it with others.

I then asked, “how many of you do not know what digital pathology is? Over a dozen people raised their hands.  I was not surprised but it highlights the point that we have a lot of educating to do.  Not just to educate about digital pathology, but to change perceptions that digital pathology is just a scanned glass slide.   Here are some other interesting points I took home from my audience:

• Barcodes: Another poll of the audience revealed that not a single lab represented in the room has automated their histology process with barcodes, beyond the stainer barcode.
• File Size: I asked the audience “what is the average file size of a whole slide image?”  I had a few hands go up and the guesses were 30 MB and 50 MB!  I heard audible gasps and WOWs when I revealed the actual average size was between 250-300 MB each (at 20x) and that some WSI could be a Gig or larger.

We’ve got some work to do! It is time to educated beyond the pathologist and reach our laboratory administrators, histotechs, IT managers, hospital administrators, and physicians who routinely interact with pathologists.

Digital Pathology Consultants introduces a new webinar “The New World of Laboratory Medicine” presented by Richard Friedberg MD, PhD on May 23, 2011 at 3 PM EST / 12 PM PST, supported by our sponsors at www.thedigitalpathologywiki.com.

Description

To thrive in highly competitive markets, clinical laboratories need to look beyond traditional models of service delivery and begin to think outside the box. This may mean integrating with other diagnostic services and delivering different types of results, from laboratory to imaging, to physicians and other clients. This webinar, presented by Richard Friedberg MD, PhD, will explore how lab medicine has changed and is likely to evolve in the coming years and how you can position yourself for the future.

About Richard Friedberg MD, PhD

Chairman,
Department of Pathology, Baystate Health, Springfield, MA
Medical Director, Baystate Reference Laboratories

Professor and Deputy Chairman
Department of Pathology, Tufts University School of Medicine, Boston, MA

In 2007 and again in 2010, Dr. Friedberg was elected to the Board of Governors of the College of American Pathologists, where he also serves on the Council on Accreditation (vice-Chair) and Council of Government & Professional Affairs (Executive Committee), as well as CAP committees such as Strategy Management (Chair) and Finance. Dr. Friedberg holds a BS with Honors from Stanford University, an MD from Duke University, a PhD in coagulation biochemistry from Duke University, and a Master’s (SM) in Health Care Management from Harvard University. He is a Certified Physician Executive (CPE) by the American College of Physician Executives.

To register visit:

https://www1.gotomeeting.com/register/557090784

I grew up with my mom touting the phrase…

If at first you don’t succeed- try, try again.

There are times in all of our lives that we have failed but look failure in the eye and… (say it with me) try again!  Failure is very helpful.  It gives you insight into what did not work which is just as valuable as figuring out what does.  Yet why are so many people scared to fail with digital pathology? Unfortunately people, technology, processes etc are not given the time, opportunity, and money to fail.  So the question is… how do we fail safely?

I have not failed.  I’ve just found 10,000 ways that won’t work.  ~Thomas Edison

Dr. Mark Pool, pathologist and fellow blogger at The Daily Sign Out, had a very nice post about CAP’s Futurescape conference.   One of his comments regarding the keynote address said:

The theme of this year’s iteration of Futurescape was innovation. This term has almost become hackneyed but Dr. Jeffrey Myers (DIrector of AP at University of Michigan) provided Saturday’s keynote address. He provided clear, concrete examples of innovation rather than theoretical or poetical definitions. One clear point is that innovation needs its own “space” outside of day-to-day operations to develop, fail, be tested, be refined, etc. before being put into production. Dr. Myers stressed that PDCA is the essential link between innovation and operations/safety/quality. The expectation that innovation will be as “productive” as processes already in operation is not only unrealistic but counter-productive to “innovation.” True innovations probably need to fail a few times before they become successful innovations.

I thought the comments by Dr. Myers were very accurate.  It was great to hear him encouraging others to face this fear and fail in a safe environment by creating a dedicated space to work with innovation.  But what else can we do to fail safely?  Here are a few of my suggestions:

1. Expect failure and plan for it (see #2).
2. Have a Plan B: A back-up plan to help you recover quick and effectively from failures.
3. Use Six Sigma! Six Sigma takes an established process and improves it.
4. Hire a consultant- an expert who can contribute the knowledge necessary to be successful.
5. Slow down! Do not procrastinate using innovation like digital pathology but take it slow. Give the process and technology time to succeed in your environment.

I recently did an audio interview with ADVANCE for Administrators of the Laboratory on adopting digital pathology.  My interviewer, Jill Hoffman Managing Editor for ADVANCE, asked me two questions and here is a teaser of my responses:

What are the first steps to take when considering converting to digital pathology?

Digital pathology is a complex project. It changes the diagnostic process and interrupts the laboratory workflow.  The project of converting to digital pathology must be well thought out and managed carefully.  With that in mind, the first and most important step is for a lab to create a plan.  The plan must…

Hear the rest of my response…

Once a laboratory has made the decision to adopt digital pathology, do you have any advice for facilities in selecting a vendor and working with that vendor during the transition process?

The selection process is not easy. There are over 30 vendors who manufacturer some type of digital pathology solution.  This large and evolving market presents a challenge to adopters, especially since adopters want to know they have made the best possible decision for their lab.  To make the best decision…

Hear the rest of my response…

The second most popular question people ask me as a consultant in digital pathology is,

Have there been any updates to the FDA’s position on Digital Pathology?

No, but there are safe and effective ways to use digital pathology in a clinical setting today.   The FDA regulates what digital pathology manufacturers can claim or say their technology is used for, not what a pathologist or a hospital does with digital pathology. Safe and effective uses of digital pathology are available today that can benefit hospitals, labs, pathologists, medical students, residents, patients and more.  Examples include tumor boards, consultations, intra-operative, education, archival, decision support, peer review, quality assurance, and manual or automated image analysis.

You are thinking…

Blah, blah, blah, blah.. and blah. I’ve heard all of this before!  Tell me when will this be ready and safe for primary diagnosis?

Okay, but let me warn you… you asked for it! CLIA is who regulates laboratory use of digital pathology.  So, let’s see what CLIA says:

Sec. 493.1253  Standard: Establishment and verification of performance
specifications

    (a) Applicability. Laboratories are not required to verify or
establish performance specifications for any test system used by the
laboratory before April 24, 2003.
    (b)(1) Verification of performance specifications. Each laboratory
that introduces an unmodified, FDA-cleared or approved test system must
do the following before reporting patient test results:
    (i) Demonstrate that it can obtain performance specifications
comparable to those established by the manufacturer for the following
performance characteristics:
    (A) Accuracy.
    (B) Precision.
    (C) Reportable range of test results for the test system.
    (ii) Verify that the manufacturer's reference intervals (normal
values) are appropriate for the laboratory's patient population.
    (2) Establishment of performance specifications. Each laboratory
that modifies an FDA-cleared or approved test system, or introduces a
test system not subject to FDA clearance or approval (including methods
developed in-house and standardized methods such as text book
procedures, Gram stain, or potassium hydroxide preparations), or uses a
test system in which performance specifications are not provided by the
manufacturer must, before reporting patient test results, establish for
each test system the performance specifications for the following
performance characteristics, as applicable:
    (i) Accuracy.
    (ii) Precision.
    (iii) Analytical sensitivity.
    (iv) Analytical specificity to include interfering substances.
    (v) Reportable range of test results for the test system.
    (vi) Reference intervals (normal values).
    (vii) Any other performance characteristic required for test
performance.
    (3) Determination of calibration and control procedures. The
laboratory must determine the test system's calibration procedures and
control procedures based upon the performance specifications verified
or established under paragraph (b)(1) or (b)(2) of this section.
    (c) Documentation. The laboratory must document all activities
specified in this section.

The sentence highlight above “… or introduces a test system not subject to FDA clearance or approval” means that a laboratory should be able to validate a digital pathology solution on their own for clinical use.  And although the FDA has not formally stated whether scanners will be “subject to FDA approval” it seems clear through they will.  The background briefing document about the Advisory Panel Meeting held in October 2009 stated,

FDA hopes to gather information about how to evaluate and compare the performance characteristics of both the light microscope- the reference method- and the digital WSI method-…FDA follows the Code of Federal Regulation 21 CFR 860.7 for ensuring the safety and effectiveness of regulated medical devices…FDA believes the first requirement for adoption of digital whole slide imaging will be the maintenance of the diagnostic accuracy and reproducibility of current surgical pathology diagnostic performance using the conventional light microscope- the current reference method for the diagnosis of cancer and other histopathological entities.

At the Advisory Panel Meeting, Tremel Faison the Scientific Reviewer in the Office of In Vitro Diagnostic Device Evaluation and Safety, stated:

“…everything here at the FDA starts with an intended use. Intended use shapes how the device will be regulated, in what population and ultimately the study design.  For the scope of this Panel meeting, the intended use is defined as the use of whole slide imaging for primary diagnosis of surgical pathology microscope slides in lieu of a microscope. This is not an adjunctive intended use, and for our purposes, we will be considering the use of whole slide imaging for all surgical pathology specimens. It will not be organ or disease specific…

We recognize that the technological advances associated with whole slide imaging make its use a reality. Whole slide imaging systems are not Class I exempt and are therefore subject to premarket requirements.

As I said above, although the FDA has not formally stated whether scanners will be subject to FDA approval it seems clear they will.  So, now what? You could try and go through CLIA for approval of your scanner within the lab or wait for direction from the FDA.  Neither seems like that great of an option.

I started this post with the second most popular question asked of me and here is my response:

What does it matter!  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.

In post USCAP Part 1: The BIG Players In Digital Pathology I said, “A shift in the mindset of pathologists could be felt throughout the meeting and left the digital pathology industry energized about what 2011 will bring. No more just looking and talking about digital pathology, pathologists were truly starting to plan and think about how to adapt to their digital future.”   This is a big step toward the “tipping point” of digital pathology, however, we still have several barriers to work through including cost, regulatory, technical, and psychological.

COST

Cost justification is difficult in digital pathology, however, there are several options to help deal with this barrier.   At USCAP two companies, MikroScan and Motic, showcased small, affordable, high-quality scanners for only $35,000.

Mikroscan's D2 Desktop Scanner

Mikroscan’s Victor Casas said “we are here to disrupt the workflow” by creating an affordable system that is outside the lab and on the pathologists desk.  Mikroscan believes that they do not compete against the high-throughput systems created by other manufacturers, instead their systems are positioned to work with them.  Mikroscan wants to focus on intra-operative/frozen section scanning; small, remote labs in rural areas; and the personal scanning needs of pathologists.  The D2 scanner’s has a very nice “desktop” look and  the paddle (aka slide holder) can load four 1×3 slides, two 2×3 slides, or one 2×3 and two 1×3 slides.  Objectives include a 2.5x for the macro scan, 20x, and 40x for high resolution scanning.

Motic’s microscope based system can be configured for 1 or 25 slides, and offers microscope-like flexibility with slide acquisition up to 100x and of the z-axis.  Scans average around 4 minutes for a 15 mm2 area (scan time only).  Their system supports a server software and viewer, and has the capability for real-time remote telepathlogy of the microscope.

However, if your digital pathology needs include mid or high-throughput scanning the cost barrier will not be overcome simply with low cost equipment.  Instead you need a business plan and strategy.  My company, Digital Pathology Consultants, helps organizations of all sizes create a business plan that will  ”cost justify” digital pathology and set you up for digital success now and in the future.  Our 5WH program provides clients with a cost-effective, unbiased business case for digital pathology.  The 5WH program is based on a common methodology for information gathering and the goal is simply to answer the who, what, where, when, why and how of digital pathology.  Although the methodology is simple, discovering the best answers to these questions is not easy and that is why you need help.

REGULATORY

Some day (hopefully within the next 10 years…) I’ll be able to blog about the FDA’s plan on how to regulate digital pathology manufacturers.  Until that day comes pathologists, and their labs, must determine ways to safe guard themselves but still move forward with the use of digital pathology.  Remember the FDA regulates what digital pathology manufacturers can claim or say their technology is used for, not what a pathologist or a hospital does with digital pathology.   CLIA is who regulates laboratory use of digital pathology.  At USCAP, CAP announced that the Pathology and Laboratory Quality Center were developing guidelines for digital pathology titled “CAP Validation Principles for Whole Slide Imaging in Digital Pathology.”  The goal of this document is to develop principles to assist pathologists in properly validation WSI digital imaging systems. The draft recommendations will be available for public review in Sring 2011.

TECHNICAL

In post USCAP Part 2: Innovation Trends in Digital Pathology I discussed technology trends and how these are helping to address technical barriers of adoption.  However, our biggest initiative must be to educate others in the HIT world and share what we learn, and to not shy away from this very real component of digital pathology.  Two white papers were published by the Digital Pathology Association in 2010 and are good examples of what we must do to prepare for the  data wave and the level of integration necessary to ensure pathology departments are successful with digital pathology now and in the future.

PSYCHOLOGICAL

Psychological barriers is a “hot topic” for me.  I firmly believe this is an area the digital pathology industry must have a plan to address or adoption may never truly succeed.   At Digital Pathology Consultants we have developed a coaching program to help departments or individual pathologists overcome the psychological impacts of digital pathology.  I also know this is a point of interest for Aperio, and their CMO Jared Schwartz, MD PhD.  Dr. Schwartz recently did a webinar on the Psychological Barriers and how Aperio is working to address them.

Overall, USCAP 2011 was an amazing meeting with lots to see and discuss about digital pathology.  What do you think- take the poll below: