Lab Soft News

Additional Discussion about the Utility of the Respiragene IVDMIA

About a month ago, I posted a note discussing the Respiragene IVDMIA, which is a lab test comprised of a set of biomarkers and used to determine the predisposition of the patient to develop lung cancer (see: Respiragene as a "Not So Useful" Lung Cancer Risk Test Comes to Market). Kevin Murphy, CEO of Synergenz, the company that developed the test, responded with this comment on November 12, 2009 :

I saw your comments about the Respiragene test and hope you'll allow me to make a few clarifying points in response. By way of disclosure, my company Synergenz Bioscience Ltd has helped fund much of the 8 years of studies that underpin the core technology, including trials involving thousands of individuals. The urgent medical need for the Respiragene test is to help doctors and patients establish which individuals -- among all smokers -- are most likely to get lung cancer from their habit and to do something clinically useful with that information. We agree, no one needs a test to confirm that smoking increases the overall risk of lung cancer. However, there is great benefit in helping identify the people for whom smoking is especially dangerous  -- as genetic predisposition and habit collide -- and while there is still time to help them lower their risk of lung cancer, and other smoking-related diseases.

Many smokers rationalize their ongoing risky behavior by believing that the risk of dying of lung cancer is someone else's risk -- not theirs. That's known as "optimistic bias"....Helping someone break their smoking habit is among the most cost-effective medical interventions available, let alone improving their health and well-being....Equally, knowing who is at greatest future risk of lung cancer may help prioritize individuals for closer monitoring ....Yes, these survival rates are terrible, and haven't improved much in decades. This is largely because when obvious lung cancer symptoms emerge, the cancer is often found in a more advanced and less treatable stage. We strongly believe Respiragene can also help act as a "funnel" for identifying patients most likely to benefit from screening with CT scans, or other relatively expensive early detection approaches as they hopefully emerge.... Your idea that some individuals will ask their doctor for this test to avoid a higher lung cancer risk result and convince themselves it's still safe for them to smoke is a stretch.

Dr. Karl Robstad who blogs over at the 1X Objective responded on December 1, 2009, to Kevin's comment with his own, which is copied below:

My *gut* instinct, here, is to side with the New York Times and Dr. Friedman in this case, and, it’s not because I have an innate distrust in for-profit labs....I think, for me, the devil really lies in the details. So, I have taken Kevin’s advice and have read just about everything I could find on the product....Having read all of that...it seems as if the hard data just isn’t conclusive enough to really make a case; it may be promising, but I’m just not convinced that it’s there yet. For example: one of the studies involving GSTM-1...reported *lower* confidence that quitting could reduce lung cancer risk ...than those receiving GSTM1-present results. There were no other significant between-group differences.” Another ...concluded: “Although the program [Biofeedback with GSTM-1, again] increased short-term cessation rates compared with standard intervention, genetic feedback of susceptibility may not benefit smokers with high baseline risk perceptions.”

Now, granted, Respiragene is composed of much more than just GSTM-1, but, according to your website’s references, all of the articles referenced were about this GSTM-1....I suppose, for me, if meta-analysis of the genetic markers *without* the non-genetic risk factors mixed in showed significant correlation with Lung CA propensity, then I would totally be behind your product!....Finally, perhaps the most helpful data would come from comparison trials, putting Respiragene up against traditional cessation methods, like the nicotine lozenge. I know many modalities are usually used at once in the real world, but if you could show benefit compared to traditional modalities, then you might be on to something big!

In summary, it seems to me that there are three critical issues to be understood here. The first is whether the Respiragene test is able to accurately predict those individuals who both smoke and have a greater risk of developing lung cancer. Secondly. we need to know whether these patients, having acquired knowledge about their predisposition to cancer, are successful in their smoking cessation efforts. Thirdly, we need to know whether their smoking cessation has altered in some way the progression of the disease for them.

Confusion Caused by Conflating "False Positive" and "Overdiagnosis" in Breast Cancer

I have previously discussed some of the issues regarding the recent controversy about mammography screening for women in their 40's (see: Science-Driven Medicine Bumps Up Against Perception of Risk with Mammography; President of the ACP Defends Evidence-Based-Medicine and USPSTF). Gina Kolata, a highly regarded health reporter for the New York Times, has written one of the best articles to date about how the panel of experts developing the mammography guidelines arrived at their conclusions (see: Behind Cancer Guidelines, Quest for Data). Having said this, I also should also state that a portion of her article was very confusing, conflating false positive test results with overdiagnosis. Below is an excerpt from it. The Dr. Heidi D. Nelson referred to in this excerpt led a team of researchers in Oregon whose work was the basis for new guidelines on breast cancer screening.

Dr. Nelson’s group drew upon a National Cancer Institute database of eight million mammograms in the United States telling what sort of mammogram — digital or film — the women got, when they got it, and whether they had follow-up tests. Analyzing those data, she concluded that women in their 40s have about a 10 percent chance of a false positive and a 1 percent chance of having a biopsy each time they have a mammogram. While those risks are small, they gain more significance when weighed against the relatively small risk of cancer for women in their 40s — a risk of 1.5 per of 1,000 women. The serious harm, panel members said, is overdiagnosis, finding cancers that are better off not being found. In 2002, when the group last reviewed breast cancer screening studies, the idea of overdiagnosis was not well formed. It has been hard for many people, even scientists, to believe that some cancers start then stop or even regress. But researchers all over the world have been finding overdiagnosis in studies of all sorts of cancers. Dr. Barnett Kramer of the National Institutes of Health, who was not part of the panel, described overdiagnosis as “pure harm” because it means that women are treated with measures like chemotherapy, radiation and surgery for tumors that do not need treating.

A false positive test is one that it erroneously confirms that a patient has a particular disease (i.e., breast cancer). It's a misdiagnosis plain and simple, a misinterpretation. In the case of a breast biopsy report, it's commonly the result of an error on the part of the pathologist interpreting the biopsy. Overdiagnosis, in my opinion, is very different. The various stages of the development of breast cancer constitute a spectrum of disease from a lesion that shows the earliest signs of malignancy to one in which the cells are highly atypical under the microscope and represent an aggressive lesion. One type of overdiagnosis can occur if and when a pathologist tilts in his or her judgment toward a slightly more malignant interpretation on this continuum. This may not be an error on the part of him or her but may rest within the range of correct diagnoses. The pathology report may simply reflect a difference in judgment. The diagnostic criteria may be broad or the experts may not totally agree about them.

However, there is yet another form of overdiagnosis based on the biologic nature of the cancer. Into this category falls those lesions referred to above as "better off not being found." In such cases, for example, all pathologists diagnosing such the lesion might agree that it shows similar morphological criteria of malignancy. However, the lesion may not possess the genes programming it to invade and metastasize in vivo. A competent pathologist would be unable to make this determination because the lesion's morphology would not reveal its true nature. In fact, such a determination might impossible given today's state of knowledge. Lesions of this type should not be biopsied at all because they could lead to the "pure harm" referred to above. Unfortunately and at this time. we don't have a means to determine a priori which breast masses not to biopsy because any diagnosis would constitute overdiagnosis and any treatment would be overtreatment.

Some Key Questions in Cytopathology That Rquire Immediate Answers

I recently shared the podium for a lecture with Dr. Liron Pantanowitz. This took place at the annual conference of the American Society of Cytopathology (ASC) in Denver. The two of us discussed innovation and the relevance of information technology (IT) for the field of cytopathology. At the end of his lecture, he presented to the audience the following key questions that are confronting the field and require immediate answers:

• Are conventional Pap smears still considered acceptable standard of care?
• Is autoverification (no human review) of imaged abnormal Pap tests feasible?
• Will future re-screening require morphology review or molecular tests?
• Will automated screening be applied to non-GYN specimens and FNA biopsies?
• Once [cytopathology] images are [stored] in...computer system[s], [can or] will [their interpretation] be outsourced?
• Are new technologies being incorporated into [our training and] educational programs?
• Can we do it? i.e. keep cytologists in the center of [the] clinical decision-making [process]?
• Can this technology help provide affordable cytology services in unscreened populations without an effective cytology infra-structure? If not, what is the best way to develop this infrastructure?
  
• Will disruptive technology (i.e. new technology that transforms markets) “replace” cytotechnologists &/or pathologists?

I have concluded on the basis of my participation in this conference and other observations that cytopathology professionals have been energized by the availability of vaccines such as Gardasil against human papilloma virus. These vaccines have the potential to eventually eliminate most cervical carcinoma. Much of the energy and professional attention of this group over many decades has been devoted to screening Pap smears for cervical disease. Logically, questions are now being raised within the group about the future of the specialty if and when carcinoma of the cervix is largely eliminated.

From my perspective, it is an urgent matter for pathology groups such as the ASC develop answers to questions such as the ones developed by Dr. Pantanowitz. In fact, I am confident that the ASC leadership is already in the process of addressing many of them. However and for me, these answers are required so quickly that what I regard as the standard approach used by professional societies is no longer adequate. I would recommend instead some variant of the following process:

• Set a deadline of, say, six months to a year hence for the delivery of answers to these and related questions from newly empaneled task forces drawn from the members of the society.
• Although the members of the society should comprise the bulk of the membership of these task forces, they may need to be supplemented by technical and medical advisers from outside of the society when necessary and appropriate.
• It may also be necessary to engage outside consultants to help manage and advise these task forces in order to deliver reports in the aggressive time-frame described above.
• Additional financial resources may be required to support these task forces and quickly arrive at the necessary answers. It may thus be necessary to turn to vendors in the cytopathology field to help fund these initiatives with grant support. These vendors, of course, would not be able to influence the deliberations of the task forces but would obviously derive great benefit from their deliberations.
• Finally, I believe that it is insufficient to merely provide an informed academic discourse about these questions in reports or white papers. In addition, it will be necessary to develop a set of actionable items such that the talent and expertise of cytopathology professionals can be utilized  in diagnosing and treating disease in the face of the new types of "disruptive technology" and social forces that will be confronting them.

Respiragene as a "Not So Useful" Lung Cancer Risk Test Comes to Market

We are entering the golden era of diagnostics ushered in by new biomarkers with greater specificity, measured alone and in also in groups called IVDMIAs. For me, the value of any lab test is whether the integrated result provides key diagnostic or therapeutic information that is otherwise unobtainable. A recent story appropriately questioned the value of a new lab test now being marketed for lung cancer (see: Questioning a Test for Cancer). Below is an excerpt from it:

Christopher Taylor says he never lasted more than a week when he tried to quit smoking in the past. But it has been four weeks and counting this time, since a genetic test indicated he had a much higher risk of developing lung cancer than the average smoker. Of course, said Mr. Taylor, a 45-year-old salesman who has smoked for 25 years, he already knew that cigarettes were dangerous. But he thought, “It’s not going to happen to me.” Then came the gene test....Scaring people into quitting is the marketing rationale for that new genetic test, called Respiragene, which purports to identify which smokers have the highest risk of developing lung cancer. The test, developed by a company called Synergenz BioScience in New Zealand, where Mr. Taylor lives, is now being offered over the Internet in the United States for $700....Respiragene has not been approved by the Food and Drug Administration, which usually does not regulate such tests. Some states do, however, and the test has not been approved for use by residents in New York, California and Maryland....The justification for many of these tests is that knowing one’s risk will prompt people to change their behavior. Such is the premise, for example, of the genome scans offered by 23andMe, costing $400, and one by Navigenics, for $1,000, that are meant to tell one’s propensity for numerous diseases. Navigenics and an organization affiliated with the Scripps Research Institute are now monitoring 4,800 people to see if the Navigenics test results prompt them to eat better, exercise more or get more medical checkups. But smoking could prove the clearest test yet of the behavior modification pitch.

As far as I can determine from this story, Synergenz BioScience developed this test by choosing a list of biomarkers that can purportedly determine whether one is at "high risk" for lung cancer. I take this to mean that one is predisposed to the disease and that this predisposition can be exacerbated by smoking or by being exposed to other risk factors. The company then markets the test based on the premise that it's more "scary" than having your physician say that you are at higher risk. Although not referenced in the story, the picture of the Respiragene report shows the MDL logo, referring to what I assume to be the performing laboratory for the test, Molecular Diagnostic Laboratories. This lab's web page also displays the Respiragene logo.

This notion of using a genetic test to assess whether a current smoker or a previous smoker is at risk for cancer strikes me as sketchy, particularly for a price $700. Here's what I would recommend instead. Stop by one of the local panhandlers on the street, hand him $10, and tell him that you have a 20-pack-year history of smoking. Then, ask him if you have an increased risk of developing cancer. I also suspect that some smokers who don't want to quit smoking are using the test to determine if they are in the lucky minority who have a low cancer risk and can thus continue with their addiction. It's not worth it, pal.

Continuing Discussion About Citrix as a Critical Component of EMRs and LISs

In response to my recent note about the role of Citrix in prolonging the lifespan of obsolete fat-client EMRs and LISs (see: Citrix Has Become a Barrier to Improvements in Healthcare Software), Dr. Ulysses Balis has responded with a comment. He is Director of the Division of Informatics in the Department of Pathology, University of Michigan Medical School. In this interest of continuing this discussion, I quote it in its entirety below with boldface emphasis mine:

I couldn't agree with you more, Bruce. With the continued insistence of many vendors to push thick client applications, Citrix is often the only effective methodology to purvey support for 100's of concurrent users. As an example, our informatics division looked at the Cellavision product about a month ago. It's a big, bloated thick client app that REQUIRES Open GL. Does that run on Citrix? Nope. Given that our department does not want to support this as a native application on a myriad of hematologist’s PC's that aren't even under our [guidance and control because they are managed by central IT], the answer is simple: Cellavision is a non-starter. There is only one long-term solution to this present slow-burning fiasco, and that is web-based applications, which make use of open architectures whenever possible. Hence, my take is that in the end, Citrix is dead. Epic is dead. Eclipsys is dead. Cerner is dead. I expect a new breed of web-based solutions to replace these Mumps and Cobol-based clunkers within the decade. And when that finally happens, it won't be a minute too soon. So, in summary, I would offer the friendly amendment to your thesis statement that it is not only Citrix that is a barrier to improvement in healthcare software, so too are the myriad of poorly-written thick-client applications that continue to fuel the demand for Citrix. Both need to go.

So here is an interesting question based on Ul's comment. Why are the shares of Cerner, a major vendor of EMRs, at historic highs, reaching about $85 per share in October if their products are dead, to quote Dr. Balis. Let's put aside for the moment some of the bad publicity that Cerner has continued to receive in the U.K. (see: Another Saga of "Blame the Vendor" Leaks Out of the UK). I am sure that most of this tends to be discounted by American investors. Let's also put aside the fact that most of the EMR purchases by major health systems have gone to Epic lately (see: Forbes.com Puts Some Numbers to the Epic Systems Success Story). Everyone agrees that this latter system is the EMR clunker du jour.

Answering my own question, I am sure that the success of the Cerner shares is based on its most recent quarterly financial performance and the infusion of federal money into hospital EMRs (see: CCHIT Certification and "Meaningful Use" of EMRs). I certainly agree that the days of our obsolete EMRs are numbered. "Within the decade" is a rather long span of time, however. The key question at hand is whether the incumbents in the EMR field are investing some of their capital in developing the "next-gen" web-based systems. New EMR market entrants face the formidable task of confronting the computerization of complex healthcare transactions using new tools and with severe penalties for errors. The will also confront very risk averse buyers of their systems who may not be that sophisticated technically.

Are You a Primary Care Pathologist, Asks Dr. Henderson

A new pathology blogger has appeared on the scene -- Dr. Gregory Henderson. He calls himself a primary care pathologist and his first blog note is about this very topic (see: You Might Be A Primary Care Pathologist). Here are the criteria he lists to determine whether one falls into this category:

• If you have ever taken phone calls from patients to help explain their diagnosis, you might be a primary care pathologist.
• If you have ever scrubbed into a surgical procedure to help the surgeon identify key areas to sample for frozen section, you might be a primary care pathologist.
• If you have ever manned a booth at a community health fair that educates women about Pap and HPV testing, you might be a primary care pathologist.
• If you have spent an enormous time over the past 3 months helping your hospital prepare for the impending H1N1 epidemic, you might be a primary care pathologist.
• If you look around your lunch table most days and see physicians of other specialties and no other pathologists, you might be a primary care pathologist.
• If your pattern of practice looks anything like any of the pathologists on this CAP website, you might be a primary care pathologist.

I need to confess that my first reaction, on reading his inaugural note, was to flinch a bit. After all, the notion of "primary-care-anything" seems to be quickly losing its luster in our rush to become uber-specialists, particularly those who can bill for a procedure. However, and after reading his list, I have changed my mind. There is a tendency for one's first blog note to focus on a topic that one really cares about. It goes to the nature of this obsession -- the need to communicate one's ideas on a broader scale. There is the ring of authenticity and sincerity about his list that any pathologist will be proud of. I wish him the best of luck in his future blogging career. I am sure that he will provide us all with better insights into the valuable services that individuals like him provide to their communities. Oh, and the fact that Dr. Henderson refers to Lab Soft News on his home page as one of his favorite blogs had no influence on these remarks.

Some Laboratory Managers Getting Carried Away by Lean/Six Sigma Projects

Don't get me wrong. I am just as enthused as the next person about correcting lab errors and work product defects. The bone that I have to pick with some of the Lean/Six Sigma experts is that this approach to lab management seems to becoming the answer to all lab problems. Some aspects of Lean/Six Sigma have always seemed to me to be vaguely ominous -- turning lab professionals into automatons who paste tape outlines on benches so that the scotch tape dispenser does not wander around the lab. All of my concerns came to the surface when I read a recent article in the Wall Street Journal (see: How Labor Is Liberated). Here is the excerpt from the article that caught my eye:

"Jean-François Zobrist ...captured his leadership philosophy with a distinction. There are, he said, two kinds of companies: 'Comment' in French, or 'how' companies, and 'pourquoi,' or 'why' companies. 'How' companies spend their time telling workers how to do their jobs—where to place the machinery, when to come to work and when to leave, and so on.The second is that it becomes difficult, if not impossible, to change any of the myriad rules about how to get things done. You want to move that cart to a different spot on the shop floor? You need clearance from your manager, who may have to ask his manager, and so on, creating a never-ending 'chain of comment.' The result, as Zobrist put it, is that it becomes impossible to get the work done without disobeying somebody in the chain of command. A pourquoi company is different. It replaces all the myriad 'hows' with a single question: Why are you doing what you're doing? The answer is always the same: to keep the customers happy. As long as what you do satisfies that commandment, Zobrist doesn't worry about how you do it. Freedom at FAVI meant replacing the chain of comment with a single pourquoi." This has two consequences. The first is that you end up judging employees by everything except what counts, which is whether the job gets done and the customer is happy.

So, for me, lab personnel who spend most of their time worrying about "how" or "comment" questions may be too involved with improving daily work processes and perhaps avoiding some of the more challenging "why" or "pourquoi" questions. I am sure that lab executives who specialize in Lean/Six Sigma can readily point to customer feedback to buttress their claims that they are pursuing goals that please their customers. For a change of pace, however, how about responding to this question: Is your laboratory sufficiently innovative in addressing the questions of tomorrow that many clients may not even be asking about? In order to begin to explore some of these strategic "why" questions, it might help to begin with consideration of the four rapidly developing fields that I think will pose the greatest challenges for labs in the upcoming years: (1) molecular diagnostics; (2) information technology; (3) digital pathology; and (4) ultra-fast histology processing. Here's another "why" question. Is your lab a regional or national leader in these four areas?

Physicians Using an iPhone Application to Triage Their Patients

John Moore, who blogs over at Chilmark Research has discovered an iPhone application that reinforces my belief that smartphones may soon rival the stethoscope as an essential healthcare delivery tool (see: iTriage: A Business Model Gaining Traction). iTriage assists physicians in referring their office patients to regional hospital emergency rooms when necessary. I have posted previous notes about the myriad healthcare applications that can potentially be deployed on smartphones and this is certainly a good example of the potential of these devices. Below is an excerpt from his note:

iTriage is a slick iPhone app.... Since its launch in April 2009, iTriage has maintained an enviable position as one of the top downloaded apps in the iPhone AppStore, currently in the top 10% of all apps downloaded....The parent company’s (Healthagen) business model is to solicit providers, mostly large integrated delivery networks (IDNs) to become premier sponsors who pay an annual subscription fee...to Healthagen to have their facility listed along with some brief marketing content, including the ability to upload videos, as to why one would want to go to their facility (typically ER) versus others. Thus, Healthagen is tapping into the marketing budgets of IDNs....On October 5th, HCA announced that they would become a premier sponsor as well for their facilities in South Florida.  What is particularly cool about this announcement is that in addition to the standard promotional marketing content that one may find in iTriage on a given HCA facility, HCA will also be providing real-time information on expected wait-times in ER, right there in the palm of your hand on your iPhone and in a recent upgrade of the software, a Blackberry as well.  (In November, they’ll release versions for Android and PalmPre.) This is all part of a larger push by HCA, which includes posting wait-times on billboards in this region to drive consumers seeking medical attention to their facilities as a significant percentage of those admitted to ER wind up being admitted for more extensive care.

 I am not surprised that the executives at HCA immediately understood the value of iTriage for their hospitals. What a clever way to market their emergency departments to community physicians! Adding expected wait-times will provide added valuable information for healthcare consumers who download the application. I pointed out in a previous note how emergency departments are an important portal for inpatient admissions to hospitals (see: Hospital Admission of Patients with Chronic Disease from the Emergency Department). Here is a quote from that note:

In 2005-2006, hospital admissions through EDs accounted for approximately 60% of acute care hospitalizations in Canada (excluding hospitalizations in Quebec and those among women admitted for childbirth and infants born in hospital). These patients accounted for 65% of in-patient days, 11% of which were alternate level of care (ALC) days.

We have only scratched the surface of smartphone applications that are directed to both physicians and healthcare consumers. For example, it would be relatively easy to adapt content currently on the web concerning the interpretation of lab tests for smartphones (see: The Mobile Web and the Future of eHealth). Here is a quote from this blog note:

...[I]t's now time, in my opinion, to begin to adapt [the content of] consumer-oriented web sites about the significance and interpretation of lab tests to the mobile web. One good example of such a site is Lab Tests Online. Such modification would allow, for example, patients who have just completed a physician visit to use their cell phones to query [their smartphones to] obtain a better understanding of their test results.

Differences Increasingly Blurred Between PCs and Smartphones

Smartphones are rapidly becoming the new PCs (see: Smartphones as the New PCs; Connecting to Healthcare Professionals and Consumers). This trend is now accelerating, if the rumor mill is correct that Dell, historically one of the major PC manufacturers, may bring a version of the Android smartphone to market with AT&T (see: Dell May Bring Android Smartphones To AT&T). Below is an excerpt from this article:

The lines between smartphones and laptops are increasingly blurring as hardware and mobile data networks rapidly improve, analyst says. Dell may be successful in its foray into the U.S. smartphone market if it manages expectations, but it may have difficulties standing out from the crowd, according to an industry analyst. The computer maker is reportedly close to announcing a deal to bring Android-powered smartphones to AT&T. This comes after years of speculation that it would enter the mobile space, and a few months after it unveiled Android-powered smartphones for China Mobile. AT&T and Dell have not confirmed the report....Computer makers such as Acer have already taken the smartphone plunge, while Nokia, the world's leading handset maker, recently introduced a 3G netbook....[An analyst] said Dell's first handset will not outsell Apple's iPhone, but could potentially match the sales of the Palm Pre, which analysts estimate has sold more than 700,000 units since its summer release. The first Dell smartphone will reportedly be an upgraded version of the Mini 3i smartphone that will hit China soon. It features a large touchscreen with an iPhone-like user interface....The computer maker has a recognized brand name and strong direct-to-consumer sales channels that may woo mid-tier smartphone buyers.... It also should not be difficult for Dell to create or outsource the design of an attractive Android-based handset. Additionally, Dell may not want to compete against the BlackBerry in the corporate realm because Android is not yet enterprise-friendly, although that is expected to change with future software updates.

The interest on the part of Dell in the smartphone market is additional evidence that these devices are rapidly becoming the new PCs. Partnering with Google, the developer of the Android smartphone operating system, also makes sense. I am not surprised at the statement above that "Android is not yet enterprise-friendly." The Google approach to software has always been to release early versions and then improve it based on the input from users and experience in the field. Probably only Google could get away with such a strategy because of its strong relationship with the user-community and the fact that most Google products have generally been free. Dell's well known strength is its understanding of the needs of corporate users and, as noted above, its target of mid-tier buyers. This is in sharp contrast to Apple and its iPhone with its appeal to the hip twenty-somethings who are willing to pay a premium price for Apple products. The problem for Dell with such a strategy, also as noted above, is that both BlackBerry and the Palm Pre are strong players in this same space.

Variations of "Integration" Relating to Lab Computing and Clinical/Anatomic Pathology

I have just returned from Toronto where I delivered a lecture at the Executive Edge conference which focuses on Canadian lab management. All of the conference presentations were outstanding and are available on-line. I will return to some of them in upcoming notes for a more detailed analysis. My own presentation addressed various type of integration as the term applies to lab computing and to Clinical and Anatomic pathology. In this lecture, I tease out the following for detailed analysis:

• Integration of Clinical Pathology with Anatomic Pathology; integration of upstream diagnostics with downstream therapeutics.
• Workflow integration of digital pathology with the LIS; introduction of the pathologist dashboard/console.
• Integration of Pathology, Lab Medicine, and Radiology to form the new medical specialty of Diagnostic Medicine; evolution of Integrated Diagnostic Centers.
• Development of lab networks (hospital LISs + esoteric reference lab LISs); pursuit of integrated clinical lab databases for patient care.
• Downstream integration of the expanding LISs with hospital EMRs; consideration of the technical and political challenges involved.
• Dis-integration of pathology, driven by reimbursement issues and upstream diagnostic integration by clinical office-based specialty groups.