Lab Soft News

"Eminence-Based" Surgical Pathology and the Digital Pathology Department

In a recent note, I commented on the new strategic alliance between GE Medical and the University of Pittsburgh Medical Center (UPMC) in the pursuit of the digital pathology department and whole slide imaging (see: GE Medical Partners with UPMC in Pathology Imaging Venture). It is often stated that digital radiology took about a decade to mature and that digital pathology will take an equal amount of time to become the accepted standard of practice. However, major incentives were available in the conversion to digital radiology such as the ability to offer new imaging procedures with attractive profit margins plus a groundswell of enthusiasm on the part of hospital clinicians for these new offerings. These same incentives do not exist for digital pathology -- there are no additional profit margins to be gained for the hospital and the pathology reports to clinicians are largely the same except for the routine integration of digital images into surgical pathology reports.

However, it you are searching for a "killer app" associated with digital pathology, it is most certainly image search. By this I mean the ability to isolate "fields of interest" in a challenging surgical pathology case, an unusual malignant tumor for instance, and then match them against a large image database of diagnosed lesions for similar lesions. For challenging cases today, this same process often takes place laboriously by searching surgical pathology atlases on the shelf. Parallel to this process, many such cases are also referred to local colleagues for their opinions and also sent to "marquee" surgical pathologists who have established reputations as having superb diagnostic skills in various specialty areas. This is the basis for what has been called eminence-based surgical pathology.

And now comes the rub. These marquee pathologists have little to gain and much to loose by the introduction of digital pathology and image searches. Image searches and pattern matching is, in fact, what is taking place in the brains of these eminent pathologists. I suspect that they will have little enthusiasm for any technology that serves to lessen their influence, prestige, and livelihood. Many of these latter pathologists are also highly placed in the hierarchy of prestigious pathology departments. I suspect that they will be leaders of the chorus opposing the conversion to digital pathology and perhaps highlighting the failures and inadequacies of digital pathology departments.

Epic Systems and Its Corporate Culture

Anyone deeply involved in lab computing needs to understand the companies supplying  LISs and EMRs to this market. Part of this understanding involves the "culture" of these companies. The term corporate culture is complex and incorporates a number of variables. As one measure of the complexity of the term, a Google search for it yields 4,450,000 hits. As only one example, some HIT companies are technology-driven whereas others are more marketing-driven. Probably no company is as interesting culture-wise as Epic Systems, currently the market leader in the EMR market. A recent article (see: Behind the Curtain) discusses the company in great detail. For me, the most interesting part of the article was the list of the differences between Epic and its competitors. Below is that portion of the article:

• Epic almost never advertises, and relies almost entirely on word-of-mouth recommendations to market itself.
• Epic does retain salespeople, but they make no commissions on sales, and act more like advisers and consultants than traditional salespeople.
• Epic turns away potential business. Indeed, prospective customers meeting with Epic representatives find they are being evaluated as much as they are evaluating.
• Epic executives have evolved a very specific implementation process over time, one that involves intensive pre-implementation analysis and planning, but then focuses very strongly on meeting go-live dates.
• Rather than seeking experienced healthcare IT professionals, Epic relies on hiring a large corps of the brightest young, just-out-of-college IT professionals for its programming and implementation positions.
• Epic never grows through acquisition, but rather relies on internal development, in extreme contrast to all its competitors among the largest clinical IS vendors.
• Most of all, Epic has a very unusual corporate culture, one that intrigues and sometimes puzzles those who encounter it or hear about it....That culture emanates to an extraordinary degree from the personality of the company's visionary, media-averse founder and CEO.

The true test of the value of any corporate culture is the success of that company in the competitive market. There are clearly no rigid rules. And by this test, the Epic culture has been, and continues to be, a successful one. My guess is that its competitors may  review this list and then probably decide that their own cultures will triumph in the end.

Direct Access Genetic Testing in California

Dr.Scott Shreeve, in my opinion, is one of the country's leading experts on the regulatory control of direct access testing (DAT), particularly as it applies to the state of California. He has just posted a note in Crossover Health, his excellent blog, on the attack by the California regulators on DAT genetic testing (see: Cease and Desist? How about Understand and Resist!). Please read it and ponder the logic of his arguments. I can't improve on his thinking in any way.

The Evolution of Integrated Diagnostics into Integrated Diagnostic Centers

In a recent post (see: A Call for the Development of Integrated Diagnostic Centers), I posted an abstract of a lecture that I will be delivering at the 42nd annual Congress of the Brazilian Society of Clinical Pathology (Sociedade Brasileira de Patologia Clínica; SBPC) on July 3, 2008, in Sao Paulo, Brazil. In it I emphasize the idea that pathologists, lab medicine specialists, and radiologists should collaborate to develop physical or virtual integrated diagnostic centers (IDCs) to which patients can be referred with early symptoms of disease or for wellness/preventive medicine consultations. In these centers, diagnostic specialists would use the most advanced imaging modalities and in-vitro laboratory testing to quickly arrive at the correct diagnosis. These patients would then be referred to clinicians for treatment. This idea is the logical outgrowth of the concept of integrated diagnostics (see: Siemens' Pursuit of an Integrated Diagnostics Portfolio) and the early health model, both of which have been addressed extensively in Lab Soft News. It is also closely related to the merger/conversion of pathology, radiology, and lab medicine into the new specialty of diagnostic medicine. I am now posting the entire lecture here (see: Integrated Diagnostics Emerges as Key Element in Healthcare) and would welcome any comments from readers about any of the ideas contained in it.

Some New Insights into "Bypass Brain"

The cognitive and behavioral aspects of bypass brain are now in the news as a result of the presidential political campaign and Bill Clinton's behavior. Read more about this in a recent blog note (see: 'Bypass Brain': How Surgery May Affect Mental Acuity). Below is an excerpt from the story with boldface emphasis mine:

Aides to Bill Clinton last week vehemently denied speculation that the former president's intemperate remarks on the campaign trail were due to mild cognitive damage from his quadruple-bypass surgery in 2004....But the condition dubbed "pump head" or "bypass brain" has long been recognized by doctors, even if they seldom warn patients about it....Symptoms include short-term memory loss, slowed responses, trouble concentrating and emotional instability....[R]esearchers at Duke University Medical Center tested 261 patients before and after bypass surgery and found that 53% of them had significant cognitive decline when they were discharged -- and 42% still suffered from it five years later....One explanation is that when a patient's blood is pumped through a heart-lung machine during bypass, tiny air bubbles, fat globules and other particles may enter the bloodstream. The pump can also damage platelets, which form clumps, and clamping the aorta loosens bits of plaque. That debris can travel to the brain and clog tiny capillaries, forming microscopic strokes....There's little dispute that heart surgery does cause short-term cognitive problems -- anesthesia alone can do that, particularly in older patients. But recent studies suggest that the cognitive decline years later may be due more to the underlying artery disease than to the effects of surgery.

I don't think that it's fair that the cardiac surgeons need to bear the brunt of Clinton's off-the-cuff remarks on the campaign trail. I also understand that more research is needed to further delineate the true nature of bypass brain. Nevertheless, I suspect that all of us have grown far too complacent about the inherent risks of any surgical procedure and general anesthesia. Here's some food for thought from the U.K. (see: 'Care flawed' in many bypass ops):

Coronary artery bypass graft operations, the focus of their latest project, has approximately a 2% death rate, and over the three year period checked, there were 1,198 deaths reported....There were problems found in every step of the process, from delays after referral, to the way tests were carried out, doctors communicated with each other, and the way patients were cared for after their operations. Overall, they concluded that in two-thirds of cases which ended in the death of a patient, some aspect of care was flawed, due to poor organisation, communication or teamwork.

If the time comes, I guess that I will opt to have a cardiologist snake a catheter into my heart, steer the tip into the ostium of one of my coronary arteries, and drop off a small spring-like device to keep the vessel open. This seems to be the safest course of action.

Indian Clinical Lab Penalized by Government for Late Report

Late lab reports can be problematic for both clinicians and their patients. As a result, all of the lab professionals that I know place a very high premium on test result rapid reporting. Nevertheless, I was a little shocked to read about the Indian government levying a fine against a clinical lab for a late report (see: Lab fined for late report that led to death). Below is the story with boldface emphasis mine:

The state consumer commission has pulled up a specialty laboratory for inordinate delay in sending a patient’s report to a hospital, as a result of which he died. The lab report for a CMV test — carried out for viral detection — was crucial for the treatment of a 56-year-old patient, who was awaiting a renal transplantation. It took the laboratory 25 days to send the report, by which time the patient died. Now, the commission has asked the lab, Speciality Ranbaxy Limited, to pay Rs 50,000 as compensation to the victim’s family....The patient, V K Garg, had been admitted to AIIMS [All India Institute of Medical Sciences] on June 1, 1999 for a renal transplant. As his CMV test reports from two pathological labs gave conflicting results, doctors advised him to go for another CMV test from Speciality Ranbaxy Ltd. Accordingly, his blood sample was sent for testing on June 17, 1999, and the laboratory at Yusuf Sarai market assured to deliver the report on or before July 3. But the lab failed to deliver on the promise — despite a written reminder — Garg’s treatment could not begin and he died on July 13. In fact, the report was only prepared on July 14 and dispatched on July 17, with a remark that the report was delayed owing to a problem in laboratory information system at Specialty Laboratories, Inc, USA. While denying allegations of deficiency in service, the laboratory cited this technical problem for failing to deliver the report on time. It added: "The record showed that doctors at AIIMS continued with the treatment."

Oh, give me a break. Blame a late report on the LIS and particularly one installed in a U.S. reference lab. However, this story gets a little confusing, involving both Specialty Ranbaxy Lab in India and Specialty Laboratories in the U.S. It appears that this latter lab was used to try to break the initial CMV assay tie with a specimen turfed to it from Ranbaxy in India. I must also strongly express my preference for the use of the term pathology lab rather than pathological lab as used in the article above, although the later may sometimes be more apt. What is also interesting about this story is that the patient, V.K. Garg, was tasked with shopping around his own specimen in order to reconcile the conflicting CMV results.

Sometimes Consultants Surprise You with Their Reports

Reports from healthcare consultants can sometimes be warmed-over pap or merely external validation of decisions already made by hospital executives. On occasion, however, reports from consultants can surprise you. This was obviously the situation described in the following article with boldface emphasis mine (see: WVU dumps its consultant):

West Virginia University officials fired a $75,000-a-month consulting firm Friday, saying the consultants' scathing report about WVU's health science division and affiliated hospitals was full of errors and misunderstandings. The nine-page report, by R&V Associates of Pittsburgh, alleged that "serious," "intolerable" and "alarming" problems at WVU hospitals put patients' lives at risk.  The consultants cited the unexpected deaths of two children and an adult. They also criticized WVU for serious shortages of general surgeons, anesthesiologists and heart surgeons that forced hospitals to send patients to facilities in Columbus, Ohio, and Pittsburgh. WVU said R&V reached false conclusions, in some cases, and the university already was working to fix other problems brought up in the report....[The interim vice president of health sciences] said the university plans to hire another outside consultant that "has experience with academic medical centers." R&V Associates, which has been paid $321,789, plus expenses, for its work since March, has said the report is accurate.

What in the world is going on here? A consulting firm accuses the hospital that engages it of putting "patients' lives at risk." It then adds insult to injury by inserting this claim in only a nine-page report. However, the interim vice president of health sciences at WVU hospitals seems to be heading in the right direction when he says that the organization is now seeking another consultant with "experience with academic medical centers." The web site of R&V Associates describes the discharged firm as specializing in "business consulting and crisis management." It's not clear from the article whether the officials at WVU hospitals anticipated that the consulting firm that they first engaged would precipitate the crisis that now apparently needs to be managed by yet another set of consultants. 

Who "Owns" PACS: Radiology or Central IT in Hospitals?

Veteran readers of this blog will probably know that I am a strong proponent of having laboratory professionals "manage" their own LISs. Lab tests results are a strategic asset in hospitals, underlying about 70% of hospital diagnoses and constituting about 70% of the data contained in electronic medical records. How does one determine who manages (i.e., owns) the LIS? Easy! Who makes the decisions regarding access to lab information? Who formats that information? Who has the final word on policy issues regarding that information. Who has both de jure and de facto control (i.e., stewardship) over it? If you need to pull out an org chart to answer these questions, you are in trouble. Needless to say, I was interested in a recent article (see: Who owns PACS -- Radiology or IT?) about this same question as it applies to radiology information and images. Below is a longish excerpt from the article with boldface emphasis mine:

Should radiology or the IT department take responsibility for managing PACS in a hospital? It depends on the facility's corporate culture and the level of sophistication of the IT department, an animated "debate" at the 2008 Society for Imaging Informatics in Medicine (SIIM) meeting concluded. The premise of the argument presented by Dr. Paul J. Chang on behalf of IT department ownership is that PACS technology has become a component of the entire hospital informatics enterprise rather than its own unique entity. In an increasing number of hospital infrastructures, dedicated networks for PACS are unnecessary. Thick-client workstations are facing obsolescence....Modern healthcare IT should be structured as a matrix, according to Chang, who straddles both worlds as vice chairman of radiology informatics and director of pathology informatics at the University of Chicago Pritzker School of Medicine....Because PACS is the multimedia component of an electronic health record (EHR), the EHR must be optimized to support radiology workflow. Not only is this a complex undertaking, but it logically fits as the responsibility of the IT department -- as long as the IT department has a global vision and a progressive philosophy, Chang said.

Dr. David Channin, chief of imaging informatics at Northwestern Memorial Hospital and the Feinberg School of Medicine in Chicago, disagreed. "Radiology has led informatics technology innovation in hospitals and will continue to be the source of informatics leadership in healthcare," Channin said. "Domain expertise must take precedence over IT expertise. Tools don't drive domain innovation. If controlled in a central manner, such as a matrix structure, the priorities of a radiology department will be subjected to control by an IT department juggling priorities representing multiple domains in a hospital," he said. "If you don't have budgetary control of your bucket of allocated capital dollars, you have lost control. Your critically needed PACS upgrade will be competing with acquisition of a new laser doodad for OR." Radiology departments should wield the power they have as cash cows for hospitals, define their IT domain borders, provide access to them with standard interfaces, and demand autonomy, according to Channin. He recommended that radiology departments contract with IT departments for "commodity services" such as networks, virtual operating systems, and data storage.

Well, no one can say that Drs. Chang  and Channin did not speak their minds in this spirited exchange. There is too much interesting material here to cover at one time. Here are some of my initial reactions:

• Matrix shamtrix. You either own the LIS/RIS/PACS or you don't. See my discussion above about system management/ownership. Pathology owns (or should own) lab information and pathology images and radiology owns (or should own) radiology information and images. Central IT + clinical personnel should then negotiate with pathology and radiology for access to the information managed by the latter two groups.
• According to Dr. Channin, "radiology has led informatics technology innovation in hospitals." LISs were developed and commercialized in the late 1970s and thus preceded RISs by at least five years in hospitals. AIMCL, the LIS conference that preceded Lab InfoTech Summit, was launched in 1983. Radiologists are the acknowledged leaders in hospital image management and storage. Let's call it a draw.
• I agree with Dr. Channin regarding the IT capital and operating budget for the LIS and RIS. If you don't control the information system budget, you don't control the information system.
• I have no problem with the central IT departments providing "commodity services" to pathology and radiology. They are best able to provide institution-wide services like networks and generic data storage for the entire institution. However, I believe that the latter is now a commodity and best provided via a vertical cloud (see: A Closer Look at the Vertical Cloud in Healthcare Computing; The Potential for "Sereverless" Healthcare Computing).

IT Budget Allocation Categories for Healthcare CIOs

John Moore at the Chillmark Research blog introduced one of his recent blog notes (see: Tradition Grapples with Insatiable Demand) in the following way:

Dan Nigrin, the CIO from Children’s Hospital Boston ...is struggling with the insatiable demand for HIT among care providers ...at Children’s while concurrently dealing with an industry that is so bound by tradition. On one hand he must prioritize spending across any number of categories that he characterized as infinitely long (healthcare still spends a woefully low 1-3% of revenue on IT, as a comparison, manufacturing is spending between 4-6% and financial institutions spend even more). Yet on the other-hand, he needs to find new ways to more effectively leverage this spend to insure effective adoption occurs. Not an easy task in this tied to tradition industry.

Moore then goes on in the note to provide a detailed list the following HIT spending priorities that had been enumerated by John Halamka, the other CIO on the panel. John publishes his own excellent blog (Life as a Healthcare CIO) and is chief Information Officer of the Caregroup Health System and Chief Information Officer and Dean for Technology at Harvard Medical School, among many other things. CareGroup includes Beth Israel Deaconess Medical Center. Below is Halamka's list of high level priorities in addition to the obvious support for business and clinical applications.

• Getting non-affiliated doctors on-board in using an EMR throughout the New England region
• Addressing the demand for data storage
• Insuring secure communication throughout the network
• Tackling security
• Compliance
• Creating dynamic websites
• Disaster recovery

It's a good idea to take stock of the larger set of challenges facing healthcare CIOs today. However, the list is not much different than that of the CIO of any major enterprise. The only surprise for me in his list was the first point -- getting non-affiliated doctors on-board in using an EMR throughout the New England region. Clearly, getting "outsiders wired" would not be the goal of any corporate CIO outside of the healthcare enterprise. One wonders if John is pursuing such a goal as part of his overarching interest in the improvement of healthcare IT or whether connecting such non-affiliated physicians is a strategic goal to spur admissions at his own hospitals. In a previous note and pertaining to the challenge of data storage (see: A Closer Look at the Vertical Cloud in Healthcare Computing), I discussed how some hospitals are turning to external web-based storage solutions such as InsiteOne for PACS records.

Pathology Is Not Disintegrating in Canada!

Today's guest blog has been written by the very distinguished Canadian pathologist, Dr. Michael McNeely. Mike is currently the President of the Association for Pathology Informatics (API) and Past-President of the Canadian Association of Pathologists. He lives in Victoria, British Columbia, Canada.

No, Pathology in Canada is NOT “coming apart at the seams”.  Our country continues to enjoy exemplary clinical laboratory service. The situation is tight and, in certain instances, is dangerous.  Recent newsworthy events and an editorial in the CMAJ (see:  Canada's pathology) speak to two issues which I would like to clarify: (1) “lack of a national QA program” and (2) a shortage of laboratory professional staff.

Quality Assurance: This part of the report has caused some to believe that Canada does not use QA. This is clearly not correct. Although Canada has government-funded health care, each individual province is responsible for the administration and management of health care within its own jurisdiction. With some provincial variation, lab accreditation and mandatory QA has been standard across the country for 30+ years.  What has not been routinely available (until several recent notable projects were launched) has been scrutiny of the professional work of pathologists.  This has been compounded by situations where pathologists work alone. 

Professional Staffing: During the 1960s and early 70s, Canada was the beneficiary of an influx of highly trained pathologists from other countries (mainly the UK). This bolus took up the open positions but neutralized the need to develop a full stream of residents. Twenty-seven years ago (commenting on research conducted by the late Vern Waldorf), I wrote an editorial in the Canadian Association of Pathologists Newsletter (Vol 24: March 1982; p. 18) in which I stated “It is probable that retirement will produce a manpower shortage that will start in about five years and will reach crisis proportions around the year 2000.”  Since, the early 80s, medical school output was curtailed and pathology residencies not expanded to meet the declining requirements. Today, we are “holding on” but all groups are stretched thin and specific locations are inadequately serviced.