Lab Soft News

Kaiser's Epic Project, VeHU, and Customer-Extensible EMRs/EHRs

I received an email narrative from Dr. Bob Miller who is the Director of Pathology Informatics at Johns Hopkins. It was full of very useful information so I am posting it below as received. I am sitting on some other emails from him in a similar vein that I will also post in upcoming days. (BAF)

I recently got a copy of the book that Kaiser just published about their multi-billion dollar Epic deployment: [Connected for Health: Using Electronic Health Records to Transform Care Delivery]. Unlike many similar tomes, which typically contain theories and grandiose plans, Kaiser's book contains hard facts and descriptions of what they have actually accomplished.  I would encourage you to look at a copy.

I had a fascinating time a couple of weeks ago attending the VA's "VeHU conference" in Las Vegas. The VeHU is their VistA EHR yearly technical and team-building conference, which they allowed outsiders to attend this year for a small fee for which 2010 content is just now being readied. There  was no conference last year.

The Conference lasted four days at Caesar's Palace: 2,000 attendees, 180 technical presentations; 150 vendors, and 140 posters from VA sites. The plenary sessions that were at times reminiscent of revival meetings and/or a rock concert. Excellent and informative technical sessions; and I found I was there from 8 o'clock in the morning until 7 o'clock at night.

I attended not so much to learn about the VA's technology, which I already know a lot about, but rather to hear about the VA's organizational processes and values -- some of which we may have to adopt if we are to succeed with a monolithic "One Patient, One Record" system (i.e., Epic).

Each VeHU attendee carried a Nintendo console-like SpotMe device that was used with RFIDs for recording attendance at sessions, and for finding other attendees by RFID "ranging".  Cool technology which the Caesar's Palace technical folks said maxed out their conference area wireless infrastructure.

I am beginning to refine my thoughts on "customer-extensible (programmable) EHRs", of which the VA and Epic are quintessential examples.  Also, I am learning more about Cerner system extensibility using Command Language (CernerCCL) -- which you know much about; and Eclipsys'...ObjectsPlus and other extensibility mechanisms.

Kaiser and the VA are a way ahead of everybody else -- including joint NHIN projects with the Navy at San Diego and Norfolk and their EHR accomplishments are convincing me that "EHR-extensibility" is a critical success factor. And I am believing more and more that the generalization also applies to health care, "Organizations that make strategic use of IT are all writing software -- at least at some level."

Rising Rate of Esophageal Cancer in the U.K.; Relationship to Obesity

I came across an interesting news items about the rising rate of esophageal cancer in the U.K. This initially surprised me because I assumed that smoking/drinking were declining in the U.K. These behaviors have a causal relationship to squamous cell carcinoma of the esophagus, but read on (see: Oesophageal Cancer Rates In Men Up 50 Per Cent In A Generation, UK), Below is an excerpt from the article:

Oesophageal cancer rates in men [in the U.K.] have risen by 50 per cent over the last 25 years, according to new figures....In 1983 around 2,600 men were diagnosed with oesophageal cancer ...and according to the latest figures around 5,100 men were diagnosed with the disease. The most dramatic rise was among men in their 50s, as rates increased by 67 per cent over the same period. Rates in women also rose, but only by eight per cent, from 5.1 to 5.5 per 100,000 people...."[W]e think the obesity epidemic may be a big reason behind the increase [said an author of the study]. We know that being overweight significantly increases the risk of adenocarcinoma - the main type of oesophageal cancer that's on the up. Our changing diets are also likely to be influencing the rise with people eating less fruit and vegetables....In 1983, 9.6 in every 100,000 men were diagnosed with oesophageal cancer but now 14.4 in every 100,000 men are diagnosed with the disease - an increase of 50 per cent.

On a hunch and to pursue this topic further, I googled the key words esophageal cancer and obesity. Here's an article on the topic with an excerpt below (see: Esophageal Cancer and the Effects of Obesity):

GERD, or gastroesophageal reflux disease, is one of the more common effects of obesity. GERD causes stomach fluid to leak into the esophagus, damaging the delicate inner lining of the esophagus. GERD can cause a condition known as Barrett's esophagus, which increases the incidence of esophageal cancer. For unknown reasons, the incidence of esophagus cancer has risen dramatically over recent years in the United States and Europe. Researchers at the University of Michigan (2007) documented a 350 percent increase in esophageal adenocarcinoma, a type of esophagus cancer, since the 1990s. Researchers are trying to determine why this increase has occurred at a time when stomach cancers have decreased....[The answer to this question of the rising rate may lie with the relationship between Barrett's Esophagus and cancer of the esophagus]. Barrett's esophagus is a condition in which the inner lining of the esophagus is replaced with tissue resembling the intestinal lining....[P]eople with GERD are up to five times more likely to develop Barrett's esophagus....According to one theory, excess abdominal fat pushes stomach acids back up into the esophagus, starting the cycle of inflammation that can lead to Barrett's esophagus.

So piecing all of this together: obesity > GERD > Barrett's esophagus > adenocarcinoma of the esophagus. However, there is still the need to explain why the incidence of adenocarcinoma of the esophagus is not rapidly rising in the U,K. among women. It's possible that, overall, they do not suffer from the same rate of obesity as men or that, for some reason, they do not have the same incidence of GERD in the face of their obesity. I have blogged before about how various diseases as linked to "lifestyle" issues (see: Seeking the Correct Definition for a "Lifestyle Disease"; Can We Reduce the Number of Preventable Deaths Occurring Yearly in the U.S.?). It looks like we can place adenocarcinoma of the esophagus in this same column.

Clarification of Comments about the U.C. Berkeley Genetic Testing Program

Joe Plandowski has emailed me to correct a portion of my blog note of yesterday (see: UC Berkeley "Adjusts" Its Freshman Genetic Testing Program). Here is his comment:

I don't believe [the following] statement [from your note] is totally correct; "He and his other team members appear to have been blissfully unaware of the CLIA regulations whereby only licensed labs can release test results to individuals." As I understand it, there are only a handful of states where individuals can directly order lab tests and receive lab results. In all the rest of the states the tests are ordered by a physician and the results are returned to that physician. Only the ordering physician can release test results to the patient. When I ran labs years ago this was always a problem.Patients would call for results and we could not release them. Patients would argue it was their blood/urine/whatever specimen and they were paying to have the test(s) run so why couldn't they get the results?

Also, all labs other than research labs in this country that test patient specimens and release those test results to physicians or patients, where allowed by the state, must be CLIA registered. Last time I looked, there were about 180,000 CLIA registered labs. Of that total, about 110,000 such labs are in physician office practices. Commercial labs occupy about 5,000 of the total and hospitals have about 8,000 of the registered labs. There are more CLIA lab registrations for hospital labs than there are hospitals because some hospitals have multiple registrations (ex - Cleveland Clinic has 4 CLIA registrations).

Joe is correct. I conflated the two separate issues of (1) CLIA certification of labs and (2) the release of test results directly to a patient, the latter being  controlled by state regulations. Here is a brief summary of the CLIA regulations (see: Clinical Laboratory Improvement Amendments).

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 200,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) has the responsibility for implementing the CLIA Program.The objective of the CLIA program is to ensure quality laboratory testing.

So, here are the salient take-home points:

• Research labs are not required to be CLIA certified, presumably because they are not pursuing the diagnosis of disease in humans. Some research labs obviously do perform tests on humans, as in the case of drug trials, but these tests are part of a project and the results are not released to the subjects.
• CLIA regulations are quality-driven and apply to those labs performing tests on humans for the diagnosis of disease. Physicians order their tests from such labs.
• As emphasized by Joe above, there are a set of states where individuals can directly order lab tests and receive lab results. California is not one of them. The ASCP has determined that direct-access-testing (DAT) is allowed in some form in 34 states.  In all the rest of them, the tests are ordered by a physician and the results are returned to that physician. Only the ordering physician can release test results to the patient.

Private Donations Rescue Medical Technology Program at the U. of Hawaii

We are facing a major shortage of medical technologists in this country (see: Comments on the Medical Technologist Shortage; The Continuing Shortage of Medical Technologists: a Challenge for Hospital Labs). They constitute an absolutely essential component of the clinical labs. They are the front line troops who perform nearly all of the essential tasks including most new test development. Many medical schools and universities have walked away from their medical technology programs because they can be complex to organize and manage and faculty members may be difficult to recruit. Now comes the news that the University of Hawaii will once again admit students to its medical technology baccalaureate degree program (see: UH to admit medical technology students again). Below are the details:

Donations are enabling the University of Hawaii to once again admit students to its medical technology baccalaureate degree program. Clinical Laboratories of Hawaii and Diagnostic Laboratory Services saved the program with $100,000 in donations to the university. The money is allowing the John A. Burns School of Medicine to support a full-time faculty member for the next two years. State budget cuts forced the school's Medical Technology Department to stop admitting new baccalaureate students last summer.The university since sought private support for the program.

As we all know, many states like Hawaii are in severe financial stress and are thus cutting back on allocations to their state university programs. For various reasons, med tech programs seem to be particularly vulnerable to cutbacks and closure. I think that part of the problem is that the essential role of this group of healthcare professionals is not well understood by politicians and the various higher education officials. It's telling with regard to the University of Hawaii that: (1) the funding of only one faculty member for two years was sufficient to resurrect the program; and (2) the money was obtained from two local commercial reference labs. Of course, these labs have a significant vested interest in such a program, often hiring the graduates for their labs.

UC Berkeley "Adjusts" Its Freshman Genetic Testing Program

I previously raised the issue of an ill-conceived project at UC Berkeley whereby incoming freshmen were asked to undergo genetic testing using oral mucosa cells (see: UC Berkeley Offers DNA Testing to Incoming Freshmen; Does This Make Sense?).To quote from my note: This whole project sounds to me like it was cooked up in the mind of a UC Berkeley professor with an interest in genetics and who views the entire freshman class as potential lab rats. Now comes word that the program is being adjusted (see: UC Berkeley adjusts freshman orientation's gene-testing program). Also see: DNA test flip-flop stirs debate at UC. Below is an excerpt from the article:

UC Berkeley announced on Thursday a rollback in its controversial plan for voluntary genetics testing of incoming students, part of an orientation program called "Bring Your Genes to Cal." In response to a state Public Health Department ruling on how DNA samples should be handled, UC Berkeley scientists reluctantly abandoned the idea to have freshmen and transfer students individually and confidentially learn about three of their own genetic traits. Instead, only collective results for all the 1,000 or so participants will be available and discussed at the orientation seminars.... Mark Schlissel, UC Berkeley's dean of biological sciences and an architect of the DNA program, said he disagreed with the state Department of Public Health's ruling that the genetic testing required advance approval from physicians and should be done only by specially-licensed clinical labs, not by university technicians. The campus could not find labs willing to do the work and probably could not afford it anyway, Schlissel said. He also contended that the project deserved an exemption from those rules because it was an educational exercise....Berkeley officials contend that the test results would not be medically significant. But the program was controversial with privacy advocates and ethicists complaining that it presented an unprecedented and disturbing use of genetic data by a university....In a statement issued Thursday, Kevin Reilly, an official at the state Public Health Department, said only licensed laboratories are allowed to perform medical tests on human specimens if the results are to be released to an individual. That rule is "designed to protect the public by ensuring that testing provides accurate and reliable results."

So it appears the UC Berkeley dean of biological sciences who hatched this idea has been stymied by the California state public health department, one of the toughest in the country. He and his other team members appear to have been blissfully unaware of the CLIA regulations whereby only licensed labs can release test results to individuals. Putting this all together, the project was probably only feasible from a cost perspective if the specimens were analyzed in a local research lab and not a CLIA-certified lab. In fact, the costs may have been covered by a research grant. When individual reporting was ruled out by the state authorities, the back-up plan was to reveal only collective results to the students.

So what was probably the real reason for this project? As noted above, I suspect that one or more researchers wanted access to a large pool of normal student samples as part of their research agenda. This is still possible with the revised plan but the number of specimens may be reduced absent the appeal of individual reports to the students. Forget all of the hot air about the educational benefits of the program for the incoming freshmen. This was mainly window dressing, in my opinion. In fact, Dean Schlissel admitted as much in the second news link above by saying the following:

"We're very much afraid that if (the ruling) is interpreted as applicable for other teaching programs ..., it will have a real stultifying effect on our ability to conduct research," said Dr. Mark Schlissel....

By the way, this same CLIA lab issue poses one of the major obstacle to the release of genetic test data to research subjects recruited for clinical trials. Most of this lab testing is performed in research labs similar to the one involved in the Berkeley project.

The Future of Healthcare and the Four P's: Preventive, Predictive, Personalized, Participatory

I have posted a number of previous notes on the topics of preventive, predictive, personalized, and participatory medicine (see: Preventive and Predictive Medicine as Components of the Healthcare Continuum; Some Encouraging News About New Federal Funding for Preventive Medicine Initiatives; Wellness, Preventive Medicine, and the Classic Disease Model; The Need for a Preventive Medicine Infrastructure in the U.S.; A Key Link Between Predictive and Preventive Medicine; Further Consideration of the Definition for Personalized Medicine; Recruiting Office Patients into a Participatory Model of Healthcare Delivery; "Participatory Medicine" and Its Relationship to Clinical Lab Testing). There are more but you get the idea.

Putting it all together, they together constitute a blueprint for the healthcare development arc in the near term. Tony Killeen, who blogs over at iPathology, makes reference to a recent lecture by Leroy Hood about P4 Medicine (see: P4 Medicine: Predictive Preventive Personalized and Participatory). Below is an excerpt from his note:

One of the best talks at the recent AACC Annual Meeting was given by Leroy Hood from the Institute for Systems Biology. His topic was P4 Medicine, a term he coined for "predictive, preventive, personalized, and participatory". What he's describing will, I believe, have significant and exciting implications for Laboratory Medicine because the concepts are based on the idea of clinical laboratory genomic analysis for identification of disease risk alleles, blood analysis for early detection of disease by measurement of disease specific biomarkers, and interpretation of data by knowledgeable experts. With the prospect of a $1000 genome sequence in the not-too-distant future, and rapid advances in protein analysis by mass spectrometry, it seems realistic to think that many of the technical limitations are surmountable. The question in my mind is how does one deal with the enormous amount of data from these analyses and distill it into something intelligible to physicians and patients alike?  And will patients really take an interest in modifying their lifestyle in response to new risk factors when it's so difficult for many people to adjust to well known disease risk factors today, such as smoking, diet, lack of exercise, and so on? But back to Laboratory Medicine. What is being described as P4 Medicine is obviously very reliant on clinical laboratory analysis, and could bring about a new era for advanced Lab Medicine in specialized centers that can offer such testing.

One "deals" with the enormous amount of data that will be accessible to us using information technology, but Tony already knows this. I think the question that he is really asking here is how the IT tools that will be at the disposal of both physicians and patients will be integrated into healthcare delivery. What's most revolutionary about the Four P's is the last one -- participatory. The truly unique aspect of this formula will be the nearly unfettered access by patients to the same information about their health status as the healthcare professionals (see: Should Patients Be "Allowed" to Read Their Medical Records?; Paging Dr. Google! We Are Waiting for a Second Opinion.; Teaching Consumers to Say "No" to Physicians' Recommendations). The most engaged of them will become key partners in the quest for continuing wellness.

Bariatric Surgery Cures Adult-Onset Diabetes; Is This a Problem?

Three years ago, I discussed early reports that bariatric surgery can cure adult-onset diabetes through a mechanism not solely related to weight loss (see: "Curing" Diabetes with Bariatric Surgery). Now comes more information confirming these initial observations (see: Study: Surgery May Reduce Diabetics' Need for Drugs; subscription required). Below is an excerpt from the article

The majority of people with diabetes who had bariatric surgery to lose weight were able to stop taking their diabetes medications, which led to a significant decline in health-care costs, according to a [recent] study....Researchers at Johns Hopkins in Baltimore, looked at 2,235 adults who had the stomach-reducing surgery and who also had Type 2 diabetes, a common form of the disease often associated with weight gain. Six months after surgery, nearly 75% of patients had eliminated their diabetes medications and after two years 84.5% of patients were off medicine....Many patients were able to stop taking their medications almost immediately after surgery and before they'd lost large amounts of weight, backing theories that stomach hormones altered by surgery are better able to control blood glucose levels than weight loss alone....About 86% of the patients, who were covered by Blue Cross and Blue Shield insurance, were on at least one diabetes medication before surgery, with an average of 4.4 medications per patient. About 23% of patients were on insulin.

Who would have thought, say, five years ago that we would have been discussing a surgical cure for adult-onset diabetes? However, we still need to study this issue on an even longer-term basis. It's possible that the body may adapt to the surgery-induced hormonal effects and that the disease may recur at a later time. However and as noted above, the beneficial effects do appear to last for more than two years for most patients. We  have known for many years that weight loss can cure or ameliorate adult-onset diabetes. For example, the metabolic syndrome is a pre-diabetic state that can be cured with weight loss (see: Metabolic Syndrome: The Problem You May Never Have Heard About; Visfatin, A "Belly Fat" Hormone, and Its Relationship to the Metabolic Syndrome).

Her's something to keep in mind. A physician told me recently that some of his patients do not show improvements in their lipid "numbers" when he prescribes statins for them. It turns out that many of them are unable or unwilling to alter their diets to correct a lipid problem. They view the statin treatment as a "quick fix" which permits them to avoid making the necessary lifestyle changes. I am therefore nervous about the use of bariatric surgery to cure Type 2 diabetes. Here's the choice being offered to these patients in my opinion: (1) surgical intervention with its attendant risks to create a greatly altered physiologic state and uncertain long-term consequences; (2) increased physical activity and an altered diet leading to gradual weight loss with certain long-term gains.

For me the choice would be obvious. Opt for less intervention. However and with bariatric surgery, the insurance companies gain with long-term reduced costs and hospitals and surgeons gain with the revenue from the procedures. With these types of returns now available for the healthcare establishment, I think that I know what the future holds. All of the incentives seem to be lined up in favor of bariatric surgery.

Too Much Management May Account for Lack of Innovation in Big Pharma Companies

In a recent note, I cited evidence for the lack of innovation in Big Pharma, at least from the perspective of stock market investors (see: Some Evidence that Big Pharma Has Lost Its Innovation Mojo). I did not go into issues of causality for this observation other than to cite the bloated cost structures of these companies. A recent article discusses the lack of an entrepreneurial spirit in many U.S. companies and suggests that the problem is that they suffer from excessive management (see: The End of Management). In other words, they employ too many managers with oversight over resources and new product development. The subtitle of this article is: Corporate bureaucracy is becoming obsolete. Why managers should act like venture capitalists. This says it all. Here is a key excerpt from this article:

In recent years, however, most of the greatest management stories have been not triumphs of the corporation, but triumphs over the corporation. General Electric's Jack Welch may have been the last of the great corporate builders. But even Mr. Welch was famous for waging war on bureaucracy. Other management icons of recent decades earned their reputations by attacking entrenched corporate cultures, bypassing corporate hierarchies, undermining corporate structures, and otherwise using the tactics of revolution in a desperate effort to make the elephants dance. The best corporate managers have become, in a sense, enemies of the corporation. The reasons for this are clear enough. Corporations are bureaucracies and managers are bureaucrats. Their fundamental tendency is toward self-perpetuation. They are, almost by definition, resistant to change. They were designed and tasked, not with reinforcing market forces, but with supplanting and even resisting the market.

The era of the block-buster drug with huge profits for Big Pharma seems to be long gone (see: Pharma industry prepares for end of 'blockbuster medicines'). Along the lines of the article cited above, I think that many of the managers in Big Pharma are bureaucrats who are primarily interested in self-perpetuation. Absent the potential for blockbuster drugs, they have little interest in the arduous and risky task of shepherding new drugs with smaller prospects for profit through the clinical trial and regulatory process. They would rather sell foot power with a smaller, but steady, profit and then purchase the smaller companies that are innovative enough to develop the new drugs. However, I fear that the innovative spirit of these smaller companies will be smothered when their fate is in the hands of the managers in these larger companies after purchase.

Roche's Ventana Acquires BioImagene

Roche Holding... said it will buy closely held BioImagene for $100 million, helping the Swiss drug company to extend its diagnostics business (see: Roche to Buy BioImagene, U.S. Diagnostics Firm). As part of the deal, Roche's unit Ventana Medical System Inc. will acquire 100% of the California-based company, which specializes in tissue-based cancer diagnostics and research. The U.S. company makes digital images from glass microscope slides that can be processed with computers, thus helping researchers and doctors save costs and time....The takeover is part of Roche's efforts to boost activities in personalized medicine, whereby companies develop diagnostic tests to help determine which therapy is the best for a patient....Efforts in the realm of diagnostics should also give pharmaceutical companies a better understanding of the molecular structure of diseases, enabling them to develop new ways to produce drugs.

Important Deadline Approaching for the Pathology Informatics 2010 Conference in Boston

The Pathology Informatics 2010 conference will take place on 19-22 September at the Westin Copley Place Hotel in Boston. It's an amalgam of three previous pathology informatics conferences: (1) APIII, held for 14 years, mainly in Pittsburgh; (2) Lab InfoTech Summit, presented for six years in Lab Vegas; and (3) AIMCL with a 21 year tenure in Ann Arbor.

A key date is approaching for those interested in registering for this conference -- August 27. This marks the deadline for the reduced conference registration fee for the event and also for making a reservation at the Copley. A block of rooms have been set aside at the hotel by the conference organizers for registrants at a special price but there is no guarantee that rooms will be available after this date. On-line registration is available at the conference web site as well as details about how to reserve a room at the hotel.

Early indications are that the conference will provide a very valuable educational experience for registrants. A record has been set this year for the number of scientific presentations on the basis of abstract submissions (see: New Record Set for Scientific Abstract Submissions to Pathology Informatics 2010). In addition, a record number of exhibitors, 41, will be demonstrating their products in the large exhibitor ballroom. Forty-eight faculty members will participate in three workshops, three separate content tracks, and three plenary sessions.

Managing Your Daily Interactions with Selected Pathologists

There is the old joke about how you can distinguish between an introverted pathologist and an extroverted one. The former looks at his own shoes when talking to you and the latter looks at your shoes. Many of us are familiar with the common daily habit of the pathologist who takes a stack of slide trays into his or her office, shuts the door, and spends the rest of the day dictating cases, exiting only for a coffee refill. These are people who enjoy their solitude, In short, they like being alone, if you do not define a stack of glass surgical pathology slides as company. It turns out the the brain anatomy and physiology of introverts may actually be different than that of the extrovert (see: Brains of Introverts Reveal Why They Prefer Being Alone). Below is an excerpt from this article:

Human faces may hold more meaning for socially outgoing individuals than for their more introverted counterparts, a new study suggests. The results show the brains of extroverts pay more attention to human faces than do introverts. In fact, introverts' brains didn't seem to distinguish between inanimate objects and human faces. The findings might partly explain why extroverts are more motivated to seek the company of others than are introverts, or why a particularly shy person might rather hang out with a good book than a group of friends. The study also adds weight to idea that underlying neural differences in people's brains contribute to their personality....The researchers studied a particular change in the brain's electrical activity known as P300. The change, which shows up as a deflection on a person's EEG, can be elicited by certain tasks or by a change in the environment, such as when the room is very quiet and you all of a sudden hear a loud nose. The brains' reaction occurs within 300 milliseconds, before the person is aware of the change....There was no link between [P300] scores on extroversion and the P300 response to flowers. Introverts had very similar P300 responses to both human faces and to flowers.

So as to the best way to manage your relations with such a pathologist, here's my best advice. He or she will generally not be interested in hearing about what you watched on TV last night nor how you will be spending your vacation. If encountered in a hallway, what he really wants to do is get back to his office and get the day's work done. If you are trying to engage him in a conversation and he looks slightly flummoxed, you may not doing anything wrong. He may just be trying to distinguish you from the flowers in the nearby vase.

More than 30,000 Pharmacists Now Administering Flu Shots in Neighborhood Drug Stores

Pharmacies and pharmacists seem to be evolving into neighborhood healthcare centers. I have posted previous notes about this phenomenon (see: Local Pharmacies Emerge as Centers for Care of Diabetics; Pharmacist-Staffed Coagulation Clinics in a Large Health System). I have also discussed the deployment of retail, walk-in clinics staffed by physicians and nurses in retail pharmacy chains like CVS and Walgreens (see: Cleveland Clinic Partners with Minute Clinic in Retail Health Services; Growth of Walk-In Clinics Slows Down; Study of Patients Patronizing Walk-In Retail Clinics). However, I have not been tracking the extent to which pharmacists have been trained to administer flu shots. Some details about the trend were revealed in a recent article (see: Suntan Lotion, Flip-Flops... and Flu Shots; registration required). Below is an excerpt from it:

Drugstores, still struggling with a weak economy, are pushing flu vaccinations earlier and harder than ever. They've bolstered the ranks of pharmacists certified to give shots and are promoting the service through TV commercials, in-store displays, Facebook and Twitter. CVS Caremark Corp., which is reaching out to some of its 64 million loyalty-card members via e-mail, is letting customers book an appointment by computer, phone or in-person. Walgreen Co. is even advertising flu-shot gift cards, for $29.99, aimed at kids headed off to college and other family members,....Rite Aid Corp. this year tripled to 7,400 the number of pharmacists who can administer flu shots. Walgreen has 25,000 pharmacists trained to give flu shots, up from 16,000 last year. Until recently, retail pharmacists couldn't get state certification to provide flu shots. This is the first season all 50 states will allow pharmacists to provide vaccinations. In the past, drugstores brought in outside vendors. Stores are generally charging $25 to $30 for shots....Pharmacies could use a sales boost, as prescriptions have shrunk as people cut back on doctor visits in the poor economy. Fewer visits to the pharmacy mean fewer chances to sell toothpaste, mascara and potato chips. CVS recently trimmed its fiscal-year outlook amid a 12% drop in pharmacy claims, while both Rite Aid and Walgreen saw sales dips.

I have been a little surprised that the evolution of chain drug stores into mini-heath centers has not proceeded more rapidly. I attribute part of this slow-down to the general lack of success of some of them. Some of these in-store clinics are now in the process of refining their business models to a more appropriate mix of services and staffing. However and as emphasized in the excerpt above, the poor economy is causing pharmacy chain executive to look for new medical services to raise revenue and increase foot traffic -- flu shots seem to fit the bill.

The question then remains whether retail pharmacies will seek to expand to other healthcare services such as blood drawing for lab testing. The local drug stores could operate as convenient patient service centers (PSCs) and draw blood for the national reference labs such as Quest and LabCorp. LabCorp has already used such a strategy within Duane Reed drug stores in New York City (see: LabCorp To Offer Medical Tests At Duane Reade Drugstores In New York City). Of course, these national reference labs are a high-volume, low-margin business and already have their own blood-drawing facilities. They may have no incentive to expand into higher-priced drug stores merely for the sake of greater customer convenience.

Some Evidence that Big Pharma Has Lost Its Innovation Mojo

Think quickly when I say "innovation" in relation to healthcare. What types of organizations come quickly to your mind. Hospitals? No. The pharmaceutical industry? No. I personally think of sectors such as medical devices, molecular diagnostics, genomics, medical imaging, biotech. Well, recent trends in the market cap of various healthcare sectors bear out this conclusion (see: The Net Innovation Trend), Below is an excerpt from the article making this point, including pie charts illustrating the comparative value of sectors for 2000 compared to 2008:

The relative absence of innovation set against a bloated cost structure has led to a rapid decline in value of large-cap pharmaceuticals, from nearly two-thirds of the market cap of healthcare in 2000 to less than one-third today. Over the past eight years, the pharmaceuticals sector has lost a stunning $593 billion (-65%) in market cap while the two sectors with innovation—biotech and med tech—have each added $71 billion (+46%) and $19 billion (+6%) in market cap, respectively....Generic drugs have also fared well (+$27 billion or +139% in market cap) as generics represent a low-cost solution to high drug costs. Furthermore, the generic companies have aggressively launched generics “at risk” or negotiating settlements with large-cap companies.

Here's a definition for "at-risk generic drugs" mentioned in this excerpt, a reflection of the extent to which the generic drug manufacturing companies, some of them off-shore, are willing to take risks in the pursuit of new products:

"At-risk" generic launches refer to generic pharmaceuticals that are approved by FDA based on the review of an abbreviated new drug application (ANDA) and are subsequently launched while patent litigation is ongoing. Launching these generics is risky because they can be pulled from the market if courts determine that patents protecting a branded reference product are violated or infringed, thus allowing the brand company to seek triple monetary damages.

If you share my belief that Big Pharma has lots its ability to innovate, the logical next question is why this has occurred. I think that the answer is multifactorial. First of all and as noted in the quote above, the industry has a "bloated cost structure" with too many layers of bureaucracy and too many mouths to feeds. In its quest for profits, it keeps shedding/outsourcing the costly, but key, development and manufacturing components (see: CROs Continue to Prosper; Benefits of Big Pharma Outsourcing). What the executives really want to sell to you is foot powder (see: Why Drug Companies Want to Sell You Foot Powder). Accordingly, the companies devote their resources to marketing rather than scientific discovery and clinical trials (see: Drug Company Emphasis on Marketing an Unfavorable Shift for Consumers). By way of contrast, listen to a lecture from a scientist from smaller company with a focus on, say, molecular diagnostics or genomics. You will hear much less about blockbuster products, marketing, and reimbursement and much more about the scientific basis for the company's R&D efforts.

Where does all of this leave us? Well from my point of view, it reinforces my idea that we are entering the golden era of diagnostics (see: Interpreting the Tea Leaves: Ten Trends in Healthcare, Lab Medicine, and Pathology Informatics; slide #30). The most complex and sophisticated part of the workup of a patient with a complex disease such as cancer is arriving at the diagnosis. This process will increasingly involve the interpretation of both serum and tissue biomarkers and various types of medical imaging. Once the diagnosis is arrived at, the appropriate treatment will be determined by referring to a table of available drugs with dosages and treatment cycles. And where will our "new" drugs come from. Largely from small, innovative drugs companies with a scientific culture and emphasis on a small number of products.

New Record Set for Scientific Abstract Submissions to Pathology Informatics 2010

Pathology Informatics 2010 will take place on September 19-22, 2010, at the Westin Copley Place Hotel in Boston. This conference has been formed from a merger of APIII, held primarily in Pittsburgh for the past 14 years, and Lab InfoTech Summit/AIMCL that were presented in Las Vegas/Ann Arbor for the past 27 years.

AIMCL has always included scientific sessions and e-posters in its programming. The former are 15-minute oral presentations selected on the basis of submitted abstracts. E-posters, as the name implies, are lecture-demo's using PCs as a substitute for the standard physical posters presented at many medical conferences.

A new record has been established for scientific abstract and e-poster submissions for this year's conference with 60 of the former and 24 of the latter. In order to accommodate these 60 abstract presentations, the conference organizers have expanded the number of available conference rooms to five. The sessions will run in parallel on Monday and Tuesday mornings, September 20 and 21, from 7:30-9:00 a.m.

This new record for abstract submissions bodes well, I think, for pathology informatics, reflecting broad interest and ferment in the field with a large group of researchers exploring new technical and scientific directions.

Epic Staffing Guide: Replicating the Epic Culture in Its Hospital Clients

When hospitals purchase the Epic EMR, they may get more than they bargained for. One of the fascinating aspects of Epic is the extent to which the company attempts to put its own spin on the culture of its hospital clients. One such example relates to the hospital personnel who will install/manage their software and also interact with Epic personnel. This is quite different than the usual healthcare IT company that usually tries, when feasible, to accommodate to the hospital client culture. A case in point is illustrated by the Epic staffing guide, a set of recommendations from the company to newly-signed clients in preparation for the deployment of Epic software. Mr. HIStalk discussed this topic in as recent blog note. Here is the item:

Epic Staffing Guide: A reader sent over a copy of the staffing guide that Epic provides to its customers. I thought it was interesting, first and foremost in that Epic is so specific in its implementation plan that it sends customers an 18-page document on how staff their part of the project. Epic emphasizes that many hospitals can staff their projects internally, choosing people who know the organization. However, they emphasize choosing the best and brightest, not those with time to spare. Epic advocates the same approach it takes in its own hiring: don’t worry about relevant experience, choose people with the right traits, qualities, and skills, they say. The guide suggests hiring recent college graduates for analyst roles. Ability is more important than experience, it says. That includes reviewing a candidate’s college GPA and standardized test scores. I bet many readers were taught by their HR departments to do behavioral interviewing.... Epic says that’s crap, suggesting instead that candidates be given scenarios and asked how they would respond. They also say that interviews are not predictive of work quality since some people just interview well. Don’t just hire the agreeable candidate, the guide says, since it may take someone annoying to push a project along or to ask the hard but important questions that all the suck-ups will avoid. Epic likes giving candidates tests, particularly those of the logic variety. Given my dismal experience with clueless hospital HR departments (was that redundant?), I love this guide.

i understand Mr. HIStalk's suspicions about hospital "clueless" HR departments. I can also understand why Judith Faulkner, CEO and founder of Epic, seeks a particular type of employee at hospital client sites who will be responsible for the new system. The more competent they are, the more likely that the project will proceed successfully and on schedule. The irony here, however, is that within the Epic organizational structure, HR makes all of the hiring decisions -- the various work groups to which the new hires are assigned apparently have no say in the matter at all (see: More on the Epic Systems Culture: HR Responsible for All Hiring Decisions). Here is an excerpt from this note:

The CEO and founder of the company, Judith Faulkner, shapes the company's culture but she rarely speaks to the press. I was therefore interested to discover an article from December, 2002, describing her own views about the Epic corporate culture (see: Epic's Founder Judy Faulkner Speaks on Culture, Business Beliefs, and Recruiting). [Here] is an excerpt from it:

All potential employees go through a rigorous screening process. HR is responsible for all hiring decisions. There are no job descriptions. The employees in the workgroup have no input. Faulkner believes, "teams hire people they like ... this eventually breeds bad attitudes and ego-protection" Faulkner tries to take personality out the decision process and hire on skills. "Beware of the articulate incompetent ... a bad weed is a flower in another garden," according to Faulkner. She believes it takes three years for a person out of college to become an "Epic Person," and six years for those hired from the outside.

LabCorp Collaborates with Clearstone in Support of Global Clinical Trials

Contract research organizations (CROs) such as Covance and Charles River, particularly those with expertise in clinical and anatomic pathology, have been in the forefront of efforts to develop global networks for collaborative work and information exchange (see: A Look at the World's Largest Central Laboratory Network; Covance's Execution of a Global Virtual Clinical Lab; Charles River Acquires Molecular Imaging Company; Status and Challenges of Offshore Clinical Trials). They are also leading the way in the adoption of digital pathology for their veterinary pathologists (see: Veterinary Pathologists Adopting Digital Pathology Faster than MDs). These networks allow for archiving of digital image files in central global locations plus collaborative efforts across multiple sites in the analysis and interpretation of digital images. These clinical trial and research networks will be important models for the future exchange of scientific and medical data, which will be of increasing importance as healthcare transitions to a more global model.

The CRO market is particularly attractive now for clinical and pathology reference labs because Big Pharma is withdrawing from its drug-development and clinical trial efforts, turfing them instead to the rapidly growing CROs (see: CROs Continue to Prosper; Benefits of Big Pharma Outsourcing). This retrenchment is one facet of Big Pharma's cost-cutting efforts and disappointment with its new drug pipeline. A recent press release indicates that LabCorp has seen the handwriting on the wall and is collaborating with privately held Clearstone Central Laboratories in order to quickly establish its own global network (see: LabCorp Establishes Global Clinical Trials Collaboration with Clearstone Central Labs). Below is an excerpt from it:

Laboratory Corporation of America Holdings...announced...a collaboration between Esoterix Clinical Trials Services, a division of LabCorp, and Clearstone Central Laboratories, a global central laboratory specializing in drug development and pharmaceutical services....The collaboration provides LabCorp with access to Clearstone’s global network of labs, including China, France, Singapore and Canada, in addition to LabCorp's existing labs in the United States and Belgium. The companies will collaborate on providing standardized central laboratory testing for clinical trials to their respective clients. The transaction also provides LabCorp access to Clearstone’s clinical trials management system APOLLO CLPM [Central Lab Protocol Management System], enhancing the ability of clients to conveniently send, receive and manage data.

Here's how Clearstone describes itself on its web page:

Clearstone is the largest and most experienced private company exclusively focused on providing central laboratory services in mature and emerging markets to many of the leading pharmaceutical and biotech companies around the world. Through our unique network of wholly owned CAP certified laboratories, we offer central laboratory services spanning the clinical development lifecycle. Our reach and experience spans the globe with strategically placed facilities in Asia, Europe and the Americas all bound by global SOPs and APOLLO CLPM our global Central Lab Protocol Management System.

Obviously, a physical global network is only one part of the success equation. A second key element, as noted in this excerpt, is Clearstone's clinical trials management software, APOLLO CLPM, that is part of the deal for LabCorp. As you can imagine, managing complex clinical trials across multiple physical locations is a complex endeavor and requires direction from some higher-level "guiding hand." Here is a description of the APOLLO CLPM, also from the Clearstone web site:

APOLLO CLPM is a secured globally accessible web based, 21 CFR part 11 validated application. Designed and developed by subject matter experts of every applied discipline integral to the system. Built on an Oracle database, the APOLLO CLPM system is a truly singular database that replaces multiple legacy systems and sub-systems, helping to drive improvements in efficiency and quality across the central laboratory business Apollo provides for global standardization of requisitions, reports, kits, barcode labels, as well as scientific information, and improves the accuracy and speed of sample reception and processing.

Plagiarism, Singularity, and the Appropriate Use of Data from the Web

It appears that many of today's students do not consider verbatim copying of information from the web as plagiarism. Although this conclusion surprised me, it did not astonish me. Here's an excerpt from the article (see: Plagiarism Lines Blur for Students in Digital Age):

At DePaul University, the tip-off to one student’s copying [from the web] was the purple shade of several paragraphs he had lifted from the Web; when confronted by a writing tutor his professor had sent him to, he was not defensive — he just wanted to know how to change purple text to black....Professors used to deal with plagiarism by admonishing students to give credit to others and to follow the style guide for citations, and pretty much left it at that. But these cases — typical ones, according to writing tutors and officials responsible for discipline at the three schools who described the plagiarism — suggest that many students simply do not grasp that using words they did not write is a serious misdeed. It is a disconnect that is growing in the Internet age as concepts of intellectual property, copyright and originality are under assault in the unbridled exchange of online information, say educators who study plagiarism. Digital technology makes copying and pasting easy, of course. But that is the least of it. The Internet may also be redefining how students — who came of age with music file-sharing, Wikipedia and Web-linking — understand the concept of authorship and the singularity of any text or image. “Now we have a whole generation of students who’ve grown up with information that just seems to be hanging out there in cyberspace and doesn’t seem to have an author,” said [an expert on this topic] “It’s possible to believe this information is just out there for anyone to take.”

To start exploring the ideas contained in this article, I first needed some working definitions for plagiarism, original, and authorship. Here's what I came up with:

Plagiarism: The wrongful appropriation, close imitation, or purloining and publication, of another author's language, thoughts, ideas, or expressions, and the representation of them as one's own original work.

Original: preceding all others in time or being as first made or performed; something that serves as a model or a basis for making copies.

Author and authorship: The person who originates or gives existence to anything; that authorship determines responsibility for what is created.

I readily admit that times are changing regarding the exchange and replication of information. First of all, we are confronted with the incredible ease with which ideas, and even whole passages of articles, can be "lifted" from the web. Secondly, there is the long-held notion in this digital era that everything on the web "wants to be free." Although free in this context is usually interpreted as free of cost, it can also be viewed as free of other constraints such as authorship. I think that almost everyone defines web content as "there for the taking."

I was most struck in the passage quoted above that students "fail to understand the concept of authorship of the singularity of any text or image." Prior to today's posting, I have published 1,516 blog notes here over the course of about four and a half years. Almost every one of them is based on the format of today's note: an excerpt from some other web source plus my personal analysis and interpretation. Most of these analyses and interpretations are derived from ideas that I have picked up elsewhere on the web, during lectures, or in hallway conversations. Of these 1.516 notes, how many would I personally consider singular, which I define as unique and totally original? Not many. Except perhaps for the great authors and journalists of today and of the past, and you know who they are, I am not sure that singularity has any relevance. If this is the case, then I find myself groping for a better understanding of the meaning of plagiarism. I also could not resist the irony of the fact that one of the definitions for original is to serve as a model for making copies.

PathologyLinks: A Comprehensive Gateway to a Host of Resources

I have just discovered PathologyLinks (Eric's Links) by way of a referral to Lab Soft News. It's a compilation of approximately 230 separate links (there were so many that I lost count) with relevance for the practice of pathology and categorized in the following way:

• Surgical Pathology (general)
• Subspecialty Surgical Pathology     
• Cytopathology
• Autopsy
• Histology
• Anatomy & Physiology
• Microscopes and Microscopy
• History of Pathology
• Other Pathology Resources
• Bioinformatics
• Internet Research

Eric turns out to be Eric K. Morgen, M.D., an AP resident in the Department of Lab Medicine and Pathobiology at the University of Toronto. This meta-site is obviously a labor of love for Eric -- great work. We can all derive benefit from his efforts. I could spend a couple of days and still not adequately scan all of material to which these links lead.

I can't pass up a brief comment on the use of the term pathobiology for the University of Toronto department in which Eric is a trainee. The Wictionary defines the term in the following way: The branch of biology that deals with pathology with greater emphasis on the biological than on the medical aspects. The specialty of pathology focuses on abnormal biology, which is to say the broad spectrum of disease. It's understood that one cannot understand the abnormal unless one has a grasp of the normal states from which the abnormal is derived.

For the name of a department with a strong bench research component, the use of the term pathobiology seems to make good sense. However and for the clinical side of the department with the job of focusing on the diagnosis of disease, I am not sure that the name is completely apt. I could be all wet here -- a Google search shows about 13 million hits for the term so perhaps it is currently in vogue and I just plain missed the shift.

The iPad as a Key Learning Tool for Medical Students at UC Irvine

The current norm for medical school lectures, and it seems for many undergraduate programs as well, is to make all lectures available on the web in the form of PowerPoint presentations. Frequently, these files have been audio-synced so that the presentations are self-contained and can be viewed anywhere and anytime. Many medical schools also offer video lectures on the web that provide more of a real-time experience. Some students use these media, appropriately in my opinion, as a means to review the live lectures that they actually attend. Their additive value is that the learner can stop them at will to review complex ideas or read a textbook passage to help explain the material being presented. Other students may never attend the live lectures at all but it's their loss. Here's an excerpt from a recent blog note describing how incoming medical students at UC Irvine School of Medicine will receive an iPad preloaded with course material and other key apps (see:Monday Morning Update 8/9/10)

Incoming medical students at the UC Irvine School of Medicine will receive  an iPad preloaded with mandatory course materials and hundreds of medical applications. Interesting: they’re ditching the sage-on-the-stage lecture model in favor of student-controlled learning.

If I were a member of one of the medical school curricular committees, I would vote to modify the current lecture model entirely. After all, the students will already have their course lectures preloaded on their iPads that they can view whenever they choose. However and in my plan, the faculty member is not off the hook after he or she records a series of lectures. I would ask the faculty member to show up at the appointed lecture time, having requested that the students view the lecture prior to the assigned time. The task of the faculty member would then be to answer questions or interact with the students, exploring knowledge areas beyond the didactic material presented in the canned lecture. For me, this same model is also relevant for continuing medical education (CME). In short, the "sage-on-the-stage" approach will soon be obsolete, at least in terms of the delivery of basic material.

Regarding the future of healthcare when these medical students enter their last two clinical years of medical school and then pursue postgraduate training, I will guarantee that they will not tolerate sitting in front of a fixed PC or interacting with an antiquated EMR user-interface. The future of healthcare computing is "mobile" which can be succinctly defined as the use of smartphones and/or tablets for clinical data management by physicians. Here's a quick look at how our young physicians will be operating in the future (see: Monday Morning Update 8/9/10):

From Ollie: “Re: mobile healthcare. I was getting blood drawn at Emory Midtown and saw an infectious disease MD tapping away on an iPad in the Starbucks line. I asked how he liked it using his Cerner PowerChart EMR that way. He said it loves it, it runs great, he places orders, does documentation, etc. He was happy to share and smiling when he said it. An MD reviewing an EMR, maybe even placing orders, while in line to get coffee … what is the world coming to?” That’s pretty cool. As much as we debate software usability, mobile device capabilities are right up there when it comes to physician satisfaction — just like it is in the consumer world, where the same old e-mail app takes on another dimension when you can use it untethered.

Defining Uptime & Downtime for the EMR -- The Devil's in the Details

When I first broke into the lab computing area in 1982, I attended a meeting with the central IT manager of the hospital. This was before the era of the CIO and we used the term hospital rather than health system. Our IT manager was an IBM retread. The software running on the IBM mainframe computer in those days was referred to as the hospital information system (HIS). This software suite was used mainly for business rather than clinical applications and consisted of two major modules called PA/PM (patient accounting/patient management). Patient management included patient admission and discharge.

At this meeting, she was bragging about 95% up-time for the mainframe computer. My eyes popped out of my head. I said, "Wait a minute. You take the computer down for four to five hours every night. There are twenty-four hours in a day, at least in Michigan. How do you arrive at the figure of 95% up-time." She flashed a smug and knowing smile. "We start with the number of hours that we intend for the mainframe to be running each day. That is our target and the denominator that we use for our up-time calculation is based on this number of hours," she said. The only reason that the number was not 100% -- this nagging 5% -- was because of frequent unplanned/unexpected computer interruptions.

A recent item in HIStalk brought back this memory for me (see: News 8/6/10). I copy it below in its entirety:

“Re: Kaiser. They say they have 99.96% availability. At least now we know that $5 billion doesn’t even get you five nines of uptime. They have come a long way from aiming for 99.7%, though! Remember that Oakland forced Pleasanton to come up with a ‘revised systems availability formula’ a few years ago — a formula that would have made Arthur Andersen blush. It basically only counts the power being off in the data center as downtime. Still, if you’ve got $5 billion and some change, you can get a nice, fully (and somewhat frequently) functioning EMR than can help improve and save lives. We just need to get the cost down and the reliability up, and then we’re good to go.”

I am not in the mood to quibble about a 99.96% availability for the clinically critical EMR at Kaiser but it sounds like there has been some tweaking along the way with the "availability formula" by the consultants assisting in the project. It does appear, however, that we have come a long way in "mainframe" hospital computing.

Prediction About the "Next Gen" EMR: Emphasis on Coordination and Communication

I came across a recent interview of Dr. Peter Stetson, CMIO, Columbia Doctors, in which he discusses, in part, the "next generation" of electronic health records (EHRs) (see: HIStalk Interviews Peter Stetson, CMIO, Columbia Doctors). Columbia Doctors is a multi-specialty physician group of about 1,000 physicians in New York. The company has about 150 practice sites in the Tri-State area of New Jersey, Connecticut, and New York, with its primary base at Columbia University Medical Center. Here's the portion of the Q and A interview that interested me the most:

Q: What should the next generation of EHRs do that the current generation doesn’t?

A: I think that the challenges that we face are specifically in coordination of care. If you imagine trying to infuse an EHR with the principles of Patient-Centered Medical Home and the Accountable Care Organization, it’s going to require workflow solutions that enable communication and coordination. I see elements that have Web 2.0 and 3.0 technologies being major factors in that design....You may have read David Bates’[articles] where he’s talked about trying to improve diagnostic accuracy, improve coordination of care, and try to get the EHRs to move in that direction (see: Using information systems to measure and improve quality). I wholeheartedly support that. I think that’s where a lot of the vendors are already looking....The second thing that I think is going to become more infused into EHRs, and is something that we’re working on here at Columbia, is to enable the representation, the manipulation and physician understanding of personalized medicine concepts — genomic and pharmacogenetic data. I’m not aware of many EHRs that support that as structured data or actionable data that physicians can use to make decisions right in the EHR....[A]s HL7 special interest groups and clinical genomics start to have their standards permeate the health IT space, I think we’re going to start to see ways of collecting and manipulating genetic and pharmacogenetic data in EHRs in ways that we haven’t seen today.

The connection between the EHR/EMR and diagnostic accuracy is a topic of great interest to me. I have previously commented on the topic of the high mortality associated with diagnostic adverse events (DAEs) (see: New Attention Being Directed toward Diagnostic Adverse Events (DAEs)). Here's a passage from that note;

The causes of DAEs [diagnostic adverse events] were mostly human, with the main causes being knowledge-based mistakes and information transfer problems. Prevention strategies should focus on training physicians and on the organization of knowledge and information transfer. We can do little to correct a "knowledge problem" on the part of a clinician who has received timely and correct diagnostic reports from pathology and radiology. However, there is much work to be done in terms of timely reporting from these two diagnostic services and also better integration of the diverse diagnostic reports from them.

As emphasized in this paragraph, the contribution of the major diagnostic services (pathology, clinical labs, and radiology) to diagnostic accuracy, and the reduction of DAEs, will consist of timely and accurate reporting from the LIS, RIS, and PACS to the EMR plus, at some later time, integrated diagnostic reporting. By this latter term, I mean that diagnostic specialists (i.e., pathologists and radiologists) will collaborate on challenging cases and render diagnoses back to clinicians based on a multiplicity of information inputs. These would include imaging studies, molecular diagnostic studies, and the analysis of stained thin tissue sections.

A key question, though, is how are we going to arrive at the Next Gen EMR described by Dr. Stetson that will include "workflow solutions that enable [efficient and effective] communication and coordination." In my mind, this will not be possible without an effective set of computerized rules operating in the background of EMRs that automatically manage the majority of such communication and coordination tasks. For example, if there is any significant change in the status of a patient or new diagnostic information acquired, the key members of the team caring for the patient should be automatically notified. The development and testing of such a comprehensive set of rules for an EMR is a daunting task. Moreover, the tendency when deploying such rules in the past has been to err on the side of distributing more information rather than less for medicolegal reasons. This results in information overload for the recipients and causes nurses and physicians to turn off the alert system or ignore the alerts, making the system meaningless.

More Information about Epic's Beaker LIS and Its Sibling

We are gradually acquiring more information about the status of Epic's LIS, which is called Beaker (see:Introducing the Epic Laboratory Information System (LIS); It's Called Beaker.; An Update on Epic's LIS, Called Beaker, from HIStalk). Now we have a submitted comment from HIStalk that the Sisters of Mercy Health System may be taking the plunge with Beaker in two of their hospitals (see: News 8/6/10). Below is the comment:

From PrettyKitty: “Re: Epic Beaker LIS. After a four-year project rolling out Epic to 10 of their hospitals and replacing existing systems in an effort to standardize, Sisters of Mercy Health System is developing Epic’s Beaker lab application for their next two hospitals to be implemented in the second quarter of 2011. They had been retaining and integrating the previous lab systems — Cerner and Meditech — but have been told that Beaker is ready. They are in the selection process for a Blood Bank system since Epic will not offer that.”

It turns out that Beaker is Epic's "best-of-breed" LIS but it also has an AP-LIS sibling:

Beaker Clinical Laboratory Information System supports inpatient and ambulatory laboratory workflows, combining best-of-breed LIS functionality with the benefits of enterprise-wide integration. With Epic's Web-based OutReach application, external submitters to your reference laboratory can enter orders and receive results online.

Anatomic Pathology Laboratory Beaker for Anatomic Pathology supports the needs of surgical pathology and cytology labs. Barcode enabled workflows help promote safe practices, while dedicated pathologist, cytotech, and histotech worklists help guide cases through the lab. Integration with Beaker Clinical laboratory provides one click access to the patient's history and synoptic reporting allows for efficient data mining.

So we have the BCLIS and APLBAP. Although I think that the name Beaker is a shade too precious for my taste, I think that it's a whole lot better than the name that the Epic name-mavens came up with for the RIS:

Radiant Radiology Information System combines tools for rules-based scheduling, documentation, results communication, chart/film tracking and detailed statistical reporting in a unified system that is fully integrated with our clinical systems. Radiant allows clients to link images and reports with a single system that can be accessed simultaneously by multiple users in multiple departments.

I thought that radiant was a term reserved for Miss America pageants and astrophysicists. Perhaps the alternative name of Radiation Information System was already taken.

An Update on Epic's LIS, Called Beaker, from HIStalk

I raised the topic of Epic's LIS, Beaker, in a recent note (see: Introducing the Epic Laboratory Information System (LIS); It's Called Beaker). Now comes another unverified piece of news about the product from a comment in HIStalk (see: News 8/4/10), I present it in its entirety:

From LISales: “Re: Epic Beaker LIS. Word on the street is that they have one SMALL site using the system within the Wisconsin area, but nothing major yet. I’ve also heard that they are beefing up the development team while including the licensing right to the module within ALL of their enterprise licensing agreements. Also heard is that the functionality is being somewhat oversold compared to actual capability with no desire to develop certain aspects of a full-scale laboratory’s needs, Blood Bank to name but one.” Unverified [by HIStalk].

One word of caution here: this comment was submitted by someone with the nom de plume of LISsales, suggesting perhaps that he or she is involved with sales of a competing LIS product. However, the comment contains at least a grain of truth. It's a common practice for major EMR vendors such as Epic to shrink-wrap an inadequate LIS, or one early in development, with the sought-after EMR in the contract. This is probably even more prevalent these days with many CIOs seeking an enterprise rather than a best-of-breed solution (see: Are You an Enterprise or Best-of-Breed CIO? Access to Cash May Make the Difference.).

This EMR + LIS packaging may be offered for no additional licensing fees as a come-on. The company will then obtain their LIS margin "on the come" with the yearly support fees for the total system. Of course, there is also some padding in the up-front licensing fees. The net result of all of this is that pressure is applied on the lab leadership to join the crowd in the support of the "enterprise solution" from a single vendor. This is fine in theory but the pursuit of such a solution should not penalize the lab personnel who are required to work with a suboptimal LIS.

You may suggest at this point that the position of Epic with their immature Beaker LIS product is no different than any of the current best-of-breed LISs like SCC or Sunquest or Cerner. All of these products at one time or another had a small installed client base and worked with their beta clients to improve their product. Fair enough! In my mind, here's the difference with this Epic scenario. For Epic, their LIS will always be a subservient feeder system for their EMR and never a best-of-breed system. The LIS has always been more than a reporting system for the labs -- it optimizes lab workflows and also provide critical quality control functions. A "good enough" LIS will never suffice and that's why most lab professionals endorse the best-of-breed approach.

Another key point needs to be raised here. I believe that medical diagnostics, composed primarily of in-vitro diagnostics (IVD), pathology, and radiology, has been operating on a different IT development curve than hospital and office EMRs for a number of years. This will eventually result in two separate but inter-connected medical information networks: the clinical EMR and the diagnostic EMR. The reason for this dichotomy is that clinical EMRs (hospital plus physician office systems) will never be able to adequately manage, report, and store the increasingly complex data ( textual, numerical, and image) generated in the diagnostic services. Even the specialized LIS vendors are having trouble satisfying the information processing requirements of molecular diagnostics. Aa another example of this complexity, vendors are having difficult merging RISs and PACS systems. This clinical/diagnostic dichotomy will never be recognized, or even fully understood, by Epic executives.