Lab Soft News

New Features Added to Lab Soft News

A new search engine feature have been added to Lab Soft News courtesy of Type Pad, the company that hosts this blog. It allows readers to search both previous notes on the blog plus the entire blogosphere. You can find it labeled "Sphere blog search" in the right hand column of the home page. Search returns are labeled recently on this blog and recently on other blogs. A Google search option continues to be provided. You can use it to search this blog or the entire web.

Two additional features for readers are still in place and are also located in the right hand column.  You can enter your email address and have all new notes emailed to you, courtesy of Feedblitz. The second feature, provided by Feedburner, allows you to subscribe to this blog using RSS with new content downloaded to a news aggregator. Standard browsers like Internet Explorer 7.0 beta are also offering the capability of using them to enable RSS subscriptions.

The bottom line of all of this activity is that the tool set for blog readers and the blogosphere is becoming more robust as evidence of the rapid maturation of Web 2.0 and focused media (links here, here, and here). In the same way that the web differentiated itself from the Internet and email, the blogosphere is now differentiating itself from the web. While this is happening, the blogosphere itself is being segmented into public blogs and private blogs, dark blogs, which are accessible only by password and ID. Here is a description of dark blogs focusing on project-oriented corporate blogs.

Celera, Personalized Medicine, and Genomic Testing

Celera Genomics announced that it has developed a genetic test it says can help predict which patients with hepatitis C will eventually suffer liver scarring and are thus in most need of treatment. Here is the link to the story which is quoted below (emphasis mine) and here is a link to the Celera home page.

The test, which looks at variations in seven genes, represents another step toward personalized medicine, in which treatments are tailored to patients.....Although there is some disagreement about this, it has been estimated that only 20 percent of the roughly three million Americans chronically infected with the virus will develop cirrhosis, the severe scarring that can lead to liver failure or liver cancer. But it has not been possible to predict which patients are at greatest risk. Celera's new test is meant to gauge an individual patient's odds....Kathy P. Ordonez, the president of Celera, said the company hoped to license the test to a laboratory that could offer it as early as the end of this year. Tests performed by a single laboratory do not require approval from the Food and Drug Administration. Ms. Ordonez said pricing would be up to the laboratory, but she expected it to cost $1,000 or a bit less....Treatment of hepatitis C now involves weekly injections of alpha interferon for periods of a few months to more than a year. The therapy, which also includes the pill ribavirin, can cost more than $30,000 a year. Yet many people can live with the virus for decades without needing treatment. Celera...developed its test by scanning the DNA of about 1,000 people who had hepatitis C for 10 years or more, long enough that many would have developed cirrhosis. The company looked at 25,000 genetic variations in each patient and found seven that could best be used to calculate a risk of developing cirrhosis.

This item is interesting on multiple counts:

• "Celera Genomics researchers were among the first to show the feasibility of the whole genome shotgun strategy for sequencing large eukaryotic genomes. Celera sequenced the human genome at a fraction of the cost of the public project (approximately $3 billion of taxpayer dollars versus about $300 million of private funding); however, its effort was tarnished when they published their results in 2001, because they combined their data with the public data, making it impossible to tell how much of the human genome had been independently sequenced by Celera." Link for more background information about Celera here.
• If successful, this test to determine a priori which patients among all those chronically infected with hepatitis C will go on to develop liver scarring and therefore require treatment with alpha interferon and ribavirin will truly usher in the era of personalized medicine by selecting for treatment only those patients actually requiring it.
• Although expensive, the cost of this test will gladly be underwritten by insurance companies because of the cost avoidance by the majority of potential recipients who need not receive the expensive therapy with all of its side effects.
• The story also illustrates the new approach to identify diagnostic biomarkers using genomic testing. The company started with a cohort of patients with chronic hepatitis C and identified seven genetic marker variants shared by those patients who had developed chronic scarring.  The researchers may not actually know the role that the proteins being coded for by these markers play in the predisposition to scarring -- only that the biomarkers can predict this serious outcome of the disease.
• Note the reference to the fact that tests performed by a single laboratory do not require approval from the Food and Drug Administration.

Walgreens to Open In-Store Health Clinics

Walgreens will open its first in-store health clinics nationwide this summer in St. Louis and Kansas City. Here is the link to the story and below are excerpts from it.

The clinics are believed to be among the first of their kind in the St. Louis area, and part of a trend by pharmacy chains...to move beyond their core prescription drug business. Patients will be able to receive health screenings, vaccinations and care for common ailments from nurse practitioners - all without an appointment....The clinics will be operated by Take Care Health Systems of Conshohocken, Pa., which runs nine similar clinics at Osco Drug Stores in the Kansas City area.

Here is a link to the home page of Take Care Health Systems. You may want to refer to my recent note here about Wal-Mart opening its own in-store health clinics. Here is more information about Take Care's business model from this link.

Take Care already operates in-store clinics at seven Rite Aid drugstores in Oregon and nine Osco stores in Kansas City. Take Care expects to close its Osco locations this summer and move its personnel to the Kansas City Walgreens locations...Take Care rents space at market rates from Walgreen and receives no compensation from its host for writing prescriptions.... Its revenue comes from insurance reimbursements or patient payments, which for the uninsured average $50....

This raises some very interesting issues relating to the potential for adding blood-drawing services in these clinics for local reference labs or hospital labs. Large reference labs such as Quest already have numerous patient services centers in place but hospital labs generally have not developed many of them, if any.

Update on 4/30/2006 @ 6:16 p.m.

Take Care is also deploying new IT to increase the efficiency of its operations (link here):

In one of the more-novel uses of technology employed by Take Care, a computer software program will be involved in actually diagnosing illnesses. The patient's sign-in information will be transmitted electronically to a computer terminal inside the treatment room, where the nurse can enter additional information about the patient's symptoms and conditions as he or she talks with the patient.

The software system will eventually generate a diagnosis and a recommended course of treatment. If the nurse practitioner disagrees with a computer-generated diagnosis, he or she can opt to override the system. When a prescription is written, it will be transmitted electronically to the store pharmacy, or another pharmacy. The system will also create an electronic medical record for each patient that can be transferred to a primary-care physician.

Safe Harbor for Extension of Hospital IT to Affiliated Physicians

Outgoing HHS healthcare IT coordinator David Brailer said that the Stark and anti-kickback safe harbors aimed at enabling hospitals to subsidize the extension of IT to their affiliated physicians are nearing completion, but might not be released before he leaves office next month. Here is the link to the article and below are some relevant quotes from the article.

HHS had prepared draft regulations for Stark safe harbors while the Justice Department had issued an advisory opinion on its direction regarding anti-kickback measures, but the Stark proposals had generated considerable controversy regarding their complexity and other issues....The goal, he said, is to have rules that cleanly state what a facility can and cannot do to supply or subsidize healthcare IT.

For those who don't have an understanding of the Stark rules, here is a brief description:

...the Stark rules prohibit a physician from referring Medicare patients for a “designated health service” to any entity where the physician or an immediate family member of the physician has a financial relationship, unless an exception applies. Designated health services include: clinical laboratory services... The law also prohibits an entity from billing for services provided as a result of a prohibited referral.

So the Stark rules prohibit a physician from sending lab work from his office to a reference lab in which is has a financial interest.  Anti-kickback rules prohibit the reference lab from supplying a physician office with, say, a PC and software unless that PC is only used to order lab tests from that the laboratory in which case the PC and software would be considered a tool provided only to facilitate lab transactions. Clearly, Stark and anti-kickback rules have had a chilling effect by inhibiting hospitals, and the labs embedded in these hospitals, from providing IT services to physician offices that would facilitate physician interactions with the hospital system such as admitting patients to the hospital, scheduling outpatient services, and order and reporting lab tests.

It will be very interesting to review the new rules when they are published, particularly with an eye toward any potential advantages they may provides to hospital labs. Obviously, whatever shape they will take will generate some controversy. Stay tuned.

Siemens Buys Diagnostic Products Corporation

Siemens entered into a definitive agreement to acquire Diagnostic Products Corp. today for approximately US$1.7 billion in cash. Here is the link to the story. Here is another link about the transaction and below are quotes from it:

Siemens AG, Europe's largest engineering company, agreed to buy Diagnostic Products Corp. for about $1.86 billion in cash to bolster its medical division, the manufacturer's most profitable unit....Siemens, General Electric Co. and Royal Philips Electronics NV are acquiring companies in the medical-equipment field as aging populations spur sales of devices diagnosing and treating conditions such as cardiac arrests and cancer.

Here is a brief summary of DPC from this source:

Diagnostic Products Corporation (DPC) develops, manufactures and markets immunodiagnostic systems and immunochemistry kits used throughout the world in hospital, reference and physicians' office laboratories, as well as in veterinary, forensic and research facilities. The test kits utilize technology derived from immunology and molecular biology to obtain precise, rapid identification and measurement of medically significant chemical substances that are often present at infinitesimal concentrations....The main clinical applications of DPC's immunoassays (test kits) relate to the diagnosis and management of thyroid, reproductive and cardiac disorders; allergies, infectious diseases, anemia, diabetes and certain types of cancer; bone metabolism disorders, and therapeutic drug administration.

This is Siemens' first foray into in-vitro diagnostics and complements its current strengths in medical imaging and healthcare information technology.

Web 2.0, Vertical Search, and Blogs

I have written previously about Web 2.0 (you can read the notes here and here), which is a term that encompasses the current state of the websphere. This second note also raised the issue of focused media in relation to Web 2.0 including podcasts and blogs as a means for providing content at a very low cost to a very specialized audience. In the same way that cable television enabled specialized TV channels, focused media provides a web-enabled means to communicate with very small audiences and the ability to build communities around specialized interest areas. There is no better example than Lab Soft News. Only a very small number of people have a special interest in clinical laboratory informatics.

Although it may not be immediately obvious, business intelligence blogs (previously discussed here and here) such as this one are an essential component of Web 2.0 and have a close relationship to vertical search. Vertical searching refers to the process of launching a more refined search with fewer irrelevant hits than general searches such as those offered by Google. There is even a search engine called Vertical Search, accessible here, that allows you to pick a specific industry category before launching your search. Here is a sample of some of the categories that you can choose when using the Vertical Search engine:

Advertising & Marketing
Agriculture & Farming
Architecture
Automotive
Aviation & Aerospace
Banking
Boating & Maritime
Building & Construction
Chemicals & Chemical Processing
Computers

By the way, I don't want to disparage the value of the general searches such as those performed by Google. Based on this idea, the company has achieved a market cap of $127B in the eight years since its incorporation. One might say that Google whetted our appetites for efficient web searching and, in do doing, paved the way for new and potentially more focused approaches to web searching. And, of course, the well known search companies are not standing still. Google has created a financial search engine called Google Finance and Yahoo just developed a travel search engine called FareChase.

So what is the connection between business intelligences blogs and vertical search? The business intelligence blogger functions as an aggregator and filter for his blog visitors, creating notes in a specialized content area that highlight current news and add value to the news by analyzing and interpreting it. In this way, it allows the readers to stay current in a field. It's a form of vertical search. In effect, the blogger acts as a trusted intermediary between the breaking news and those working in a field. This notion of trust in relation to a blog on the part of its readers is interesting.  Returning readers of a blog are investing a precious commodity in that blog -- their time and attention. In a very real sense, they are paying with their time and attention for what is usually described as a free resource.

Healthcare IT and Biomedical Engineering Merging

I ran across an interesting article describing the changing relationship between healthcare IT and hospital bioengineering departments. I must confess that in my 24 years as director of an LIS, I have had no interactions with biomedical engineering in my hospital, so the article caught my attention. Here is a link to the article and below are some quotes from it:

The sometimes-contentious relationship between IT and Biomedical Engineering is quickly becoming a cliché. These two groups are quite different, and market forces are conspiring to throw them together with greater frequency. In an effort to make this relationship work, some hospitals are changing biomed's reporting structure and placing them under IT....Biomeds work with clinicians. Especially in hard-core patient care areas like critical care and surgery, this principal relationship gives biomeds their 24/7 responsiveness and focus on patient safety....External factors are conspiring to push IT and biomeds together. As technology advances, and computing power becomes commoditized, medical devices have taken on many information system characteristics....Most medical devices are shifting away from private networks as wireless medical devices adopt 802.11a/b/g for wireless connectivity, causing many IT shops to get more involved in medical device systems.... Decisions surrounding data integration between medical devices and EMRs can create conflict between IT and biomeds (and bad decisions), when both parties' interests are not considered.

There is no question in my mind that biomedical engineering and hospital IT have much in common but I question the wisdom of having "biomed" reporting to the CIO of a healthcare system. Although this could potentially result in closer coordination and integration of projects, my concern is that it would force CIOs to become even more oriented toward hardware, with its engineering focus, than they are today.

I don't want to minimize the importance of hardware, but, for me, the most challenging and exasperating aspect of lab computing is software and the functionality that it provides. Hardware tends to be concrete, definable, and stable. Software is often messy and unpredictable and error-prone but it's also the "secret sauce" for increasing lab efficiency and productivity. It can't be treated as a commodity in the same way as network, server, and PC hardware. There are very good reasons why the FDA is moving very cautiously in terms of regulation of healthcare IT software. They understand that they can't get their arms around it and therefore cannot regulate it, with the exception of blood bank software. And there are those who feel that the regulation of the latter has seriously set back its development.

Clinical Order Sets Evolve as Separate Healthcare Product

Geisinger Health System is looking to cash in on its expertise with clinical order sets by selling them for use in CPOE systems and as a basis for hospitals to develop their own evidence-based care programs. This initiative is in partnership with with Thomson Micromedex. Here is the link to the article and below are some details about the initiative:

The order sets include both consensus protocols for testing prior to a final diagnosis and for post-diagnostic treatment ....Geisinger will provide hundreds of "real-world tested" diagnostic actions and treatment plans developed over the past five years by the staff of two of its three inpatient facilities ...The new offering is designed to give hospitals a place to start for electronic order sets. A startup order set should be viewed as "a platform for a user to customize over time" ...The new product will include a tool to allow for local customization and developing links to other decision-support modules for drugs and drug formularies, laboratories, diseases and patient education.

In a similar vein, Vanderbilt Medical Center will deploy Zynx Health's Executable Knowledge Manager (EKM). Here is the link to the article and below is some details.

EKM is an advanced internet-based tool for developing and maintaining evidence-based order sets, rules, and alerts for use in clinical decision support....Vanderbilt Medical Center will use EKM to help its clinical order set development teams review relevant evidence as the teams decide on appropriate elements to include in each order set. The development teams will also use EKM to alert order set authors to new evidence that might require updating of existing order sets.

I find it both interesting and probably inevitable that "clinical order sets" have evolved as a product that is separate and distinct from EMR software. I must confess to a high level of suspicion as to whether this new category of specialized healthcare software will succeed in the marketplace. Listed below are a few of my reservations about this trend:

• I would look to the EMR vendors to provide a clinical-order-set authoring environment and the absence of such a robust tool in the software suites suggests that the purchaser of these systems are not getting full value for their purchase.
• It is possible that the Geisinger order sets would have an advantage in the market by being real-world tested but such an advantage would be short-lived because the starting rule sets would only be the basis for subsequent customization by hospital personnel to represent local physician practice.
• One of the marketing claims for the Zynx Health's EKM is to "alert order set authors" to new evidence that might require updating of existing order sets, so there appears to be a continuing service that sits behind the software product that may be of value.

For me, the conundrum that conundrum that hangs over clinical-order-sets as a component of CPOE is the following: Only minor efficiency gains are achieved if the order sets simply automate and replicate hospital physicians' current ordering practices. In order to gain the greatest cost-savings and quality gains, any new optimized new order sets need to be made mandatory and imposed on the hospital physicians by fiat. This can work [sometimes] in teaching hospitals where the house officers are young and more pliant but such a goal is more difficult to achieve when the medical staff consists of older physicians with staff privileges at the hospital.

:: Update on 4/25/2006 @ 12:02 p.m.

I was not aware until now that Cerner has acquired Zynx Health in 2002. Here is a link to the accouncement.

Laboratory Economics Newsletter Launched

Jondavid Klipp, formerly of Laboratory Industry Report, has launched a new laboratory newsletter called Laboratory Economics. Here is a link to display a PDF file of the inaugural issue. The subtitle of the publication is: competitive market analysis for laboratory management decision makers. It's well worth a look. There's a subscription form on the last page of the document.

Walmart Offers to Fix Healthcare System

In what I consider to be a brilliant strategic move, Wal-Mart is turning the tables on its critics and offering to help the U.S. healthcare system become more efficient. Here is the link to the story and below are some relevant quotes from it:

Wal-Mart Stores Inc., at the center of debate over corporate responsibility for health care, said on Tuesday that it wants to use its cost-cutting expertise to help make the U.S. health care system more efficient. Wal-Mart, the world's biggest retailer, has become a lightning rod for labor unions, environmentalists, anti-sprawl groups and others ...The Bentonville, Arkansas-based retailer, the largest U.S. private sector employer, has been taking steps to change such negative perceptions, including adding a lower-priced health care plan for employees, but so far the efforts have done little to quiet critics...The retailer said the key is to figure out what is driving up health care costs -- just as Wal-Mart does with its vaunted supply chain network -- and then wring inefficiencies out of the system...Wal-Mart also said that lessons could be learned from health clinics it is opening in dozens of stores around the country, many of which serve uninsured patients who would otherwise go to the emergency room -- a major drain on health care resources.

There is no question in my mind that Wal-Mart will be able to succeed in driving down costs in the health clinics that it operates by standardization, economies of scale, and holding down labor costs. I also think that it's a brilliant strategic move, in countering the pressure from politicians and labor unions regarding health insurance for their employees, to counter by saying that the problem lies with the system and not with the company. I also believe that the healthcare system in the U.S. needs reform and Wal-Mart may well have the economic and political clout to change the status quo, at least in the ambulatory care sector. I also believe that part of the attraction U.S. healthcare delivery system for the more affluent healthcare consumers is its flexibility and ability to individually customize services. In other words, many consumers like the healthcare system because it's not Wal-Mart.

This is not to say that affluent shoppers do not frequent Sam's Club and Costco -- they like bargains as much as anyone else. There is ample evidence that our healthcare system delivers at least two tiers of service. The lower tier, both for now and also in the future, will be highly standardized, automated, and relatively inexpensive (the Wal-Mart tier). Consumers of all stripes will buy their "mass produced" services at this level. The higher tier, more customized and available for an insurance payment plus out-of-pocket co-pay, will be available for those who desire the added perceived benefits of this level and are able to pay for it. So one will go to the local Wal-Mart clinic for a flu shot, the equivalent of an inexpensive DVD player, and will go to an academic center for a hip replacement.