Lab Soft News

Rural Hospitals Fighting for Survival; How Can Care in Them Be Improved?

Many hospitals are now in severe financial difficulty, particularly smaller ones (see: Some Hospitals Experiencing Financial Distress and Even Bankruptcy). A recent blog note by Robert Pearl posted on the KevinMD blog discussed the financial challenges being experienced by small hospitals and one way to provide higher quality care to patients admitted to small, rural hospitals (see: Why rural hospitals are fighting a losing battle). Below is an excerpt from it:

Over the past five years, more than 40 rural facilities have closed their doors due to lack of funding. And because the majority of their funds come fromMedicare and Medicaid...,many rural hospitals may be fighting a losing battle. Understandably, small-town residents fear hospital closures or downsizing may leave them vulnerable when serious illness strikes. But the reality is patients in rural communities often don’t receive optimal care from their local hospitals. In fact, critical access hospitals in rural areas experienced increased death rates from 2002 to 2010 while mortality rates fell in other hospitals.....Fundamental to [the] Hill-Burton [Act] was the belief that residents of rural and low-population areas were best served by local community hospitals, no matter how small....[A]dvancements in medical practice further exploit the differences between America’s leading hospitals and the kind of care available to many of the 60 million people living in rural areas. The truth is many hospitals serving low-population areas don’t have the patient volume or specialists to manage the breadth of complex medical conditions they encounter today....What if rural facilities were used for the kind of routine care and simple procedures that generalist physicians and nurses can safely provide while designating regional hospitals for more complex, specialty care? With today’s video technology, a remote specialist can immediately evaluate a patient and initiate care prior to transport, minimizing delays in treatment. After preliminary testing and stabilization, patients could be safely transported to an operating room in a regional hospital for treatment mere minutes after arrival....But overall, more patients will die in sub-optimal hospitals than during transport to state-of-the-art facilities with the best doctors and nurses.If our goal is to save more lives, we as a country should invest in 21st century technology, communication, and transportation....

Small hospitals are not going to disappear because they are the major employers in many smaller towns. Perhaps Congress will come up with some new subsidy programs to offset the decreased reimbursement from Medicare and Medicaid. However, I am generally in agreement with the arguments made by Pearl. For patients with complex problems, it stands to reason that the care delivered in small rural hospitals will often not be equivalent to that delivered in regional referral centers with medical specialists on their staffs. The question here then reduces to what is the best way to ameliorate this problem without undercutting the mission of the smaller hospitals. I agree with the above statement by Pearl: After preliminary testing and stabilization, patients could be safely transported to an operating room in a regional hospital for treatment mere minutes after arrival. I also agree with the idea of creating telemedicine links between smaller hospitals and regional centers to assist the admitting physicians, when necessary, in the initial diagnosis of patients and their stabilization. Perhaps federal programs are necessary to deploy the necessary technology for telemedicine in small hospitals and put financial incentives in place to so that the regional centers are willing to participate eagerly in such relationships. However, It's not clear to me how the healthcare scenario outlined by Pearl will protect the small rural hospitals from impending bankruptcy.

Post Sandy, NYC Subway Station May Be a New Home for Marine Bacteria

Some very interesting studies are now staring to emerge using DNA analysis to study the presence and distribution of bacteria in cities like New York. One such study revealed the presence of marine bacteria in a NYC subway station, probably as a result of previous flooding due to superstorm Sandy (see: Post-Sandy NYC Subway Brims with Unknown Microbes). Below is an excerpt from the article:

Researchers identified nearly 1,700 species of bacteria, viruses and eukaryotes to create a “metagenomic” map of the city. One cluster of points on this grid offered a reminder of exactly how inundated and overwhelmed the city was more than two years ago when Superstorm Sandy hit. Nearly half of the mapped DNA came from as-yet undocumented organisms, highlighting how much remains unknown to science about the microbial world around us. The results are detailed in ,,,[a recent study]. ....The most commonly identified DNA in the sample came from bacteria. And although strains of the causative agents of anthrax and bubonic plague surfaced, the vast majority of species identified were harmless....[The author of the study] says these dangerous DNA snippets occurred only at trace levels, so they could have been fragments that other bacteria picked up through horizontal gene transfer or even have come from dead organisms. Most of the bacteria identified are types that placidly thrive on our skin and are of no concern ....But researchers found one of the [subway] stations was not like the others. The South Ferry station in Lower Manhattan had the most unique profile of bacteria in the system, and still resembled a marine environment. When the storm surge from Hurricane Sandy hit the city in 2012, the station filled with about 57 million liters of water that rose to 25 meters deep....The researchers isolated 10 bacterial species that were only found at South Ferry. Among these were Shewanella frigidimarina, which has been found in the North Sea, and Flavobacterium, which can harm certain species of fish. The unique bacteria are usually found in cold, marine environments, so the researchers wondered if Sandy's storm water dragged them in. 

Here's another quote that makes reference to this same microbiology DNA study (see: Big Data and Bacteria: Mapping the New York Subway’s DNA):

The big-data project, the first genetic profile of a metropolitan transit system, is in many ways “a mirror of the people themselves who ride the subway,” said Dr. Mason, a geneticist at the Weill Cornell Medical College. It is also a revealing glimpse into the future of public health. Across the country, researchers are combining microbiology, genomics and population genetics on a massive scale to identify the micro-organisms in the buildings and confined spaces of entire cities.

For me, an interesting aspects of this study is the suggestion that marine organisms might be able to thrive in a "dry" NYC subway station unless the DNA detected is merely residual from dead organisms or related to horizontal gene transfer to other bacteria. If, in fact, these marine bacteria are growing in the South Ferry subway station, one wonders if there are any possible adverse health consequences. However, I suppose that most New Yorkers would consider bacterial growth as one of the lesser threats encountered in subway stations.

If There is a Reliable Test for Alzheimer's, Would You Want to Know the Results?

I have blogged previously about tests and imaging procedures relating to the diagnosis of Alzheimer's disease (see: Early Detection of Alzheimer's Disease: Mutations of Three Genes Studied; Using Altered Metabolic Pathways to Diagnose Alzheimers Disease; Alzheimer's Amyloid Tangle Theory Will Be Tested with Merck Drug Trial). I don't think that any test or imaging procedure to date has proven to be foolproof. However, a recent article raised the important question of whether one would want to even know the result if such a test were available (see: New Test Claims It Can Tell If You Will Develop Alzheimer's... But Do You Want To Know?). Below is an excerpt from the article:

The dichotomy of those who want to know and those who do not is separated by a deep chasm in beliefs, and could forever alter the way individuals, families and wealth managers prepare for disease, as well as how insurers and care providers pay for and provide care. While genetic tests are presently able to determine about 4,000 diseases and disorders, the breakthrough of predicting Alzheimer’s disease could vastly change the behaviors and costs to society, actually bending the cost curve health experts so often talk about as necessary for economic stability....In January, Amarantus reported positive top-line results of its LymPro Test...for Alzheimer’s disease. The Company also entered into an exclusive option agreement with Georgetown University (GU) to commercialize sets of blood-based biomarkers for Alzheimer’s disease....But how will individuals react? How about the care provider and insurance markets? When there is presently no cure, it is expected that individuals and families will be torn on the decision to test.  In contrast, it seems inevitable that employers, health officials and insurers will want to know the future demands, needs and composition of their populations....While LymPro is not ready for the shelves of CVS or Walgreen ’s, it may not be long before in clinic and in home testing is available to consumers. Without a cure or highly effective symptomatic treatments to go hand-in-hand with the blood test, the risk and reward of such a test will certainly take a toll on individuals, families, health care markets and communities.

Here's a brief summary of the LymPro test mentioned in this excerpt copied from the Amarantus web page:

The Lymphocyte Proliferation Test (LymPro Test) is a diagnostic blood test that measures the ability of peripheral blood lymphocytes to withstand an external stimulation inducing them to enter the cell cycle. It is hypothesized that certain diseases are the result of a compromised cellular machinery that leads to abhorrent cell cycle re-entry by neurons.The inventive step for LymPro that makes a unique asset involves using peripheral blood lymphocytes (PBLs) as a surrogate for neuronal cell function, suggesting a common immune-based relationship between PBLs and neurons in the brain.

There is no single answer as to whether one would want to know if he or she was destined to develop Alzheimer's disease with no effective treatment for the condition. Some individuals with a strong predisposition to planning might benefit from such information, particularly if the test would offer some time prediction for the onset of the disease. On the other hand, such bad news could destroy another person psychologically. What is clear, however, is that the precise identification of those who have, or will develop the disease, is a requirement for the development of clinical trials for drugs that ameliorate or cure the disease. In fact, the availability of such clinical trials could provide an incentive for individuals to seek the test because only those who test positively would be admitted as a subject to them.

23andMe Customers: Suckers or Empowered Consumers?

I have posted a number of previous notes about 23andMe, a company that offers consumer-oriented genomic testing on the web (see, for example: 23andMe Database Sheds Light on Genetic Aspects of Racial Mixing; 23andMe Requests FDA Clearance for DNA Saliva Testing; Pfizer and 23andMe Collaborate to Study Inflammatory Bowel Disease). There has been substantial criticism of the company revolving around questions about the quality of the testing, whether the company was acting inappropriately by providing medical advice to customers, and whether it was acting unethically by selling the genetic information obtained from its customers specimens. A recent Forbes article summarized these questions about 23andMe and posed the salient question of whether its customers were suckers or empowered consumers (see: Are 23andMe Customers Suckers Or Empowered Consumers?). Below is an excerpt from the article:

The mock shock we’re seeing is based on the assumption that 23andMe customers have been hoodwinked into contributing their data to these partnerships....But is that really the case? I’m a 23andMe customer and have received regular communications from the company detailing how to opt into or out of research. There’s another way to look at this: that customers know what they’re doing and see this as a way to make a difference. Most of us know that drug company pipelines are weak, and that it costs far too much to develop new therapeutics. It’s in everyone’s interest to find faster, cheaper ways to develop more effective drugs. If access to data at 23andMe helps accomplish that, we all win. Sure, there are different models to consider. For example, I’d like to see an approach that financially rewards people who contribute their data to research that leads to a viable new drug. The fact that Pfizer signed on for a second deal could be a validation of the idea that mining massive amounts of aggregated data can lead to better drug candidates. One of the most expensive elements in developing a new medication is the clinical trial process. It costs a fortune to locate the right people, convince them to participate, account for all those who stop partway through, and of course monitor drug reactions throughout. There’s also the physical toll for all the participants who discover first-hand the side effects of a new drug. 23andMe can’t solve the clinical trial problem, but its data may help drug companies better target their trials toward patients whose genetics make them more likely to do well on a drug, or less likely to suffer adverse reactions. That kind of targeting could save money, put fewer people at risk, get drugs to market faster, and ensure new medications are given to people most likely to benefit from them.

I agree with the author of this article. In my opinion, the company has been transparent about what it was doing with the genomic data derived from submitted cell samples. I personally have obtained important genetic information about myself from the test that I probably would not have otherwise been aware of. I am sure that other companies will copy the 23andMe business model and sell genetic information to drug companies to facilitate drug research and clinical trials. The biggest mistake that the company has made thus far, in my opinion, is underestimating the the power of the FDA. I do suspect that some of the criticism of 23andMe comes from physicians and scientists who are not comfortable with the idea of consumers ordering lab tests, particularly genetic testing for themselves. I don't agree with this viewpoint.

There is a growing movement among consumers of taking more ownership of their own health and healthcare. An important facet of this movement will be to enable them to order lab tests by and for themselves, including molecular and genomic testing. In short and with reference to the headline of the Forbes article, I think that such testing opportunities will lead to more empowered healthcare consumers. The article also broadly endorses the sale of genome data to foster research as long as the consumers submitting their personal specimens are made aware of the sale of such anonymized data.

CMS Appproves CT Scans for Lung Cancer Screening for High Risk Medicare Patients

After a prolonged and contentious debate, CMS has approved CT scans for lung cancer screening for high risk medicare patients (see: Medicare approves lung cancer screening coverage). Here is the link to the decision summary from CMS and below is an excerpt from an article on this topic:

The Centers for Medicare and Medicaid Services have finalized coverage guidelines for lung cancer screening with CT scans for people at high-risk of developing lung cancer. Coverage goes into effect immediately.....The CMS decision stems from the National Lung Screening Trial, a large-scale clinical trial funded by the National Cancer Institute. It found that among 53,000 heavy smokers at high risk of lung cancer, CT screening demonstrated a 20 percent reduction in lung cancer deaths. CMS, which provides health care benefits to those 65 and older through Medicare, will cover annual lung screenings for people age 55-77 who have smoked at least 30 pack years and are either current smokers or quit within the last 15 years. Patients will need a written order from their doctor for screening and must undergo counseling that emphasizes smoking cessation. The decision includes requirements for qualifying radiologists and screening facilities to ensure quality and safety. It also creates a lung screening registry.

I think that this debate has resulted in the right decision that may even save the government some money by detecting early cases of lung cancer amenable to treatment. It makes sense that the CT lung screening was restricted to only high-risk older patients. Although the smoking rate is declining precipitously among younger people (see: Trends in Current Cigarette Smoking Among High School Students and Adults, United States, 1965–2011), it will take decades for the carcinogenic effects of tobacco to "wash out" of the general population. Screening of populations with CT scans was debated fiercely because of the cost of the procedure and uncertainty about its effectiveness. Some of these same arguments have arisen in relationship to molecular and genomic screening but this will get sorted out in time.

Hospital to Allow Patients to Annotate Their Personal Health Records

I first reported on the OpenNotes project in 2010 in a note discussing whether patients should be allowed to review their own hospital records (see: Should Patients Be "Allowed" to Read Their Medical Records?). It's rather silly that this question even needs to be raised given that HIPAA specifically gave patients the right to do so and even amend their own records. A later note stressed the importance of transparency of medical records in terms of promoting patient engagement (see: The Quest for Fully Transparent Medical Records and Greater Patient Engagement). A recent news article describes yet another step in patient engagement with OpenNotes with the opportunity for patients to  annotate their personal health records (see: Hospital to let patients add to own EHRs). Below is an excerpt from the article:

Beth Israel Deaconess Medical Center is launching a pilot that gives patients unprecedented input to their electronic health records. Thanks to a $450,000 grant from The Commonwealth Fund, BIDMC will be one of the health systems to introduce OurNotes, the latest step in the evolution of the OpenNotes movement, which gives patients easy, online access to their doctors' jottings. This new engagement initiative will enable patients to write directly into their own EHRs.....The Commonwealth Fund grant will support work at five sites: original OpenNotes study partners BIDMC, Pennsylvania's Geisinger Health System and Seattle's Harborview Medical Center, in addition to more recent members Group Health Cooperative, also in Seattle, and Mosaic Life Care in St. Joseph, Mo.....At BIDMC, a multi-center team will work clinicians, patients and others on a user-centered design process, focusing initially on primary care."During this phase we'll be asking clinicians questions about what kinds of information they think would be helpful to receive from patients," said [a hospital spokesperson]. "Likewise, we'll be talking to patients to find out what kinds of information they would like to contribute to their records and their notes." Findings from that phase will be used to develop prototypes at each site and to conduct pilot testing that will pave the way toward formal clinical trials.

I have long been an advocate of direct access testing (DAT) whereby patients can order laboratory tests for themselves and family members on the web. The out-of-pocket cost of such tests is relatively low and often makes sense if one has a policy with a high deductible and high co-payments. However, the usual scenario in relation to DAT is for the customer to receive his or her results on-line or sometimes also in the form of a downloadable PDF file. It would be highly desirable to be able to upload such a file to a patient's personal health record including the name of the performing lab. This would provide a low-cost testing option to consumers with the results accessible in his or her electronic medical record for review by healthcare providers.

Clinical Trial Data Goes Missing; How Best to Resolve This Problem?

The U.S. government has created a web site, ClinicalTrials.gov, that is designed to be a registry and results database of all publicly and privately supported clinical studies of human participants around the world. It currently lists 183,742 studies with locations in all 50 states and in 187 countries. It's obviously an extremely useful asset for patients, researchers, and study record managers. However, a problem with the web site has been recognized that was highlighted in a recent article (see: What Happens When Results Data From Clinical Trials Goes Missing?). Below is an excerpt from it:

Over the past few years, several studies have indicated that drug makers and academic researchers fail to report results of clinical trials to a U.S. government website. Only about 15,000 of the approximately 178,000 registered trials in the U.S.’s main database, ClinicalTrials.gov, currently include summaries of results....That works out to a paltry 8%. It is a cause for concern since the lack of results means that potentially important information about medicines is unknown. The issue has been especially contentious for the pharmaceutical industry, which has endured scandals following disclosures that trial data containing safety or effectiveness information wasn’t previously disclosed.....There is “a disappointing track record on disseminating clinical trial results,” NIH director Francis Collins said last month. “It’s simply not acceptable…and it doesn’t live up to our arrangement with trial participants.” To remedy the problem, the U.S. Department of Health and Human Services recently proposed new rules that should clarify requirements for researchers to post findings on the government site. The move, which federal officials say will increase transparency, was largely praised. But one lingering criticism remains. Although NIH and Food and Drug Administration officials say the proposed rules are designed to make it easier to crack down on violations, the agencies already possess the authority to penalize miscreants. The NIH, for instance, can withhold grant money, while the FDA can levy a $10,000-a-day civil penalty for trials that aren't registered or results that aren't reported.Yet both the NIH and FDA acknowledge they have never gone to the mat. As a result, questions are being raised about the extent to which the new initiative will be taken seriously. 

Note that ClinicalTrials.gov was designed to be a registry and database of both publicly and privately supported clinical studies. Although not mentioned in the excerpt above, one of the drivers for the creation of this web site was the fact that some pharmaceutical companies would fund clinical trials and then withhold the publication of unfavorable results about their drugs (see: Unfavourable results from medical trials are being withheld, MPs warn). Such cherry-picking of trial results is extremely harmful but may be one reason why some test results are being withheld from some of the registered clinical trials. All of this suggests that the FDA and the NIH needs to pay more attention to unregistered studies and also studies with unreported results in CliicalTrials.gov. As noted above, the NIH and the FDA already have the authority to penalize companies and organizations that are now complying with the rules pertaining to the web site.

Coordinated Diagnostics Defined in a New White Paper from Atlas Medical

Worthy of your attention is a new white paper from Atlas Medical. Click on the image of the document on the right of the Atlas web page to download a copy. The basic theme of this report is that the coordinated care model of healthcare is gaining wide acceptance and that we should apply this same logic to the coordination of diagnostics across multiple encounters. This is to say that lab testing often goes unmanaged from both a clinical and cost perspective, particularly when testing is performed in multiple sites. Here's a cut-and-paste of a paragraph about the continuity of diagnostic information from the white paper that resonated most with me (page 8):

....The importance of Continuity of Information in the diagnostics practice is not to be underestimated. Historically, laboratories and other diagnostics organizations have treated each encounter with a patient (each order request and its related results) as an isolated transaction. Even though most physician EMRs associate numerous encounters for any given patient, the lab or hospital receives orders from multiple physician EMRs, in addition to other individual outreach, outpatient and inpatient encounters. Healthcare organizations need to take a patient-centric approach to gathering and accessing all of this data to ensure better clinical efficacy and enable better coordinated care. For example, many patients (particularly patients with chronic diseases under active management) have multiple tests performed over time, and when the information about these encounters is combined into a consolidated record, potentially valuable insights about that patient’s history and care emerge.

All of this leads to the point that we need greater EHR interoperability in order to achieve coordinated diagnostics (see, for example: What Will Motivate Hospital CEOs to Seek HIT Interoperability?; Epic Retains Lobbying Firm to Improve Its Interoperability Image on Capital Hill; Revisiting EHR Interoperability; Standardized Content and Vendor Strategy; ONC calls for interoperability by 2017). My recollection regarding lab testing many years ago is that tests were often repeated for patients admitted to the hospital based on the following assumptions: (1) past results were not available electronically; (2) many test results are highly dynamic so some past results were probably not relevant to current disease; and (3) some of the prior tests may have been performed in unreliable labs. Such an approach is probably unnecessary in most cases today. Note that the excerpt above from Atlas appropriately singles out patients with chronic diseases for whom historic results can be very informative.

There is a close relationship between Atlas Medical's call for coordinated diagnostics and my previous notes about integrated diagnostics (see: Revisiting Integrated Diagnostics and the Integrated Diagnostic Report; INTEGRATED DIAGNOSTICS & INTEGRATED DIAGNOSTIC SERVERS: THE PERSPECTIVE OF A PATHOLOGIST; Why the Culture of Pathology/Radiology Can Militate Against Integrated Diagnostics). The former is defined as correlation of lab information across encounters and the latter is defined as correlation of all diagnostic results (lab + surgical pathology + radiology), both within encounters and across encounters.

Sunquest Purchases Data Innovations; Implications for other LIS Vendors?

Sunquest has just announced its purchase of Data Innovations (see: SUNQUEST INFORMATION SYSTEMS ANNOUNCES ROPER INDUSTRIES’ ACQUISITION OF DATA INNOVATIONS FROM BATTERY VENTURES). 

Here's a quote from the press release:

With more than 4,500 customers in 83 countries, Data Innovations’ partners and customers span the healthcare continuum, providing leading middleware solutions to the diagnostic laboratory market. As part of Sunquest’s strategy to provide integrated pathology solutions internationally, Data Innovations will enhance the product offerings and geographic reach of Sunquest, while retaining its market-leading brand and independent position providing services to its clients and partners. Data Innovations will remain headquartered in Burlington, Vermont.

Obviously, there are huge synergies between Sunquest and DI which is the major purveyor of lab middleware such as interfaces between LISs and lab instruments as well as to EHRs. DI also provides business rules, software that manages and interprets lab test results. One interesting facet of this acquisition is that the the DI software is a major component of the LISs provided by other vendors. I suspect that Sunquest will be running DI as a distinct business unit but who knows where this will go.

Relevance of an "Uberized" Economy for Healthcare and Even Perhaps Pathology

Some say that the economy is becoming "uberized" which is to say that the business model launched by Uber is being more widely adopted across various industries. A Forbes article provide some insights into uberization (see: Let's Uberize The Entire Economy)

Today Uber has turned the smart phone into a tool for dynamically pricing and allocating car rides in real time, throwing the traditional taxi business into turmoil. It’s also given rise to a buzzword—Uberization—that is driving venture-capital investment and pundits to look for the next big business ripe for Uber-style disruption.... For some, Uber is synonymous with its “surge pricing” policy—when cars are scarce and rides in high demand, users are warned that the cost of a ride may be much higher than normal. It’s then up to them whether to pay the premium or find another way to get where they’re going. Surge pricing both tempers demand and encourages drivers to increase supply, helping ensure that a ride is there if you want it or need it. It’s made possible by real-time data about ride requests and the location and number of available drivers.

Here's another article about an "uberized" economy (see: The rise of the ‘Uberized economy’ and what it means for business)

It’s becoming clear, that in a not too distant future, our companies and corporations will be built on virtual networks vs marble lobbies. While we have seen an explosion of “Uberized” labor marketplaces that make things like grocery delivery and home cleaning a mobile click away, labor marketplaces are quickly moving in more sophisticated directions...[A] new generation of virtual labor marketplaces is rising...and unlocking highly skilled services in a whole new way. Our vision of the future is that these vertical marketplaces will make even the most white-collar professions accessible to every individual and business, and will provide new homes for highly skilled individuals where the traditional corporate life is no longer a fit or an option....Up until a couple years ago, most online labor had been contained within large horizontal marketplaces like oDesk and Elance.... But, horizontal marketplaces are just the first chapter in a multi-trillion dollar story. While horizontal marketplaces can make sense for many types of labor, they have their limitations within certain verticals. These limitations include inconsistent product experiences, demand- and supply-side quality control, and a lack of specialized resources for skilled providers to improve their delivery of service....Simply put, vertical marketplaces can focus on getting few things really right rather than doing hundreds of things decently, resulting in a better experience for both sides. While these vertical marketplaces are still in their infancy, some of the deliberate differentiations they are making from horizontal marketplaces are becoming standard practice.

What's the relevance of all of this talk about uberization and the vertical healthcare market. There may be a number of positions in, say, pathology and hospitals where an on-line workforce could be tapped into periodically. In short, there may be times of unexpected work surges when additional personnel such as medical technologists or even pathologists must be quickly sought and an on-line marketplace for such personnel would be helpful. Needless to say, companies that enter into such a market as intermediaries like Uber would need to pay special attention to training, credentials, and reliability of participating personnel. The same applies obviously to Uber drivers but the skill set is more demanding for lab and hospital professionals. There are precedents here such as the "nighthawk" telepathology companies that provide radiologist support at night and on the weekends when the normal hospital-based radiologists are unavailable (see: Leverage The Expertise Of Cleveland Clinic eRadiology From Your Own Practice).