Lab Soft News

New Clinic for High-Risk Prostate Cancer Patients at the University of Michigan

A new trend is developing relating to the outpatient management of patients with prostate cancer. The major driver is the ability to identify patients who have high-risk disease and treat them in a more aggressive way (see: U-M launches new clinic for ‘high-risk’ prostate cancer). Below is an excerpt from the article:

While every year about 30,000 men die of prostate cancer in the United States, the most common cause of death in men with prostate cancer is heart disease. That’s because not all prostate cancers are the same. Some are slow-growing while others are very aggressive. The University of Michigan Comprehensive Cancer Center has started a new clinic focused on men with the fast-growing type of cancer. This kind of high risk disease is thought to possess a high likelihood of causing harm....The clinic brings together experts in urology, medical oncology, radiation oncology and pathology. All of these specialists review cases together, discussing each patient’s unique factors and agreeing on the best treatment plan. Patients also receive free cancer genome sequencing along with several recently introduced predictive genetic tests. Clinical trials are offered when appropriate....The high-risk prostate cancer clinic also offers survivorship services, including a team of social workers and other health care providers who help patients and their families deal with the challenges that go along with a cancer diagnosis. As evidence grows that no two cancers are the same, doctors are more and more focusing on precision medicine, in which the particular genes, proteins or other markers in an individual’s tumor tell doctors what kind of drug might be more effective – and what might be less effective. It allows patients to avoid drugs that are not likely to work for them....

What is high-risk prostate cancer? Doctors start with the results of blood tests and biopsies to guide the classification of high-risk prostate cancer. The key is that these are tumors likely to return or spread and cause poor outcomes. Some of the markers that come into play include:

Gleason score (8 or more)

PSA score (20 or more)

Advanced stage (T3 or higher)

Relapse after prior surgery or radiation therapy

This report is interesting on a few counts. Recall that it's now rather common to refer to cancer as a chronic disease. By this it is meant that, for most patients, the disease can be managed well and is not life-threatening. I would amend this statement to say that cancer, except the high-risk varieties, can be treated as a chronic disease. At least at the University of Michigan, they are now separating some of these high-risk patients out into a separate clinic. This identification/separation process is accomplished with the Gleason score, PSA testing, cancer staging, and, more recently, next generation genomic screening (NGS) of the tumor tissue. Here's a quote from the article above about this latter approach: Patients also receive free cancer genome sequencing along with several recently introduced predictive genetic tests.

Several other key aspects of the special care that these high-risk prostate cancer patients receive is also mentioned in the article. The first is that they are diagnosed and treated with multidisciiplinary teams (see: Multidisciplinary Diagnostic Teams and Integrated Diagnostic Centers; Cleveland Clinic Use of Multidisciplinary Teams; Salaried Physicians Deemed Essential). The value of these MDTs is that the instincts of individual specialists (e.g., oncologic surgeons, oncologists, radiation therapists) are suppressed in favor of overall team recommendations. The second is access to survivorship services (see: Cancer Survivorship, an Emerging Subdiscipline in Oncology; Cancer Survivorship and the Role of PCPs in Continuing Care of Cancer Patients). Because these high-risk patients will be subjected to the most aggressive therapeutic regimens, there is the greatest likelihood of post-treatment complications, both medical and psychologic. Lastly, the article makes mention of precision medicine by which is meant NGS of tumor tissue to ensure that the optimal treatment is selected. This is now the preferred term over personalized medicine which is being used in a much broader way.

CT Scans May Be Too Efficient in Detecting Pulmonary Emboli

I am fascinated by the idea that some forms of imaging in radiology are too good. One aspect of this "too good" phenomenon is the so-called incidentaloma about which I have previously blogged (see: How to Avoid the Risks of a CT Incidentaloma; More (and Interesting) Discussion about Incidentalomas). An incidentaloma is an "incidental" radiology finding that is reported and may prompt unnecessary intervention. A recent article address another form of "too good" radiology reporting relating to the detection of a pulmonary embolus (see: CT Scan May Be Too Good at Finding Lung Problems, Study Finds), In this second type of "too good" reporting, the radiologist reports the presence of a pulmonary embolus to the clinician, the detection of which was the purpose of ordering the CT scan in the first place. However and due to the sensitivity of the CT scan, the lesion reported may be so small that it will usually resolve on its own without clinical intervention. Below is an excerpt from the article:

CT imaging is a very good way to find pulmonary embolisms — sudden blockages of an artery in the lung, which can be fatal if not treated quickly. But a new analysis finds that the procedure might be too good, revealing tiny embolisms that are harmless and leading to treatments that are unnecessary, expensive and potentially dangerous. Until the introduction of CT angiography in 1998, the primary test for pulmonary embolism was ventilation/perfusion scanning, in which inhaled or injected radioisotopes are used to create an image of air and blood flow in the lungs....But when CT angiography was introduced, doctors enthusiastically adopted it. It is now widely used instead of ventilation/perfusion and often employed to find the causes of various other lung disorders.Its versatility is only one reason for its popularity. Missing a pulmonary embolism can be a fatal mistake that doctors obviously want to avoid. A CT scan can reassure them and protect against claims of malpractice....CT scanning devices are expensive, and when a hospital buys one, officials want to use the machine as often as possible to justify the investment. “There’s a lot pressure to order the most advanced tests, no matter how small the problem,” said the lead author of [a new study], Dr. Renda Soylemez Wiener....According to the report, published on Tuesday in the journal BMJ, the number of diagnoses of pulmonary embolism was steady at 62.1 per 100,000 in the five years before the introduction of CT scanners. In the eight years after their appearance, pulmonary embolism diagnoses increased by 80 percent. Despite this, age-adjusted deaths from pulmonary embolism hardly changed at all. Treatment of the condition has not changed and is no more effective, but in-hospital deaths in diagnosed cases have decreased to 7.8 percent from 12.1 percent. In other words, the report’s authors said, CT scans are finding many pulmonary embolisms that are harmless and should never have been treated. According to [one of the study authors], 80 million scans are performed every year in the United States, about a quarter of them unnecessary. “The real concern is that the treatment is so dangerous,” Dr. Wiener said. “In the case of these very small emboli, the treatment may be more dangerous than the pulmonary embolism itself.” The standard treatment — blood-thinning medication — is a leading cause of drug-related death, and patients may end up on lifelong treatment to prevent recurrent embolisms. 

So the CT technology places physicians between a rock and a hard place. The radiologist must reveal the presence of the embolus, albeit small, and the clinician receiving the report may feel that he or she must treat the reported lesion on medico-legal grounds. It seems to me that there is some middle ground here and I am sure that such a scenario occurs countless times in many hospitals. The radiologist only need report that the visualized embolus is small and that the radiology literature indicates that most such small lesions need not be treated. Life-long anticoagulation therapy is more risky for the patient than the small embolus itself. The clinician receiving such a report mirrors this opinion in his own clinical notes. He or she indicates that an embolus identified in the radiology report is small and the medical literature supports not treating it. Physicians on both sides, diagnostic and therapeutic, are thus protected if the patient's pulmonary emboli recur and most patients come out ahead.

Nursing Union Demand Delay of Hospital EHR Go-LIve in Massilon, Ohio

I am seeing a trickle of evidence that hospital physicians and nurses are beginning to push back in small ways on EHR deployments (see: Nurses demand delay of EHR rollout). Below is an excerpt from a recent article on this topic:

Citing insufficient training, system shortfalls and the hospital's failure to involve direct-care nurses in the implementation process, RNs at the 266-bed Affinity Medical Center in northern Ohio have asked hospital officials to delay the rollout of its new Cerner electronic medical records system. The 250 or so direct-care nurses at AMC, represented by the National Nurses Organizing Committee — a national union representing nurses — have attempted to postpone the EMR go-live date.... "Nurses are very disturbed that the hospital would fundamentally alter the practice of nursing at Affinity Medical Center without consulting and including direct-care RNs in this process," Affinity RN Facility Bargaining Council wrote in a June 14 letter sent to AMC chief nursing officer William Osterman.... Nurses also called into question the safety of such a system that prevents registered nurses from overriding the EMR in many cases. "There has been no planned increase in staffing and no decrease in elective procedures during the time of the transition," the letter continues.  "We're not anti-technology," said National Nurses United spokesperson Liz Jacobs, RN, in a June 19 interview with Healthcare IT News. "We want smart technology that embraces and includes the clinical expertise of a registered nurse who really knows how best to put together a system that will work for them." ....According to [a hospital spokesperson], Cerner EMR guidelines recommend 16 hours of training for each nurse, and close nearly 95 percent of nurses have met this requirement.  It's just not enough, Jacobs said. She explained that the meaningful use financial incentives for hospitals have a lot of groups hurrying to implement these big systems without laying the proper groundwork and without consulting the actual care providers during the process. 

I have the following ideas about this news:

• In a previous note, I commented on the negative effect that an EHR deployment can have on nurse and physician productivity (see: Who Says a Hospital CIO Can't Get Fired for Picking the Epic EHR?). It was only a matter of time before the nursing unions picked up on this. For hospitals being crippled by the cost of EHR deployments plus a drop in nurse productivity, the inevitable result will be to hire fewer nurses and force them to work harder. Hence the interest of the nursing unions. It's logical for the unions to start with the issue of inadequate training prior to go-live although I am a little dubious about this. It's not part of an EHR deployment that most hospitals will skimp on.
• Also of interest is the charge from the nursing union that the "direct care" nurses have not been involved in the EHR implementation process. Again, a bit of a clash with reality similar to the complaint that physicians and nurses are insufficiently involved in the design of an EHR and EHR patient safety issues that I previously blogged about (see: Physician & Nurse Involvement in EHR Design; Patient Safety and EHR Gag Clauses). Both the design of an EHR and the installation procedures are more-or-less cast in concrete by the vendor, be it Cerner or some other company, based on successful deployments in other hospitals.
• We can all sympathize with the following statement by National Nurses United spokesperson Liz Jacobs: meaningful use financial incentives for hospitals have a lot of groups hurrying to implement these big systems without laying the proper groundwork and without consulting the actual care providers during the process. In practice and during the deployment of most EHRs, any significant feedback from physician and nurses will be solicited mainly to create a sense of faux participation. Both the design of such systems and the process for going-live will be dictated by the vendor. Not much wiggle room. 
• I covered the only other ruckus about an EHR deployment that came to my attention in a previous note (see: Concern Over Epic EMR Go-Live in Contra Costa, California). In this latter case and like the Affinity Hospital nurses issue above, the nurses played the "patient safety" card which will always be the strongest one they have in their deck.

Sloppy Data in Clinical Trials Conducted by Big Pharma in China

I have posted previous notes about the offshoring of clinical trials (see, for example: Clinical Trials Increasingly Move Offshore, Many to China). I previously believed that this trend would continue, and even accelerate, because they were less expensive and it was easier to recruit subjects for them, particularly those who had never been treated for their disease. Now, partly on the basis of a recent article, I am not so sure about this conclusion (see: Chinese clinical trials probed). Below is an excerpt from it:

Drugmakers have increasingly been turning to China for large clinical trials because they’re cheaper and there’s a bigger population of subjects to draw on. Now U.S. regulators have stepped in, questioning sloppy data and irregularities from the world’s most populous country. Bristol-Myers Squibb Co. and Pfizer Inc.’s blood thinner Eliquis, approved in December, was stalled for nine months because of misconduct, errors and an alleged cover-up attempt at a Chinese trial site overseen by Bristol-Myers....The delay came after the company told the FDA that patients got the wrong medicine, records were secretly changed and “serious adverse events” went unreported, the documents show. The errors led to a lengthy reanalysis of the data and spurred a debate within the agency on what the drug’s label should say about its effectiveness. An agency official also questioned whether large trials in countries like China with similar data shortfalls were a viable basis for approving treatments....The mistakes showed a “pattern of inadequate trial conduct and oversight,” according to minutes of a Feb. 9 agency meeting involving the two New York companies and the FDA, posted on the agency’s website. Sales for Eliquis may one day reach $10 billion a year, according to analysts. The delay, though, may cut the time Eliquis is protected by patent, reducing revenue by billions of dollars. The Eliquis case is an example of the increasing scrutiny the pharmaceutical industry is facing on its research in China, which offers a huge base of test subjects and costs that...can be half those in the United States. Drugmakers will keep having problems with sloppy data and misconduct as long as they keep doing trials in places like China without providing better oversight, said Thomas Marciniak, an FDA medical team leader....“What we need is high-quality trials. If we’re not getting them in the low-cost areas, either fix the low-cost areas, or stop doing them,”....Last month, London-based GlaxoSmithKline said it fired its head of Chinese research after the scientist allegedly misrepresented data that was published in a medical journal [see: GSK fires China research head over 'misrepresented' data].

The FDA has a powerful weapon in its ability to stall the drug approval process in the U.S. because of errors in the clinical trials conducted in China. Such delays can cost a company dearly in terms of a reduction in the length of patent protection if the new drug ultimately comes to market. Such costs can add up quickly and offset the savings initially enjoyed by the company by moving the trials off-shore. Graft and corruption will often be the norm in business conducted in developing countries. Drug companies will hardly be able to change the norms in these countries. There may also be the problem of the FDA perception that all such studies in China may be inherently tainted (see: Why Bribery is Rampant in China’s Healthcare System). Finally, recent reports have suggested that the pharmaceutical companies themselves may be active and knowing participants in bribery schemes (see: China names 4 GSK managers in drug bribery probe).

It's one thing to manufacture computer chips or PCs in China. Such physical goods should be made to precise specs and can be checked for defects. It's another thing to contract for services such as clinical trials where the deliverable is in the form of information. It will be much more difficult for a company to detect corruption in the recruiting of subjects or whether patient serum specimens are subjected to "sink testing" (poured down the drain with the test results fabricated)? In fact, the methodology of clinical trials in general is now being questioned (see: Do Clinical Trials Work?). Look for more serious scrutiny of clinical trials held abroad by the FDA with Big Pharma beginning to recalculate the ROI of conducting such trials in developing countries like China.

Myriad Sues Two Competitors Offering Less Expensive BRCA Testing

As might be expected, we have not seen the last of the legal wrangling around BRCA1 and BRCA2 testing. This despite the recent US Supreme Court against the Myriad Genetics (see: Supreme Court Breaks Myriad Monopoly).The details about a new suit were discussed in a recent article an excerpt of which is shown below (see: Myriad Sues 2 Competitors Offering Cheaper BRCA Testing):

Myriad Genetics...is suing 2 companies that offer less expensive testing for the BRCA1 and BRCA2 genes....The genes are associated with an increased risk of developing breast, ovarian, and other cancers. The suit alleges that the competitors — Ambry Genetics ...and Gene by Gene, Ltd. ...— are infringing on specific Myriad patents that are distinct from those invalidated by the US Supreme Court in June. DNATraits, a division of Gene By Gene, offers testing for the BRCA1 and BRCA2 genes in the United States for $995, according to the company. Ambry's testing reportedly costs $2280. Both prices compare favorably to Myriad's testing, which costs $4000. According to documents filed ... in US District Court in Utah, Myriad is not contesting the Supreme Court's rejection of their patents on naturally occurring DNA for the BRCA genes. In fact, the company's lawyers state that their new lawsuit "involves none of those 5 rejected claims."Instead, the suit relates to patent claims on "synthetic DNA," which Myriad asserts "were not affected by the Court's decision and remain valid and enforceable." Synthetic DNA, also known as cDNA, is patentable, according to Myriad's interpretation of the Supreme Court's ruling in June, because it involves "physical, transformative steps" in the laboratory. A number of the patent claims in the new lawsuit involve gene-specific probes, primers, and arrays that are part of the Myriad BRCA testing process and employ cDNA synthesized in a laboratory, according to the documents. Even after the Supreme Court decision, Myriad reports having 24 patents and 515 patent claims that involve BRCA1 and BRCA2 testing. Ambry, in turn, announced ...that it intends to "vigorously defend itself" against the patent infringement suit....When the Supreme Court invalidated 5 Myriad patents in June, patient advocates hailed the ruling as opening the door to less expensive testing. However, at the same time, Myriad immediately set the stage for more legal action.

It's only a matter of time before Myriad Genetics' stranglehold on BRCA1/BRCA2 testing is loosened. However, the legal battles will continue for some time with much at stake for the genetic testing industry. As I understand the article quoted above, the legal battle now turns to a discussion of patent claims and synthetic DNA (cDNA), This involves the extent to which Ambry and Gene by Gene infringe on the Myriad intellectual property relating to the role of cDNA in testing for BRCA1/BRCA2. I am sure that another bone of contention at some point will be the clinical information that Myriad has collected over the years about the various DNA missense mutations that can occur at the BRCA1/BRCA2 loci and the clinical significance of them (see: BRCA2). Of course, researchers working in the area of breast cancer genetics have been accumulating their own data over the years about BRCA mutations and much of this data is publicly available rather than proprietary for Myriad. 

Who Says a Hospital CIO Can't Get Fired for Picking the Epic EHR?

A maxim that seems to be on the lips of a lot of people to explain the phenomenal success of Epic is that no CIO will get fired for choosing Epic. This is reminiscent of a similar saying about IBM thirty years ago or more when it dominated the mainframe computer industry. A recent blog note raised this same question (see: Who Says Chief Information Officers Can't Lose By Choosing Epic?). Here is an excerpt from that note:

As the saying goes in health IT circles: You can’t lose your job by picking Epic Systems. With its reputation for consistently high marks, and a prestigious roster of clients, hospital chief information officers view it as a safe bet. Not Barry Blumenfeld, it appears. He recently vacated the post of chief information officer at Maine Medical Center, a well-regarded medical center in Portland, and the state’s largest. A story in...Healthcare IT News implies that his departure was related to the hospital’s implementation of Epic’s electronic health record system, estimated at $160 million. In an April letter to employees, Maine Medical Center’s chief executive Richard Petersen partly blamed the launch for an operating loss. The hospital had botched its implementation, disrupting revenue....Maine Medical Center is not the only hospital to run into financial trouble over an Epic implementation. There’s been a trickle of local press reports about others with similar stories. In May, the Winston-Salem Journal reported that the chief information officer of Wake Forest Baptist Health resigned in the middle of a difficult Epic launch, although the hospital says it’s unrelated. Last month, Greensboro, N.C.-based Cone Health announced a wave of layoffs and cuts. Epic is often blamed for hospitals’ financial woes. But, hospitals that can’t afford it should think twice before taking on the burden of a costly implementation.

I think that there are probably three major ways in which a hospital CIO can get in trouble with an Epic install:

• First and foremost, and as emphasized above, one path is not preparing the hospital for the numbing cost of the Epic EHR, exacerbated by the abrupt decline in physician and nurse efficiency and productivity when working with the system (see: The Cost of Deploying an Epic EMR and the "Oreo Cookie" Analogy). In this regard, Epic is probably not much different than its competitors in the EHR market. Unknown at this time is to what extent this drop in efficiency is recoverable as nurses and physicians become more familiar with the system. You may ask why the CIO and not the CFO will take the fall for the cost of the Epic EHR. I suspect that most CFOs will gag initially at the cost of the system and go on record that the hospital can't afford it. This gets them a pass when heads start to roll.
• The second error, closely tied to the first, is for the CIO to oversell the system to hospital nurses and physicians. They need to be told the following at the outset of the Epic journey: Your work efficiency and productivity will take a major hit after our go-live and may never return to what it was previously. We are installing this system because of pressure from the government and because everyone else is doing it. Of course, if the CIO goes on record with such a statement, his or her days will be numbered on this basis alone.
• The last way for a hospital CIO to be fired is not to closely follow the Epic go-live procedures and stumble along the way. Epic has little patience for failures because the success of the company is based, in part, on their high percentage of successful installs. Such missteps on the part of the hospital CIO can be the result of personal shortcomings or aggressive push-back by the CIO regarding the Epic culture or policies. The firing news can come from the hospital executive suite or sometimes be the result of a bad report from Epic after a failed "Judy check" (see: Some Hospitals Can't Get Past the Final Epic Deployment Step: the "Judy Check"). In this latter scenario and If Epic decides that a hospital go-live process is a cause for concern, Epic takes control over the project or walks. In either case, the hospital CIO may end up in the dog house.

Georgia Regents Health System Signs Deal with Royal Philips

Royal Philips has signed a $300 million, 15-year alliance with Georgia Regents Medical Center in Augusta to study ways to deliver more cost efficient healthcare (see: Georgia system, Philips sign $300M deal; Venture aims to design new model for healthcare delivery). Six years ago I blogged about Philips expanding its presence in the consumer health product and services area (see: Philips' Healthcare Expansion Strategy Revealed). Below is an excerpt from the current article:

Through the agreement, the largest of its kind for Philips, the company will provide GRMC with a broad range of consulting services, advanced medical technologies, and operational performance, planning and maintenance services with pre-determined monthly operational costs over a 15-year term. The alliance...will work to deliver faster, more effective and cost-efficient care from diagnostics to therapeutics, and inpatient and outpatient clinical services....[It] will impact all care areas, including radiology, cardiology, neurology, oncology and pediatrics, and enhance medical research and clinical technology R&D initiatives for care delivery innovation. The agreement encompasses Philips imaging systems, patient monitoring and clinical informatics solutions, as well as lighting and consumer products. Philips will also furnish GRMC rapid access to new equipment as well as educational resources. Philips and GRMC will work together to cost-effectively design and deploy innovative patient care strategies.....The long-term alliance with GRMC in the U.S. follows collaborations with hospitals in Europe, Asia, the Middle East and Africa that have resulted in improved clinical operations and care delivery performance.

I was not very familiar with GR Health. Here's a brief description of the healthcare organization from its web site home page (see: GRHealth)

In addition to providing care in the Augusta area, Georgia Regents physicians travel to satellite practice sites throughout Georgia illustrating our commitment to care for people across the state and region. Georgia Regents Medical Center is part of a thriving academic health center that also includes the following entities:

Georgia Regents University – GRU's Health Sciences Campus is composed of the Colleges of Allied Health, Dental Medicine, Graduate Studies and Nursing and the Medical College of Georgia, the nation's 13th oldest and sixth largest medical school.

Faculty group practice plans, including the Physicians Practice Group, the Dental Practice Group, the Allied Health Practice Group and the School of Nursing Faculty Practice Group.

This relationship strikes me as interesting. Here you have a global Dutch company setting up hospital collaborations across the world to study more efficient ways to deliver diagnostic and therapeutic inpatient and outpatient services. I wonder what both sides are getting out of these deals. Royal Philips competes globally with GE Medical and Siemens in the medical imaging business plus many other health related businesses. I am sure that these latter two companies have also established similar hospital relationships. I am curious about the chemistry that evolved between Philips and GRMC and where the the product development emphasis is being placed.

Urine Biomarker Signature Found to Diagnose Kidney Transplant Rejection

There now seems to be some real progress in the use of non-invasive, urine biomarkers to diagnose, or even predict, the rejection of a transplanted kidney (see: Urine Test Can Diagnose, Predict Kidney Transplant Rejection). Here's an excerpt from a recent article on this topic:

Analysis of three biomarkers in the urine of kidney transplant recipients can diagnose — and even predict — transplant rejection, according to results from a clinical trial....This test for biomarkers ...offers an accurate, noninvasive alternative to the standard kidney biopsy....The findings appear in the July 4 issue of the New England Journal of Medicine.....Following a kidney transplant, patients receive therapy to prevent their immune systems from rejecting the organ. Even with this immunosuppressive therapy, approximately 10 to 15 percent of kidney recipients experience rejection within one year after transplantation. Typically, a biopsy is performed only after a transplant recipient shows signs of kidney injury. Although the procedure seldom causes serious complications, it carries some risks, such as bleeding and pain. In addition, biopsy samples sometimes do not give doctors an accurate impression of the overall state of the kidney because the samples are small and may not contain any injured tissue.....In the study...investigators at five clinical sites collected urine samples from 485 kidney transplant recipients from three days to approximately one year after transplantation. Researchers...assessed the urinary cell levels of several biomarkers that previously have been associated with rejection. Statistical analysis revealed that a group of three urinary biomarkers formed a diagnostic signature that could distinguish kidney recipients with biopsy-confirmed rejection from those whose biopsies did not show signs of rejection or who did not undergo a biopsy. The biomarkers include two messenger RNA molecules that encode immune system proteins implicated in transplant rejection and one noncoding RNA molecule that participates in protein production. The researchers used the signature to assign values to each urine sample and identify a threshold value indicative of rejection. With this test, they could detect transplant rejection with a high level of accuracy.

As emphasized in this article, the use of diagnostic signature of three urinary biomarkers seems to offer a better alternative to assessing the status of a transplanted kidney than the current gold-standard, a kidney biopsy. Although such biopsies usually do not result in serious complications, kidney biopsies are not undertaken lightly and, as noted above, may not yield tissue that accurately represents what is happening to adjacent tissue (sampling error). These is also considerable expense associated with a biopsy. However, there will also be a cost for the biomarker testing.

It's important to note, and as noted above, that there is the distinct possibility that the biomarker signature may be able to predict future rejection of the kidney and prompt a change in the immunosuppressive therapy to save the organ. This is also possible with a biopsy but the biomarkers may prove to be better at this, more quantitative, and can be repeated frequently. Although the kidney is the most commonly transplanted organ, I am sure that this biomarker approach is being evaluated for other transplanted organs but with serum used as the analyte and not looking at the same biomarkers.

More Hospitals Refusing to Hire Smokers; Such Policies Illegal in 29 States

Cleveland Clinic was one of the first hospitals to refuse to hire smokers (see: Want a Job at the Cleveland Clinic?: Smokers Need Not Apply; Geisinger Follows Cleveland Clinic; Won't Hire Smokers; Tobacco-Free Hiring Takes Hold; Both Smoking and Smokers Excluded). A recent article indicated that this trend is continuing but it's also illegal in 29 states (see: More hospitals refusing to hire smokers). Below is an excerpt from the article:

Both the highly rated University of Pennsylvania Health System...as well as the Children's Hospital of Philadelphia... will join dozens of hospitals across the country when they implement their [smoker exclusion hiring] policy Monday, July 1. The move has generated criticism among civil liberties activists, hospital employees and even doctors who fear that smokers will lie about their habit — and therefore become less likely to seek help in stopping it. "It's not all slopes that are slippery, but this one really is," said Lewis Maltby, a former American Civil Liberties Union lawyer who now runs the National Workrights Institute in Princeton, N.J. He is critical of an employer's intrusion into the private time of employees....Maltby noted that drinking alcohol, eating lots of junk food and not exercising are also bad for you....The policy at Penn, with more than 28,000 employees, will extend to all the university's health centers, including three large city hospitals, a center for advanced medicine and six other clinics and medical practices. Penn's clinics and offices in New Jersey will not be affected because New Jersey is among 29 states and the District of Columbia that have passed smoker-protection laws preventing employers from discriminating against employees or job applicants because they do or do not smoke....Penn will rely on an applicant's word on tobacco use, whereas the children's hospital will test applicants to determine if they're smokers. Those who admit to having started smoking after hiring would be offered a smoking-cessation program but also would have to pay higher health insurance premiums — about $30 more a month

What I found most interesting about this article was the fact that New Jersey and 28 other states plus the District of Columbia have smoker-protection laws in force, preventing employers "from discriminating against employees or job applicants because they do or do not smoke." By the way, I don't really anticipate a groundswell of enthusiasm for hospital policies that require only smokers to be hired. Here's a list of the 29 states that have passed smoker protection laws (see: State "Smoker Protection" Laws). Six of these states passed their laws in 2000's. The remainder of states passed their laws in the 1900's with Illinois being the first in 1987. The most recent law was passed in California in 2005. If I had to guess, I think that there might be some movement now to rescind these smoker-protection laws in some of these states. I don't think that most people these days are highly motivated to "protect" smokers and a large number are concerned about the negative health effects of passive smoking on innocent bystanders.

Physician & Nurse Involvement in EHR Design; Patient Safety and EHR Gag Clauses

When the major EHRs in the market are being installed in hospitals, there is little latitude for making significant changes to them on the basis of input from physicians or nurses. These systems are so complex that any possible customization is rather minor. For example, physicians and nurses can provide input about clinical order sets (see: EMR-Based Order Sets as a Locus of Control of Hospital-Based Physicians; Evidence-Based Order Sets Deployed at the University of Kansas Hospital). By way of defense of EHR vendors, they all have had (or claim to have had) significant physician and nurse input during the alpha and beta phases of their systems. And, of course, all EHR vendors will certainly implement rapid changes to their systems when critical patient safety problems are pointed out to them. A recent article discussed the need for the involvement of physicians and nurses in EHRs designs and improvement, particularly with regard to modules used in Emergency Departments (EDs) (see: Clinician Involvement Critical in EHR Design, Improvement). Below is an excerpt from it:

To ensure patient safety and quality of care, front-line clinician involvement is critical in the design and deployment of electronic health record (EHR) systems, as reported in an article published...in the Annals of Emergency Medicine. Efforts to improve EHR systems are constantly evolving....The researchers represent a joint committee [of members] of the American College of Emergency Physicians, who combined efforts to analyze the benefits and potential threats to patient safety that can result from EHR choices. Some vendors prohibit users from sharing hazards even in the academic literature.  Although EHR systems that are marketed and sold to hospitals and healthcare providers are certified by the Certification Commission for Health Information Technology, that process is not focused on safety issues....and no mechanism exists to allow or encourage system users to address ongoing safety issues or provide feedback. "In fact, some vendors prohibit users from sharing hazards even in the academic literature," they write. Emergency Department (ED) characteristics, including rapid turnover, frequent transitions of care, continual interruptions, large patient volume, and unfamiliar patients, make EDs "particularly error prone" when using EHR systems or ED information systems (EDISs) to reduce medical errors and standardize care, the authors write. The report describes 4 potential "fictitious yet realistic clinical scenarios" in which choice of EDIS can make a difference and offers 7 recommendations to improve patient safety when using EDIS. 

The issue of patient safety with regard to any clinical information system, be it an LIS, RIS, or EHR, is critical. There now seems to be a growing chorus of system users as well as governmental and regulatory bodies that are beginning to discuss patient safety issues as they relate to EHRs (see: Joint Commission puts focus on EHR, patient safety; HHS Releases Health IT Safety Plan; How Often are EHRs Placing Patients at Risk?). The committee members quoted in the article above are correct in highlighting EHR vendor's contract "gag clauses" as a major barrier to EHR improvements in patient safety (see: EHR vendor contracts and the gag clause).

I would draw an analogy here between adverse reactions to drugs and EHR errors that threaten patient safety. Reporting the former to the FDA is mandatory and information about these problems is widely reported. EHR errors, when reported to the vendor and by way of contrast, may result in a quiet discussion between the vendor and the reporting hospital client with contractual restrictions on public disclosure. Even public disclosure of the specific language in EHR vendor gag clause contractual language is prohibited. Here's an important quote from the IEEE Spectrum article referenced above:

Part of the reason for the lack of safety-related information is that, unlike medical devices, reporting of problems with electronic health record systems to the US Federal Drug Administration is not mandatory. In addition, it is often difficult to identify whether an “EHR problem” is due to a simple human error, a design flaw that encourages human errors to occur, or some specific software or other type of system-related error. Further, even if there was a reliable means to identify and classify these issues, EHR vendors frequently include “hold harmless clauses” in their contracts that help them escape responsibility for errors or defects in their software, as well as nondisclosure or confidentiality clauses that can prevent EHR users from disclosing the problems they encountered with a vendor’s software. 

For me, the difficulty in assessing whether patient harm is attributable to human or software error is an insufficient reason for not reporting such perceived problems to a federal agency. Gag clauses in contracts regarding disclosure of EHR patient safety issues should also be prohibited.