Informatics educators and readers:  Please let me know how you found this site.  Additional case examples are also sought.

 

Note:  2009 has proven to be a pivotal year in Medical Informatics regarding healthcare IT challenges, risks and failures.  Links to noteworthy reports and articles are here. 

 

The Oct. 16, 2009 letter to major healthcare IT vendors from Senator Charles E. Grassley (ranking member of the United States Senate Committee on Finance) initiating a Senate investigation of corporate practices is here (PDF).  

 

Jan. 2010:  A followup investigation letter from Sen. Grassley to thirty hospitals is here.  My commentary is here.

 

Introduction:  Why was this site created?

 

Healthcare information technology (HIT) holds great promise towards improving healthcare quality, safety and costs. As we enter the second decade of the 21st century, however, this potential has been largely unrealized. A significant factor impeding HIT achievement has been mismanagement of the technology. Mismanagement of HIT is largely due to false assumptions and naïveté concerning the challenges presented by this still-experimental technology, and underestimations of the expertise essential to achieve the potential benefits of HIT. This results in mission-hostile HIT design, and HIT leaders and stakeholders operating outside (often far outside) the boundaries of their professional competencies. Until these issues are acknowledged and corrected, HIT efforts will waste precious healthcare resources, will not achieve claimed benefits for many years to come, and may actually cause harm. Numerous reports in the 2009 articles link corroborate this view, including those from the U.S. Joint Commission and National Research Council. 

 

As an initial example of health IT mismanagement and failure causing possible patient harm, as Director of Medical Informatics in a large U.S. hospital, the dominant facility in a small state, I encountered endangerment of the very sickest of patients from information technology. ICU patients were being put at mortal risk via inappropriate, dust-laden, air-circulating, business class computers subject to bacterial colonization that were mounted on the ceilings above each ICU bed.  An ICU is a setting where one finds the most noxious and drug-resistant organisms, many airborne.  These pathogens (e.g., MRSA, TB, and even worse) can spread from a sick patient, to the dust and contaminants inside the computer, then to the room’s next occupants via the PC’s internal air circulation fan. The PC’s were malfunctioning as well due to a system architecture inappropriate for mission critical settings, and keyboards and mice were unprotected from bacterial contamination. My advice on changes to more appropriate hardware and other measures to ensure patient safety were simply overruled by IT personnel.

 

My counsel as postdoctoral-trained Medical Informaticist and ICU-trained clinician was simply dismissed and overruled by the IT staff and CIO on grounds that the IT staff were unfamiliar with existing, ICU-appropriate computer hardware and wouldn't support or even evaluate "nonstandard" (to them) computers in any case.  Further, hospital administration sided with the IT department, a department led and staffed by business computing personnel (of “management information systems” or MIS background) totally lacking in clinical knowledge and experience.  Patients remained at risk. 

 

At the same time, hospital management was markedly averse to incorporating a low powered volunteer shortwave (ham) communications backup into the hospital’s emergency communications capabilities for fear of such equipment causing interference with medical devices, despite documented evidence from other hospitals that this was not the case as described here.  Management priorities were exactly backwards based on technological dyscompetence and incompetence, and mismanagement of critical assets was the result.

 

Having spent much time in medical and cardiac ICUs during my residency and having done what it takes to provide the very best of care to extremely ill patients with little consideration for my own convenience, I found this experience remarkable. This experience informs the first case example of health IT dysfunction at this website.  It led to a search for additional published information on such situations in the healthcare community.  Finding almost none, and through my inquiries finding that many others in similar roles worldwide were witnessing similar, major healthcare IT dysfunction that was not being reported on in either the IT or biomedical literature and were being ignored by IT and executive staff, I decided to write on these issues.

 

This led to the collection of many such cases, presented in an anonymized form under the the “Case Examples” tab on this page.  The cases are presented as learning examples of a problem all too often buried in an atmosphere of blind exuberance over information technology as a “magic bullet” to healthcare’s problems.  Healthcare IT is in reality a clinical tool that happens to reside on computers, not a management information system that happens to involve physicians and other healthcare professionals.  It is clear, however, that the scientific rigor of medicine itself – rigor that requires critical examination of evidence, both pro and con towards new drugs, treatments, and tools - is lacking in healthcare IT.  This must change.

 

What are the problems that lead to healthcare IT dysfunction and innovation failure?

 

Major advancements have been made in the field of information technology (IT) and in the discipline of biomedical information science or biomedical informatics since the invention of the general purpose electronic computer roughly sixty years ago.  As a result of these advancements and the synergies they have enabled, in recent years many of the early - and often overstated - predictions about the use of computers in medicine have become at least technically feasible. 

 

Yet diffusion of clinical information technology (IT specifically intended for use by clinicians in clinical care settings) after 30-plus years of effort and billions of dollars spent remains limited.  As per the 2008 statistics in the NEJM article "Electronic Health Records in Ambulatory Care - A National Survey of Physicians", NEJM 359:50-60, just four percent of physicians in the U.S. reported having an extensive, fully functional electronic-records system, and just thirteen percent reported having a basic system.  Most hospitals are also lacking the technology to any meaningful extent.

 

This website is concerned with the reasons for this apparent paradox.  It is not a website about traditional best practices and well-known or obvious “what to do’s” in clinical IT.  Rather, it is a site about what has been shown best not to do.  For those seeking best practices, I recommend the new textbook “Medical Informatics 20/20: Quality And Electronic Health Records Through Collaboration, Open Solutions, And Innovation by Goldstein et al., Jones & Bartlett Publishers, 1st edition.  This book is an excellent resource on current best practices and “what to do” in clinical IT.  (A quote in the book from this website that I consider key in understanding how clinical IT and business IT differ appears here.)  

 

On the other hand, eighty percent of one of the foundational documents of western society consists of instructions on what not to do.  There were good reasons for that stylistic choice, and that is the prevailing purpose of the case studies at this site: to show what not to do.  I believe it is important to study not just the “hits” but also the “misses” in order to succeed in any challenging endeavor, and clinical IT is one of the most challenging domains in the field of biomedicine.

 

While clinical IT is now potentially capable of achieving many of the benefits long claimed for it such as improved medical quality and efficiency, reduced costs, better medical research and drugs, earlier disease detection, and so forth, there is a major caveat and essential precondition:  the benefits will be realized only if clinical IT is done well.  For if clinical IT is not done well, as often occurs in today’s environment of medical quick fixes and seemingly unquestioning exuberance about IT, the technology can be injurious to medical practice and biomedical R&D, and highly wasteful of scarce healthcare capital and resources. 

 

Those two short words “done well” mask an underlying, profound, and, as yet, largely unrecognized (or ignored) complexity.  This website is about the meaning of "done well" in the context of clinical computing, a computing subspecialty with issues and required expertise quite distinct from traditional MIS (management information systems, or business-related) computing.

 

This site is dedicated to the improvement of healthcare via enlightened approaches to clinical information technology, and to the field of Medical Informatics that helps inform the innovative thinking required to achieve the full benefits of clinical IT.  Medical informatics is a cross-disciplinary field that studies information-seeking activities and tools, analytic processes, and workflows in biomedical research and clinical care delivery. The field focuses upon the innovative use of computers in clinical medicine, molecular biology, neuroscience, and other areas of biomedical research.

 

This website is also dedicated to my early mentor, Dr. Victor P. Satinsky, who ran NSF-funded science programs for high school students at Hahnemann Medical College and Hospital in Philadelphia in the 1960’s and 1970’s.  It was there that my interests in both medicine and computation began.   Dr. Satinsky, inventor of the Satinsky clamp and many other cardiothoracic surgery tools and techniques used to this day, ran rigorous programs emphasizing critical thinking, responsibility, and clear, direct language in the interests of patient care.  These core values of medicine are reflected in this website.

 

Medical informatics research informs the best approaches to clinical information technology design, implementation and ongoing maintenance and adaptation. (Paraphrasing Dr. William Hersh at OHSU, "It is unwise spending millions on Electronic Medical Records without investing thousands in Medical Informatics expertise.")  Unfortunately, that advice is often not followed, even though specialized postdoctoral training in Medical Informatics is funded by The U.S. National Institutes of Health (NIH) at a number of major universities, and is provided by other universities in the U.S. via internal funds and internationally as well. 

This website focuses on the leadership aspects of clinical IT.  It promotes viewpoints based on repeated observations by this author and Medical Informatics colleagues of a concerning phenomenon.  We observe healthcare support personnel in information technology, and the non-medical management personnel overseeing them, assigned roles and responsibilities (largely via custom and tradition) that increasingly fall outside their core competencies, due in large part to advancements in biomedical information sciences and in the computer applications used at the point of care.

 

These advances mandate cross disciplinary expertise and insights for optimal leadership of clinical IT initiatives.  The existing leadership model, where technology-focused healthcare support personnel (facilitators of healthcare) control the information tools and assets essential to clinicians (the enablers of healthcare), can adversely affect clinical medicine and biomedical research.  More on the issue of cross disciplinary expertise is below.

 

It should be noted that the purpose of these writings is not to assign "blame", but to start a needed dialog on addressing solutions to the multidimensional problems faced by healthcare organizations with regard to clinical IT. 

 

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All is unfortunately not well in the world of clinical information technology. In medicine, a field characterized by significant risk and unpredictability, a somewhat remarkable and unexpected atmosphere of "technologic determinism" (a belief that computer-based automation is almost magically beneficial) seems common. The appropriate levels of critical thinking and skepticism essential in a demanding area such as introduction of computer automation in medicine appear largely absent, on a worldwide basis, to the point that those who've led IT projects to automate traditional business activities (e.g., accounting, finance, manufacturing) are deemed the appropriate leaders to automate clinical medicine.

Why is this an important issue?  As in the ICU case above that led to creation of this site, and the other cases under the “Case Examples” tab, patient well being and the financial resources of healthcare organizations are being put at risk.  The efforts to implement HIT, when they go poorly, also can distract healthcare leadership from more fundamental non-IT related quality assurance measures.

Unfortunately, even well-designed clinical IT applications often lack the sustained agility in critical functions such as charting, information retrieval, and decision support to keep up with the pace of the hospital and clinic, and with the pace of change in medical science and practice. These applications can distract clinicians and make their work harder and more stressful. Worse, much of the technology now available comes nowhere near the optimal design possible.

 

Further, the use of electronic health records, without a major change in health care delivery, would not significantly reduce overall health care costs, the director of the Congressional Budget Office said at the release of the agency's 2007 report on long-term health care spending.  Peter Orszag, CBO's director, said that according to data from the report, the return on investment for EHRs "is not going to be as substantial as people think."

 

A 2003 press release about research at OHSU (one of numerous NIH-funded centers for Medical Informatics research and training) entitled "Most hospitals don't use latest ordering technology" (link) is particularly illuminating:

 

Computers programmed to screen out errors and standardize physicians' orders for prescriptions, tests and other care have been a source of hope in reducing medical errors and improving patient safety. The problem is that most hospitals aren't using this technology, known as computerized physician order entry (CPOE) ... Reducing medical errors gained a sense of urgency in 2000 when the Institute of Medicine reported on the issue. The institute found that medical errors may be responsible for up to 98,000 deaths in hospitals and cost the U.S. health care system approximately $38 billion per year.

 

Despite a wide array of quality, policy and financial incentives to use CPOE, fewer than 10 percent of American hospitals make it completely available to their physicians. This was among the findings of a study conducted by researchers in the Oregon Health & Science University School of Medicine and recently published in online edition of the Journal of the American Medical Information Association (JAMIA).  [Use of CPOE] is not yet widespread because it has a reputation for being difficult to implement successfully. Patient care information systems like CPOE ... can create unintended or "silent" errors, according to a separate study conducted by the same author in the Netherlands and Australia.

 

"Many information systems simply don't reflect the health care professional's hectic work environment with its all too frequent interruptions from phone calls, pages, colleagues and patients. Instead these are designed for people who work in calm and solitary environments. This design disconnect is the source of both types of silent errors …Some patient care information systems require data entry that is so elaborate that time spent recording patient data is significantly greater than it was with its paper predecessors," the authors wrote. "What is worse, on several occasions during our studies, overly structured data entry led to a loss of cognitive focus by the clinician."

 

Software designed for calm and solitary environments, intended for physicians, nurses and other clinical personnel?  This is nothing short of remarkable. 

 

In 2005 University of Pennsylvania sociologist Ross Koppel, PhD and clinical colleagues, at some risk to their professional reputations, further amplified issues with CPOE in “Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors” (JAMA 2005;293:1197-1203, link to abstract here).  These investigators found that a leading Computerized Practitioner Order Entry (CPOE) system often facilitated medication error risks, with many reported to occur frequently.  This article created much controversy in the clinical IT industry, although its lessons are well-known to medical informaticists.  My commentary on the controversy created by the Koppel article is at this link.  Further, I am convinced this is not, as some vendors and those supporting them claimed, a “versioning problem.”  I’d learned about such issues as a postdoctoral fellow in informatics via participation in implementation of the same CPOE product over a decade earlier.  

 

In effect, systems that ignore the healthcare workplace's well-known realities are finding their way into real products costing millions of dollars that are acquired and implemented by hospitals, and these systems might actually be causing adverse effects.  How is this possible?  This phenomenon should raise a number of questions to the critical thinker, such as:  who are the CPOE designers, exactly, and what are their backgrounds? How could investor dollars have been spent in such a fashion as to ignore the fundamental realities of clinical settings? How could IT companies have designed and implemented systems that "led to a loss of cognitive focus by the clinician" and created error?  How could hospitals have acquired and put such systems into operation?  What is behind this irrational exuberance and blind faith, or, as I have described it, an “inappropriate overconfidence in computers?” Why has commerically available clinical IT, developed under the management information systems (MIS) paradigm, not lived up to expectations that in turn are based on the experiences of medical centers with advanced information systems developed internally under the aegis of clinicians and experts in Medical Informatics?

 

In a 2007 research study involving the University at Buffalo and other institutions, "Design of Patient Tracking Tools May Have Unintended Consequences", researchers found that “Virtual Patient Status Whiteboard” systems to replace traditional, dry-erase patient status boards in hospital Emergency Departments (ED’s), but designed by technologists without adequate domain expertise, often do not work as expected.  The computer-based system interferes with staff communications.   From the report:

 

In some cases, providers noted that computer systems hid some of the information; if only three comments could be viewed per screen, they had to click to get to another screen, requiring them to search for information that might demand immediate attention.  [How such an ill-conceived design for an ED status board could have been put into production is remarkable – ed.]  The study also found that there were fewer visual cues with the computational system. Some providers noted that they used to be able to get a sense of the status of the emergency department just by walking through the room and visually checking the manual whiteboard.  “Without that public display, providers have to sit down at the computer and check it, which can add time or reduce awareness,” said a principal investigator.

 

These are potentially disastrous consequences in an ED environment where patients can be highly unstable and serious events transpire rapidly and irreversibly.  An investigator in the study observed that "the results provide an important case study of what can happen when new technologies are developed without sufficient understanding by designers of the nature of the work in which they will be used." 

 

This last observation raises a more fundamental question:  why does such an axiomatic, common-sense statement, especially in a domain as complex as medicine, need to even appear in print?

 

With regard to electronic health records (EHRs), a research article in the Archives of Internal Medicine entitled “Electronic Health Record Use and the Quality of Ambulatory Care in the United States” (Arch Intern Med. 2007;167:1400-1405, link to abstract here) reached what to many was a counterintuitive and paradoxical conclusion.  The authors examined electronic health records (EHR) use throughout the U.S. and the association of EHR use with 17 basic quality indicators.  They concluded that “as implemented, EHR’s were not associated with better quality ambulatory care,” and were bold enough to publish their findings, sure to be unpopular in the health IT industry. 

 

An informal poll taken by Dr. David Brailer (the first director of the U.S. Office of the National Coordinator for Health IT) while speaking to a group of clinicians, was reported as indicating that as many as 20% of physicians have tried to implement EHR. Of those, 50% had experienced a failure. Over 70% of the clinicians knew of a colleague who had experienced an EHR implementation failure.

 

These findings and others like it are indeed troubling.  An EHR for small-group and solo-practice physicians costs $44,000 per physician, and generates an average ongoing $8,500 per year in annual costs, ACP president Lynne Kirk, MD told the house Subcommittee on Regulations, Healthcare and Trade of the House Committee on Small Business in October 2007. "The business case does not exist to make this kind of capital investment," Kirk told the Subcommittee. 

 

It appears the clinical case may not exist, either, for clinical IT as it is designed and implemented today.   Promises made about how this technology, as it is today, will revolutionize healthcare might better reflect a “magic bullet theory” of IT-enabled transformation than clinical and social reality.

 

How can it be that “as implemented, EHR’s were not associated with better quality ambulatory care?”  It has been said that there are no paradoxes, only false assumptions.  To medical informaticists, the key phrase that explains these findings about EHR’s is “as implemented”, to which I would also add “as designed.”  In other words, EHR design and implementation across a wide variety of settings were so suboptimal that in some cases and for some clinical quality indicators, clinicians using paper performed better than clinicians using EHRs.  Considering the expense of these information systems, the lack of discretionary funds within healthcare for IT experimentation, and the scarcity of resources to be wasted upon “IT misadventures” that might be better spent on providing clinical care, these results are troubling. 

 

These issues are international in scope.   Richard Granger, former head of the UK's “Connecting for Health” national clinical IT program, had this to say about a program described by some UK members of Parliament as “the largest government IT debacle ever” (see here for more):

 

"Sometimes we put in stuff that I'm just ashamed of ... Some of the stuff that [our large American clinical IT vendor] has put in recently is appalling ... [vendor] and [prime contractor] had not listened to end users ... Failed marriages and co-dependency with subcontractors ... A string of problems ranging from missing appointment records, to inability to report on wait times ... Almost a dozen cancelled go-live dates ... Stupid or evil people ... Stockholm syndrome -identifying with suppliers' interests rather than your own ... A little coterie of people out there who are "alleged experts" who were dismissed for reasons of non-performance."

Australia is also having its problems with national EHR.  See “The Blight on the Landscape Health IT Awards” by Dr David G More MB, PhD, FACHI, a Health IT consultant in Sydney, at this link.

 

Finally, At a website of the Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI) entitled “Bad Health Informatics Can Kill” (link) are summaries of a number of reported incidents in healthcare where IT was the cause or a significant factor in patient harm. 

 

Is there a unifying issue that can explain these findings about healthcare information technology systems?

 

Medical Informatics, Information Technology Leadership, and Clinical IT Success

 

As clinical and biomedical IT becomes increasingly more complex, and as it supports increasingly complex medical science, research and practices, the number of ways that failures and mishaps can occur from errors in judgment, inadequate knowledge, mismanagement, and related factors increases markedly. Competence, excellent management, logical decision making, and the wide-angle view of true cross-disciplinary expertise have therefore become imperatives for leadership and success in this field.  Unfortunately, the reality in today's hospital, EHR vendor and biomedical R&D IT departments falls short of this.

 

Studies of IT failure have been limited, but statistics on failure rates from some of the studies performed in the business IT sector may be found here.  Clinical IT failure rates may be even higher than those of business IT, due to the greater social and technological challenges of the clinical IT subspecialty. 

 

A 2007 Medical Records Institute survey of about 800 health IT stakeholders is summarized in the Modern Healthcare article “Failure, de-installation of EHRs abound” at this link.  Nineteen percent of respondents indicated they either have experienced the actual abandonment of an EMR system or are now going through a de-installation, and some had actually gone back to paper.  I believe these results markedly under-represent true problem rates, as the sample size was small and health IT stakeholders are quite reluctant to share such negative information due to internal healthcare organization and health IT industry backlash.

As far back as 1969, EMR and Medical Informatics pioneer Donald A. B. Lindberg, M.D., now Director of the U.S. National Library of Medicine at NIH, made the following observation. He wrote that "computer engineering experts per se have virtually no idea of the real problems of medical or even hospital practice, and furthermore have consistently underestimated the complexity of the problems…in no cases can [building appropriate clinical information systems] be done, simply because they have not been defined with the physician as the continuing major contributor and user of the information" (Lindberg DAB: Computer Failures and Successes, Southern Medical Bulletin 1969;57:18-21).

Surprisingly, there has been little change in this issue in thirty-five years. Today the IT personnel and non-medical managers (e.g., non-degreed IT staff, BS or MS in computer science, MBA's, even PhD's) who by custom and tradition are assigned leadership roles in EMR and clinical data research initiatives via control of critical decisions, budgets and resources, often lack clinical experience and insight. Specifically, personnel of an information technology background, with little or no background in the biomedical sciences, often are positioned by senior management as enablers, rather than facilitators, of such initiatives. They retain a major say in what is -- and is not -- done, and in the tools provided to perform clinical care and biomedical R&D.

 

From a dual perspective as both a clinician and computer professional, it is evident that this arrangement is faulty, and that critical clinical computing projects benefit greatly from an alternate approach to project preparation, development, implementation, customization and evaluation as compared to management information systems (MIS) projects. Clinical computing and business computing are different, highly distinct subspecialties of computing, much as neurosurgery and psychiatry are highly distinct medical subspecialties.  (Both of the latter fields focus on the same body part, but the approaches and methodologies of neurosurgery do not work well in psychiatry, and vice versa.)

 

The true nature of clinical settings and the major fault in the management model for clinical IT is captured quite pithily in the article “Hiding in Plain Sight:  What Koppel et al. tell us about Clinical IT” (Nemeth & Cook, Journal of Biomedical Informatics 2005;38:262-263, link to pdf):

 

On the surface, healthcare work seems to flow smoothly. That is because the clinicians who provide healthcare service make it so. Just beneath the apparently smooth-running operations is a complex, poorly bounded, conflicted, highly variable, uncertain, and high-tempo work domain. The technical work that clinicians perform resolves these complex and conflicting elements into a productive work domain. Occasional visitors to this setting see the smooth surface that clinicians have created and remain unaware of the conflicts that lie beneath it. The technical work that clinicians perform is hiding in plain sight. Those who know how to do research in this domain can see through the smooth surface and understand its complex and challenging reality. Occasional visitors cannot fathom this demanding work, much less create IT systems to support it.

 

The Office of the National Coordinator for Health Information Technology (ONC) has recognized numerous barriers to clinical IT adoption.  One barrier is a high failure rate for electronic health record implementation:

 

Current Market Barriers and Challenges to Widespread Adoption of Health Information Technology (ONC)

 

·         Payers don't reward efficiency or quality; they pay based on volume

 

·         Adoption issues

o        There is a negative business case for typical health information technology adopter

o        There is a significant electronic health record adoption gap based on organization size

o        There is a first mover disadvantage for health information technology buyers

 

·         High failure rate for electronic health record implementation

o        There is variable availability of IT expertise in physician offices

o        There is a high failure risk for business re-engineering

o        There is limited implementation support for 75,000 small practices

 

·         Limited capacity for interoperability

o        Few health information technology products include standards

o        Standards are not rigorous and lag behind commercialization

o        There is no viable health information exchange infrastructure

 

IT personnel in healthcare often believe that success in implementing management information systems applications ("business computing") supersedes or actually renders unnecessary the mastery of medicine in leading and controlling implementation of clinical computing tools. Yet, mastery of applied IT towards implementing management information systems is in large part mastery of process (e.g., in acquiring and supporting vendor-written software) and repetition, as opposed to the practice of medicine, which requires mastery of complexity.

In other words, applied IT is a field of a relatively small number of principles, a large number of arbitrary conventions and rules, and a narrow body of knowledge applied repetitively and programmatically, often without scientific rigor. This may be illustrated by the fact that most areas of applied IT can be done well, and often are, by those with little or no formal training. This is not to imply that applied IT is itself easy, which it is not. There is no substitute for talent and real-world experience.

In clinical IT settings, however, there must be the right experience. Experts in clinical computing must provide effective solutions via seasoned application of the concepts, techniques, knowledge, and processes of medicine, and display an expert level of critical thinking in applying principles, theories, and concepts on a wide range of issues that are unique to clinical settings. Business IT experience alone does not provide a sufficient background for such responsibilities to be carried out effectively. Further, medicine is a domain of many difficult, nonintuitive principles, experimentally-derived natural laws, and a large body of knowledge applied in a broad, interconnected manner, ideally with critical scientific rigor. It cannot be practiced successfully without significant mastery of an enormous body of biomedical knowledge and significant hands-on patient care. The IT model of "If it's information, we do it" starts to fall apart and impede progress in such organizationally and sociologically-complex environments.

Leaders in clinical IT must be experienced in medical sciences and in the complex social and organizational issues of healthcare, such as the need for multiple, contextual levels of confidentiality, the politics and psychology of medical practice and referral, the complex medical workflow and the need to rapidly improvise due to the unexpected ("there are no committees in cardiac arrest situations"), and societal and personal sensitivities towards the physician-patient interaction.

In effect, management information systems and clinical systems are highly distinct. The belief that mastery of IT process and repetition for management information systems implementation entitles IT personnel to lead and control implementation and operationalization of essential tools in complex domains such as medicine (e.g., electronic medical records systems) is presumptuous and creates an environment strongly misaligned with the business of healthcare delivery. The belief often results in the exclusion or misutilization of Medical Informatics experts, appropriate clinicians, and other forms of mismanagement exemplified in the typical cases below.

Unfortunately, clinical IT journals avoid covering these issues due to an apparent but understandable “prior restraint” of items that ruffle industry feathers.   Remarkably, those same publications commonly offer articles acclaiming the value of IT personnel allowing clinicians to participate in clinical systems implementation. Clinician involvement is so obviously necessary that such articles might be compared to the New England Journal of Medicine publishing articles on the value of employing sterile technique during surgery. A critical reader should question why articles about IT personnel needing to allow clinicians to participate in clinical IT still appear in print.

The familiar stories of clinical IT failure and organizational discord in hospitals and academia below reflect, as their root cause, basic mismanagement due to significant inadequacies in organizational thinking, structures and support of clinical information technology. Such technology is vital to healthcare quality improvement and prevention of errors. As these stories illustrate, however, this technology is not always treated as such by healthcare leadership, including officers at the "C" level (CEO, COO, CIO etc.) and Boards of Directors.

It should be remembered that failed clinical IT projects are not caused by immutable organizational or political issues. Importantly, failures are caused by the mismanagement of the organizational and political issues and of the people who create the problems associated with these issues.

The direct economic costs of such IT failures (often caused by a minority of personnel in an organization) is in the millions of dollars per year per healthcare organization. The resultant less tangible costs of lost opportunity are more difficult to quantify, but are probably much greater than the direct losses in the long term.

Medical professionals are being held to increasingly stringent standards of quality and accountability at the same time they are becoming highly dependent on clinical IT in taking care of patients. Those who are responsible for clinical IT, including senior healthcare management, have not been held to the same standards of quality and accountability as the medical professionals dependent on this critical IT. This needs to change.

Healthcare, pharmaceutical, and other biomedical R&D organizations that conflate "information provision" with "information technology" and depend on business-IT personnel to do the work of medical informaticists and clinical information scientists do so at their peril.

 

We believe there are a number of key issues that need to be addressed.  These might be categorized as follows:

 

1.  Resistance of some clinicians to rigorous information practices that support quality and safety (which is inclusive of, but not exclusive to, IT resistance);

 

2.  Resistance of the clinical IT vendors to high-quality user-centered design practices;

 

3.  Resistance of IT personnel within delivery organizations to user-centered design practices i.e., in customizations of vendor-acquired products, or internal development of specialized systems;

 

4.  A belief in IT solutions by many stakeholders as a "magic bullet" or panacea - i.e., build an IT system and miracles in clinical quality, operational, compliance and documentation improvements will occur.

 

5.  Financial disincentives for many providers, expecially community based clinicians, to adopt clinical IT;

 

6.  Knowledge that existing systemic organizational faults do contribute to errors in health care delivery.

 

As leaders in the transformation of modern medicine, addressing these issues requires consensus to build strength and voice for which the informatics community must lobby.   The policy initiatives that informaticists  pursue should result in:

 

·        user-centric design practices in industry through studying health IT problems that legitimately cause physician resistance,

·        empowerment of Chief Medical Information Officers (CMIO's) with executive presence and managerial authority,

·        reformation of the hospital MIS department "designer-centric" culture,

·        improved financial incentives for IT adoption,

·        studies of systemic organizational and societal barriers with an aim to improve them.

 

"Blame" as an issue does not move us forward as a medical subspecialty with mission, vision and values.  If we are to issue "blame", it should perhaps be directed towards those minority of individuals among the stakeholder groups who make suboptimal decisions out of self-interest.  Empowered CMIO's and trained informatics personnel with proven expertise are one remedy to "filtering" those who have lost sight of the broader perspective of improving healthcare with appropriate HIT tools.  

 

An article worth reviewing is "Human error: models and management ", James Reason (a fitting name!), BMJ 2000;320:768-770 ( 18 March ), http://www.bmj.com/cgi/content/full/320/7237/768 :

 

Summary points:

 

·        Two approaches to the problem of human fallibility exist: the person and the system approaches

·        The person approach focuses on the errors of individuals, blaming them for forgetfulness, inattention, or moral weakness    

·        The system approach concentrates on the conditions under which individuals work and tries to build defenses to avert errors or mitigate their effects

·        High reliability organizations---which have less than their fair share of accidents---recognize that human variability is a force to harness in averting errors, but they work hard to focus that variability and are constantly preoccupied with the possibility of failure.