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Saturday, July 19, 2014

Medical Error, Interop, and the Patient Safety-Health IT nexus

"Preventable medical errors persist as the No. 3 killer in the U.S. – third only to heart disease and cancer – claiming the lives of some 400,000 people each year."
Wow. Where does Health IT fit into that?

I've been reviewing the recent RAND study (pdf).
Promoting Patient Safety Through Effective Health Information Technology Risk Management
Health information technology (IT) safety has several dimensions: using health IT to make care safer, ensuring that health IT is itself safe, and ensuring that health IT is used safely. The potential for health IT to improve the safety of health care delivery has been appreciated for decades, but the role of health IT in introducing safety risks has been recognized only more recently. As the use of health IT has grown, users have begun also to observe its fallibility. Hardware and software can malfunction. Data can be lost or corrupted during transmission. Deploying complex technologies in a complex organizational environment can introduce new hazards and safety risks. Identifying and mitigating health IT safety risks is a relatively new undertaking for most health care organizations. The introduction of health IT safety improvement initiatives could be expected to face many of the challenges that accompany introduction of any change to clinical practice. Introduction of new tools and practices can require substantial organizational effort...
None of these concerns are actually "news." And, the most strident critics of Health IT continue to angrily assert that EHRs are dangerous, unregulated "medical devices." I joust with them regularly on the major HIT blogs. Not that I summarily dismiss their concerns. Having commenced my white collar career writing apps code in a forensic-level radiation lab in Oak Ridge in the 80's, I know a thing or two about software QA and "usability" (dated as my keyboard-level experience may now undeniably be). Skeptics are a necessary and good thing, insofar as they don't wander off into "Perfectionism Fallacy" territory (sometimes called the "Nirvana Fallacy"). While there is indeed much merit in the HIT criticisms, I find a good bit of the anti-HIT carping as unscientific as the charges of lack of rigor they lob (usually from behind their untraceable troll screen names) at the industry and the regulators.

You gotta Walk your Talk, boys.

The RAND methodology:
To learn about the sites’ experience with the process improvement strategy, including the resources and safety event reporting, an evaluation team from the RAND Corporation conducted in-person and telephone interviews with representatives of six of the hospitals and ambulatory practices. The evaluation team used a semi-structured interview protocol to elicit information about the sites’ experiences with identifying risks and implementing new health IT safety practices, as well as their experiences with the AHRQ Common Formats. The evaluation data were analyzed thematically and described in case study reports. A comparative analysis was performed to identify differences and similarities in sites’ implementation experiences; to develop a series of lessons learned; and to offer recommendations that may be useful to hospitals and ambulatory practices seeking to manage safety risks posed by health IT, policy makers, electronic health record (EHR) developers, and other stakeholders.
More excerpts:
Health IT Safety Risk Identification and Mitigation
Identifying and mitigating health IT safety risks is a relatively new undertaking for most health care organizations. The introduction of health IT safety improvement initiatives could be expected to face many of the challenges that accompany introduction of any change to clinical practice. Introduction of new tools and practices can require substantial organizational effort.11, 12 Health IT improvement poses unique challenges. Line authority over health IT–related risks within health care provider organizations is not well articulated or standardized. The multiple distinct lines of management authority over health IT, quality, and safety within organizations may create a hurdle to the systematic and coordinated identification and management of IT risk. For example, in hospitals and larger medical groups, operation of EHRs is typically managed by an IT department, efforts to improve safety may be carried out by a quality management group with a medical director and a patient safety officer, risk management is the purview of risk and liability managers, and regulatory compliance and reporting may be embedded in a compliance department. In ambulatory settings, one individual may be responsible for several of these tasks. Hospitals and ambulatory practices may be able to collaborate with health IT developers to reduce health IT–related safety risks, but it is unclear how developers and their customers should work together to identify and mitigate such risks...
Fostering Collaboration Among Departments and Disciplines
Health IT safety is a cross-cutting area that creates an opportunity for risk management staff, safety staff, and IT staff to collaborate. Each disciplinary perspective contributes distinct knowledge to the detection, analysis, and mitigation of health IT safety risks. Several enablers of collaboration could support future initiatives: (1) disseminating best practices (case study examples of organizations that have successfully tackled a particular problem) and project templates (step-by-step project guides for specific problems or checklists); (2) providing staff from distinct disciplines with training in core terminology and methods related to safe use of health IT; and (3) developing a cadre of experts who can provide consultation through regional extension centers (RECs), PSOs, or other organizations and can facilitate training programs. The SAFER Guides provide a valuable tool for multidisciplinary, multifunctional teams to optimize the safety and safe use of health IT, EHRs in particular...
Content I was most interested in finding is referenced in Table 2.1
  • Internal organizational features -- Policies, procedures, work environment, and culture.
Cutting to the chase,
Beyond expertise and infrastructure for quality improvement, staff at several sites emphasized the need for a “culture of safety” within the organization. A culture of safety (or “just culture”) implies that an organization treats error as an opportunity for improvement rather than cause for individual blame. Indicators of a culture of safety include a system for encouraging and rewarding staff for identifying risks and reporting adverse events and a non-punitive approach to addressing medical error...
OK, so far, so good. Recall my "Talking Stick" post. to wit:
My recent posts have ruminated on what I see as the underappreciated necessity for focusing on the "psychosocial health" of the healthcare workforce as much as focusing on policy reform (e.g., P4P, ACOs, PCMH), and process QI tactics (e.g., Lean/PDSA, 6 Sigma, Agile), including the clinical QI Health IT-borne "predictive analytics" fruits of ""Evidence Based Medicine" (EBM) and "Comparative Effectiveness Research" (CER). Evidence of psychosocially dysfunctional healthcare organizational cultures is not difficult to find (a bit of a sad irony, actually). From the patient safety-inimical "Bully Culture" down to the "merely" enervating emotionally toxic, I place it squarely within Dr. Toussaint's "8th Waste" (misused talent).
Summing things up:
The challenges and lessons identified in this pilot project point to several opportunities to increase the safe use of health IT systems. We draw several conclusions about the current state of health IT safety risks:
  1. With few exceptions, awareness of the safety risks introduced by health IT is limited. Many organizations sense that health IT is difficult to implement successfully, and some have experienced significant patient safety events, but organizations vary in their appreciation of the connection between those difficulties and events and their health IT installation. At the current time, engagement of front line clinicians in detecting and mitigating health IT–related safety risks appears to be limited.
  2. The traditional departmental “silos” between risk management, IT, and quality and safety management may impede the ability of organizations to recognize and respond to health IT safety risks. This is especially the case in hospitals. For some hospitals, this project represented the first time that staff from these different departments had worked in collaboration with one another.
  3. External facilitation appears to be important to hospitals and practices, but the model for providing consultation and technical assistance requires further elaboration. This model has to account for wide variation in the capabilities of most hospitals and ambulatory practices to take on health IT risk mitigation projects.
  4. Most ambulatory practices lack the risk management, IT, and quality and safety expertise that is available in hospitals. Ambulatory practices have limited staff capacity to address health IT safety, given the more pressing challenges of maintaining a financially viable ambulatory practice in a rapidly changing health care market.
  5. There is an urgent need for tools and metrics to enable project teams in hospitals and ambulatory practices to detect, mitigate, and monitor health IT safety risks. Tools available to project teams during this project were not adequate to fully support the needs of the organizations participating in this pilot project.
  6. The current structure of the EHR marketplace, and the low awareness of the risks introduced by health IT systems, lead to weak incentives for EHR developers and providers to invest in the type of joint effort required to reduce health IT safety risks. Because of that market failure, certification and standards will continue to be an important mechanism for ensuring that EHR products are designed to minimize the introduction of new safety risks.
The RAND report concludes:
The investment that is converting the U.S. health data infrastructure into a 21st century enterprise has the potential to improve care for patients in countless ways. However, “digitizing” the health system also has the potential for harm. In this project, we worked with 11 hospitals and ambulatory practices to evaluate a process improvement strategy and tools developed to help health care organizations diagnose, monitor, and mitigate health IT–related safety risks. While many of the health care organizations (especially the hospitals) had expertise in process improvement, we found a general lack of awareness of health IT–related safety risks (especially in ambulatory practices) and concluded that better tools are needed to help these organizations use health IT to improve care and to optimize the safety and safe use of EHRs. The SAFER Guides provide an excellent beginning, but until health care organizations have a better understanding of the safety risks posed by EHR use, tools like the SAFER Guides may not be used to their full potential. There may also be a need for additional tools and metrics (and further usability study of existing tools and metrics) to better support the needs of health care organizations. ONC could additionally support efforts in this area by strengthening incentives for EHR developers to make safer health IT products and to participate with providers in risk mitigation.
Yeah. One persistent limitation I find in all of these reform proposals is that we continue to have a near-exclusive "transactional / instrumental" view of people in the healthcare workforce. Maybe that works fine for Amazon or WalMart (see Simon Head's "Mindless"), but I would like to see more explicit "Just Culture" emphasis on what I have come to call the "psychosocial health" of care delivery organizations. Maybe I'm being naive, running the risk of becoming the butt of Dilbert Zone jokes.

I don't think so. I repeat once more:
A psychosocially healthy workplace is a significant profitability and sustainability differentiator.
Again, some of my recent recommended reading list on the subject:

To which I will add one more.

This book is an utter delight. An important read. I read it quite some time back, and am going back through it closely with the highlighter for further triangulation.
To err is human. Yet most of us go through life tacitly assuming (and sometimes noisily insisting) that we are right about nearly everything, from the origins of the universe to how to load the dishwasher. If being wrong is so natural, why are we all so bad at imagining that our beliefs could be mistaken – and why do we typically react to our errors with surprise, denial, defensiveness and shame?

In Being Wrong, journalist Kathryn Schulz explores why we find it so gratifying to be right and so maddening to be mistaken, and how this attitude toward error corrodes our relationships—whether between family members, colleagues, neighbors, or nations. Along the way, she takes us on a fascinating tour of human fallibility, from wrongful convictions to no-fault divorce, medical mistakes to misadventures at sea, failed prophecies to false memories, “I told you so!” to “Mistakes were made.” Drawing on thinkers as varied as Augustine, Darwin, Freud, Gertrude Stein, Alan Greenspan, and Groucho Marx, she proposes a new way of looking at wrongness. In this view, error is both a given and a gift – one that can transform our worldviews, our relationships, and, most profoundly, ourselves.

In the end, Being Wrong is not just an account of human error but a tribute to human creativity – to the ways we generate and revise our beliefs about ourselves and the world. At a moment when economic, political, and religious dogmatism increasingly divide us, Schulz explores the seduction of certainty and the crisis occasioned by error with uncommon humor and eloquence. A brilliant debut from a new voice in nonfiction, this book calls on us to ask one of life’s most challenging questions: what if I’m wrong?
"Human factors," "culture of safety," "UX," etc, yeah, all fine and necessary. But, a more nuanced view of the breadth of the nature of error -- "being wrong" -- is warranted, in my view.


From a Journal of Quality and Safety in Healthcare paper cited in the RAND study:
Safety culture assessment: a tool for improving patient safety
in healthcare organizations

V F Nieva, J Sorra

...Professional and organizational cultures in health care must undergo a transformation in the interests of promoting safer patient care. Health care must come to see itself as a high hazard industry which is inherently risky. It must abandon the philosophy of requiring perfect, error free performance from individuals and focus, instead, on designing systems for safety. Healthcare systems must move away from the current ‘‘blame and shame’’ culture that prevents acknowledgement of error and therefore obstructs any possibility of learning from error. Safety improvement requires that healthcare systems have ready access to information that supports learning from experience in order to promote systems that both prevent errors and mitigate the impact of errors that occur. In contrast to a ‘‘pathological culture’’ where failure is punished or concealed and people refuse to acknowledge that problems exist, a positive safety culture recognizes the inevitability of error and proactively seeks to identify latent threats...

For example, adverse event reporting systems will not overcome chronic under-reporting problems within a punitive culture where acknowledgement of error is not acceptable. Analytical methods such as root cause analysis (RCA) and failure mode effects analyses (FMEA) will not succeed in uncovering latent sources of error if staff, bound by an implicit ‘‘code of silence’’ and a fear of challenging the institutional hierarchy, are uncomfortable with exposing weaknesses in processes for which they are responsible. Even benefits from new technologies designed to improve safety, such as computerized physician order entry, may not be realized if they are not accompanied by cultural and process changes...

OK, that was published in 2003! Are we just gonna study things to death forever, publishing an endless stream of papers for wonk audiences, redundantly advocating for that which has already been advocated multiple times? I know: maybe AHRQ can let an RFP for an $800,000 two-year research grant via which to study the RAND study (like they've done with topics such as workflow).


It's been a tough week for focusing attention on the issues pertinent to this blog. First, the renewed acute violence in Gaza, and then the astonishing atrocity of the shooting down of Malaysian Airlines flight 17 over the Ukraine. Very depressing.

More to come...

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