Improving patient safety is one of the most urgent issues facing healthcare today. Patient Safety and Quality Healthcare (PSQH) is written for and by people who are involved directly in improving patient safety and the quality of care.
PSQH welcomes original submissions from all healthcare professionals on topics related to safety and quality. PSQH publishes a variety of articles, to reflect the breadth of work being done in this field: case studies, surveys, research, book or technology reviews, guest editorials, essays, and letters to the editor.
By Susan Carr
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By Anna Mariani Reseigh, RN
As a registered nurse, I often feel like I am torturing our elderly. Why? Because of the protocols we follow in the United States. Below is the story of my patient DP. It is one of thousands of similar stories where we, healthcare providers, do bizarre things that would equate to torture in other contexts: We force our elderly to live, when their bodies are attempting to die.
DP was a 69-year-old woman who lived in a nursing home. Her health history was largely unknown, because she was a poor historian because of her Alzheimer’s disease. She had a PEG tube because she could no longer eat, and a urinary catheter because she could no longer urinate. She had pressure ulcers on her sacrum, elbows, shoulder blades, and left ear. She was 63 inches tall and weighed 110 pounds. She was being kept alive, but she was not living.
At 08:40 a.m. on November 8, 2014, DP stopped breathing, and her heart stopped beating. She died. Cardiopulmonary resuscitation (CPR) was started. Paramedics arrived within minutes. On the cardiac monitor, her heart rhythm was asystole. CPR was continued until spontaneous circulation returned at 9:20 a.m., following a 40-minute period without a known pulse. While CPR in TV shows has good outcomes, for frail, elderly people it is dangerous, often causing broken ribs and other complications. DP was transported to the emergency department of my hospital.
There, a tube was inserted down her throat and attached to a ventilator to oxygenate her since she could not breathe on her own. A second tube was put down her throat and into her stomach to remove gastric fluid. A tube was placed into her femoral artery to deliver medications and fluids.
Next, she was transferred to the ICU into my care. Knowing this situation had a poor prognosis, the ICU team next attempted to contact DP’s emergency contact, which was a law firm, where the pertinent person was on vacation until the 17th. A family member was eventually found. An order was initiated to allow natural death and provide comfort care. We finally stopped interfering in DP’s life and allowed her to pass peacefully and comfortably at 2:23 p.m. on November 10, 2014.
Why did we, the medical community, do all of this to DP? Why do we intervene in the natural dying process of our elderly? The answer is that allowing a natural death runs counter to the U.S. medical model, which strives to prolong life, using a wide array of procedures, such as intubation, feeding tubes, catheters, cardiopulmonary resuscitation, medications, and tests.
Is this what our elderly want? In most cases, the answer is no. The goal of a peaceful death is valued according to findings of a national survey of more than 2,500 patients old enough to qualify for Medicare (Barnato et al., 2007). Presented with a hypothetical terminal illness, 86% preferred to die at home, while only 9% preferred to die in a hospital; 83.9% did not want potentially life-prolonging drugs that would make them feel worse all of the time; 71.7% preferred palliative drugs even if they might be life-shortening; 87.4% stated they would not want to be put on a ventilator if it would extend their life one week; and, 77.4% would not want to be put on a ventilator even if it extended their life one month (Barnato et al., 2007).
Sadly, these preferences are not being realized. According to an analysis of 20% of Medicare claims in 2009, the site of death for over 52% of Medicare beneficiaries aged 66 years and older was an acute care facility or nursing home (Teno, et al., 2013). The site of death only provides information on where the person was at the time of death. It does not describe the end-of-life (EOL) experience. The Medicare claims were further analyzed for the 90 days prior to death to get a more accurate picture of the EOL experience: 69.3% were hospitalized, 29.2% had intensive care unit admissions, 42.8% had nursing home admissions, and 11.5% had three or more hospital admissions (Teno, et al., 2013). In summary, the data show that while a majority of people prefers to die at home, a majority of people are in an institutional setting at the time of their death and/or during the 90 days prior to their death.
This data leads us to the following question: How do we, the medical community, honor our patients’ wishes for EOL care? First, we need to know what their wishes are. We need to talk to our patients about death. Most patients and their family members are fearful of dying. They fear pain, unrelieved symptoms, and abandonment. We need to educate our patients on the dying process, provide the pros and cons for interventions, identify their goals for EOL, and align our care with their wishes. In DP’s case, that should have happened early in the diagnosis of her Alzheimer’s disease.
Second, we need to re-evaluate our protocols, which are designed to stop disease processes. Dying is not a disease process. It is a natural process. Our protocols need to distinguish the difference and treat them accordingly.
As a nurse, I take great pride in providing safe, excellent care to my patients and their families. At times, that care is EOL care. In those cases, my goal is to help patients and their families experience a peaceful passing. While it is certainly sad to lose our loved ones, it is even sadder to torture them in their final days.
Barnato, A. E., Herndon, M. B., Anthony, D. L., Gallagher, P. M., Skinner, J. S., Bynum, J. P., Fisher, E. S. (2007). Are regional variations in end-of-life care intensity explained by patient preferences? A study of the U.S. Medicare population. Medical Care, 45(5), 386-393. doi: 10.1097/01.mir.0000255248.79308.41
Teno, J. M., Gozalo, P. L., Bynum, J. P., Leland, N. E., Miller, S. C., Morden, N. E., . . . Mor, V. (2013). Change in end-of life care for medicare beneficiaries. Journal of the American Medical Association, 309 (5), 470-477.
By Susan Carr
Diagnostic improvement—the new frontier in patient safety—was the focus of important events held recently in and around Washington, D.C. At a public briefing on September 22, the Institute of Medicine (IOM) announced the release of a new report, Improving Diagnosis in Health Care.A few days later, the Society to Improve Diagnosis in Medicine (SIDM), which had encouraged the IOM to develop the report and supplied funding, held the 8th annual International Conference on Diagnostic Error in Medicine (DEM) in Alexandria, Virginia.
Although few DEM attendees had yet absorbed the more than 350-page report, it provided food for thought and debate. SIDM’s founder and president, Mark L. Graber, MD, served on the committee that helped develop the report, as did a number of attendees and speakers, while others served as reviewers or shared their expertise with the committee.
On the final morning of DEM, Victor Dzau, MD, president of the National Academy of Medicine and chair of the IOM, spoke to the conference, emphasizing the report’s importance as a next step in the IOM’s continuing efforts to improve the quality of healthcare delivery. Earlier IOM reports, To Err Is Human: Building a Safer Health SystemandCrossing the Quality Chasm: A New Health System for the 21st Century, alerted the country to deficiencies in healthcare, prompting concern and activity. Dzau acknowledged, however, that the patient safety movement has not addressed diagnosis until recently. He hopes that the new report serves as a “serious wake-up call” for the provider community and the public.
Beyond its eight goals and related recommendations for improving diagnosis, the aspect of the report that generated the most discussion at DEM was its definition of diagnostic error:
The failure to (a) establish an accurate and timely explanation of the patient’s health problem(s) or (b) communicate that explanation to the patient. (p. 3-4)
Attendees at prior DEM conferences, as well as participants on SIDM’s listserv and LinkedIn group, have been debating for years how to define diagnostic error. Three distinct definitions—put forward by Mark Graber; Hardeep Singh, MD; and Gordy Schiff, MD—have focused much of that discussion. And now there are four. While the distinctions are important, most debaters, as well as conference attendees and SIDM leaders, agree that the challenge of defining diagnostic error should not impede improvement efforts.
Many topics addressed at DEM, in scheduled presentations or informal discussion, deserve detailed coverage, but for now, here’s a brief list of themes:
• Although making a diagnosis has been considered primarily the physician’s responsibility and domain, other professionals and stakeholders are central to improving diagnosis. They participate by contributing information and expertise, communicating effectively, developing and deploying technology, and improving healthcare systems. Bringing more participants, including patients and their advocates, into the diagnostic “tent” is part of an effort to improve diagnosis by treating it as a process—not a physician’s discrete, solitary experience. Attendance at DEM grew by more than 25% compared to last year. Although physicians are still in the majority, others—nurses, administrators, engineers, and this year, DEM’s first physical therapist—are attending and presenting in growing numbers.
• Diagnostic safety is an international movement. Three hundred and twenty attendees at DEM represented 15 different countries, including 22 attendees from Japan. In addition to the main DEM conference in the fall—scheduled for November in Los Angeles—SIDM plans to hold a “satellite” DEM conference in spring 2016 in Europe and possibly one in Asia in spring 2017. Those conferences will be designed to expand the DEM network, not to replace DEM in the fall.
• Some physicians are concerned that documentation may unwittingly lead to misunderstandings and errors by forcing premature specificity about diagnosis. Especially in electronic records, diagnoses may appear to be more certain than they are. Codes in ICD-10, the system that went live in the United States on October 1, are more specific than they were in ICD-9, which will make this problem worse. As heard at DEM and seen on the SIDM listserv and LinkedIn group, many physicians wish there were a way to record a tentative diagnosis or to note the degree of certainty/uncertainty for a given diagnosis. Diagnoses may change over time as symptoms evolve and more data become available, but current medical records are not designed to make this apparent. Once entered in the medical record, a diagnosis will tend to stick and be taken at face value by other clinicians.
Two internists practicing in New Zealand—Art Nahill and Nic Szecket—offer occasional podcasts about clinical reasoning and diagnostic safety. They attended DEM and recorded their reflections on the presentations and discussion at the end of each day; those thoughts are now available on their website, IMreasoning.com. Nahill and Szecket manage to cover serious issues in an informal style that listeners from different backgrounds will find appealing and accessible.
By Timothy Kelly, MS, MBA
“Sorry doc, Medicare isn’t going to cover the cost for me to stay overnight. I’m going home.” These were the words of a savvy elderly patient to an emergency department (ED) physician in Indianapolis a few months ago. That ED physician described the encounter to me when I visited the hospital to discuss a new automated patient follow-up solution. The ED physician characterized the patient, who refused to be admitted for observation, as exactly the type of patient who would benefit from a text, email, or call to check on how he was faring the next day.
Complexities of Observation Status
The financial concern of that Indiana patient was both astute and a little unusual. Many Medicare patients do not understand the ramifications of an observation admission. Last July, the U.S. Senate heard testimony on both the confusion associated with observation status and the Medicare coverage implications for seniors.
In a nutshell, there are two significant financial challenges that patients may face when admitted to a hospital under observation status:
- An admission for observation is usually considered outpatient status, and thus the patient may, in some cases, bear a higher burden of the hospital expenses than would occur under an inpatient admission
- The outpatient stay does not count toward the three consecutive inpatient days required for subsequent care at a skilled nursing facility to be covered
States Take Action
Several states have enacted legislation that requires written notification of patients’ observation status along with the potential coverage consequences:
- Maryland (effective October 1, 2013)
- New York (effective October 21, 2013)
- Connecticut (effective October 1, 2014)
- Pennsylvania (effective April 20, 2015)
- Virginia (effective July 1, 2015)
All of these states have recognized the benefit of better informing patients whose Medicare coverage, and frequently private insurance coverage, may not fully pay for tests, x-rays, scans, and other services if the patient is considered an outpatient.
On August 6, 2015, President Obama signed into law a bill that mirrors the requirements set forth by these East Coast states. The Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act) requires specific disclosures to Medicare beneficiaries. Key provisions of the NOTICE Act include the following:
- Hospitals must notify patients of their status no later than 36 hours after they begin receiving observation services
- Patients must receive a written explanation of their status, which includes:
- Explanation that the patient is considered an outpatient, not an inpatient
- Explanation of the coverage implications, including cost-sharing requirements and impact on eligibility for coverage at a skilled nursing facility
- The written explanation must be formatted using “plain language” and signed by the patient or the patient’s representative
Reaction to the Legislation
A number of organizations have lent their support to the NOTICE Act. The American Hospital Association, the American Academy of Emergency Physicians, and the American Health Care Association all support the transparency demanded by the legislation.
Some, however, may argue that the bill does not do enough for Medicare patients. For example, there is legislation pending in New Jersey that seeks to allow patients admitted for observation to use their own medications rather than pay for them out of pocket, as is required for an admission under outpatient status. The AARP Public Policy Institute has recommended Medicare coverage changes along with improved communication. Those changes include a cap on out-of-pocket spending for observation patients and counting the time spent under observation care toward the three-day inpatient stay required to qualify for coverage at a skilled nursing facility.
What will be the impact of the NOTICE Act as it is implemented in the coming months? Are hospitals prepared for the task of educating patients about the financial implications of various types of care? One would expect that patients will face fewer surprises relative to their Medicare coverage. Armed with that information, will more of those patients decline observation care, as did the patient in Indianapolis? How will hospitals and providers respond to a potential increase in patients leaving against medical advice?
Ultimately, transparency and disclosure are foundational to patient autonomy. The NOTICE Act expands that duty of disclosure to a particularly complex care scenario. Forward-thinking organizations are preparing for the NOTICE Act by reassessing their observation programs, preparing for the task of better informing patients, and expanding their follow-up programs to extend the care of patients who have been discharged from their facilities.
Tim Kelly is responsible for patient education and patient follow-up solutions at Standard Register Healthcare and is an active member of HIMSS, ASHRM, and ACRP. On November 6, 2015, at 1 p.m. EST, he will present a free webinar: “The NOTICE Act – What Your Organization Needs to Know.”
Now available online, the latest issue of Patient Safety & Quality Healthcareoffers articles on a wide range of topics and a continuing focus on education. The cover story, “A Model for Simulation-Based Interprofessional Team Learning,” is by Brian Patterson, a fourth-year medical student at Wright State University’s Boonshoft School of Medicine in Dayton, Ohio. Patterson’s article and another article in the issue, “Training for Integrated Multidisciplinary Care,” by Ramon Cancino, MD, share a connection to the Institute for Healthcare Improvement’s Open School. Patterson and Cancino are among more than a dozen members of the Open School who responded to a call for essays, which has developed into a series of articles in print and online that highlight interprofessional education.
The series began in the May/June issue with “Interdisciplinary Education: More Than Just Buzzwords?” by Josh Adams, a student at the California School of Podiatric Medicine at Samuel Merritt University in Oakland. The series continues this month online, with “Labor and Management Working Together to Improve Patient Satisfaction,” by Preeti Jadhav, MD, a resident in internal medicine at Bronx Lebanon Hospital in Bronx, New York.
In addition to education, the current issue offers articles on improving care in behavioral health. Laura Young reports on a first-of-its-kind health information exchange in Arizona devoted to mental health information. Young, who is executive director of the Behavioral Health Information Network of Arizona (BINHAZ) explains,
Sponsored by seven nonprofit behavioral health organizations, BHINAZ gathers, routes, and queries data from a wide range of service providers, including substance abuse programs, crisis professionals, general mental health practitioners, and children’s behavioral health specialists, in three separate repositories for clinical data, documents, and patient consent.
In the second article, Judith Shields and her co-authors describe a patient satisfaction survey process developed by Liberty Healthcare to monitor and improve the quality of acute and primary care delivered to patients with behavioral health needs in a variety of settings, including in prisons.
By Victor Lee, MD
The Latin phrase “primum non nocere” means “first do no harm” and is a shared goal for clinicians across a wide variety of healthcare professions. It should also be a shared goal for all health information technology (IT) professionals. Health IT solutions, while intended to improve the quality, safety, and efficiency of patient care, may sometimes result in patient harm. Although a recent study shows an overall benefit from using health IT, it is still imperative that we continue to better understand and minimize any unintended consequences of these solutions.
One of the goals of the Food and Drug Administration Safety and Innovation Act (FDASIA) was to strike the right balance between fostering health IT innovation and optimizing patient safety. As required by FDASIA, the Food and Drug Administration (FDA), Office of the National Coordinator for Heath IT, and Federal Communications Commission released a Health IT Report on Proposed Risk-Based Regulatory Framework in April 2014. The report places most clinical decision support (CDS) solutions under a health IT category called “health management health IT functions.” It states that the FDA does not intend to focus its regulatory oversight on such functions because CDS is generally associated with a favorable benefit-risk profile. Instead, the FDA recommends that health IT stakeholders work together to mitigate safety risks.
To that end, the report also included a recommendation for the formation of a national Health IT Safety Center envisioned since the 2012 Institute of Medicine report as a public-private entity. It would convene stakeholders committed to using health IT to make care safer and to continuously improving the safety of health IT. On July 17, 2015, ONC released its long-awaited Health IT Safety Center Roadmap, which proposes the following four focus areas:
- Collaborate on solutions to address health IT safety-related events and hazards.
- Improve identification and sharing of information on health IT-related safety events and hazards.
- Report evidence on health IT-related safety and on solutions.
- Promote health IT-related safety education and competency.
The Health IT Safety Center will depend on public-private stakeholder collaboration to succeed. Since the Health IT Safety Center will not conduct regulatory enforcement activities, and participation will be voluntary, we will only harvest the wisdom of the crowds if we can engage stakeholders in open dialogue about safety issues and best practices that can be shared non-punitively and disseminated broadly.
At a minimum, we need representation from providers and health IT implementers within healthcare organizations. We also need representation from the vendor community, including EHR, CDS, and other health IT vendors who will work alongside researchers and policymakers. Our experiences with patient safety are likely to be more similar than different, and our collective learnings could be extrapolated across the industry.
All healthcare organizations must work toward developing and enhancing a culture of safety. While the Health IT Safety Center may work toward the four focus areas, it is incumbent upon all constituents in the health IT ecosystem to leverage the work produced and to be engaged and committed to advancing patient safety through their own local programs.
This call to action must be communicated to organizations through the actions of executive leadership. Will they engage in the Health IT Safety Center? Are they staffing roles that are accountable for patient safety? Do they support a systems approach to patient safety through transparent organization-wide processes as opposed to blaming individuals? Are safety issues being addressed in a timely manner? These are some potential barometers of a safety culture.
In my workplace, we embrace the Swiss cheese model of system accidents that says a systems approach to understanding healthcare errors is far more likely to result in productive change than blaming individuals. Hence, there is a strong orientation toward internal process definition and change for CDS development and implementation.
For example, it is possible that medication orders entered in the order set templates may generate potential patient safety issues if written erroneously. Simply entering a decimal in the wrong position or selecting the incorrect unit of measure from a pick list can result in prescriptions that are orders of magnitude different than the intended doses. Therefore, we invest heavily in quality assurance processes to review all medication orders. This is done from both a standalone perspective (e.g., does this medication order fall within normal dose limits for any condition and in any population?) as well as in the context of a given order set (e.g., an antibiotic dosage might be acceptable for an adult with community-acquired pneumonia but not for a pediatric patient).
Processes have also been developed to escalate the evaluation of potential patient safety issues and the rapid implementation of corrective actions if necessary. As an example, our order sets and plans of care can be transferred electronically to electronic health record (EHR) systems. Whenever updates are applied to our software or to that of our EHR vendor partners, subtle changes can sometimes produce unexpected results as we test the integration between systems. Our employees are empowered to trigger our evaluation process to call on clinical and technical resources to evaluate whether potential patient safety issues are present—and if so, their severity and likelihood. This work then informs subsequent steps to correct and prevent the issue.
We look forward to elaborating on these and other best practices with the health IT community via the Health IT Safety Center, as well as learning other safety best practices from our peers. Openness and transparency in this forum can go a long way toward filling the holes in patient safety and minimizing unintended consequences of CDS and other health IT solutions.
What an expert diagnostician and physician podcasters have learned from radio’s favorite car mechanics.
One can only imagine how radio personalities Tom Magliozzi and his late brother, Ray, would react to news that physicians are taking their approach to solving automotive problems and applying it to improving medical diagnosis. Recently, patient safety experts have begun to pay more attention to understanding and preventing diagnostic failure; those efforts often focus on the cognitive process—clinical reasoning—that physicians use in diagnosis. Looking beyond traditional lectures and textbooks, some experts find that the Magliozzi’s method of car repair—build a relationship, take the history, generate a hypothesis, and eventually arrive at a diagnosis and treatment plan—also works well in medicine.
In weekly episodes of Car Talk on National Public Radio, the Magliozzi’s entertained listeners and themselves with real-time analysis of problems described by callers in need of help with their cars and, sometimes, life’s other problems. The program became a local favorite soon after it debuted in 1977 on WBUR, Boston University’s radio station. Ten years later, it went national and developed cult status.
In JAMA in 2011, expert diagnostician Gurpreet Dhaliwal, MD, analyzed the Magliozzi’s cognitive method and recommended that medical students and faculty learn from “media’s finest example of clinical reasoning” (p. 918).
More recently, two internists in New Zealand weave references to the Magliozzis’ Car Talk—including folksy theme music and friendly style—through a new podcast series called IM Reasoning, “conversations to inspire critical thinking in clinical medicine and education.” The series begins with a brief introduction focused on hosts Nic Szecket and Art Nahill, both of whom settled in NZ as adults. Nahill is originally from the Boston area, which may explain the series’ close ties to Car Talk. As of early August, three episodes are available: “Setting the Stage, How Drs Think,” “Biases,” and “Differential Diagnosis and Problem Representation.” On the website, links to supporting articles accompany each episode.
Listening to the podcasts, I am reminded of the universal appeal and relevance of many lessons in safety and quality improvement. Szecket and Nahill don’t dumb down their discussion of clinical reasoning and case-based examples, but their approach—like the Magliozzi’s—is honest and kind in a way that should appeal to anyone with an interest in how humans think and work together to solve problems.
(Hat tip: I learned about the podcast series through messages posted to a Listserv moderated by the Society to Improve Diagnosis in Medicine.)
In July, investigative news organization ProPublica published a “Surgeon Scorecard,” an interactive database that supplies consumers with information about the performance of individual surgeons for specific operations. To construct the scorecard, ProPublica used five years of Medicare data (2009–2013) covering 2.3 million surgical procedures and 17,000 surgeons. Patients were enrolled in Medicare’s fee-for-service program, and results were risk-adjusted for the patient’s age and health, as well as the hospital where the surgery took place. Patients admitted from emergency departments or nursing homes were excluded. The scorecard covers eight common surgeries, including total knee and hip replacements, and uses inpatient mortality and 30-day readmissions as indicators of patient harm.
In addition to giving consumers access to information, the scorecard and related materials give policy experts and healthcare professionals a springboard for deeper conversations about how best to measure and publish comparative data about provider performance. ProPublic.org includes links to the interactive scorecard and supporting materials:
Surgeon Scorecard by Sisi Wei, Olga Pierce, and Marshall Allen for ProPublica
In addition to the searchable database, the scorecard website guides consumers through understanding what information is available and how it was constructed. The website links to many other resources, including:
How We Measured Surgical Complications by Olga Pierce and Marshall Allen
A brief description of the methodology used to create the Surgeon Scorecard
Assessing Surgeon-Level Risk of Patient Harm During Elective Surgery for Public Reporting by Olga Pierce and Marshall Allen
Detailed analysis of the development of the Surgeon Scorecard
Why We Are Publishing Surgeons’ Complication Rates by Stephen Engelberg
‘Dr. Abscess’ and Why Surgeon Scorecard Matters by Stephen Engleberg
Jha, who consulted on the project, acknowledges that the scorecard is imperfect but believes it is an important, disruptive first step toward transparency.
By Paul Batalden and Earl Conway
The poet William Stafford describes the way that words sometimes seem like magic to come together and live together. In some ways, his simile—“like magic”—remains true about “Every system is perfectly designed to get the results it gets” as noted in the Editor’s Notebook column in the July/August 2008 issue of Patient Safety & Quality Healthcare.We write today to offer some additional context.
We worked together as co-chairmen of the U. S. Quality Council of the Conference Board in the 1970s. While together, we learned that both of us had been tremendously influenced by the thought and practice of Dr. W. Edwards Deming. His invitation to think in terms of results generated by systems within which we all work were deeply important to us then—and now. His teachings build on the Theory of Variation and the need to redesign (i.e., improve) the system to narrow variation as the principal cause of error.
Earl had the benefit of knowing and working with David Hanna at Procter and Gamble. Hanna, a student of organization development and expert who eventually put his thoughts together in a book, Designing Organizations for High Performance, as part of the Addison-Wesley [now Prentice Hall] OD series of volumes. He shared with Earl (and in his book, p. 36) the insight of his P&G colleague from the U.K., Arthur Jones: “All organizations are perfectly designed to get the results they get!” Earl brought that insight to the attention of the U. S. Quality Council in one of our meetings.
As Paul thought about the profound truth of that insight and of its use for work with health professionals, some of whom were less interested in “organizations” than in “systems,” Paul created a corollary to the Jones words: “Every system is perfectly designed to get the results it gets” and has shared the words with many others.
We write to share our joy in bringing these additional words of context to others—but in some ways still appreciating the poet’s insight that words come together and live together in what seems—at some level—to be “magic.
Saying, “We can do better,” Jim Bagian declared that root cause analysis (RCA)—the subject of a new report by the National Patient Safety Foundation (NPSF)—offers uncommon potential to improve safety and that, in general, healthcare has not used it well and wasted opportunities to prevent future harm.
Bagian and Doug Bonacum were co-chairs of the working group that developed the new report for NPSF. They also led “Patient Safety Science: Successful Practices to Optimize Root Cause Analysis,” an all-day workshop offered the day before NPSF’s annual Patient Safety Congress, held earlier this year in Austin, Texas. With their time and lively discussion, those who attended the workshop endorsed Bagian’s sentiments about “doing better.”
Following introductions, the workshop began with attendees sharing their success stories and disappointments related to RCAs. Some described their organizations’ RCA processes as being well developed and effective, while others expressed frustrations related to poor training, inadequate leadership, and lack of follow up. Bagian and Bonacum identified action, improvement, and measurement as crucial components of RCAs and regretted that the name “root cause analysis” leaves out the most important steps.
The report, RCA2: Improving Root Cause Analyses and Actions to Prevent Harm, renames the process root cause analysis and action—“squaring” the A—and says that its only purpose is to prevent harm:
If actions resulting from an RCA2 review are not implemented, or are not measured to determine their effectiveness in preventing harm, then the entire RCA2 activity may be pointless. (p. 2)
The report, which was developed with support from The Doctors Company Foundation, is available for free download on the NPSF website. Jim Bagian and Doug Bonacum will discuss the report during a free webcast at 1 p.m. ET on Wed, July 15, 2015. Shortly thereafter, a recording of the webcast will be available on the report’s webpage.
Ensuring that clinicians are treating the patient they intend to treat—accurate patient identification (ID)—is one of many perennial patient safety problems. Some of the perennials, including handwashing, wrong site surgery, and patient ID, seem simple enough on the surface. They remain unsolved, however, because they are deceivingly complex. It is understandable that “improvement fatigue” may set in for organizations and individuals who have known for years that they have an unsolved problem, sometimes one they’ve been addressing unsuccessfully for years.
The annual conference known simply as HIMSS will take place in Chicago next week, April 12–16. By far the largest educational program and exhibition focused on health information technology each year, HIMSS is daunting and exciting. Each year, preparing to attend HIMSS begins to demand attention shortly after New Years. The conference usually takes place in February. When it is held in Chicago—where the parent organization, the Health Information Management and Systems Society is based—the schedule is moved back to April for obvious reasons. Of course, last time HIMSS was held in Chicago in April, it snowed. This year, few of us will be shocked by cold precipitation after the winter we’ve had.
This is Patient Safety Awareness Week (PSAW), which is focused on the theme “United for Safety.” The National Patient Safety Foundation (NPSF) explains that the theme is meant to rally all stakeholders—from care providers, corporate executives, and vendors, to patients and their families—around a commitment to “keeping patients and those who care for them free from harm.” The campaign emphasizes patient engagement, communication among patients and clinicians, and on how the quality of relationships affects the delivery of care. United for Safety is also the theme of NPSF’s Patient Safety Congress, to be held next month in Austin, Texas.
On January 28, the Institute for Safe Medical Practices (ISMP) published an alarming report exposing the dirty secret about drug safety in America. Its report properly chronicled that pharmaceutical companies are largely responsible for collecting and reporting adverse drug events to the Food and Drug Administration (FDA) and most notably, that they’re doing a substandard job at it.
Although consumers and providers may also report adverse events, the FDA Adverse Events Reporting System (FAERS) relies primarily on reports from pharmaceutical companies. Those pharmaceutical companies view this task as burdensome and expensive. According to the Wall Street Journal, they have outsourced it for the lowest possible cost or allocated the fewest resources to it internally. Clearly, there’s a conflict of interest in a system that relies on self-regulation. And that conflict is only amplified when those tasked with monitoring post-approval drug safety turn around and outsource the responsibility to the lowest bidder. The result is a drug safety monitoring system that, according to ISMP, “suffers from a flood of low quality reports from drug manufacturers.”
As many expected, a malpractice lawsuit was filed on Monday, January 26, against the physicians and endoscopy clinic that treated the late Joan Rivers. CNN reported that the family of the 81-year-old comedian wants to "make certain that the many medical deficiencies that led to Joan Rivers' death are never repeated by any outpatient surgery center."
As this lawsuit unfolds in the months ahead, it will examine alleged errors made at Yorkville Endoscopy in New York City, including failing to identify Ms. Rivers’ deteriorating vital signs and respond in a timely manner. Significantly, the lawsuit will also review numerous deficiencies cited by the New York State Department of Health regarding basic patient rights, including failing to obtain informed consent for each procedure performed.
The high-profile nature of this case should be expected to increase the scrutiny of healthcare organizations’ informed consent processes and documents. Articles in the lay press will likely advise the public to do the following...
In title of every post in his long-running blog, Mark Neuenschwander offers readers a snapshot of what’s on his mind. From “I’ve been thinking about Tina, Sarah, Slinkies, and how improve may improve your group’s productivity,” to “…Dodgers, Webinars, leadership, and the importance of sitting near an exit,” Neuenschwander covers a wide swath of what’s important in life while always zeroing in on medication safety, point-of-care technologies (especially barcoding), and foundational principles of patient safety. He’s always entertaining, real, and informative.
Most recently, in “…drugs, wars, Christmases, and your hospital,” Neuenschwander describes a medication error that killed Loretta Macpherson in December 2014. He points out that although more than two-thirds of hospitals in the United States now (finally!) barcode scan patients and medications at the bedside, only five or six percent scan to verify the component ingredients in compounded products.
PSQH editor Susan Carr shares her experience hearing Don Berwick, who recently ran for governor of Massachusetts and is also previously CEO of the Institute for Healthcare Improvement and administrator of the Centers for Medicare and Medicaid Services, speak on election night.
I pay close attention to efforts to quantify the number of errors and amount of harm caused by medical error, and I am often uncertain what to make of the results at least as they sometimes are reported.
Numbers are powerful, especially when conveyed in concrete, familiar units.
…80,000 die each year partly as a result of iatrogenic injury, the equivalent of three jumbo-jet crashed every 2 days” (Leape, 1994).
…the results of the study in Colorado and Utah imply that at least 44,000 Americans die each year as a result of medical errors. The results of the New York Study suggest the number may be as high as 98,000 (Institute of Medicine, 2000).
Those numbers caught everyone’s attention years ago and became mantras for the patient safety movement. More recently, John James’ estimate that between 210,000 and 440,000 patients die prematurely each year due to preventable harm renewed discussion about quantifying the magnitude of the problem (James, 2013).
Our responses to the news that Ebola had been diagnosed in the United States for the first time reveal gaps in our understanding of how to protect others and ourselves from Ebola and other infectious diseases. When we overreact in fear and take comfort from actions that don’t actually make us safer, we may overlook aspects of our systems and institutions that really do put us at risk.
The case of Thomas Duncan, diagnosed in Dallas with Ebola on September 26, 2014, reveals how unreliable our systems can be, especially under stress. The actions of Texas Health Presbyterian Hospital Dallas, where Duncan went for emergency care when he first became ill, reveal broad problems with implications that reach beyond the immediate response to one patient with Ebola.
First, I must disclose a conflict of interest: I am co-author of one chapter in this edited collection, and the editor, Lorri Zipperer, is a close friend and colleague. I was pre-disposed to like this book, and as I spend more time with the other chapters, my respect for Lorri’s vision and the resulting text continues to grow.
Efforts to improve patient safety should be informed by the best evidence, information, and knowledge (EI&K) available, but often they are not. This is a familiar, if unexamined, problem in this time of “information overload,” but first I should review how the terms EI&K are defined and used in the book. These terms are common but not often used in the safety and quality improvement literature as precisely as they are in Patient Safety:
- Evidence is the result of research, of tested hypotheses, such as trials and studies published in peer-reviewed publications across all disciplines (not just medicine).
- Information is data that has been analyzed, organized, and printed/presented for a specific use.
- Knowledge is what individuals know, either implicitly or explicitly. Knowledge is dynamic, with elements of action or experience.
Many of us are familiar with the challenge posed by the abundance of evidence, information, and knowledge currently available about all things. It is exhilarating that we live in a time of rich and increasingly available resources, but it is rarely self-evident how best to access the EI&K we need or easy to feel confident that we’ve found the best advice on a given subject. How do we know, for example, that what we really need is on page 10 or 25 of our Google search results or will only appear if we use a particular search word. Social media such as Twitter and email discussion groups have made experts more accessible than ever, but knowing who has the answer to your question, having the time to search, and simply knowing where to begin, is not always easy. These challenges exist in patient safety, too, with potentially profound implications for patients and all who are involved in their care.