Claims
Data as a catalyst for change: Stories from the frontlines By Dana Siegal, RN, CPHRM, and Gretchen Ruoff, MPH, CPHRM
The landmark 1999 Institute of Medicine report, “To Err Is Human,” challenged us all to reduce the number of preventable medical errors. While vulnerabilities and patient harm continue at unacceptable rates, there are also many success stories. This article presents a series of case studies that illustrate how healthcare organizations have used data—quantitative, qualitative, and comparative—to address vulnerabilities and guide meaningful change to improve patient safety. These examples are drawn from the data-sharing community of CRICO Strategies, a division of the Risk Management Foundation of the Harvard Medical Institutions, Inc. (CRICO). CRICO’s data-driven strategy uses intelligence from thousands of medical malpractice cases across the country to examine what has gone wrong and why, and to help members and clients manage their risk and provide better care. I N TR O D U C TI O N In late September,1 the Centers for Disease Control and Prevention confirmed the first case of Ebola to be diagnosed in the United States. While media coverage raised questions and concerns about a delay in making the diagnosis, many of us in the healthcare industry empathized with a distressingly familiar scenario. As confirmed cases of the virulent virus emerged in two of “patient zero’s” nurses, the media shined additional light on the questions that we who study medical error grapple with daily: What caused the initial delay in diagnosis? Was there miscommunication among the care team? Did the electronic medical record contribute in some way? Were there system failures or a breach in protocol that led to caregivers contracting Ebola? These questions, and many like them, are at the core of the work that analysts and clinical experts at CRICO Strategies and the Risk Management Foundation of the Harvard Medical Institutions, Inc. (CRICO)2 study every day. Using data from thousands of medical malpractice cases across the country, they study the specific system and process failures that put patients and providers at risk, and collaborate with their Harvard-based members and national clients to share data and seek solutions that advance patient safety efforts.
The value of data The landmark 1999 Institute of Medicine (IOM) report, “To Err Is Human,”3 challenged us all—government, healthcare providers, industry © 2015 American Society for Healthcare Risk Management of the American Hospital Association Published online in Wiley Online Library (wileyonlinelibrary.com) • DOI: 10.1002/jhrm.21161 18
JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
leaders, and consumers—to reduce the number of preventable medical errors that cost lives, dollars, and trust in the healthcare system. There is no question that the medical community has responded since then with significant efforts to understand error, develop the science of safety, and mobilize resources and initiatives to improve care. However, there is still debate over whether these efforts have been as impactful as we would like. While the 1999 IOM report’s estimate of 44 000–98 000 preventable deaths3 was likely conservative, a recent evidence-based review published in the Journal of Patient Safety in 2013 reflects new estimates—based on improved reporting and a broader recognition of what to report—that at least 210 000 and as many as 400 000plus deaths associated with preventable harm occur in US hospitals each year.4
And yet, even as we continue to struggle with these questions, CRICO’s data show that the number of malpractice cases asserted annually has been declining in recent years.5 Numerous parallel initiatives focused on mitigating clinical and system vulnerabilities may contribute to this trend; however, CRICO believes the most significant reason for improvements in its client base is the use of datadriven intelligence focused not only on what has gone wrong, but why.
Data captured in CRICO’s Comparative Benchmarking System (CBS)—a national database exceeding 300 000 medical professional liability (MPL) claims from more than 400 hospitals and 165 000 physicians—demonstrate that many of the issues noted in the 1999 study and elsewhere still exist in measurable numbers today, for example, medication errors, wrong-site surgeries, communication issues, diagnostic failures, and treatment delays. If we in the healthcare community have been focused on solving these problems for more than a decade, why do they
CRICO’s approach, which involves detailed coding and clinical analysis of the medical malpractice cases in its CBS database (using medical records and legal files), allows for in-depth study of the frontline clinical and system issues driving medical error (see Figure 1). This strategy has been instrumental in helping us understand not just what the errors are but the underlying vulnerabilities that cause them. This awareness has led to targeted solutions to the identified problems in CRICO member and client organizations and has catalyzed meaningful
continue to occur? Have we focused on solutions that address the specific root causes of known errors? Have we implemented the right solutions but been unable to sustain them? Do we understand exactly what is driving the errors and system breakdowns that harm our patients, or are we missing something?
Figure 1: Example of Comparative Data
DOI: 10.1002/jhrm
AMERICAN SOCIETY FOR HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
19
improvements that enhance patient safety and minimize the potential for lawsuits. The following initiatives and case abstracts, drawn from CRICO’s CBS data-sharing community, illustrate the power of quantitative, qualitative, and comparative data to spotlight real issues and to fuel meaningful change in healthcare.
Figure 2: Examples of Specific Causative Factors Found in Emergency Medicine Cases
Project addresses diagnostic failures in ED The multilayered Ebola situation previously described illustrates the most common challenge in the emergency department (ED): diagnostic failure. Often fast-paced, crowded, and unpredictable, EDs can be both exciting and risky. New patients arrive with everything from small cuts to major trauma, but often with little in the way of medical histories. Several years ago, CRICO’s analysis of CBS claims raised concern about a potential upward trend in medical malpractice cases from the ED. Emergency Medicine was among the top 5 most frequently identified responsible services, and diagnostic failures were the most common and costly allegation. Data6 showed that between 2004 and 2008: • Fifty-five percent of ED cases involved an alleged wrong or delayed diagnosis, including missed opportunities to order the appropriate test, consult, or treatment, or a premature discharge. • Nearly half of diagnosis-related ED cases led to permanent injury or death. • Cases were not driven by rare diagnosis or unusual presentation. • Cases involved patients between the ages of 31 and 60, most often with uncomplicated health histories. To better understand these issues, in 2010 CRICO convened a council of ED chiefs, nurses, and quality leaders from 19 academic and community hospitals in 6 states. During a yearlong study, the group analyzed 479 diagnosis-related ED claims from the Comparative Benchmarking System and did a detailed study of some 200 clinical cases. In addition, participants surveyed their frontline staff to evaluate their perceptions of key issues and trends noted in the data, and then piloted potential solutions. At the conclusion, the council shared findings and best practices in a white paper.6 The council’s research and analysis suggested that breakdowns in collecting and communicating critical information were the top cause of diagnostic failure in the ED. Most notable in these cases were physicians lacking essential pieces of information for making decisions (see Figure 2). And while errors occurred throughout the process of care, from patient assessment to discharge and
20
follow-up, the primary vulnerabilities occurred before the diagnosis was made. Perhaps not surprisingly, the electronic health record was blamed for hindering face-to-face communication. Commented one provider, “I can go a whole shift without ever seeing the nurse/physician I work with.” The council’s self-assessment validated that vulnerabilities identified in the ED data analysis still existed in their clinical environments. These common factors were6: • Historical information gaps: Missing information from referring MD or medical record; • Reconciliation of abnormal vital signs: Patient discharged without MD adequately addressing an abnormal vital sign; • Communication of lab and X-ray results: Delayed or inadequate reporting of abnormal lab or X-ray finding; • MD–RN communication: Work often proceeds in parallel without opportunity to communicate adequately; • Communication with consultants: Lack of clear communication between MD and consultant; and • Patient handoffs: Inadequate transfer of care between providers at shift change, or from ED to inpatient ward. Seizing on the imperative to improve RN–MD communication in the ED, the leadership council developed several strategies. Among them: • Structured communication updates. These allow clinicians to exchange information at critical points in a patient’s ED visit and address “bigger picture” issues in the department, including flow and bed availability. Trigger systems, for example, alert both the nurse and physician
JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
DOI: 10.1002/jhrm
when a patient is unstable (elevated heart rate or blood pressure, altered mental status, etc.). In one hospital, the system cut by half the time it took for a physician to respond and provide therapeutic intervention to patients in need.6 Several hospitals began regular MD–RN huddles to review key information and clarify questions about patients, aiding the exchange of real-time information prior to diagnostic decision making. And some EDs introduced discharge timeouts to make sure clinicians discuss patients’ treatment plans and any unresolved issues. One developed the timeout mnemonic “STOP”: Significant events/facts, Therapies/tests, Oxygen and last vital signs, and Pending issues. • Simulation-based team training. CRICO’s response to the findings in this analysis was to focus on MD–RN teamwork and communication. To help build those skills, CRICO worked with ED leaders from Harvard-affiliated hospitals on a simulation-based team-training program focused on management of (initially) nonemergent, diagnostic needs across multiple patients. Participants “care” for 3 patients at a time while simulation leaders control the communication flow and challenges that providers will face during the scenario. The simulation is followed by a debrief, during which all parties reflect on their experiences and lessons learned. By late 2013, the voluntary training had reached some 1500 providers at 7 hospitals. The feedback has been positive; staff report feeling more empowered to speak up and appreciate the opportunity to learn together. And in order to ensure trainees’ participation in this important program, it has now become a required element of residents’ annual training curriculum. This case demonstrates the value of comparative patient safety data to sound the alarm about potential trends, of thorough analysis of the whats and whys signaled by the data, and of the benefits of collaboration to produce action plans that meet organizations’ different needs.
Data dive yields unexpected finding A few years ago, an obstetrics service at an urban East Coast hospital faced a spike in medical malpractice claims. To no one’s surprise, analysis of their MPL experience revealed a communication barrier in labor and delivery. One contributing factor was that physicians and nurses were not aligned in how they interpreted and expressed electronic fetal monitoring (EFM) readings, opening the door to miscommunication. To address this, MDs and RNs began attending the same class—together—so they could learn to share the same terminology and communication expectations. In addition, the data revealed another—and surprising— vulnerability: The obstetrics service faced a notably larger proportion of prenatal-related malpractice claims than its peers. This news was devastating to the obstetricians, who had not realized the magnitude of this problem. The
DOI: 10.1002/jhrm
hospital immediately convened a rapid-turnaround task force to probe the specific issues driving these claims and then took steps to enhance its prenatal care. Changes included better collaboration with resident-managed patients and improved education and follow-up efforts with noncompliant patients in this inner-city population. This hospital’s experience underscores the value of local and comparative data in uncovering an organization’s unique vulnerabilities and helping to identify clear opportunities for targeted intervention.
Reminder cards encourage resident-attending exchanges In this hypothetical case, it is 3 am; Dr. Miller’s surgical patient is experiencing postop complications and seems to be declining quickly. A worried nurse suggests that Dr. Miller, a resident, contact the attending surgeon for guidance, but he doesn’t want to bother her unnecessarily or appear incapable of managing the situation. Dr. Miller then glances down at his lanyard and calls the attending. They discuss the situation, and action taken based on their collaboration stabilizes the patient. Attached to Dr. Miller’s lanyard is a reminder card listing changes in a patient’s status that require notifying one’s attending surgeon promptly. Every resident in Dr. Miller’s hospital has one. The card grew out of a successful riskreduction program that CRICO sponsored several years ago to improve surgical communication at 4 Harvard teaching hospitals. Communication breakdowns, especially those during the postoperative period, are a common cause of avoidable errors in surgical cases. Deeper analysis of CRICO’s comparative data identified resident-attending communication as a particularly serious patient safety concern; in one study, one-third of critical events were not relayed from residents to surgical attendings.7 This issue was further explored through interviews with residents regarding their decision-making process for contacting their attendings. The surgery chiefs from these 4 academic medical centers—which typically compete in the marketplace—began exchanging information and ideas. As a result of this collaboration, they decided to formally adopt and implement policies aimed at changing the culture of communication practices within their respective departments. One key strategy was the pocket reminder card with triggers for contacting a surgical attending, such as specific vital sign changes, unplanned intubation, transfer in/out of the intensive care unit (ICU), or a request from nursing staff. Faculty could add division-specific practices to the basic card. (The other interventions involved improving resident-attending notification about the status of weekend patients and increasing weekend patient visits by attendings.)
AMERICAN SOCIETY FOR HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
21
A before-and-after Harvard study, published in the Annals of Surgery in May 2011,7 found that the intervention “significantly reduced the incidence of potentially harmful communication breakdowns.” The proportion of critical events NOT conveyed to an attending fell from 33 percent to 15 percent, and to 2 percent at 2 hospitals where timing allowed for additional data collection. Residentattending contact led to a change in patient management in one-third of cases (56 of 171), and 26 events involved a “major change in care.” Residents reported that attendings were easy to reach, receptive, and willing to provide adequate coverage if covering for a primary surgeon. Although the broader effect of this initiative on outcomes is challenging to measure, these cards have made care safer by ensuring that attending expertise is a regular part of the team management and resident oversight in the care of surgical patients. In addition to reminding house staff that attendings want to know what is happening with their patients, the card highlights the importance of patient safety measures in the hospital. Michael J. Zinner, MD, chair of the surgery department at Brigham and Women’s Hospital in Boston, said, “What the introduction of the trigger card did was codify to both sides that communication is both welcome and expected.”8 This story spotlights the power of data, validation, and collaboration in identifying and addressing the factors driving a larger safety issue. In addition, it highlights the
benefits of postintervention studies in ensuring specificity between the identified problem and the implemented solution (see Figures 3 and 4).
Small size has big impact CRICO’s deep dive into surgery-related malpractice claims several years ago, using its Comparative Benchmarking System, focused on technical errors (see Figure 5), the leading cause of malpractice claims against general surgeons. One group of errors involving a particular type of surgery sparked the interest of analysts. Probing the data further, they discovered a small but concerning cluster of cases identifying technical issues in laparoscopic surgery, a minimally invasive technique that uses small incisions and lighted viewing instruments called laparoscopes. Its learning curve is often steep, and recognizing the patient safety and financial vulnerability in the growing use of laparoscopy, CRICO began an incentive program to ensure that surgeons have the knowledge, judgment, and technical skills required for the procedure. Participants took the Fundamentals of Laparoscopic Surgery (FLS) simulation course, created by the American College of Surgeons and the Society of American Gastrointestinal Endoscopic Surgeons. The 1-day continuing medical education (CME) course consisted of
Figure 3: Sample Resident Trigger Card (front)
22
JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
DOI: 10.1002/jhrm
Figure 4: Sample Resident Trigger Card (back)
didactic presentations, hands-on training, psychomotor testing, and a computer-based exam. Thirty-seven practicing surgeons in the Harvard system attended the pilot course. Since then, surgeons in multiple specialties, including gynecology, urology, thoracic, and vascular surgery, have completed FLS training. This opportunity for personal skills assessment proved impactful. As a result of their experience with the course, a few surgeons decided to stop performing laparoscopic surgery. In addition, some of the Harvard institutions have made the course a requirement for credentialing in general surgery.
Figure 5: Top Causative Factors Found in Surgical Cases
According to research published in Surgical Endoscopy in 2010,9 pilot attendees felt mastery of the course material would improve safety and technical knowledge. The authors concluded that “this unique cooperative effort between a liability carrier, a professional surgical society, and proactive surgeons should be considered a model for advancing competency and patient safety.” Based in part on the success of the pilot study, the American Board of Surgery now requires FLS training for all residents. This story underscores that size doesn’t always matter when it comes to data. Even a small data set, like the one that led to adopting FLS, can be extremely informative. It also points to the value of a larger body of comparative data in helping organizations gain perspective on risks that may not have generated claims yet, but that may represent areas of potential vulnerability.
Qualitative approach reveals vulnerabilities Leaders at a large urban academic hospital noticed that their surgical suite had a sizable number of adverse events that hadn’t been reported to senior leadership in real time. Only after these situations gained focus, either through formal family complaints or worse— through notification of a lawsuit—did senior management become aware of the events. Concerned that this “siloed” approach to protecting event reporting impeded the organization’s ability to address and learn from these events, hospital leaders wanted to take a broader look at the culture and effectiveness of their data collection and analysis operations.
DOI: 10.1002/jhrm
AMERICAN SOCIETY FOR HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
23
They contacted the CRICO Strategies team of clinical and leadership experts to conduct a Risk Appraisal & Plan (RAP).10 This qualitative tool assesses the ability of an organization to identify and respond to vulnerabilities that put its patients and providers at risk. The RAP is particularly sensitive in evaluating an institution’s culture of reporting, sharing, and learning from mistakes.
Figure 6: Top EHR-Related Issues Found in MPL Cases
Each RAP involves extensive and objective in-depth interviews with a cross-section of providers, staff, and employees about what is and isn’t working, after which the team synthesizes its findings into recommendations. The goal is to identify the structural, cultural, and leadership gaps that prevent an organization from taking best advantage of its data and maximizing its patient safety agenda. In this case, the RAP uncovered some underlying internal fears about sharing information. The hospital responded by recognizing its cultural challenges and creating interdepartmental teams to begin to build trust and awareness of the mutual benefits of sharing both vulnerabilities and potential solutions. The lesson of this story? While data is critical, the environment in which it lives will determine the degree to which it accurately reflects the real issues and concerns of the organization. If an organization is unable to gather accurate data on all its vulnerabilities, its improvement efforts will fall short. Capturing and analyzing this kind of qualitative data is essential for understanding the structural and cultural barriers that thwart sharing of information that drives successful change. The effort can reap significant rewards, allowing organizational leadership to maximize the use of data to deliver the safest patient care.
Study spotlights EHR-related risks Healthcare organizations everywhere are adopting electronic health record (EHR) systems as a way to improve quality and safety and to reduce costs. Unfortunately, these systems have proven to be fraught with unintended consequences because of human error, design flaws, and technical problems. As noted in the ED section earlier in this article, EHRs can also limit face-to-face communication between doctors and nurses, leading to missed opportunities for preventing costly errors. Recently, CRICO expanded its proprietary coding system to include a set of specific codes that help analysts identify EHR-related issues that have contributed to patient harm. A pilot analysis conducted in 2013, which reviewed several years’ worth of MPL claims in CRICO’s Comparative Benchmarking System, identified 147 cases involving EHR-related vulnerabilities such as user error, technical problems, or both.11 The key driver, incorrect information, was found in 20% of the claims involving EHR-related errors (see Figure 6). For example, a clinician might enter a wrong measurement in a patient record or accidentally open the wrong 24
file and order medication meant for someone else. In some cases, paper and electronic records are inconsistent as an institution converts to an EHR system. On the technology side, care may be compromised when computers crash or test results are misrouted. In early 2015, CRICO will do a follow-up analysis to gauge the ongoing impact of EHR systems on medical error. CRICO plans to continue monitoring risks in EHRs and work to promote ways in which vendors might enhance EHR reliability and usefulness so clinicians everywhere can deliver better, safer care. This case highlights the need to be alert to emerging risks in the digital age and the power of data to support our efforts to do that.
C O N C LU S I O N The stories described in this article underscore how data—quantitative, qualitative, and comparative—can help reveal vulnerabilities and developing trends and provide broader context for these challenges. The raw numbers are critical, but we must also understand the environment in which they live and how the
JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
DOI: 10.1002/jhrm
numbers compare to our peers. Armed with that intelligence, healthcare leaders are best positioned to focus on the most pressing priorities, so they can devise solutions that caregivers and staff will readily support. The most successful leaders keep revisiting the data and listen to the voices of their providers and staff when asking, “What’s next? Did we fix the right problem? Did we develop the wrong fix for the right problem?” Ensuring that safety improvements stick requires alignment from every aspect of an organization—culture, structure, and leadership— and a commitment to continuous examination. This kind of united commitment, anchored in the data, is needed to help catalyze meaningful, long-lasting change in healthcare. Data hold the key to risk reduction—to understanding not only what happened but why—and point the way toward solutions. The introduction of frightening and tragic Ebola cases on our shores this fall was a sobering reminder that our healthcare is never immune to vulnerabilities, and we must work together tirelessly, within and across organizations, to protect our patients and our caregivers from harm. It is our belief that this is best achieved when we allow data to drive the agenda.
RE FE REN C ES 1. Centers for Disease Control and Prevention website. http://www.cdc.gov/vhf/ebola/outbreaks/2014-westafrica/united-states-imported-case.html. Accessed October 29, 2014. 2. CRICO Strategies is a division of the Risk Management Foundation of the Harvard Medical Institutions, Inc., a CRICO Company. CRICO, a recognized leader in evidence-based risk management, is a group of companies owned by and serving the Harvard medical community. 3. To err is human: building a safer health system. Institute of Medicine report, November 1999. http:// www.iom.edu/Reports/1999/To-Err-is-HumanBuilding-A-Safer-Health-System.aspx. Accessed December 9, 2014. 4. James J. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Saf. 2013;9:122–128. 5. Comparative Benchmarking System, CRICO Strategies website. http://www.rmfstrategies.com/Products-andServices/Tools/CBS. Accessed December 9, 2014. 6. Optimizing physician-nurse communication in the emergency department: strategies for minimizing
DOI: 10.1002/jhrm
diagnosis-related errors; February 2011, 2010 CRICO/RMF Strategies Emergency Medicine Leadership Council white paper. 7. Arriaga AF, Elbardissi AW, Regenbogen SE, et al. A policy-based intervention for the reduction of communication breakdowns in inpatient surgical care: results from a Harvard Surgical Safety Collaborative. Ann Surg. 2011;253:849–854. 8. Padoll M. Better surgical safety is in the cards. CRICO website, February 16, 2012. https://www .rmf.harvard.edu/Clinician-Resources/Article/2012/ Better-Surgical-Safety-is-in-the-Cards. Accessed December 9, 2014. 9. Derevianko AY, Schwaitzberg SD, Tsuda S, et al. Malpractice carrier underwrites Fundamentals of Laparoscopic Surgery training and testing: a benchmark for patient safety. Surg Endosc. 2010 March;24(3):616–623. 10. Risk Appraisal and Plan on CRICO website. https:// www.rmf.harvard.edu/Strategies/Home/Products-andServices/Services/RAP. Accessed December 9, 2014. 11. Ruder D. Malpractice claims analysis confirms risks in EHRs. Patient Saf Qual Healthc. 2014 January– February;11:20–23.
A BO U T TH E A U TH O R S Dana Siegal, RN, CPHRM, is director of Patient Safety Services for CRICO Strategies, a division of the Risk Management Foundation of the Harvard Medical Institutions, Inc. in Cambridge, Massachusetts. She brings 30 years of experience in healthcare quality and risk management to her role providing clinical leadership and analytical/ educational services to leading academic medical centers, community hospitals, and physician practices throughout the country. Ms. Siegal currently serves on the board of the Society for Improvement of Diagnostic Medicine and is a member of the planning committee for the annual ASHRM conference. Gretchen Ruoff, MPH, CPHRM, is a senior program director of Patient Safety Services for CRICO Strategies, a division of the Risk Management Foundation of the Harvard Medical Institutions, Inc. in Cambridge, Massachusetts. She provides analytical and educational services to leading academic medical centers, community hospitals, physician practices, and medical professional liability insurers on the issues of medical liability and patient safety initiatives. Prior to her tenure, Ms. Ruoff served as a patient advocate/conflict mediator at Brigham and Women’s Hospital in Boston.
AMERICAN SOCIETY FOR HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
25
Data as a catalyst for change: Stories from the frontlines By Dana Siegal, RN, CPHRM, and Gretchen Ruoff, MPH, CPHRM
The landmark 1999 Institute of Medicine report, “To Err Is Human,” challenged us all to reduce the number of preventable medical errors. While vulnerabilities and patient harm continue at unacceptable rates, there are also many success stories. This article presents a series of case studies that illustrate how healthcare organizations have used data—quantitative, qualitative, and comparative—to address vulnerabilities and guide meaningful change to improve patient safety. These examples are drawn from the data-sharing community of CRICO Strategies, a division of the Risk Management Foundation of the Harvard Medical Institutions, Inc. (CRICO). CRICO’s data-driven strategy uses intelligence from thousands of medical malpractice cases across the country to examine what has gone wrong and why, and to help members and clients manage their risk and provide better care. I N TR O D U C TI O N In late September,1 the Centers for Disease Control and Prevention confirmed the first case of Ebola to be diagnosed in the United States. While media coverage raised questions and concerns about a delay in making the diagnosis, many of us in the healthcare industry empathized with a distressingly familiar scenario. As confirmed cases of the virulent virus emerged in two of “patient zero’s” nurses, the media shined additional light on the questions that we who study medical error grapple with daily: What caused the initial delay in diagnosis? Was there miscommunication among the care team? Did the electronic medical record contribute in some way? Were there system failures or a breach in protocol that led to caregivers contracting Ebola? These questions, and many like them, are at the core of the work that analysts and clinical experts at CRICO Strategies and the Risk Management Foundation of the Harvard Medical Institutions, Inc. (CRICO)2 study every day. Using data from thousands of medical malpractice cases across the country, they study the specific system and process failures that put patients and providers at risk, and collaborate with their Harvard-based members and national clients to share data and seek solutions that advance patient safety efforts.
The value of data The landmark 1999 Institute of Medicine (IOM) report, “To Err Is Human,”3 challenged us all—government, healthcare providers, industry © 2015 American Society for Healthcare Risk Management of the American Hospital Association Published online in Wiley Online Library (wileyonlinelibrary.com) • DOI: 10.1002/jhrm.21161 18
JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
leaders, and consumers—to reduce the number of preventable medical errors that cost lives, dollars, and trust in the healthcare system. There is no question that the medical community has responded since then with significant efforts to understand error, develop the science of safety, and mobilize resources and initiatives to improve care. However, there is still debate over whether these efforts have been as impactful as we would like. While the 1999 IOM report’s estimate of 44 000–98 000 preventable deaths3 was likely conservative, a recent evidence-based review published in the Journal of Patient Safety in 2013 reflects new estimates—based on improved reporting and a broader recognition of what to report—that at least 210 000 and as many as 400 000plus deaths associated with preventable harm occur in US hospitals each year.4
And yet, even as we continue to struggle with these questions, CRICO’s data show that the number of malpractice cases asserted annually has been declining in recent years.5 Numerous parallel initiatives focused on mitigating clinical and system vulnerabilities may contribute to this trend; however, CRICO believes the most significant reason for improvements in its client base is the use of datadriven intelligence focused not only on what has gone wrong, but why.
Data captured in CRICO’s Comparative Benchmarking System (CBS)—a national database exceeding 300 000 medical professional liability (MPL) claims from more than 400 hospitals and 165 000 physicians—demonstrate that many of the issues noted in the 1999 study and elsewhere still exist in measurable numbers today, for example, medication errors, wrong-site surgeries, communication issues, diagnostic failures, and treatment delays. If we in the healthcare community have been focused on solving these problems for more than a decade, why do they
CRICO’s approach, which involves detailed coding and clinical analysis of the medical malpractice cases in its CBS database (using medical records and legal files), allows for in-depth study of the frontline clinical and system issues driving medical error (see Figure 1). This strategy has been instrumental in helping us understand not just what the errors are but the underlying vulnerabilities that cause them. This awareness has led to targeted solutions to the identified problems in CRICO member and client organizations and has catalyzed meaningful
continue to occur? Have we focused on solutions that address the specific root causes of known errors? Have we implemented the right solutions but been unable to sustain them? Do we understand exactly what is driving the errors and system breakdowns that harm our patients, or are we missing something?
Figure 1: Example of Comparative Data
DOI: 10.1002/jhrm
AMERICAN SOCIETY FOR HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
19
improvements that enhance patient safety and minimize the potential for lawsuits. The following initiatives and case abstracts, drawn from CRICO’s CBS data-sharing community, illustrate the power of quantitative, qualitative, and comparative data to spotlight real issues and to fuel meaningful change in healthcare.
Figure 2: Examples of Specific Causative Factors Found in Emergency Medicine Cases
Project addresses diagnostic failures in ED The multilayered Ebola situation previously described illustrates the most common challenge in the emergency department (ED): diagnostic failure. Often fast-paced, crowded, and unpredictable, EDs can be both exciting and risky. New patients arrive with everything from small cuts to major trauma, but often with little in the way of medical histories. Several years ago, CRICO’s analysis of CBS claims raised concern about a potential upward trend in medical malpractice cases from the ED. Emergency Medicine was among the top 5 most frequently identified responsible services, and diagnostic failures were the most common and costly allegation. Data6 showed that between 2004 and 2008: • Fifty-five percent of ED cases involved an alleged wrong or delayed diagnosis, including missed opportunities to order the appropriate test, consult, or treatment, or a premature discharge. • Nearly half of diagnosis-related ED cases led to permanent injury or death. • Cases were not driven by rare diagnosis or unusual presentation. • Cases involved patients between the ages of 31 and 60, most often with uncomplicated health histories. To better understand these issues, in 2010 CRICO convened a council of ED chiefs, nurses, and quality leaders from 19 academic and community hospitals in 6 states. During a yearlong study, the group analyzed 479 diagnosis-related ED claims from the Comparative Benchmarking System and did a detailed study of some 200 clinical cases. In addition, participants surveyed their frontline staff to evaluate their perceptions of key issues and trends noted in the data, and then piloted potential solutions. At the conclusion, the council shared findings and best practices in a white paper.6 The council’s research and analysis suggested that breakdowns in collecting and communicating critical information were the top cause of diagnostic failure in the ED. Most notable in these cases were physicians lacking essential pieces of information for making decisions (see Figure 2). And while errors occurred throughout the process of care, from patient assessment to discharge and
20
follow-up, the primary vulnerabilities occurred before the diagnosis was made. Perhaps not surprisingly, the electronic health record was blamed for hindering face-to-face communication. Commented one provider, “I can go a whole shift without ever seeing the nurse/physician I work with.” The council’s self-assessment validated that vulnerabilities identified in the ED data analysis still existed in their clinical environments. These common factors were6: • Historical information gaps: Missing information from referring MD or medical record; • Reconciliation of abnormal vital signs: Patient discharged without MD adequately addressing an abnormal vital sign; • Communication of lab and X-ray results: Delayed or inadequate reporting of abnormal lab or X-ray finding; • MD–RN communication: Work often proceeds in parallel without opportunity to communicate adequately; • Communication with consultants: Lack of clear communication between MD and consultant; and • Patient handoffs: Inadequate transfer of care between providers at shift change, or from ED to inpatient ward. Seizing on the imperative to improve RN–MD communication in the ED, the leadership council developed several strategies. Among them: • Structured communication updates. These allow clinicians to exchange information at critical points in a patient’s ED visit and address “bigger picture” issues in the department, including flow and bed availability. Trigger systems, for example, alert both the nurse and physician
JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
DOI: 10.1002/jhrm
when a patient is unstable (elevated heart rate or blood pressure, altered mental status, etc.). In one hospital, the system cut by half the time it took for a physician to respond and provide therapeutic intervention to patients in need.6 Several hospitals began regular MD–RN huddles to review key information and clarify questions about patients, aiding the exchange of real-time information prior to diagnostic decision making. And some EDs introduced discharge timeouts to make sure clinicians discuss patients’ treatment plans and any unresolved issues. One developed the timeout mnemonic “STOP”: Significant events/facts, Therapies/tests, Oxygen and last vital signs, and Pending issues. • Simulation-based team training. CRICO’s response to the findings in this analysis was to focus on MD–RN teamwork and communication. To help build those skills, CRICO worked with ED leaders from Harvard-affiliated hospitals on a simulation-based team-training program focused on management of (initially) nonemergent, diagnostic needs across multiple patients. Participants “care” for 3 patients at a time while simulation leaders control the communication flow and challenges that providers will face during the scenario. The simulation is followed by a debrief, during which all parties reflect on their experiences and lessons learned. By late 2013, the voluntary training had reached some 1500 providers at 7 hospitals. The feedback has been positive; staff report feeling more empowered to speak up and appreciate the opportunity to learn together. And in order to ensure trainees’ participation in this important program, it has now become a required element of residents’ annual training curriculum. This case demonstrates the value of comparative patient safety data to sound the alarm about potential trends, of thorough analysis of the whats and whys signaled by the data, and of the benefits of collaboration to produce action plans that meet organizations’ different needs.
Data dive yields unexpected finding A few years ago, an obstetrics service at an urban East Coast hospital faced a spike in medical malpractice claims. To no one’s surprise, analysis of their MPL experience revealed a communication barrier in labor and delivery. One contributing factor was that physicians and nurses were not aligned in how they interpreted and expressed electronic fetal monitoring (EFM) readings, opening the door to miscommunication. To address this, MDs and RNs began attending the same class—together—so they could learn to share the same terminology and communication expectations. In addition, the data revealed another—and surprising— vulnerability: The obstetrics service faced a notably larger proportion of prenatal-related malpractice claims than its peers. This news was devastating to the obstetricians, who had not realized the magnitude of this problem. The
DOI: 10.1002/jhrm
hospital immediately convened a rapid-turnaround task force to probe the specific issues driving these claims and then took steps to enhance its prenatal care. Changes included better collaboration with resident-managed patients and improved education and follow-up efforts with noncompliant patients in this inner-city population. This hospital’s experience underscores the value of local and comparative data in uncovering an organization’s unique vulnerabilities and helping to identify clear opportunities for targeted intervention.
Reminder cards encourage resident-attending exchanges In this hypothetical case, it is 3 am; Dr. Miller’s surgical patient is experiencing postop complications and seems to be declining quickly. A worried nurse suggests that Dr. Miller, a resident, contact the attending surgeon for guidance, but he doesn’t want to bother her unnecessarily or appear incapable of managing the situation. Dr. Miller then glances down at his lanyard and calls the attending. They discuss the situation, and action taken based on their collaboration stabilizes the patient. Attached to Dr. Miller’s lanyard is a reminder card listing changes in a patient’s status that require notifying one’s attending surgeon promptly. Every resident in Dr. Miller’s hospital has one. The card grew out of a successful riskreduction program that CRICO sponsored several years ago to improve surgical communication at 4 Harvard teaching hospitals. Communication breakdowns, especially those during the postoperative period, are a common cause of avoidable errors in surgical cases. Deeper analysis of CRICO’s comparative data identified resident-attending communication as a particularly serious patient safety concern; in one study, one-third of critical events were not relayed from residents to surgical attendings.7 This issue was further explored through interviews with residents regarding their decision-making process for contacting their attendings. The surgery chiefs from these 4 academic medical centers—which typically compete in the marketplace—began exchanging information and ideas. As a result of this collaboration, they decided to formally adopt and implement policies aimed at changing the culture of communication practices within their respective departments. One key strategy was the pocket reminder card with triggers for contacting a surgical attending, such as specific vital sign changes, unplanned intubation, transfer in/out of the intensive care unit (ICU), or a request from nursing staff. Faculty could add division-specific practices to the basic card. (The other interventions involved improving resident-attending notification about the status of weekend patients and increasing weekend patient visits by attendings.)
AMERICAN SOCIETY FOR HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
21
A before-and-after Harvard study, published in the Annals of Surgery in May 2011,7 found that the intervention “significantly reduced the incidence of potentially harmful communication breakdowns.” The proportion of critical events NOT conveyed to an attending fell from 33 percent to 15 percent, and to 2 percent at 2 hospitals where timing allowed for additional data collection. Residentattending contact led to a change in patient management in one-third of cases (56 of 171), and 26 events involved a “major change in care.” Residents reported that attendings were easy to reach, receptive, and willing to provide adequate coverage if covering for a primary surgeon. Although the broader effect of this initiative on outcomes is challenging to measure, these cards have made care safer by ensuring that attending expertise is a regular part of the team management and resident oversight in the care of surgical patients. In addition to reminding house staff that attendings want to know what is happening with their patients, the card highlights the importance of patient safety measures in the hospital. Michael J. Zinner, MD, chair of the surgery department at Brigham and Women’s Hospital in Boston, said, “What the introduction of the trigger card did was codify to both sides that communication is both welcome and expected.”8 This story spotlights the power of data, validation, and collaboration in identifying and addressing the factors driving a larger safety issue. In addition, it highlights the
benefits of postintervention studies in ensuring specificity between the identified problem and the implemented solution (see Figures 3 and 4).
Small size has big impact CRICO’s deep dive into surgery-related malpractice claims several years ago, using its Comparative Benchmarking System, focused on technical errors (see Figure 5), the leading cause of malpractice claims against general surgeons. One group of errors involving a particular type of surgery sparked the interest of analysts. Probing the data further, they discovered a small but concerning cluster of cases identifying technical issues in laparoscopic surgery, a minimally invasive technique that uses small incisions and lighted viewing instruments called laparoscopes. Its learning curve is often steep, and recognizing the patient safety and financial vulnerability in the growing use of laparoscopy, CRICO began an incentive program to ensure that surgeons have the knowledge, judgment, and technical skills required for the procedure. Participants took the Fundamentals of Laparoscopic Surgery (FLS) simulation course, created by the American College of Surgeons and the Society of American Gastrointestinal Endoscopic Surgeons. The 1-day continuing medical education (CME) course consisted of
Figure 3: Sample Resident Trigger Card (front)
22
JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
DOI: 10.1002/jhrm
Figure 4: Sample Resident Trigger Card (back)
didactic presentations, hands-on training, psychomotor testing, and a computer-based exam. Thirty-seven practicing surgeons in the Harvard system attended the pilot course. Since then, surgeons in multiple specialties, including gynecology, urology, thoracic, and vascular surgery, have completed FLS training. This opportunity for personal skills assessment proved impactful. As a result of their experience with the course, a few surgeons decided to stop performing laparoscopic surgery. In addition, some of the Harvard institutions have made the course a requirement for credentialing in general surgery.
Figure 5: Top Causative Factors Found in Surgical Cases
According to research published in Surgical Endoscopy in 2010,9 pilot attendees felt mastery of the course material would improve safety and technical knowledge. The authors concluded that “this unique cooperative effort between a liability carrier, a professional surgical society, and proactive surgeons should be considered a model for advancing competency and patient safety.” Based in part on the success of the pilot study, the American Board of Surgery now requires FLS training for all residents. This story underscores that size doesn’t always matter when it comes to data. Even a small data set, like the one that led to adopting FLS, can be extremely informative. It also points to the value of a larger body of comparative data in helping organizations gain perspective on risks that may not have generated claims yet, but that may represent areas of potential vulnerability.
Qualitative approach reveals vulnerabilities Leaders at a large urban academic hospital noticed that their surgical suite had a sizable number of adverse events that hadn’t been reported to senior leadership in real time. Only after these situations gained focus, either through formal family complaints or worse— through notification of a lawsuit—did senior management become aware of the events. Concerned that this “siloed” approach to protecting event reporting impeded the organization’s ability to address and learn from these events, hospital leaders wanted to take a broader look at the culture and effectiveness of their data collection and analysis operations.
DOI: 10.1002/jhrm
AMERICAN SOCIETY FOR HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
23
They contacted the CRICO Strategies team of clinical and leadership experts to conduct a Risk Appraisal & Plan (RAP).10 This qualitative tool assesses the ability of an organization to identify and respond to vulnerabilities that put its patients and providers at risk. The RAP is particularly sensitive in evaluating an institution’s culture of reporting, sharing, and learning from mistakes.
Figure 6: Top EHR-Related Issues Found in MPL Cases
Each RAP involves extensive and objective in-depth interviews with a cross-section of providers, staff, and employees about what is and isn’t working, after which the team synthesizes its findings into recommendations. The goal is to identify the structural, cultural, and leadership gaps that prevent an organization from taking best advantage of its data and maximizing its patient safety agenda. In this case, the RAP uncovered some underlying internal fears about sharing information. The hospital responded by recognizing its cultural challenges and creating interdepartmental teams to begin to build trust and awareness of the mutual benefits of sharing both vulnerabilities and potential solutions. The lesson of this story? While data is critical, the environment in which it lives will determine the degree to which it accurately reflects the real issues and concerns of the organization. If an organization is unable to gather accurate data on all its vulnerabilities, its improvement efforts will fall short. Capturing and analyzing this kind of qualitative data is essential for understanding the structural and cultural barriers that thwart sharing of information that drives successful change. The effort can reap significant rewards, allowing organizational leadership to maximize the use of data to deliver the safest patient care.
Study spotlights EHR-related risks Healthcare organizations everywhere are adopting electronic health record (EHR) systems as a way to improve quality and safety and to reduce costs. Unfortunately, these systems have proven to be fraught with unintended consequences because of human error, design flaws, and technical problems. As noted in the ED section earlier in this article, EHRs can also limit face-to-face communication between doctors and nurses, leading to missed opportunities for preventing costly errors. Recently, CRICO expanded its proprietary coding system to include a set of specific codes that help analysts identify EHR-related issues that have contributed to patient harm. A pilot analysis conducted in 2013, which reviewed several years’ worth of MPL claims in CRICO’s Comparative Benchmarking System, identified 147 cases involving EHR-related vulnerabilities such as user error, technical problems, or both.11 The key driver, incorrect information, was found in 20% of the claims involving EHR-related errors (see Figure 6). For example, a clinician might enter a wrong measurement in a patient record or accidentally open the wrong 24
file and order medication meant for someone else. In some cases, paper and electronic records are inconsistent as an institution converts to an EHR system. On the technology side, care may be compromised when computers crash or test results are misrouted. In early 2015, CRICO will do a follow-up analysis to gauge the ongoing impact of EHR systems on medical error. CRICO plans to continue monitoring risks in EHRs and work to promote ways in which vendors might enhance EHR reliability and usefulness so clinicians everywhere can deliver better, safer care. This case highlights the need to be alert to emerging risks in the digital age and the power of data to support our efforts to do that.
C O N C LU S I O N The stories described in this article underscore how data—quantitative, qualitative, and comparative—can help reveal vulnerabilities and developing trends and provide broader context for these challenges. The raw numbers are critical, but we must also understand the environment in which they live and how the
JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
DOI: 10.1002/jhrm
numbers compare to our peers. Armed with that intelligence, healthcare leaders are best positioned to focus on the most pressing priorities, so they can devise solutions that caregivers and staff will readily support. The most successful leaders keep revisiting the data and listen to the voices of their providers and staff when asking, “What’s next? Did we fix the right problem? Did we develop the wrong fix for the right problem?” Ensuring that safety improvements stick requires alignment from every aspect of an organization—culture, structure, and leadership— and a commitment to continuous examination. This kind of united commitment, anchored in the data, is needed to help catalyze meaningful, long-lasting change in healthcare. Data hold the key to risk reduction—to understanding not only what happened but why—and point the way toward solutions. The introduction of frightening and tragic Ebola cases on our shores this fall was a sobering reminder that our healthcare is never immune to vulnerabilities, and we must work together tirelessly, within and across organizations, to protect our patients and our caregivers from harm. It is our belief that this is best achieved when we allow data to drive the agenda.
RE FE REN C ES 1. Centers for Disease Control and Prevention website. http://www.cdc.gov/vhf/ebola/outbreaks/2014-westafrica/united-states-imported-case.html. Accessed October 29, 2014. 2. CRICO Strategies is a division of the Risk Management Foundation of the Harvard Medical Institutions, Inc., a CRICO Company. CRICO, a recognized leader in evidence-based risk management, is a group of companies owned by and serving the Harvard medical community. 3. To err is human: building a safer health system. Institute of Medicine report, November 1999. http:// www.iom.edu/Reports/1999/To-Err-is-HumanBuilding-A-Safer-Health-System.aspx. Accessed December 9, 2014. 4. James J. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Saf. 2013;9:122–128. 5. Comparative Benchmarking System, CRICO Strategies website. http://www.rmfstrategies.com/Products-andServices/Tools/CBS. Accessed December 9, 2014. 6. Optimizing physician-nurse communication in the emergency department: strategies for minimizing
DOI: 10.1002/jhrm
diagnosis-related errors; February 2011, 2010 CRICO/RMF Strategies Emergency Medicine Leadership Council white paper. 7. Arriaga AF, Elbardissi AW, Regenbogen SE, et al. A policy-based intervention for the reduction of communication breakdowns in inpatient surgical care: results from a Harvard Surgical Safety Collaborative. Ann Surg. 2011;253:849–854. 8. Padoll M. Better surgical safety is in the cards. CRICO website, February 16, 2012. https://www .rmf.harvard.edu/Clinician-Resources/Article/2012/ Better-Surgical-Safety-is-in-the-Cards. Accessed December 9, 2014. 9. Derevianko AY, Schwaitzberg SD, Tsuda S, et al. Malpractice carrier underwrites Fundamentals of Laparoscopic Surgery training and testing: a benchmark for patient safety. Surg Endosc. 2010 March;24(3):616–623. 10. Risk Appraisal and Plan on CRICO website. https:// www.rmf.harvard.edu/Strategies/Home/Products-andServices/Services/RAP. Accessed December 9, 2014. 11. Ruder D. Malpractice claims analysis confirms risks in EHRs. Patient Saf Qual Healthc. 2014 January– February;11:20–23.
A BO U T TH E A U TH O R S Dana Siegal, RN, CPHRM, is director of Patient Safety Services for CRICO Strategies, a division of the Risk Management Foundation of the Harvard Medical Institutions, Inc. in Cambridge, Massachusetts. She brings 30 years of experience in healthcare quality and risk management to her role providing clinical leadership and analytical/ educational services to leading academic medical centers, community hospitals, and physician practices throughout the country. Ms. Siegal currently serves on the board of the Society for Improvement of Diagnostic Medicine and is a member of the planning committee for the annual ASHRM conference. Gretchen Ruoff, MPH, CPHRM, is a senior program director of Patient Safety Services for CRICO Strategies, a division of the Risk Management Foundation of the Harvard Medical Institutions, Inc. in Cambridge, Massachusetts. She provides analytical and educational services to leading academic medical centers, community hospitals, physician practices, and medical professional liability insurers on the issues of medical liability and patient safety initiatives. Prior to her tenure, Ms. Ruoff served as a patient advocate/conflict mediator at Brigham and Women’s Hospital in Boston.
AMERICAN SOCIETY FOR HEALTHCARE RISK MANAGEMENT • VOLUME 34, NUMBER 3
25
