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Patient Safety and Quality Improvement in Obstetrics
Physicians have always striven to provide patients with the very best care and outcomes. However, in the past 40 years, health care has become progressively more complex, increasingly dependent on technology, and reliant on more team members to provide care. The physician is still the ultimate leader of the team, and yet more than a dozen staff, including physicians, nurses, social workers, therapists, and trainees at various levels, may care for a patient on an obstetrics service through numerous work shifts. The opportunities for error have increased along with the complexity of care, and the expectations of federal and local regulatory bodies, employers, the insurance industry, the public as a whole, and individual patients have never been higher.
Although the idea of keeping patients safe and providing them with the best outcomes is certainly not new, turning these ideas into tangible practice has taken center stage in the health care industry. This chapter reviews the origins of the patient safety movement, discusses patient safety in obstetrics specifically, and outlines techniques to improve safety and cope with the aftermath of adverse events. Table 46.1 offers definitions for many of the terms in this chapter and in related literature.
TABLE 46.1
Glossary
| Term | Definition |
|---|---|
| Adverse event | A medical event or intervention that has an unexpected or undesired outcome. |
| After-action review | A debriefing after a notable event (e.g., code or other emergency) focusing on the processes that went well and those that could have gone better. |
| Callout | A communication tool used to convey critical information during an event such as a code. Allows everyone working on a problem to know what is going on and how to anticipate the next step, and it identifies who is in charge. |
| Chain of command (or of consultation) | An algorithm or flow diagram for the escalating involvement of leadership to aid in the resolution of disputes, differences, or questions. |
| Check-back | A communication tool to verify accurate verbal or written information exchange, borrowed from the military and aviation. Usually takes the form of repeating what is heard to acknowledge receipt and verify accuracy. |
| Checklist | A list, usually written, of actions to be performed for a specific procedure. Team members will use a checklist to assist the staff in incorporating all necessary steps before or during a procedure. Checklists aim to implement evidence-based and best-practice strategies in a systematic fashion, making their use routine and universal. They also attempt to improve the function of a team by creating a shared set of standards and goals. |
| Crew resource management | A style of group training to confront imperfect interpersonal interactions by emphasizing communication and teamwork. Gives individuals examples of highly functioning teams. Often incorporates specific communication tools (chain of command, CUS, check-back, or two-challenge rule) to reduce hierarchies and empower individuals to speak up when they recognize an abnormal situation. , |
| Cross-monitoring | The practice by which staff members observe each others’ practice from a safety perspective. For example, one staff member may point out to another a hand hygiene failure. |
| Culture of safety | The integration of safety thinking and practices into clinical activities, including development of systems for data collection and reporting, reducing blame, involving leadership, and focusing on systems. Recognizes the fallibility of human workers and aims to create a blame-free environment. , |
| CUS | The acronym for communication keywords ( c oncerned, u ncomfortable, s cared) that demonstrate a level of alarm in regard to a clinical scenario. The words in the order listed indicate an escalation of worry. |
| Four “whats” | An approach to ensure complete information is relayed during a handoff: What is the patient here for? What are the situation and major issues? What are you most concerned or worried about? What needs to be followed up on? |
| Handoff | The transfer of responsibility or accountability between caregivers or teams. A leading source of medical errors because each handoff is associated with a loss of information or a void in coverage. Structured handoff tools can be used to fill these gaps. (See also Four “whats” and SBAR .) |
| Huddle | A brief, regularly scheduled meeting of staff and providers to discuss short-term planning, problems, or workflow. |
| Just culture | A model for a safety culture that balances no blame with accountability in attributing the source of an error. In this model, human errors (slips, lapses, or mistakes) are distinguished from at-risk or reckless behaviors. Emphasis on accountability is placed on at-risk and reckless behavior. |
| Mitigating speech | A manner of softening the tone of speech to be more acceptable to the receiver, often occurring when a subordinate does not want to assert his or her opinions or impressions. Structured communication tools aim to prevent the use of mitigating speech. |
| Near miss | An unplanned event deemed potentially harmful that does not result in an adverse outcome. The investigation of near misses can help prevent events leading to harm in the future. Often, harm is prevented in near misses because of chance or the presence of preventive measures resulting from individual conscientiousness or systemic barriers. |
| Normalization of deviance | The acceptance of events that are not supposed to happen. Can occur within an organization when recurrent system failures or near misses happen and do not lead to serious consequences. Over time, these failures are not recognized as unexpected deviations but rather become routine and normal. |
| Obstetric Adverse Outcome Index (AOI) | A set of indicators of significant adverse events related to pregnancy and childbirth. The AOI is expressed as the percentage of pregnancies affected by one or more indicators. May be used as a tool to compare quality and outcomes within a single institution or between multiple institutions. The occurrence of an AOI event may serve as a trigger for investigation of quality and safety practices. |
| Root cause analysis | A systematic method of error analysis led by a trained facilitator and performed after a serious adverse event. Usually performed as a quality improvement tool to identify the various contributors (e.g., human factors, policy gaps, system latencies, environmental or equipment failures) to an adverse event. Mandated by The Joint Commission for use in the investigation of health care sentinel events. Usually results in a formal action plan calling for the implementation of tools for improvement, inspiring the acronym RCA, or Root Cause Analysis and Action Plan (RCA2). |
| Safety climate | The way safety concerns are perceived by a team and its individuals. Often assessed with quantitative tools such as the Safety Attitudes Questionnaire or the Agency for Healthcare Research and Quality’s Hospital Survey on Patient Safety Culture. |
| SBAR | Structured communication and debriefing technique for precise transfer of information. Acronym for s ituation, b ackground, a ssessment, and r ecommendation. |
| Sentinel event | As defined by The Joint Commission, a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, permanent harm, or severe temporary harm and intervention required to sustain life. Severe temporary harm is defined as critical, potentially life-threatening harm lasting for a limited time with no permanent residual, but requires transfer to a higher level of care/monitoring for a prolonged period of time, transfer to a higher level of care for a life-threatening condition, or additional major surgery, procedure, or treatment to resolve the condition. Such events are called “sentinel” because they signal the need for immediate investigation and response and are the most serious and significant adverse events. |
| Shared mental model | An organized way for team members to conceptualize how a team works and to predict and understand how their team members will behave to improve overall team performance, while sharing a joint vision of the desired outcome. , |
| Situational awareness | The extent to which team members are aware of the status of a situation, from detailed to global. Includes the status of a team’s patients and workload, and operational issues such as staffing, unit acuity, and bed availability. Interteam and intrateam huddles can be effective for creating better situational awareness. |
| System failure | Adverse outcomes occur as a result of human errors or system failures. Most errors do involve a human element, but systems (e.g., infrastructure, protocols, equipment) are usually intentionally and unintentionally built to create barriers to harm. Systems are designed to be “fault tolerant,” to prevent an individual error from causing harm. A system failure is a breach in one of these structures. |
| Time-out | A preprocedure pause that includes all members of the involved team and is aimed at ensuring correct identification of patient and procedure. Often performed verbally and used to review key preparatory thoughts or actions. For example, a presurgical time-out will ensure the correct patient, the correct procedure, and the correct surgical site. |
| Trigger | A signal that alerts a health care team to the possibility of an adverse event. An actual adverse event may serve as a trigger, but a trigger may simply be an event that is often connected with adverse events. For example, a blood transfusion is not necessarily adverse, but its occurrence can alert a team to investigate a case for possible errors or failures. |
| Two-challenge rule | A quick conflict resolution technique in which one team member may question an action two times and, if a sufficient answer is not provided, may halt that action. |
The Patient Safety Movement
A seminal moment in the patient safety movement occurred at the Annenberg Conference, a 1996 meeting convened in the wake of a series of highly publicized medical mishaps, which brought together leaders from the American Association for the Advancement of Science, the American Medical Association, and The Joint Commission (JC) (formerly the Joint Commission on Accreditation of Healthcare Organizations, or JCAHO) to discuss errors in health care. This meeting launched efforts devoted to improving patient safety, such as the National Patient Safety Foundation and the Institute for Healthcare Improvement (IHI), and other efforts, including the Patient Safety Initiative of the US Department of Veterans Affairs (VA), IHI’s 5 Million Lives Campaign, and JC’s sentinel event reviews, all of which tackle the various issues that relate to unanticipated adverse outcomes and quality of care delivery in medicine.
Four years after the Annenberg Conference, the Institute of Medicine (now the National Academy of Medicine) published a landmark report assessing the prevalence and impact of medical errors in the United States, estimating that 44,000 to 98,000 patients died each year as the result of medical errors. Concluding that a majority of medical errors are caused by correctable faults, this report was a call to improve quality and deliver care more safely. More recent studies suggest that medical error may be the third leading cause of death in the United States, though this deduction is controversial. A key foundation of the patient safety movement is the recognition of the ubiquity of human and system deficiencies that contribute to error. By understanding that error is nearly inevitable but often preventable, patient safety efforts seek to enhance communication and fail-safe measures that decrease the likelihood that an error will manifest itself at the bedside.
A large amount of patient safety work is based on techniques established in aviation. Recognizing the influence of human error and interpersonal interactions in airline accidents, the aviation industry took an early lead in adverse outcome reduction in the 1980s. Their two-pronged approach confronts human error by establishing guidelines, checklists, and drills to improve automation of processes, while enhancing interpersonal interactions by reducing hierarchies, teaching effective teamwork practices, and empowering individuals to speak up when they recognize an abnormal situation. Acknowledging that medicine is similarly stressful, time constrained, and teamwork dependent, patient safety leaders have adapted many of these principles and techniques to the health care environment, effectively making health care institutions high-reliability organizations. ,
Computerized order entry and medication reconciliation, preprocedure time-outs to ensure that the correct procedure is being performed on the intended patient, centralized management guidelines, and formalized handoffs are becoming routine measures in a number of hospitals. With the implementation of these techniques, improvements in patient safety have been documented in cardiology, critical care, and anesthesiology. More generally, these approaches have created major improvements in the US health care system. Preliminary results from the Agency for Healthcare Research and Quality (AHRQ) suggest a 21% decline in hospital-acquired conditions from 2010 to 2015, yielding a cumulative total of 3.1 million fewer hospital-acquired conditions, 125,000 fewer patient deaths, and a $21 billion savings in health care costs.
Safety Challenges in Obstetrics
Patient safety initiatives in obstetrics have lagged behind those in other specialties, despite the fact that childbirth is one of the most common reasons for hospital admission in the United States, accounting for more than 4 million hospitalizations each year and ranking second only to hospitalization for cardiovascular disease. Few published models have existed for the reduction of obstetric adverse outcomes. One limited example is the IHI’s “Idealized Design of Perinatal Care,” which presents two perinatal care “bundles” proposed as policies for the induction and augmentation of labor. Moreover, there is no standard determination of which adverse events in perinatal care are most important to measure and track.
Lack of traction in obstetrics is especially perplexing because the discipline is considered to be in a long-standing professional liability crisis. In fact, although obstetrician-gynecologists represent about 5% of physicians in the United States, they traditionally generate 15% of liability claims and 36% of total payments made by medical liability carriers. Good outcomes are typically expected around the time of childbirth, although adverse events are estimated to occur in up to 16% of deliveries in the United States. According to a benchmark study from the American Society for Healthcare Risk Management, birth-related claims are more severe and costly than claims related to other allegations in health care. The expectation of a favorable outcome in a largely healthy and young patient population and the fact that two patients—mother and child—can be affected make any adverse outcome particularly devastating and shocking. The profound impact of an adverse outcome on the family unit is one contributor to the liability crisis in obstetrics, in which the average payment for just one liability claim is estimated as $500,000 to $1,900,000. Because 90.5% of obstetricians have experienced at least one liability claim during their careers, with an average of 2.59 claims per physician, the liability crisis has a significant impact on the practice of obstetrics, according to a 2015 American College of Obstetricians and Gynecologists (ACOG) survey. In response, obstetricians have changed their practice considerably, with 9.6% performing more cesarean deliveries, 8.4% eliminating attempts at vaginal birth after prior cesarean delivery, 13.6% reducing the number of high-risk obstetric patients they care for, 6.4% decreasing their number of deliveries, and 3.9% stopping practice altogether. Though these frequencies are lower in magnitude than those in a previous survey, they continue to show a decline in the provision of obstetric services. The impact of these changes was so substantial that ACOG issued a Red Alert in 2004, naming 12 states in which the medical liability crisis was affecting the availability of obstetricians.
Potential Strategies to Improve Patient Safety
There are many different strategies an obstetrics practice or service may choose to employ to enhance patient safety. Both JC and ACOG have issued statements addressing obstetric safety concerns, and ACOG has produced a monograph to help guide obstetric safety and quality projects. Although few strategies have been subjected to the rigor of a randomized clinical trial, an increasing number of approaches, especially techniques that address suboptimal communication, are now mandated by regulatory bodies, such as JC. Depending on its needs, a service may choose to employ some, most, or all of these strategies.
A JC Sentinel Event Alert provided an overview of the common approaches to preventing failures and latencies inherent in complex systems and human activities. This review investigated the root causes of 47 perinatal deaths. Although the review was limited to perinatal deaths, the root causes of other obstetric adverse outcomes are likely similar. The most frequently cited root cause was poor communication (72%), with 55% of cases involving an organizational culture that prevented effective teamwork and communication ( Fig. 46.1 ). Specific cultural factors included hierarchy and intimidation, lack of a structured chain of communication, and failure to function as a team. Other important root causes included staff competency (47%), orientation and training process (40%), and inadequate fetal monitoring (34%). Although the characteristics of individual settings may require different tools and approaches, knowledge of the common gaps should help any obstetrics unit tactically move toward improving safety and quality.
Outside Expert Review
At times, it is useful to bring a fresh pair of eyes to examine a service or practice. The potential benefits include an enhanced ability to recognize a gradual drift in practice away from accepted standards, also known as normalization of deviance, , as well as greater credibility in advocating for organizational change by virtue of being a disinterested party. A review may consist of a multiday visit to assess organizational risk and patient safety issues. The review team may interview staff from all personnel categories (physicians, nurses, ancillary staff, administration) and use a triangulation method to resolve differences in perspectives, reporting only those findings repeated in at least two of the various domains. , The team often reviews hospital policies and protocols and compares them with national standards. The review and recommendations—focused on principles of patient safety, evidence-based practice, and consistency with the standards of professional and governing bodies—provide an outline with specific observations and recommendations for improvement. There are several widely known consultants in the field, and ACOG offers a similar service via the Voluntary Review of Quality of Care program. ,
Protocols, Guidelines, and Bundles
In response to a review, or in the course of maintaining practice patterns that conform to changing standards, it can be exceptionally useful to develop a series of protocols and guidelines delineating practice. The purpose of such documents is neither to enumerate care in excruciating detail nor to serve as a cookbook, but rather to provide a common foundation for physicians and nurses to use in approaching the patient. Such protocols may be directed at the organization of patient care (e.g., admission criteria to different units and appropriate disposition of high-risk cases), as well as practices considered most in need of standardization (e.g., induction criteria and administration of oxytocin, prostaglandin, and magnesium sulfate).
When combined with education and the support of senior physician leadership, protocols and guidelines can have a wide-ranging impact. For example, in an effort to reduce the incidence of scheduled births between 36 0/7 and 38 6/7 weeks that lacked appropriate medical indication, 20 Ohio maternity hospitals collected baseline data for 60 days and then selected locally appropriate IHI Breakthrough Series interventions designed to reduce the incidence of early-term scheduled births. The rate of scheduled births between 36 0/7 and 38 6/7 weeks without a documented medical indication declined from 25% to less than 5% ( P < .05) in participating hospitals, and birth certificate data showed inductions without an indication declined from a mean of 13% to 8% ( P < .0027). It is notable that this work was accomplished largely over a 2-year span. Protocols to respond to maternal hemorrhage have been shown in a large health care system to reduce blood product use. The Maternal Early Warning Trigger tool, addressing the four most common areas of maternal morbidity (sepsis, hypertension, hemorrhage, and cardiopulmonary dysfunction), is designed to trigger attention and management of a patient with one severe or two nonsevere abnormal vital signs and has been shown in postimplementation studies to reduce severe maternal morbidity.
Bundles are sets of evidence-based interventions grouped together under a care target that aim to be implemented together or in part. Bundles collect together checklists, guidelines, protocols, and educational materials to make implementation easier. The Council on Patient Safety in Women’s Healthcare, an interdisciplinary alliance of women’s health organizations, has developed a set of core bundles—including those for venous thromboembolism, obstetric hemorrhage, postpartum care, primary cesarean prevention, and severe hypertension—that are easily used and accessed on their website. Importantly, the Council recognizes equity as an essential component of quality and safety work, and has developed a bundle aimed at the reduction of peripartum racial/ethnic disparities, which should serve as a template for this important work on obstetric units today. Many of these bundles form the basis for state-wide maternal health collaborative efforts under the Alliance for Maternal Health. Validating their primacy for safe maternity care, the bundles for severe hypertension in pregnancy and obstetric hemorrhage now form two “elements of performance” for JC accreditation.
Guidelines and protocols should be based on evidence whenever possible. However, even if based only on consensus and expert opinion, guidelines can still provide the level of consistency necessary for smooth workflow and safe practices. The US Department of Health and Human Services and its Agency for Healthcare Research and Quality have developed a National Guideline Clearinghouse ( https://www.guideline.gov ) to assist health care teams in implementing and disseminating clinical practice guidelines.
Checklists
Checklists in Medicine and Surgery
The use of checklists to improve quality and safety dates back to the 1930s and the first flight tests of the B-17 bomber. Nicknamed the Flying Fortress , this airplane was significantly larger and faster and had a longer range than any prior bomber in the US Army Air Corps. As a result, it required a crew who had a much higher skill level, were able to cope with the vastly increased complexity of the controls, and were well-versed in procedures required to fly safely. One of the first flights ended soon after takeoff in a fiery crash that killed two members of the five-man crew. The crew forgot to release the airplane’s gust lock, a device that held the bomber’s movable control surfaces in place while the plane was parked on the ground. After takeoff, the plane climbed, stalled, and headed nose first into the ground. Subsequent investigations into the accident showed no mechanical failure but rather pilot error. Experts of the day wondered if it was “too much plane for one man to fly.” In response, rather than increasing preflight training or reducing the complexity of the technology, the test pilots introduced a system of checklists to simplify the processes of takeoff, flight, and landing. From that moment, pilots guided the B-17 bomber through 1.8 million flights without a single accident, and aviation adopted the checklist as a critical tool for all aspects of defense and civil aviation.
Medicine has adopted the checklist concept to simplify complex systems as well. Checklists use two strategies to improve care quality and reduce adverse outcomes in medicine. First, they aim to implement evidence-based and best-practice strategies in a systematic fashion, making their use routine and universal. Second, they attempt to improve the function of a team by creating a shared set of standards and goals.
One well-known application of checklists tested as an intervention to improve outcomes was developed from work in the intensive care unit of Johns Hopkins Hospital. Investigators implemented a checklist for the insertion and care of central line catheters; at the end of the study, the unit that did not use checklists had no change in catheter-related bloodstream infections, whereas the intervention unit showed a decrease from 11 to 0 per 1000 catheter days, with an estimated savings of 43 catheter-related infections, eight lives, and nearly $2 million over 1 year. When expanded to intensive care units in the entire state of Michigan, this same checklist reduced infections by 66%, saving more than 1500 lives and $175 million over just 18 months. What is most remarkable is that the checklist involved only five steps: hand washing, using sterile draping, cleaning the skin with chlorhexidine, avoiding the femoral site, and removing any unnecessary or redundant catheters.
Application of the checklist concept to the surgical specialties has shown further remarkable results. A World Health Organization (WHO) program implemented a 19-item surgical safety checklist in operating room facilities over 1 year in eight hospitals in a diverse range of health care settings. Complication rates decreased from 11% to 7% ( P < .001), and death rates were reduced by nearly 50% (1.5% to 0.8%; P = .003). Implementing checklists, however, is more complex than simply introducing a new document to a clinical team, and there are also examples in the literature of disappointing results. Checklists are tools that need to be implemented with appropriate engagement and leadership to ensure adherence and usability and must be monitored and adapted for utility to the specific environment and culture.
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