Checklists to guide critical procedures are becoming an increasingly important part of medical practice. These tools have proved effective in improving outcome in a variety of medical settings, including obstetrics. In this review, we outline essential principles of successful checklist creation and implementation and review our experience with checklist development in a worldwide, multiinstitutional health care delivery system.
In recent years, the use of protocols and checklists to guide care in select, critical situations has become a major focus of efforts to improve patient safety in both medical and nonmedical professional endeavors. We present in this study a review of general principles of checklist development, and an example of the process as implemented in a moderate sized health care system—the United States Air Force Medical Corps.
As early as 1999, the use of checklists was advocated by the Institute of Medicine as an integral part of a larger effort to prevent medical error in the US health care system. The Institute of Medicine has stated that the standardization of key processes with the use of checklists and protocols is a key to the prevention of errors in health care systems and listed the definition of standards of practice as a primary role professional organizations should take in creating a culture of safety. Many specialties have adopted these recommendations— Figure 1 details the exponential growth of publications indexed by PubMed under “safety checklist” in the past 3 decades.
The use of checklists has been demonstrated to be effective in improving outcomes in a variety of clinical settings, including the prevention of central-line associated infection, reduction in ventilator associated pneumonia in adults and children, improved compliance with clinical recommendations for the management of acute myocardial infarction and stroke, the administration of general anesthesia, diabetes care, and improved decision making in the diagnosis of brain death. General acceptance of the need for checklist-guided care in obstetrics has been slower, and largely limited to the past few years. Most efforts have been modeled after the groundbreaking programs developed by the Hospital Corporation of America to standardize the monitoring and administration of oxytocin, misoprostol, and magnesium sulfate, and the documentation of the management of shoulder dystocia. These approaches have been shown to significantly decrease both adverse outcomes and obstetric litigation in the nation’s largest obstetric health care delivery system.
Checklists adopted by high-reliability organizations typically take 1 of the following 4 forms :
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Static parallel checklists typically are read and performed by a single individual. Published oxytocin administration checklists and those governing the use of anesthetic equipment are examples of this approach.
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Static sequential checklists with verification involve a “challenge and response” approach in which one individual reads a list and a second verifies completion of the requisite tasks. Many aircraft safety checklists, as well as those used for central line insertion and the administration of blood products are examples of this type of checklist.
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Static sequential checklists with verification and confirmation are typically used in larger team settings in contrast to a team of 2 as above. Such checklists are typically read by one team member with verification of task completion by multiple additional team members. Comprehensive operative room time outs often use this approach, which may also be applied to the management of shoulder dystocia ( Figure 1 ).
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Dynamic checklists generally take the form of flow charts to guide clinical decision making. Flow charts lend to a visual display that is particularly useful when dichotomous decisions follow to different subsequent checklist items. Such checklists have been used to guide the intubation of patients with difficult airways, and more recently to assist in clinical decision making regarding the administration of magnesium sulfate for neuroprotection of premature infants and the management of hypertensive crisis in obstetrics ( Figure 2 ) . Checklists currently being developed for the management of category II fetal heart rate tracings will also likely take this form.
Despite the evident importance of checklists to patient safety and quality improvement, no universally accepted processes exist for the effective development of medical checklists. Published recommendations regarding checklist development tend to suggest the importance of several key areas of checklist development. This approach may be outlined as follows:
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Choose your clinical processes carefully. Not all medical conditions or procedures are amenable to management by checklist. In selecting processes or procedures for checklist development we suggest following closely the requirements set forth by the National Quality Forum for quality metric development. The following questions should be critically addressed for each potential checklist topic:
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Is the topic of high importance? Is it currently associated with significant numbers of poor outcomes? Is there a gap between recommended and actual performance in your facility or community?
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Is there a scientifically acceptable approach to effective diagnosis or treatment of the condition in question? Although the management of shoulder dystocia meets this criterion for checklist development, the management of amniotic fluid embolism does not.
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Does the development and implementation of a checklist have the enthusiastic support of senior and respected department medical and administrative leadership? Without such support, change will be slow, painful, and ineffective.
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How intrusive will such a protocol be in the overall scheme of patient care? Will its implementation interfere with other, more critical processes? Will resource use be matched by expected clinical benefit? Does implementation of the checklist run the risk of devaluing other, more important checklists, and the development among clinicians of “checklist fatigue.”
- a
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Processes are ideally developed by representatives of all groups (physicians and nurses) expected to implement the checklists. Often, an arbitrary initial “straw man” protocol will serve as an effective template for effective and efficient discussion and modification. Efforts of such working groups must be supported by strong clinical and administrative leadership.
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Checklists should be short and unambiguous. It is better to break a complex process into several short, specific checklists rather than deal with a single cumbersome process.
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Leave room for clinical judgment in exceptional cases. With a properly selected topic and a properly constructed checklist, such exceptions will be rare, and should be routinely subject to peer review.
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Checklists should be reviewed frequently to assure ongoing compliance with new data and changing standards of care.
Incorporation of a checklist-based protocol approach to high-risk obstetric conditions seemed especially well suited to patient safety efforts of the US Air Force Medical Corps for several reasons.
First, military aviation was the birthplace of the checklist-based approach to reducing error in critical and complex situations, and is commonly cited as the inspiration for such practices adopted by other high-reliability organizations. This concept was born out of the experience of the US Army Air Corp with the B-17 bomber in World War II. After the crash in 1935 of an original prototype during an initial flight demonstration, the B-17 was deemed “too much plane for one man to fly.” This realization led to the development of an entirely new approach to flying in which most critical portions of the operation were guided by uniform checklists; pilot autonomy was purposefully made subordinate to guidance by such protocols. In the next few years, the B-17 went from an abject failure to the workhorse of the American war effort and was a major factor in the eventual Allied victory. Ever since this experience, reliance on checklist-based protocols has been a mainstay of military and later commercial aviation. Indeed, even today, the aviation industry (military and civilian) remains the prototypical high-reliability organization against which all other such endeavors are compared.
Based on this flight experience, checklists and protocols have become vital components of virtually all complex military procedures from mechanical maintenance to weapons readiness and even military law. Disciplinary charges of dereliction of duty across a wide variety of responsibilities are often based on failure to follow established protocols or checklists. This approach has contributed significantly to the current status enjoyed by the US military as the preeminent fighting force in the world.
Finally, the realities of military medical practice include great degrees of mobility and change. A physician or nurse can be practicing in a military treatment facility in Alaska today, and in Italy tomorrow. Such conditions are not dissimilar to those experienced in many civilian settings in which physicians, nurses, or both may simultaneously practice in different hospitals with different cultures, patient populations, and medical teams. Thus changing teams and practice conditions would seem to make process standardization vital in both military medicine and in the civilian world. The recent development of checklists to guide critical process performance in US Air Force facilities provides a useful example of the above principles in practice.
In 2008, the Air Force Medical Operations Agency was established in San Antonio, TX, to assist in the centralization of personnel and policies across the US Air Force Medical Corps. In concert with this process, the Air Force Surgeon General’s Perinatal Nursing, Obstetrics, and Gynecology, and Maternal-Fetal Medicine consultants began a united effort to bring to the specialty of obstetrics the same type of process standardization that has worked so well for other components of the military. This effort had several aspects:
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The US Air Force Surgeon General’s Maternal-Fetal Medicine Consultant was appointed to direct and oversee standardization efforts.
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A patient safety task force was assembled, consisting of a representative obstetrician and/or maternal fetal medicine specialist and experienced obstetric nurses from each US Air Force medical facility with an obstetrics unit. The task force was assisted by a civilian patient safety consultant.
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In consultation with these facility representatives, a list of 10 specific high priority situations in obstetric practice was developed. These were situations that were deemed by the team to pose particular challenges with respect to patient safety and system error, based on existing medical literature and the experience of physicians and nurses on the task force ( Table 1 ).