As he has since graduating from surgical training 15 years ago, the orthopedic surgeon stands confidently at the operating table. He has hundreds of successful procedures under his belt but is tight on time—anxious to finish this one quickly so he can grab lunch prior to his afternoon clinic appointments. Turning to the surgical technician, Petty Officer Third Class Jerry Smith, a hospital corpsman who graduated from surgical technician “C” school six months previously, he asks for a scalpel. Anxious to please, Smith reaches for the ten blade, but hesitates. Mustering his courage, he says, “But, sir, we haven’t completed the surgical time out.” Taken aback, the surgeon responds: “I don’t have time for that. Let’s go.”
Pulse pounding, Smith sees his brief career in the operating room disappearing before his eyes, but he stands firm. “Sir, I am invoking the ‘two-challenge’ rule and respectfully requesting that we perform the required time out.”
Other than the cadence of the anesthesia ventilator, the room falls silent. Stepping away from the table, the surgeon turns and makes eye contact with the technician. “Petty Officer Smith, you are absolutely correct. Lieutenant Jones, as the circulating nurse, would you please read the signed operative permit to verify we are performing the correct procedure on the correct limb?”
Smith sags, relieved he was not ordered to “scrub out,” but even prouder that his voice was heard and that he may have prevented a wrong-site surgery.
In October 2014, then-Secretary of Defense Chuck Hagel released the results of a comprehensive review of the Military Health System (MHS), the enterprise that provides health care to 9.6 million active-duty service members, military retirees, and their families.1 Overall, this review found that the MHS provides safe, timely, and quality care. There was variability across the system, however, with some areas outperforming their civilian counterparts and national benchmarks and others underperforming. Stating that “we cannot accept average,” Secretary Hagel challenged the MHS to become a “High Reliability Organization” (HRO).
High Reliability Principles and Practices
As defined by Karl Weick and Kathleen Sutcliffe in their landmark study Managing the Unexpected, an HRO is an organization that functions in a complex and hazardous environment with a much lower rate of mishap and error than expected.2 Most important, the hallmark of an HRO is not that it is error-free, but that it is not disabled by errors. Based on their analysis of several highly reliable organizations, including naval aviation and the nuclear power industry, the authors identified five characteristics defining these organizations, divided into principles of “anticipation” and “containment.”
Seemingly counterintuitively, HROs are preoccupied with failure, meaning they strive to identify the sources of failure at the lowest possible amplitude to prevent catastrophic failure. In addition, HROs are reluctant to simplify or rationalize the interpretation of data that varies from expected normal operations, instead viewing variances as a window into larger underlying systemic problems. Staff members working in an HRO remain actively engaged and sensitive to routine operations, recognizing that complacency is antithetical to safety. When an error or mishap does occur, HROs are committed to returning the system to normal operations as quickly as possible to prevent or mitigate harm. One primary mechanism by which this resilience is achieved is by deferring to subject matter expertise, at whatever level it may reside in the organization. HROs acknowledge that it is impossible to anticipate and prevent all possible failure modes and rely on the active engagement or “mindfulness” of all hands to recognize and intervene when operations do not go as planned.
As Navy medicine pursues its journey to high reliability it need not look further than the fleet to find superb examples to emulate. Few organizations are more frequently cited for their track record of safety than the Navy nuclear propulsion program. Under way for more than 60 years without a serious incident involving its nuclear reactors, the Navy nuclear community is a model for producing operational safety in a complex engineering and operational environment. Equally impressive, naval aviation has demonstrated a remarkable safety record despite the hazards of launching and recovering high-speed aircraft in the space constrained, dynamic, and unforgiving environment of the carrier flight deck. Naval Special Warfare SEAL teams also have demonstrated unparalleled effectiveness and resilience in consistently completing high-risk missions, such as the Abbottabad raid in Pakistan or the rescue of Captain Richard Phillips from Somali pirates.
Translating High Reliability to Navy Medicine
Since the 1999 publication of the Institute of Medicine’s seminal report on medical error, significant attention has been focused on reducing patient harm caused by the health-care system itself.3 Nevertheless, preventable medical errors still occur in our nation’s hospitals and clinics. A recent study reported that medical errors claim at least 251,000 lives every year.4
By identifying and adopting some of the high-reliability characteristics of three Navy operational communities, the Navy medical community can meet its mandate to become an HRO. This already is occurring. For example, the Department of Defense Patient Safety program has instituted a teamwork-training program called TeamSTEPPS® based on the principles and practice of aviation crew resource management. This evidence-based set of teamwork tools is aimed at optimizing patient outcomes by improving communication and teamwork skills among health-care professionals. All Navy medicine personnel, both clinicians and administrators, have received TeamSTEPPS training. HM3 Smith, the operating room technician in the opening stage setter, was using a TeamSTEPPS protocol when he invoked the “two-challenge rule.”
Standardized But Dynamic Operating Systems
At the heart of highly reliable fleet communities is a meticulously structured operating system incorporating a time-tested yet dynamic doctrine that defines how that community operates, as well as the who, what, where, when, and why it does so. In naval aviation, for example, a Naval Aviation Training and Operating Procedures Standardization (NATOPS) manual exists for each airframe. These “bibles” provide the standardized and mandated methods for operating specific aircraft. The operating procedures defined in the NATOPS manuals are reinforced and “hard wired” through extensive training, detailed mission prebriefs and debriefs, and checklists that use a “challenge-reply” methodology to avoid complacency on fundamental but critical steps for safe operation of the aircraft. As stated in the NATOPS instruction, “Inputs from many sources are used to maintain the integrity of the program. Any NATOPS publication user who notes a deficiency or an error is obligated to submit a change recommendation. The participation of the individual is essential, if continued improvement of the manuals is to succeed.”5
The medical field has been slow to develop such a standardized operating model, although it increasingly is developing and refining clinical practice guidelines that outline recommended treatment methods for specific conditions. Unlike in aviation, however, which has a relatively small number of individual airframes, there are literally thousands of discrete medical conditions and diagnoses, very few of which reliably follow a predictable course. The increasing use of comparative effectiveness research, focused on demonstrating whether a given treatment is justified based on the best medical evidence, is an emerging method of reducing unnecessary variation of treatment methods despite this complexity.
At the organizational level, there has been a concerted effort over the past two years to “reinvent” the Bureau of Medicine and Surgery (BUMED) to accelerate its development as an HRO. Establishment of an executive director position to maximize coordination across functional codes and ensure the coherence of policy guidance provided to the field has been a central element in this effort. Much more work remains to be done, however, and the examples provided by the fleet offer opportunities by which Navy medicine can tighten and speed its feedback loops and increase the “signal to noise ratio” of communication throughout its enterprise.
The ability to anticipate, identify, and rapidly resolve variations from normal operations at the lowest possible threshold, before they produce harm, is a hallmark of an HRO. HROs actively resist complacency based on prior success and remain acutely sensitive to ongoing operations. Fleet high performers know “you can’t navigate by your wake.”
Central to anticipating and minimizing preventable error in the fleet is the practice of operational risk management (ORM). Anticipating risk, weighing the likelihood of its occurrence and its severity, and incorporating validated techniques and procedures to eliminate, or at least minimize, the sources of risk and the possibility of mission degradation are the first steps in ensuring highly reliable performance. Rigid adherence to performing detailed prebriefs prior to an aviation mission is a well-known example of how ORM can be incorporated into routine operations, but other communities also have developed ORM-based protocols to systematically anticipate, understand, and mitigate risk.
While coping with fear and fatigue in deep depths, high altitudes, and dark skies and through live-fire weapons and explosives training, Naval Special Warfare (NSW) operators learn to mitigate risks with checklists, inspections, rehearsals, and most of all, teamwork. NSW uses proven practices in the Joint Special Operations mission planning and execution process, which mixes regimented planning with creative brain-storming and collaborative interagency and joint target analysis with repeated walk-throughs and rehearsals. If a platoon member is wounded, if a helicopter crashes, if a parachute tears, Special Operations plans always include branches and sequels to deal with these and other plausible contingencies. SEAL team members believe “amateurs train until they get it right, professionals train until they can’t get it wrong.“
Within the submarine force, a disciplined approach to maintenance and operational checks prior to getting under way removes uncertainty with respect to the material condition of the nuclear power plant and all systems directly related to ship safety. The force’s quality assurance (QA) program ensures the quality of materials, integrity of maintenance, and strict procedural compliance for maintenance on systems vital to propulsion plant and platform survivability. In-process controls, to include supervisory inspection points and two-person checks, validate the final condition of the system to exacting standards. Ingrained in a “trust but verify” culture, the QA program includes post-maintenance records reviews, with vertical audits to verify the integrity of the overall process from end to end and horizontal audits that focus on one item across many efforts to validate systemic successes or challenges.
Within Navy medicine, a number of initiatives have been undertaken to emulate the principles of fleet ORM in medical treatment facilities. Clinics start their days with TeamSTEPPS “huddles,” akin to mission prebriefs. The entire team gathers to discuss the plan of the day, identify and plan mitigation for challenging clinical situations, assign roles and responsibilities, and coordinate the day’s work. Many clinics also perform an end-of-day huddle, similar to a mission debrief. In the operating room, the multidisciplinary “pre-op huddle” allows the surgeon to highlight important aspects of each planned procedure, specify unique equipment requirements, identify recognized patient risk factors, and discuss mitigating techniques with the team. This also provides an opportunity to reinforce the importance of each team member’s active engagement in producing a safe, quality outcome for the patient. At the end of the procedure, prior to closing the surgical incision, the team pauses for “sixty seconds of safety” to verify sponge, instrument, and needle counts, clarify postoperative requirements, and solicit and address any concerns by team members.
From an enterprise perspective, one clear opportunity for Navy medicine is to emulate the “discipline of engineering” practiced by the Navy nuclear propulsion program to more closely integrate and coordinate the multiple subsystems that must come together successfully to provide safe patient care.
Responses to Variation and Feedback
Rapid and appropriate responses to recognized variations from normal operations are essential to high reliability. The ability to interrupt a cascade of events, which if left unchecked could lead to catastrophe, requires the active participation of everyone involved in the process. Engagement by all team members, each of whom is obligated to speak up if he or she recognizes a deviation from established procedure, is an essential counterweight to the most common source of error—human factors. In naval aviation, for example, 85 percent of mishaps are because of human factors. Recognizing the potentially intimidating effect of differences in rank and qualification levels, Aviation Crew Resource Management (ACRM) empowers all members of the crew to speak up when it is their judgment that additional critical information needs to be considered. This “egalitarian vigilance” also is a hallmark of Naval Special Warfare. Dive buddies check each other’s equipment and jumpmasters inspect everyone’s parachutes, but regardless of rank, all platoon members are obligated to alert their teammates if they see something wrong.
Having recognized a low-amplitude signal of impending malfunction or that a deviation from normal processes has occurred, highly reliable teams respond rapidly and, when necessary, with a well-coordinated, multidisciplinary approach. As demonstrated in our opening vignette, Navy medicine’s commitment to TeamSTEPPS has empowered all members of the health-care team to speak up if they believe an error is about to happen or if they think critical information has been overlooked. The development and use of multidisciplinary “Rapid Response Teams” to intervene in patient care when it is recognized that a patient’s condition is deteriorating is another means by which the medical field is attempting to improve its response to unexpected variation. Emerging efforts to apply the tools of predictive analytics to monitor for and identify impending clinical deterioration before it occurs has shown tremendous promise in clinical trials. This is one way to harness the promise of “big data.” In the event emergency interventions are required, medical teams also would do well to adopt the SEAL mind-set that “slow is smooth and smooth is fast.”
Equally important to well-coordinated, immediate responses to imminent mishaps are formalized feedback mechanisms by which all components of the standard operating system can be modified and optimized. When an untoward outcome occurs, feedback obtained as close to the precipitating event, before critical nuances are lost, is particularly valuable. Immediate “hot washes” and debriefs are a time-tested fleet gold standard and are used routinely in Navy medicine. The larger challenge is to distill and capture the lessons learned in such a way that they can be validated and widely shared. One important example is the Aviation Safety Awareness Program, an anonymous survey taken by each aircrew after each flight or daily by maintenance personnel that captures the good, the bad, and the ugly of daily operations. This system provides for rapid cycle mid-course corrections to policy and personnel based on perishable data that might not surface during normal debriefs.
Within the medical community, each staff member has access to the Patient Safety Reporting (PSR) system and is encouraged to identify and report events that may have contributed to patient harm. Several factors—such as difficulty in accessing the system and barriers to entering detailed data—have impeded realization of the full value of PSR, but efforts to improve its fidelity and utility are under way. Despite its shortcomings, several quality improvement efforts have been initiated based on the trends identified by PSR data review.
Formal mishap investigations are another essential means by which highly reliable organizations objectively face the facts and assess the integrity and effectiveness of all elements of their enterprises. The aviation safety reporting system produces detailed safety investigation reports (SIRs) to determine root causal factors without retribution and includes human factors analysis codes to identify specific human error elements. SIRs include mishap recommendations focusing on changes to policy and procedures, as well as airframe or safety equipment improvements. Similarly, root-cause analysis in the submarine force and its associated nuclear propulsion program does not focus on who is to blame, but rather on determining the “whys” of the problem. Once the root cause is identified, corrective actions are assigned to a specific department, with a defined completion date. When corrective actions are complete, further analysis is conducted to ensure the root cause has been eradicated and lessons learned are shared formally.
The medical field has long embraced the use of root-cause analysis to assess “sentinel events”—any unanticipated event resulting in death or serious injury to a patient not related to the natural course of the patient’s illness—and to drive required changes. Compared to the fleet, however, the lessons learned have not consistently driven enterprise-wide improvement, in large part because risk management efforts have been disconnected from the clinicians and support staff actually performing the work.
A critical element of the BUMED reinvention is the establishment of chief medical officer (CMO) positions at each level of the organization who are responsible for the overall quality and safety of care delivered. In addition to their day-to-day clinical responsibilities and oversight of all elements of the QA and Safety departments, medical treatment facility CMOs participate in monthly Regional Quality Collaboratives in which they review quality and safety data and discuss near misses, “good catches,” and sentinel events. To date, the collaboratives have launched four multidisciplinary clinical improvement projects based on detailed analysis of PSR and sentinel event trends.
Another current project is the development of a “swarming” methodology, long practiced by aircraft carrier flight deck crews to resolve hurdles to normal operations.6 Leveraging the TeamSTEPPS infrastructure, Navy medicine will add swarming techniques to improve the real-time, multidisciplinary response to emerging mishaps. In addition, this multidisciplinary approach will be applied to the assessment of sentinel events, with the intent to augment and amplify the root cause analysis process. The aim is to eliminate patient harm by anticipating, identifying, resolving, and sharing the sources of medical error rapidly and transparently across the Navy medicine enterprise.
The Critical Role of Culture
Optimal fleet performance occurs in a culture that is vigilant and accountable yet strongly supportive of its members, and a climate of integrity is essential for command success. Insisting on high ethical and performance standards makes it easier to identify deviation from expected norms. Good leaders invest the time to identify the strengths of individual crewmembers and then place them in positions to maximize these strengths. NSW leaders know, for example, that even though not everyone has the aptitude or skills to become a sniper, they can fulfill other mission-critical roles.
In an HRO, leaders must establish a safe environment for engagement. Even when incorrect, input by all personnel, especially those most junior or newest to the team, should be acknowledged and discussed. This is the basis for the egalitarian vigilance that is critical to high reliability and is one way to accelerate high-velocity learning at the deck plate. Every engaged sailor is an additional “sensor” monitoring the complex operating environment for unexpected and potentially dangerous variation. An environment of psychological safety also makes it easier for a crewmember to ask for help and to have this request viewed as a sign of strength rather than weakness.
One tool used in the aviation community is the Aviation Command Assessment Survey System (ACASS), which includes 14 separate surveys, including the Command Safety Assessment and Maintenance Climate Assessment Survey. This survey is taken within 90 days of commanding officer turnover and provides a baseline assessment of the command climate, identifying areas that may be impeding high reliability performance. Medical commands also perform command climate surveys on an annual basis and within 90 days of a change of command. Using the command-generated questions to assess the staff’s confidence that they can report safety concerns without retribution is one way this tool can be used to measure psychological safety and identify ways to improve it.
The Way Ahead
Like their civilian counterparts, the women and men of Navy medicine have made significant progress in improving the safety and quality of the medical care they provide; however, hard work remains and constructive change needs to occur if military medicine is to become an HRO. By embracing the disciplined, systematic approach of the submarine force and its nuclear propulsion program, the complex yet fluid choreography of carrier aviation, and the unparalleled teamwork of NSW, Navy medicine can accelerate its journey to high reliability and continue to ensure it provides the safest and highest possible quality of care to all warfighters, past and present, and their families.
2. Karl Weick and Karen Sutcliffe, Managing the Unexpected: Assuring High Performance in an Age of Complexity (San Francisco: Jossey-Bass, 2001).
3. Linda T Kohn, Janet Corrigan, and Molla S. Donaldson, To Err is Human: Building a Safer Health System (Washington, DC: The National Academies Press, 1999).
4. Martin A Makary and Michael Daniel, “Medical error—the third leading cause of death in the US,” The BMJ 2016;353:i2139 (3 May 2016), www.bmj.com/content/353/bmj.i2139.
5. OPNAVINST 3170.7U, NATOPS General Flight and Operating Instructions, 2-15.
6. Steven J. Spear, The High-Velocity Edge: How Market Leaders Leverage Operational Excellence to Beat the Competition (New York: McGraw-Hill, 2009).