Operating management system for high reliability: Leadership,accountability,learning and innovation in healthcare

Abstract

The healthcare industry is on the journey toward high reliability. The industry works diligently to improve safety and quality, adopting some vitally important high reliability organization practices. While positive steps forward, these practices tend to be discrete initiatives to address specific challenges, and high reliability remains elusive. The journey taught us to view quality and safety not as a project, or even a portfolio of projects, but as an integrated operating management system. We are learning from industries that are further along on the high reliability organization journey, especially those compelled by widely publicized mishaps. These industries developed international consensus standards for integrated management systems to assure operational safety, quality, and reliability. Healthcare needs to evolve accordingly. Our work is informed by advanced systems engineering and mission assurance methodology, and research in high reliability organizing. The operating management system fosters two fundamental ways of working. First, it organizes processes and practices using a systems engineering approach to anticipate and reduce risks, mindfully standardizing work to prevent mishaps and improve performance. Second, it creates a culture of systems thinking and collaboration, building resiliency to recover from mishaps, when they occur, and promote mindful variation to deal effectively with unexpected situations. We share our motivation and approach to developing the operating management system, implementation examples and results achieved. While there is currently a large gap between idealized, highly reliable operations and current practice in healthcare, our experience demonstrates the benefits of this integrated systems management approach to address contemporary challenges and advance on the journey toward high reliability.

Keywords

Operating management system management system high reliability organization high reliability systems engineering quality

Background

Healthcare safety and quality efforts have evolved into what is often a fractured, reactionary, whack-a-mole approach as healthcare organizations scramble to address the rapid and uncoordinated expansion of publicly reported performance measures.¹ This is not a sustainable or effective strategy for healthcare. An Institute of Medicine survey “found that health systems require an average of 50 to 100 full-time equivalent employees, including physicians, at a cost ranging from $3.5 to $12 million per year, to carry out these efforts.”² Many of these reported measures are perceived by clinicians to be either invalid or clinically irrelevant. When we ask clinicians how the next patient will be harmed, few of the publically reported measures are included in their response.³ The pace of change, and often a lack of stability and transparency in measurement methodology, does not promote the highly reliable performance that healthcare seeks. Most importantly, this fractured approach distracts from our prime purpose to partner with patients, their loved ones, and interested parties to eliminate preventable harm, to continuously improve patient outcomes and experience, and to enhance value in healthcare.⁴ A structured approach to strategic planning, goal setting, and implementation is therefore essential to promote staff engagement, organizational alignment, and focus on what matters most.

High reliability is the sustained pursuit of excellent performance under complex and dynamic conditions.⁵ Healthcare has worked diligently to improve safety and quality, adopting some vitally important high-reliability practices such as standardized protocols and checklists, team huddles, pre-procedural and post-procedural briefings, incident reporting, etc. While these are very positive steps forward, these practices tend to be discrete initiatives to address specific challenges.⁶ Despite significant effort and discussion, low reliability persists in healthcare due to diffuse accountability, reliance on local over sector-wide improvement efforts, poor understanding of the true nature and culture of high reliability, and the absence of an integrated approach to the implementation of the key principles of high reliability.⁷

When people think of High Reliability Organizations (HROs), they often have in mind organizations associated with industries such as commercial aviation, aerospace and defense, nuclear power, or oil and gas.⁵ Despite their remarkable safety records, many of these organizations have endured high-visibility, high-consequence mishaps significant enough to threaten their existence and even affect the future of their entire industry. Extensive operational experience and success, accompanied by an unacceptable number of near misses, major mishaps, and catastrophes such as the Space Shuttle Challenger, Three Mile Island, and Deepwater Horizon served to motivate these and other industries to take a sector-wide, systematic approach to improving safety and quality. Healthcare, despite the pervasiveness of preventable harm, has not adopted a similar systemic approach on a commensurate scale.⁸

Learning from HROs

Existentially motivated to learn from and prevent future occurrences of their distinct mishaps, the aerospace and defense, nuclear power, oil and gas industries each developed integrated management systems to assure operational safety, quality, and reliability.^9–11 The management systems among these diverse industries are remarkably similar in context and content. The management systems merge organizational governance, safety and quality management, and technical domain best practices. These industries combined shared learning from their worldwide networks of organizations to create consensus on practices and protocols that are incorporated into international management system standards to sustain excellent performance under complex and dynamic conditions.

The aviation, space and defense industry quality management standard is designated AS9100.⁹ At the core of AS9100 is ISO 9001, the International Organization for Standardization (ISO) quality management system standard for any kind of organization, in any industry. Excellent performance under complex and dynamic conditions, however, requires a management system that is more comprehensive and rigorous than one with basic compliance to ISO 9001. The aviation, space, and defense industry reached international consensus on the addition of a number of requirements critical to consistently meeting customer and stakeholder expectations in their high performance, high-risk domain. These additional requirements address topics including the sequence and interaction of quality processes, with associated roles and authorities; the awareness by all staff of their contribution to quality and safety; operational planning, process control and risk management; verification and validation activities, non-conformance reporting, corrective and preventive actions; and the evaluation and improvement of customer satisfaction. As an example of the importance placed on this industry standard by the U.S. government, a recent report by the Inspector General of the Department of Defense states “Safety, airworthiness, product conformity, and reliability are key outcomes of AS9100C compliance.”¹² Many of these more rigorous and comprehensive management system requirements have important applicability to healthcare, if mindfully translated across domains and tailored to each organization.

As mentioned above, the commercial airline industry is often cited as a prime example of an industry that has achieved remarkably high levels of safety and reliability. To achieve this, many airlines voluntarily developed safety management systems to identify and reduce risk. The Federal Aviation Administration (FAA) now requires most U.S. commercial airlines to have safety management systems in place as a “formal, top-down, organization-wide approach to managing safety risk and assuring the effectiveness of safety risk controls.” The FAA takes an operational perspective and believes the “set of business processes and management tools…promotes a safety culture to improve the overall performance of the organization.”¹³

Taking this concept to an even higher level, the United States space systems community provides an excellent example of inter-organizational collaboration to develop an integrated approach to high reliability. Subject matter experts and senior operational leaders from various federal agencies, aerospace corporations, and academic institutions collaborate on a systematic approach and best practices for “Mission Assurance – the disciplined application of proven scientific, engineering, quality, and program management principles toward the goal of achieving mission success”.¹⁴ The mission assurance approach combines systems engineering and quality management methodology in a risk-informed decision-making construct. This collaboration continues in a sustained manner to achieve the common goals of this community for mission success. The ongoing dialog and advancement of practice allow the community to anticipate and mitigate emerging risks, and cope in a timely and coordinated manner with unexpected issues as they arise. While the healthcare mission and the national space systems mission have many similarities and differences, our work demonstrates that healthcare can benefit from a similar integrated approach to safety, quality, and reliability to achieve our mission and vision. Mission success in healthcare requires a state-of-the-art approach incorporating the latest systems engineering and mission assurance insights and best practices from HROs.

Development of an operating management system for high reliability in healthcare

Healthcare lacks such integrated management systems and generally fails to learn from mishaps in a systematic, sustainable manner to prevent recurrence.¹⁵ To significantly reduce harm, improve reliability and resiliency, healthcare requires a sector-wide systems approach to transform patient safety.¹⁶ To rectify this and advance our progress toward high reliability at Johns Hopkins Medicine (JHM), the Armstrong Institute for Patient Safety and Quality created and continues to mature an integrated management system model for healthcare. Such systems may be described in other industries as a “quality management system” or “safety management system.” We prefer the terminology “Operating Management System (OMS)” to emphasize the way we work together, across the full spectrum of disciplines and functions, in a high-tempo, high-consequence operational environment to assure the success of our vital mission.

The JHM OMS builds most directly upon the past 15 years of progress and leadership in patient safety and quality. As our fractal-based infrastructure with shared accountability for safety and quality evolved, discrete improvement initiatives became more systematic and integrated. The work extended across our health system, from our flagship academic medical center to the other hospitals, and then to the other entities within our health system. As we increasingly combined the expertise of clinicians and professionals from a broad range of disciplines, the portfolio became increasingly comprehensive and innovative. The journey taught us to view quality and safety not as a project, or even a portfolio of projects, but as an integrated system. From these organic roots, we realized about five years ago that we were developing an integrated management system similar to other high reliability industries. At that point, we began to plan and implement the OMS in a more conscious, structured manner as a formal management system.

In addition to the multi-dimensional scope of its content, the OMS development and implementation is in itself multi-dimensional. These dimensions include system design and content creation, consensus building and policy coordination, change management and version control, awareness and implementation guidance, operational management and effectiveness evaluation, corrective and preventive actions. It requires centralized leadership and administration to be developed and implemented effectively. To guide this work, we are fortunate to have OMS leadership with prior executive responsibility and authority for enterprise management systems, operational systems management, and mission assurance within HROs. This accelerates the evolution of the OMS based on direct knowledge of best practices, potential pitfalls, and lessons learned in critical and complex environments. An OMS Steering Committee comprised of clinical, quality and safety leaders, as a subset of our health system’s Quality, Safety and Service Executive Committee, provides the governance structure to develop and sustain the OMS as a functional and evolving system.

The OMS supports and advances the realization of our organization’s strategic goals in many ways. The OMS provides the integrated framework that governs the way we work together and partner with patients, their loved ones and all interested parties to end preventable harm, to continuously improve patient outcomes and experience, and enhance value in healthcare. It promotes alignment and integration across our extensive healthcare delivery system. Grounded by contemporary research in high reliability organizing, the OMS works to create a social-relational context of trust and respect, with attention to upstream and downstream coordination. It incorporates bundles of high-performance work practices consistent with the five principles of high reliability organizing: preoccupation with failure, avoidance of simplification, sensitivity to operations, commitment to resilience, and flexible decision structures.^17–19 Healthcare’s efforts to learn from other highly reliable industries have been generally superficial and siloed. Therefore, the OMS functions as a mechanism to actively manage the organizational learning from our own advances toward high reliability as well as our innovative application of approaches proven to assure safety, quality, and reliability in HROs. We are applying lessons from the National Aeronautics and Space Administration as an applicable example of a complex organization systematically working to enhance performance as a learning organization to reduce the risk of mishaps.²⁰

Core elements of the JHM OMS

HROs work tirelessly toward the pinnacle of high reliability, yet soberly understand they will never get the work fully behind them. Mishaps and near misses will inevitably occur despite best efforts. Therefore, conscious that the journey never ends, our work is guided by two overarching commitments. First, we model sensitivity to operations, and flexible decision structures whereby problems migrate to people who have the expertise to solve them, by respecting patients and clinicians on the forefront of caring for patients. Second, is our commitment to learning from all we do, aligning systems, and processes for continuous improvement and innovation.

In pursuit of excellent performance under complex and dynamic conditions, the OMS also fosters two fundamental ways of working that reflect the two logics of high reliability. The first logic is anticipation and prevention, which rely on the ability of the organization to predict accident scenarios. Therefore, we organize processes and practices using a systems engineering approach to identify and mitigate risks, standardizing work to prevent mishaps. This embodies the principles of preoccupation with failure and avoidance of simplification. The second logic of high reliability is resilience and recovery. Standard work processes are necessary to promote discipline and reliable performance, but not sufficient given the complexity of processes and systems. Research indicates that resilience may be more important than anticipation.²¹ We must ask ourselves—how well does the organization respond to unexpected events and mishaps not covered by established procedures? HROs develop the capability to deal with unanticipated events in an effective, timely, and minimally disruptive manner. They demonstrate a strong commitment to resilience. Therefore, our second fundamental way of working is to creating a culture of systems thinking and collaboration. The goal is to build resiliency to recover from mishaps or unexpected events, when they occur.

The OMS is organized and elaborated through five core elements that incorporate the high reliability principles, adhere to our two overarching commitments, and expand upon our two fundamental ways of working. The five OMS core elements are:

Governance, leadership, and accountability

Systems thinking, risk identification, and mitigation

Capacity and infrastructure

Transparency, communication, and teamwork

Insight and innovation

Figure 1 illustrates the OMS model with the patient at the focus, our commitments and ways of working for high reliability, and the five core elements. A brief description of the rationale, generalized expectations, and a few specific practices for each of the five core elements are provided below.

Figure 1.

Operating management system.

Element 1—Governance, leadership, and accountability

The Board of Trustees ensures focused oversight for quality and safety anywhere care is delivered within the health system. Quality and safety oversight is provided, and accountability maintained, with the same rigor as processes to monitor and account for financial performance. Leaders create shared accountability, meaning that leaders only hold others accountable if they first hold themselves accountable for ensuring others know the goals, know their role, have the skills, time and resources to achieve the goal, and receive feedback toward the goal. Leadership and shared accountability cascade from Board to bedside, through all levels of the organization.^22,23 Brief examples of specific practices:

A standard Management Discussion and Analysis (MD&A) reporting format, similar to the widely used business reporting template, is utilized with standardized content expectations in the domains of safety, patient outcomes, patient experience, and value.

A Performance Subcommittee of the JHM Patient Safety and Quality Board Committee provides focused oversight of quality and safety performance. Presidents of each entity within the health system report using the standard MD&A format.

At Johns Hopkins Hospital (JHH), all clinical department directors utilize the same standard MD&A format to provide individual department reports to the Performance Subcommittee of the JHH Patient Safety and Quality Board Committee.

Element 2—Systems thinking, risk identification and mitigation

Systems thinking is the essence of harm prevention and high reliability.²⁴ Yet too often, healthcare assumes the simplistic, linear mechanism as the cause of patient harm.²⁵ The healthcare operational environment is a complex system of distributed system components, sub-systems, and interdisciplinary work processes. Systematic processes to identify, analyze, evaluate, mitigate, and track risk are necessary at all levels of the organization to facilitate timely risk communication and risk-informed decision-making. Performance results and identified risks may indicate the need for a detailed systems engineering assessment involving the associated people, processes, and technology. Corrective and preventive actions, including system redesign, may be required to optimize performance, reduce mindless variation, prevent mishaps, and promote resiliency. Brief examples of specific practices:

Given that timely, accurate and clinically relevant data are the foundation of quality improvement, systems engineering methodology is utilized to ensure that leaders and staff from various organizational elements work as one multidisciplinary team. Team members understand the upstream and downstream implications of their work, and work together to optimize the integrated work flow processes and information technology systems to assure data validity and high reliability.

Data from safety culture surveys, employee engagement surveys, event reporting, and other sources are utilized to identify potential risks and develop unit-specific corrective and preventive actions.

A non-rate-based preventable harm initiative provides an enabling system-wide infrastructure for the prevention and mitigation of harms that cannot be counted in the same way as typical measures of safety and quality.³

Element 3—Capacity and infrastructure

Capacity and infrastructure for quality, safety and service are developed according to a fractal organizational model. Applying the design found widely in nature, the repeating structure of fractals is used as a model to build and support the development of quality improvement expertise and promote communication. The fractal system approach is used to link all levels of the organization and align staff around common goals. It supports peer and organizational learning, grounding solutions in the wisdom of local teams. The approach promotes accountability and effective use of resources.²⁶ Brief examples of specific practices:

The role of vice chair for patient safety and quality was created for each clinical department and these individuals are tasked with managing patient safety, performance on external measures, patient-centered care, and value for their department. Vice chairs report to their respective department director and to the Armstrong Institute director.⁴

Role-tailored continuous learning opportunities for patient safety and quality are provided so that healthcare workforce members are engaged, prepared, and ready to improve care.²⁷

The Comprehensive Unit-based Safety Program (CUSP) creates clinical teams to improve patient safety culture and provide frontline caregivers the tools and support to eliminate preventable harm.²⁸

Element 4—Transparency, communication, and teamwork

Multiple modalities are provided for frequent, open communication, and engagement of staff, patients, and families in the shared mission of the organization. Leadership aims to be transparent in their actions and communicates frequently with staff to maintain alignment of initiatives and strategic priorities. Staff are empowered, encouraged, and coached to speak up and stop hazardous conditions to eliminate harm and share wisdom to improve patient outcomes and experience.²⁸ Multidisciplinary collaboration, coordination of care, and patient communication are a hallmark of clinical and administrative functions. Workflows are designed and proactively assessed to provide staff with a clear understanding of the upstream and downstream interfaces and impacts of their work.²⁹ We seek to align the science, the availability of information, performance incentives and organizational culture for continuous improvement. Brief examples of specific practices:

Patient and Family Advisory Councils are established with representatives on key quality and safety committees.

Lean Daily Management strategies including huddle boards are employed to support peer learning and accountability.

Implemented enhanced recovery after surgery (ERAS) protocols, involving close teamwork among patients, families, surgeons, anesthesia providers, nurses, etc., with the novel approach of joining ERAS with CUSP for enhanced engagement of front-line staff.

Element 5—Insight and innovation

Insights are gained through synthesis of precise, actionable information from various available internal and external data sources. These insights lead to new discoveries and innovation of new strategies and techniques to prevent harm, improve outcomes and experience, and enhance value. The robustness of the system is improved based on these insights and the resulting innovation increases mindful variation, in contrast to mindless variation, to advance the performance and resiliency of the organization. Robust knowledge management practices provide the foundation for performance as a learning organization and facilitate innovation. Brief examples of specific practices:

Clinical communities support peer and organizational learning, and change norms. Several teams of multidisciplinary, cross-entity stakeholders are convened regularly to work on safety and quality improvement for specific clinical topic areas.^30,31

A cross-disciplinary analytics community supports improvement work and synthesizes information from multiple sources to identify improvement opportunities

A learning laboratory integrates engineers, clinicians, and safety researchers using systems engineering and human factors approaches to design care systems.^32,33

OMS implementation progress and results

The OMS is particularly beneficial to leadership of the organization on at least two planes. Fundamentally, it provides a structured, hierarchical mechanism to pull together all of the requirements for a high reliability program into a logical, coordinated management system. The OMS also provides a powerful integrated systems management tool with which leadership can effectively orchestrate all of the interdisciplinary and interdependent activities necessary to achieve and sustain high reliability in a complex, dynamic environment. The power of this integrated management system approach is best illustrated by a variety of examples that elaborate on the implementation and benefits. The first two examples demonstrate the systems engineering discipline of requirements management where increasingly specific and actionable requirements flow hierarchically from higher level strategic objectives and are delineated into increasingly manageable functional allocations. The requirements derivation is sufficient when requirements are decomposed and cascaded into lower tiers with resultant requirements that are directly actionable and verifiable with clear accountability. Subsequent OMS examples provide quantitative results for improved process performance and reduction in potentially preventable harm. Finally, we provide an example of the kinds of insights and innovations facilitated by this systematic management approach.

Building capacity

Development of capacity is one example of how we evolved the OMS implementation, cascading from the summary description of Element 3—Capacity and Infrastructure. In order to achieve the mission of JHM, organizational leadership recognized that a robust framework for building capacity must be developed and implemented throughout the organization. Every individual must understand their roles and responsibilities with regard to patient safety and quality, and each organizational element must take accountability and action to ensure each individual has been trained to achieve our goal of eliminating harm.

We utilize a model for building capacity which considers organization-wide competencies for patient safety and quality and provides role-tailored continuous learning opportunities so that healthcare workforce members are engaged, prepared, and ready to improve care.²⁷ This framework provides role-tailored training for three broad distinct categories of healthcare workers. Category 1 represents all clinical and non-clinical workers who provide care to patients or interact with patients.²⁷ The educational content provided for Category 1 individuals includes basic patient safety, quality, and high reliability principles.²⁷ In our health system, to date, we have 40,514 course completions of our Category 1 courses. Category 2 represents three different types of managers and local improvement personnel.²⁷ The educational content provided for Category 2 individuals includes content to prepare them for the improvement-related aspects of their job. These are often a-la-carte courses that are taken on an as-needed basis and can include Lean Sigma, patient safety certificate, human factors engineering in healthcare, etc.²⁷ In our health system, to date, we have 13,481 course completions for our Category 2 courses. Category 3 represents individuals who dedicate their careers to patient safety.²⁷ This group of individuals are strongly encouraged to get formal training in degree programs that can include a Masters’ in Public Health or a doctoral degree for individuals interested in senior-level organizational leadership roles.²⁷

Systematic plan to eliminate preventable harm

Table 1 provides a highly-simplified, introductory example of how the achievement of a multi-faceted improvement goal, such as eliminating preventable harm, can be addressed systematically using the OMS. The action plan to achieve the goal (top-level requirement) is derived, in a manner consistent with other initiatives, through the lens of each of the OMS core elements. Extending the lens analogy, the top-level requirement is split into constituent elements (lower-level requirements), magnified to provide the necessary specificity, and focused to be actionable with traceability and accountability.

Table 1.

Example of OMS requirements derivation.

Clear goal communicated by leadership	OMS core element	OMS delineation of the stated goal	Accountable, actionable implementation using Fractal Quality Model (cascade to service-specific)
Partner with patients, families, and others to eliminate preventable harm	1. Governance, leadership, and accountability	1.1 Diagnosis – Diagnoses shall be determined with the highest precision and timeliness possible.	1.1.1 Implement focused diagnosis improvement projects for sepsis, stroke, and other common diagnostic errors.
			1.1.2 Implement tools and practices for early identification of a deteriorating patient.
		1.2 Treatment – Treatment shall be appropriate and timely.	1.2.1 Design and implement best practice advisories and triggers to ensure timely and appropriate treatment.
	2. Systems thinking, risk identification, and mitigation	2.1 Measurement – Data elements for risk-adjusted survival rates and risk of mortality shall be measured accurately.	2.1.1 Systematically review work flows and data flows and implement data validation for critical data elements.
	2. Systems thinking, risk identification, and mitigation	2.2 Harm prevention – Strategies to prevent harms shall be implemented and monitored for effectiveness.	2.2.2 Establish interdisciplinary task forces specific to common harms (e.g. healthcare-associated infections, deep vein thrombosis)
	3. Capacity and infrastructure	3.1 Competency – Clinician competency shall be systematically developed and evaluated.	3.1.1 Methods shall be established and implemented to assess competency for specific procedures.
	3. Capacity and infrastructure		3.1.2 Thresholds shall be established for procedure volumes and monitored for each provider.
	4. Transparency, communication, and teamwork	4.1 Communication – Interdisciplinary teams shall be trained and mentored on care coordination and communication.	4.1.1 Conduct team huddles to facilitate communication.
	4. Transparency, communication, and teamwork	4.2 Resiliency – Work processes and training and shall build resiliency to recover from misdiagnoses and treatment errors, when they occur	4.2.1 Implement lean daily management practices and tools.
	5. Insight and innovation	5.1 Investigate – Mortality and morbidity shall be systematically reviewed to determine corrective and preventive actions.	5.1.1 Form an Interdisciplinary Mortality Review Committee to analyze and discuss common themes, trends, and opportunities.
			5.1.2 Ensure clinical departments conduct robust M&Ms through establishment of core standards for M&M.
			5.1.3 Conduct root cause analysis of all potentially preventable deaths.
		5.2 Data quality – Implement systematic evaluation and controls for data to assure data quality.	5.2.1 Develop and maintain workflow and data flow diagrams for quality-related data.
			5.2.2 Develop tools to monitor data integrity as it passes through various work processes and information technology systems.

High reliability in evidence-based process measures

The Joint Commission Top Performer on Key Quality Measures® program was created in 2011 to recognize organizations that performed reliably (at 95% or greater compliance) on evidence-based process measures, also referred to as accountability measures that improve outcomes for clinical conditions such as heart attack and stroke.³⁴ Our leadership, accountability, and governance system supported by robust process improvement and use of cascading A3 systematic problem solving tools facilitated root cause identification, effective interventions, and shared learning to improve performance on The Joint Commission Accountability Measures. In consultation with the Board of Trustees and clinical quality leaders, we set our goal at 96% or greater compliance for each core measure. Performance on each core measure was aggregated into an annual mean performance score. In 2011, before implementation of this approach, 42.9% of core measures met or exceeded our 96% goal at JHH. After implementation, in 2012 and 2013, 85.7% of core measures met or exceeded 96% compliance. Consequently, JHH was recognized by The Joint Commission as a Top Performer on Key Quality Measures® and also received the Delmarva Foundation Award for this performance.^22,23 We continue to apply this model to core measures and expanded the implementation to other performance measures across our health system.

Improvement in potentially preventable complications

We participate in a state government quality improvement program that translates hospital administrative data into a measure of potentially preventable harm using the 3M™ potentially preventable complication (PPC) classification system.³⁵ Performance on various individual PPCs is indirectly standardized and scored in a manner that results in a single composite number that ultimately determines the amount of payment adjustment for each hospital. In calendar year 2012, this program measured over 3800 PPCs for our hospital. Five years later, we ended calendar year 2017 with 3000 fewer PPCs as shown in Figure 2. This 79% reduction in this measure of potentially preventable harm is one example of results we are seeing using the OMS approach.

Figure 2.

Reduction in potentially preventable complications (PPCs).

With respect to the OMS element of governance, leadership and accountability, we established goals and communicated expectations throughout the organization. It quickly became apparent, rather than oversimplifying and neglecting the true complexity of the challenge, we needed to derive the expected performance on each individual PPC for each unique clinical department and service. This was quite a challenge to develop reliable algorithms for this derivation. However, for communication, engagement, and accountability, the goals needed to be relevant and actionable throughout the hospital. Deferring to the expertise of our clinical quality improvement and analytic resources, we were able to institute case level tracking, cascading from hospital level to clinical department to division/service and all the way down to each individual attending physician. These cascading levels of tracking reports provided the necessary transparency and sensitivity to local operations to effect the necessary improvements.

Systems thinking was essential as we investigated the workflow, data quality and documentation challenges associated with each indication of potentially preventable harm. The work was exacerbated by the inherent problems in using administrative data for precise clinical quality measurement and improvement. The root and contributing causes could then be determined along with the necessary corrective and preventive action. Risk identification continues to be key to our approach including the realization that patient safety risk and revenue risk are not fully aligned due to imperfections in the program methodology.

We built capacity for this unique pay for performance program through intensive training of clinical, quality, coding, finance, and information technology staff. Active, continuous collaboration, and teamwork are necessary, including periodic enhancements and reengineering of interdisciplinary workflow, supporting data systems, and management tools. Based on insights gained over the course of this program, in collaboration with other hospitals, we recommended many measure specification and methodology changes which have been implemented along with other program changes year to year. Further changes are indicated to improve the accuracy of measurement and stability of the methodology. Our holistic OMS approach provides the systems thinking, teamwork, transparency, learning, and innovation necessary to advance accuracy in measurement and eliminate potentially preventable harm. The resulting modification of human behavior, as well as the modification of supporting processes and technology, continues to drive improved performance for these and other measures of quality and safety.

Improvement in healthcare-associated infections

Our work to eliminate preventable, device-related healthcare-associated infections (HAIs) such as catheter-associated urinary tract infections (CAUTI) and central-line associated bloodstream infections (CLABSI) constitutes another example of OMS implementation.^36–40 At the highest levels of our organization, trustees and executive leaders clearly articulate and hold everyone accountable to the strategic objective of eliminating these sources of preventable harm. Governance, leadership, and accountability are cascaded from the Board of Trustees to each health system entity’s executive leadership and all the way through the departmental and unit levels to the frontline staff. We ensure that each level of the organization is able to articulate the goal of zero preventable harm, know the current status of their area’s HAI data, and speak to their specific action plan to address HAI prevention. An accountability model leads to a series of escalating interventions and transparent conversations with institutional leaders when units or areas have metrics that do not meet their targets.

We utilize systems design thinking to evaluate and optimize the workflow regarding device insertion and maintenance practices and to mitigate risks that are potentially introduced at each step of these processes. Capacity and infrastructure are addressed by developing and implementing robust educational support and competency assessments to ensure that frontline staff have the knowledge, skills, and tools that they need to insert and care for central lines and urinary catheters according to the evidence-based best practices, and multidisciplinary rounds are utilized to ensure that these devices are removed as promptly as possible to prevent harm from HAIs. This infrastructure also requires attention to providing educational support and competency assessment for new staff, temporary staff, and trainees who continually refresh the pool of personnel caring for patients with these devices.

We incorporate teamwork, transparency, and communication into our HAI prevention work by regularly reporting CLABSI and CAUTI data in a very transparent way across the health system and by using an accountability model to track and respond to units’ and departments’ performance trends. This fosters a sense of competition, as well as accountability, and raises awareness of how each areas’ performance compares to benchmarks, other areas, and themselves over time. Publically reported metrics, scores, and financial incentives or penalties are reported and broken down into their components so that everyone is aware of the impact CLABSI and CAUTI events have on these outcomes in addition to the patient harm they cause. Finally, insight and innovation are fostered by conducting investigation and mini-root cause analyses for each CLABSI and CAUTI and by incorporating the findings into design solutions and future risk mitigation strategies. Using this disciplined OMS approach, our health system hospitals have met and exceeded CAUTI targets and sustained this success while dramatically reducing the number of CLABSI events over the past two years.

Accounting for harms that cannot be counted

An important example of the insights and innovation resulting from the OMS approach is our Non-Rate Based Preventable Harm (NRBPH) Initiative.³ The NRBPH Council was convened in January 2015 to develop an enabling system-wide infrastructure for NRBPH prevention and risk mitigation through the use of high reliability principles and OMS strategies. The major aim of the council is to mitigate or eliminate non-rate-based preventable harms by supporting the following:

Identification of safety hazard signals from various sources from across the health system and externally (e.g. publically reported national benchmarks)

Development of novel ways to prioritize the mitigation of non-rate-based risk

Organization of methods to implement such mitigation or elimination strategies

Encourage and foster a culture of accountability within the organizational framework

Facilitate learning and feedback between all levels of the health system

In order to achieve this, sub-councils were formed to address specific non-rate-based harms which were chosen based on systematically identified health system risks and industry trends. The NRBPH sub-councils will initially focus on patient identification, medication safety, retained foreign objects, equipment and devices, and health information technology safety. Each sub-council is comprised of staff from throughout the health system who provide subject matter expertise in these specific areas and can advise and inform the council on best practices. A seventh sub-council on workplace violence was recently added as a result of this ongoing risk identification and analysis.

Summary

Our organization, and most healthcare organizations, has worked for years to learn how to eliminate specific harms such as CLABSI. As a result, the number of projects multiplied in a reactionary manner to address the rapid expansion of performance measures. As we sought to eliminate all preventable harms, we realized the need for a more comprehensive approach and created this OMS to efficiently guide our work. Our sustained pursuit of excellent performance under complex and dynamic conditions requires this kind of integrated management system.

The OMS provides the integrated framework that governs the way we work together and partner with patients, their loved ones and all interested parties to end preventable harm, to continuously improve patient outcomes and experience, and enhance value in healthcare. The OMS supports and advances the realization of our strategic goals. It promotes alignment, integration, and precision across our healthcare delivery system. We continue to work towards additional specificity regarding the implementation at all levels of our organization and to further quantify the benefits of this approach to improve clinical performance and healthcare value. No doubt, this system and its implementation will evolve as it has for HROs in other industries over the past few decades.

Mission success in healthcare requires a state-of-the-art approach incorporating the latest systems engineering and mission assurance insights and best practices from HROs. The latest research in high reliability organizing will continue to be incorporated. We are working to mature educational materials and evaluation tools to further advance the implementation, to assist other healthcare organizations on the journey toward high reliability, and to continuously learn and innovate. The OMS will help us preserve and apply the resulting knowledge.

We are convinced of the transformative value and universal applicability of the OMS approach. The worldwide adoption of this type of management system in other industries, and the novelty of this comprehensive approach in healthcare, makes this description of the OMS development and implementation in an academic health system an important contribution for our shared journey toward high reliability.

Footnotes

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

References

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