Donahue, Moreen DNP, RN, NEA-BC; Brown, Joseph P. MAS, ATP; Fitzpatrick, Joyce J. PhD, RN, FAAN
Commercial aviation has an impressive safety record. Over the past decade, the focus on implementing system safety design principles as sound management practices has become more commonplace. Other factors enhancing safety in aviation have included the use of nontechnical skills such as crew resource management (CRM), technological advances (ie, air traffic collision avoidance systems, global positioning system, etc), and improved aircraft and human factors design. Together, these changes have contributed to significant reductions in overall aviation accident rates. However, in any industry, regardless of the safety statistics, hazards and risks that could lead to adverse events always exist.
Healthcare, also a high-risk, technologically advanced industry, can benefit from the many years of safety management lessons learned in commercial aviation. For example, the critical components of CRM, the focus on team training, group interaction for decision making, performance improvement processes, and the interaction of human factors within high-risk, high-stress environments have relevance and applicability in healthcare.1 Crew resource management programs have been implemented in operating room environments2,3 and for team training.4 Learning from the aviation industry, healthcare leaders can transform adverse event statistics through a global paradigm shift that migrates toward systemwide safety improvement, error reduction, and improved operational efficiencies. A system safety perspective includes oversight and adoption of safety management protocols. The intent of this approach toward safety management is for all healthcare constituents to work together to produce a viable, evidence-based, patient safety solution.5
Medication administration is a major safety issue for patients and providers. Many factors contribute to the complexity of this process, including, for example, incomplete, unknown, or conflicting information presented by patients on admission (because of multiple care providers or sources of information); multiple handoffs in the hospital; differences in medication formularies; and the number and types of medications available and prescribed.6,7 Thus, medication administration was chosen as the first area for application of a system safety process in the hospital where the first author is the chief nurse executive.
System Safety and Its Application in Healthcare
Historically, safety has been thought of as an organization's "highest priority" or as "something to strongly believe in." Traditional safety management has primarily focused on internal auditing, reporting, and investigating events that have already occurred. These are indeed important functions, but what is lacking is a fundamental and practical understanding of what safety actually is. More importantly, the focus needs to be on how to manage safety from a system point of view to better address root causes rather than symptoms of problems.
Simply put, safety is freedom from harm. Or, more specifically, safety is the minimization and management of operational risk to lower, more acceptable levels. System safety is "the application of special technical and managerial skills in a systematic, forward-looking manner to identify, analyze, assess, and control hazards and risks within our organization."8 Under system safety, the organization is no longer viewed as individual departments or processes. Rather, system safety takes a more holistic, interactive approach in how individual departments and processes work together in the overall system. Safety, or more appropriately stated, safety management, is seen as an integral component of a system where system failures are analyzed and processes and hazards are effectively controlled.
The Salus Network has created a "system safety architecture" that visually describes the functional components of a system: the operational system itself, its supporting subsystems, and all associated working level processes or elements.9 The resulting framework allows for better identification, understanding, and management of safety (risk) at usable levels. Attempting to collect useful data at the system or subsystem level is not practical because these system levels are too broad to generate meaningful data. Instead, the focus should be on working level processes, or elements, in each subsystem because these areas represent a point in a system that allows for easy data collection and data dissemination.
To illustrate, any typical management system in an organization will, or should, have structure. For example, a hospital department finance system has several subsystems (ie, financial programs and procedures) and subsequent working level processes or elements, each with a definitive structure. These elements serve as a primary data source through which data are collected, analyzed, managed, and disseminated. Visually, the structure appears as follows:
* System: finance management
⇒Subsystem: financial programs and procedures
⇒Element: general accounting principles
A system safety architecture, as an organizational design philosophy, is no different. The first step required in system safety is to identify all the operational systems in an organization (ie, business units, service lines, departments, etc). The Federal Aviation Administration has done this already for 14 CFR Part 121 Commercial Airlines in their oversight methodology known as ATOS (Airline Transport Oversight System).10 By defining operations from a system perspective, it is now possible to identify each operational system, supporting subsystem, and specific working level process (element). Two examples, one from aviation and one for healthcare, are provided below:
* System: flight operations management
⇒Subsystem: air carrier programs and procedures
⇒Element: deicing procedures
⇒Element: airman duties/flight deck procedures
⇒Element: operational control
⇒Element: aircraft performance and operating limitations11
* System: Medication Management
⇒Subsystem: medication administration
⇒Element: procuring and storing
⇒Element: preparing and dispensing
By defining an organization in this systems-based, architectural manner, all working level processes (elements) can be displayed clearly. This allows the system to be effectively analyzed from an operational risk standpoint. Each identified working level process (element) serves as a data collection/data distribution point. These processes (elements) can be used to assess and monitor operational efficiency and overall system performance in terms of safety and risk.
The hospital is a 371-bed community teaching hospital and regional medical center that serves a population of 350,000. The hospital's mission is to advance the health and well-being of people in the community. Hospital goals are focused on high quality, safe care, advanced technology, and exceptional service to support patients and their families. The hospital employees approximately 900 registered nurses.
In March 2008, the chief quality officer reported concerns about the number of adverse events related to medication administration. On the basis of the overall hospital commitment to patient safety, the chief nurse executive decided that applying CRM techniques could be advantageous and brought the issue to the weekly clinical leadership team meeting. One of the nurse leaders, the wife of a pilot, recommended the Salus Network, a safety management consulting service, be approached to provide consultation. The chief nurse executive initiated a plan to address the issue and engaged the consultant. Members of the clinical leadership team who worked with the consultant included the chief nursing officer, directors of patient care services, nurse managers from the surgical and medical floors, the director of pharmacy, clinical pharmacists, the chief medical officer, and the chief quality officer.
Safety Assessment Methodology
The safety assessment methodology used at the hospital contained specific pre-assessment activities and specific task modules. Pre-assessment activities were designed to identify the hospital management system and gain a sound working knowledge of the policies and procedures for the medication management system. Specific objectives of pre-assessment activities included the following:
* Identification of clear process ownership (ie, responsibility and authority);
* Obtaining an understanding of the management system (ie, reporting relationships, lines of authority, etc);
* Review of the documentation system to determine how medication management policies and procedures are structured and disseminated to frontline personnel.
The on-site safety assessment consisted of 40 hours; the assessment was conducted by the consultant over all work shifts and included 2 weekends. The initial stage of the assessment was an open meeting with nursing leadership. Additional meetings were held with the nurse managers and staff on the medical and surgical units selected for the review. They were informed about the data to be collected, the time frame for the assessment, and the reporting process for identification and prioritization of risk into high, medium, and low classifications. Data collection included assessment of the hospital medication management system processes against commercial aviation-based system safety attributes (responsibility, authority, procedures, controls, risk-point process measurements, and interfaces) in accordance with the following12:
* Responsibility-Is there a clearly identifiable, qualified, and knowledgeable person who is accountable for the quality of the process? In other words, who is in charge?
* Authority-Is there a clearly identifiable, qualified, and knowledgeable person with the power to establish and modify the process?
* Procedures-Are there clearly developed procedures for processes that answer who, what, when, where, and how type questions?
* Controls-Are checks and restraints designed into a system to ensure that a desired result is achieved?
* Risk-point process measurements-Does the organization regularly assess its processes to identify and correct problems or potential problems?
* Interfaces-Are processes coordinated between clinical and administrative disciplines?
On-site activities included direct observations (all work shifts) and review of pertinent documentation such as physician orders, medication administration records, and nursing notes. Interviews were held with key frontline and management personnel, including senior management (chief nurse executive, chief medical officer, and chief quality officer), nursing personnel (managers, assistant managers, and staff nurses), nursing instructors, pharmacy personnel, hospitalists, and information technology personnel. The objectives of the on-site assessment were to determine if:
1. The medication management system design incorporated defined safety attributes to ensure safe operations;
2. Documented policies and procedures were followed by all personnel; and,
3. The medication management system worked as planned.
The safety assessment also sought to determine regulatory compliance with applicable Joint Commission and other oversight agency standards.
Safety Assessment Outcomes
Seven subsystems and 43 working-level processes within the medication management system were identified through the safety assessment. An abbreviated view of the medication management system safety architecture is depicted in Figure 1. Opportunities for improvement were identified in each medication management subsystem. Changes recommended for the hospital are as follows.
Organization and management
* Establish clear ownership (responsibility and authority) for the medication management system.
* Implement cross-functional process mapping for all critical processes.
* Conduct a biannual review to ensure system integrity, safety, and quality.
Documentation and records management
* Consider an enterprise-wide document management system to centrally manage and control all hospital documentation. Consideration should be focused on achieving a standardized document naming and numbering convention, content consistency across documents, interdisciplinary document revision and control process, and other factors associated with document management such as document currency, distribution channels, and availability.
* Incorporate system safety attributes (responsibility, authority, procedures, controls, risk-point process measurements, and interfaces) into all processes containing procedures.
* Design a standardized "end-to-end" medication administration process beginning with process ownership (responsibility and authority), paying specific attention to "a day in the life of a patient." Effort should be made to structure the standard of care from patient admission to discharge.
* Centralize the medication administration function in terms of control and reliability. For clarity, this activity is similar in concept to airline maintenance control, whereby all aspects of aircraft maintenance, including parts, are centrally managed. Each aspect of an aircraft's maintenance follows strict planning, scheduling, and execution to maintain the highest levels of control and reliability.
* Consider implementing a sterile communications environment when administering medications, such as a quiet room, or creation of visual symbols indicating medication administration in progress.
* Reinforce a standardized definition of medication reconciliation throughout the continuum of care.
* Consider assigning the pharmacy department ownership responsibility of this critically important process because pharmacy personnel are considered the primary, in-house subject matter experts on medication.
* Validate consistent, accurate patient medication reconciliation throughout each patient interval (admission, in-patient stay, and discharge).
* Consider the use of an electronic bedside verification system such as bar coding or radio frequency identification as budget permits.
* Further enhance the interface capabilities of both existing and future information technology applications.
* Adopt an interdisciplinary CRM education program. Special emphasis should be placed on identifying expected work behaviors in each core hospital process and providing the nontechnical tools (ie, effective communication, team building, workload management, technical proficiency, situational awareness, conflict resolution, and leadership) to enhance safety and operational efficiency.
* Implement a comprehensive, data-driven, evidence-based, safety management system. An effective safety management system allows a healthcare organization to systematically manage operational risk across the entire system safety architecture.
* Establish risk-point process measurements for each identified working level process associated with the subsystem depicted in the system safety architecture diagram. Risk-point process measurements serve as the origin for a robust internal evaluation program. This provides the organizational basis to manage safety, improve operational efficiency, and achieve "inspection readiness" related to the Joint Commission, state, and other regulatory/oversight authorities.
Recommendations that emanated from the safety assessment were organized into a risk-prioritization framework. Risk prioritization was determined on the following classification criteria13:
* High risk: a high likelihood that a failure in a particular process could cause a potential loss (or breakdown) of an entire system or subsystem, possibly resulting in an adverse event or serious unsafe condition.
* Medium risk: a moderate likelihood that a failure in a particular process could cause a partial breakdown of a system or subsystem, possibly resulting in violation of regulations or hospital rules, which may lead to an unsafe condition.
* Low risk: a low likelihood that a failure in a particular process could cause poor system or subsystem performance, possibly resulting in an unsafe condition.
Additional considerations for the generation of the risk-prioritization framework were the degree of implementation difficulty (ie, cost factors to implement change, resource requirements, time to complete, etc). Figure 2 includes an abbreviated example of the risk-prioritization framework.
Any healthcare organization can improve its safety culture by incorporating system safety principles. Culture, in general, is most commonly understood as "the way we do things around here." Cultural issues can be expanded to consider the implications of other factors that impact safety and operations.14 Regulatory and professional requirements are often misinterpreted or superimposed on the organization's safety culture. Implementing system safety on a hospital-wide level combats this issue because the organization is able to define work practices and behaviors in a clear and concise manner. This allows frontline personnel to better understand what is expected of them when performing their duties instead of simply relying on clinical experience. Thus, the use of work-arounds is significantly reduced, allowing safety culture to advance in a positive direction.
Results of the assessment led to categorization of risk areas as high, medium, or low. These results were presented to the hospital senior executive team and members of the nursing department shared governance committee. On the basis of these results, the hospital executive team plans to engage in a full medication management review, from procurement to monitoring and evaluating effectiveness. In addition, as a result of this initial work focused on medication safety from the nursing perspective, senior hospital executives selected this as one of the key quality initiatives for fiscal year 2009.
The medication management system safety assessment performed at the hospital demonstrated the immediate and valid applications of system safety and its accompanying safety management strategies. As proven in the commercial aviation industry, system safety and its associated safety management tools and strategies are an excellent organizational protocol for improving safety, reducing risk, and enhancing operational efficiencies.
Organizational leaders must ask the following question. If the most technically competent nurse, physician, or pharmacist leaves the hospital, does any operational system degrade? The answer is most likely a resounding yes if the organization is lacking a fundamental, systems-based approach to safety management and process design. System safety moves away from traditional thinking in that effective organizations no longer rely primarily on individual talent to form the basis for high-quality, safe operations. Rather, effective hospital leaders tap into their talent to improve organizational processes from a systems-based perspective, thereby continually improving operations.
This qualitative safety assessment of the hospital's medication management system revealed several positive recommendations to improve patient safety and simultaneously satisfy the Joint Commission's patient safety solutions, which are defined as "Any system design or intervention that has demonstrated the ability to prevent or mitigate patient harm stemming from the processes of healthcare."15 Because of this qualitative safety assessment, the hospital will be able to deliver evidence-based, quantitative data. Doing so will facilitate rapid risk reduction, as well as safety and performance improvements, across the entire continuum of patient care. It is important to remember that safety must be designed into operations, not inspected into them.
© 2009 Lippincott Williams & Wilkins, Inc.