ABSTRACT

All healthcare safety personnel should understand the importance of patient safety and how it fits into the organization’s total safety system� We need to view patient safety as a discipline within healthcare professions and organizations� Healthcare leaders should consider both the science and practice of safety when addressing patient care issues� Healthcare risk and quality management personnel should learn to view patient safety as a function associated within their disciplines� Patient safety could be defined as preventing patient adverse events and errors while minimizing the harm of those events that do occur� We should approach patient safety effectiveness from two key directions� First, consider organizational issues such as leadership, organizational dynamics, operating cultures, and patient care effectiveness� The coexistence of the organizational operating culture and the overall safety culture may be in conflict in many hospitals� They may attempt to operate in parallel dimensions� Second, make patient safety a function of the organization� Educate organizational members that patient safety is not just another program but a subsystem of the total safety system�

Many healthcare leaders consider patient safety a clinical concern, some view it as a function of risk management or quality improvement processes, and others define patient safety concepts using their own definitions or reference points� Medical specialization, organizational fragmentation, and compartmentalization can hinder safety efforts� Improving patient safety performance at all organizational levels must become a strategic goal of all healthcare organizations� Healthcare organizations should learn to “connect the dots” of the many well-intentioned efforts to improve patient safety� Many organizations spend too much time touting the mere existence of their transactional patient safety endeavors� Connecting the dots in a children’s book, if done correctly, produces a recognizable picture� The picture of patient safety “progress” over the past 10 years is not a clear one� Patient safety should focus on more than just methods, tools, surveys, policies, buzzwords, and trendy thematic books� Leaders must learn to consider the patient safety function of every medical or healthcare organization as a recognizable “subsystem” of the total safety system� Effective patient safety requires more than a policy statement signed by senior leaders� Patient safety is much more than an office location, a phone number, an email address, or a slogan strategically placed on an organizational website�

When seeking patient safety information on the Web, one quickly learns that the wealth of information is a challenge to sort through, resulting in a disappointing endeavor� Some recent patient safety innovations have yielded good results, such as preventing central line and surgical wound infections� Many hospitals took actions to reduce medication and surgical adverse events with some positive results� Healthcare organizations should learn to connect the dots, build bridges, and understand that many hidden cultures exist in all organizations� These “covert” or “hidden” cultures operate within the “overt” or “formal” cultures on a daily basis� The informal cultures can and in many instances do operate independently of the recognized organizational culture�

Another hindrance to patient safety success at the local level relates to failure of leaders to understand open and closed systems� High-reliability methods, no matter how appropriate they may seem, will never be effective in all hospital areas, departments, or functions� Healthcare can best be described as an “open system” with some “closed micro-systems�” High-reliability methods can work well in highly closed and controlled settings� However, “open systems” should anticipate many uncontrolled elements that impact effective operations� The terms “patient” and “their families”

should send the message, loud and clear, that healthcare organizations operate as open systems� Healthcare organizations should implement policies and hazard controls to ensure visitor safety while in the facility� Organizations should implement measures to educate visitors on how they can help protect the safety of patients�

We can base patient safety efforts on three key concepts� First, view patient safety as an organizational function and not a program or department� Never consider patient safety efforts as a function of risk management or quality improvement� Second, view patient safety as an operational “subsystem” of the organization safety system� Implementing a comprehensive safety system requires an organizational culture change� I spoke to a “patient safety coordinator” a few years ago and she quickly pointed out that the patient safety function in her organization operated separately from the hospital’s “environmental safety” function� I calmly mentioned to her that patient safety occurs or does not occur in the “environment of care�” Patient safety does not compete with the components or subsystems of its own system� Patient safety complements the other safety system components of worker safety, visitor safety, contractor and vendor safety, and community safety� The function of healthcare safety within the organization should derive its value from people� The third aspect relates to the fact that many senior leaders incorrectly believe that patient safety requires a “clinical” professional to lead the efforts� Patient safety can only improve if the organization undergoes transformational changes�

Fatigue resulting from an inadequate amount of sleep or insufficient quality of sleep over an extended period can lead to a number of problems, including inattention and the inability to stay focused� It can also lead to lack of motivation and trouble in solving problems� It can be demonstrated through a person’s memory lapses, poor communication ability, lowered reaction speeds, and even loss of empathy� Shift length and work schedules can impact healthcare provider quantity and quality of sleep� The dangers associated with shifts lasting longer than 12 hours is well documented� Healthcare organizations must

• Assess the organization for fatigue-related risks by reviewing staffing policies • Evaluate handoff processes and procedures • Invite staff input into designing work schedules • Create and implement a fatigue management plan • Educate staff about sleep hygiene and the effects of fatigue on patient safety • Provide opportunities for staff to express concerns about fatigue • Encourage teamwork as a strategy to support staff who work extended work shifts or hours • Consider fatigue as a potentially contributing factor when reviewing all adverse events • Assess the environment provided for sleep breaks to ensure that it fully protects sleep

Leading people can prove more difficult than managing other organizational assets� Leaders should assess how well staff and other healthcare providers support the patient safety function� Education, communication, and feedback must become a top priority� Promote the use of “action plans” to guide patient safety processes and needed innovations� Leaders place the focus on improving processes and not blaming people� Don’t “talk the talk” unless you “walk the walk�” Frequent walking tours promote safety, improve communication, and provide valuable information to the leadership team� Finally, safety leadership requires allocation of adequate resources to support the ongoing function of patient safety� Leaders can help improve organizational safety functions by focusing on patient-centered strategies� Implement system-centered approaches and look for evidence-based solutions� Create teams with the knowledge and resources to act when appropriate� Develop effective monitoring and measurement tools�

Peer review of physicians historically focused on a punitive process and not an opportunity to learn� To engage physicians in safety, target the 20 percent of physicians who spend the most time in the hospital and not the 80 percent that rarely enter the hospital� Making physicians partners, not consumers, permits the patients to become the customers� This will require physicians to become responsible not just to their patients but also to the system providing care� Organizational leaders committed to improving patient safety should also create an environment that attracts and retains the best nurses� Create ways to acknowledge the value of nurses and support continuous learning activities� The nursing profession needs leaders that value and support frontline nurses� Leaders should learn to encourage and promote more collegial nurse and physician relationships� Developing a true safety culture will include demanding that nurses be treated with respect� Organizational excellence in patient safety can never occur without implementing policies that address nursing safety, wellbeing, and job satisfaction�

Healthcare organization oversight and governing boards should lead the patient safety journey� Board members spending less than 25 percent of their time addressing patient safety and quality issues do a disservice to their organization� Oversight boards should develop and publish policies addressing formal quality improvement measures� Boards can promote patient safety only by continuously interacting with the medical staff� The board should require that the CEO lead the way by being the person most identified with patient safety and quality improvement�

The Institute of Healthcare Improvement (IHI) recommends that governing boards establish organizational patient safety goals, listen to sharp end stories, implement system-level measures, and monitor important issues such as organization culture change� Organization accountability should focus on full disclosure to patients and their families� Conduct a sequence of event analysis after medical errors and adverse events� Gather facts including the timeline of an event� Use the information collected to assist with a focused analysis� Hold individuals accountable by clearly defining roles and relationships� A just culture dictates a balance between nonpunitive actions and situations requiring accountability and discipline� Humans will and can make mistakes� Hold people accountable when they overestimate their abilities and underestimate their limitations� Humans often fail to recognize fatigue, stress, and work environmental issues such as noise or poor lighting� Illness, boredom, frustration, home situations, and substance abuse can also impair job performance� Create policies that enforce and support accountability� Make an effort to educate frontline staff on the accountability system� Educate all managers, supervisors, and team leaders about expectations� Senior leaders should take actions to publicly embrace the need for more accountability and the development of a culture that learns from errors�

BOX 4.1 CARE ENVIRONMENT SAFETY CHALLENGES

• Establishing a multidisciplinary process or committee to resolve care environment issues

• Appointing appropriate representation from clinical, administrative, and support areas

• Ensuring that the multidisciplinary improvement team or committee meets at least bimonthly or as necessary to address environment and quality-of-care issues

• Identifying and analyzing care and environment issues in a timely manner • Developing and approving recommendations for improvement as appropriate • Establishing appropriate measurement guidelines with appropriate staff input • Communicating issues to organizational leaders and improvement coordinators • Providing an annual recommendation for at least one performance improvement

activity • Coordinating environmental safety issues with leadership of the patient safety program

The 1999 Institute of Medicine (IOM) Report, To Err Is Human, challenged the public and healthcare industry to create a climate to support change� There has been controversy since the release of the 1999 IOM Report related to mandatory versus voluntary error reporting� The 2001 IOM report, Crossing the Quality Chasm, focused on the theme of providing a common purpose for changing healthcare� The 2001 IOM report listed the following six aims for improving healthcare: (1) safe, (2) effective, (3) outcome focused, (4) timely, (5) efficient, and (6) equitable care� The 2003 IOM report, Patient Safety: Achieving a New Standard of Care, emphasized the importance of an electronic health record (EHR) with regard to patient safety� It also recommended the development of better definitions for patient safety, including the terms “near misses” and “adverse events�” The 2004 IOM report, Transforming the Work Environment of Nurses, recommended that healthcare organizations evaluate and improve areas such as nurse management practices, workforce capability, workplace design and organizational culture� The 2005 IOM report, Quality Through Collaboration: The Future of Rural Healthcare, proposed a strategy for meeting the health challenges facing rural communities, including providing quality care�

BOX 4.2 KEYS TO CREATING CULTURES OF TRUST

• Promote the value of members and acknowledge contributions • Allow team members to participate in decisions • Reduce discipline for errors for valid reasons • Simplify job and process tasks • Stress the importance of practicing good human relations • Forbid senior leaders and physicians from verbally abusing subordinates • Give staff a chance to express a voice in operational matters • Solicit suggestions for improving safety or clinical processes • Practice better oral and written communication • Redesign processes that contribute to errors • Provide quality continuing education • Design clinical processes by using a systems approach • Decrease reliance on personal vigilance and memory • Develop good data collection and analysis systems

BOX 4.3 PATIENT SAFETY INFORMATION SOURCES

• Agency for Healthcare Research and Quality (AHRQ) Patient Safety Network • American Hospital Association • Canadian Nurses Association Patient Safety Resource Guide • Institute for Safe Medication Practice (ISMP) • Institute of Medicine of the National Academics • Joint Commission International Center for Patient Safety • Medline Plus Patient Safety • National Center for Patient Safety • National Coordinating Council for Medication Error Reporting and Prevention • National Patient Safety Agency • World Health Organization Alliance for Patient Safety

An adverse event is an injury caused by medical management rather than by some underlying disease or patient condition� Medical errors result from a complex series of system-related issues and not from a single individual� Errors may or may not result in an adverse outcome� IOM defines errors in two ways: (1) an “error of execution” refers to a correct action that did not proceed as intended and (2) an “error of planning” occurs when an intended action was accomplished incorrectly� The National Patient Safety Foundation (NPSF) defines patient safety as the prevention of and elimination or mitigation of patient injury by errors� NPSF defines a healthcare error as an unintended outcome caused by a defect in the delivery of care to a patient The AHRQ defines a medical error as an act of commission (doing the wrong thing), omission (not doing the right thing), or execution (doing the right thing incorrectly)� Consider the following examples of error:

• Physician failed to use an indicated diagnostic test or misinterpreted a test • Emergency room personnel could not use a defibrillator with dead batteries • Patient developed a post-surgical wound infection, resulting in a longer stay • Patient received the wrong blood type during a transfusion

Characteristics of high-reliability organizations include (1) acknowledging and planning for human variability and fallibility, (2) anticipating the worst and planning for it, and (3) planning for failure to help avoid harm when failures occur� Leaders understand technical, organizational, environmental, and human factors that impact error� Trust pervades the organization so people report safety concerns and errors because they understand what constitutes unsafe practice� Reporting can prove valuable to staff and leaders aware of the importance of accurate data� Organizations should reward reporting of errors and near misses� Flexibility gives frontline personnel responsibility for immediate situations�

Research and anecdotal evidence indicates that a number of factors can impair human performance� Working in complex surroundings, humans can easily experience limited short-term memory� Running late or being in a hurry can impact task performance� Some individuals find it very difficult to multitask�

Others lose their concentration due to job or task interruption� Healthcare workers and professionals often deal with stress, lack of sleep, and fatigue on the job� Workplace environmental factors, personal or home distractions, and substance abuse can also impair performance� James Reason in his studies developed some questions to address errors committed on the job� Consider the following questions when investigating an error or other adverse event:

• Did the incident involve malicious intent? • Did someone knowingly work impaired? • Did someone knowingly do something wrong or unsafe? • Would a person with identical training make the same mistake? • Has someone demonstrated a history of adverse event involvement?