Quality in health care is the measure of the best possible outcomes in patient-centered care considering the circumstances and the resources available. Safety is a central dimension of quality in health care. It is the measure of standards in place to mitigate the risk of hazards and keep patients and health care workers free from harm due to error, patient management, and environmental factors. Hazards can result from human factors (e.g., poor communication), system factors (e.g., a mismatch between resources and workload), and external factors (e.g., weather). System errors (e.g., using outdated guidelines, untrained staff) generate potential hazards that pose the greatest risk to the quality and safety of an organization. The greatest risk factor in patient safety is medical error, which can result from acts of commission (e.g., amputation of the wrong limb) or omission (e.g., failure to amputate a necrotic limb). The deliberate deviation from standards, laws, or rules constitutes a violation. If an error or violation has occurred, health care workers must inform the patient immediately, disclose the nature of the error, and implement corrective measures to minimize harm to the patient. Although individuals must be held accountable for the errors they commit, error mitigation is most effective when it relies less on disciplining error and focusing more on eliminating hazards on a systemic level while fostering a safety culture that encourages individuals to openly express safety concerns, admit error.
Continuous quality improvement in health care is based on improvement science and employs tools such as variation management and the Plan-Do-Study-Act cycle (PDSA cycle) to identify areas of improvement and establish standards of quality. Error prevention relies on safety culture, error analysis, and human factors design to identify and address risks in actionable ways. Teamwork and communication are essential in high-risk organizations, such as hospitals, where collaborating and sharing information are vital in maintaining high standards of quality and safety.
Health care quality
Health care quality refers to the degree to which health services generate the desired outcomes efficiently and in line with current standards of care.
Key aims of health care (STEEEP) 
- Safety: Avoid or minimize risks and hazards that may lead to harm (e.g., iatrogenic injuries/conditions).
- Timeliness: Reduce delays that may lead to harm.
- Effectiveness: Provide evidence-based health care and avoid services or treatments of doubtful benefit.
- Efficiency: Provide the highest quality care at the least investment of resources (e.g., avoid overutilization of medical resources, unnecessary diagnostics, overmedication).
- Equitable care principles: Provide equal care to all patients regardless of gender, ethnicity, sexuality, and socioeconomic status.
- Focus on patient needs: Individualize treatment with respect for patient preferences, values, and needs (see also “” in “”).
- Definition: a multidisciplinary approach aimed at coordinating health care across levels, services, and settings to ensure the continuous improvement and delivery of health promotion and prevention, diagnosis and treatment, rehabilitation, and palliative care
- Education, shared decision-making, and local services to empower individuals and communities to share in health care responsibilities
- Services tailored to the needs of individuals, communities, and the population as a whole
- Continuous improvement of health care access, quality, user satisfaction, and efficiency to ensure the best possible outcomes with the resources available (e.g., shared guidelines and protocols)
- Performance improvement through with feedback loops
Attributes of high-quality health care 
- Definition: a focus on controlling the costs of health care with the aim of providing affordable and accessible high-value care to the population at large
- Health care providers have an obligation to manage resources responsibly and promote the accessibility as well as affordability of health care.
- Health care providers should be constantly aware of the cost of illness
- Treatment recommendations and decisions should be individualized to foster adherence and prevent unnecessary treatment (see also “”).
Decisions should be made in accordance with evidence-based recommendations and guidelines to ensure effective and efficient treatment.
Avoid overutilization of resources 
- Overutilization can cause financial, physical, and psychological harm to patients.
- Health care providers should collaborate with patients on defining health care goals and provide realistic recommendations to achieve those goals.
- Health care providers should be transparent regarding treatment alternatives but recommend the course of action that provides the greatest benefit at the least expense of resources (e.g., prescribing a generic drug over the brand-name alternative)
- Unnecessary diagnostic tests or procedures should be avoided (e.g., unnecessary consultations, imaging studies, antibiotic or opioid prescriptions, maternity care interventions)
- Only truly necessary interventions or treatments should be recommended (e.g., ineffective nonpalliative services at end of life such as routine screening tests for cancer patients, Pap smears for patients with limited life expectancy and no relevant clinical features)
Antibiotic stewardship programs (ASPs) 
- Key elements to optimizing antibiotic use in hospitals are hospital leadership commitment , accountability , pharmacy expertise , action , tracking , reporting , and education
- Initiatives with the goal to measure, critically review, and improve the way antibiotics are recommended by physicians and used by patients in order to guarantee effective treatment, prevent adverse effects to unnecessary antibiotic use (e.g., C. difficile infection), and reduce antibiotic resistance
- Avoid overutilization of resources 
Organizations should assess the benefits, harms, and costs of diagnostic tests and interventions to determine whether they provide value in the treatment of specific diseases.
- Promotion of cost data transparency
- Facilitation of training regarding health care costs and health care spending for health care providers
- Collaboration between health care providers and government agencies to reduce financial and other obstacles to health care access
- Develop patient-friendly summaries to facilitate patient understanding of commonly used tests and procedures
Benefit-cost analysis 
- An economic method used to compare the costs and benefits of an intervention or program
- Evaluates the impact of a program or intervention in quantifiable, monetary terms
- Assesses costs in the immediate (intervention) as well as the more distant future (intervention benefits)
- Allows ranking interventions and programs in order of decreasing net benefits in order to budget priorities accordingly (i.e., improves resource stewardship)
- Benefit-cost ratio
Net benefit (preferred measure)
- The costs are subtracted from the benefits.
- Programs or interventions are generally implemented if the net benefit is > 0.
- Staff, facilities, and medical supplies
- Psychological costs of disease increase long-term financial costs.
- Decreased medical expenditures due to a prevention initiative or treatment of a disease
- Increased productivity and satisfaction for health care employees due to improved outcomes
- Positive outcomes for patients have secondary, psychological benefits for health care workers
Equitable care 
- The provision of high-quality, affordable, and prompt care to all individuals regardless of age, gender, race, ethnicity, or socioeconomic status (see also “ ” in “ ”).
- Stakeholders in health care (i.e., health care organizations, health insurance companies, physicians, medical societies public policy makers) should collectively ensure access to appropriate health care for all people.
Patient-centered care 
Overview: a collaborative approach to the decision-making process between physicians, patients, and patient families that focuses on patient needs, requests, and desired outcomes
- Health care providers should keep the emotional, social, and financial effects of health care in perspective for each individual patient.
- Family members should be encouraged to participate if the patient desires. Their views and values should be discussed, respected, and taken into account.
Pillars of patient-centered care
- Respect the patient's values, preferences, and needs.
- Provide adequate information and education (e.g., information for patients on condition, treatment plan, assistance with behavioral changes).
- Ensure access to care (e.g., facilitate making an appointment, short waiting time in office, timely response to telephone calls, efficient use of consultation time, electronic prescription refills).
- Provide emotional support.
- Involve family and friends, if the patient so desires.
- Ensure a safe and appropriate transition between health care settings (e.g., posthospital follow-up and support, proper information transfer between physicians and care providers)
- Provide a psychologically and physically comfortable setting for the patient.
- Guarantee proper coordination of care (e.g., coordination of specialist care, filling prescriptions to monitor patient adherence).
Timely care 
Principles to improve care timeliness
Convenient operational hours
- Staggered shifts to extend operational hours
- Integrated services to provide appointment flexibility
- Appropriate number of staff and service hours
- Remote consultation or telemedicine services
Low waiting times
- Easy-access appointment system for patients
- Enable making appointments via homepage, email, and SMS as well as telephone.
- Specific days or times for walk-ins or same-day appointments
- Convenient operational hours
High-Reliability Organizations (HROs) 
- Definition: organizations that consistently experience fewer accidents or harmful events than anticipated and manage to avoid these despite operating in complex, high-risk environments
Principles of HROs (principles of reliability) 
Reliability in health care refers to the maintenance of a system's capability of performing its intended functions consistently according to the given standards of quality and safety. HROs operate under the principles of patient-centered, timely, and effective care to promote consistency and quality.
Preoccupation with failure
- High sensitivity to the potential consequences of failure and error maintains vigilance for hazards and risks high even as rates of failure and error decrease
- Accordingly, near misses are regarded as potential failures that provide opportunities to test and improve the system rather than the confirmation of safety.
Reluctance to simplify
- The appreciation of a system's necessary degree of complexity prevents individuals from cutting corners in the endeavor for efficiency in areas where safety is a concern.
- At the same time, there is an awareness of how unnecessary or excessive complexity also poses a hazard and that efficiency can be an important aspect of safety (as reflected, e.g., by standardization, streamlining processes, and reducing variation).
- Sensitivity to operations: situational awareness of how individual processes and actions affect the operations of a system as a whole
Commitment to resilience
- Recognition of the fact that failure can be unpredictable and that a completely error-free environment cannot be created.
- Individual members are trained to continuously analyze challenging situations efficiently and minimize harm effectively.
- Deference to expertise: an organizational culture that encourages collaboration with and seeking advice from individuals with the experience and expertise necessary for the task at hand rather than relying on the authority of senior rank in challenging situations
Measures of health care quality 
- Definition: indicators used to assess and compare the quality of health care systems, based on the model developed by physician and health care services researcher Avedis Donabedian
- A framework for evaluating the quality of health care based on the assessment of structural, process, outcome, and balancing measures
- Based on the assumption that the structural context of health care (i.e., facilities, equipment, staff), the processes that take place within that context, the outcomes generated by the processes, and the interaction (balancing) of systems affect one another and determine the overall quality of health care
|Structural measures|| |
|Process measures|| || |
|Balancing measures|| |
Physician Quality Reporting System (PQRS) 
- Definition: a reporting program created by the Centers for Medicare and Medicaid Services (CMS) and in place until 2017, which gave health care professionals the opportunity to assess the quality of care they were providing to their patients in order to ensure patients were receiving timely and appropriate care.
- Eligible health care providers: Medicare physicians providing covered professional services based on the Medicare Physician Fee Schedule (MPFS) (e.g., physicians, practitioners, therapists) could submit data about the quality of their care. 
Quality measures (based on STEEEP)
- The types of measures reported changed from year to year.
- Generally varied by specialty and focused on areas such as public health, care coordination, patient safety, clinical processes, and effectiveness
- 254 quality measures and outcome measures were defined, for which health care providers could submit data, including:
- Effective clinical care
- Cost reduction
- Patient safety
- Communication and care coordination
- Goal: collecting data on quality of care across health care systems
- Prior to 2015
Between 2015 and 2017
- Shift to a mandatory program
- Health care professionals who did not satisfactorily submit data on quality measures, for their covered professional services, for the quality reporting period for the year would be subjected to payment adjustments for noncompliance.
- Based on a system
- In 2017, PQRS was integrated into the (MIPS).
Merit-based Incentive Payment System (MIPS)
- Definition: a performance-based incentive program implemented by the Centers for Medicare and Medicaid Services (CMS) in place since 2017 that offers payments to eligible health care providers for high-quality and cost-effective care; aimed at improving overall health care quality, reducing costs, and increasing the use of appropriate health care information
- Integrates various Medicare incentive and payment programs into a single system (e.g., PQRS, Value-based Payment Modifier Program, Medicare Electronic Health Record Incentive Program)
- Participation is mandatory for all eligible clinicians and practices (e.g., part of Medicare Part B program, previously involved in Medicare).
- Those who fail to report are penalized financially.
- Eligible participants can report as individuals or groups.
- Those who fail to report are penalized financially.
- Performance measures: reporting requirements vary for each category
- Quality measures
- Improvement activities: measure of patient engagement and improvements in health care and process management
- Promoting interoperability: an effort to make health information more available for patients, providers, and payers in order to facilitate information exchange and reduce administrative burdens across the health care system
- Participants who meet the specified minimum case volume required are scored using different performance measures (e.g., total per capita cost, medicare spending per beneficiary).
- CMS collects this data directly from the Medicare claims data.
- Aimed at making health care more cost-efficient and affordable
- Participants are financially incentivized to submit data and scored according to the amount of data provided.
- In order to achieve maximum points, participants must report sufficient data for every performance category as well as demonstrate improvements in the quality of health care and a reduction in its costs.
- The overall score is compared to a performance threshold to determine payment adjustments.
- Scores above the threshold: receive a payment incentive
- Scores below the threshold: receive a negative payment adjustment
- Scores equal the threshold: receive a neutral payment adjustment
Continuous quality improvement in health care
Quality improvement is a continuous process of prospectively and retrospectively reviewing measures of quality control and maintenance to progressively improve the standard of health care and prevent medical error.
Improvement science 
- Multidisciplinary approach
- Applied science field based on researching and determining which improvement strategies work in the health care system and policies in order to ensure quality, safety, and value
- Focuses mainly on three areas of health care: interventions to improve or change existing processes, the implementation and systematic study of changes implemented, and the context or conditions in which the changes are applied.
Variation in health care refers to the difference between the expected outcome of an intervention or process and the actual outcome. Some variation is expected and even necessary (e.g., new guidelines, new treatments, changes to processes) since every patient is different and should receive personalized care. However, the frequent occurrence of unexpected events due to unpredictable processes can also pose a risk to health care workers and patients. Proper variation management involving patients, health care managers, clinicians, and researchers increases the predictability of a health care system and the understanding of how care is being delivered, thereby improving the overall quality of care (i.e., stable and safe processes, care effectiveness and generalizability, clinical outcome).
Types of variation
Common cause variation
- A natural variation that is inherent to processes in a health care system
- Generally occurs at stable and predictable intervals, but may be unpredictable
- Typically cannot be traced back to a root cause
- Examples: patients with different manifestations for the same disease, demographic or socioeconomic differences between patients, hospital staff skills
Special cause variation
- A variation attributable to a specific cause that is not inherent to processes in a health care system
- Occurs sporadically and unpredictably
- Typically, can be traced to a root cause that can then be identified and addressed
- May occur due to system or process management
- Examples: patient information is missing due to human error (file misplacement or wrong patient coding), the order in which patients are seen and treated (i.e., patients being seen out of turn), how hospital services are scheduled, the staff's workload during a shift, ordering different tests for the same clinical presentation
- Common cause variation
Goals of managing variation: reducing special cause variation and properly managing common cause variation
- Understanding the type of variation before using internal data to positively impact systematic improvement strategies and, subsequently, improve quality and reduce potentially costly variations
- Improving patient safety and satisfaction
- Introducing instruments to assess and control variation in order to facilitate the detection of flaws in the system and establish consistency based on best practices
Instruments of variation management
- Identify the sources and types of variation.
- Determine how variations affect the system across time, place, and staff within the system.
Variation management: implement measures to control variation
- Standardization of care and implementation of guidelines: protocols, checklists, clinical pathways (see “ ”)
Quality improvement interventions or models: a systematic framework for establishing change processes in health care systems, services, or suppliers for the purpose of increasing the likelihood of optimal quality of care
- The components of quality improvement interventions can be applied to organizations, health care systems, the behavior of health professionals, and the patients cared for
- These interventions aim to identify inefficiencies and implement standardized processes to reduce costs and improve overall productivity.
- Typically measured by positive health outcomes in individuals and populations
- Examples: Plan-do-study-act cycle, Six Sigma, LEAN, physician education, physician reminder systems, facilitated clinical data to providers, feedback, benchmarking, practice guidelines, critical pathways, patient education, patient reminder systems, and promotion of self-management.
- Providing feedback of performance data to the health care provider
- Establish a data monitoring system to review physician performance and appropriate use of standardized criteria
- Implement peer review programs to identify problems in performance and conduct focused professional practice evaluations
- Identifying the areas within the system that have the most variation utilization potential (e.g., hospital readmissions, CU utilization, emergency room utilization, surgical procedures, imaging tests)
- Creating a work culture based on improvement, transparency, safety, and excellence: Systems should strive for continuous performance improvement by implementing benchmarks, being open to collaboration, and providing external or internal leadership examples.
- Variation monitoring: Routinely collect, analyze, and report variation in clinical outcomes and outliers, in order to measure the impact of applying certain clinical practices and processes on clinical outcomes.
Conceptual models of improvement
Continuous process control and improvement are fundamental aspects of quality management in any health care system. The models most commonly used today are the plan-do-study-act cycle (PDSA) and the plan-do-check-act cycle (PDCA), iterative four-step cycles that ideally culminate in the consolidation of the lessons learned through process standardization. The cycles are repeated until the problem is resolved or the process is perfected. However, due to the effects of variation in complex systems, process improvement is rarely finalized, and the PDSA/PDCA typically begins anew based on the standards set in the previous cycle.
- Plan: assessing the need for improvement and planning the actions required to achieve the desired outcomes
- Do: carrying out the actions determined necessary for improvement and testing their applicability
- Study/Check: evaluating the data collected in the previous steps/inspecting compliance
- Act: implementing the measures of process improvement based on the data collected
- The precursor to the PDSA model, but still preferred in some business settings
- Focus on testing currently running processes to ensure compliance
- Process inspection to ensure compliance
- Comparison of expected results and actual results
- Measurement of the improvement necessary for progressing to the Act-stage
- Often preferred in health care organizations
- Focus on the development and testing of process changes
- Focus on continuous learning as a basis for continuous improvement
- Analysis of data collected in previous stages
- Reflection of metrics being analyzed
Steps in the cycles
- In this phase, an area that needs improvement is defined, followed by the planning of potential changes or actions to bring about a corrective change.
SMART criteria can be applied to accurately define and develop the objectives of change
- Specific: objectives are clear and specific with regard to actions required, expected impact, target population, and responsibilities
- Measurable: determine indicators that allow quantification of an objective's impact and the progress made towards achieving it
- Assignable: determine responsibilities in the team and set objectives that can realistically be achieved with the resources available.
- Realistic: set objectives that align with the intended goal and mission
- Timely: set objectives that can be achieved within a specific time frame and establish realistic timelines
- In this phase, the new action is tested.
- Attempt to solve the defined problem by mapping out possible hypotheses and trying new methodologies.
- Problems and unexpected observations should be documented.
This phase completes the analysis of the data before and after the action took place and assesses its impact on the quality of health care.
- Outcomes are measured and monitored
- Outcomes are compared with the predictions and hypothesis
One of the following improvement measurement tools may be used:
Pareto chart: a type of graph that combines bars and a line, in which the bars represent a total for each category (arranged from highest to lowest) and an overlaid line represents the cumulative percentage of the total. 
- Typically used to identify defects and prioritize improvement processes for the most significant categories (frequency or cost of problems).
- Example: identifying the highest ranked reason for inadequate patient transfers and what percentage of the total this reason represents.
Shewhart chart (control chart): a graphic representation of data plotted over time by comparing the degrees of variation in a measure to determine if a perceived improvement in quality is statistically significant in the long term.
- Typically uses lines determined by previous data: a central line (shows the average), an upper line (shows the upper control limit), and a lower line (shows the lower control limit)
- Helps to identify variation (common cause vs. special cause) within the process by comparing current data to the aforementioned lines.
Run chart (time plot): a line graph that plots data over time to analyze trends
- The data displayed visualizes process performance over time
- Vertical axis: represents the process (currently being measured)
- Horizontal axis: represents time
- Center line: represents the mean or average
- Run charts do not use control limits; accordingly, they cannot provide information on whether a process is stable or not.
- Example: analysis of the impact of an intervention over time to help determine whether the improvement is a random occurrence or a true trend
- Pareto chart: a type of graph that combines bars and a line, in which the bars represent a total for each category (arranged from highest to lowest) and an overlaid line represents the cumulative percentage of the total. 
- This phase completes the analysis of the data before and after the action took place and assesses its impact on the quality of health care.
- Review the effects of the implemented change (i.e., what was intended to be achieved actually happened)
- Analyze the results and identify learnings.
- This phase revolves around taking action
- Will result in either of the two options:
- Implementation of new processes according to the data collected in the “do” and “study” phases, if these showed a positive impact on health care quality
- Determine what modifications should be made to the tested action and prepare a new change plan (i.e., begin the cycle again)
Patient safety is concerned with maintaining health care systems that keep patients free during management and reducing the risk of harmful incidents to an acceptable minimum.
A medical error is a preventable adverse effect of medical care, regardless of whether or not it causes the patient harm or becomes evident. As the 3rd leading cause of death in the US, responsible for ∼ 250,000 deaths per year, it represents the greatest threat to quality and patient safety. Medical error is distinct from iatrogenesis, which describes harm to the patient caused by medical care. Iatrogenesis may be due to unforeseeable events (e.g., previously undocumented allergic reactions or drug interactions, calculated risks of treatment) as well as medical error. For the legal consequences of medical error, see “.” 
Classification of medical errors 
The classes of medical error listed below are not mutually exclusive but rather tend to occur in conjunction or complement each other. For example, the administration of the wrong drug due to medications with similar packaging being stored together is a latent systems error and a potential never event (a flaw in the storage system precipitated the administration of the wrong drug) as well as an active and individual error of commission (the person who gave the drug is responsible).
|Overview of medical error types|
|Type of medical error||Definition||Examples|
|Active error|| || |
|Latent error|| |
|Individual error|| |
|Systems error|| || |
|Error of execution|| || |
|Error of planning|| || |
|Error of omission|| |
|Error of commission|| || |
|Never event/sentinel event || |
|Near miss (close call) || |
Specific medical errors
|Overview of specific medical errors|
|Type of error||Definition||Examples|
|Communication error|| |
|Diagnostic error|| || |
|Treatment error|| || |
|Preventive error|| || |
|Medication error|| || |
|Patient identification errors|| |
|Device errors|| || |
| || |
|Documentation errors|| |
|Procedural errors|| || |
|Transition of care errors|| |
Hazards, risk, and risk factors
- Hazard: a source of potential harm
- Risk: the probability that the hazard will actually cause harm and the degree of harm it might cause, depending on the circumstances
- Risk factor: a variable or attribute that increases the probability of developing a disease or injury
- Example: A wet floor represents a hazard that can lead to falls and subsequent injury. The degree of risk depends on the circumstances of the floor, e.g., it will represent a greater risk in a busy emergency department than in a storage closet that is rarely opened. Additional factors that could influence the risk of slippery floor causing harm could be the spill of soapy water, a lack of personnel to quickly address the hazard, or a lack of "Caution: wet floor"-signs.
System-associated risk factors
Complex systems 
- Complex systems (e.g., hospitals) consist of innumerable interacting elements (e.g., machines, staff, facilities).
- The interaction of many individual elements introduces a certain degree of unpredictability (e.g., malfunction, illness) that makes these systems susceptible to failure (e.g., incorrect results, interruption of processes).
Complex systems are characterized by:
- Nonlinear processes
- Multiple/circular causality
- Multilevel cooperation
- Open systems
- Environmental factors (e.g., high noise level, poor lighting, inadequate room temperature, weather) 
Workspace design 
- Floor plan of wards (e.g., location of nursing station for optimal proximity to all patient rooms)
- Ergonomy of facilities (e.g., a designated place with fresh gloves, bandages, syringes in every patient room), furniture, and equipment
- Communication technology (e.g., ineffective nurse call systems)
- Staffing (e.g., understaffing)
Health care personnel-associated risk factors
Excessive workload (e.g., due to mismatched ratio of medical personnel to a number of patients)
Burnout: overall exhaustion due to an excess of stress over an extended period of time
- Lack of motivation and interest
- Feelings of failure and helplessness
- Cynical and detached work attitude
- Impaired immune function
- Decreased concern
- Chronic sleep deprivation
- Decreased energy and motivation
- Impaired cognitive function
- Impairment in intellectual function
- Burnout: overall exhaustion due to an excess of stress over an extended period of time
- Alert fatigue: the tendency to become desensitized to and subsequently ignoring alerts prompted by clinical decision support systems due to the excessive number or limited clinical relevance of the alerts in the past
- Inexperience: deficiency of practical skills and/or knowledge, predisposing for judgment and/or diagnostic errors
- Overcommitment: associated with burnout (especially exhaustion and cynicism) 
- Anchoring bias: the tendency to inappropriately rely on initial perception or information, which hinders later judgment when new information becomes available (e.g., favoring a diagnosis proposed earlier despite new evidence)
- Availability bias: the tendency to make judgments based on the availability of information from memory (e.g., when a physician makes a premature diagnosis that comes to mind easily and quickly due to having seen several patients with a similar clinical presentation)
- Framing bias: the tendency to be influenced by how information is presented (e.g., the order of symptoms and/or emphasis placed on specific findings)
- Visceral bias: a tendency for clinical decisions to be influenced by positive or negative feelings towards the patient (e.g., doubts regarding symptoms when described by a patient with substance use disorder)
Patient-associated risk factors
- Poor adherence to treatment regimen (e.g., failure to make lifestyle changes, take medication as prescribed, or make follow-up appointments)
- Low level of health literacy and awareness, often associated with low socioeconomic status 
- Cultural factors (e.g., religious rules that do not permit man to examine women or vice versa)
An adverse event is any untoward reaction following medical treatment that may or may not be the result of a medical error. 
- Preventable adverse event: any adverse event that could have been prevented by observing the rules of safety and error prevention
- Ameliorable adverse event: unpreventable adverse event whose severity could have been reduced through the application of specific strategies
Responding to adverse events 
- Implement corrective measures immediately to minimize patient harm.
- Health care providers who have reason to believe a colleague has committed an error should urge that colleague to report the error to the patient and their supervisor.
- If a colleague refuses to report an error when urged, the individual suspecting the error should report the event via the standard protocol in place.
- If the cause of an adverse event is not immediately known, the physician should inform the patient and maintain contact while investigations are being carried out.
- A just culture that holds individuals accountable for their actions but discourages blame and focuses on addressing system errors rather than punishing individual errors encourages error reporting.
- Use of an incident reporting system
Disclosing the error
- Disclose error to the patient and, if necessary, a supervisor and administration
The following points should be considered for optimal error disclosure:
- Clearly admit an error has occurred.
- State the course of events leading up to the error.
- Explain the consequences of the error, both immediate and long-term (if applicable).
- Express personal regret and apologize.
- Describe corrective steps.
- Allow ample time for questions and continued dialogue.
Regardless of the outcome of a treatment, a physician must inform the patient immediately if an error has occurred and disclose the nature of that error.
Incident reporting systems (IRS) 
- IRS provide a means of reporting errors and expressing concerns (e.g., aggregation of near misses).
- Analysis of the reports collected facilitates the identification of risks within the organization.
- Goal: developing and implementing strategies to address identified risks and prevent further errors
- Useful in identifying commonly occurring and local systemic errors (e.g., medication errors due to trailing zeros on labels), for which substantial data can be collected
- Aggregation of data with the help IRS facilitates the analysis of more severe adverse events (e.g., never events) for which only limited data exists.
- Conclusions drawn from IRS data can be shared within and/or across organizations, which is also generally recommendable as this helps identify risks and prevent future error on a larger scale.
- IRS cannot be used to measure safety in general and/or changes over time.
- Comparing organizations with one another based on data from IRS is impossible.
- Organizations might not have enough resources to thoroughly review the large number of reports that IRS generate.
- Medical error analysis investigates the existing and potential causes of error in order to mitigate the occurrence of new errors and prevent the recurrence of past errors.
- Goal: to minimize the number of medical errors by implementing safety measures and checkpoints; focus on systemic errors
- There are 2 types of medical error analyses:
- Retrospective: an analysis of past errors done to gain knowledge of the types and causes of error
- Prospective: an analysis of potential errors done to assess risks and hazards that may lead to errors in the future
Root cause analysis
- Definition: a retrospective analysis used to identify the (root) causes of an error and develop measures to prevent its recurrence
Identify the medical error (“What happened?”)
- Retrospective analysis of all possible factors that could have led to the error considering patient documentation, the equipment/drugs used, and the environment the patient was in
- Examples include: slippery floor, infectious ward, nonquarantined patient, incorrect management protocol
Determine what could have prevented the error from occurring (“Why did it happen?”).
- Tool used: Fishbone diagram
- Also called Ishikawa diagram or cause-and-eﬀect diagram
- Used to break down and visualize all potential events that led to the error
- Tool used: Fishbone diagram
- Develop preventive measures (“What can be done to prevent recurrence?”): e.g., updating technology, employing double checks, using checklists, staff education on new policies
- Identify the medical error (“What happened?”)
Failure mode and effects analysis (FMEA)
- Definition: a prospective analysis used to identify potential risks and hazards by assessing the failure modes (i.e., the manner in which failure occurs) of a system's components, determining the effects such failures may have, and developing measures to prevent these failures from occurring
- Choose a specific system component.
- Select a specific potential failure (failure mode).
- Identify why it could go wrong (failure causes).
- Identify the consequences of potential failures (failure effects).
- Prioritize the hypothetical failures by their probability of occurring and the severity of their effects.
- Proactive implementation of corrective measures.
- Component: medication error
- Failure mode: dispensing error (in this case: wrong medication given to the correct patient)
- Failure causes
- Nurse confused medication due to similar appearance or name
- Wrong medication in the packaging
- Medication accidentally got swapped during dispensing
- Failure effects: ranging from no effect to severe patient harm/death
- Nurse confused medication due to similar appearance or name
- Medication accidentally got swapped during dispensing
- Wrong medication in the packaging
- Implementation of corrective measures
- Introduce measures to reduce the probability of medication getting swapped, e.g., changes in storage, tall man lettering.
- Implement measures to prevent medication getting swapped during dispensing, e.g., physical barriers between the single medications, not dispensing the medications for all patients on the ward in one run.
- Educate staff to double-check packaging before removing medication from wrapper.
- Error prevention is a core aspect of quality and patient safety that begins with identifying and mitigating the risks and hazards that can result in medical error.
- No environment can be maintained completely free of risks, hazards, or errors.
- Accordingly, the goal of error prevention is to reduce medical error to an acceptable minimum.
- Error prevention is most effective when its focus lies on systemic errors, rather than individual errors.
- Safety culture should, therefore, incentivize openness in error reporting rather than focusing on disciplinary action against individuals who have made an error.
Fundamentals of error prevention
- Safety culture
- Hazard and risk awareness
- Error reporting
- System error monitoring
- Ongoing personnel training: keep up-to-date with current guidelines, standards, and procedures
- Ongoing equipment maintenance: sorting out of outdated or malfunctioning equipment
Safety culture 
- Definition: a workplace culture that promotes safety awareness, develops and implements measures for the maintenance of a safe work environment, and ensures that individuals can openly express safety concerns and so improves prevention as well as identification of errors.
- Create awareness for risks and consequences of errors
- Foster a sense of responsibility in maintaining a safe work environment
- Create an environment in which employees are not afraid to report errors
Flattening steep hierarchies in order to:
- Promote collaboration between different ranks and disciplines
- Reduce the reluctance to speak up to superiors
Swiss cheese model of error causation 
- Every safety system is imperfect and will, therefore, have flaws that allow hazards to provoke errors and, potentially, harm.
- The Swiss cheese model illustrates how a multilayered safety system (multiple slices of cheese) can help prevent flaws (holes in each slice) from allowing hazards to pass through the entire system, i.e., if a hazard manages to pass one layer, the next will likely block it.
- Alignment of flaws in the individual layers will allow a hazard to pass through and allow the error to occur.
Human factors and ergonomics (HFE) 
Human factors and ergonomics deals with the design and engineering of equipment, systems, processes, methods, and environments to fit the individuals who interact with them.
- Incompatibilities between health care personnel and the equipment they use, constitute a safety risk/hazard (e.g., surgical scissors designed with loops that are too small to handle comfortably and precisely).
- Poor design generates obstacles in the workflow, forcing staff to adopt temporary solutions that will increase the risk of errors.
- Key HFE measures include:
- Goal: reducing error while improving efficiency, productivity, safety, and comfort
- Equipment, process, method, or system design features that prevent error by forcing the best option by default
- The most effective technique for minimizing adverse events because it inhibits a chain of action that causes or perpetuates error
- Examples include:
- Anesthesia gas cylinders with gas-specific nozzles for different gases
- Software that prevents incorrect dosages of drugs and warns the user of potential adverse reactions or interactions
- Avoiding shared storage of drugs with similar labels or names
- A software design that requires the physician to log out of one patient's electronic medical record before opening a second one
- Electronic medical record that requires the user to enter a password and a reason for accessing confidential psychiatric records
- The development and implementation of standards that apply to various aspects of a process or system in order to improve reliability, efficiency, communication, and safety
Examples of standardization:
- Protocols and guidelines: help ensure a consistent level of quality and increase efficiency (e.g., a standard protocol for antepartum hemorrhage reduces response time and increases the likelihood that the physician takes the correct action)
- Equipment: facilitates use across a system (e.g., the same model of patient monitors across the hospital reduces the risk of improper use)
- Checklists: help prevent common errors (e.g., instrument and mop count before abdominal closure following laparotomy ensures no material is accidentally left inside the patient)
- The exchange of predefined items of information between health care providers when passing on responsibility for the care of patients (e.g., at the end of a shift) to reduce the risk of medical errors
A complete handoff should include the following information of every patient:
- Relevant diagnoses
- Code status
- Summary of the hospital course
- Current medications
- Recent changes to management
- Explicit suggestions for anticipated concerns
- Tasks to complete
- Performed during transitions of care (e.g., admission, transfer, discharge) in which new medication orders are compared to past medication orders
- Used to avoid medication errors such as duplication, omission, dosing errors, and drug interactions
- Terminology: helps prevent communication errors (e.g., use of the chemical name of a drug rather than its generic name or brand name)
Abbreviations and writing styles
- Help prevent communication and transcription errors
- Tall man lettering: a strategy used to prevent dispensing errors related to medications that look or sound alike (e.g., buPROPion vs. busPIRone)
Standardized prescription order writing
- Use precise, simple language.
- Name the drug, dosage, route, frequency, and duration of administration.
- Indicate the reason for the medication on the prescription as an additional safety checkpoint.
- Avoid Latin, abbreviations, and acronyms that may be misinterpreted.
- Example: nitrofurantoin, 100 mg, orally, twice a day, for 5 days; prescribed for an uncomplicated lower urinary tract infection
- Time out: a perioperative pause conducted by the surgical team to confirm the patient's identity, surgical site, and planned procedure to prevent harm from a wrong procedure at the wrong site or patient
- Reduction of complexity of equipment, systems, and processes to increase efficiency and reduce the risk of error
- Ordering laboratory tests electronically
- Streamlining administration
- Readily available standard equipment (e.g., tongue depressors, latex gloves, scissors)
- Clinical decision support system (CDSS): a computer-based system designed to analyze data within electronic health records to assist health care professionals in clinical decision-making tasks (e.g., by reporting drug-drug interactions).
- Multicompartment medication device
- Closed-loop communication
- Patient involvement: prior to administering drugs or inducing anesthesia, the patient is asked for verification of identity and any further relevant information (e.g., site of surgery, planned procedure, consent)
- Computerized order entry (CPOE); : a system in which electronically placed orders for medications, tests, procedures, and consults are directly transferred to the recipient (used to prevent errors due to poor handwriting or ambiguous abbreviations)
Morbidity and mortality reviews (M&M)
- A standardized process that involves regular interdepartmental meetings to review complications and deaths that occurred in hospitals to improve safe clinical practice and avoid preventable errors
Collaboration and teamwork
General domains 
- Teamwork and mutual support
- Situation monitoring
- Conflict resolution
General principles 
- Objective: communicating effectively and avoiding communication errors, e.g., by sharing incomplete, wrong, or ambiguous information
Nonviolent communication 
- Communication approach developed by Marshall Rosenberg designed to improve communication through empathy and awareness for the violence inherent to coercive and manipulative communication strategies
- According to Rosenberg, the source of conflict often lies in miscommunication about human needs, and violent language further fuels the conflict. Understanding the needs of others empathetically and expressing one's own needs honestly can prevent and help resolve conflict.
- Involves 4 components (i.e., observation , needs , feelings , and requests ) and 3 modes (i.e., self-empathy , honest expression , and empathetic reception
- Cultural humility: open-minded and respectful attitude towards aspects of other persons' cultural identity that may be particularly important to them
- Active listening: technique that involves listening closely, employing verbal (e.g., “I understand,” “Ok”) and nonverbal cues (body language, e.g., nodding), and paraphrasing back to the speaker to signal that one is positively engaged in the conversation
- Information sharing: making sure to provide all the information team members need to fulfill a task
Strategies for effective communication 
- Definition: a framework used in health care to avoid errors in the communication of a patient's condition
Example scenario: A physician communicates the patient's condition to a colleague.
- Situation: assess what is happening at the moment (e.g., patient is showing signs of arousal, discomfort, chest pain)
- Background: provide patient history (e.g., the patient was jogging when she began to feel chest pain)
- Assessment: express what the issue is (e.g., chest pain, discomfort, and/or arousal are potential signs of myocardial infarction)
- Recommendation and Request: develop a solution for the issue and take the appropriate steps to implement the solution (e.g., getting help from senior residents, ordering the nurse to take an ECG, preparing the patient for cardiac catheterization)
- Definition: a form of closed-loop communication used in health care to avoid communication errors in which the listener repeats the information received back to the speaker and the speaker confirms that the information has been received as intended
Example scenario: During surgery, a patient loses a significant amount of blood and requires blood transfusions.
- The anesthesiologist (sender) calls out: “The patient is losing a lot of blood, we need two bags of A+ blood as soon as possible.”
- The nurse responsible (receiver) for taking care of this request responds: “Got it, we need two bags of A+ blood. I will order those right away.”
- The anesthesiologist (sender) confirms that the information has been received as intended by saying: “Correct!”
Strategies for escalating concerns/making assertions
Definition: a technique in four steps employed to give concise, constructive feedback
- Describe: Describe the situation or behavior in question as objectively as possible.
- Express: Express your thoughts and feelings associated with the situation (using first-person statements, e.g., “I feel my concerns are not being considered,” and avoiding blame, e.g., “you never listen”).
- Specify: Specify your wishes and preferred outcome.
- Consequences: Outline the consequences, i.e., the positive payoff for you and others, of your preferred outcome.
Example scenario: A nurse pages a resident in the middle of the night with a nonurgent question.
- Description: “Nurse Roberts, you paged me in the middle of the night with a question that didn't need answering right away.”
- Expression: “I woke up thinking there was an emergency, only to realize that you had a question that, in my opinion, could have waited until tomorrow.”
- Specification: “I encourage you to closely evaluate the urgency of your requests before paging me outside work hours and, especially, at night.”
- Consequences: “I have to perform brain surgery tomorrow morning and without proper rest, I might not be able to perform to the height of my abilities.”
- Definition: a technique for avoiding conflict while escalating a situation that involves voicing concern, e.g., regarding unsafe conduct, at least twice to the person responsible, before initiating a more assertive approach (e.g., intervening) or alerting a person in a higher position if the concerns are not addressed.
- Definition: technique that involves voicing that you feel Concerned, Uncomfortable, and that the situation is not Safe.
PACE model for graded assertiveness
Definition: a strategy to escalate concerns effectively and appropriately in situations of potential crisis
- Probe the situation by voicing your concerns and assessing the reaction of others.
- Alert the persons involved if unsatisfied with the response, reiterating your concerns more emphatically.
- Challenge the situation openly if still unsatisfied with the response, formally stating your concerns and pointing out the consequences.
- Emergency action should be taken if all previous efforts to avert the crisis have been unsuccessful.
Example scenario: A patient needs an antibiotic. An inexperienced resident is about to give penicillin to the patient. He appears to have missed the documented penicillin allergy in the patient's file. An attentive nurse intervenes:
- P: “Doesn't this patient have a severe penicillin allergy?”
- A: “The antibiotic you're about to give to the patient is penicillin and the patient has a documented penicillin allergy!”
- C: “If you administer penicillin, the patient may have an anaphylactic shock. You should not give penicillin to this patient and change the antibiotic regimen immediately.”
- E: “Step away from the patient! I am taking over and contacting your supervisor!”
Teams are composed of various individuals and in health care, the individuals working together often come from different medical specialties (e.g., cardiologists, surgeons, anesthesiologists) and professional backgrounds (e.g., nurses, physicians, physiotherapists, psychiatrists). The foundations of good teamwork are efficient, clear, and open communication; mutual respect and support; and psychological safety (i.e., a work environment that permits and encourages voicing ideas, concerns, mistakes, and questions without fear of negative consequences).
- Interprofessional team: a team composed of individuals with different professional backgrounds or specialties (e.g., a nurse, a physical therapist, and a physician; a surgeon, an anesthesiologist, and a radiologist) collaborating towards a common goal
- Intraprofessional team: a team composed of individuals with the same professional background (e.g., a team of physical therapists) collaborating towards a common goal
Fundamentals of teamwork 
- Adaptability: the ability to react adequately to changes in a team’s circumstances (team reflections, debriefing)
- Collective intelligence in medical decision-making: pooling insights and skills of a team to generate more effective decisions
Cooperation: defining shared goals, consulting with one another, and working together to achieve goals efficiently
- Being aware of other team members’ skills and roles
- Staying open to suggestions from others, even when they concern one's own area of expertise
Coordination: structuring the different individual levels of skill, knowledge, and behavior
- Clearly defined shared goals, norms, expectations
- Role clarification
- Effective Communication: clear, proactive communication aimed at facilitating cooperation and minimizing communication errors
Mutal respect and support
- Cooperation founded on trust, decision-making based on collective intelligence, and positive attitudes towards conflict resolution, ensuring that contributions from all members are equally recognized and respected
- A positive attitude towards conflict resolution
- A culture that fosters individuals feeling comfortable admitting mistakes and knowledge gaps
- Synergy: The benefits of teamwork are greater than the sum of what individuals can achieve working separately.
A team will complete a task more efficiently than the same number of individuals working on the same task separately.
Goals of teamwork 
- More job satisfaction
- Greater role clarity
- Improved sense of well-being
- Improved coordination of care
- Efficient use of resources
- Enhance communication efficiency and professional synergy
- Reduce time/costs of hospitalization
- Better accessibility for patients
- Better care
- Greater satisfaction
- Lower cost
Challenges in teamwork
- Changing roles
- Changing settings
- Individualistic approaches of different team members (e.g., bedside manner, treatment choices) that may cause inconsistencies within the team
- Frequent changes in team composition (emergency teams, chronic care)
Leadership is a central factor in determining the culture of a health care organization and developing strategies for effective and efficient delivery to patients. Health care leaders should lead by example and shape their team through collaboration from within. Accordingly, successful leadership requires interpersonal (soft) skills as well as organizational (hard) skills.
Organizational skills 
- Clarify roles
- Set clear goals
- Assign tasks
- Structure team
- Manage resources
- Modify plans as necessary and communicate changes
- Evaluate team performance
- Provide necessary feedback
- Lead by example
- Encourage teamwork through engagement in the team
- Foster positive team culture and atmosphere
- Provide team members with the necessary information and facilitate information sharing
- Encourage and mediate conflict resolution
- Goal: ensuring a common understanding of the situation to reach common goals efficiently and safely
STEP components of situation monitoring
- Status of patient
- Team members (skills, performance, stress, and fatigue)
- Environment (resources and equipment)
- Progress towards goal
- Cross-monitoring: Team members monitor each other to ensure that procedures are followed appropriately and safely.
- One-Minute Telegram 5-2020-1/3: Are 24-hour shifts getting a boost? The jury is still out on optimal shift length to avoid medical errors.
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