Definition/Introduction

Avedis Donabedian, noted by many as the father of quality improvement, helped form the foundation of the field in 1966 with the publication of the article "Evaluating the Quality of Medical Care."[1] This article first details fundamental concepts still central today in quality improvement, such as the importance of considering structures, outcomes, and processes.[2]

Quality improvement (QI) is a process of approaching systemic problems in healthcare. The healthcare system comprises many people with different scopes of training and expertise functioning in social hierarchies[3] that use many pieces of technology, such as the electronic medical record. The way that these people, technologies, and patients interact is crucial and forms the processes that affect the care of patients and ultimately can affect patient outcomes. Human error is unavoidable. In 1999, it was estimated that 98,000 patients died because of medical errors.[4] QI aims to achieve predictable outcomes from these processes that improve patient care.

Quality initiatives and performance improvement efforts must clearly define the problem on which the quality initiative focuses. A single project goal should be defined, and it must be specific, measurable, achievable, realistic, and timely.[5] Defining the locations, processes, and disciplines involved in the QI initiative is imperative. Once a clear, concise problem statement and a hypothesis regarding the outcome of the proposed intervention are formed, it is often helpful to deliver a powerful emotional message among the stakeholders to motivate them and emphasize the importance of the quality initiative. A patient-centered approach that considers the patient's experience is central to all approaches to QI.

QI initiatives utilize several methods to plan and frame systemic change in healthcare. These include Lean, Six Sigma, and the Model for Improvement theories. Essential tools are also utilized in QI initiatives, including Pareto charts, Ishikawa diagrams, Shewhart charts, run charts, and scatter plots.

Issues of Concern

Six Sigma

Six Sigma aims to decrease the error rate to 3.4 per million opportunities.[6][7] Sigma is used as an abbreviation for standard deviation, and the name implies the goal of keeping the process output within six standard deviations of the mean.[8] However, the aim of 3.4 per million opportunities accounts for a decrease of 1.5 standard deviations to account for random variation.[8] Its primary focus in reducing error is to decrease variability.[6][9] It employs a process known as DMAIC (Define-Measure-Analyze-Improve-Control).[6] In this process, the problem is defined and fully understood, the defects in the system are measured, the root causes are analyzed, the system is improved with the intent to remove the causes of error, and the process undergoes continuous control measures to ensure that the root causes do not recur.[6] Six Sigma has been utilized in healthcare to improve the processes of admission, discharge, and medication reconciliation. As the focus of Six Sigma is error reduction, often error rate is used as the driving metric; however, it has also been used to focus on productivity and process time.[6] The control step must be maintained to ensure that the achieved improvement continues. Six Sigma is often combined with Lean and is called Lean Six Sigma.[10]

Lean

Lean was first developed by the Toyota company, which utilized it in automobile manufacturing.[11] It was later used in the healthcare and business sectors after it was noted to be successful in manufacturing. The purpose of Lean is to decrease waste by eliminating processes that do not add perceived value from the customer's standpoint.[11] The Lean methodology for healthcare describes eight kinds of waste: defects, overproduction, transportation, waiting, inventory, motion, overprocessing, and human potential.[11] In short, the Lean methodology aims to eliminate unneeded work and product and use everyone involved in the process to their highest potential. The five steps used to eliminate waste are to understand the perceived value by patients, observe the system as it currently works as a team, visualize how the system would work if all steps flowed into each other without stopping while entertaining all suggestions for change by all parties in the group, and the rapid deployment of the improvement plan with guides that encourage everyone involved in the process to think past historical and interdepartmental challenges.[11] The final step involves continuous improvement by finding all opportunities for improvement.[11] There is an emphasis on giving power and accountability to all people involved in the system rather than those in administration, as those involved in the day-to-day implementation of processes can understand the nuances of the process.

The Model for Improvement

The Model for Improvement was conceived in the 1990s by Associates in Process Improvement.[12] It is based on the work of Deming, who first developed the PDSA (plan, do, study, act) cycle.[12] It serves as a framework for organizations to improve, as there is an emphasis on interconnected processes and continual improvement.[12] In this framework, the problem is thoroughly explored, desired outcomes are defined in detail, an aim statement is created that comprehensively describes the scope and aims of the initiative, and a team is formed that brings technical expertise, knowledge, and involvement in the routine implementation of the process.[12]

Measurement is critical in The Model for Improvement, and measurements are divided into process, outcome, and balancing measures.[12] Outcome measures have to do with the desired result, process measurements center around the process itself, and balancing measures note other metrics to ensure that there is no worsening in other areas because of the implementation of the intervention.[12] PDSA cycles are implemented in continuous cycles that define crucial metrics and opportunities for improvement, execute an intervention, study the results of that intervention, and use the data obtained from the intervention to determine whether it represents an improvement.[12] In summary, this framework hinges on carefully defining what is trying to be achieved, obtaining data to know that the planned implementation is an improvement, and thinking carefully about what changes can result in improvement.[12] Once the end goal has been achieved, this can be followed by an SDSA (standardize, do, study, act) cycle to maintain the achieved improvement.

Tools

Ishikawa diagrams, or fishbone diagrams, endeavor to clarify an issue's root cause by diagraming all contributors.[13] They are often used during the Plan stage of the PDSA cycle to evaluate potential root causes and contributions to complicated systemic issues. The SIPOC Tool can outline the processes required from beginning to end to complete the initiative. SIPOC includes suppliers, inputs, processes, outputs, and customers.[14] Once the processes have been defined, the team can focus on outcomes of interest.

Run charts and scatter plots help visualize simple trends in data.[15] Control charts can be used to visualize more complex trends and variations.[16] Common cause variation is defined as variation that is inherent to the system.[16] Special cause variation is the variation that is introduced by adding an additional element to the system.[16] Shewhart charts are a type of control chart meant to detect decreases in error rates that display binary data.[17] It tracks the proportion of consecutive time with the event of interest and the number of cases that do not have the event of interest.[17]

A Pareto chart can be of value per the 80/20 rule. The 80/20 rule, or Pareto rule, dictates that 80% of outcomes originate from 20% of factors.[18] A Pareto chart is a special bar chart with several factors that contribute to the outcome arranged in the magnitude of occurrence from highest to lowest that combines a line graph.[18] The overlying line graph displays the cumulative percentage.[18] The data categories contributing to 80% of the bar chart are where the focus should be to achieve an adequate quality goal.[9] These charts can help to visualize whether the change is an improvement.

Ethics

One of the most important issues linked with research is that the rights and confidentiality of human subjects must be protected. Ethics are of utmost importance. To ensure this, institutional review boards are tasked with reviewing research to ensure that they adhere to ethical standards.

In 1949, the Nuremberg Code was enacted for medical experiments.[19] The Nuremberg Code was developed because of the ethical issues that arose from the trials and war crimes in Nuremberg.[19] Research participants must have the right to withdraw from a research project anytime.[19] The World Medical Association developed the Declaration of Helsinki.[20] These guidelines note that the potential value of the knowledge obtained needs to outweigh any risk to research participants.[20] Research should only be conducted once informed consent has been taken from involved human subjects.[19]

Quality improvement projects are generally not considered research; however, the distinction sometimes becomes less clear.[21] Many scholars have attempted to delineate the difference between work considered research and that considered quality improvement.[21] QI projects are based on evidence-based medicine, built upon existing knowledge, and aim to improve institution-specific processes. If there is doubt whether a proposed quality improvement project would be considered clinical research, then the institutional review board of the healthcare facility should be consulted.[21] Many institutions require the institutional review board to review proposed quality improvement projects.[21] QI projects that involve vulnerable populations are more likely to be classified as research.

Quality improvement projects often utilize PDSA cycles. At least several iterations of PDSA are used during a QI project, which often reveals new inefficiencies and tests creative potential solutions. These results can be published to aid in the improvement of similar facilities. However, every system and facility is different, and initiatives may not have the same outcomes in other facilities. Any ethical concerns associated with the publication of QI need to be addressed with the appropriate institutional review board. Suppose a new tool is developed as an outcome of the quality improvement project. In that case, it becomes a part of the institution's intellectual property and ideally needs to be copyrighted.[22]

It should be noted that continuous improvement is the goal of QI.[23] Projects should start with an exploration of the system and process to gain a clear understanding of the current status of the process, then plan an intervention and state a clear hypothesis about the result of the intervention.[23] Metrics should be defined to determine whether the intervention would result in the indicated improvement. Interventions should start with a small, pre-determined target population, and results should be evaluated before scaling out the intervention as confidence grows.[23] After assessing the results of the intervention, further action should be determined based on the effects of the prior intervention.[23] Data collected as part of the intervention should be carefully documented.[23] It has been noted that few published studies adhere to these principles.[23] However, adherence allows the process to be driven by data and based on the scientific method.

Clinical Significance

QI projects are crucial for improving processes and practices at an institution. Evidence-based medicine (EBM) has formed the basis of many quality improvement projects, such as those focused on reducing rates of venous thromboembolism[24] and bloodstream infections related to catheters.[25] EBM has also been applied to ventilator-associated pneumonia and other hospital-acquired infections.[26]

A significant number of deaths result from medical errors; it is estimated to be the third leading cause of death in the US.[27] Medication errors have been estimated to cause every 1 in 131 outpatient and 1 in 184 outpatient deaths.[28]  Reducing over-expenditure has been the focus of high-value care in healthcare. Choosing wisely is an essential resource created by the ABIM to provide physicians with a framework to reduce wasteful expenditure, provide cost-effective care, and reduce harm.[29] Unnecessary medical tests can cause harm rather than provide effective and efficient care. Although the Choosing Wisely campaign has been widely publicized, it has been noted that this has not been enough to change practice in many instances.[30] Quality improvement projects led by local leaders that can craft interventions specific to specific hospitals and situations are imperative to effect change.

Clinical evidence must be used to develop and apply adaptive work in healthcare. Barriers to implementing EBM at an institutional level are analyzed in quality improvement projects. An essential strategy for improving adaptive work has been storytelling. The involvement of patients' families and their perspectives contribute to quality care and help develop quality improvement projects [31]. Anecdotal evidence and narrating stories about a given intervention and how it can prevent harm in a particular scenario can help engage stakeholders. Outlining the processes involved in a quality project, team-building exercises, and communication boards can help adapt an intervention. PDSA cycles employed by leaders and frontline practitioners can identify strategies that can improve outcomes.[12]

A cross-sectional survey of physicians found that 85.7% expressed interest in being involved in quality improvement initiatives, but only 68.6% had been in the last year.[32] Physicians cite a lack of participation due to scarcity of time and heavy clinical loads.[32] Physicians have responsibilities in varied areas, and quality initiatives of hospitals or other healthcare organizations may not align with the quality issues physicians face. Physician involvement can increase by streamlining processes to perform QI and prioritizing issues that directly affect physicians and their patients.[33] Patient and family involvement helps identify improvement opportunities and potential solutions and persuade healthcare providers.[34]  Via participation of multiple stakeholders, QI efforts aim at continuous process improvement to reduce variations and improve outcomes at the institutional level.

Nursing, Allied Health, and Interprofessional Team Interventions

Quality improvement initiatives must, of necessity, include all staff members, not just the clinicians. This means that nursing and other allied health professions that comprise the interprofessional healthcare team must be included in the initiative, not only as it applies to enacting decisions for quality improvement, but also these team members must be empowered to contribute to developing these initiatives. All persons working in the system have valuable insights and vital contributions to make. Participation and understanding by all staff members ensure that quality improvement initiatives have the highest chance of success possible. To increase participation, the rationale for proposed changes and the value to the patient must be made clear to all involved.