QI (quality initiatives) or performance improvement efforts must have a clear definition of the problem on which the quality initiative is focusing. It is imperative to define the locations, processes, and the various disciplines that are involved in the QI initiative.

QI initiative should be defined in terms of the steps involved and the scope of the project. Time of completion, resource allocation, any costs involved in the project needs to be defined early on. QI initiatives can be more successful if their scope aligns with the organizational strategy. Quality care can be provided when the initiative is patients and family-centered care and focusing on patient satisfaction. The involvement of patients and families can achieve better patient outcomes, and in turn, it can eliminate preventable harm.

In process improvement, SIPOC Tool can be used to outline the processes that are required from beginning to end to complete the initiative. SIPOC includes suppliers, inputs, processes, outputs, and customers. Once the processes have been defined, the team outlines the project outcomes. A Pareto chart can be of value to identify the 80/20 rule. It is a type of bar chart, with several factors that contribute to the outcome arranged in the magnitude of occurrence from highest to lowest. The data categories which contribute to 80% in the bar chart are where the focus should be to achieve an effective quality goal.[1] Once a clear, concise problem statement is defined for a QI, a burning platform should be created to involve and motivate the stakeholders to get involved in the QI. The burning platform delivers a powerful emotional message among the stakeholders to motivate them and emphasize the importance of the quality initiative.

Every quality initiative should have a single key metric, while multiple support metrics can be utilized. Examples of support metrics can include seasonal variation, provider variation; these can impact the key metrics which under evaluation in the quality initiative. A single project goal should be defined, and it must be specific, measurable, achievable, realistic, and timely. The project goal should outline completion time and percent improvement in the key metric. 

One of the most important issues linked with a QI project is that the rights and confidentiality of the human subjects must be protected. A quality improvement project must not cause harm to the human subjects participating in the project, and complete disclosure about the project must be provided to those involved in the process. Informed consent and ethical issues are of utmost importance.

Historically, In 1949 Nuremberg code was defined to lay down rules for medical experiments that can be permitted. The Nuremberg Code was developed because of the ethical issues that arose from the trials in war crimes in Nuremberg. Any person involved in the project must have the right to quit on a research or quality project at any time. The World Medical Association developed the Declaration of Helsinki. These guidelines mentioned that the risk-benefit ratio needs to be included in projects, and research should be conducted once informed consent has been taken from involved human subjects, and independent committees should review the study.

In 1978 Belmont report was prepared, and it focused on the basic ethical principles which included respect of persons, justice, and how the project is conducted. The quality project does not always count as clinical research. If there is any doubt whether it counts towards clinical research, then IRB needs to be consulted. QI projects are based on evidence-based medicine and are built upon existing knowledge. Quality improvement projects aim to improve the institution-specific processes.QI projects that involve vulnerable populations are more likely to be part of the research. The research involves a systematic investigation to provide knowledge to improve institutional processes.

Quality improvement projects may often utilize the PDSA cycle (Plan do study act). Several iterations of PDSA are used to analyze a QI project. These projects are untested interventions; these results can be published and can be part of clinical research. Any ethical concerns need to be addressed with IRB, or risk management at the institutional level. If a new tool is developed as an outcome of the quality improvement project, then it becomes a part of the intellectual property of the institution and ideally needs to be copyrighted. Not all work in quality improvement can be adaptive. Attitudes and values can be improved by adaptive work. Technical work can focus on evidence-based medicine; however, to bring changes in behavior, it needs to translate to adaptive work.

Traditionally performance improvement methods, including reengineering and Six Sigma, have been used in efficient QI projects. In the 1980s, Six sigma was developed, and quantitative tools were utilized to understand the processes involved. The focus is to reduce unwanted variability. Six Sigma has derived from the Greek symbol for Standard deviation. Six SDs from mean implies 3.4 defects in 1 million.[2] Control charts and ANOVA are some quantitative methods used to devise projects based on six sigma. Typically projects utilizing Six sigma are not used to identify an immediate solution. DMAIC (Define key metrics, measure past performance, analyze current problems and opportunity, improve by developing solutions and control by standardizing the measurements are the main processes involved).[1]

QI projects are crucial for the improvement of processes and practices at an institution. Evidence-based medicine (EBM) forms the basis of quality improvement projects focusing on reducing rates of venous thromboembolism and bloodstream infections related to catheters. EBM has also been applied to ventilator or hospital-acquired infections.

Preventable harm becomes the third leading cause of mortality. A significant number of deaths result from medical errors, nearly 44,000 to 98,000 deaths have been reported to result from medical errors.  Reducing over-expenditure has been the focus of bringing 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. Unnecessary medical tests can cause more harm rather than providing effective and efficient care. Increasingly hospitals are focusing on resources such as Choosing wisely to bring high-value care. Quality improvement projects and evidence-based medicine form the basis of high-value care. There are several reasons including diagnostic uncertainty, physician training culture, aggressive marketing of tests and procedures, lack of transparency of costs of procedures and tests, all these lead to overutilization in healthcare.

Clinical evidence needs to be used to develop adaptive work and apply it in healthcare. Barriers to the implementation of EBM at an institutional level are analyzed in quality improvement projects. An important strategy for improving adaptive work has been storytelling. The involvement of families of patients and their perspectives contribute to quality care and help to develop quality improvement projects [3]. 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 are frequently used in quality projects. Leaders and frontline practitioners can use these techniques to identify strategies that can improve outcomes [4].

One of the quality improvement studies involved a technique called "Getting to outcomes"[5]. Another study published on a quality project on HPV vaccine involved interventions like implementing a client reminder and client call system, vaccine education, provider feedback system, and reminders on awareness of the protocol.[6] 

Physicians participate less frequently in quality initiatives. Less than 35% of physicians have been noted to be involved in quality initiatives because of a lack of time, financial incentives, and skills in quality improvement. Physicians have responsibilities in varied areas, and quality initiatives of hospitals or other health care organizations may not align with the quality issues that are faced by physicians. Physician involvement can increase in this area by making the processes easy and finding issues that affect physicians and deserve their time and contributions.[7] The implementation of checklist-based management in postpartum hemorrhage improved maternal mortality for obstetric patients.[8] Patient and caregiver involvement helps identify improvement opportunities, storytelling, offering change ideas, and persuading health care providers.[9] Quality initiatives to reduce hypothermia in surgical patients utilized techniques including define, measure, analyze and control and improve approach; phase 1 focused on staff comfort and satisfaction, and phase 2 focused on alternatives to reduce hypothermia without compromising on the satisfaction of the staff.[10] QI efforts aim at continuous process improvement to reduce variations and improve outcomes at the institutional level.