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Overview and Description

Definition of Quality Improvement and Patient Safety

Quality improvement (QI) and patient safety (PS) are closely linked. PS, viewed as a component of quality, refers to preventing unnecessary harm to the patient. QI activities may improve outcomes such as reducing costs, enhancing efficiency, improving satisfaction, and preventing harm.

QI consists of systematic and continuous actions that lead to measurable improvement in health care services and the health status of a targeted patient group. Competence in QI is important for medical trainees, as the Accreditation Council of Graduate Medical Education (ACGME) now recognizes QI as a required component of graduate medical education. Involvement in QI can take many forms through improvements in educational programs, patient care and safety, and research.

There are many definitions of quality. Donabedian classical review on quality of medical care concludes that “quality of care is a remarkably difficult notion to define”; often based on value judgments as they relate to general goals or standards.1 Donabedian suggests that, in general, quality has to do with the following measures:

  • Processes of medical care, that is, the way care is performed.
  • Outcomes of these processes, that is, the results.
  • Settings/structure in which these processes take place, that is, the people, buildings, and organization.

Quality improvement, as defined by Centers for Medicare and Medicaid Services, is “the framework used to systematically improve care.”2 Systematic behavior allows standardization of processes to reduce variation, identify best practices, and improve overall outcomes. The Institute for Healthcare Improvement (IHI) espouses the Model for Improvement as their framework for instituting change.3 The model starts with a question rooted in understanding of a system and then creates a plan of change with importance placed on measuring effectiveness of the change.

Each of these definitions has its value and limitations. Processes are the functions over which healthcare providers have the most control. Certain processes, such as mortality discussion and patient satisfaction questionnaires, have been linked to improved outcomes. However, improving the process may not always improve the overall quality of care perceived by the patient. For example, the esthetic appeal of structures (e.g., hospital buildings) may have little to do with the quality of care provided. Although QI often strives to improve outcomes, multifactorial aspects of outcomes need to be considered. For instance, length of hospital stay as an outcome may be influenced by psychosocial factors, disease severity, and comorbidities which make it challenging when comparing length of stay among different patients with the same diagnosis.

A critical aspect of implementing any QI initiative is following a systematic approach, of which there are many formal frameworks that can be utilized. For example, two of the most common examples of QI models used in healthcare include the Plan-Do-Study-Act (PDSA) Cycle and Lean Six Sigma.1,4   

Relevance to Clinical Practice

Sources and Methods of Obtaining Information

Sampling/selection from these sources needs to be representative of the general population.


  • Clinical records.
  • Direct observation by a colleague, for example, secret shopper for hand hygiene.
  • Indirect method, for example, surveys, data quality assessments, global ratings, and 360° evaluations. These are particularly useful for measuring behaviors, attitudes, and safety in the health care setting.

Measurement Standards

Collected data may be assessed against internal or external standards. Internal standards assess change from a baseline for a given program, for example, an increase in the average Functional Independence MeasureTM (FIM) efficiency from one year to the next. Examples of external standards are guidelines, which may be normative (e.g., expert opinion), empirical (i.e., supported by clinical evidence), or comparative data from multicenter datasets.

Clinical Examples in Physical Medicine and Rehabilitation


  • Single vial dosing for epidural steroid injection.
  • Use of appropriate venous thromboembolism (VTE) prophylaxis during an inpatient rehabilitation stay.
  • Prescription of aspirin for secondary stroke prevention.
  • Documentation of red flags in initial evaluation of a patient with back pain.
  • Performance of hand hygiene in the hospital or clinic.
  • Preventing falls.

Assessment of implementation of established processes is often measured as adherence to guidelines. These guidelines may be established by expert panels (e.g., American College of Chest Physician Guidelines for VTE Prophylaxis) based on various levels of evidence. The National Guideline Clearinghouse, run by the Agency for Healthcare Research and Quality, contains searchable links to many commonly accepted guidelines.5  Physical Medicine and Rehabilitation (PM&R) specific guidelines are also available online.6 These include guidelines developed and/or endorsed by the American Academy of Physical Medicine and Rehabilitation (AAPM&R).


  • Cost
  • Length of stay for inpatient rehabilitation
  • Medical complications after injections
  • Improvement in function during outpatient therapy
  • Uniform Data Set FIM for inpatient rehabilitation
  • Patient satisfaction
  • Thirty-day re-hospitalization rates
  • Mortality rates

Outcomes are generally compared with criterion standards or by benchmarking them against similar institutions regionally or nationally. A classic example is the FIM, used by most inpatient rehabilitation programs throughout the United States to measure the level of a patient’s disability and how much assistance they need to carry out activities of daily living.

Outcome measures should be risk-adjusted for factors such as disease severity, comorbidities, and psychosocial status.


Structure is often dictated by external reviewers:

  • The Joint Commission on Accreditation of Healthcare Organizations (TJC) publishes many healthcare organizational standards such as fire safety, disinfection and sterilization, and medication management.
  • The Commission on Accreditation of Rehabilitation Facilities (CARF) has, among many guidelines, extensive standards on the types of therapy services that must be available for a program to achieve accreditation.
  • The ACGME specifies guidelines for graduate medical education. The appropriate credentials for residency and fellowship programs and working hour restrictions are examples.

Clinicians performing quality improvement activities need a toolbox of methods to collect and analyze data. The IHI website serves as an excellent resource for detailed descriptions of several QI tools.7 Tools can generally be subdivided into 2 categories: (1) tools that delineate problems and (2) tools to assess possible solutions to those problems.

Tools for Delineating Problems

  • Brainstorming with focus groups can provide qualitative analysis of the source(s) of a deficiency in quality. It is particularly important to include representatives of all stakeholders in these focus groups.
  • Flowcharts track the processes and structures from the beginning to the end of an event. More sophisticated flowcharts also include the time required to complete each step, to better define rate-limiting steps to achieve completion in a timely manner.
  • Cause and effect (also referred to as Ishikawa or fishbone diagrams): these diagrams, which look like fish skeletons, identify all the inputs/causes leading to a given outcome. Generally, inputs are subdivided into categories, such as people, buildings, information systems, communication, and training.


Example: Cause and effect/fishbone diagram to identify barriers for discharging patients on naloxone (Van et al).8

Tools for Assessing Solutions

QI assessment and interventions can be done by scrutiny of single cases or by analyzing general trends.

  • Analyze single cases
    • Root cause analysis (RCA) is a tool prescribed by TJC for analyzing a sentinel event, that is, an error that led to death or permanent disability. It requires interdisciplinary input from frontline staff.
    • Morbidity and mortality rounds are designed to explore situations  that contributed to medical error or adverse outcomes in patient care. Morbidity and mortality models can vary, but should involve interprofessional discussions with all team members to ensure in-depth review and root cause analyses.9  Increased implementation of “Good Catch Awards” have created positive incentives for providers and staff to report patient safety events by identifying and reporting adverse events, near-misses, and other medical errors.10
  • Analyze general trends
    • Processes
    • Control charts: to monitor a process over time, study variation, and its source. It not only allows tracking of results over time, but also evaluation of how different interventions influence results (e.g., staff education, signage, self-monitoring programs). For example, monitoring compliance with hand hygiene over time.
    • Effort-yield matrix: helps the team decide which of the possible solutions to implement will have the best impact/outcome with the least effort.
    • Collect information from many sources (e.g., chart review, electronic medical records).
    • Describe the information via descriptive statistics and other tools. These tools can be found on the Institute for Healthcare Improvement website.7
  • Outcome
    • Histograms: to describe different categories of outcomes.
    • Scatter plots: to describe general trends in two sets of variables to determine their correlation.
    • Pareto charts: a combination of a bar and line graph. Individual inputs into an outcome are represented in descending order by bars, and the cumulative total is represented by the line. This allows one to see the relative contribution of each input into an outcome.

Example: A Pareto chart follows the 80/20 principle – for many events, roughly 80% of the effects come from 20% of the causes.11 Chart source: East London NHS Foundation Trust’s quality improvement programme, https:/qi.elft.nhs.uk

Implementing Changes

If assessment of the current problem or process fails to yield satisfactory results, a QI intervention may need to be planned and implemented. Pronovost et al12 laid out the following criteria for QI interventions to be successful:

  • Evaluate the progress of improvements
  • Use more evidence-based practices
  • Improve the culture of safety and open communication
  • Use prospective and retrospective analyses to identify and address patient safety hazards at all levels of the organization
  • Evaluate the characteristics of the organization that affect patient safety practices in both positive and negative ways
  • Identify potential barriers to implementation
    • Potential barriers to the intervention should be considered prior to development of an implementation strategy.13
    • Tools, such as an effort-yield matrix and Pareto charts, may be helpful in determining which intervention to employ.

Implementation Strategies

  • Once a planned intervention has been determined to satisfy the criteria, implementation strategies must be developed.
  • Successful studies have used feedback reports in conjunction with implementation strategies, as well as educational tools and programs.14
    • QI interventions are most effective when interventions are evaluated continuously. Tools, such as a plan-do-study-act cycle, minimize negative outcomes throughout the implementation of new strategies and continues to advance improvements.7
    • Continuous QI is most effective when implemented systematically and organization wide.13
  • Successful implementation also benefits from a culture that is receptive to change with capable, sustained leadership and a strategic implementation plan that is not burdensome.13
  • Involvement of leadership, such as the use of executive rounds, that is, Comprehensive Unit-based Safety Program teams, allows senior management to meet with staff regularly and evaluate current practices.

Putting It All Together: Example QI Project

Van et al (2019) successfully implemented an interdisciplinary quality improvement project for opioid risk reduction in the Acute Comprehensive Inpatient Rehabilitation setting.8 The project conducted a Plan-Do-Study-Act framework in a multidisciplinary setting with flexibility to adopt changes in response to feedback. Since initiation of a take-home naloxone program, there was a 7-fold increase in the likelihood of patients on opioids receiving a naloxone prescription and a 10-fold increase in the likelihood of patients being weaned from opioids.

Barriers to QI and Potential Solutions15

Cutting Edge/ Unique Concepts/ Emerging Issues

QI is an emerging interdisciplinary scientific endeavor. Increasingly, nonmedical scientists, such as anthropologists, industrial engineers, economists, and psychologists, have become involved in promoting cultural and workflow changes vital to QI. Research, which aligns structure and processes to outcomes, brings new validity to these measures. There is ample opportunity for quality improvement in PM&R because of the interdisciplinary nature of the field and the focus on improving outcomes and functionality. Thus, it is imperative that more researchers focus on patient safety and continually review and implement new tools to improve multidisciplinary communication.12, 16

The increasing complexity of health care, severity and acuity of illness in rehabilitation patients, rapidly changing health delivery systems, and developments in technology continue to have a significant impact between patients’ expectations and the delivery of care.

The SARS-CoV-2 (COVID-19) pandemic has placed a large stress on our healthcare system, revealing many shortcomings including safety of patients and clinicians, timeliness of non-COVID patient care, and equity regarding burden of COVID-19 on low socioeconomic populations.17 In particular, emergence of COVID-19 necessitated utilization of telemedicine in care delivery. This rapid escalation has shown benefits and sustainability after the reopening of in-person clinical care but remains to have limitations and opportunity for quality improvements.18


  1. Donabedian A. Evaluating the quality of medical care. Milbank Mem Fund Q. 1966;44:166-206.
  2. Centers for Medicare and Medicaid Services. Quality Measurement and Quality Improvement. Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Quality-Measure-and-Quality-Improvement-. Accessed May 3, 2022.
  3. Institute for Healthcare Improvement. How to Improve. Available at: http://www.ihi.org/resources/Pages/HowtoImprove/default.aspx. Accessed May 5, 2022.
  4. Schriefer J, Leonard MS. Patient safety and quality improvement: an overview of QI. Pediatr Rev. 2012;33(8):353-359.
  5. Agency for Healthcare Research and Quality. National Guideline Clearinghouse. Available at: www.guidelines.gov. Accessed Sep. 13, 2016.
  6. American Academy of Physical Medicine and Rehabilitation. AAPM&R Endorsed or Affirmed Guidelines. Available at:  https://www.aapmr.org/quality-practice/evidence-based-medicine/clinical-practice-guidelines/aapm-r-endorsed-guidelines. Accessed Feb. 21, 2022.
  7. Institute for Healthcare Improvement. Tools. Available at: http://www.ihi.org/resources/Pages/Tools/default.aspx. Accessed Feb. 21, 2022.
  8. Van SP, Yao AL, Tang T, Rohjani S, Sprankle LA, Hoyer EH. Implementing an opioid risk reduction program in the acute comprehensive inpatient rehabilitation setting. Arch Phys Med Rehabil. 2019;100(8):1391-1399.
  9.  Lo A. Morbidity and Mortality Rounds in Rehabilitation – Benefits for Enhancing Quality Beyond Just the “M&M”. PM&R The Journal of Injury, Function and Rehabil. 2018;10:865-869.
  10. Wallace SC, Mamrol C, Finley E. Promote a Culture of Safety with Good Catch Reports. PA-PSRS Patient Saf Advis. September 2017;14.
  11. Quality Improvement East London NHS Foundation Trust. Pareto Chart. Available at: https://qi.elft.nhs.uk/resource/pareto-charts/. Accessed May 7, 2022.
  12. Pronovost PJ, Goeschel CA, Marsteller JA, Sexton JB, Pham JC, Berenholtz SM. Framework for patient safety research and improvement. Circulation. 2009;119:330-337.
  13. Shortell SM, Bennett CL, Byck GR. Assessing the impact of continuous quality improvement on clinical practice: what it will take to accelerate progress. Milbank Q. 2001;76:593-624.
  14. De Vos M, Graafmans W, Kooistra M, Meijboom B, Van Der Voort P, Westert G. Using quality indicators to improve hospital care: a review of the literature. Int J Qual Health Care. 2009;21:119-129.
  15. Aaron M, Webb A, Luhanga U. A narrative review of strategies to increase patient safety event reporting by residents. J Grad Med Educ. 2020;12(4):415-424.
  16. Eldar R. Methodology matters-XIII. Quality of care in rehabilitation medicine. Int J Qual Health Care. 1999;11:73-79.
  17. Corrigan J, Clancy CM. Assessing progress in health care quality through the lens of COVID-19. JAMA. 2020;324(24):2483-2484.
  18. Dempsey CM, Serino-Cipoletta JM, Marinaccio BD, O’Malley KA, Goldberg NE, Dolan CM, Parker-Hartigan L, Williams LS, Vessey JA. Determining factors that influence parents’ perceptions of telehealth provided in a pediatric gastroenterological practice: A quality improvement project. J Pediatr Nurs. 2022 Jan-Feb;62:36-42. doi: 10.1016/j.pedn.2021.11.023. Epub 2021 Dec 8. PMID: 34894421.

Original Version of Topic

R. Samuel Mayer, MD, Mi Ran Shin, MD, W. Bernard Abrams MD. Quality improvement/patient safety issues relevant to rehabilitation. 9/20/2013

Previous Revision(s) of Topic

R. Samuel Mayer, MD, Seth Oliphant, MD, Levan Atanelov, MD. Quality improvement/patient safety issues relevant to rehabilitation. 3/23/2017

Author Disclosure

R. Samuel Mayer, MD, MEHP
Nothing to Disclose

Ohmin Kwon, MD
Nothing to Disclose

Kavita Nadendla, MD
Nothing to Disclose

Bhavesh D. Patel, DO
Nothing to Disclose