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Definition of Quality Improvement and Patient Safety

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

QI consist of systematic and continuous actions that lead to measurable improvement in health care services and the health status of targeted patient group.

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:

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

Each of these types of quality measures has its value and limitations. Processes are the functions over which healthcare providers have the most control. However, improving the process may not always improve the overall quality of care perceived by the patient. Not all process improvements lead to improved outcomes. However, certain process such as mortality discussion, patient satisfaction questionnaires have been linked to improved outcomes. On the other hand, 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.

There are several models that present a systematic, formal framework for establishing QI processes. Examples of QI models include the following: 1-3

  • Plan-Do-Study-Act [PDSA] Cycles, or Deming Cycle
    • Plan: Plan a change or test of how something works.
    • Do: Carry out the plan.
    • Study: Look at the results.
    • Act: decide what actions to take to improve.
  • Lean Six Sigma
    • Measurement-based strategy for improving process and reducing problem through application of improvement projects.
    • DMAIC (Define, measure, analyze, improve, control): used for exiting processes falling below specification to improve incrementally
    • DMADV (Define, measure, analyze, design, verify): used to develop new process at Six Sigma quality levels.
  • Focus-Analyze-Develop-Execute [FADE]
    • Focus: Define and verify the process to be improved
    • Analyze: Collect and analyze data to establish baselines, identify root causes and point toward possible solutions
    • Execute: implement the action plans, on a pilot basis as indicated
    • Evaluate: install an ongoing measuring/monitoring system to ensure success
  • Continuous Quality Improvement [CQI] or Performance Quality Improvement (PQI)
    • ‘a comprehensive management philosophy that focuses on continuous improvement by applying scientific methods to gain knowledge and control over variation in work processes’4
    • It is a cycle and most commonly PDSA is used.
    • It focuses on team approach
  • Total Quality Management [TQM]

A management approach to long-term success through patient satisfaction that involves all persons in an organization.


Sources and Methods of Obtaining Information

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


  1. Clinical records.
  2. Direct observation by a colleague, for example, secret shopper for hand hygiene.
  3. 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 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


  1. Single vial dosing for epidural steroid injection.
  2. Use of appropriate venous thromboembolism (VTE) prophylaxis during an inpatient rehabilitation stay.
  3. Prescription of aspirin for secondary stroke prevention.
  4. Documentation of red flags in initial evaluation of a patient with back pain.
  5. Performance of hand hygiene in the hospital or clinic.
  6. 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 Clearinghouse2 contains links to many commonly accepted guidelines. It is run by the Agency for Healthcare Research and Quality, and has searchable links to hundreds of published guidelines. Physical Medicine and Rehabilitation (PM&R) specific guidelines are also available online.3 These include guidelines developed and/or endorsed by the American Academy of Physical Medicine and Rehabilitation.


  1. Cost
  2. Length of stay for inpatient rehabilitation
  3. Medical complications after injections
  4. Improvement in function during outpatient therapy
  5. Uniform Data Set FIM for inpatient rehabilitation
  6. Patient satisfaction
  7. Thirty day re-hospitalization rates
  8. Mortality rates

Outcomes are generally compared with particular 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 measures the level of a patient’s disability and how much assistance they need to carry out activities of daily living.

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


Structure is often dictated by external reviewers:

  1. The Joint Commission on Accreditation of Healthcare Organizations (TJC) publishes standards on fire safety for hospitals.
  2. The Commission on Accreditation of Rehabilitation Facilities has extensive standards on the types of therapy services that must be available for a program to achieve accreditation.
  3. The Accreditation Committee for Graduate Medical Education specifies the appropriate credentials for a residency or fellowship programs.

Clinicians performing quality improvement activities need a toolbox of methods to collect and analyze data. The Institute for Healthcare Improvement website5 serves as an excellent resource for detailed descriptions on a number of QI tools. 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

  1. 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.
  2. 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.
  3. 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


People                 Buildings           Training
\____________\__________\_________|> Outcomes
/                                                                                   /
Information systems            Communication


Tools for Assessing Solutions

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

  1. Analyze single cases
    • Root cause analysis is a tool prescribed by TJC for analyzing a sentinel event, that is, an error that lead to death or permanent disability. It requires interdisciplinary input from frontline staff.
    • Morbidity and mortality conferences, are designed to explore things that might have contribute to medical error or adverse outcomes in patient care. Recently, there had been a shift to a more multidisciplinary and systems-based approach,6 as well as increased focus on reward and recognition, for example, via Good Catch Awards.7 Good Catch Award creates positive incentive for providers and staff to report patient safety effects by identifying and reporting adverse events, near-misses, and other medical errors.
  2. Analyze general trends
    • Processes
      • Control charts: to monitor process over time, study variation, and its source. It allows tracking of results over time. For example, you can look over time compliance with hand hygiene. You can also track how different interventions influence results (e.g., staff education, signage, self-monitoring programs).
      • 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.4
High Effort Low Effort
Low Yield Waste of time Not meaningful
High Yield Cost-effective Low hanging fruit
  1. 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.

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 al8 laid out the following criteria for QI interventions to be successful:

  1. Evaluate the progress of improvements
  2. Use more evidence-based practices
  3. Improve the culture of safety and open communication
  4. Use prospective and retrospective analyses to identify and address patient safety hazards at all levels of the organization
  5. Evaluate the characteristics of the organization that affect patient safety practices in both positive and negative ways
  6. Identify potential barriers to implementation
    • Potential barriers to the intervention should be taken into account prior to development of an implementation strategy.9
    • Tools, such as an effort-yield matrix and Pareto charts, may be helpful in determining which intervention to employ.

Implementation Strategies

  1. Once a planned intervention has been determined to satisfy the criteria, implementation strategies must be developed.
  2. Successful studies have used feedback reports in conjunction with implementation strategies, as well as educational tools and programs.10
    • QI interventions are most effective when interventions are evaluated continuously. Tools, such as a plan-do-study-act cycle, minimizes negative outcomes throughout the implementation of new strategies and continues to advance improvements.5
    • Continuous QI is most effective when implemented systematically and organization wide.9
  3. 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.9
  4. 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.

Barriers to QI

  1. One of the common barriers in QI implementation is lack of communication.
    • Barriers in communication can be addressed by educating the personnel to report a potential hazard that may harm a patient.
    • Encouraging the use of concerned, uncertain, safety can help care team members effectively communicate their concerns to other team members.
    • Encouraging team members to use a two attempt rule of bringing up concerns can help to communicate potential hazardous situations that may be misinterpreted initially, as well as escalating the concern to a higher level provider when necessary, is not discouraged.
    • Situation, background, assessment, and recommendation is a brief communication format for urgent issues.
    • Handoffs between shifts and among different levels of care is vital for patient safety.

3. 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.8, 11

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


  1. Donabedian A. Evaluating the quality of medical care. Milbank Mem Fund Q. 1966;44:166-206.
  2. Agency for Healthcare Research and Quality. National Guideline Clearinghouse. Available at: www.guidelines.gov. Accessed Sep. 13, 2016.
  3. American Academy of Physical Medicine and Rehabilitation. Practice guidelines. Available at: www.aapmr.org/practice/guidelines. Accessed Sep. 11, 2016.
  4. Tindill BS, Stewart DW. Integration of total quality and quality assurance. . In: The textbook of total quality in healthcare. Delray Beach, FL: St Lucie Press; 1993:209-220.
  5. Institute for Healthcare Improvement. Available at: www.ihi.org. Accessed Sep. 11, 2016.
  6. Esselman PC, Dillman-Long J. Morbidity and management conference: an approach to quality improvement in brain injury rehabilitation. J Head Trauma Rehabil. 2002;17:257-262.
  7. Herzer KR, Mirrer M, Xie Y, et al. Patient safety reporting systems: sustained quality improvement using a multidisciplinary team and good catch awards. Jt Comm J Qual Patient Saf. 2012;38:339-347.
  8. Pronovost PJ, Goeschel CA, Marsteller JA, Sexton JB, Pham JC, Berenholtz SM. Framework for patient safety research and improvement. Circulation. 2009;119:330-337.
  9. 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.
  10. 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.
  11. Eldar R. Methodology matters-XIII. Quality of care in rehabilitation medicine. Int J Qual Health Care. 1999;11:73-79.
  12. Beau Wiseman, V. S. (2016). QI, patient safety-Quality improvement. Retrieved from What is quality improvement: http://patientsafetyed.duhs.duke.edu/module_a/methods/six_sigma.html
  13. Almorsy L, Khalifa M. Lean six sigma in health care: Improving utilization and reducing waste. Stud Health Technol Inform. 2016;226:194-197.
  14. Knapp S. Lean six sigma implementation and organizational culture. Int J Health Care Qual Assur. 2015;28(8):855-863.
  15. Knapp S. Lean six sigma implementation and organizational culture. Int J Health are Qual Assur. 2015;28(8):855-863
  16. Kahan, B. (1999). Continuous quality improvement and health promotion: can CQI lead to better outcomes? Health promotion international, Vol.14, No. 1:83-91

Original Version of Topic

R. Samuel Mayer, MD, Mi Ran Shin, MD, W. Bernard Abrams MD. Quality improvement/patient safety issues relevant to rehabilitation. 09/20/2013.

Author Disclosure

R. Samuel Mayer, MD
Nothing to Disclose

Seth Oliphant, MD
Nothing to Disclose

Levan Atanelov, MD
Nothing to Disclose