Quality and Patient Safety

Before you begin: Lessons are based on community-based, continually updated online sources such as Wikipedia . Relevant terms for this lesson are listed under Topics and presented in a narrative format in the Read about sections. Click on each of the linked items and visit the Wikipedia article to get the most out of the lesson, and then hit the Back button on your browser to return to the lesson.




quality management , patient safety , medical error, Six Sigma , Lean laboratory, Just In Time , quality assurance, managing laboratory quality, quality control

Read about

Research on medical errors

In the year 1999, a 312-page report was published that would radically change public dialogue about America’s healthcare system. This was the now-famous Institute of Medicine report, “To Err is Human: Building a Safer Health System ,” which brought to the public’s attention that about 98,000 people die each year from medical errors that occur in hospitals, more than the number of deaths from motor vehicle accidents, breast cancer, or AIDS. Suddenly, the “do no harm ” aphorism taught in medical schools was viewed in uncomfortable contrast with the data. Similarly as impressive was the evidence that the problem was not “bad people in healthcare,” but rather, that good people were working in “bad systems that need to be made safer.”

This first report was followed by another in 2001, called “Crossing the Quality Chasm: A New Health System for the 21st Century .” In their analysis, the authors found that the health care system had failed to keep up with the rapidly changing demands of modern medical practice. The organizational structure of healthcare was designed for acute episodic care, when in fact, patients were living longer and chronic conditions were the major causes of morbidity and mortality. The report highlighted six core needs: for healthcare to be safe, effective, patient-centered, timely, efficient, and equitable. In addition, the committee outlined 10 general principles for future efforts to redesign a better system (many are particularly relevant to informatics):
  1. Care is based on continuous healing relationships. Patients should receive care whenever they need it and in many forms, not just face-to-face visits. This implies that the health care system must be responsive at all times, and access to care should be provided over the Internet, by telephone, and by other means in addition to in-person visits.
  2. Care is customized according to patient needs and values. The system should be designed to meet the most common types of needs, but should have the capability to respond to individual patient choices and preferences.
  3. The patient is the source of control. Patients should be given the necessary information and opportunity to exercise the degree of control they choose over health care decisions that affect them. The system should be able to accommodate differences in patient preferences and encourage shared decision making.
  4. Knowledge is shared and information flows freely. Patients should have unfettered access to their own medical information and to clinical knowledge. Clinicians and patients should communicate effectively and share information.
  5. Decision making is evidence-based. Patients should receive care based on the best available scientific knowledge. Care should not vary illogically from clinician to clinician or from place to place.
  6. Safety is a system property. Patients should be safe from injury caused by the care system. Reducing risk and ensuring safety require greater attention to systems that help prevent and mitigate errors.
  7. Transparency is necessary. The system should make available to patients and their families information that enables them to make informed decisions when selecting a health plan, hospital, or clinical practice, or when choosing among alternative treatments. This should include information describing the system’s performance on safety, evidence-based practice, and patient satisfaction.
  8. Needs are anticipated. The system should anticipate patient needs, rather than simply react to events.
  9. Waste is continuously decreased. The system should not waste resources or patient time.
  10. Cooperation among clinicians is a priority. Clinicians and institutions should actively collaborate and communicate to ensure an appropriate exchange of information and coordination of care.

Quality improvement processes

Statistical process controls usually use techniques like random sampling to test a subset of the output of a process for quality control purposes. Participant-derived means as targets for quality standards have also been used in national laboratory inspection processes.

“Six Sigma” was originally designed by Bill Smith at Motorola as a type of statistical process control. Six Sigma assumes that in a process with a measurable output, the output can be described with a mean and a standard deviation. A “specification limit” is set for errors. Ensuring that the mean of an output falls six standard deviations, or six sigma units, from the specification limit insures that the probability of error is less than four one-millionths. One of the criticisms of Six Sigma is the arbitrary nature of the “six” standard deviations, when different products/processes may require different standards. In addition, for healthcare, the model assumes a normal distribution of the output, which may not hold true for all biological processes.

“Lean principles” also came out of Japanese manufacturing systems, and was coined by a former quality engineer for Toyota, John Krafcik. It is an improvement process that focuses on reducing waste in the system. The Lean model uses the “Just-In-Time” concept and places an emphasis on automation to promote smoother workflow, eliminate work that does not add value to the process, and transition from large to small batch processing to continuous processing.

Root cause analysis ” (RCA) looks at errors after they have occurred, and tries to identify and fix “causes” rather than “symptoms” of problems. There are a number of techniques associated with RCA, including the 5 Whys, Pareto analysis, and others.


(this needs some work)

Online Resources


(we can keep this blank for now)

Advanced courses

Expert corner

Help with Wikipedia article(s):

Quality and Patient Safety | Goals | Topics | Read about | Activities | Online Resources | Questions | Advanced courses | Expert corner

This page was last modified by - JYKim_Path JYKim_Path on Nov 30, 2009 9:24 am.