Assessing and Improving Health Care Quality
After reading this chapter, you will be able to:
- Summarize the importance of patient safety and the various forms of adverse events, including adverse drug events;
- Define quality in health care;
- Describe approaches to managing care quality;
- Describe the main methods of quality improvement.
Linking these topics to the Medical Council exam objectives, especially section 78-4.
Every health care professional wants to do a good job and help patients. However, things do not always go according to plan and the safety of patients is compromised. Sometimes patients’ laboratory results get lost and tests have to be repeated. Sometimes patients are given medications to which they are known to have contraindications. Practices are not always based on the best available evidence.
Terms for adverse outcomes
From the outset, three concepts should be distinguished:
- Adverse outcome: an unsatisfactory outcome that arises as part of the natural course of the disease, for instance, a gastrointestinal bleed due to a stress ulcer in a patient with pneumonia.
- Adverse event: unintended injury or complication that was caused by health care management, rather than by the patient’s underlying disease, and that leads to death, disability or prolonged hospital stays.1 Adverse events include complications that arise from treatment, inherent (and often unforeseeable) risks of interventions, and errors. For instance, a gastro-intestinal bleed may occur even with adequate monitoring of warfarin treatment.
- Medical error: an adverse event that was preventable. For instance, a gastro-intestinal bleed in a patient on warfarin treatment that was not monitored adequately. Medical errors include: errors of execution, such as slips (operating on the wrong side), lapses (forgetting to check for allergies), or fumbles (needlestick injuries). These are errors in automatic functioning that are often due to fatigue or stress. Other errors are due to mistakes or failures of reasoning that result in a poor choice of treatment plan (treating for heartburn when the patient has classic symptoms and signs of myocardial infarction). These errors can be due to a failure in attitude resulting in inadequate investigation, or to gaps in knowledge.
Because many adverse events arise from inherent risks and not from errors, it is prudent to use the term “adverse event” unless error has definitively been established.
Patient safety has become a universal concern, and is more likely to be improved by overall quality improvement than by piecemeal reaction to adverse events. In Canada, the Romanow Commission found that responsibility for ensuring quality and safety of care is distributed among a number of different players and organizations in the health care system, including numerous professional and regulatory bodies.2 In such a system of divided responsibilities, lines of accountability can be unclear, so required actions may not be carried out or may not be followed up thus errors occur. Furthermore, sharing of information and learning are inhibited. Following the publication of the Canadian Patient Safety Strategy, a Patient Safety Institute was set up in 2003. Also, the Health Council of Canada was created in 2004 to provide a perspective on health care issues, including quality and safety, and their impact on the health of Canadians. Most provinces have created agencies responsible for examining the quality of care and for informing both public and government of their findings. Many hospitals have some kind of safety audit, often in the form on morbidity and mortality conferences, and physicians can be required to carry out regular assessments of their practice. However, coordinated and integrated structures to support patient safety are still lacking.3
One method of classifying adverse events is to relate them to the stage of medical intervention at which they occur.4 (For another, see Nerd’s corner: Using services appropriately)
- Error or delay in diagnosis
- Failure to employ indicated tests
- Use of inappropriate tests
- Use of outmoded tests or therapy
- Failure to act on results of monitoring or testing
- Failure to provide prophylactic treatment
- Inadequate monitoring or follow-up of treatment
- Error in the performance of an operation, procedure, or test
- Error in administering the treatment
- Error in the dose or method of using a drug
- Avoidable delay in treatment or in responding to an abnormal test
- Inappropriate (unnecessary) care
- Failure of communication
- Equipment failure
- Other system failure
Using services appropriately
A simple way to define quality of health services is in reference to how interventions are used: they may be underused, overused, or misused.5
- Underuse: Failure to apply effective care that would improve outcomes. Examples include low income women not getting routine Pap smears, women aged 50-69 not getting screening mammography, and patients not adhering to therapy for high blood pressure.
- Overuse: Providing a treatment even if cost exceeds benefit. Examples include prescription of antibiotics for minor upper respiratory tract infections, and ordering an X-ray of an ankle when the Ottawa Ankle Rule indicates that a fracture is improbable.
- Misuse: Ordering tests or providing treatments that increase cost or the risk of complication and that are not significantly better than other options. Examples include using the latest, most expensive antibiotic when a cheaper or generic one would be equally effective, or prescribing opioids for patients with chronic pain before exploring other ways of resolving the problem.
This simple classification of quality is useful when patient safety is the only focus, but it is one-dimensional. In fact, quality assessment encompasses all the direct and indirect factors that determine patient safety as well as those relating to patient and provider satisfaction (see Table 13.1, below).
Adverse drug events are a particular area of concern, especially in older adults and people with complex disease. In these cases, a ‘prescribing cascade’ may occur; this happens when an adverse drug reaction is not recognized as such but is approached as a new medical problem that is then treated with another drug.6 Adverse drug events are significant causes of death of hospitalized patients.7 In long-term care facilities, one study estimated that two thirds of residents experienced an adverse drug event over a four year period; one in seven of these events resulted in a hospitalization.8 The Beers Criteria and similar lists indicate drugs to avoid in older adults to avert adverse drug events.8, 9 A simple mnemonic for possible types of reaction to drugs is shown in Nerd’s corner: the ABCDEF of adverse drug reactions.
The ABCDEF of adverse drug reactions10
– Common and predictable reaction
– Related to the pharmacological mechanism of action of a drug
– Uncommon and unpredictable
– Not related to the pharmacological mechanism of action of a drug
|Chronic||Dose-related and time-related
– Related to the cumulative dose
|Chronic oral steroid use|
– Usually dose-related
– Occurs some time after the use of a drug
|End of use||Withdrawal of drug
– Occurs soon after withdrawal of drug
|Opiate withdrawal syndrome|
|Failure||Unexpected failure of therapy
– Often caused by drug interaction
|Reduced efficacy of oral contraceptive when used with antibiotics|
Quality of care is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with professional knowledge.5 Quality and quality improvement involve much more than preventing adverse events; different authors include different facets in their definitions of quality. Table 13.1 offers a fairly comprehensive list.
|Dimensions of quality||Health service values|
|Safety||People should not be harmed by an accident or mistakes when they receive care.|
|Effectiveness||People should receive care that works and is based on the best available evidence.|
|Patient-centred||Health care providers should offer services in a way that is sensitive to an individual’s needs and preferences.|
|Timeliness||People should get the care they need when they need it.|
|Appropriateness of resources||Caregivers and professionals should have the appropriate skills for their practice and have access to the information, equipment, supplies, and facilities they need to look after people’s health needs.|
|Efficiency||Supplies, equipment, time, ideas, and information should not be wasted.|
|Equitableness||People should get the quality of care that is appropriate to their needs regardless of whom they are and where they live.|
|Accessibility||People should be able to get the right care at the right time in the right setting from the right provider.|
|Continuity||All parts of the system should be organized, connected, and work with one another to provide high quality care.|
|Population health||Health care professionals should recognize their responsibility to prevent sickness and improve the health of the wider community and population.|
|Rewarding||Caring for people who need health care should be a rewarding occupation. Some people consider this a health service value; others do not. Nevertheless, people who consider their jobs rewarding generally produce work of higher quality than those who are unhappy in their work. Salary level is usually only a minor part of what makes a job rewarding.|
Unfortunately, dimensions of quality may conflict with each other. For example, the most effective therapy may not be the most patient-centred or the most rewarding for the provider. Hence, it may be necessary to establish a hierarchy among these criteria.
There are two ways of approaching quality improvement in health care.13 The inspection model (also known as ‘name, blame, and shame’), although ineffective and inefficient, is still in common use. This model operates according to the theory of bad apples (so called because one bad apple can spoil the whole box), which holds that once the ‘bad apples’ are removed from the system, their spoiling effect is also removed. There are two major drawbacks to this theory. The first is that most people who make mistakes are not bad apples, but act erroneously because of pressures in the system surrounding them. Blaming people encourages them to hide errors or close calls, creating a ‘culture of silence’. The second drawback is that, unlike bad apples that sit individually and unmoving in a box, the health care system boils with interacting people and complex processes, offering numerous opportunities for error. Monitoring every critical point for error is difficult, consumes resources and has not yet been shown to be effective in preventing mistakes. Furthermore, the standard of quality the inspection model achieves can be no higher than the standards imposed by the inspection: usually the bare minimum.
The second and more effective way of ensuring quality is to focus on the system that delivers the health care. This ensures there are multiple checks and safety nets in place to prevent errors, while encouraging open communication about errors and near misses, and also inviting ideas for improving quality.
Providing high-quality health care is the goal of all clinical professionals. Many professional colleges and regulatory bodies (for instance, provincial colleges of physicians and surgeons) have incorporated quality improvement practices into their mandate and operational approaches. Most have quality assurance committees and routinely conduct audits of professional practices. Whereas in the past many of these bodies merely responded to complaints, they are now studying and implementing ways of improving quality. In turn, their relationship with clinicians is shifting from a focus on discipline to one of continuing professional education and training.
In most medical situations, people are protected from possible hazards by several layers of barriers. The most immediate barrier is the skill and knowledge of the people caring for them. Routines in the way procedures are carried out also protect patients. For instance, good sterile technique reduces wound infection and good management and organization help staff to apply safety procedures and make safe decisions.
No protective barrier protects 100% of the time. Most have transient or lasting defects. Most of the time this does not result in an adverse event because the other barriers present are sufficient to protect the patient. Injury results only when defects in several barriers are aligned, exposing a vulnerable patient to a hazard. As Swiss cheese is known for its holes, the idea of barriers with defects or holes brought James Reason to propose the Swiss cheese model of error (Figure 13.1).14
The bad apple approach to problems in quality focuses on the error itself or its immediate cause. This is rarely sufficient to prevent recurrences. The Swiss cheese model focuses on the system to examine all barriers that should have prevented a lapse in quality: individual and team actions, the environment or context in which the error occurred, and the organizational factors that influence the actions and their context. Thinking along these lines, the Toyota Company developed the ‘Five Whys’ as a simple way to find the root causes of an error. This is adapted to a health context in Figure 13.2.
In reality, there are usually several answers to each ‘Why?’ question (this was illustrated in Table 10.7). For instance, the nurse might have been inexperienced or rushed or the light might have been low. Following all the answers leads to a full description of the situation, which gives a number of options for preventing further errors.
At a practice meeting, Dr. Rao mentions Mrs. Richards’ hypertension. Here is an excerpt from the Minutes of the meeting:
Dr. Middleton: Over-medication is a huge problem in healthcare generally.
Nurse Jennings explained that she includes a drug history in her preventive checks, but patients are often quite vague about what they are taking.
Mr. Bertoli (practice manager): If we had the money we could buy a computer application that checks recent prescriptions for drug interactions.
Dr. Middleton: Yes, but when patients get a prescription from a specialist or a walk-in clinic, our computer application wouldn’t take account of it.
On his way home, Dr. Rao drops into Mr. Roy, the local pharmacist, who says that the pharmacies in the area have a system for tracking prescriptions, although it’s not perfect. Dr. Rao asks if the local physicians could be linked into the system so they could check what drugs their patients are on before prescribing others. Mr. Roy promises to look into it.
After some more discussions in the practice, Nurse Jennings and Mrs. Austen, the receptionist, agree that Mrs. Austen will instruct patients with chronic illnesses to bring all their drugs with them to their appointment, including the over the counter medicines. Nurse Jennings will list the drugs and how the patients take them and put this list in the chart for the doctors to see.
Dr. Rao welcomes this initiative; he sees that they will be able to evaluate it using the number of patients’ charts with drug lists. They might even be able to follow how many prescriptions are changed as a result. However, he worries that it will take too much of Nurse Jennings’s time so he resolves to check with her in a couple of weeks to see how she is doing. He will also check with Mrs. Austen to see if the arrangement seems to be increasing the patients’ waiting time. Dr. Rao wonders if he can persuade the managers of the long-term care home to keep a drug list for each resident.
Quality improvement can be thought of as a continuous cycle that starts by examining needs, goes on to changing practice, checking to see if the planned changes have happened, checking to see if goals have been reached, then beginning again. This should result in a continuous improvement in quality. The cycle is known as the Plan, Do, Study, Act (PDSA) cycle or the Shewart or Deming cycle, after two of the experts who developed it:
- Plan: Plan what you want to change and make measurements to confirm the problem, using the dimensions of quality as a guide. Diagnose what can be improved and decide on the best way to make the change.
- Do: Implement the change.
- Study: Using the indicators in the “Plan” step of the cycle, measure the impact of the change. Look for positive, negative and unexpected impacts, because changes in complex systems can have negative side effects and unintended consequences.
- Act: Act on the results of the study. The net result should be more modifications and changes. Depending on the results, you then re-enter the “Plan” step again (see Figure 13.3).
It is often better to do many mini-PDSA cycles rather than one big one. Clinicians do not usually have the resources to take on a major PDSA cycle. A sequence of successful small cycles is likely to achieve greater improvement in quality than a failed large one.
The Precede-Procede model17 uses a similar but more elaborate approach to planning (figure 13.4). Although the model, developed by Lawrence Green, was developed for health promotion, it can be adapted to other areas of health care including clinical practice.18 Its advantage is that it considers quality of life as the ultimate outcome and takes account of most factors that influence it.
The idea is that the planning phase begins at the upper right corner of the model by assessing quality of life, the health status that influences it, and lifestyle and environmental factors that influence the practice population’s health status. This guides the development of objectives for improving health and quality of life of patients living in this community (top arrow). The predisposing, enabling, and reinforcing factors that promote or inhibit the achievement of these objectives can be listed as targets that should be addressed by a health programme, and from this the policies, resources, and organization of services and programmes required to achieve these targets can be chosen. In this way a complete portrait of the problem is drawn up along with a plan for implementing solutions. Once a programme has been set up, it can be evaluated. For this, the steps of the evaluation phase are followed in the opposite direction to see if the planned action took place, if targets were achieved, and if the expected outcomes followed (bottom arrow).
Several principles guide actions to improve quality:18
- The primary responsibility for quality rests with the production worker; in health care, this is the clinician.
- Quality assurance systems aid, support and strengthen production systems; they are not simply a form of inspection.
- Workers want to improve quality but need extra energy and skills to do so.
- Vague exhortations, threats and blame are not effective quality improvement interventions.
- Statistical methods should be used to measure performance and compare it with standards.
- Quality assurance is designed to produce improvements, not to exert control.
- Quality assurance systems should cover all aspects of an organization, including the process of management itself.
- Quality assurance without consumer involvement is inadequate and incomplete.
- Quality assurance focuses on systems and system failure, not on individuals and individual failure.
An approach to quality improvement
According to Juran, quality improvement consists of three main activities: quality planning, quality control, and quality improvement.19
- Quality planning
- Determine who the patients or populations are and identify their needs:
What are the health problems in the practice population and what can be done about them?
- Orient services being offered to meet these needs:
Do staff members or professionals need training? Does the clinic environment promote health?
- Make sure that service processes and systems are capable of producing the services:
What can the practice do?
- Quality control (measure against goals)
- Evaluate quality:
How does the practice measure up in the different dimensions of quality?
- Quality improvement
- Establish an infrastructure:
Information systems for monitoring quality and a team responsible for quality
- Identify projects:
What can the practice do? What would an alliance with other health services contribute? Could local authorities be persuaded to make healthy policy choices?
- Establish teams with enough resources and motivation to lead projects:
The teams will look at the causes of the problem, decide on a remedy, and decide what information needs to be collected to test whether the remedy has improved matters.
Linking quality improvement to health improvement
Practical steps in quality improvement
The practical steps in conducting a quality improvement are as follows:
- In consultation with the people affected, decide what to try to improve and why.
- Gather a team that includes those who will be affected by the likely changes.
- Establish specific improvement objectives that are feasible and, if possible, measurable.
- Select measures or indicators of these objectives, preferably ones that are easily available.
- Choose what to change to make the improvements.
- Evaluate the change.
- Write a report and look at what else you might improve.
Some leaders in quality improvement
Walter Shewart (1891–1967) is known as the father of statistical quality control. Having a strong scientific background, he adapted the steps of observation, hypothesis generation and testing to quality management, where the steps became Plan, Do, and See what happens.
Edwards Deming (1900–1993) saw that quality depends on systems more than on individuals. In Japan, his work led to the rise of many very powerful Japanese companies, such as Sony, Panasonic, and Toyota. He generally aimed to reduce complexity, duplication, and waste. He saw variation as an opportunity for improvement, not as a problem.
Joseph M. Juran (1904–2008) trained as an electrical engineer and worked around the world as a management consultant. His particular contribution was to focus on the role of management in ensuring quality, reinforcing the idea that the system as a whole and its processes are at the base of most quality problems.
Avedis Donabedian (1919– 2000) practiced family medicine and was recruited into the School of Public Health of the University of Michigan. In 1966 he wrote the paper that introduced the concepts of structure, process and outcome, which is still the dominant paradigm for the evaluation of quality of health care and health care programme evaluation.
James T. Reason (b. 1938) started with an interest in controlling risks in the aviation industry. Reason has worked in a range of industries, including the health system. In particular, he focuses on the study of the safety and reliability of complex, well-defended hazardous systems.
1. What are the steps in the quality improvement cycle?
Plan: evaluate the current situation, prioritise what should be done, decide what can be done, decide what to do, and decide how to measure success. This step should be carried out in collaboration with the people that the action will affect.Do: carry out what was planned. Plans may need to be adjusted.
Study: assess what was done, its success, its positive and negative impacts, and obstacles and facilitating factors.
Act: act on the results of the “study” step and proceed to the next step, which can be a reassessment of the current action or a “plan” step to reassess how the current action has affected the overall situation and whether or not to change priorities and goals.
2. What are the dimensions of quality?
2. Develop a plan to address it.
- Baker GR, Norton PG, Flintoft V, Blais R, Brown A, Cox J, et al. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. Canadian Medical Association Journal. 2004;170(11):1678-86.
- Romanow RJ. Building on values: The future of health care in Canada. Ottawa: Privy Council of Canada 2002 [cited 2016, November]. Publication number CP32-85/2002E-IN:[Available from: http://publications.gc.ca/site/eng/237274/publication.html.
- Leatherman S, Sutherland K. Quality of healthcare in Canada: A chartbook. Ottawa, Ont.: Canadian Foundation for Healthcare Improvement; 2010 [cited 2016, November]. Available from: http://www.cfhi-fcass.ca/SearchResultsNews/10-02-10/42054d49-16fb-4764-be05-1d03e6ff3bbb.aspx.
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- Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279(15):1200-5.
- Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH. Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Archives of Internal Medicine. 2003;163(22):2716-24.
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- Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-9.
- Institutes of Medicine. Crossing the quality chasm: A new health system for the 21st century. Washington: National Academy Press; 2001.
- Ontario Health Quality Council. QMonitor: 2009 Report on Ontario’s health system. 2009.
- Berwick DM. Continuous improvement as an ideal in health care. New England Journal of Medicine. 1989;320(1):53-6.
- Reason JT, Carthey J, de Leval MR. Diagnosing “vulnerable system syndrome”: an essential prerequisite to effective risk management. Quality in Health Care. 2001;10(Suppl 2):21-5.
- Reason JT. Managing the risks of organizational accidents. Aldershot: Ashgate; 1997.
- Institute for Healthcare Improvement. Science of Improvement: Testing Changes Cambridge, MA: Institute for Healthcare Improvement; 2010 [cited 2017, August]. Available from: http://www.ihi.org/resources/Pages/HowtoImprove/ScienceofImprovementTestingChanges.aspx.
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