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An Overview of Quality Improvement and Accreditation
Framed copy of the Hippocratic oath in a doctor’s office.
After reading this chapter, you should be able to do the following:
Examine the history of healthcare quality improvement.
Outline the concepts of quality and quality improvement in healthcare.
Show how quality is assessed, including structure, process, and outcome measures in quality improvement.
Examine the purpose of accreditation.
The Hippocratic Oath was written thousands of years ago but is still recited by physicians and other healthcare providers before they are allowed to practice medicine. “Never do harm,” expressing the concept of beneficence, is heavily emphasized by this oath, which continues to resonate in the medical field. As mentioned in the introductory chapter, the groundbreaking report from the Institute of Medicine (IOM) in 1999 titled To Err Is Human: Building a Safer Health System also touches on this theme. The report emphasized the urgency of decreasing medical errors and improving patient safety. One of its key components was that errors happen because they are part of human nature (in other words, we are not robots or machines). Even reputable healthcare facilities can make mistakes in both the clinical and administrative sides of healthcare delivery.
For instance, Jesica Santillan, a 17-year-old girl who came to the United States seeking medical treatment for a life-threatening heart condition, died on February 23, 2003, after surgeons at Duke University Hospital in Durham, NC, transplanted a heart and lungs from a person whose blood type did not match hers on February 7. Her death followed a second transplant operation in which doctors attempted to fix the error by transplanting organs that were a match, but the damage to her body was too great and she was declared brain dead.
Her transplant surgeon, who said he was “devastated” by the mistake, blamed human errors, including the assumption that the blood type match was confirmed by the transplant agency. Miscommunication between the surgeon and the organ transplant coordinating agency that provided the heart and lungs resulted in a failure to check the compatibility of the donor organs with the patient. The hospital reviewed the events leading up to the mismatch and revised its procedures to prevent such an error in the future.
As a result of the new procedures, additional physicians are involved in the compatibility process and there is a system for double-checking blood types and organ suitability before organ acceptance and transplant. Changes were also made in the nation’s organ transplant system to strengthen its safety. Duke University Health System and Jesica’s family reached an undisclosed legal settlement.
Errors in healthcare commonly have a number of contributing factors, as it is complex and made up of many components, including people, processes, and organizations. Healthcare delivery is not as simple as manufacturing, in which a product may be moved slowly down an assembly belt as parts are added one by one. Yet there are key lessons in quality improvement from the manufacturing world that have been embraced in healthcare organizations and are helping to reshape the quality of care that patients receive in the United States. We will explore those specific quality improvement methods in future chapters.
But just how does a healthcare organization determine what an acceptable error rate is and where it needs to focus its quality improvement efforts? One way is benchmarking, where a healthcare organization compares itself to other organizations in its local area, region, state, or country. Knowing what a normal error rate is for different procedures, types of organizations, and organizational processes is part of the process that organizations use to determine how to prioritize the resources allocated to quality improvement projects. For example, what is the mortality rate for major metropolitan hospitals that conduct triple bypass surgery? What is the fall rate for nursing homes in Iowa or the vaccination rate at Indian Health Service clinics across the country? How does an organization stack up against competing facilities when it comes to a customer needs assessment?
Benchmarking is a way to determine where an organization is not measuring up to other similar organizations. How does one facility benchmark against others? For instance, if a hospital has three medication errors in a year, those may result in lawsuits from the patients who were injured and, therefore, costs to the organization. However, the hospital will not really know how big of a problem it has until it compares itself with, for instance, national data on medication errors in other comparable organizations. If the national benchmark is an average of five medication errors per year, then the hospital is doing comparatively well from a quality standard. Every hospital strives to have zero medication errors, but that may not be a realistic goal. And granted, while improvement is desired to try to eliminate medication errors, it may not necessarily justify the purchase of an electronic medication distribution system that might cost the hospital $3 million or more. On the other hand, if the medication rate is much higher than the average, the hospital may be justified in purchasing such a system to cut the number of errors.
Before we get started looking at how quality improvement works in the healthcare system, let’s provide some historical perspective.
2.1 History of Quality Improvement in Healthcare
A portrait of Florence Nightingale.
Florence Nightingale initiated one of the first quality improvement projects in healthcare.
Improving the quality of products and services has been a goal for centuries, but was really emphasized in the mid-nineteenth century. Most healthcare organizations have a long history of trying to improve care for their patients. They may not have thought about it as quality improvement per se or used the continuous quality improvement methods developed by modern industry, but physicians and nurses have always been trying to save more lives and improve the care of their patients.
During the Crimean War (1854–1856), Florence Nightingale, who became known as the founder of modern nursing, began what was essentially one of the first “quality improvement” projects, although it is unlikely she thought about it in those terms. She helped increase the quality of care provided to patients by trying to improve sanitation in medical facilities. During the 1860s in Europe, Louis Pasteur’s germ theory gained support; it stated that diseases are caused by the presence of specific microorganisms that later came to be known as bacteria. Nightingale proved the need for proper sanitation through statistical analysis. She was able to correlate proper hygiene with healthy recovery from various illnesses and wounds. Her research resulted in a major reform of the entire military hospital system (Chassin & O’Kane, n.d.).
As the twentieth century approached, sanitation and proper hygiene gained support and compliance in the healthcare system. In 1906, President Theodore Roosevelt signed the first Food and Drug Act, which was an effort to bring quality standards to food and drugs (also discussed in Chapter 3). This new law was designed to protect the consumer and brought national awareness to the importance of safe products and goods used for human consumption.
Shortly after the regulations of the Food and Drug Act were enforced, Dr. Ernest Codman, a physician from Massachusetts General Hospital in Boston, proposed instituting standards that could assess the effectiveness and success rate of various hospital treatments and procedures. In 1910, Dr. Codman’s methodology of measuring effectiveness came to be known as the “end result system of hospital standardization.” His methodology consisted of tracking the progress of hospital patients to assess how successful the treatment was. In 1913, Dr. Codman’s colleague, Dr. Franklin Martin, founded the American College of Surgeons (ACS). Inspired by Dr. Codman’s end result system of hospital standardization, the ACS developed the Minimum Standards for Hospitals in 1918.
As the emphasis on quality standards took shape, the first official quality manual was published in 1926, totaling only 18 pages. A few decades later in 1945, Joseph Juran and W. Edwards Deming became well-known figures in the field of quality management within the healthcare industry. More complex than Dr. Codman’s end result method, quality improvement became a primary method to assess the performance of organizations in various industries, such as healthcare, government, manufacturing, and education. In the manufacturing industry, quality improvement was used to reduce human error by reorganizing the production process. Some quality improvement methods to reorganize processes are through standardization, decisions based on data and science, and responsiveness from staff to uphold the mission of improving the quality of products and services. The quality improvement approach was successful in manufacturing and business, and therefore was applied to the U.S. healthcare system in hope of similar results.
In the mid-twentieth century, organizations were created in an effort to enforce quality standards in the healthcare industry. In 1951, the ACS, the American College of Physicians, the American Hospital Association, the American Medical Association, and the Canadian Medical Association established what is now known as The Joint Commission or TJC (also formerly known as JCAHO). Originally, this group was focused only on hospitals and was called the Joint Commission on Accreditation of Hospitals (JCAH). This non-profit organization started to provide accreditation for hospitals that met the minimum quality standards.
Congress passed the Social Security Act Amendments in 1965, which allowed hospitals accredited by the original JCAH to receive reimbursement payments for treating Medicare and Medicaid patients. In 1987, the JCAH, which had widened its scope to accredit more than just hospitals, changed its name to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). In 2007, the accreditor shortened its name to simply The Joint Commission, the name which most people use for the organization.
After the establishment of The Joint Commission, other organizations formed to ensure the well-being of healthcare organizations in the United States. In 1970, the National Academies of Science established the Institute of Medicine (IOM), which has become an essential advisor to health regulation and expectations. Almost a decade later, in 1979, the Accreditation Association for Ambulatory Health Care (AAAHC) was established, focusing exclusively on the quality of care received in ambulatory care settings, such as surgical centers and kidney dialysis centers. The Department of Health and Human Services (HHS) recognized the need for accountability and efficiency in healthcare research and overall quality. Therefore, the Agency for Healthcare Research and Quality (AHRQ) was formed in 1989 to ensure safe and effective care in the United States.
Every organization created its own methods of measuring performance. In 1990, the National Committee for Quality Assurance (NCQA) developed what is now known as the Healthcare Effectiveness Data and Information Set (HEDIS), which is widely used by healthcare employees to evaluate the quality of managed care organizations, as well as physician credentialing agencies and physician groups that can include independent physician associations (IPA), physician-hospital organizations (PHO), and management services organizations (MSO).
HEDIS was uniquely created with six primary categories for measuring performance. These categories include access and availability, effectiveness of care, utilization of services, member satisfaction, cost of care, and health plan stability.
In response to the increases in mortality from medical errors and the lack of initiative in addressing flaws in the healthcare system, the IOM published various works. The two most influential were To Err is Human: Building a Safer Health System (1999) and Crossing the Quality Chasm: A New Health System for the 21st Century (2001). As mentioned previously, To Err is Human focused on bringing awareness to the mortality rates from medical errors, specifically errors in medication order entry and administration. Some of its staggering statistics indicated that between 44,000 and 98,000 Americans die annually as a direct or indirect result of medical errors, costing from $17 billion to $29 billion in additional healthcare expenses. The results of medication errors revealed approximately 7,000 deaths annually, which is 1,000 more deaths than workforce injuries.
However, it is important not to fixate solely on inpatient hospital statistics. Errors also occur in an outpatient setting, such as surgery centers, as well as in physician offices and long-term care or nursing home facilities (Schilli, 2007). Every safety and quality inspection organization continues to amend the minimum standards of care as new problems appear in the fight for optimal quality.
During this time, quality healthcare has become a high priority for the government, employers, insurance companies, and healthcare providers, whose work is highly scrutinized and publicized. The Centers for Medicare & Medicaid Services (CMS) began to closely monitor the quality of care delivered to Medicare beneficiaries and thus assured quality healthcare for all Americans through accountability and public disclosure. Most initiatives focused on publicly reporting quality measures for nursing homes, home health agencies, hospitals, and kidney dialysis facilities. Consumers can use the quality measures information that is available on the Official U.S. Government Site for Medicare (http://www.medicare.gov/) for these healthcare settings to assist them in making healthcare choices or decisions.
In 2003, President George W. Bush signed the Medicare Prescription Drug, Improvement, and Modernization Act (the Medicare Modernization Act or MMA), which produced the largest overhaul of Medicare in the public health program’s 38-year history. Medicare Part D, also called the Medicare prescription drug benefit, was established under this law. It provides prescription drug coverage, subsidizing the costs of prescription drugs and prescription drug insurance premiums for Medicare beneficiaries. Individuals on Medicare are eligible for prescription drug coverage under a Part D plan if they are signed up for benefits under Medicare Part A and/or Part B. This improved the overall quality of care because Medicare patients no longer worried about how they would pay for prescription drugs and no longer needed to skip pills or reduce the dosages of their prescription drugs to save money.
The Patient Safety and Quality Improvement Act was enacted in 2005, demonstrating efforts to improve patient safety and quality of care. The act created patient safety organizations (PSOs) to collect and analyze information from voluntary and confidential reporting of events that adversely affected patients. As a result, PSOs came up with measures to eliminate patient safety risks and hazards.
On March 23, 2010, President Barack Obama signed the Patient Protection and Affordable Care Act (PPACA), which primarily expanded health insurance coverage to about 30 million uninsured people in the United States. This insurance expansion covers several areas that include: (1) requiring uninsured individuals to purchase insurance, (2) requiring employers to provide coverage if they have 50 or more employees, (3) expanding Medicaid to a large number of people with certain eligibility conditions, (4) mandating that states establish a health insurance exchange so that individuals and small employers can purchase insurance, and (5) making it illegal to deny health insurance to people with pre-existing conditions.
The PPACA not only increased the scrutiny on healthcare providers and insurance carriers in terms of quality care but also helped these providers and health plans take advantage of economies of scale, or cost advantages, and produce better quality of care through specializations, as well as vertical and horizontal integration (strategies where organizations create or acquire competitors or integrate them under common ownership), which would eventually result in formation of accountable care organizations.
Table 2.1 displays major significant events and laws passed in the twentieth century to improve the quality of care in the United States. After this overview of history, let’s move on to look at quality improvement in healthcare.
Table 2.1: Key dates for quality improvement in healthcare
President Theodore Roosevelt signed the Food and Drug Act, regulations established to protect the consumer. Led to national awareness of the quality of food and drugs that Americans consumed.
Dr. Ernest Codman proposed the measurement of effectiveness of hospital treatments. He was a physician at Massachusetts General Hospital who wanted to track every patient to determine whether the particular treatment was effective.
Onsite inspections of hospitals began. Dr. Codman influenced the founding of the American College of Surgeons, which developed the Minimum Standards for Hospitals. Only 13% of hospitals surveyed met the standard.
The first quality manual was published.
Joseph Juran and W. Edwards Deming became prominent figures in the field of quality management within the healthcare industry. Quality improvement became an official method to assess performance of public and private organization in industry, healthcare, government, and education.
The Joint Commission on Accreditation of Hospitals (JCAH) was established as a non-profit organization to provide accreditation to hospitals that met the minimum quality standards. It later broadened its scope and became the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and today is referred to as The Joint Commission (TJC).
Juran and Deming were invited to Japan, where they influenced the Japanese to embrace total quality concepts.
Congress passed the Social Security Act Amendments, which allowed hospitals accredited by what was known then as JCAH to participate in treating Medicare and Medicaid patients.
Avedis Donabedian, MD, published “Evaluating the Quality of Medical Care,” (2005) which built on the foundation of Juran and Deming and defined quality of healthcare services through three parts: structure, process, and outcome.
The National Academies of Science established the Institute of Medicine (IOM), which is a non-profit scientific advisor to improve the United States’ health.
The Accreditation Association for Ambulatory Health Care (AAAHC) was formed, which assisted ambulatory care organizations in improving the quality of care provided to patients.
The Agency for Healthcare Research and Quality (AHRQ) was created, which is a public health service agency in the Department of Health and Human Services. The purpose of the AHRQ is to improve the quality, safety, efficiency, and effectiveness of healthcare for the United States.
The National Committee for Quality Assurance (NCQA) was given a mandate to offer accreditation programs for managed care organizations. The NCQA utilizes what is now known the Healthcare Effectiveness Data and Information Set (HEDIS) as performance measures to assist employees in analyzing the quality of HMOs.
The Institute of Health Care Improvement (IHI) was founded as a non-profit organization that campaigns for healthcare changes worldwide.
The National Patient Safety Foundation (NPSF) was established to provide more voice for the patient as a consumer.
The Quality Interagency Coordination Task Force (QuIC) was established by a presidential directive to ensure all federal agencies were working toward the common goal of improving quality care.
The IOM published To Err is Human: Building a Safer Health System (1999), based on the magnitude of mortality due to medical errors.
The IOM published Crossing the Quality Chasm: A New Health System for the 21st Century (2001), stating marginal reforms would be inadequate to address the systemic flaws.
JCAHO (now TJC) announced the Shared Vision—New Pathways program that was designed to sharpen the focus of the accreditation process to the safety and quality of patient care.
JCAHO (now TJC) announced the first set of National Patient Safety Goals, which included: Improve the accuracy of patient identification, improve the effectiveness of communication among caregivers, improve the safety of using high-alert medications, eliminate wrong-site, wrong-patient, and wrong-procedure surgery, improve the safety of using infusion pumps, and improve the effectiveness of clinical alarm systems (Duke University Medical Center, 2005).
In the same year, President George W. Bush signed the Medicare Prescription Drug, Improvement, and Modernization Act (the Medicare Modernization Act or MMA), which provided prescription drug coverage to Medicare beneficiaries under Medicare Part D.
The Patient Safety and Quality Improvement Act was enacted, which created patient safety organizations (PSOs) to collect and analyze information from voluntary and confidential reporting of adverse events. As a result, many measures were developed to eliminate patient safety risks and hazards.
President Barack Obama signed the Patient Protection and Affordable Care Act (PPACA), which primarily expanded health insurance coverage to a large number of uninsured people in the United States.
In October, a marketplace was launched in which Americans have broad access to compare and choose the insurance health plan that meets their needs.
By January 1, most Americans were required to have a basic level of health insurance.
Questions to Consider
In your opinion, what three events and dates were the most influential in quality improvement history? Why?
In which time period or decade did the most quality improvement efforts take place? Why do you think this is?
2.2 Quality and Quality Improvement in Healthcare
The quality of a product describes how good or bad it is, such as if the product meets the customer’s needs and is free of errors. Quality improvement (QI) is taking a product or a process and improving upon it. These concepts are easily applied to healthcare. The quality of healthcare describes how good or bad the direct care of a patient is, and quality improvement can mean improving the care a patient receives.
Consumers often base value on the quality and reliability of a good or service. As quality has become an expectation, businesses and organizations have made it a primary objective to continuously improve their services. In the United States’ healthcare system, continuous quality improvement has become a requirement for sustainability and growth. With rising competition, healthcare organizations are continuously trying to understand their strengths and improve areas of weakness or inefficiencies. Probably the most important take-home message is that improving quality in healthcare is critical because patient lives are always at stake. In the next sections, a detailed look at quality, the definition of quality in healthcare, and the approach to quality improvement will be discussed.
Background on Quality
In 1951, as previously mentioned, Joseph Juran, an advocate of quality control and quality management, provided two views of quality. First, quality can identify characteristics of a specific product or service based on its ability to satisfy the needs of customers. An increase in customer satisfaction often correlates with an increase in the use of a service, or an increase in the number of products sold. In this case, higher quality can be revenue generating.
There are several healthcare facilities in the nation that are recognized for their quality of care and services. The Mayo Clinic, Sloan Kettering Center in New York, Johns Hopkins Medical Center in Baltimore, and the Geisinger Health Center in Pennsylvania are known for providing a high quality of care and boast higher success rates with many healthcare procedures and treatments. Simply, patients seek care at these facilities because they receive higher satisfaction or “better results,” providing overall superior quality of care.
Quality can also characterize a product or service that is free of error. When quality products or services lack deficiencies, it allows for less failure and modification. Therefore, high quality products can be perceived as having cost-saving benefits. Viewing quality as a character of having fewer errors or flaws reduces inefficiencies, attracts new customers, and retains existing ones for products and services. The opposite occurs when a product or service has many defects that cost customers more money, time lost for repeat work, or, worse yet, recalls. For instance, a hospital may purchase blood pressure cuffs from a manufacturer that costs three times less than another brand. However, if the blood pressure cuff is 10 times more likely to fail than the more costly brand, then the rational decision is to purchase the more expensive brand because it is cost effective and quality enhancing.
A more dramatic example of this view of quality is related to the Martin Luther King Jr./Drew Medical Center (King/Drew) that had been a champion healthcare provider for Los Angeles’s south side since the 1970s. A series of reports by the Los Angeles Times in the early 2000s showed that King/Drew had provided poor quality of care to patients, including the preventable death of a homeless woman. The December 5, 2004, issue of the Los Angeles Times reported several examples of failures in King/Drew Medical Center that eventually led to its closure in 2007 (Weber, Ornstein & Landsberg, 2004). This is an extreme example of what can happen in a healthcare organization as a result of poor quality. Most hospitals are not shut down. However, all hospital and healthcare organizations are prone to errors and must make the provision of the highest quality of patient care a top priority.
Defining Quality in Healthcare
The IOM has developed a working definition of quality in healthcare. It is defined as the extent to which the healthcare delivered improves the health outcomes of individuals and nations (Institute of Medicine, 2012). This definition incorporates patient satisfaction and benefit. Healthcare quality must be considered a priority so that everyone within the healthcare organization is focused on providing the best care possible. In 2001, the IOM brought public awareness to the importance of patient safety in the United States and produced six aims for improving quality of care. Healthcare must be safe, effective, patient-centered, timely, efficient, and equitable (Institute of Medicine, 2001).
These are similar to the seven ‘pillars of quality’ as set out by the physician Avedis Donabedian, one of the early proponents of quality assurance in healthcare. Donabedian listed seven attributes of healthcare that define its quality, including: 1) efficacy: the ability of care, at its best, to improve health; 2) effectiveness: the degree to which attainable health improvements are realized; 3) efficiency: the ability to obtain the greatest health improvement at the lowest cost; 4) optimality: the most advantageous balancing of costs and benefits; 5) acceptability: conformity to patient preferences regarding accessibility, the patient-practitioner relation, the amenities, the effects of care, and the cost of care; 6) legitimacy: conformity to social preferences concerning all of the above; and 7) equity: fairness in the distribution of care and its effects on health (Donabedian, 1990, p. 1115).
A woman holding a pill capsule between her thumb and index finger.
In some cases, patients preferring to take many prescription drugs harm themselves with the toxicity that results from combining certain medications.
Let’s look at the six aims of healthcare defined by the IOM (Institutes of Medicine, 2012):
Safe care should include minimizing the risk of injury. In many research studies, lower staffing levels are associated with heightened risk of poor patient outcomes, such as higher mortality and complications. For example, nurse-to-patient ratios are critical for better patient outcomes (Shekelle et al., 2013). If nurse-to-patient ratios are too low, patients may receive inadequate care because they are not being attended to as frequently as needed.
Effective care means providing services that are based on scientific knowledge. Healthcare organizations should apply that knowledge to clinical practice; for example, they should prescribe beta-blockers to every elderly heart patient who would benefit from them. Data and information gathered from patients and providers must be truthful and accurate, and that data must remind patients and providers that there is a cost associated with the care and services provided.
It is important to note that more care does not mean more effective or better quality care. Patients with generous health plans prefer more tests, more drugs, and, in some cases, more procedures, but this does not always result in better outcomes. For example, a patient with a virus will receive no benefit from a prescription for antibiotics, since antibiotics can fight bacterial infections but are not useful to treat a virus. In some cases, patients preferring to take many prescription drugs can harm themselves with the toxicity that results from combining certain medications.
Patient-centered care includes understanding patient demographics, promoting patient self-empowerment, and encouraging accountability for the patient’s health. In simple terms, patient-centered care supports the active involvement of patients and their families, particularly when it comes to decisions about individual options for treatment. Patient-centered care promotes active participation, which leads to improved outcomes for patients and providers, given the improved effectiveness of care. For instance, a physician can explain why a patient needs to take an antibiotic being prescribed for bronchitis and that the full prescription must be taken. A patient who does not take medication as prescribed can prolong symptoms, which can lead to more costly office visits.
The IOM report defines patient-centered care as care that is “respectful of and responsive to individual patient preferences, needs, and values,” and ensures that patient values guide all clinical decisions (Institute of Medicine, 2001, p. 6). Care should be customized according to those patient needs and values, responding to individual patients’ choices and preferences. Patients should be the source of control, the IOM report says. Healthcare providers should give patients the necessary information and opportunity to make healthcare decisions that affect them. Systems need to be able to accommodate differences in patient preferences and encourage shared decision making between providers and patients. Patients should have access to their own medical information and to clinical knowledge, with effective communication between clinicians and patients.
For instance, an 81-year-old patient who has been diagnosed with bone cancer in her jaw may decide she does not want possibly disfiguring surgery that will be followed by more reconstructive surgery and intense chemotherapy and radiation. She may decide she wants to live out her life without these medical interventions, asking her physician to keep her as pain free as possible and opting for hospice care at the end of life. After physicians explain the medical options, the patient chooses which care she wants.
Timely care should strive to reduce waiting times and be attentive to the needs of the patient. For instance, when a cancer goes untreated, it can metastasize and cause greater risk and discomfort. Therefore, it is important not to delay treatments and diagnostic efforts as much as possible.
Efficient care should decrease costs, limit the waste of supplies and equipment, and improve future opportunities for better quality care. The IOM report said healthcare organizations should strive to continuously reduce the waste, with the healthcare system not wasting resources or patient time (Institute of Medicine, 2001). For instance, in most cases patients will first seek care for any health problem from their primary care provider’s (PCP) office. For routine healthcare, there may not be a need to seek higher levels of care. By first consulting the PCP, the patient may receive a diagnosis and treatment without seeing a specialist, which can be more costly. Perhaps a patient’s sore knee can be treated with physical therapy or a set of exercises, without the patient seeing an orthopedic surgeon or ordering x-rays or MRIs.
Equitable care should promote equal access to care among various social and ethnic groups. Care should not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, or socioeconomic status, according to the IOM report (2001).
Care should be blind to race, gender, and income to ensure unbiased, equal quality of care. Patients should receive care based on the best available scientific knowledge, which, unless there is a reason for it, should not vary from doctor to doctor or from place or place. Patients covered by private health insurance and those covered by government insurance programs such as Medicaid or Medicare should receive the same quality of care. A woman who suffers a heart attack should receive the same standard of care as a man who does.
Quality Improvement in Healthcare
Quality improvement involves the use of quantitative and qualitative methods to improve processes, systems, and the performance of human resources in delivering products and services. Quantitative methods are strongly based on numerical and statistical data, while qualitative methods focus on the meaning and significance of research observations. Quality improvement has also been defined as a distinct management process by which organizations use a set of tools and techniques to ensure various departments’ commitment to their communities’ health needs, through better service delivery and process improvement (Riley, Moran, Corso, Beitsch, Bialek, & Cofsky, 2010).
The Robert Wood Johnson Foundation and the Centers for Disease Control and Prevention (CDC) support the Accreditation Coalition, a collaborative of the key national organizations supporting accreditation. The coalition is an organization that acknowledges the importance of a uniform definition of QI to ensure the opportunity for quality improvement. In response to this need, a subcommittee was established to create a uniform definition that could be used universally among providers and public health departments.
After researching previous definitions, in 2009 the subcommittee created the following definition of QI: Quality improvement in public health is the use of a specific improvement process that focuses on community needs and improving population health, such as Deming’s Plan-Do-Study-Act (PDSA), in a continuous effort to reach measurable improvements in all quality indicators in services or processes that achieve equity and improve the health of the community (Public Health Quality Improvement Exchange, n.d.). With Deming’s PDSA model, a healthcare organization will plan improvements to address a problem it has uncovered, put actions in place, study how effective the steps were, and act to revise the plan if needed. This particular definition focuses on the application of quality improvement on public and community health while using a specific process, including any of the methods that will be discussed throughout the book.
Although there are slight variations in the exact definition of quality improvement in healthcare, all definitions address the IOM’s six pillars of quality. Simply, the message is that a network of health providers should work to be mindful of their patients, analyze their current methods and processes of care, test and improve their methodologies, and continuously redesign and monitor results to improve performance. While quality improvement often focuses on patient care and safety, it is not limited to direct patient care. Quality improvement has been implemented across many healthcare settings, involving many different areas of the organization. Quality improvement often requires a working partnership between clinicians, managers, and other workers across the healthcare system.
For instance, while quality improvement strategies have long been the domain of patient safety and risk management, the techniques can also help hospital safety officers tackle adverse events. Quality improvement can focus on facilities issues such as preventing fires, electrical outages, water failure, or facility damage—events that not only affect one patient, but everyone in the hospital or healthcare facility. Patient safety officers, risk managers, facility managers, and safety officers are teaming up at some organizations to prevent safety-related adverse events that affect facility management operations, which can most definitely have an adverse effect on patient care.
Quality Improvement Methodologies
Quality improvement methodologies typically focus on a step-wise approach that includes a combination of quantitative and qualitative methods to obtain desired outcomes such as efficiency, effectiveness, performance, and accountability. This systematic approach generally includes the following steps:
Set a goal for performance or quality improvement;
Collect data and analyze current practices;
Revise or completely change current practices; and
Measure outcomes and determine success.
These are commonly shared features among the many quality improvement methodologies currently available. Some of the most common examples used in healthcare are Plan-Do-Study-Act (PDSA) (formerly PDCA; see Chapter 1), Six Sigma, and lean theory. You will find more on Deming’s PDSA in Chapter 5 and more on Six Sigma and lean theory in Chapter 7.
PDSA involves a sequence of four steps that are intended to provide a structured process that is to be continuous, or repeated in successive cycles. This method is covered in great detail in Chapter 5. Six Sigma was developed by the Motorola Company in the 1970s to reduce defects in the production process, aiming for less than 3.4 defective parts per one million opportunities. Lean theory was developed by Toyota and focuses on elimination of waste.
Questions to Consider
How do the six pillars of healthcare quality play a role in today’s quality efforts?
Are delays in treatments and diagnoses considered a quality problem in today’s healthcare system? If so, why? If not, why not?
What are some of the main characteristics of QI? Which do you think are most important?
What do the different QI definitions have in common? What qualities do they promote?
What are the common themes in all quality improvement models?
2.3 Assessing Quality
The healthcare industry has many stakeholders, including patients, purchasers, health plans, regulators, clinicians, and care delivery systems. Improving the overall quality of care in the United States requires that these stakeholders work together to improve patient outcomes. However, it is important to recognize that the pursuit of quality is a continuously moving target and that there is always room for improvement. How the quality of healthcare is assessed is an important question for all stakeholders.
Assessing Healthcare Quality
Quality measures have become a standard for assessing the quality of service at healthcare organizations. Some quality measures collected by CMS include whether healthcare organizations order statin medications for patients with coronary artery disease, monitor patients on the blood thinner Warfarin, or prescribe mood stabilizers for patients with bipolar disorder.
In general, quality measures are used for (1) quality improvement, (2) accountability, and (3) research. Quality improvement within an institution or system of care is called internal quality improvement, while improvement across institutions or systems of care is called external quality improvement. In the internal quality improvement model, healthcare organizations must:
Identify problems or opportunities;
Select proper quality measures;
Obtain current measures of quality indicators as a threshold; and
Re-measure the indicators to determine if there is improvement as a result of quality efforts (National Quality Measures Clearinghouse, 2014).
One movement in healthcare that has coincided with all of these quality improvement efforts is that of patient-centered care, as discussed above. As the name implies, patient-centered care revolves around the patient. In fact, patient-centered care is a core component of healthcare quality recognized by the IOM. Effective care is defined by each patient and his or her satisfaction with that healthcare. Such questions as “What was the patient’s experience with triple bypass surgery [or hip replacement or other aspect of their medical care]?” explore this concept. Good care reflects overall satisfaction or outcome from the viewpoint of the patient. Patient-centered care supports the active involvement of patients and their families in decision-making about treatment options.
If patients are not happy with the care they receive, it’s up to healthcare organizations to improve that experience. For instance, consider a patient who undergoes hip replacement surgery. There is a problem healing from the surgery. An infection is discovered. That patient needs to undergo further surgery to clean out the infection that has occurred. Is it likely that patient will give the surgery center high satisfaction ratings? Can the surgery center take action to reduce infections that occur after the surgery takes place? Or was there a problem with the hip replacement device itself?
Quality measures are used for external quality improvement in programs operated by outside agencies such as the state and federal government, accreditation and quality improvement organizations, and professional organizations. This type of quality improvement model allows healthcare organizations to compare themselves to their competitors and provides incentives for quality improvement to catch up with organizations ahead of them. These organizations frequently collect performance measurement data and report quality performance results among providers of care in a format that allows for their direct comparison.
A doctor writing on a medical chart.
Part of the accreditation process is recording and collecting specific data in order to demonstrate that specific health outcomes (or processes) have been met.
Quality measures are also used for accountability by consumers, health plans and providers, and provider organizations. Using quality measures, individual providers or provider organizations receive certification or recognition to attract additional patients and, in some cases, even obtain bonus payments. For example, the Diabetes Recognition Program is offered by the NCQA to provide clinicians with tools to deliver and recognize high quality care for diabetic patients. The program has 11 measures that cover areas such as blood sugar control, eye examinations, and smoking cessation advice. The NCQA publicly recognizes those organizations that exceed or maintain a composite score above the minimum threshold as achieving program “recognition” for providing high-level diabetes care, which may be highly beneficial for additional financial composition and a competitive edge. The American Diabetes Association also offers an Education Recognition Program that assesses whether applicants meet the National Standards for Diabetes Self Management Education and Support, which can be used in many healthcare settings, from physician offices to health maintenance organizations and outpatient settings.
Lastly, quality measures can be used to produce new knowledge about the healthcare system that is generalizable to a wide range of settings and provides valuable input in setting health policy. Quality-of-care research is often conducted to evaluate programs and assess the effect of policy changes on healthcare quality. Research also allows policymakers and managers to identify best practices in their field or unit of work and test existing practices against best practices.
Structure, Process, and Outcome
In 1966, Avedis Donabedian developed a three-measure framework for assessing quality of care: structure, process, and outcome (Donabedian, 2005). All three measures of quality can be concurrently used to assess quality of the healthcare system. In the next section, each of these will be reviewed.
The National Quality Measures Clearinghouse (NQMC) defines a structure as the platform (or place) for where and how goods and services are produced and delivered (National Quality Measures Clearinghouse, 2014). The structure of an organization or clinician practice includes physical plant, medical supplies and materials, and employees, as well as organizational arrangements, policies, and protocols. These elements are related to the capacity to provide high quality healthcare.
Measuring the environmental structure of the organization is useful to determine the competence of administrative leadership, the quality of the facility and equipment, and the overall structure and flow of operations in the institution (Donabedian, 2005). The Agency for Healthcare Research and Quality (AHRQ) has identified recent measures of structural quality based on the use of health information technology or a hospital specializing in a specific surgical procedure. Structure can also include patient volume.
Most process measures are related to the delivery of medical care by healthcare professionals, who are often guided by evidence-based clinical guidelines and best practices. For example, the percentage of heart attack patients who receive an aspirin prescription on discharge is a process measure based on strong evidence that aspirin can prevent future cardiovascular events. Process measures have many advantages over outcome measures, including being easier and less costly to measure than outcomes and more useful when outcomes of interest are rare or sample sizes are small.
Measuring the healthcare process is an accurate method to gain insight into the appropriateness of care received and the level of performance on services or procedures, and it provides data on the accessibility of care (Donabedian, 2005). For example, therapeutic procedures or diagnostic tests can be monitored and analyzed to detect possible quality barriers before negative health outcomes can occur, as in the measurement of the number of women who use preventative mammography screenings (process) compared to the number of women who develop breast cancer (outcome). Patient outcome is not the major unit of measure for healthcare quality.
The following are common organizational processes:
Customer needs assessment
Monitoring and measuring
Outcome measures are critical to any quality improvement program and may include health states, such as mortality and hospital infection rates; laboratory test results; or patient-reported outcomes, such as functional status and satisfaction scores. Measuring outcomes is essential for evaluating the effectiveness of care, but outcomes are not always easy to interpret because they can be attributed to other factors, such as additional healthcare received by a patient, age, gender, or co-existing conditions (such as diabetes or obesity).
In addition, the type of healthcare services delivered to the patient can be a major determinant of a health outcome. For a heart attack patient, these could include services delivered by emergency medical technicians in the ambulance, emergency room (ER) teams, cardiac catheterization staff, and rehabilitation professionals (Agency for Healthcare Research and Quality, n.d.). Attributing outcomes after a heart attack to specific healthcare services or to specific providers in a context such as this proves challenging. Instead, quality of care can be measured through aspects of care that are directly associated with patient outcomes (Donabedian, 2005). These aspects of care occur through process and structure.
There may be many complications with using outcome data, such as risk adjustments to health outcomes because of other factors, small sample size, and difficulty and cost of collecting outcome data from patients. That is why process measures are used as proxies, or indirect estimates of patients’ health states. For example, hospital readmission rate is considered to be an outcome measure because it reflects a change in health state. In reality, readmissions can occur for many reasons other than the deteriorating health state of the patient. A high readmission rate may be related to a lack of caregivers in the home or the early discharge of the patient.
Let’s look at an example of how the Donabedian model works when it comes to improving the number of children who receive their scheduled vaccinations. The structure in which care is delivered affects processes and outcomes. For instance, if a facility itself is dirty and not a pleasant place to be, patients will not want to come to the office and children will not be immunized. If the wait time for appointments is too long, parents might not keep their children’s appointments. If the physician office has no office hours at night or on weekends, parents may have to miss work to take a well child to see a physician. Rather than lose money out of their paychecks, the parents will forego medical appointments and children will not get scheduled vaccinations.
The outcomes indicate the combined effects of structure and process. Both are readily measured. Is a child up-to-date on vaccinations? Is the waiting room clean? Are staff polite to the patients? Is the physician office accommodating for working parents?
A particular outcome is chosen to measure a particular performance or process. In order to ensure children are immunized, vaccinations are tracked and a reminder system is created that flags children who are not up to date on their immunizations. Low rates imply poor performance and might be due to number of factors: the facility’s appearance, the poor attitude of staff members, or the facility’s limited hours (requiring parents to take time off from work for children’s appointments).
System redesigns, such as offering longer weekday office hours or weekend hours or creating a system to track vaccinations of individual children, will hopefully correct deficiencies and improve quality of care. Continued performance monitoring keeps the quality of care high.
Together, outcome, process, and structure provide a comprehensive platform to assess the overall quality of care provided to patients. Some healthcare examples are provided in Table 2.2.
Table 2.2: Examples of structure-process-outcome measures
Compliance with facility codes
Disease screening (e.g., diabetes)
Cost per procedure, cost per admission, number of outpatient office or ER visits
Heart attack, stroke, adverse events, death
Experiences with care
Partly adapted from the American Medical Association Physician Consortium for Performance Improvement (PCPI). (2011, August). Measures Development, Methodology, and Oversight Advisory Committee: Recommendations to PCPI Work Groups on Outcome Measures. Retrieved from http://www.ama-assn.org/resources/doc/cqi/pcpi-outcome-measures-framework.pdf
Questions to Consider
How does patient-centered care tie into healthcare quality? Why?
Quality measures can be used in different ways. What are some of those ways?
Why is it important to use structure and process in addition to outcomes measures to determine healthcare quality?
How do proxies factor into the measurement of healthcare outcomes?
2.4 Quality and Accreditation
Creating a high quality healthcare organization is a common goal among hospitals and other healthcare organizations. Since the early 1900s, there has been an emphasis on creating the ideal environment to encourage high quality care. As standards began to develop, several third party organizations began serving as regulatory agencies to help set standards, monitor compliance, and provide accreditation. Accreditation is a voluntary process in which healthcare organizations, providers, or programs meet set standards developed by an official agency (Miller-Keane & O’Toole, 2003).
Accrediting organizations in the United States, such as The Joint Commission and National Committee for Quality Assurance, usually conduct surveys and site visits to determine if the organization meets accreditation standards. Those standards have been expanded in recent years to require that healthcare organizations engage in continuous quality improvement to improve their processes. The accreditation process motivates practitioners, administrators, and health system staff to continuously improve their quality of care and promote their organizations as leaders in the healthcare community.
Chapter 3 provides an overview of third party agencies that are responsible for the accreditation of healthcare organizations in the United States. Each agency maintains a minimum set of standards and methods of gathering data on performance, analysis, and reporting. It is not uncommon for significant overlap among agencies, particularly on the minimum standards that must be met for accreditation. In many cases, healthcare organizations must show that they possess enough resources, including manpower and facilities/equipment, to meet the standards. Collecting data, writing reports, and participating in a site visit require significant time and cost investments on the part of the organization and can be barriers to participation in the accreditation process.
Questions to Consider
Why is accreditation important? What are the potential benefits of accreditation for healthcare organizations?
What are some potential risks for healthcare organizations to consider when deciding whether or not to seek accreditation?
Summary & Resources
In healthcare, quality and quality improvement are key. Health reform is already underway, and there is an even greater need to improve the quality of care in healthcare organizations. The understanding of the meaning of quality in healthcare will help in identifying areas that are important to health organizations. While quality is nothing new to the healthcare industry, quality improvement practices have been recently transferred from other industries. Healthcare and these other industries share similar needs, such as customer attraction and retention, safety, reduced operational costs, and so on. Quality improvement efforts are important for the safety of patients and for the viability of health organizations.
As defined by the IOM report, the six goals of quality in healthcare are providing safe, effective, patient-centered, timely, efficient, and equitable care. Quality improvement requires a systematic approach with qualitative and quantitative methods to achieve desired outcomes. Methodologies such as Six Sigma, lean theory, and Plan-Do-Study-Act are the most commonly applied by healthcare facilities to improve the quality of patient care.
In healthcare, quality is often maintained and demonstrated through accreditation. Both quality improvement and accreditation require significant resources and persistent desire to continuously improve the delivery of healthcare through structure, process, and outcomes.
Mini Case Study
William is in his early 40s. He has Type I diabetes and has been a heavy smoker for years, which has resulted in chronic obstructive pulmonary disease (COPD), a progressive disease that makes it hard to breathe. More than a year ago, William lost his job, and now his unemployment has run out. He has been unable to find full-time employment and works odd jobs to support himself. His erratic work schedule prevents him from coming to regular appointments with his primary care physician and the endocrinologist who helps monitor his diabetes. Without medical insurance and a regular income, William has trouble filling all his prescriptions and sometimes does not take the medications his doctors have prescribed.
In the last 24 months, he has come to the same local community hospital’s emergency room a dozen times, and he was admitted twice when his blood sugar dropped to a dangerous level. Each time he comes to the hospital, his condition is a little bit worse. He has begun to have trouble with his eyesight as a result of not taking care of his diabetes and he is showing signs of heart trouble, which could eventually lead to congestive heart failure. Hospital staff fear that if something doesn’t change, William will not live to age 50.
William is also costing the hospital a lot of money. His emergency room visits are expensive and the hospital is not being fully reimbursed.
The hospital’s director of case management is worried about William’s survival, as well as the care of other high-risk people with multiple chronic conditions who frequently come to the facility’s emergency room for treatment. The director and hospital case managers and social workers know the system is not working for these patients, who are at risk for continued emergency room visits, hospital readmissions, and early mortality if an intervention program is not developed.
What situation is taxing the hospital’s resources? What changes could the hospital make to prevent this situation from continuing?
How would William’s family and friends likely feel about this situation in which the system seems unable to help him? How would the public feel about the high cost to their community hospital?
How could the use of hospital case managers and social workers help in this situation?
If you were the director of case management, what steps would you take to help keep this situation from recurring?
At what point is it necessary to make changes to the case management process?
The process through which an organization is recognized for its compliance with the accrediting agency’s standards.
Care whereby services are provided based on scientific knowledge.
Care that ensures high quality while limiting waste and managing costs.
Care that is equally accessible to all social and ethnic groups with equal quality of care delivery.
external quality improvement
Improvement conducted across healthcare organizations.
internal quality improvement
Improvement conducted within a healthcare organization.
A measure of clinical results that are delivered by healthcare organizations. May include health states, such as mortality and hospital infection rates; laboratory test results; or patient-reported outcomes, such as functional status and satisfaction scores.
Care that focuses on patient self-empowerment, accountability, and demographics.
A measure of a series of actions taken by healthcare professionals to deliver their services.
Indirect estimates of patients’ health states.
Research methods that focus on the significance of observations made in a study rather than on the raw numbers themselves.
Tools that help measure or quantify healthcare processes, outcomes, patient perceptions, and organizational structure and/or systems that are associated with the ability to provide high quality healthcare or that relate to quality goals for healthcare.
Research methods that depend on comparing quantities.
Care that focuses on minimizing the risk of injury.
A measure of the capacity to provide high quality healthcare in an organization; includes physical plant, medical supplies and materials, and employees, as well as organizational arrangements, policies, and protocols.
Care that focuses on reducing waiting times and being more attentive to patient needs.
Critical Thinking Questions
How do accreditation programs improve the performance of healthcare systems?
Will quality improvement raise the healthcare cost? Explain your reasoning.
How do medical staff balance between commitment in providing the best course of treatment for a patient and efforts to control costs?
Who benefits from health performance improvement?
In your opinion, which quality measure is the most important in evaluating healthcare quality?
Medical Group Ranking Report:
State-owned source offering California consumers necessary information to make the best health insurance decisions.
National Committee for Quality Assurance (NCQA):
A non-profit organization making efforts to improve healthcare quality through accrediting and certifying a wide range of healthcare organizations.
Malcolm Baldrige Program—National Institute of Standards and Technology:
The Baldrige Program is the nation’s public-private partnership, with a mission to improve the competitiveness and performance of U.S. organizations
The Joint Commission:
An independent, non-profit organization that provides accreditation and certificates to healthcare organizations and programs in the United States.
Centers for Medicare & Medicaid Services:
A federal agency within the U.S. Department of Health and Human Services (HHS) whose mission is to administer Medicare and Medicaid programs, the State Children’s Health Insurance Program, and Health Insurance Portability Standards.