HMGT 420 WEEK 4

CHAPTER

165

QUALITY IMPROVEMENT AND VALUE- DRIVEN CARE

Learning Objectives

Upon completion of this chapter, you should be able to

• enumerate the attributes of a high-quality health delivery system; • explain how improved quality can facilitate value delivery in healthcare; • summarize the role of stakeholders in delivering on the parameters

involved in quality healthcare; • point out the role that the entire continuum of care plays in delivering

value in healthcare; • understand the ways that variability reduces healthcare quality and

prescribe steps to eliminate such variability; • identify factors contributing to errors and harm in healthcare; • propose strategies to improve quality and illustrate the connection

between these strategies and value delivery; and • understand the role of the Choosing Wisely initiative, comparative

effectiveness research, and other programs in promoting better quality, lower costs, and enhanced value.

Value in healthcare delivery can be enhanced by improving the quality of care delivered while keeping the price the same, or by delivering the same quality of care at a lower price. Reports from the Institute of

Medicine (IOM) have noted that a healthcare quality gap exists in the United States, with care often delivered at a quality deemed unacceptable for US society (IOM 2000b, 2001). Society has come to recognize poor-quality healthcare has a very high cost.

As the movement toward value progresses, the demand for improved outcomes is increasing, and cost pressures are rising. If we are to deliver on the promise of value-driven care, quality healthcare must be delivered consistently to all stakeholders, while at the same time reducing cost. The cost-reduction aspect of the equation will be discussed in later chapters. This chapter will describe, in detail, what a high-quality healthcare system can look like. It will

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C o p y r i g h t 2 0 1 8 . H e a l t h A d m i n i s t r a t i o n P r e s s .

A l l r i g h t s r e s e r v e d . M a y n o t b e r e p r o d u c e d i n a n y f o r m w i t h o u t p e r m i s s i o n f r o m t h e p u b l i s h e r , e x c e p t f a i r u s e s p e r m i t t e d u n d e r U . S . o r a p p l i c a b l e c o p y r i g h t l a w .

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The Core Elements of Value in Healthcare166

identify key elements and determinants of quality, and it will further examine the linkage between quality and value.

The Extent of the Problem

The cost of healthcare in the United States is extremely high, but the results of this expenditure have not been impressive. Such findings reflect insufficient value, and poor quality is a key reason.

A 2014 report by the Agency for Healthcare Research and Quality (AHRQ) examined the core healthcare domains of effectiveness, safety, time- liness, patient-centeredness, care coordination, efficiency, and adequacy of system infrastructure; looked at clinical conditions such as cancer, cardiovas- cular disease, and chronic kidney disease; and evaluated measures of structure, process, and outcomes. Among other findings, the report found that only 70 percent of the care recommended in the United States is actually received. It also found that wide variation occurs across the states. Ultimately, the report made clear that the quality of US healthcare had substantial room for improve- ment (AHRQ 2014b).

Various stories in the media have further highlighted the extent of the problem. Incidents involving wrong-site surgeries, retained objects, hospital falls, delays in diagnosis, faulty medication administration, iatrogenic harm, and deaths due to medical errors are frequently reported. According to estimates, between 210,000 and 440,000 patients per year suffer preventable harm in a hospital that contributes to their death (J. T. James 2013). Preventable harm is the third leading cause of death in the United States, after heart disease and cancer (Allen 2013). The total cost of poor quality in healthcare—including lost income, lost household production, disability, and healthcare costs—is estimated to be between $17 billion and $29 billion annually (IOM 2000b; Johnson et al. 1992). A 2011 report suggests that the number of errors might actually be ten times higher than what had been previously reported, and that adverse events might be occurring in as many as one-third of all hospital admissions (Classen et al. 2011).

Most studies estimate harm and errors from voluntary, sentinel event, and never event reporting systems. Sentinel events are instances of unexpected death or serious injury in a healthcare setting, and The Joint Commission has called for such events to be reported since 1995. Never events—shocking medical errors that should never occur—were first identified as a category in 2001 (Patient Safety Primer 2017). Reporting processes may also be mandated at the state level. Some studies have suggested, however, that standard reporting approaches may fail to detect a large number of adverse events (Classen et al. 2011). A more labor-intensive review of records, combined with an assessment

sentinel event An instance of unexpected death or serious injury in a healthcare setting.

never event A shocking medical error that should never occur.

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Chapter 8: Qual i ty Improvement and Value-Driven Care 167

of the risk-adjusted mortality rate in hospitals, may provide a more accurate assessment. The Office of Inspector General (OIG) in the US Department of Health and Human Services has called for the identification of adverse events to be enhanced. The OIG has recommended periodic, ongoing measurements of the incidence of adverse events. It has also urged hospitals to work with patient safety organizations, which are set up to receive event reports and forward the information to a national AHRQ database. The OIG also recommended that the Centers for Medicare & Medicaid Services use present-on-admission indicators (which indicate what conditions were present at the time a patient was admitted) in billing data to calculate the frequency of adverse events within hospitals (Levinson 2010).

In 2010, the OIG reported that 13.5 percent of hospitalized Medicare beneficiaries—about 134,000 per month—experienced adverse events during hospital stays. An additional 13.5 percent of Medicare beneficiaries experi- enced events during hospital stays that resulted in temporary harm requiring intervention but did not cause lasting harm. Of the adverse and temporary harm events, 44 percent were preventable. These events cost Medicare an estimated $324 million in a single month, amounting to almost $4 billion annually (Levinson 2010).

Reasons for Low Quality

A variety of factors are likely contributing to the low level of quality in US healthcare. Medical care is technically complex, and large amounts of new data and studies are generated every year, which can overwhelm practitioners. Medical providers spend years mastering details related to medical care, but their training might not involve exposure to issues related to safety gaps that occur within health systems. Guidelines that are written to reflect best-of-class data can quickly become outdated. The various handoffs that occur between teams taking care of patients can be complex events that introduce opportuni- ties for harm.

Typically, care in the United States is delivered through a patchwork of fragmented systems, the safe navigation of which can be difficult. For instance, consider a patient who has received care at hospitals in different health systems; who receives services from various urgent care centers, primary care physicians, specialists, radiology centers, and laboratories; and who deals with different payers. As this patient traverses the care continuum, gaps in care may occur, and important details may fall through the cracks. As more care is delivered, costs can become burdensome, and burnout, fatigue, and reduced staffing can contribute to errors. Furthermore, transparency in reporting harm and poor quality is low, making accountability a challenge (J. T. James 2013).

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The Core Elements of Value in Healthcare168

Types of Errors John T. James (2013) identifies several types of errors that lead to preventable harm:

• Errors of commission are instances in which harm occurs as a result of a mistaken action. Such errors may also occur when the right action is taken but performed improperly. For instance, a surgeon performing an appropriate vascular surgery might still cause harm by mistakenly puncturing an adjacent organ.

• Errors of omission are instances in which harm occurs because the appropriate treatment was not given. Such an error might occur, for instance, if a beta blocker is not administered to an individual who has suffered a myocardial infarction.

• Errors of communication may involve insufficient exchange of information during patient handoffs or a lack of appropriate advice provided to the patient. For instance, a student athlete with hypertrophic cardiomyopathy could suffer cardiac arrest during intense physical activity if his doctor has failed to advise him against running.

• Errors of context occur when a patient’s unique life constraints are not accounted for. For instance, an impoverished patient with no refrigerator at home might be unable to take insulin for her diabetes because she cannot appropriately store the drug.

• Diagnostic errors may result from inadequate testing, inappropriate testing, or overtesting. Such errors may lead to delays in diagnoses, as well as treatment errors that could be considered errors of commission or omission.

The IOM (2000b) also specifies various types of errors. An error of execution involves the failure of a planned action to be completed as intended. An error of planning occurs when the wrong plan is used to achieve an aim. Errors may also be classified as active or latent. An active error occurs at the front line and may be evident immediately. A medication administration error is an example of an active error. A latent error is removed from the direct control of the operator and may result from faulty design, incorrect installa- tion, poor systems control, or ineffective management decisions. An example of a latent error might be a surgical site infection that occurs because of poor autoclaving techniques linked to budget cuts two years earlier.

Causes of Common Errors Potential sources of error can be evaluated using Perrow’s (1999) model of DEPOSE, which stands for design, equipment, procedures, operators, supplies and materials, and environment. A healthcare system is highly complex and

error of commission An error that involves a mistaken action being taken.

error of omission An error associated with the failure to give an appropri- ate treatment.

error of communication Insufficient exchange of infor- mation or lack of appropriate advice to the patient.

error of context An error that occurs when a patient’s unique life constraints are not accounted for.

diagnostic error An error associated with inadequate testing, inappro- priate testing, or overtesting.

error of execution An error that involves the failure of a planned action to be completed as intended.

error of planning An error that occurs when the wrong plan is used to achieve an aim.

active error An error that occurs at the front line and is often immediately evident.

latent error An error caused by something that is removed from the direct control of the operator.

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Chapter 8: Qual i ty Improvement and Value-Driven Care 169

“tightly coupled”—meaning that processes occur quickly and are not isolated from other processes. In such a system, any of the DEPOSE components can fail, potentially leading to harm or error. Many experts believe that an over- arching concern with safety can mitigate any systems failure and lead to the creation of a high reliability organization. However, due to cascading factors in a complex system such as a healthcare organization, failure at times may be inevitable (Perrow 1999). The assessment of errors can be difficult, particu- larly if hindsight bias—the tendency to review errors retrospectively—causes contributing factors to be overlooked. Further complicating error assessment is the fact that, when harm occurs in healthcare, the actors themselves often are not directly affected. For instance, when a submarine accident occurs, the crew is directly affected; however, when a wrong-site surgery occurs, the team itself is typically not injured (IOM 2000b).

Active errors represent a significant safety threat, but latent errors carry an even greater risk. The detection and reduction of latent failures is likely to have a systemic, positive effect on safety (IOM 2000b). Tightly coupled orga- nizations with time-dependent processes and few buffers to absorb errors are highly prone to failures. For instance, consider a patient who is being monitored in a telemetry unit and being administered two antiarrhythmic drugs simul- taneously in preparation for a cardioversion. The antiarrhythmic drugs keep the patient’s heart rhythm steady. Cardioversion involves sedating the patient and delivering a direct current shock to the chest so that an irregular heart rhythm can be made regular. A patient receiving this treatment might be at risk for receiving an incorrect medication in the wrong dosage. The cardioversion might not deliver the adequate shock, and the telemetry monitor might not be connected correctly, thus not demonstrating the arrhythmia. This scenario is a setup for significant errors. Multiple processes are occurring simultaneously, and errors in one area can lead to errors in another (IOM 2000b).

Conditions for error often occur when a worker has to repeatedly switch from routine work to technically challenging work, when fatigue leads to lapses in concentration, or when repeated tasks are performed as habits with reduced attention to individual steps. Lack of adequate training or support can increase stress and decrease concentration, making errors more likely. Inadequate time or tools for processing data into meaningful information can also increase the risk of error. Finally, some errors may simply result from willful neglect (Reason and Hobbs 2013).

As we gain a better understanding of errors and the conditions that contribute to them, solutions become possible. Simple changes—such as pro- tocols for care delivery, communication algorithms, changes in training, and adjustments to stakeholder authority and accountability—have the potential to improve quality with little increase in cost. Sources of error are discussed further in appendix 6.

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The Core Elements of Value in Healthcare170

Anatomy of Harm Based on the interplay of errors, culture, human factors, organizational struc- ture, and defense mechanisms, Reason and Hobbs (2013) have proposed a model of the factors that contribute to harm in any environment, including healthcare. The model is shown in exhibit 8.1.

At the left side of the model, organizational factors—such as workplace culture; management support for safety and quality; and processes for moni- toring, auditing, budgeting, and communicating—set the stage for negative consequences. They become the latent factors that are put in place long before the actual harm occurs. These latent factors manifest in the workplace conditions and serve as fertile ground for errors and violations. At the individual level, these conditions conspire with people’s behaviors, training, and values to cre- ate unsafe acts. Defenses will prevent some of these unsafe acts from reaching the patient; however, some acts will penetrate through the safety mechanism, especially if weaknesses in the defenses align (Reason and Hobbs 2013).

Latent failure pathway

Organization

• Management decisions • Policies/procedures • Culture

Workplace conditions

• Error-prone • Violation-prone

Individual

• Errors • Violations

D ef

en se

sD ef

en se

s D

ef en

se s

D ef

en se

s Harm

Source: Adapted from Reason and Hobbs (2013, 90).

EXHIBIT 8.1 Factors

Contributing to Patient Harm

Case Example: Error in Organ Transplantation This case example has been adapted from a news report by Comarow (2003).

In 2003, a teenager received a heart and lung transplant at Duke Medical Center in North Carolina. The donor organs had been harvested from a 7-year-old brain-dead child at Children’s Hospital in Boston, Mas- sachusetts. The transplant failed, however, because the blood types of the recipient and the donor did not match. The patient died as a result. Analysis of the incident revealed potential for error across the entire system. The

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Chapter 8: Qual i ty Improvement and Value-Driven Care 171

hospital concluded that it lacked adequate checks and balances that might have prevented the surgeon from proceeding with the surgery.

The United Network for Organ Sharing (UNOS) facilitates the process of matching donors and recipients. A computer database tracks organ donors and recipients and uses an algorithm—incorporating geographic proximity, medical urgency, blood type, and other variables—to match them. In this instance, however, the algorithm did not locate a local recipient for the organs from the child in Boston. When the search range was expanded to 1,000 miles around Boston, a match was found in Durham, North Carolina. The intended match was a different patient at Duke Medical Center, but that patient was deemed too ill to undergo the surgery. The surgeon then asked if the teenager, who was on the organ-donation wait list but not on the list of matches for the child’s organs, could receive the organs instead. The surgeon was on call when he was contacted about the available organs, and he did not have a printout of the wait-listed patients’ blood types at home. The teenager was blood type O, and the donor was type A—a mismatch.

The investigation revealed that it is not unusual for suitable candidates to not appear on the match list, perhaps because of errors in typing the blood group or size. In this case, during the verification process of the recipient, the coordinator had misspelled the patient’s last name and incorrectly identified her blood type as A—which should have been a warning flag. After some effort, the patient’s name was located. However, the blood types were not confirmed, and UNOS policy did not require the confirmation. The UNOS coordinators and the medical center had been working together for a long time without issues; thus, people on both sides were confident that errors were not occurring.

Once the match had been approved and the surgeon notified, the transplant coordinator had to inform the family. The coordinator role is both logistical and clinical, but this coordinator had not yet received extensive training and did not confirm the blood types. Ultimately, confirming the blood types is the transplant surgeon’s responsibility.

The attending surgeon who was supposed to go to Boston to harvest the organs was unavailable, so the transplant resident went instead. The resident had 12 years of postgraduate training but was not yet an attend- ing transplant surgeon. The donor information was labeled with the blood type A. The organs from the donor were harvested, but no one was aware of the recipient’s blood type.

Once the organs were harvested in Boston, they were to be delivered to the recipient. The time that organs are outside a body is ideally kept within four hours, to minimize ischemic injury. However, the plane back to North Carolina was delayed 45 minutes for deicing, and nearly six hours had

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The Core Elements of Value in Healthcare172

Variability in Healthcare Variability in healthcare occurs when processes are not hard-wired and control systems are not in place, and it can have a significant negative impact on qual- ity. Some researchers have maintained that about 30 percent of US healthcare spending is unnecessary, and much of this spending can be attributed to variation (Skinner and Fisher 2010). A certain amount of variation, known as random variation, is based on probability and does not have a root cause. Special cause variation, on the other hand, is based on a specific factor that causes certain occurrences and observations with a high degree of frequency (Joshi et al. 2014). Special cause variation might occur, for instance, if the lack of adequate temperature and humidity controls in the autoclaving process for sterilization of surgical instruments contributes to an increase in surgical site infections. In this example, the source of variation can be identified and eliminated.

Process variation occurs when different diagnostic and therapeutic modalities are used to treat the same medical condition (Joshi et al. 2014). Typically, healthcare professionals adhere to guidelines that have been estab- lished based on the comparative effectiveness of the available options. For example, specific guidelines for the appropriate workup of chest pain may include cardiac computed tomography scanning, stress testing, and cardiac catheterization (Amsterdam et al. 2014). Similarly, screening for colon cancer may include fecal occult blood testing, sigmoidoscopy, and colonoscopy (Levin et al. 2008). Process variation develops from the lack of such guidelines or the failure of practitioners to use them.

Even if research on best practices has been conducted and evidence- based guidelines have been put in place, actual practice may still diverge from best practices and lead to different processes and outcomes (Joshi et al. 2014).

variability Inconsistency stemming from a lack of hardwired processes and control systems.

random variation Variation that is based on probability and does not have a root cause.

special cause variation Variation based on specific, identifiable factors.

process variation Variation that occurs when different diagnostic and therapeutic modalities are used to treat the same medical condition.

passed by the time the organs arrived for the transplant. Still, no one seems to have noticed the blood type mismatch. The organs were transplanted into the recipient, and the teenager developed acute organ rejection. At this point, in the transplant laboratory, another technician noticed that the blood types did not match. The error was identified, but it was too late.

As this unfortunate episode reveals, a variety of factors can contribute to patient harm. In this instance, long-standing policies, training issues, stress, fatigue, familiarity, gaps in policies, and faulty assumptions all came into play as the incorrectly matched organs passed through the defenses and reached the recipient. The likelihood of this type of harm can be mini- mized through systems changes, realignment of policies and processes, and appropriate accountabilities. An understanding of the ways in which errors can occur and a commitment to addressing potential sources of harm can go a long way in making healthcare delivery safer, cheaper, and more effective.

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Chapter 8: Qual i ty Improvement and Value-Driven Care 173

Such performance variation is detrimental to the delivery of quality care. Some performance variation occurs in cases where uncertainty exists about appropriate best practices; however, variation can be observed even in situa- tions where no ambiguity exists.

Unwarranted variation in healthcare delivery often results from one of three conditions: underuse, preference, and supply. Effective care processes that have been validated should be provided to every individual who meets the criteria; underuse occurs when the specified care is not delivered. Prefer- ence often comes into play when more than one generally accepted treatment exists. In such situations, patient preference will often dictate the treatment used. Finally, concerns about supply can lead to variation, particularly if treat- ment is determined by the capacity of a particular health system (Wennberg, 2004, 2011). For instance, a facility with a cardiac catheterization laboratory might be more likely to perform percutaneous interventions, whereas a facil- ity without such a lab might treat ST-elevation myocardial infarctions with thrombolytic agents.

Improving Quality, Eliminating Harm, and Reducing Variability

Greater value can be achieved in healthcare by removing sources of harm and reducing variability. Techniques to achieve these goals may focus on tactics, strategy, comparative effectiveness research, and innovative demonstration projects, and they may incorporate tools such as statistical control, project management, the implementation of guidelines, Six Sigma control, Lean pro- cesses, and quality improvement initiatives. Such efforts may address individual and team factors, workplace factors, or organizational factors.

Addressing Individual and Team Factors Systems and culture are critical elements in improving quality and safety, but individuals are the last line of defense between the patient and harm. The work- force—both individually and collectively—must be committed to increasing value through increased quality and reduced errors.

Worker errors related to excessive reliance on memory can be mitigated through the use of effective protocols and checklists (Gawande 2010). The World Health Organization has supported the use of checklists before surger- ies to reduce variability and preventable harm. Checklists can ensure routine checking for common safety issues, while also supporting better communica- tion and team dynamics, ultimately improving perioperative mortality and morbidity. Studies have revealed that the surgical checklist, when appropriately implemented, can make a significant improvement in patient safety (Walker, Reshamwalla, and Wilson 2012).

performance variation Variation between the actual result of an action and the optimal result.

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The Core Elements of Value in Healthcare174

Errors of omission can be made less likely by minimizing the interrup- tions that occur during critical clinical functions. Ensuring that meetings are not scheduled during clinical rounds in the morning and establishing interruption-free zones in the medication dispensing areas can be helpful. Providing sufficient breaks during shifts, ensuring adequate rest, and controlling the amount of pressure in the workplace can help raise worker vigilance. This vigilance can help identify sources of harm and support an environment conducive to safety (Reason and Hobbs 2013).

Shift work is a fact of industrial life, and thus coordination and safe handoffs will always be top priorities. A handoff occurs whenever the respon- sibility for care is transferred from one caregiver or team to another. Safe handoffs require effective communication devoid of assumptions. Structured communication between the sender and the receiver, adequate time for the communication to take place, and a culture of teamwork and mutual respect can all help ensure safe handoffs (Halm 2013).

Breakdowns in safety processes often occur in ambiguous situations and unfamiliar jobs; however, they also occur in highly routine procedures. The likelihood of such breakdowns can be minimized by properly training all personnel and by empowering personnel, regardless of rank, to stop and ask for clarification when necessary. Constant vigilance during routine procedures is essential. All stakeholders must recognize the importance of seeking help, speaking up when in doubt, exercising caution, and maintaining a constant dedication to safe practices (Reason and Hobbs 2013).

Addressing Workplace Factors Individual and team-based approaches are essential, but they alone are not sufficient. Without a workplace culture and processes dedicated to the elimina- tion of harm, the individual worker is limited in what can be achieved in the safe delivery of care.

Workplaces should have clear and easy-to-understand checklists for the expeditious execution of tasks, as well as effective protocols, developed with worker input, that take into account workflows specific to various units or departments. Fatigue management is also important. Workplaces must comply with labor laws, such as those that limit overtime, to ensure that the workforce is rested for effective functioning (Bae, Brewer, and Kovner 2011). It is well documented that fatigued workers are highly prone to errors (Keers et al. 2013).

Healthcare is a highly technical field, and workplaces must ensure that staff have proper training with the various technologies in use. Equipment may be designed by the producer in a way that is not well understood by the user, who may then use the equipment erroneously. For example, a lock on an intravenous line may be designed to fit a bag of intravenous saline, but the design feature may be such that the lock also fits a bag of enteral feeding. A nurse may erroneously connect the feeding bag to the intravenous line, thus introducing food into the bloodstream, with catastrophic results. Equipment

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Chapter 8: Qual i ty Improvement and Value-Driven Care 175

should be designed with significant input from users, and it should have error- proof features to the extent possible (AHRQ 2007).

Working conditions also play a significant role in safety. If intravenous poles, pharmacy stations, and anesthesia carts are carelessly maintained, such poor housekeeping might be indicative of organizational malaise or ineffective managerial leadership. Management must set proper workforce expectations and facilitate safe, swift, and effective operations, while at the same time avoiding the error of micromanagement. Furthermore, personnel must be provided the appropriate tools for their work (Hughes 2008). For example, electronic medical records systems should facilitate appropriate documentation and effective care. However, if systems are too onerous, personnel may engage in workarounds that lead to frustration and carelessness (Hughes 2008).

Addressing Organizational Factors An organization that has a culture of safety is driven to respect operational hazards, continually learns from past events, and is committed to avoiding catastrophic errors. The organization should also provide a just culture, where all employees feel comfortable reporting misses and near misses that could have led to patient harm (Boysen 2013). People throughout the organization should have trust in senior leadership that such reporting will be encouraged.

An organization with an informed culture uses root cause analysis (RCA) to better understand errors, their causes, and ways the errors can be avoided (Hughes 2008). The formalized techniques of an RCA can thoroughly inves- tigate the underlying causes of an event and also evaluate potential events that were intercepted. Reactive and proactive analyses help the organization avoid catastrophic errors.

Although the majority of errors are honest mistakes, a small minority result from the willful neglect of established procedures by certain individuals. A just culture holds everyone accountable; in some instances, this accountability may require that personnel not be allowed to remain with the organization. However, the departments responsible for quality should be separate from the departments that deal with disciplinary actions; such an arrangement helps promote a just, learning, and reporting culture (Boysen 2013).

just culture An organizational approach that respects truth, integrity, and transparency so that workers feel safe reporting errors and harm.

root cause analysis (RCA) A formalized approach to evaluating the cause of a breakdown in a process.

Case Example: Evaluation of Falls in a Nursing Facility The transitional care unit (TCU) of a local healthcare facility is responsible for the post-acute care of patients who were being discharged from area hospitals but were too sick to be sent home, and who did not necessarily need long-term supervised nursing facility admissions. Over a three-month period, the TCU noticed a sharp increase in the number of falls by residents.

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The Core Elements of Value in Healthcare176

To ensure a just culture, an organization should use four tests to deter- mine the necessary actions when a worker’s actions lead to patient harm:

• The deliberate harm test. In this test, the supervisor determines whether harm was intended (Boysen 2013). If a worker’s actions were intended to inflict harm, disciplinary and regulatory action must be taken.

• The incapacity test. If no intentional harm has been detected, the supervisor determines whether the worker was incapacitated due to sickness or substance abuse (Boysen 2013). The supervisor finds out if the worker was aware of his condition and its implications and if he took steps to protect the patient.

These findings were reported at the health system’s quality assurance (QA) committee meeting of the board of directors (BOD). The rate of falls had increased to three times the annual average rate. Of note, the organization had a goal of achieving zero falls over a 12-month period.

The BOD instructed the manager of the TCU to work with the QA committee to determine the reason for the increase in falls. A formal root cause analysis was then undertaken. Initially, several potential sources of falls were identified. They included slippery floors, high beds, poor lighting, overmedication of patients, call lights that were inaccessible to patients, and staffing concerns. Closer analysis revealed that all the falls had occurred during shift changes. Thus, staffing was determined to be the key issue.

Four months before the spike in falls, the organization had under- taken major layoffs to cut costs. As a result, the number of nursing aides had been reduced. Now, there were no staff members in the patient rooms during shift changes, when the nurses were signing off to the incoming staff in the nursing stations. This staffing had previously been provided by the nursing aides.

The organization’s just culture enabled the staff to speak freely about the impact of the staffing shortage. At the same time, the staff understood the financial pressures facing the organization. All the stakeholders dis- cussed ways to address the issue of patient falls, and they determined that shift-change handoffs could easily be conducted closer to the patient rooms, so that staff could continue monitoring the patients. By making this change, work could be completed more effectively at the end of a shift, incoming staff could have a better idea about the status of patients, and frail patients could be more effectively monitored during shift changes.

The intervention led to an immediate drop in patient falls, which led to an organization-wide change in the way shift changes are conducted. Out- going and incoming teams now conduct sign-out rounds by patient rooms.

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Chapter 8: Qual i ty Improvement and Value-Driven Care 177

• The foresight test. The supervisor next determines if the worker knowingly engaged in behavior that an average worker would associate with a heightened risk of error (Boysen 2013). Such behavior would often involve a protocol violation. If the protocol is reasonable, the cause of the violation should be explored. The more control the worker has, the more likely the violation is to be egregious. However, in an emergency, a violation may be acceptable. If an existing protocol makes the job difficult, the violation may reflect a systems issue.

• The substitution test. In a hypothetical scenario, the supervisor asks whether another reasonable person would have acted differently (Boysen 2013). If not, it is likely that systems issues exist (Reason and Hobbs 2013; Meadows, Baker, and Butler 2005).

Consider, for instance, the process that might be undertaken by a nursing home’s performance improvement department as it evaluates a wrong medi- cation administration. The nursing leadership first identifies the stakeholders and maps out the processes in which the error occurred. Everyone involved in the handling of the medication is assessed, including members of the procure- ment department, the pharmacy, and the nursing team. Administration of the first test establishes that nobody acted deliberately with the intention to cause harm. The second test determines that none of the individuals involved were ill or under the influence of a medication or substance at the time of the error. The third test indicates that all protocols were followed appropriately. Finally, a substitution test determines that other reasonable people would have acted in the same manner. Further evaluation reveals that the medication that was incorrectly administered was packaged similarly to the correct one. Evaluation also reveals that the medication was administered just before a shift change. In light of these findings, the nursing department creates a protocol in collabora- tion with the pharmacy to make packaging more distinctive. It also decides that, to the extent that timing can be adjusted, medication administration will occur a certain amount of time before or after a shift change.

Training Initiatives and the Choosing Wisely Campaign A variety of studies and articles have noted that patients often receive unneces- sary treatments, imaging, and other care that simply increases costs and often increases the risk of patient harm (Marcus 2015; Span 2015). Such findings highlight the need for providers to be educated about value-based approaches to the delivery of care (Wolfson, Santa, and Slass 2014). If such knowledge is given to providers early in their careers and reinforced during training, positive outcomes can be sustainable.

In assessing the clinical environments in which trainees learn, a number of reviews have revealed a lack of resident trainee engagement in the systems- based practice of medicine. To address this concern, the Accreditation Council

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The Core Elements of Value in Healthcare178

for Graduate Medical Education (ACGME) initiated the Clinical Learning Environment Review (CLER) program (ACGME 2014). The ACGME deter- mined that meaningful improvement required collaboration between graduate medical education leadership and the executive leadership and governance of teaching hospitals. Silos would need to be broken, and trainees would need to be involved in safety and quality improvement systems within the context of patient care (Nasca, Weiss, and Bagian 2014). Failure to do so would result in a lost opportunity to train a generation of doctors in the science and art of sustainable systems-based improvements.

Healthcare delivery is fundamentally based on the efforts of profession- als, and these professionals must understand how their knowledge and practice can enhance value. What begins early in training must be sustained during the years of clinical practice. For value to be maximized, a focus on systems-based care and performance improvement must be supplemented with a focus on resource stewardship. Governments have attempted cost control with price regulation and utilization management. The role that physicians should play in controlling healthcare costs has been a subject of controversy, but if clini- cians can be successful stewards of resources, external efforts to control costs can be mitigated. Effective financial stewardship can reduce costs and increase access, ultimately supporting population health and the delivery of value (Ubel and Jagsi 2014).

This emphasis gained support as studies in primary care identified com- mon clinical activities that could lead to better care while using finite clinical resources. Furthermore, an analysis of common procedures that do not neces- sarily result in improved outcomes revealed excess expenditures of billions of dollars (Kale et al. 2011). Such procedures could include routine laboratory studies, antibiotic use for children with pharyngitis, use of brand-name statins, imaging for back pain, cough medicines for children, Pap tests for patients younger than 21 years of age, head injury imaging for children, and DEXA (dual X-ray absorptiometry) scans for younger patients.

The American Board of Internal Medicine (ABIM) Foundation has spon- sored the Choosing Wisely campaign to encourage physicians to avoid interven- tions that might be unnecessary and are potentially harmful (ABIM Foundation 2014). Recognizing the need to eliminate waste in care delivery, healthcare provider organizations in the United States have developed lists of “Things Providers and Patients Should Question,” which incorporate guidance on the timing and nature of appropriate tests and procedures. The ABIM Foundation presents these lists as evidence-based recommendations that can help provid- ers make decisions in specific situations, with the aim of reducing the overuse of medical tests and procedures of dubious value (ABIM Foundation 2014).

The recommendations in the Choosing Wisely lists have been developed by the involved specialties. For example, the American College of Cardiology includes

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Chapter 8: Qual i ty Improvement and Value-Driven Care 179

the following recommendation on its list: “Don’t perform echocardiography as routine follow-up for mild, asymptomatic native valve disease in adult patients with no change in signs or symptoms” (ABIM Foundation 2014). The recom- mendation explains that, because patients with native valve disease usually have no symptoms for years before clinical deterioration starts, an echocardiogram can be deferred unless a clinical change occurs. To arrive at this recommendation, the American College of Cardiology evaluated its existing appropriate use criteria (AUC) and identified clinical practices that had the highest inappropriateness score. Similarly, the American College of Chest Physicians provides a recommendation against excessive computed tomography surveillance of indeterminate pulmonary nodules in low-risk patients. This recommendation is based on studies suggesting that intensive surveillance does not lead to improved outcomes in such cases.

The Choosing Wisely campaign acknowledges that unnecessary testing occurs and can be reduced, and it builds on a growing consensus in the medi- cal profession that physicians have a responsibility to protect patients from such low-value exposure. The initiative supports an organizational approach to providing physicians with the intellectual framework and infrastructure necessary to counsel patients away from unnecessary interventions. As such, it represents another arrow in the expanding quiver of value-based healthcare.

Comparative Effectiveness A key concern in the US healthcare delivery system is the variability that occurs in the treatment of diseases. The same disease might be treated differently from one region to another, or from one provider to another (Wennberg 2011). Healthcare is a highly technical and scientific field, and innovation is essential (Kovner et al. 2011). Continued innovation leads to multiple modalities and medication options being available for various diseases; however, these differ- ent treatment options are not always equally efficacious. Further complicating matters is the fact that certain treatments may be more effective than others but also significantly more expensive, raising questions of whether the treatments are justified at such a high cost.

The US population has traditionally been skeptical of attempts to control access to care, regardless of the care’s effectiveness or cost (Martin 2010). How- ever, growing amounts of data indicate that choice is not necessarily translating into better care or outcomes. As the movement toward value-based care has progressed, and as laws such as the American Recovery and Reinvestment Act (ARRA) and the Affordable Care Act (ACA) have been passed, comparative effectiveness research (CER) has taken on greater importance. The Institute of Medicine (IOM) has defined CER as “the generation and synthesis of evi- dence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care” (Sox et al. 2009, 1).

appropriate use criteria (AUC) Guidelines that indicate when a procedure can be appropriately used, based on research, consensus, or standard of care.

comparative effectiveness research (CER) Efforts to compare the results of different health delivery options available to patients; CER enables consumers to assess treatment modalities and choose the one that delivers the most value.

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The Core Elements of Value in Healthcare180

Medicare and Medicaid are the predominant funding sources for US healthcare, so the Centers for Medicare & Medicaid Services has both leverage and interest in ensuring that diverse treatment options have been compared and that the most clinically effective and cost-effective options are provided to patients. Achievement of this aim requires easily accessible, high-quality research, as well as a central mechanism by which to evaluate information to make recommendations.

Professional medical societies often evaluate the research literature to issue best-practice recommendations. For example, the Heart Rhythm Society has assessed the research and made recommendations about the appropriate- ness of high-cost devices such as implantable cardioverter defibrillators based on clinical scenarios and the life expectancy of the patient (Russo et al. 2013). These recommendations have partially satisfied the need for evidence-based practitioner guidance to eliminate variability in practice. However, such recom- mendations are not binding on the physicians or the payers.

The United Kingdom has extensive experience with CER. The National Institute for Health and Care Excellence (NICE), based in the National Health Service (NHS), has the mandate to evaluate research and to support practices that increase innovation and value in the British healthcare system (Chalki- dou 2009). NICE’s policies are geared toward improving health outcomes and social care, reducing practice variation, and disseminating information about the effectiveness of emerging technologies. The institute’s standards provide the basis for NHS reimbursement (Chalkidou 2009). NICE (2017) aims to help practitioners deliver the best possible care, provide people the most effective care based on the latest evidence, provide value for money, and reduce inequalities and variation. Healthcare professionals and organizations are expected to consider NICE’s guidance when caring for patients, though the institute’s policies are not intended to supersede clinical autonomy. NICE does not license drugs or devices, but it evaluates drugs and devices when uncertainty exists about their value or when their use varies across the United Kingdom. It sets national standards, replaces local recommendations, and promotes standardization.

In the United States, CER is becoming more widely used and accepted, and a number of groups are expected to play important roles. In a survey of business coalitions, insurers, researchers, employers, and trade groups, 91 per- cent of respondents believed that CER would represent a slight to substantial improvement in healthcare decision making (National Pharmaceutical Council 2012). The respondents indicated that the key groups involved would be the Agency for Healthcare Research and Quality (AHRQ), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Patient- Centered Outcomes Research Institute (PCORI), academia, health plans, and the pharmaceutical industry.

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Chapter 8: Qual i ty Improvement and Value-Driven Care 181

The same stakeholder survey identified a series of key issues to be addressed in the use of CER (National Pharmaceutical Council 2012):

• Availability of new research methods • Availability of agreed-upon research standards • Research priorities that adequately address treatment choices faced by

patients and providers • Use of objective and transparent processes for interpreting evidence • Predictability of adoption and diffusion of medical treatments and

technologies • Exchange of medical evidence across payers, providers, industries, and

agencies • Consideration of quality, outcomes, and value in treatment assessments • Development of outcomes-based contracting

With the passage of ARRA in 2009, Congress appropriated $1.1 billion to accelerate the use of CER in the United States. An IOM committee stated that CER should assist consumers, clinicians, purchasers, and policy makers to make informed decisions to improve care at the individual and population levels (Sox et al. 2009). The committee concluded that a sustainable national CER program would require coordination of private and public strategies accountable to the public. The IOM also recommended 100 research areas to be given priority for funding.

The ACA established PCORI in 2010, and its mandate is to improve the quality and relevance of evidence available to assist patients, healthcare providers, employers, payers, and policy makers in making informed health decisions (Fleurence et al. 2013). It both funds CER and supports efforts to improve the methods used to conduct it (PCORI 2017). By 2014, PCORI had invested more than $464 million for large, pragmatic studies comparing outcomes between two or more approaches to addressing high-priority clinical issues in real-world settings. The organization also incorporates input from stakeholders such as patients and their caregivers (Selby 2014).

Effective use of CER requires a public–private partnership with an infra- structure to support randomized trials and data networks to enable observa- tional studies of patient care. The workforce will need expertise in biostatistics, epidemiology, systematic reviews, observational and clinical trials, and refined research techniques for CER. The information gathered will need to be dis- seminated and adopted into clinical practice (Sox et al. 2009).

Money can be saved—and value increased—through CER if research findings support less expensive treatments, as long as those treatments are as effective as the more costly treatments. CER may also contribute value if

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The Core Elements of Value in Healthcare182

research supports the use of more expensive modalities that lead to better outcomes (Grutters et al. 2015). However, value can be enhanced through CER only if the results are used and adopted by the medical community (Kai- ser Family Foundation 2009b). Such use is gaining traction as reimbursement increasingly becomes tied to quality and outcomes (J. James 2012). The United States is unlikely to adopt explicit CER-based restrictions on access to care, like those in the United Kingdom, but alternative solutions will likely incorporate well-conducted CER in minimizing unnecessary expenses (Sorenson, Drum- mond, and Chalkidou 2012).

At the turn of the twenty-first century, the IOM (2000b) wrote that national discussion and action were needed to create a culture of safety; to implement mandatory reporting systems to support learning from errors; to strengthen the work of oversight organizations, purchasers, and professional groups; and to build systems within healthcare organizations to ensure safe practices at the delivery level (IOM 2000b). Surveys such as the Healthcare Effectiveness Data and Information Set (HEDIS) and the Consumer Assess- ment of Healthcare Providers and Systems (CAHPS) have sought to provide comparative quality data to support these aims. Such efforts have raised aware- ness of the need to compare health delivery options and pursue an iterative strategy to improve upon the knowledge gained.

Summary

The current state of quality in US healthcare leaves significant room for improve- ment, and the large share of national expenditures dedicated to healthcare is unsustainable over the long term. Improved value requires better quality at the same cost, the same quality at a lower cost, or better quality at a lower cost. Of these options, the third—increasing quality while also lowering cost—is the most desirable.

This chapter has explored the quality side of the healthcare value equa- tion. It has examined the quality deficiencies in US healthcare, identified several sources of harm and error, and considered the ways in which harm can sometimes bypass a system’s safety mechanisms. It has emphasized the negative impact that variability can have on quality, and it has demonstrated how such variability can be prevented. The chapter has discussed safety and quality measures at various levels, including training programs, the Choosing Wisely initiative, and comparative effectiveness research. The chapter has also considered some of the theoretical underpinnings of the quality movement.

Growing public awareness about quality and safety concerns in US healthcare has provided a solid impetus for improvement efforts. Such efforts have drawn significantly from the learnings of other industries. Any effective

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Chapter 8: Qual i ty Improvement and Value-Driven Care 183

approach to improving healthcare quality and eliminating harm must address all parts of the anatomy of harm, whether at the individual, workplace, or organizational level. Only when these factors are appropriately managed can harm be eliminated and quality improved. Thus, a multipronged, multifaceted, multidisciplinary approach is necessary.

Discussion Questions

1. What should a high-quality healthcare delivery system look like? Does the US system meet that standard? What elements of the current system reflect high quality? What elements reflect lower quality?

2. What are some of the main causes of low quality in the US healthcare delivery system?

3. How can improved quality lead to enhanced value in healthcare? Can value still be enhanced if the cost of delivering higher-quality care increases?

4. Is the current state of quality in US healthcare acceptable? Is the current cost of such healthcare acceptable?

5. Why does variability in healthcare delivery lead to a decrease in the quality of care delivered?

6. How can variability in healthcare delivery be minimized? Can such variability be completely eliminated?

7. What is a just culture? Why is it important in driving quality in healthcare?

8. What is comparative effectiveness research? How can it lead to improved quality?

9. Describe the Choosing Wisely campaign. Who started it, and why? Has the campaign achieved its goals?

10. What changes can training programs implement to ensure that value delivery in healthcare becomes sustainable?

11. Consider the following case: Vista Health is a community clinic in Arizona. It serves more than 1 million residents in four counties through its network of satellite sites, physician offices, a home health agency, two acute care hospitals, and a nursing home. Vista Health’s board is concerned about the quality of care being delivered. You are the chief quality officer.

Members of Vista Health’s medical staff have expressed a desire to become more data driven and evidence based in their delivery of care. Presently, however, significant variability exists. For instance, in one recent study, the clinic noticed inconsistencies in the use of blood

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The Core Elements of Value in Healthcare184

transfusions for patients with varying hemoglobin levels. A patient with a hemoglobin level of 7 g/dL with the same clinical presentation could be just as likely to be transfused as a patient with a hemoglobin level of 10 g/dL.

You have been asked to lead the initiative to streamline and stan- dardize the care being delivered at Vista Health. You have decided to focus on the issue of blood transfusions. a. Determine whether the blood transfusion issue represents a quality

challenge. Identify best practices, guidelines, and the evidence base that exists to guide optimal treatment with blood transfusions. Determine whether variance from the guidelines exists at Vista Health and whether any such variance reduces the quality of care being delivered.

b. Your team determines that significant variance from the guidelines and best practices is occurring at Vista Health. What challenges might you face in motivating the health system to follow the guidelines related to blood transfusion? Consider potential resistance from the medical and nursing staff, as well as from the community. Are there any legal concerns?

c. Enumerate the advantages of adhering to the evidence base and best practices related to blood transfusions. Explain how following the guidelines can improve quality, reduce cost, and deliver value.

d. Develop a strategy to communicate the need to change blood transfusion practices at Vista Health. Convey the nature and extent of the problem; its impact on quality, cost, and value; and possible solutions.

e. Some members of the medical staff argue that the guidelines erode professional autonomy. How will you overcome this resistance?

f. Devise a dashboard that will track the progress being made and share that progress with Vista Health.

g. Compose a four-page memo to the board that articulates the issue, its cause, its effects, and the strategy that will be used to address it.

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CHAPTER

185

TOOLS FOR IMPROVING QUALITY AND SAFETY

Learning Objectives

Upon completion of this chapter, you should be able to

• identify and describe the various tools available to facilitate quality and safety in healthcare;

• understand the key principles of Six Sigma and Lean; • explain why these tools are necessary for delivering value; • discuss cases in which such tools have been effectively deployed; • effectively employ these tools within a performance improvement (PI)

or quality improvement (QI) program at a health system; and • demonstrate the link between PI/QI tools and programs and a culture

of safety.

A s noted in the previous chapter, quality shortcomings in US healthcare have been well documented (Institute of Medicine 2000b; Casalino et al. 2016). Routine safety processes often fail, and preventable adverse

events—such as wrong-site surgery, hospital-acquired infections, medication errors, and retained objects during surgeries—occur with alarming frequency (Garrouste-Orgeas et al. 2012; de Vries et al. 2008). In response to these and other concerns, the movement toward value-based healthcare places a height- ened emphasis on quality, reliability, and accountability.

Increasingly, healthcare organizations are focusing on operational effec- tiveness as a means for improving quality while reducing costs—and thereby enhancing value. In particular, methodologies such as Six Sigma and Lean are helping organizations improve their processes while creating a culture of personal accountability, teamwork, open communication, trust, and zero patient harm. Six Sigma and Lean incorporate lessons from other industries and entities—such as airlines, nuclear power plants, amusement parks, and zoos—that have little room for error (Hughes 2008). Applied to healthcare, these approaches can provide durable solutions with the potential to transform patient care, produce sustainable improvement, and eliminate patient harm.

Six Sigma A process improvement framework that focuses on the elimination of error; it takes a statistical approach to imposing controls around a mean so that variability is reduced.

Lean An approach to quality and performance improvement, developed in other industries but adopted in healthcare, that focuses on the elimination of waste in processes.

9

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