HMGT 420 WEEK 5

CHAPTER

207

ACCREDITATION AND HIGH RELIABILITY

Learning Objectives

Upon completion of this chapter, you should be able to

• discuss the use of accreditation for healthcare organizations, • identify the processes involved in a successful accreditation, • state the reasons for the development of accreditation, • evaluate whether accreditation has served its purpose, • describe the options available for accreditation bodies, • assess whether accreditation facilitates the delivery of value in

healthcare, • propose ways to strengthen the value proposition of accreditation, • explain the connection between accreditation and organizations with

reliable processes and resiliency, • appraise the underpinnings of error and harm in an organization, and • summarize the techniques that can be used to build high reliability.

A n organization’s pursuit of quality, safety, and improved patient outcomes depends in large part on its adoption of standardized, evidence-based processes. Such processes are complex and demanding, and organiza-

tions must expend significant organizational energy and resources to implement and sustain them. Organizational commitment is crucial, although the level of this commitment may vary from one entity to another. The concept of accredi- tation plays a key role in encouraging organizations to support and adhere to such processes. Accreditation can help foster a culture of high reliability, in which effective care is delivered with minimal breakdown in safety or quality, thus enhancing value.

Accreditation

Accreditation is a process in which healthcare organizations participate in an evaluation by an independent organization, or accreditation body, to

accreditation A process in which healthcare organizations participate in an evaluation by an independent organization to demonstrate their ability to meet predetermined criteria and standards.

10

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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 Healthcare208

demonstrate their ability to meet predetermined criteria and standards. Accredi- tation bodies are delegated by payers and regulators to audit organizations to ensure compliance with efforts that promote safety, quality, and better outcomes. Accreditation provides for a systematic evaluation of healthcare services and a regulatory peer review of an organization’s reliability (Grepperud 2014). Given the complexity of healthcare organizations’ processes, accredita- tion requirements must be clearly defined, and the evaluation must proceed in formalized steps to ensure that all necessary actions have been taken.

The accreditation process has been driven in part by market forces and regulatory demands. With the growing competition in the healthcare market- place, organizations will often pursue accreditation to receive a stamp of quality that they can use for branding purposes. Whether accreditation results in safety, quality, and better outcomes—and thus enhanced value in healthcare—has been a subject of debate (Brubakk et al. 2015). One potential drawback is that the complexity of the accreditation process adds to operating costs, which can negatively affect value. However, the support for accreditation is strong, and the trend is spreading internationally. Over time, accreditation bodies have evolved from purely evaluative entities to more consultative partners, with a thorough understanding of how and why organizations can fail in delivering value. As a result, organizations are increasingly using the knowledge gained through the accreditation process to improve their reliability.

The terms accreditation and certification are related but not synonymous. Certification is a voluntary process in which an individual or organization is evaluated by an independent body and granted a time-limited recognition of compliance with certain predetermined and standardized criteria. Accreditation is used to verify that an organization has the appropriate quality management system in place to perform certain tasks.

The Accreditation Process Medicare is the largest payer for healthcare in the United States, and as such it largely determines the course of major actions in the field. To participate in Medicare or Medicaid, a healthcare organization must meet certain govern- ment requirements, including a certification of compliance with Conditions of Participation developed by the Centers for Medicare & Medicaid Services (CMS). Such a certification may be achieved through a survey by Medicare or Medicaid directly or by third-party accrediting bodies that have been given deemed status to survey healthcare facilities (Government Publishing Office 2003a). Such accreditation entities have demonstrated to CMS that their standards and survey methodology meet regulatory requirements.1 A list of CMS-approved accreditation programs is provided in exhibit 10.1.

An accreditation program evaluates processes and outcomes to ensure that organizations meet specific requirements. The process involves a review

certification A voluntary process in which an individual or organization is evaluated by an independent body and granted a time-limited recognition of compliance with certain predetermined and standardized criteria.

deemed status The status held by an accrediting body that is authorized to evaluate an organization on behalf of a government agency.

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Chapter 10: Accreditat ion and High Rel iabi l i ty 209

of documents, policies and procedures, metrics, and publicly available data, in addition to on-site surveys. The surveys are often extensive events that assess an organization across multiple dimensions. The Joint Commission survey of hospitals, for instance, has a number of requirements for accreditation, as shown in exhibit 10.2. Accreditation helps provide a framework to assist in the creation and implementation of systems and processes that improve operational effectiveness and outcomes (Joint Commission 2017b).

Assessment of Accreditation Accreditation can offer many benefits for healthcare organizations, but it also has drawbacks and challenges, many of which are related to cost. The cost of accredi- tation for a facility can be onerous (Mumford et al. 2013). In addition, some have questioned whether accreditation actually improves outcomes for patients.

Organization Program Type

Accreditation Association for Ambulatory Health Care (AAAHC)

Ambulatory surgical center

Accreditation Commission for Health Care (ACHC) Home health agency Hospice

American Association for Accreditation of Ambula- tory Surgery Facilities (AAAASF)

Ambulatory surgery center Rural health center

Center for Improvement in Healthcare Quality (CIHQ)

Hospital

Community Health Accreditation Program (CHAP) Home health agency Hospice

The Compliance Team (TCT) Rural health center

Det Norske Veritas Healthcare (DNV Healthcare) Hospital Critical access hospital

Healthcare Facilities Accreditation Program (HFAP)

Ambulatory surgery center Critical access hospital Hospital

Institute for Medical Quality (IMQ) Ambulatory surgery center

The Joint Commission (TJC) Ambulatory surgery center Critical access hospital Home health agency Hospice Hospital Psychiatric hospital

Source: Adapted from CMS (2017d).

EXHIBIT 10.1 CMS-Approved Accreditation Programs

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The Core Elements of Value in Healthcare210

1. Accreditation Participation Requirements (APR)

Submission of information to The Joint Commission, acceptance of a survey, sharing results of external evaluations, reporting of safety and quality concerns

2. Environment of Care (EC)

Promotion of a safe, functional, and supportive environment within the hospital to preserve safety and quality

3. Emergency Management (EM)

Planning for potential emergencies, creation of an emergency opera- tions plan (EOP), testing through drills

4. Human Resources (HR) Management of human resources so that safe and quality care can be provided

5. Infection Control and Prevention (IC)

Activities to establish and operate an effective infection prevention and control program

6. Information Management (IM)

The ability to accurately capture health information generated with each episode of care

7. Leadership (LD) Leadership that fosters a safety culture, with competent staff and resources available for providing care

8. Life Safety (LS) General life safety design and building construction geared toward a safe physical environment

9. Medication Management (MM)

A medication management program that addresses planning, selec- tion, procurement, storage, ordering, preparation, dispensing, admin- istration, monitoring, and evaluation; systems to reduce variability; use of evidence-based protocols; safety

10. Medical Staff (MS) Existence of an organized, self-governing medical staff that oversees the quality of care, treatment, and services

11. National Patient Safety Goals (NPSG)

Adherence to patient safety goals such as accurate patient identifica- tion, effective communication among caregivers, improved safety of medications, reduced harm associated with clinical alarm systems, reduced risk of healthcare-associated infections, reduced risk of patient falls, prevention of healthcare-associated pressure ulcers, identification of safety risks in patient population, use of universal protocol including time-out before surgery

12. Nursing (NR) Leadership role of the nurse executive and the work of qualified staff

13. Provision of Care, Treat- ment, and Services (PC)

The process of evaluating patient needs; planning care, treatment, and services; providing care, treatment, and services; and coordinat- ing across the continuum of care

14. Performance Improvement (PI)

Use of data to improve processes and outcomes

15. Record of Care, Treat- ment, and Services (RC)

Adherence to documentation requirements for medical records related to patient care

16. Rights and Responsibilities of the Individual (RI)

Compliance with directions to recognize and respect patient rights related to effective communication, informed consent, right to partici- pate in end-of-life decisions, and patient rights and responsibilities

17. Transplant Safety (TS) Development and implementation of policies and procedures for safe organ and tissue donation, procurement, and transplantation

18. Waived Testing (WT) Adherence to standards for the growing number of waived testing methods, addressing the risk to patient safety and quality of care when waived testing is performed improperly

Source: Adapted from Joint Commission (2015).

EXHIBIT 10.2 Joint

Commission Requirements

for Hospital Accreditation

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Chapter 10: Accreditat ion and High Rel iabi l i ty 211

Case Example: The Joint Commission Accreditation of a Health System—Site Visit Citrus Valley Health Partners (CVHP) is accredited by The Joint Commission, and the system therefore undergoes a site survey by accreditors every three years. During this site visit, which typically spans three days, examiners evaluate all aspects of the organization’s processes and operations to ensure compliance with regulatory requirements. The examiners also ensure that the organization achieves benchmarks related to patient safety and quality care.

During a recent accreditation survey, three examiners presented to the CVHP hospitals with Joint Commission credentials. The site visit started on a Wednesday and was planned to go through Friday. Once the examiners’ credentials were validated, the management team across the system mobi- lized to meet with the accreditation team. The CVHP executive team, senior management, and the chiefs of the medical staff met the examiners at a kickoff meeting. The Joint Commission’s team included a nurse reviewer, who oversaw the team’s activities; a building examiner, who would work with the facilities department to evaluate the physical site; and a medical reviewer. The medical reviewer was a practicing physician responsible for evaluating activities related to peer review, patient care by physicians, credentialing, and quality assurance. The nurse leader was also responsible for conduct- ing tracers, in which real patients would be followed through their entire hospitalization and all processes related to their care would be evaluated.

Once the initial interview was completed, the CVHP team received the agenda for the three-day visit, and the examiners set specific appointments with leaders of the various departments. The Joint Commission team was provided a conference room that would serve as its base station. The room had computer access and internet connectivity, and it was to remain secured at all times for the visiting team. Two staff members from CVHP’s performance improvement team stayed with the visiting team to take notes and assist with coordination.

In implementing the tracer methodology, the leader of the examina- tion team selected a patient from that day’s operating room (OR) schedule. The patient was scheduled to undergo a cholecystectomy, or removal of the gallbladder. After introducing herself to the clinical team and the patient, the lead examiner reviewed the medical chart to make sure that an appropriate record was present. She also reviewed the informed consent for adequacy. She closely observed such aspects as hand-washing during care, electronic record keeping, sterile technique in prepping the patient, instrument layout in the OR, negative air pressure when entering the OR, and use of a time-out before the start of surgery.2 She made note of whether drugs were marked correctly, and whether the appropriate team was present.

peer review A system for the review of professional activity; for instance, a committee of physicians might review another physician’s clinical care of patients, outcomes, and competency.

tracer A practice, commonly used in accreditation, in which a patient is followed through an entire episode of care and all processes related to that patient’s care are evaluated.

(continued)

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The Core Elements of Value in Healthcare212

Once the surgery was completed, the leader of the examination team followed the patient to the postanesthesia care unit (PACU). During the patient’s recovery phase, the examiner met with staff members to gain insight into staffing, medication storage and access, and the monitoring of the patient. Once the patient was awake and taken to the surgical floor, the examiner evaluated handoffs between the teams caring for the patient. She also observed the use of alarms in the patient monitoring system, efforts to control pain and infection, and the steps taken to prevent patient falls.

The medical reviewer met with the medical staff leadership to discuss peer review. He sought to make sure that the review process followed CVHP’s reported policies and was fair, transparent, responsive, and thorough. He evaluated the credentialing process and made sure that physicians were credentialed within the stipulated time frame. He reviewed the ways in which physicians who might have been sanctioned by the medical board or other agencies were identified and then monitored; such monitoring is necessary to ensure that providers excluded by regulatory agencies are being appropri- ately addressed. The examiner also reviewed minutes from the committees on pharmacy and therapeutics, peer review, credentialing, performance improve- ment, and quality assurance. He made note of items that could be improved.

The building inspector met with the facilities team and toured the entire campus. He evaluated the air conditioning system, the room where instruments were sterilized, the elevators, bathroom access, the location of call bells for patients, the water supply, the negative air pressure, and the medical gas delivery infrastructure. He measured the temperature at which the autoclave instrument operated to determine adequacy of sterilization. He also measured the temperature inside refrigerators. He reviewed tem- perature logs picked at random to determine whether records were being maintained and whether quality assurance metrics were being met.

The examination team interviewed frontline staff, supervisors, man- agers, and the executive team. They evaluated employee files in the human resources department to ensure that labor laws were being followed and that certifications were current. The team assessed CVHP’s commitment to employee development and the degree to which the organization’s culture made staff feel empowered to speak up.

Over the course of the three-day site visit and more than 60 hours of cumulative review, The Joint Commission team evaluated CVHP across all the elements shown in exhibit 10.2. During an exit interview, the team summarized its findings. It identified best practices at CVHP, as well as practices that needed improvement, and it advised CVHP leadership about changes that could be beneficial for the organization.

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Chapter 10: Accreditat ion and High Rel iabi l i ty 213

Several of the measures that are evaluated by accreditation bodies are related to processes and not necessarily to outcomes (Hinchcliff et al. 2012; Nicklin 2013).

Another issue with accreditation involves the question of whether a third party can ever truly appreciate the many operational intricacies of an organiza- tion. Additional questions may arise concerning bias and subjectivity, given that the accrediting body includes professionals from the same industry as the facilities that are being accredited (Joshi et al. 2014). Evaluation of the factors that lead to outcomes can be further complicated by inconsistent application of the accreditation criteria or by the inherent limitations of the survey system (Brubakk et al. 2015). For instance, one might think, if only hand-washing and appropriate antibiotics are necessary to reduce postsurgical infections, then what accounts for continued infections at an accredited facility?

The accreditation of an organization is supposed to reflect the achieve- ment of a basic threshold of competence; however, the process might not be well suited to assess different organizations in their individual areas of expertise. Because the accreditation process covers such a broad scope, consumers may have difficulty determining whether accreditation actually reflects quality related to a particular disease state. For example, accreditation for an organization as a whole does not necessarily indicate that the organization is a center of excellence for a specific disease state. To address this concern, some accreditation bodies, including The Joint Commission, have initiated disease-specific accreditation for such areas as congestive heart failure and stroke (Joint Commission 2017c).

Despite its shortcomings, accreditation tends to be valued by healthcare organizations, payers, and consumers, and it seems to have a positive impact on quality. One study found that hospitals that were accredited by The Joint Commission tended to outperform nonaccredited hospitals on publicly reported quality measures early in the reporting period. The differences became even more pronounced over five years of observation (Schmaltz et al. 2011). In addition to ensuring that organizations possess a basic level of competence, accreditation can also help ensure that organizations align their operational strategy with their mission and vision (Joint Commission 2017a).

The tracer methodology can help an organization identify weaknesses in its operations and processes. Some organizations use the tracer methodology

The CVHP team then was informed that it had passed the survey, and the system was given accreditation for another three years. CVHP had to perform some remediation in certain areas, and it was given a stipulated amount of time (45 days) to mitigate the issues and to provide evidence of the mitigation. Once these matters were resolved, CVHP received its accreditation certificate.

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The Core Elements of Value in Healthcare214

themselves in preparation for a survey by an accrediting body. In such instances, hospital employees follow a patient through the entire experience of care to ensure that all the aspects of competence assessed by accrediting bodies are functioning appropriately. If an organization commits to being ready for an accreditation survey at any given time, it is likely to maintain an operational status that benefits the organization, its patients, and other stakeholders (Joint Commission 2017a).

Given the constant changes taking place within healthcare, accreditation processes need to continually evolve to remain relevant. Accreditation pro- cesses cannot simply focus on a single entity or disease state; rather, they need to consider the entire continuum of care. As healthcare organizations break through their silo mentalities, accreditation bodies need to adjust accordingly. Recognizing the importance of the full care continuum, accreditation bodies have begun measuring the effectiveness of transitions. An effective transition incorporates leadership support, multidisciplinary collaboration, early identifica- tion of at-risk patients, transitional planning, medication management, patient and family engagement, and information transfer (Joint Commission 2013).

The National Committee for Quality Assurance (NCQA) now provides accreditation to health plans, disease management programs, case manage- ment programs, and accountable care organizations (ACOs) (NCQA 2017a; Robeznieks 2012). The Joint Commission provides post-acute care accredita- tion for nursing care, rehabilitation programs, long-term care, and home health programs. Such accreditation seems to be an important predictor of nursing home quality (Williams et al. 2017). When accreditation is associated with better delivery of value, consumers will be more inclined to select accredited post-acute care facilities, and payers will be more willing to enter into competi- tive contracts with such providers.

In one example, a 49-bed skilled nursing facility called Chaparral House, in Berkeley, California, sought accreditation to gain leverage in contracting and to become a more desirable provider among stakeholders. The facility underwent a successful accreditation with The Joint Commission and found that the pro- cess helped it to streamline policies and procedures, measure and quantify best practices, and align practices with regulations in a way that third-party payers, referring physicians, and local discharge planners could appreciate (Page 2015).

Accreditation bodies possess a deep knowledge base of systems, processes, and outcomes, and they can leverage this information to make organizations more effective in care delivery. By committing to being “survey ready,” an organization can hard-wire processes that are effective and on target, thereby improving outcomes. Where problems exist, an iterative evaluation can help identify improvements that have a direct positive impact on results. These improvements can then be publicized and replicated. An incremental process of continuous improvement helps organizations improve quality and reduce waste, enabling them to reliably deliver value.

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Chapter 10: Accreditat ion and High Rel iabi l i ty 215

High Reliability Organizations

Reliability is essential for the delivery of value, and accrediting bodies have played a key role in popularizing the idea of the high reliability organization (HRO) with regard to healthcare. An HRO delivers effective care with mini- mal breakdown in safety, constantly reevaluating its processes and examining potential causes of failure. It has an organizational culture that emphasizes the development of expertise, and it considers that expertise more valuable in given situations than one’s position in the hierarchy. An HRO demonstrates consistency, which helps eliminate errors, waste, and poor outcomes.

The concept of the HRO originated in the manufacturing industry and has been commonly associated with such settings as nuclear power plants and aircraft carriers (Tolk, Cantu, and Beruvides 2015). Because those environments tend to be unforgiving and fertile for disaster, safety and reliability are of the utmost importance. Learning from one’s mistakes is not a viable option when the consequence of error is so severe (Weick and Sutcliffe 2007).

An HRO is able to avoid preventable harm in a complex environment where risk is present (Chassin and Loeb 2011). Given the complexity and risk inherent in healthcare, the HRO concept is a natural fit.

Features of High Reliability The principles of high reliability focus on achieving consistency and eliminat- ing variation. Organizations seeking to become HROs need to engage in five key processes: tracking failure, avoiding simplification, maintaining sensitivity to operations, being capable of resilience, and leveraging the loci of expertise (Weick and Sutcliffe 2007). The first three processes focus on anticipation, whereas the latter two focus on containment.

Tracking Failure In an HRO, lapses are regarded as symptoms of inadequate processes. Even small lapses can have severe consequences, particularly if multiple lapses coincide. The “Swiss cheese” model of harm compares safety systems to slices of Swiss cheese, each with its own holes: When small issues coincide and the flaws align, a major harm can reach a patient. Reminiscent of the old adage “A stitch in time saves nine,” an HRO strives to capture small failures early on, before those failures can contribute to bigger failures. This approach requires vigilance, because failures are more difficult to detect when they are small in their early stages.

This approach also places great importance on the reporting of failure. When the reporting of errors is encouraged and rewarded, a climate of open- ness develops, and the organization’s knowledge base expands. People become more likely to report errors, discuss them, learn from them, and work to correct them, and the organization gains greater insight into its systems. Research has

high reliability organization (HRO) An organization that delivers effective care with minimal breakdown in safety; an HRO constantly reevaluates its processes, examines potential causes of failure, and emphasizes the development of expertise.

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The Core Elements of Value in Healthcare216

found that nursing units in which individuals are encouraged to speak up are better able to detect errors leading to adverse drug events (Edmondson 1999).

Avoiding Simplification An HRO acknowledges that the world is complex, unstable, and mysterious, and it resists the urge to simplify its problems. Simplifying a problem often has the effect of limiting the insights that can be gained from a situation. For instance, the diagnostic value of early warning signals of impending failure gets lost when, for simplification purposes, the signals are lumped together in crude, broad categories (Roberts 1989).

Maintaining Sensitivity to Operations Although strategy is important to an organization’s growth, operational effec- tiveness is a fundamental requirement. Thus, HROs pay close attention to the front line, where the actual work product is created. A well-developed situ- ational awareness in the workplace can help prevent errors from accumulating and causing harm. In one example, medical personnel at an organization were questioning why needle stick injuries had increased, and they found that a trash can had been placed beneath the syringe bucket. The trash can was moved, and the needle sticks stopped (Weick and Sutcliffe 2007).

HROs pay heed to both quantitative and qualitative knowledge, and they treat close calls as process breakdowns that connote potential danger. For instance, when administration of medication to the wrong patient is detected, the close call is treated as a learning opportunity. The organization might then investigate whether patients are not being identified by unique identifiers, or whether automated dispensing of medication might reduce error rates.

Being Capable of Resilience A resilient HRO is able to recover rapidly from a mistake and resolve its issues creatively. The capabilities for recovery, containment, fresh thinking, and cre- ativity allow the organization to be dynamic yet also stable in the face of a mishap. Resilience can be threatened by the fallacy of predetermination, in which organizations develop plans in advance and are lulled into believing that events will unfold in a certain manner. Reliance on predetermined plans can preclude important planning needed at critical junctures of an ongoing situa- tion (Mintzberg 1994). Advance planning and anticipatory skills are important, but planners cannot possibly predict all future events and create policies for addressing them. Thus, organizations must be capable of adaptable reactions, with well-established ways of sensing the developments of a situation. The ability to sense unexpected events in a stable manner while dealing with those events in a variable manner is a hallmark of an HRO (Weick and Sutcliffe 2007).

The National Transportation Safety Board (NTSB) demonstrates resil- ience in the way it responds to events, adapts its approach, and deepens its

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Chapter 10: Accreditat ion and High Rel iabi l i ty 217

understanding based on experience. Within the transportation field, the types of possible accidents are numerous, and the opportunities for accidents to occur are complex and unpredictable. Nonetheless, the NTSB employs a stable approach to studying events, learning from them, disseminating information, and deepening its fund of knowledge about possible mechanisms for mishaps (NTSB 2014).

Another example of a resilient organization is the Centers for Disease Control and Prevention (CDC). Although the organization has a robust sur- veillance system to detect emerging disease patterns, it often is unable to do anything about the first cases of an outbreak. However, when that initial event does occur, the CDC works to detect the outbreak rapidly, deploy resources to contain it, gather knowledge and information, and make sense of emerg- ing patterns. Being able to recognize an emerging pattern and take action to mitigate it is just as important as preparing in advance for its occurrence. The CDC has shown the ability to bounce back after mishaps to achieve operational stability, while also treating each event as a learning opportunity to deepen its understanding and readiness.

Leveraging the Loci of Expertise Because harm is either introduced or prevented based on actions at the front line, HROs empower frontline workers to make meaningful decisions. This practice prevents small errors made at the top of a hierarchy from being com- pounded at lower levels. Effectively, within an HRO, people with the relevant expertise have the authority, regardless of their rank. If the workforce is com- mitted and has been enabled, it will stop harm before it occurs. At Toyota’s automobile plants, for instance, anyone at the assembly line has the ability to stop the production if that individual detects or suspects a defect (Weick and Sutcliffe 2007). Similarly, in a hospital operating room, any worker, regardless of rank, should be able to stop the start of a surgery if a wrong-site surgery is suspected. This capability encourages people on the front lines to speak up. Often, these people might not even realize that their observations have criticality.

An HRO makes clear that people who possess knowledge about a situa- tion are regarded as experts and will be treated as such. In turn, more individuals share their knowledge, and the organization becomes increasingly reliable. At the same time, an HRO also recognizes the limits of knowledge and accepts that workers will sometimes need to seek help. Decision-making capability migrates two ways, both up and down the hierarchy (Christianson et al. 2011).

An HRO adapts to complex situations, avoids problems, anticipates challenges, leverages intrinsic strengths, and learns from mistakes. It strives to continually improve and hard-wire operational gains, while also maintain- ing flexibility to adapt to new situations. When an organization successfully embraces the principles of high reliability, harm is avoided, quality improves, and costs are reduced.

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The Core Elements of Value in Healthcare218

Assessing an Organization’s Readiness for High Reliability Organizations should strive for high reliability, and they should also develop the ability to distinguish other entities that deliver high reliability from those that do not. The accurate identification of highly reliable entities positions

Case Example: The Ebola Response from the Centers for Disease Control and Prevention From 2014 to 2016, a severe outbreak of the Ebola virus occurred in West Africa. A few smaller outbreaks also occurred in the United States and other countries. The scale of the epidemic was unprecedented for a variety of reasons, including the wide geographic spread of cases, the slow response from the international community, the high degree of population mobility, the poor public health infrastructure in Africa, and local unfamiliarity with the illness. Nearly 30,000 cases were reported, with more than 11,000 deaths (Bell et al. 2016).

The Centers for Disease Control and Prevention is the US government agency responsible for the surveillance and control of infectious diseases. Its response during the Ebola epidemic was the largest in the agency’s history. Nearly 4,000 CDC staff members—including specialists in epidemiology, infection control, laboratory analysis, medical care, emergency management, information technology, health communication, logistics, anthropology, and other disciplines—participated directly in the response (Bell et al. 2016).

In September 2014, the Ebola virus was introduced into the United States through an infected traveler, who succumbed to the illness. Two nurses caring for the traveler also were infected, but they recovered. The country quickly went on high alert. The CDC had gained experience with the virus in West Africa during the 1970s, and it had maintained a presence there. The agency had also accumulated extensive knowledge from Ebola experts, laboratory scientists, and other professionals to gain a thorough understanding of the threat the virus posed. The CDC anticipated the chal- lenge and developed widespread but targeted control measures. It boosted testing capability, case management, contact tracing, early treatment with supportive care, and social mobilization (Bell et al. 2016). The CDC’s strategy effectively prevented the spread of the disease in the United States.

The CDC also learned from the limitations in its knowledge and was therefore able to identify ways to better combat viruses in the future. Look- ing ahead, the agency emphasized the importance of building capacity, in-country presence, field work, technical expertise, and partnerships with other country health departments and international organizations (Bell et al. 2016).

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Chapter 10: Accreditat ion and High Rel iabi l i ty 219

organizations to maximize their delivery of value. The key organizational characteristics associated with high reliability are discussed in this section.

Mindfulness over Mindlessness Mindfulness involves awareness of details and attention to issues that are rel- evant to failure (Coutu 2003). An HRO pays heed to the principles of both anticipation and containment. When people become more conscious about potential disruption, mindfulness increases (Hales and Chakravorty 2016). In the previous case example, the CDC demonstrated mindfulness by acknowl- edging susceptibility to future unknown events. Numerous professionals felt accountable for reliability, and they appreciated that surveillance is fraught with the risk of missing detection. Employees had a shared understanding of what they should monitor, expect, and fear.

An HRO should also have a culture that moves away from mindless- ness. In the Ebola case example, CDC personnel were not following protocols unquestioningly. They were constantly reevaluating protocols, questioning strategies as events unfolded, and adapting to emerging issues. Various experts across diverse disciplines collaborated to solve a crisis (Bell et al. 2016). Local surveillance teams had the authority to analyze the data and come to conclu- sions that were actionable.

Interactive Coupling and Nonlinearity An HRO understands interactive coupling and nonlinearity, and it appreci- ates the domino effect that can occur between events. When various activities affect one another with little time lapse or without linearity, anticipation and adaptation can be challenging. A highly reliable entity has the ability to act effectively in such circumstances.

In the Ebola case example, the CDC understood that an upstream event, such as poor viral containment or international travel, could have the downstream effect of the introduction of the Ebola virus 5,000 miles away (Mirkovic, Thwing, and Diack 2014). The CDC remained mindful, mapped out potential outcomes to stay ahead of the problem, and was alert to issues that could spiral out of control (Sagan 1993).

Interactive coupling can be seen clearly in a hospital’s intensive care unit (ICU). A patient in the ICU might be connected to a ventilator and have several intravenous drugs injected, all while on dialysis. At any given time, any of the patient’s organs might fail, or a mechanical device such as the ventilator or dialysis machine might fail. If such failure occurs, the staff might be left with little time to resuscitate the patient. Furthermore, the patient’s complete clini- cal scenario might be unknown. In this situation, the ICU might not be able to anticipate every issue, but it should be ready to identify, as early as possible, the issues that have the potential to spiral into a wide variety of outcomes.

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Vigilance for Failure An HRO is always vigilant about failure. With regard to high reliability, failure can be defined as any inability to detect a lapse. If an unintended medication is given to a patient, an HRO would consider the event to be a failure even if no harm resulted. Near misses and sentinel events can provide early insight into a looming problem with potentially significant effects. The Joint Commission therefore advises that such events be treated as failures in processes (Chang et al. 2005). Doing so will lead to an evaluation of the system breakdown and the implementation of corrective actions to prevent bigger breakdowns in the future.

Consider the following scenario. A hospital patient had a fast and irregu- lar heartbeat and was to be administered a medication called Cardizem. The physician ordered the medication on the computerized order entry system, and the pharmacy prepared the intravenous form of the drug. The pharmacist used the bar-coding system to create a label, the label was placed on the preparation, and the medication was delivered to the unit. The nurse administered the drug and, promptly, the patient’s blood pressure dropped precipitously. The medi- cation was immediately stopped. An investigation of the incident determined that the label for Cardizem had been applied to a solution bag for Nicardip- ine (Cardene), a medication to control blood pressure. The error occurred when the pharmacist was preparing to label the drug and was interrupted by a phone call from the surgery theater; upon return, the pharmacist accidentally picked up the wrong medication and attached the label. Furthermore, when the medication reached the unit, the nurse administered the drug without checking the labeling on the original bag; she simply checked the bar-coded label. By assuming the infallibility of the system due to the use of computerized order entry and bar coding, the organization had been predisposed to failure. The patient was subsequently given the correct medication and discharged without harm. Nonetheless, the event should be considered a failure, as well as a learning experience.

An HRO takes near misses seriously, and it regards them as processes that failed and need to be improved and strengthened (Van Spall, Kassam, and Tollefson 2015). In doing so, the HRO can address troubling breakdowns before they become catastrophic, hard-wire measures to preclude recurrence, and reinforce the importance of vigilance and confirmation. Individuals who identify breakdowns and report the bad news should be encouraged and applauded for taking action to strengthen the organization (Morrison 2014).

Realistic Appreciation for Organizational Complexity Having an oversimplified understanding of processes can lead an organiza- tion to have blind spots and a false sense of security; thus, an HRO maintains a realistic appreciation for organizational complexity. It seeks diverse opin- ions, frequently reviews processes, conducts job rotations, and hires outside

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Chapter 10: Accreditat ion and High Rel iabi l i ty 221

experience. Personnel willing to buck the party line and ask probing questions should be welcomed into the organization (Coutu 2003).

An HRO acknowledges that complicated processes exist in healthcare and that key elements can potentially be overlooked, with catastrophic conse- quences. Such acknowledgment is reflected in the widespread use of checklists to prevent against errors. Checklists can serve as valuable cognitive aids in the setup for surgery and in the direction of basic workflow; such aids can free up capacity for more intricate surgical consideration (Thomassen et al. 2011).

Sensitivity to Operations An HRO demonstrates situational awareness and an appreciation for the big picture. People in the organization cultivate an understanding of the current state of the work relative to the organization’s condition; they also appreciate how the current state can support or threaten safety (Weick and Sutcliffe 2007). An HRO is committed to operational effectiveness, flexibility, and excellence. It encourages and assists staff to act on small problems and make frequent adjust- ments to mitigate potential disasters down the road. In such an organization, various levels of responsibility interact with one another frequently. Leadership is accessible to the frontline staff during a crisis, managers help with operations, and frontline staff have the discretion to resolve problems without seeking approval.

For instance, imagine an HRO that is committed to minimizing unnec- essary blood transfusions. It has developed a protocol, incorporating the evi- dence base, to ensure that certain criteria are met before a transfusion occurs. The frontline staff is empowered to make independent decisions, to evaluate orders for transfusion against the criteria, and to seek clarification on unclear orders. Managers are easily accessible in the clinical wards. If a senior physician mistakenly orders a blood transfusion for a patient before surgery, the staff assesses the order. If the protocol has not been followed, and if there are no extenuating circumstances, the nurse for the patient brings the issue to the physician’s attention. The physician is thankful for the interruption, since she had erroneously ordered the blood based on an incorrect lab value in the office.

Commitment to Organizational Resilience Even if a mindful organization is adept at anticipating issues and resolving them quickly, processes, inevitably, will nonetheless fail at times. When such situations arise, the organization must be able to survive, learn from the incident, improve on its processes, and subsequently thrive. These abilities are key to the organization’s resilience. An organization committed to resilience tends to apply knowledge in new and novel ways to resolve issues (Gawande 2012); it also devotes resources to train staff to apply their knowledge in such ways (Weick and Sutcliffe 2007). A resilient organization encourages staff to face complexity and uncertainty by using their judgment and to accept responsibility for the results of their actions.

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Deference to Expertise An HRO demonstrates flexibility when coping with stressors. During a crisis, the organization should be able to adapt its power structure, decision-making dynamics, and operational patterns (Weick and Sutcliffe 2007). In such a situ- ation, hierarchy is less important than expertise and experience. The people who are most capable of solving a problem handle it until resolution.

People within an HRO respect one another’s jobs, roles, and respon- sibilities, and decision-making authority may migrate to lower levels of the organization if the relevant expertise is available. Similarly, decision-making capacity must also be able to travel up the hierarchy if necessary. In these situ- ations, trust is an important ingredient. Research has shown that nursing units are more likely to report medication errors up the hierarchy when staff have trust in their managers (Vogus and Sutcliffe 2007).

Deference to expertise was a key feature of the CDC’s Ebola response, as described in the case example earlier in the chapter. During that crisis, hierarchy became largely irrelevant as professionals from various disciplines addressed the situation from their specific areas of expertise.

Case Example: High Reliability at Memorial Hermann Memorial Hermann, a health system based in Houston, Texas, provides an example of an organization that set out on a journey to improve processes, create a safety culture, and achieve high reliability. This case has been adapted from Shabot and colleagues (2013) and from a presentation by A. C. France (2014).

In August 2006, Memorial Hermann experienced 11 transfusion errors, with four fatalities. In response to these incidents and other concerns, the organization created a task force with representation from all the system’s hospitals and divisions. The organization sought to address its problems through system-based and local policies and procedures, and a sense of urgency was conveyed to frontline staff, leadership, and the board. The board committed to providing leadership for high-reliability, safety, and quality initiatives, and it provided financial support toward these aims. The board also ensured that senior management and incentives were aligned with high reliability and quality outcomes (Shabot et al. 2013).

A diagnostic assessment of the organization’s readiness revealed gaps in communication, critical thinking, knowledge, attention to task, and compliance. Extensive safety culture training covered such areas as expec- tations for behavior, reinforcement of behavior aligned with patient safety, attention to detail, the importance of clear communication, the need for a questioning attitude, training around best practices, and mutual support.

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This safety culture training cost $18 million, and the effort permeated the entire organization (Shabot et al. 2013). Certain team members became patient safety coaches, who were trained to observe employee work behav- iors and provide feedback regarding compliance with safety programs. The coaches acted as role models to promote behaviors to protect patients from harm.

Research has suggested that six seconds of contemplation before undertaking an activity can lead to a reduction in error probability of as much as 90 percent (White et al. 2010). Staff were therefore trained to contemplate on a process or action before executing. In addition, the rounding process was revamped to better connect frontline staff, patients, and physicians. The organization stressed that activities fundamental to patient safety needed to be performed consistently; thus, compliance was necessary and non- negotiable on such steps as patient identification safeguards,3 time-outs, and two-provider checks prior to high-risk activity such as a blood transfu- sion. Analysis indicated that such rules could have prevented a majority of the system’s prior errors (Shabot et al. 2013). The organization sought to ensure a just culture through the use of such tools as the deliberate harm test, the incapacity test, the foresight test, and the substitution test—all of which were discussed in chapter 8 (France 2014).

Memorial Hermann sought to identify and categorize incidents using a standardized taxonomy. According to the taxonomy, a good catch is a pro- cess breakdown in which the problem is identified and addressed before it hurts the patient. When good catches are celebrated as successes, employ- ees are encouraged to speak up in the future. A close call is a potentially adverse event not related to the patient’s illness or condition that could have caused significant harm but does not. A serious safety event is an actual adverse event that is not related to the patient’s illness or condition and that causes significant harm (Sadeghi et al. 2013). Events in the system were collected and analyzed, and a system risk and patient safety review committee looked at the completed investigations and root cause analysis reports (France 2014).

Evaluation of a safety failure involves asking the question of why a particular action made sense at the time it was committed. Using an indi- vidual failure mode analysis, the investigating team was able to consider the expectations placed on the staff, as well as the staff’s understanding of those expectations (Shabot et al. 2013). For instance, a mislabeled blood sample might have resulted from the phlebotomist drawing blood at 3 a.m. without turning on the lights, because of concerns about disturbing the patient.

good catch A process breakdown in which the problem is identified and addressed before it hurts the patient.

close call A potentially adverse event not related to the patient’s illness or condition that could have caused significant harm but does not.

serious safety event An adverse event not related to the patient’s illness or condition that causes significant harm.(continued)

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Summary

Accreditation can facilitate the evolution of healthcare entities into high reli- ability organizations. When organizations commit to readiness for accreditation surveys, they embed standardized, evidence-based practices into their opera- tions. By continually practicing excellence, the organizations become excellent.

The organization paid diligent attention to processes and procedures, analyzing and improving every process step across the entire span of care. The organization selected projects where existing processes had been repetitive, where solutions were unknown, and where intervention would support the organization’s strategic vision. Senior leadership was involved throughout the process (Shabot et al. 2013).

The organization recognized that robust measurement systems would be essential for building trust in the process. One important aim was to have near-perfect compliance with hand hygiene guidelines, and the performance improvement team had begun measuring compliance (France 2014). How- ever, the data were collected after the staff had been alerted, which led to an artificially high rate of compliance. The team then implemented the secret shopper method—in which an observer monitors processes without being identified—and found compliance to be much less. Once the measurement process was improved and widely accepted, better data were made avail- able, and 42 barriers were noted. These areas were methodically targeted, leading to a meaningful improvement in hand hygiene compliance. As a result of this improvement, central line–associated bloodstream infections (CLABSIs) were eliminated (Shabot et al. 2013; Sloane 2013).

Memorial Hermann also centralized its quality departments, trained all employees in the principles of high reliability, introduced evidence-based protocols, expanded clinical decision support on its electronic health record system, and documented performance on comprehensive data dashboards (Sloane 2013). To underscore the importance of its safety initiative, Memo- rial Hermann created a High Reliability Certified Zero Award to recognize a hospital’s effective prevention of harm events for 12 consecutive months, and the award became highly coveted (Shabot et al. 2013). A number of the system’s hospitals received the award for their prevention of CLABSIs, ventilator-associated pneumonias, retained objects, or other kinds of pre- ventable harm (Sloane 2013).

Ultimately, the Memorial Hermann system completed its journey to become an HRO and was awarded the 2012 John M. Eisenberg Patient Safety and Quality Award.

secret shopper method A way of observing processes in an organization through a monitor whose identity is kept secret, so people are not aware they are being observed.

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Chapter 10: Accreditat ion and High Rel iabi l i ty 225

Of course, accreditation by itself will not make an organization excellent; it is simply a means to the goal. An accreditation body can enforce discipline and provide guidance, but the full benefits can only be achieved when the orga- nization commits to improving its operations, monitoring its outcomes, and ensuring the sustained delivery of value.

Organizations wishing to become highly reliable can learn from expe- riences in other industries, such as manufacturing, where the HRO concept originated. HROs in healthcare support a paradigm whereby processes and operations are hard-wired to facilitate the delivery of care that is of consistently high quality. Waste is eliminated, reducing costs and enhancing value. Organiza- tions become highly reliable by learning from failure, being resilient, recogniz- ing the complexity of systems, leveraging internal expertise, and maintaining an appreciation for operations. They employ many of the tools discussed in earlier chapters, such as Lean and Six Sigma techniques. They support a just culture that empowers employees and stakeholders while incorporating best practices and the latest evidence into their operations.

As HROs in healthcare expand their knowledge base, they serve as blueprints for other organizations hoping to make similar gains. The aim is to develop a culture of excellence in processes, outcomes, and cost control across all aspects of an organization’s activity, thereby creating conditions for the sustained delivery of value.

Notes

1. The Joint Commission’s website provides an in-depth discussion about certification, accreditation, and deemed status at www.jointcommission. org/facts_about_federal_deemed_status_and_state_recognition/.

2. A time-out is a presurgical safety check whereby the patient’s identity, side of surgery, type of surgery, and operating physician are verified just before the patient is provided anesthesia. This practice was established to minimize preventable surgical errors.

3. Best practices in patient identification require that two unique identifiers be used. These identifiers may include patient name and date of birth.

Discussion Questions

1. What are the similarities and differences between accreditation and certification?

2. What is deemed status? How does it relate to accreditation bodies?

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The Core Elements of Value in Healthcare226

3. Describe the role that accreditation plays for healthcare organizations across the acute and post-acute care realms.

4. Evaluate the similarities and differences among the various accreditation bodies in the United States.

5. Does accreditation help improve the quality of care delivered by healthcare organizations? Do you think it focuses too heavily on processes, or does it also help improve outcomes?

6. Does accreditation increase the cost of delivering care? 7. What is a highly reliable organization? What are the key features of such

an organization? 8. Can HROs be adapted to serve the needs of healthcare? What lessons

can be gained from other industries? 9. Can HROs improve the value of healthcare delivered? Justify your

answer with examples. 10. Review the current literature, and identify two examples of healthcare

organizations that have successfully become HROs. 11. Consider the following case: Mission Street Clinic is a community-based

clinic system that serves more than 4 million residents in a major urban area on the West Coast. The organization is highly regarded for the service it provides to members of all demographic and socioeconomic strata. Each day, the clinic sees more than 1,000 patients across its various sites.

The organization has been maintaining its records on paper, and its dedicated staff has managed to keep the clinic operational despite minimal automation. Members of the staff have worked with one another for decades and have established a significant level of comfort and trust. They rarely question any provider’s decisions or judgment. The pharmacy on the premises handles thousands of prescriptions each day using a mostly paper-based system and handwritten prescriptions. The pharmacy team has recently experienced turnover, with the retire- ment of two pharmacists. Because of budget cuts, a pharmacy techni- cian position is unfilled.

Recently, the organization has experienced six episodes in which an incorrect prescription was filled and a patient was nearly harmed. Three of the episodes were recognized within the pharmacy itself and rectified. Two of the episodes were discovered at the end of the shift, and the patients were able to be called back for a prescription change before they took the medication. One episode stemmed from difficulty in deciphering the prescriber’s prescription.

Although none of the episodes led to harm, staff is concerned that the clinic’s quality and reliability is slipping. As the clinic’s CEO,

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Chapter 10: Accreditat ion and High Rel iabi l i ty 227

you have been asked by the board to research the issue and provide recommendations. a. Are the medication errors a cause for concern? If harm did not

occur, is action necessary? Why or why not? b. What strategies will you employ to gain more insight into the

causes of the near misses? Search the relevant literature, and incorporate key findings into your answer. Who would you interview to learn details about the issues?

c. The pharmacists advise you that, because they have worked together for so long, they do not feel the need to verify one another’s work. Policies, however, clearly require a second check. Would this be considered a violation of policies and procedures? Is a respect for a just culture reasonable in this situation? How will you balance the need to ensure compliance with policies and procedures while acknowledging the transparency demonstrated by the pharmacists?

d. Budget cuts have led to chronic understaffing. Is the absence of a pharmacy technician detrimental? How?

e. You decide to conduct a root cause analysis of the near misses. Propose a methodology for identifying the causative factors contributing to the problems with medication prescription.

f. Compose a two-page memo to your board describing how your clinic can become an HRO.

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CHAPTER

229

COST STRUCTURE AND SUSTAINABLE VALUE IN HEALTHCARE

Learning Objectives

Upon completion of this chapter, you should be able to

• devise techniques to understand an organization’s cost structure, • explain the role that cost structure plays in an organization’s

sustainability, • describe steps that can be taken to reduce the cost structure to ensure

sustainability, • accurately assess the cost structure so that sustainable value-based

contracts can be used, • employ techniques to improve operational effectiveness while increasing

the value of care delivered, • propose and evaluate projects that organizations should undertake, and • assess the role that activity-based costing can play in value-based

contracts.

Value-based healthcare is based on the delivery of clinically appropriate care in a manner that is cost effective and that improves the patient experience. This paradigm requires that all components of the value

chain deliver care in an efficient manner consistent with their intrinsic cost of operations. As the shift toward value continues, organizations are increasingly entering into contracts whereby they assume the risk for delivering high-quality care. For these arrangements to be successful, the organizations must ensure that the revenue they gain from the contracts more than covers the cost of delivering care. If the contracts do not accurately quantify the costs, they may prove unsustainable.

If an organization can operate efficiently, eliminate waste, and have accu- rate knowledge of its cost structure, it is better positioned to assume the risk for the care of a population. It can also negotiate contracts that are structurally sound and that reflect the reality of its operations. To achieve these goals, the organization should track the cost of episodes of care—as well as the costs of

11

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