The federal government works in partnership with state and local agencies, national quality and safety organizations, accrediting organizations, insurers and the health care industry to protect the US public. Field describes the present regulatory structure as one that is regrettably neither uniform nor consistent. Broad range of regulatory bodies and programs apply in different ways to various aspects of the industry. Health care regulations are developed and enforced by all levels of government – federal, state and local, as well as by a large assortment of private organizations that may be operating without coordination [8].
Health care is extraordinarily complex, and hospitals are hierarchical organizations that are resistant to changes. Behavior in health care is often influenced rather than controlled. Behavioral patterns emerge, rather than respond to design [9]. In spite of this, much of the health care environment is controlled by regulations.
Regulation and accreditation are often thought to be identical, and, although they are complementary, they serve different purposes. Regulation involves established principles, rules or standards that must be followed — established by an authority in order to direct or manage specific activities. Defined broadly, external regulators include a range of entities that regulate or influence the behavior of a healthcare organization with respect to performance improvement, quality and safety. These regulators include the state and/or federal entities responsible for monitoring and ensuring compliance with state or federal government standards, rules and regulations.
Accreditation is a seal of approval verifying that an organization has met specific rules, regulations and standards. Accrediting organizations advance high quality patient care and safety through the development and enforcement of standards. Examples of private organizations deemed by CMS to accredit health care organizations are The Joint Commission (TJC), Healthcare Facilities Accreditation Program (HFAP) and Det Norske Veritas (DNV). During accreditation surveys, these organizations evaluate compliance with CMS regulations in addition to their own established standards.
The accreditation process is ultimately a risk-reduction strategy. The premise is that if organizations are doing the “right things right” as reflected in the standards, then errors and adverse events are less likely to happen than if there were no such standards [3]. When the standards and the rules are incorporated into the fabric of the organizational culture, there is an acceptance and expectation for high safety standards at all times.
In most hospitals, accreditation requirements are the primary driver of safety efforts, and because [10] accreditation is frequently such an essential component of payment, insurance coverage and reputation, it is virtually as important and has the same power as regulations. Both hospital leaders and physicians have suggested that the Joint Commission was the most important driver of change and progress towards patient safety [11]. In fact, accreditation has been observed to be more effective in promoting good safety practices than state-required error reporting or public awareness [12]
The challenging environment of health care regulation has become a public-private partnership that despite the scope, complexity and flaws has served to coordinate, support and nurture health care quality and safety [8]. Nevertheless, physicians remain highly individualistic – causing them to resist regulatory solutions and standardization [11]. It is therefore crucial to involve and partner early on with clinicians who will be impacted by the new rules and regulations.
Regulators and accrediting organizations must acknowledge the cost and resources required to implement and adopt safety initiatives and performance improvement activities. Warburton suggests that safety goals and recommended practices have been important drivers in the national efforts to improve patient safety; however the proliferation of requirements threatens to overwhelm the capacity of hospitals to safely implement change in a manner that is meaningful and sustainable [13]. Review and analysis of reliable data and ongoing monitoring of process changes are essential to determine if changes are achieved and sustained. Predictably, this cannot occur without a robust data analysis capacity. Following this analysis it is important to simplify the regulatory system by eliminating non-productive and un-measurable regulations.
In 2009, Wachter evaluated the progress of the patient safety movement 10 years after the Institute of Healthcare Improvement (IOM) landmark publication “To Err is Human” and suggested that situations may arise in which hospitals are being required to collect different data or implement varied solutions for the same problem by state regulators, federal government, Joint Commission, the National Quality Forum, the CDC’s National Healthcare Safety Network (NHSN) and a variety of benchmarking organizations. Without harmonization of efforts, there may be a point in time when providers and administrators may become reluctant to implement and work towards competing initiatives and requirements [14].
Unfortunately, the history of regulation is beset with examples of overreaching and unintended consequences, both of which can hamper flexibility and innovation. Examples include the Joint Commission release of National Patient Safety Goals (NPSGs) before evidence to support their implementation or the Accreditation Council for Graduate Medical Education (ACGME) resident work-hour restrictions without careful evaluation of the impact on workflow, communication and patient handoffs. Ultimately, work hour restrictions have not been shown to improve patient safety [11].
If “first do no harm” were sufficient to prevent medical error and keep patients safe, there would not be a need for the growing patient safety movement. The field of patient safety has grown since the mid 1990’s. Patient safety efforts have included both private and market-based initiatives both state and federally driven. The general strategies can be summarized in six major points: standardizing good medical practices, tracking adverse events in hospitals, disclosing provider performance, reforming payment systems, coordinating and integrating care, and expanding provider responsibility (Table 13.1).
Table 13.1
Regulatory strategies
Regulatory category | Examples |
|---|---|
Standardizing good medical practices | Reduce medical variation |
Checklists | |
Practice guidelines | |
Research | |
Tracking adverse events in hospitals | Patient safety organizations |
Never events | |
Sentinel events | |
Disclosing provider performance | Publically reported performance data |
Disclosure of adverse events to regulators and accrediting organizations | |
Disclosure by the provider to patients | |
Reforming payment systems | Incentives for safety through pay for performance |
Penalties for failing to meet minimum standards | |
Insurance exchanges to promote safety and quality improvements | |
Coordinating and integrating care | Innovation in health care delivery |
Expanding provider responsibility | Requirements for: disclosure, fiduciary responsibility and bad outcomes |
Regulation and accreditation have proven to be beneficial to patient safety efforts, while they are less useful in ensuring more general quality improvements. Rules should be written with attention to clarity, regulations must minimize cost and waste and allow some flexibility in response to variations in healthcare settings and compliance must be observable or measurable [15]
Where Is the “Golden Bullet”?
High-Reliability Concepts
It is essential that health care organizations continue to take an on-going, comprehensive approach to regulation and accreditation in order to improve and maintain health care quality and safety; however, quality improvement and safety programs alone cannot transform organizations [16].
Most health organizations are in a period of transition from a culture in which compliance is the primary focus to a culture that is focused on safety and high reliability concepts. Health care safety experts have turned to high-reliability concepts in order to achieve a higher degree of safety or reliability [17]
In 2005, the Agency for Healthcare Research and Quality (AHRQ) convened a group of leaders from hospital systems committed to the application of high reliability concepts, producing a document that describes the application of those concepts within the field of health care [18].
The high reliability model is intended to focus efforts towards new methodologies designed for performance improvement such as Six Sigma®, Lean, Baldrige, and Total Quality Management (TQM) [18].
Weick and Sutcliffe describe five high reliability characteristics that are helpful towards the transformation of an organization:
Sensitivity to operations – ability to focus on a specific task while maintaining awareness of the complexity of the system.
Reluctancy to simplify – recognition that the system can fail in ways that have never been anticipated.
Preoccupation with failure – focus on predicting and eliminating catastrophes, rather than reacting to them.
Deference to expertise – team members and organizational leaders defer to the person on the team with the most knowledge relevant to the situation.
Resilience – errors are quickly contained, a situational assessment is conducted and teams skillfully improvise when difficulties occur [19].
With leadership commitment, an organization can shift from those characteristics that primarily support a compliance culture to one that incorporates attributes of a mindful culture of high-reliability and patient safety concepts (Table 13.2).
Table 13.2
Becoming a high reliability organization: a shift from compliance to culture
Compliance | Key drivers | High-reliability concepts/culture |
|---|---|---|
Focus on rules and standards | Issue Awareness | Focus on patient safety and quality |
Tactical | Safety Organizations | Safety as a strategic imperative |
Reactive | Fiscal Impact of Safety | Proactive/preoccupation with failure |
Manual tracking/audits | Competitive Pressures | Robust data |
Fragmented | Transparency | Integrated |
Operations that function in silos | Media Attention | Strong leadership/coordinated effort |
Departmental responsibility/effort | Reimbursement | Engaged workforce |
Hierarchical relationships | Public Reporting | Team training/deference to expertise |
Simplistic solutions/fix with brute force | Consumers | Carefully designed processes |
No sustainability | Politics | Sustainability |
Provider autonomy | Strategic Planning | Tools, guidelines and checklists |
Simplistic solutions/brute force | Analytical Tools/Reliable Data | Preoccupation with failure |
Sluggish response to problems | Health Information Technology (HIT) | Situational awareness |
Rigidity | Strategic Planning | Resilience |
Emergence of Quality Improvement Initiatives | ||
Research Funding |
The widespread concept of “safety culture” arose in the aftermath of the Chernobyl accident in 1986 and the Clapham junction train accident in London in 1988 [20, 21].
A safety culture is defined by the beliefs, attitudes and assumptions of individual employees, shared across an organization or workgroup, and expressed in the day-to-day practices of a workplace [20, 21]. A number of researchers have sought to define “desirable” characteristics that organizations should strive for in order to reach and maintain an optimal culture of safety [22, 23].
Pidgeon and O’Leary [22] identified three key facets that an organization committed to safety should posess; attitudes of shared care and concern for hazards; realistic and flexible norms and rules about hazards and finally, continuous reflection upon practice (or organizational learning) through monitoring, incident analysis and feedback systems.
James Reason is renowned for his model of a safety culture subdivided into four subcomponents: a reporting culture, a just culture, a flexible culture and a learning culture (Fig. 13.2). These subcomponents interact to create an informed culture. A reporting culture relies on the presence of an organizational climate in which people are prepared to report errors and near-misses. A just culture is an atmosphere of trust in which people are encouraged, even rewarded, for providing safety related information but clear about the line between acceptable and unacceptable behavior. A flexible culture relies on the ability of an organization to shift from conventional hierarchical mode to a flatter professional structure, where control passes to task experts on the spot in times of crisis. Finally, a learning culture is identified when an organization possesses the willingness and competence to draw the right conclusion regarding safety and the will to implement major reforms when the need is indicated.
According to Reason, an informed culture is a safe culture. The components identify the beliefs and practices present in an organization that is informed about risks and hazards and takes action to become safer. Organization with a successful culture of safety rely upon the willingness of front line workers to report their errors and near misses. This willingness depends on the employee’s understanding that management will support and reward self-reporting [23].
Just as the Chernobyl accident served as the catalyst for critically researching and defining the concept of a safety culture, the Institute of Medicine (IOM) Report, “To Err is Human” published in 1999 served as the catalyst in focusing national attention on the need for patient safety improvement and higher quality healthcare. The landmark report drew the attention of the healthcare community with its assertion that 44,000–98,000 patients die each year from medical errors. A number of recommendations were contained in the report but the ultimate target was to create safety systems inside healthcare organizations through the implementation of safe practices at the delivery level.
It has been suggested that health care is significantly different than the industries from which it imported the safety culture concept [24, 25]. In fact, in healthcare, the customer experiences unsafe practices rather than the employee. Further noted is the fact that accidents in healthcare usually affect individuals rather than occurring as sweeping disasters.
Although numerous authors suggest there is lack of a universal, clear definition of a safety culture, common characteristics of a strong or effective safety culture can be identified [24, 26–28].
Wiegman et al. reviewed a number of high risk fields including nuclear power, aviation, oil and gas industries, manufacturing and construction and mining. Safety culture was frequently associated with reference to shared values at the group level or higher, formal safety issues related to supervision and management, contributions from every level of the organization, an impact on work behaviors, a relationship between safety behaviors and rewards, the willingness to acknowledge and learn from safety problems and being relatively enduring, stable and resistant to change [27]. Singer et al. outlined similar components of a culture of safety and suggest the characteristics of a safety culture to be:
Commitment to safety is articulated at the highest levels of the organization and translated into shared values, beliefs and behavioral norms at all levels.
Necessary resources, incentives and rewards to allow commitment,
safety is valued as a primary priority at the expense of other priorities,
personnel are rewarded for erring on the side of safety,
communication between workers and across the organization is frequent and candid,
openness about errors is evident,
organizational learning is valued, systems approach to analyzing errors instead of focusing on individual blame and acceptance of responsibility for the system.
Additionally, the means by which errors are identified, reported, and communicated to those involved or affected have much to do with how well safety is ingrained in the healthcare organization’s culture [28].
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