Danny M. Takanishi Jr.
The Institute of Medicine in 1999 published a landmark treatise, To Err Is Human: Building a Safer Health System (1). This document served as a solemn reminder to all involved in the delivery of health care that safeguards were vital in order to realize much needed improvements in patient safety. Public awareness further fortified the impetus toward the establishment of a systems approach and external evaluation measures to address this need through multiple mechanisms, at both local and national levels.
The Joint Commission on Accreditation of Health Care Organizations (JCAHO); the Agency for Healthcare Research and Quality (AHRQ); VHA (not an abbreviated word), Inc.; the Centers for Medicare and Medicaid Services; and the Leapfrog Group are a few examples of organizations that have focused attention on improving the quality of patient care (2,3,4,5,6,7,8,9,10). Despite shared vision, implementation has proved to be a challenge. The definition of reliable measures of quality continues to be debated, the sustainability of implemented programs is also being questioned, and the impact of measures formulated to improve patient safety is still unclear (2,4,5,7,8,11,12,13,14,15,16,17,18,19,20,21).
The intensive care unit (ICU) is fertile ground to test implementation of quality initiatives. More than 5 million patients are admitted to ICUs in the United States annually (2). This accounts for only 8% to 10% of the acute care beds but comprises 20% to 30% of all acute care hospital costs (19). Notwithstanding, 10% of these patients will die and innumerable others will encounter preventable adverse events (5). Giraud et al. found that iatrogenic complications occur in up to 31% of patients and can be severe in 13% (19). It has been estimated that integration of quality standards and best practices can save more than 100,000 lives and $5.4 billion in costs annually (2).
Chronicle of Performance Improvement Initiative
In 2000, the Institute of Medicine grimly reported that up to 98,000 deaths annually in the United States were preventable, all resulting from medical errors. A recommendation was made to establish as a national priority a center for patient safety. This report further justified the development of mandatory and voluntary reporting systems, essential components in the evolution of a culture of safety and quality improvement (1). In parallel, 1 year prior, at the behest of the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry, the not-for-profit National Quality Forum (NQF) was established (15). The mission of this entity was to promote improvement in health care by the establishment of national benchmarks to measure health care quality and reporting of performance. This organization formulated 30 standards directed at improving patient safety, and published this in 2003 (22). A number are applicable to the ICU setting.
Notwithstanding, JCAHO has been an active participant in the process driving improvements in patient safety. This organization originated under the auspices of the American College of Surgeons in 1917, becoming an independent group in 1951. This entity was solely driven by health care professionals and served the function of assisting hospitals to improve quality of care and staff recruitment, and for accreditation of graduate medical education programs (4). Then, in 1965, the federally funded Medicare program was established by Congress. Statutorily, under the Social Security Amendments of 1965, a category called “deemed status” was established, which declared that any hospital accredited by JCAHO was also eligible to participate in the Medicare program. This was emblematic of the changes that were gradually occurring, as use of accreditation as an external quality improvement evaluation mechanism was expanding beyond the health care sector. Now there was governmental influence, soon to be followed by the public's use of accreditation as a means to evaluate the safety of health care delivery. JCAHO currently accredits almost 15,000 health care organizations in the United States and over 96% of hospital beds in the United States are in accredited hospitals (3,4). This organization in July 2005 had instituted a reporting provision for four ICU core measures, based on the 2003 report by the NQF. These measures include ventilator-associated pneumonia prevention: patient positioning; stress ulcer prophylaxis; deep venous thrombosis prophylaxis; and central catheter-associated bloodstream infection (Table 11.1). Additionally, two test measures have also been recommended: ICU length of stay (risk adjusted) and hospital mortality for ICU patients (15).
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Table 11.1 JCAHO National Quality Forum measures for the intensive care unit (ICU) |
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There are other organizations and agencies involved in the external evaluation of health care institutions. This list includes the National Committee for Quality Assurance (NCQA), the American Medical Accreditation Program (AMAP), the American Accreditation Healthcare Commission/Utilization Review Accreditation Commission (AAHC/URAC), and the Accreditation Association for Ambulatory Healthcare (AAAHC). Other agencies, such as the Foundation for Accountability (FACCT), AHRQ, Institute for Healthcare Improvement (IHI), the National Coalition on Health Care (NCHC), and the Leapfrog Group also carry out unique roles in the assurance of safe, quality health care delivery (10). Each of these entities has differing missions and structures, and some are therefore better positioned to impact the ICU. Most of the accrediting agencies have in common, however, tenets established by JCAHO at its inception as an accrediting body: (a) accreditation is a voluntary process, (b) the evaluation of quality represents a cross-sectional analysis of the institution at the time of evaluation, (c) the accreditation is based on previously defined standards and indicators of quality, and (d) the process of accreditation must occur periodically based on a fixed number of years (8).
The Joint Commission on Accreditation of Health Care Organizations
The role of JCAHO, the oldest accrediting body for health care worldwide and the largest hospital regulator in the United States, has evolved significantly since it was first conceived as a standing committee of the American College of Surgeons in 1917 (4,7). This organization's role in the external accreditation process broadened in response to the dynamic changes that the health care environment experienced in the 1970s and 1980s. The escalating costs of health insurance threatened businesses in the globally competitive marketplace, resulting in the drive for cost containment and the eventual implementation of managed care and capitation payments. Concomitantly, rising costs of health insurance were continually passed on to employees, who were then responsible for copayments for health care services in addition to a rising proportion of employer-subsidized health insurance. In parallel, health care institutions were financially pressured to restructure and to reorganize in order to meet the challenge of providing efficient, safe, and quality health care. Hence, it was a rational direction that this external accrediting agency took, in assisting the purchasers of health care services to make informed decisions regarding choice of health plans and providers, through the accreditation process. Finally, in response to public demand for representation in policy development and in the establishment of standards, JCAHO added public members to its board and to its advisory committees in 1982 (4). This was also followed by the development of an Office of Quality Monitoring, which provides a mechanism to address public complaints pertaining to an institution's alleged noncompliance with standards, and by the disclosure of performance reports detailing the accreditation status of an institution, and their performance in each of the standards, on the JCAHO Web site.
The accreditation process is still voluntary, as it was when this organization was first conceptualized in the early 1900s. It is noteworthy that approximately 50% of the JCAHO standards have direct relevance on patient safety, although the remaining standards all possess some relationship to patient safety indirectly (23,24). Therefore, the public, employers, insurers, and governmental agencies all tend to share the common belief that those institutions with accreditation provide higher-quality professional care. Available data do not disagree with this presumption.
It is worth pointing out that the definition of quality and the best measures and outcomes to assess quality and safety in the ICU setting are still not clear and many investigators have attempted to define these variables (12,25,26). Conceptually, quality measures must be validated as reliable tools that impact performance improvement and allow for standardization, so that comparisons of quality and safety can be readily made between all ICUs. Equally important is the a priori establishment of meaningful objective goals that will translate into measurable changes in quality improvement (12,16). To this end, JCAHO has recommended for national implementation four core measures and proposed two test measures. The quality benchmarks targeted include measuring the percentage of patients with central venous catheter bloodstream infections, the percentage of patients with ventilator-associated pneumonia, the percentage of patients with stress ulcers and use of prophylaxis, and the percentage of patients with deep venous thrombosis and use of prophylaxis (3). The test measures include ICU length of stay and hospital mortality. The nuances of these measures, particularly in terms of data collection, enforcement, and shortcomings and controversy as indices of quality, are discussed elsewhere (7,15,17,18).
Institute for Healthcare Improvement
The not-for-profit, Boston-based IHI was founded in 1991, as a by-product of the National Demonstration Project on Quality Improvement in Healthcare. Their Web site provides guidelines and tools for tracking change in practice, in addition to outcomes (9). This organization has released a report in conjunction with the NCHC, Care in the ICU: Teaming Up to Improve Quality. The basic premise is that improvements in ICU care that promote safety and quality are achievable now, based on evidence-based literature. This organization has proposed the use of care “bundles” (e.g., for patients on ventilators, or those with central lines), “rapid response teams,” the implementation of multidisciplinary rounds with daily goals assessment, and implementing the “intensivist-led model” of ICU care. The IHI defines a “bundle” as a “structured way of improving the processes of care and patient outcomes: a small, straightforward set of practices—generally three to five—that, when performed collectively and reliably, have been proven to improve patient outcomes” (9,21). The initiatives of the IHI are closely aligned with JCAHO, particularly in terms of the four critical care JCAHO core measures discussed earlier.
Leapfrog Group
This agency was founded in November 2000, after a group of employers in 1998 began the process of determining how best to approach the challenge of purchasing affordable, quality health care for their employees. Notably, this came on the heels of the Institute of Medicine's report To Err Is Human: Building a Safer Health System, which had recommended that large employers provide reinforcement for the provision of safe, quality health care through market pressure. This group comprises a number of Fortune 500 corporations and spans a broad range of purchasers of health care representing more than 34 million individuals (2,7). The Centers for Medicare and Medicaid Services is supporting this group in the propagation of information-identifying facilities achieving established standards. The Leapfrog Group had proposed a tripartite approach to address the patient safety initiative, and it estimated that this would save up to 58,300 lives and prevent more than 500,000 medication errors annually. The three recommendations included use of computerized physician order entry, increased evidence-based hospital referrals, and improved ICU physician staffing.
In common with proposals put forth by other organizations and agencies vested in patient safety and quality care in the ICU environment, the Leapfrog Group has conducted its own surveys to determine the degree to which institutions have been able to implement their recommendations. Significantly, some insurers have established incentives for health care facilities that integrate Leapfrog Group initiatives into their programs. The results have been promising, but not without the ire of certain constituencies of the health care system. The American Hospital Association has questioned whether standards promulgated by outside, or external, agencies should be embraced by hospitals, and the costs to implement and to sustain programs for computerized order entry or to employ qualified intensivists already in short supply have also been challenged.
Pay for Performance
The quest for quality in health care has garnered tremendous interest during the past decade. One development is the concept of pay for performance, which is predicated on providing financial incentives to health care providers (both physicians and hospitals) who meet predetermined quality benchmarks prospectively established by insurers. A component of many iterations of this concept is public disclosure of health care provider results, in order to allow for a more informed decision in securing quality care (27). A number of organizations have provided input, such as the American Medical Association and JCAHO (28,29). Central to all models of pay for performance, both organizations concur that measurements should be “credible, reliable, and valid,” in addition to being “measurable and transparent” and evidence based.
There has been a paucity of studies done to evaluate these models, in order to determine their effectiveness on the provision of quality care. The Integrated Healthcare Association and the Center for Medicare and Medicaid Services have validated their pay-for-performance models in terms of demonstrable improvement in quality care, and the considerable physician interest and involvement. Effective July 1, 2007, those participating in the Medicare program were provided the opportunity to voluntarily report their performance data (selected from 74 performance measures) to the Centers for Medicare and Medicaid Services and receive a bonus payment of up to 1.5% of allowed charges on all Medicare claims from July 1, 2007, through December 31, 2007, as part of the Physician Quality Reporting Initiative (PQRI). This followed the federal Centers' Physician Voluntary Reporting Program, which was not associated with a financial incentive. This information will not be made public, but the mechanism was devised to provide physicians with experience reporting quality data.
Summary
Improving patient safety and delivering high-quality care to the critically ill patient is a universal goal. The ICU retains a prominent role in hospitals, given the complex nature of patients cared for and the contribution of this care to the escalating costs experienced by the health care system in the United States. A number of initiatives are in place to implement processes to improve care in this environment. To this end, external organizations are playing a crucial role in establishing policy for patient safety and the delivery of quality care through both regulatory (accreditation) and financial incentives. Correspondingly, a number of agencies are actively conducting research that will likely translate into improved patient safety, as results of these studies become incorporated into the regulatory process (supported by financial remuneration) to effect needed change (6,30).
References
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