Summary - Part III
Introduction to sentinel events: The November 1999 Institute of Medicine (IOM-1) report, To Err is Human: Building a Safer Health System, noted that a major barrier to improving safety is a lack of awareness of the problem. This is due to inadequate reporting of errors and the resulting inability to accurately measure their occurrence. Starting in 1998, the Joint Commission (JCAHO) began requiring the reporting of one specific type of medical error or serious adverse event termed a sentinel event. JCAHO updated their definition of a sentinel event in 2007 as follows:
- A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.
- Such events are called "sentinel" because they signal the need for immediate investigation and response.
- The terms "sentinel event" and "medical error" are not synonymous; not all sentinel events occur because of an error and not all errors result in sentinel events.
Reporting sentinel events: JCAHO sponsors a hotline (630-792-3700) for reporting serious events. It also provides summary information on its Web site about the occurrence and management of sentinel events, including an updated policy (.pdf) (213 KB) on SE reporting. (See Links: JCAHO Patient Safety). Although modifications have been made to the original policy, the critical requirement for organizations is performing a "root cause analysis" of the event to identify the true underlying cause. This highlights the understanding that most events are the result of system problems and are not cause for individual blame.
Sentinel event bulletins: To assist healthcare organizations, JCAHO provides aggregate data and analysis of sentinel events on the JCAHO Web site as bulletins entitled Sentinel Event Alerts. These include updated analysis of the types of errors reported since January 1995 and information on frequency, settings, outcomes, and methods of review. As of June 30, 2006, 3,811 reports of sentinel events impacting 3,935 patients had been reviewed. 2,857 events, or 73 percent, involved death, and over 385 (10 percent) involved a loss of function. The proportion of events that are self-reported each year has increased slightly.
Lessons learned: Starting July 1, 2001, JCAHO began asking organizations what actions they have taken in response to the problems and suggestions highlighted in the Alerts. Organizations must show implementation of the suggestions or reasonable alternatives taken to respond to the potential risks. In the issues of Sentinel Event Alert, healthcare organizations, the Joint Commission and various experts have provided recommendations on how other healthcare organizations can prevent the adverse events from happening in the future.
Risk reduction strategies required: The emphasis has been on "recommendations," but some readers have interpreted these suggestions as being Joint Commission requirements. The Joint Commission stresses that the suggestions should be considered for implementation, but if not appropriate for the individual healthcare organization, alternatives should be selected. The Joint Commission recognizes that other acceptable practices or approaches exist. Nineteen issues of Sentinel Event Alerts have been issued over the past 3 years; details on the events are available at the JCAHO website. The Joint Commission will portray a hospital's response as part of a "Sentinel Event Strategies" safety profile. Risk reduction strategies that reflect reported Sentinel Events to date are likely to include the following:
- Restricting access to concentrated potassium chloride,
- Reducing the risk of inpatient suicide
- Eliminating wrong-site surgery
- Eliminating the use of inappropriate & unsafe restraints
- Reducing the risk of infant abduction
- Reducing the risk of adverse transfusion-related events
- Minimizing operative/post-operative complications
- Reducing the risk of fatal falls
- Reducing the risk of intravenous infusion pump errors
- Managing "high alert" medications
In April 2002, the Joint Commission (JCAHO) appointed a panel of physicians, nurses, pharmacists, and other patient safety experts to advise the organization on developing its first set of national patient safety goals.
The first six goals and measures were announced after final voting at the July 18-19 JCAHO Board of Commissioners meeting. Each goal includes one or two evidence- or expertise-based recommendations. In the following years, certain goals are to be retained, while others are replaced as a result of emerging new priorities. To ensure a greater focus on safe practices, no more than six goals—and their associated recommendations—will be established for any given year. The first six goals are listed below.
- Improve the accuracy of patient identification.
- Improve the effectiveness of communication among caregivers.
- Improve the safety of using high-alert medications.
- Eliminate wrong-site, wrong-patient, wrong-procedure surgery.
- Improve the safety of using infusion pumps.
- Improve the effectiveness of clinical alarm systems.
In January 2003 the JCAHO survey process included compliance with these goals
and associated recommendations or implementation of acceptable alternatives, as
appropriate for the services that the healthcare organization
provides. Non-compliance will result in "accreditation with requirements for
improvement." Download the current
NSPGs for 2007 (.pdf) (94 KB) as well as the
draft 2008 NPSG (.pdf)
JCAHO approach to improving safety: In July of 2002, JCAHO began enforcing a set of standards on Staffing Effectiveness; these were recently tested and approved by the JCAHO board. However, on July 1 2001, the JCAHO already began enforcing a broad set of standards that focus on patient safety. These include revisions to a number of current standards to more clearly support medical/healthcare error reduction programs in accredited organizations, as well as new patient safety standards. The final standards describe the requirements for establishing ongoing patient safety programs in organizations accredited under the Comprehensive Accreditation Manual for Hospitals within the Managing Human Resources standards.
The standards emphasize the need to integrate all patient safety activities, both existing and newly created, with an identified focus of accountability within the organization's leadership. A number of the existing standards or intent statements have been revised by adding the phrase "to improve patient safety" to reflect this integration. They now require certain activities, e.g., security, equipment safety, infection control. The revisions encompass staff and visitors as well as patients
Patient safety-related standards
Almost 50 percent of Joint Commission standards are directly related to
safety, addressing such issues as medication use, infection control, surgery
and anesthesia, transfusions, restraint and seclusion, staffing and staff
competence, fire safety, medical equipment, emergency management, and
security. Additional patient safety standards went into effect for hospitals
in 2001, and similar standards went into effect for behavioral health care
and long term care organizations in 2003, and for ambulatory care and home
care organizations in 2004. These standards address a number of significant
patient safety issues, including the implementation of patient safety
programs; the response to adverse events when they occur; the prevention of
accidental harm through the prospective analysis and redesign of vulnerable
patient systems (e.g. the ordering, preparation and dispensing of
medications); and the organization's responsibility to tell a patient about
the outcomes of the care provided to the patient. For more information on
other patient safety related initiative go to:
Other JCAHO standards have an indirect impact on safety programs such as:
Leadership: Effective reduction of unintended adverse patient outcomes in a healthcare organization requires an environment that encourages recognition and acknowledgment of risks to patient safety and medical/health care errors. The standards require the following:
Improving Organizational Performance: This standard emphasizes the need to design processes that draw on a variety of information sources, including information about potential risks such as sentinel events. They also require attention to family perceptions of risk and staff willingness to report medical/health errors. Monitoring standards explicitly require organizations to analyze hazardous conditions and set priorities to proactively reduce patient risk.
Management of Information: The language strengthens the requirement's accurate, timely and complete verbal and written communications. It focuses on aggregation of patient safety–related data and information, the application of knowledge-based information to patient safety–related issues; and the effective communication among participants in carrying out healthcare processes.
Patient Rights and Organization Ethics: One standard relates to family communications:
- Patients and, when appropriate, their families are informed about the outcomes of care, including unanticipated outcomes.
Other Functions: Other chapters include appropriate emphasis on patient safety, with particular attention to standards for Education, Continuum of Care, and Management of Human Resources. For example, Human Resources adds a requirement that ongoing in-service and other education and training support an interdisciplinary approach to patient care.
IOM-1 and JCAHO impact on environmental safety: Recommendations from the IOM-1 report, as well as JCAHO initiatives related to safety, have implications for the entire healthcare organization's "culture of safety." A number of the recommendations impact the hospital's safety committee or environment of care (EC) as well as infection control committees.
Prevention of adverse effects is one goal of the EC committee, and the team assists in establishing and communicating procedures that promote safe practice and prevent adverse effects of all types to patients, staff, and visitors. The scope of the committee includes an organization-wide process called the "information collection and evaluation system" to improve the environment of care. This process includes all types of unexpected occurrences such as patient falls or other injuries requiring intervention and improvement.
Medical safety relationships: The safety committee interacts with medical staff committees that may have direct oversight of more clinically oriented issues. A serious occurrence or sentinel event could very well involve a product recall and/or a medical device alert, and merits additional comment within the context of patient safety.
Starting January 1, 2002, JCAHO made a more direct link to between the Environment of Care Standards and the patient safety standards. The standards most clearly require communications regarding patient safety as outlined in the Leadership standards.
Restraint standards: One facet of patient safety relates to injuries that may result from use of devices to restrain patients. While it is frequently believed that use of restraints prevents fall injuries, studies have shown that this is not the case. JCAHO and the Center for Medicare and Medicaid Services (CMS) formerly known as Health Care Financing Administration (HCFA), have issued new standards to ensure patients' rights that involve key patient safety aspects referred to under "restraints and seclusion,"
JCAHO: The new patient safety standards focus on reducing the need for restraints in most situations. The revised JCAHO standards on patients' rights include an emphasis on this aspect of patient safety, and are designed to reduce the use of restraints so they are used as infrequently as possible.
CMS (HCFA): In 2006 CMS published its final rule on patient's rights and use of restraints. CMS had published an interim final rule in 1999 and provide guidelines for interpretation. CMS established a specific Quality page on its Web site to assist with interpretation of this regulation. Resources on the Web page include the CMS rule with its interpretive guidelines, as well as a series of common questions and answers. The Patients' Rights standard applies to all Medicare- and Medicaid-participating hospitals (i.e. facilities for treatment of alcohol and chemical dependence and acute-care, psychiatric, rehabilitation, long-term care, and children's hospitals). The major controversy has been the 1-hour rule, which requires a physician (licensed independent practitioner) to evaluate — in person and within 1 hour — any patient who has been restrained or secluded. Despite the efforts of JCAHO to modify this rule, CMS and JCAHO enforced this aspect of the regulation. In December 2006, CMS published the final rule that revised and reconciled some of the issue. As noted, CMS currently requires that a patient be evaluated "face-to-face" within an hour of a patient being restrained or secluded for the management of violent or self-destructive behavior. Prior to this rule, these actions had to be reviewed within that hour by a physician or "other licensed independent practitioner (LIP)." The final rule expands that list to include a trained registered nurse (RN) or physician assistant (PA). The rule requires, however, that when an RN or PA performs the 1-hour-rule evaluation, the physician or other LIP treating that patient be consulted as soon as possible. The rule is effective February 6, 2007.