Although most biomedical equipment managers are adept at developing plans that comply with JCAHO environment-of-care standards, coming up with a plan for managing sentinel events represents a new dimension to JCAHO requirements.
Do not overlook this critical aspect of JCAHO compliance.
By now we are all adept at developing management plans that comply with the Joint Commission on Accreditation of Healthcare Organization (JCAHO) Environment of Care (EC) standards. Aside from a couple of rounds of renumbering, the EC standards have remained relatively unchanged over the past few years. That has given us a chance to refine our medical equipment–management plans and develop a degree of confidence that our JCAHO surveys will go smoothly.
However, while there has been stability in the EC standards, there has been dramatic expansion of other aspects of JCAHO compliance that affect medical equipment management: sentinel event alerts and the closely related national patient safety goals. This article tells you what you need to know about handling these important JCAHO compliance challenges.
During the 1980s, the academic field of health services research began to develop various theoretical methods for measuring the quality of health care. One approach was to define specific “sentinel health events,” each representing “a preventable disease, disability, or untimely death” that would serve as “a warning signal that the quality of preventive and/or therapeutic medical care may need to be improved.”1 In other words, the occurrence of a sentinel event would indicate a failure in the health care delivery system.
Building on this research, JCAHO now requires hospitals and other health care organizations to develop and implement policies for managing sentinel events.2 The Joint Commission defines a sentinel event as “an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof.” The phrase “or the risk thereof” is further defined as “any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.” Echoing the original health-services research, JCAHO notes that “such events are called sentinel because they signal the need for immediate investigation and response.”
The standards allow each organization to establish its own definition of sentinel events, subject to the constraint that the organization-specific definition must include the entire list of “reviewable” events specified by JCAHO. The organization is required to “identify and respond appropriately” to sentinel events that meet its organization-specific definition. An appropriate response must include “conducting a timely, thorough, and credible root cause analysis” followed by the development, implementation, and monitoring of an action plan to address the root cause (or causes) of the sentinel event.
Root cause analysis (RCA) is a method for identifying not only the proximate (immediate) cause of a system failure but, more important, the root (fundamental) cause. The emphasis on root causes rather than proximate causes is based on the fact that proximate causes are often only symptoms of underlying causes. Treatment of the symptoms often will not produce fundamental improvement in the system. By methodically working toward more fundamental explanations for a failure, RCA attempts to identify true root causes that can be addressed to produce real and sustainable improvement.3,4
RCA is a reactive technique in that it is applied after a failure occurs. As such, it is one example of a larger set of tools that can be used for incident investigations.5 These incident investigation skills are applicable not only to sentinel events but also to other clinical engineering activities, such as investigation of adverse events that may be subject to reporting requirements of the Safe Medical Devices Act or analysis of “no-problem-found” results from medical equipment maintenance.6
Health care organizations may send voluntary reports to JCAHO regarding sentinel events they experience. To be included with these reports are RCAs and descriptions of risk-reduction activities undertaken by the organizations. JCAHO enters these reports into its sentinel events database. Statistical summaries of data from the sentinel events database are available online.7
Sentinel Event Alerts
JCAHO has established the Sentinel Event Alerts Advisory Group that regularly reviews information in the sentinel events database. Periodically, the group issues Sentinel Event Alerts, a newsletter addressing “root causes and risk-reduction strategies for sentinel events that occur with significant frequency.”8 Past issues of Sentinel Event Alerts are accessible online, and a free e-mail subscription is available.9
The risk-reduction strategies described in Sentinel Event Alerts are officially regarded by JCAHO as recommendations rather than as accreditation requirements, but JCAHO surveyors will expect your organization to have reviewed the recommendations and to have implemented responses that are appropriate for your organization.
Among the 29 Sentinel Event Alerts that have been published through June 2003, several have medical equipment–related aspects, but three are of particular current interest for biomedical equipment technicians and clinical engineers:
• Issue 15 (November 2000)—“Infusion pumps: preventing future adverse events”
• Issue 25 (February 2002)—“Preventing ventilator-related deaths and injuries”
• Issue 27 (September 2002)—“Bed rail–related entrapment deaths”
The first two alerts are discussed in the next section of this article. The third alert concerns a small number of deaths by asphyxiation when elderly patients were trapped between bed rails and other parts of their beds. Sentinel Event Alerts recommendations included a variety of clinical assessments and interventions. The single technical recommendation was to “re-evaluate beds for entrapment potential, including ‘gap’ measurement and appropriate sizing of mattresses for bed frames.”10
The alert also notes, “at the present time, there are no generally accepted guidelines for ‘gap’ measurement” and, therefore, hospitals may defer implementation of the recommendation. As this article is being written, such guidelines are still not available.11 The American Society for Healthcare Engineering (ASHE) is closely monitoring this topic.12 Biomedical equipment technicians and clinical engineers should stay tuned, maintain awareness of the issue, and be prepared to respond to developments expected in the next few months.
National Patient Safety Goals
Another responsibility of the JCAHO Sentinel Event Alert Advisory Group is to develop annual national patient safety goals based on issues that have been identified in Sentinel Event Alerts. In July 2002, JCAHO published the “2003 National Patient Safety Goals,” which consisted of six goals and associated recommendations. These goals were to have been fully achieved in accredited organizations by January 1, 2003. With the addition of a seventh goal regarding hospital-acquired infections, however, all of the 2003 goals have been carried forward to become the “2004 National Patient Safety Goals.”13
National patient safety goal 5 (NPSG 5) calls on health care organizations to “improve the safety of using infusion pumps.” This goal is directly derived from Sentinel Event Alerts, issue 15, mentioned earlier. The single recommendation under this goal is to “ensure free-flow protection on all general-use and PCA [patient-controlled analgesia] intravenous infusion pumps used in the organization.”
The concern is that uncontrolled fluid flow to a patient, especially if certain powerful drugs are involved, can be harmful or even fatal. This can occur with some infusion devices when the tubing is removed from the pump without first clamping the line. ECRI has recently released a special report with updated information regarding which infusion devices incorporate free-flow protection.14 This report also includes policy and procedure recommendations for responding to NPSG 5.
NPSG 6 is intended to “improve the effectiveness of clinical alarm systems.” The origin of this goal is Sentinel Event Alerts, issue 25, which addressed ventilator-related deaths and injuries, some of which were related to ventilator alarms. This goal focuses on those alarm issues but has a much larger scope than ventilators—including, as described in the online FAQs for this goal, “any alarm that is intended to protect the individual receiving care or alert the staff that the individual is at increased risk and needs immediate assistance.”15
There are two recommendations under NPSG 6. The first, to “implement regular preventive maintenance and testing of alarm systems,” is relatively straightforward. A health care organization should prepare a complete list of its clinical alarm systems that fall under NPSG 6. The systems on this list should be incorporated into an equipment-maintenance program. This typically is the medical equipment management plan or the utility systems management plan, as appropriate.
The second recommendation, to “assure that alarms are activated with appropriate settings and are sufficiently audible with respect to distances and competing noise within the unit,” is somewhat more challenging. At first, this recommendation was taken by some organizations as requiring sound-level measurements of alarm volumes relative to ambient noise. However, it is now clear that this recommendation is primarily a matter of clinical practice—making sure that clinical personnel know how to set and how to respond to alarms, and that clinical units are arranged and staffed so that alarms will be heard.16 Nevertheless, biomedical equipment technicians and clinical engineers should participate in the planning process for responding to this recommendation, particularly when technical solutions are needed to support the clinical response.17
Practical advice to help clinical engineering programs deal with NPSG 6 is available from ECRI18 and the Association for the Advancement of Medical Instrumentation (AAMI).19
One of the most important tools for improving the performance of any system is failure mode and effect analysis (FMEA).20 The objective of the FMEA process is to identify the ways that a system can fail and to prioritize those potential failures. High-priority failure modes are then candidates for system improvement through reduction of the probability that those failures will occur and/or mitigation of the effects of those failures.
After identifying the significant failure modes for a system, each failure mode is characterized in terms of the probability of occurrence and the severity of occurrence (in other words, the degree of harm or other adverse result). The priority of a failure mode is based on a combination of probability and severity. Failure modes with high probability and high severity have the highest priority. In other words, common failures that could produce substantial harm are the ones that most deserve attention.
FMEA is a proactive technique in that it can be applied before a failure occurs. As such, it is useful in addressing NPSG 6. The FMEA process can be applied to the list of clinical alarm systems in an organization to identify high-priority issues. These issues then become the focus of the organization’s improvement activities with regard to clinical alarm systems. As is the case for RCA, failure mode and effect analysis can be applied to a wide variety of activities in clinical engineering.21
Following are some suggestions for keeping yourself aware of, and ready to respond to, sentinel event issues.
• Maintain awareness. Monitor information from ECRI, AAMI, and ASHE. These organizations will give you a “heads up” and then follow through with useful recommendations for responding to new developments. Always keep an eye on the latest from JCAHO. Subscribe to the free e-mail newsletters and regularly check the ever-evolving FAQs posted for the National Patient Safety Goals.
• Build your skills. Begin developing your skills in RCA, FMEA, and other incident investigation techniques. A working knowledge of these tools will help you deal not only with sentinel events, but also with many other issues in patient safety and clinical engineering practice.
• Join the team. Become an integral part of your organization’s patient safety program. Much of what we have been doing for many years as biomedical equipment technicians and clinical engineers can be regarded as supporting patient safety. However, you can expand your contributions (and expand your colleagues’ recognition of your contributions) by actively participating in multidisciplinary efforts to improve patient safety throughout your organization.22
Matthew F. Baretich, PE, PhD, is president of Baretich Engineering Inc (Fort Collins, Colo). He provides consulting services in clinical engineering, health care facilities engineering, and safety management.
1. Rutstein DD, Mullan RJ, Frazier TM, Halperin WE, Melius JM, Sestito JP. Sentinel health events (occupational): a basis for physician recognition and public health surveillance. Am J Public Health. 1983;73(9):1054-1062.
2. Joint Commission on Accreditation of Healthcare Organizations. Comprehensive Accreditation Manual for Hospitals: the Official Handbook. Oakbrook Terrace, Ill: Joint Commission on Accreditation of Healthcare Organizations; 2003.
3. Hirsch KA, Wallace DT. Step-by-Step Guide to Effective Root Cause Analysis. Marblehead, Mass: Opus Communications; 2001.
4. VA National Center for Patient Safety. NCPS triage cards for root cause analysis. Ann Arbor, Mich: VA National Center for Patient Safety; 2001.
5. Dekker S. The Field Guide to Human Error Investigations. Burlington, Vt: Ashgate Publishing Co; 2002.
6. Baretich MF (ed). Shepherd’s System for Medical Device Incident Investigation & Reporting. Fort Collins, Colo: Baretich Engineering Inc; 2003.
7. Joint Commission on Accreditation of Healthcare Organizations. Sentinel event statistics. Available at: http://www.jcaho.org/accredited+organizations/ambulatory+care/sentinel+events/sentinel+event+statistics.htm. Accessed January 16, 2004.
8. Joint Commission on Accreditation of Healthcare Organizations. Sentinel Event Alerts. Available at: http://www.j
caho.org/about+us/news+letters/sentinel+event+alert/sentinel+event+alert+index.htm. Accessed January 16, 2004.
9. Joint Commission on Accreditation of Healthcare Organizations. Sign up to receive free Joint Commission e-mail newsletters and information. Available at: http://www.jcaho.org/about+us/
news+letters/newsletter+signup.htm. Accessed January 16, 2004.
10. Joint Commission on Accreditation of Healthcare Organizations. Sentinel Event Alert: Bed rail–related entrapment deaths. Available at: http://www.jcaho.org/about+us/
news+letters/sentinel+event+alert/sea_27.htm. Accessed January 16, 2004.
11. Hospital Bed Safety Workgroup. Hospital Beds and the Vulnerable Patient. Available at: http://www.fda.gov/
cdrh/beds/. Accessed January 16, 2004.
12. Woodin D. Assessing the risk of bed rail-related entrapment: clinical assessment leading to equipment decisions. Inside ASHE. 2003;11(6):14-15.
13. Joint Commission on Accreditation of Healthcare Organizations. National patient safety goals. Available at: http://www.jcaho.org/accredited+organizations/patient+safety/npsg.htm. Accessed January 16, 2004.
14. ECRI. Special Report SR0018. Available at: http://
www.ecri.org/products_and_services/products/health_devices/sr0018.aspx. Accessed January 16, 2004.
15. Joint Commission on Accreditation of Healthcare Organizations. 2003 National Patient Safety Goals—FAQs. Available at: http://www.jcaho.org/accredited+organizations/
patient+safety/03+npsg/faqs+about+national+patient+safety+goals.htm. Accessed January 16, 2004.
16. ECRI. Clarifying JCAHO’s alarm-safety goal: a conversation with Richard J. Croteau, MD [Guidance article]. Health Devices. 2003;32(3):122-125.
17. Williams JS. Manufacturers move to help hospitals comply with the Joint Commission requirements on clinical alarms. Biomed Instrumen Technol. 2003;37(6):385-386.
18. ECRI. Critical alarms and patient safety: ECRI’s guide to developing effective alarm strategies and responding to JCAHO’s alarm-safety goal [Guidance article]. Health Devices. 2002;31(11):397-417.
19. Williams JS. Meeting the challenge: how hospitals complied with the new clinical alarms requirement. Biomed Instrum Technol. 2003;37(5):319-328.
20. McDermott RE, Mikulak RJ, Beauregard MR. The Basics of FMEA. New York, NY: Quality Resources; 1996.
21. DeRosier J, Stalhandske E, Bagian JP, Nudell T. Using health care failure mode and effect analysis: the VA National Center for Patient Safety’s prospective risk analysis system. Jt Comm J Qual Improv. 2002;28(5):248-267.
22. Baretich MF. Patient safety. JCAHO and You. Joint Ventures. 2001(2).