JCAHO introduced the concept of sentinel event reporting in 1998. The sentinel event requirements of the JCAHO are found in the performance improvement standards. Accredited organizations are required to investigate sentinel events, which are to be analyzed from a systems perspective by the health care organization. “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.” The sentinel event is then subject to a root cause analysis. “Root cause analysis is a process for identifying the basic or causal factors that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event. A root cause analysis focuses primarily on systems and processes, not individual performance. It progresses from special causes in clinical processes to common causes in organizational processes, and identifies potential improvements in processes or systems that would tend to decrease the likelihood of such events in the future, or determines, after analysis that no such improvement opportunities exist.” JCAHO requires an action plan that identifies the strategies the organization intends to implement to reduce the risk of similar events occurring in the future. (See http://www.jcaho.org/accredited+organizations/hospitals/sentinel+events/se_pp.htm) In addition to the self-investigation requirement, the JCAHO has a sentinel event advisory group that reviews data and decides whether to issue an alert and develop a related patient safety goal. If an alert or patient safety goal is developed and published, all accredited facilities are expected to review the information and take the necessary action to improve patient safety. Of the 25 JCAHO safety reports available, seven have a direct impact on the activities of clinical engineers:
1. Preventing Surgical Fires, June 24, 2003 2. Bedrail-related Entrapment Deaths, September 6, 2002 3. Preventing Ventilator-related Deaths and Injuries, February 26, 2002 4. Preventing Needlestick and Sharps Injuries, August 2001 5. Medical Gas Mix-ups, July 2001 6. Fires in the Home Care Setting, March 20, 2001 7. Infusion Pumps: Preventing Future Adverse Events, November 30, 2000
In addition to the accreditation requirements, the JCAHO has begun setting national patient safety goals. Two of the seven 2004 JCAHO National Patient Safety Goals are relevant to clinical engineering:
1. “Improve the safety of using infusion pumps by ensuring free-flow protection on all general use and patient controlled analgesia intravenous infusion pumps.” 2. “Improve the effectiveness of clinical alarm systems by implementing regular preventive maintenance and testing of alarm systems. Assurance that alarms are activated with appropriate settings and are sufficiently audible with respect to distances and competing noise within the unit.”
Although JCAHO is the primary accrediting body for health care organizations, there are additional accrediting bodies that address patient safety and medical device safety. Other significant accrediting organizations include:
● The Accreditation Association of Ambulatory Health Care accredits all types of ambulatory care providers, including office based surgical practices, urgent care centers, and lithotripsy centers. ● The Commission on Accreditation of Rehabilitation Facilities accredits rehabilitation facilities, adult day care services, assisted living facilities, behavioral health organizations, community service organizations, and employment training and service organizations. ● The Community Health Accreditation Program-accredits community nursing centers, community rehabilitation centers, home care services, home infusion therapy programs, and home medical equipment providers.