Effective July 1, 2001, the Joint Commission on Accreditation of Health Care Organizations (JCAHO) published new language recognizing that "effective medical/health care error reduction requires an integrated and coordinated approach." In an effort to improve patient safety, to reduce risks, and to minimize medical errors standards have been implemented which include:
1. Leaders ensuring implementation of an integrated patient safety program throughout the [healthcare] organization.
2. Designation of one or more qualified individuals or an interdisciplinary group to manage the organization-wide patient safety program. Typically these individuals may include directors of performance improvement, safety officers, risk managers and clinical leaders.
3. Procedures for immediate response to medical/health errors, including care of the affected patient(s), containment of risk to others, and preservation of factual information for subsequent analysis.
4. Clear systems for internal and external reporting of information relating to medical/health care errors.
5. Defined mechanisms for responding to the various types of occurrences, e.g., root cause analysis in response to a sentinel event, or for conducting proactive risk reduction activities.
6. Defined mechanisms for support of staff that have been involved in a sentinel event.
7. Definition of the scope of the program activities, that is the types of occurrences to be addressed, ranging from "no harm" frequently occurring "slips" to sentinel events with serious adverse outcomes.
8. At least annually, a report to the governing body on the occurrence of medical/health care errors and actions taken to improve patient safety, both in response to actual occurrences and proactively.
The new language also requires proactive programs for identifying risks and reducing medical errors. This is geared toward the obvious advantage of preventing adverse occurrences, rather than reacting to them after they have occurred. These standards also require that the organization perform at least one high-risk process proactive assessment.
Identification of "failure modes" (steps in a process where there may be undesirable variation) is emphasized. The effect of such "failure mode" on patient care and outcome must also be analyzed. Finally, redesign and implementation needs to occur, with subsequent testing.
JCAHO also recognizes the importance of data collection along with process analysis and performance monitoring to insure risk reduction and maximize patient safety. It is also recognized that barriers to effective communication among caregivers must be minimized. Specific attention is focused on "ensuring accurate, timely, and complete verbal and written communication among caregivers." Standard RI.1.2.2 also states that, "Patients and, when appropriate, their families are informed about the outcomes of care, including unanticipated outcomes." The intent of this regulation is to have the responsible practitioner (or designee) clearly explain the outcome of any treatments or procedures to the patient (and/or family) whenever the outcome differs significantly from the anticipated outcome.
Finally, specific definitions are established:
1. Error: "An unintended act, either of omission or commission, or an act that does not achieve its intended outcome."
2. Sentinel Event: "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 risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome."
3. Near Miss: "Used to describe any process variation which did not affect the outcome but for which a recurrence carries a significant chance of a serious outcome. Such a near miss falls within the scope of the definition of a sentinel event, but outside the scope of those sentinel events that are subject to review by the Joint Commission under its Sentinel Event Policy."
4. Hazardous Condition: "Any set of circumstances (exclusive of the disease or condition for which the patient is being treated) which significantly increases the likelihood of a serious adverse outcome."
While these are important standards and regulations clearly intended to improve patient safety, there will undoubtedly be financial, logistical and resource based limitations to rapid and full implementation. The article appearing in this issue, pertaining to the development of an institutional conscious sedation policy, by Dr. Jeff Kelly gives a glimpse into the complexities of such policy implementation.
The full text of these standards revisions is available from the JCAHO website at: www.jcaho.org.
Dr. Morell is Director, Preoperative Assessment Clinic, and Associate Professor, Department of Anesthesiology, Wake Forest University School of Medicine, Winston-Salem, NC, as well as currently the Associate Editor of the APSF Newsletter and soon to be its Editor.