A variety of terms are used to define aspects of patient safety, risk reduction, and quality of care. Some of these terms are duplicative. For a number of terms the meaning has changed over time. The following are terms and their definitions used by the Institute of Medicine (IOM) and the Joint Commission in their recent standards and reporting documentation.
In Crossing the Quality Chasm, the Institute of Medicine (IOM) provided a 6-part definition of health care quality that many view as the emerging standard. According to the IOM, health care should be safe, avoiding injuries to patients from the care that is intended to help them; effective, providing services based on scientific knowledge to all who could benefit and refraining from providing services to those not likely to benefit (avoiding underuse and overuse, respectively); patient centered, providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions; timely, reducing waits and sometimes harmful delays for both those who receive and those who give care; efficient, avoiding waste, including waste of equipment, supplies, ideas, and energy; and equitable, providing care that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status.2
Lucien Leape, at the Inaugural Gala of the Leape Institute in 2008, said, "A just culture and transparent culture, where no one is punished for making or reporting errors, while at the same time everyone is held accountable. A culture of mindfulness and vigilance where every individual feels personally responsible for practicing safely and for reducing hazards. A culture where everyone feels valued and respected, but processes are standardized and simplified, teamwork trumps autonomy, and safety takes precedence over productivity" (used with permission).
Medical error has been defined as the failure of a planned action to be completed as intended (failure of execution) or use of a wrong plan to achieve an aim (error of planning).3 This is clearly a very broad definition. With regard to unintended acts, it is important to recognize that activities once considered appropriate care may now be considered a medical error and vice versa.
As defined by the Joint Commission, 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 "risk thereof" includes any process variation for which a recurrence would carry a significant change of a serious event outcome." The Joint Commission notes the term sentinel reflects an event that requires immediate investigation and response. At a leadership level, the Joint Commission requires an integrated patient safety program that includes in part (1) A definition of the types of occurrences to be addressed, (2) a mechanism to ensure that all relevant areas of the health care organization participate and that their activities are integrated, (3) a procedure of immediate response including care of the affected patient, containment of the risk to others, and preservation of information for future review, (4) clear system for internal and external reporting, (5) a defined mechanism for responding to various types of occurrences, and (6) reporting at least yearly on occurrence of errors and efforts to improve patient safety both proactively and in response to actual occurrences. Thus reporting, categorizing, and review of serious events are required and mechanisms need to be established to accomplish this goal (Table 26-2).
Table 26-2 Joint Commission Sentinel Events that Might Be Related to Anesthesia Care ||Download (.pdf)
Table 26-2 Joint Commission Sentinel Events that Might Be Related to Anesthesia Care
Events that result in an unanticipated death or major permanent loss of function and are unrelated to the natural course of the patient's illness or underlying condition
Surgery on the wrong patient or body part regardless of magnitude of procedure
Unintended retention of a foreign body after surgery or other procedure
Hemolytic transfusion reactions because of major blood group incompatibilities
Unanticipated death of a full-term infant
Prolonged fluoroscopy with a cumulative dose >1500 rads to a single field
Discharge of an infant to the wrong family
Severe neonatal hyperbilirubinemia
Suicide during treatment or within 72 h of discharge
Delivery of radiotherapy to the wrong body region or >25% above the planned radiotherapy dose
Some of these events may seem remote from the experiences of anesthesiologists whose practices are confined to the operating room. Those doing interventional pain therapy, block placement with fluoroscopic guidance, or intensive care need to be concerned with the broader range of these events.
In addition to the Joint Commission, other organizations have begun to require the documentation and reporting the equivalent of the Joint Commission sentinel event. Currently in the United States (2010), about 39 states require some form of reporting. Although the specific events and terminology may vary, there are common concepts that tend to follow the Joint Commission descriptions and more recently National Quality Forum Definitions. For example, New Hampshire's Adverse Event Reporting law (HB 592) was passed in 2009 and took effect January 1, 2010. The law requires hospitals to report certain adverse events to the NH Department of Health and Human Services (DHHS) by filing the following via a secure e-mail to DHHS: (1) An Initial Report, due within 15 days of the discovery of an adverse event, and (2) the hospital's Root Cause Analysis (RCA) and Corrective Action Plan (CAP) or a no corrective action taken statement, due within 60 days of the discovery of an adverse event.
The state's objectives with the new reporting are to improve safety by encouraging systematic, open, and transparent reporting of serious adverse events and to improve knowledge and understanding of why serious adverse events occur and how they can be prevented by identifying common underlying causes. HB 592 identifies 28 reportable events in the categories of surgical, product or device related, patient protection, care management, environmental, and criminal. (National Quality Forum: Serious Reportable Events in Healthcare Update 2010, A Consensus Report; www.qualityforum.org). The events are significant and result in either death or a permanent change in function or ability. Not all states have comparable reporting requirements to New Hampshire. However, most states publish an annual report of the number of reportable events that allow a certain level of comparison on this issue.
In some states such as New Jersey, specifically delineated events that might be associated with perioperative anesthetic care include hemolytic reactions from administration of ABO incompatible blood or blood products, electric shock, burns, injuries from the use of restraints, malfunction of ventilators or infusion pumps, surgery on the wrong body part, wrong patient, and wrong surgical procedure. They also include intraoperative or postoperative (within 12 hours) coma, death, or other serious preventable adverse event for any American Society of Anesthesiologists (ASA) class 1 inpatient or any same-day surgery patient regardless of ASA class. Other states such as Pennsylvania are less prescriptive. The Pennsylvania statute, Medical Care Availability and Reduction of Error (MCARE) Act (Act 13 of 2002), does not use the "sentinel event" terminology but rather defines a "serious event" as an event, occurrence, or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury required the delivery of additional health care services to the patient. The act further defines the term incident as an event that could have produced unexpected injury to a patient in a way similar to that defined under serious event. Several investigators have begun using state databases of reported events to determine the safety of different practices such as office-based anesthesia care.
This is defined as a "process variation" that did not affect the outcome but for which recurrence carries a significant chance of a serious adverse outcome. These events are not subject to review by the Joint Commission but need to be appropriately reviewed and changes made to decrease the risk of the event happening again.
These are defined as circumstances (not including the disease or condition for which the patient is being treated) that significantly increase the likelihood of a serious adverse outcome. A wet floor, for example, presents a hazardous condition that might increase the risk of a patient fall. The Joint Commission has now made prevention of patient falls a national patient safety goal, and therefore identification of both those at risk and hazardous conditions in those at risk is a national priority.
This is a mechanism introduced by the Joint Commission to bring attention to situations that might lead to sentinel events. Among the many are a number that appear potentially to involve the practice of anesthesia or intensive care, including high concentrations of potassium chloride, wrong surgery (wrong side, wrong patient, wrong procedure, etc), restraint deaths, high-alert medications (ie, anticoagulants, hypoglycemics, sedative/analgesics, paralytics, cardio- and vasoactive medications), operative and postoperative complications, infusion pump malfunction, look-alike sound-alike drugs, medical gas mixups, needles and sharps injuries, dangerous abbreviations, ventilator-related events, delays in treatment, nosocomial infections, surgical fires, anesthesia awareness, and patient-controlled analgesia. Once an alert occurs, it is important that it is disseminated throughout the organization.
The specialty of anesthesiology has recently addressed one of these sentinel alerts more formally. On October 6, 2004, the Joint Commission issued an alert, Preventing, and Managing the Impact of, Anesthesia Awareness. The alert went on to state:
To overcome the limitations of current methods to detect anesthesia awareness, new methods are being developed that are less affected by the drugs typically used during general anesthesia. These devices measure brain activity rather than physiological responses. These electroencephalography (EEG) devices (also called level-of-consciousness, sedation-level and anesthesia-depth monitors) include the Bispectral Index® (BIS), spectral edge frequency (SEF) and median frequency (MF) monitors. These devices may have a role in preventing and detecting anesthesia awareness in patients with the highest risk, thereby ameliorating the impact of anesthesia awareness. A body of evidence has not yet accumulated to definitely define the role of these devices in detecting and preventing anesthesia awareness; the Joint Commission expects additional studies on these subjects to emerge. In its review of the Bispectral Index (BIS) ® monitor, the Food and Drug Administration determined that "Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation."
The Joint Commission recommended that health care organizations that perform procedures under general anesthesia develop and implement an anesthesia awareness policy. Because many practitioners were concerned that a particular monitoring device was being endorsed, they developed a sample departmental policy on intraoperative awareness that is available to members. It is important to recognize that resources are available to help address some of these alerts.