In late January 2001, 18-month-old Josie King turned on the hot water and climbed into a scalding-hot bathtub. She sustained second-degree burns on 60% of her body and was admitted to Johns Hopkins Medical Center. On February 22, 2001, 2 days before her planned discharge home, Josie’s parents held their brain-dead daughter for the last time as she was disconnected from the ventilator. Her death was the result of severe dehydration and a narcotic overdose—a series of medical errors that occurred in one of the best medical centers in the country.
Quality Care Movement in America
In 2000, the Institute of Medicine (IOM) Committee on the Quality of Health Care in America published a landmark report entitled To Err Is Human, Building a Safer Health System . The report cited a study that estimated 98,000 people died every year in U.S. hospitals as a result of medical errors. This is analogous to crashing a jumbo jet every day for a year and killing all the passengers on board. The analogy provided a stirring, concrete image for the magnitude of the death toll. Until this report, the magnitude of the medical error problem in the U.S. health care system was largely unrecognized.
A study published in 2013 reported the number of preventable deaths caused by medical errors to be significantly higher—an estimated 400,000 deaths annually. If the Centers for Disease Control and Prevention (CDC) ranked medical errors as a cause of death in the United States, it would rank third behind heart disease and cancer. Furthermore, medical errors that result in patient harm but not death are estimated between 4 million and 8 million annually.
In addition to the cost in human lives, preventable medical errors have been estimated to result in total costs (additional care, lost income, lost productivity, and disability) as high as $29 billion annually. That number is estimated to reach $1 trillion annually when quality-adjusted life years are considered for those who die. The less quantifiable toll of physical and psychological pain, reduced patient and provider satisfaction and trust, and poorer health status of communities and society is a significant outcome of medical errors as well.
Since the initial report was published in 2000, many public and private institutions have become involved in efforts to raise awareness of the problem and create tools for providers to use to detect and address medical errors in a systematic fashion.
Determining the Magnitude of the Problem
In 2002, the Agency for Healthcare Research and Quality (AHRQ), in collaboration with the University of California–Stanford Evidence-Based Practice Center, developed a collection of patient safety indicators (PSIs) to help health care organizations and hospitals assess, track, monitor, and improve patient safety. These PSIs can be readily identified in hospital discharge data and are deemed potentially preventable patient safety incidents. In 2003, this set of 20 evidence-based PSIs was released to the public. As of 2016, the list has been expanded to include 25 PSIs ( Box 39.1 ). These indicators are commonly used by health care organizations and governmental agencies to determine the magnitude of the problem.
PSI 02 Death Rate in Low-Mortality Diagnosis Related Groups (DRGs)
PSI 03 Pressure Ulcer Rate
PSI 04 Death Rate among Surgical Inpatients with Serious Treatable Conditions
PSI 05 Retained Surgical Item or Unretrieved Device Fragment Count
PSI 06 Iatrogenic Pneumothorax Rate
PSI 07 Central Venous Catheter-Related Blood Stream Infection Rate
PSI 08 Postoperative Hip Fracture Rate
PSI 09 Perioperative Hemorrhage or Hematoma Rate
PSI 10 Postoperative Physiologic and Metabolic Derangement Rate
PSI 11 Postoperative Respiratory Failure Rate
PSI 12 Perioperative Pulmonary Embolism or Deep Vein Thrombosis Rate
PSI 13 Postoperative Sepsis Rate
PSI 14 Postoperative Wound Dehiscence Rate
PSI 15 Accidental Puncture or Laceration Rate
PSI 16 Transfusion Reaction Count
PSI 17 Birth Trauma Rate – Injury to Neonate
PSI 18 Obstetric Trauma Rate – Vaginal Delivery With Instrument
PSI 19 Obstetric Trauma Rate – Vaginal Delivery Without Instrument
PSI 21 Retained Surgical Item or Unretrieved Device Fragment Rate
PSI 22 Iatrogenic Pneumothorax Rate
PSI 23 Central Venous Catheter-Related Blood Stream Infection Rate
PSI 24 Postoperative Wound Dehiscence Rate
PSI 25 Accidental Puncture or Laceration Rate
PSI 26 Transfusion Reaction Rate
PSI 27 Postoperative Hemorrhage or Hematoma Rate
PSI 90 Patient Safety for Selected Indicators
Why Errors Occur
Historically, medical errors have been hidden from the public. The IOM reports that “The biggest challenge to moving toward a safer health system is changing the culture from one of blaming individuals for errors to one in which errors are treated not as personal failures, but as opportunities to improve.” The modern patient safety movement has replaced the secrecy and “blame and shame” of medical errors with a systems approach used in other high-risk industries such as airlines and nuclear power plants. This paradigm acknowledges humans as fallible and seeks to create strategies to anticipate, prevent, or catch unsafe events before they cause harm. The systems approach for safety in other industries has well-known and proven strategies, but these approaches have not been applied to medicine until recently.
The Swiss cheese model of organizational accidents developed by British psychologist James Reason is a good way to illustrate how medical errors occur ( Fig. 39.1 ). Rather than errors being the result of a single incident, they are viewed as multiple layers of fail-safes in which the holes align to produce a medical error. For example, there are several layers of protection for a patient whose provider orders the wrong dosage of a home medication in the hospital. First, the order must be received by the pharmacist and not recognized as an error. Next, the nurse administering the medication must also fail to recognize the dosage error. Finally, the patient would need to accept the error as well. The model seeks ways to shrink the holes in each layer of protection, thus making the alignment less likely and resulting error less likely to occur. It also emphasizes the need to identify the root causes that make the medical errors possible.
The overwhelming majority of medical mistakes are not made because of a lack of knowledge, training, or information but rather result from faulty systems and poorly designed processes. When human errors do occur, they are made by honest, hard-working individuals who have demanding and often stressful jobs. They often occur during automatic tasks when unintentional performance lapses in an environment where faulty processes, systems, or conditions fail to catch or prevent the error. The medical profession is often compared with other high-risk occupations whose members must perform under a high degree of stress with a high degree of accuracy. The difference is that medical professionals must combine complex decision making with customer interactions and automatic behaviors. The training for medical providers has emphasized decision making with significantly less of a focus on customer interaction and essentially no training in how to manage risky automatic behaviors.
Types of Medical Errors
In 2001, the former chief executive officer of the National Quality Forum (NQF) coined the term “never event” to identify especially egregious medical errors (such as wrong-site surgery) that should never occur. Since that time, the list of never events has been expanded to include 29 events grouped into six categories: surgical, product or device, patient protection, care management, environmental, and criminal ( Box 39.2 ). More than 4000 surgical never events occur in the United States every year and have resulted in malpractice payments totaling more than $1.3 billion over the past 20 years. Relative to the number of medical errors, never events occur infrequently. When they do occur, however, they are very likely to be fatal. Over the past 12 years, 71% of never events resulted in death.
Surgery or other invasive procedure performed on the wrong body part
Surgery or other invasive procedure performed on the wrong patient
Wrong surgical or other invasive procedure performed on a patient
Unintended retention of a foreign object in a patient after surgery or other procedure
Intraoperative or immediately postoperative or postprocedure death in an American Society of Anesthesiologists class I patient
Product or Device Events
Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the health care setting
Patient death or serious injury associated with the use or function of a device in patient care in which the device is used for functions other than as intended
Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a health care setting
Patient Protection Events
Discharge or release of a patient or resident of any age who is unable to make decisions to other than an authorized person
Patient death or serious disability associated with patient elopement (disappearance)
Patient suicide, attempted suicide, or self-harm resulting in serious disability while being cared for in a health care facility
Care Management Events
Patient death or serious injury associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration)
Patient death or serious injury associated with unsafe administration of blood products
Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy while being cared for in a health care setting
Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy
Artificial insemination with the wrong donor sperm or wrong egg
Patient death or serious injury associated with a fall while being cared for in a health care setting
Any stage 3, stage 4, or unstageable pressure ulcers acquired after admission or presentation to a health care facility
Patient death or serious disability resulting from the irretrievable loss of an irreplaceable biological specimen
Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results
Patient or staff death or serious disability associated with an electric shock in the course of a patient care process in a health care setting
Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains no gas, the wrong gas, or is contaminated by toxic substances
Patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient care process in a health care setting
Patient death or serious injury associated with the use of restraints or bedrails while being cared for in a health care setting
Death or serious injury of a patient or staff associated with introduction of a metallic object into the MRI area
Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider
Abduction of a patient or resident of any age
Sexual abuse or assault on a patient within or on the grounds of a health care setting
Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a health care setting
ABO/HLA, blood group consisting of groups A, AB, B, and O/human leukocyte antigen
MRI, Magnetic resonance imaging.
The Joint Commission has also compiled a list of events that signal the need for immediate investigation. These so-called sentinel events (that include the above never events) are defined by The Joint Commission as “unexpected occurrence[s] involving death or serious physical or psychological injury, or the risk thereof.” Serious injury is further defined as including the “loss of limb or function,” and the phrase “or the risk thereof” includes any actions or events that would increase the risk of a serious adverse outcome if it occurred again. The Joint Commission’s list of sentinel events is shown in Box 39.3 .
Any event that has resulted in an unanticipated death or major permanent loss of function not related to the natural course of the patient’s illness or underlying condition or
Any event that is one of the following (even if the outcome was not death or major permanent loss of function not related to the natural course of the patient’s illness or underlying condition):
Infant discharge to the wrong family
Unexpected death of a full-term infant
Abduction of any patient receiving care, treatment, and services
Invasive procedure, including surgery on the wrong patient, wrong site, or wrong procedure
Unintended retention of a foreign object in a patient after surgery or other invasive procedures
Rape or assault or homicide of any patient receiving care, treatment, and services
Rape, assault, or homicide of a staff member, licensed independent practitioner, visitor or vendor while on site at the health care organization
Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities
Severe neonatal hyperbilirubinemia (bilirubin >30 mg/dL)
Prolonged fluoroscopy with cumulative dose >1500 rads to a single field or any delivery of radiotherapy to the wrong body region or >25% above the planned radiotherapy dose
Suicide of any patient receiving care, treatment, and services in a continuous care setting or within 72 hours of discharge
The Joint Commission’s top 10 most frequently reported sentinel events (in order) in 2015 were as follows:
Unintended retention of foreign body
Wrong patient, wrong site, wrong procedure
Delay in treatment
Operative or postoperative complication
Other unanticipated event (asphyxiation, burn, choked on food, drowned, found unresponsive)
Perinatal death or injury
The Joint Commission notes that the terms “sentinel event” and “medical error” are not synonymous. Not all medical errors result in sentinel events, and not all sentinel events are the result of medical errors. The Joint Commission reviews all sentinel events and mandates a root cause analysis after each.
In 2015, Improving Diagnosis in Health Care was published as a follow-up to the 2000 IOM report. The new report published by the National Academy of Medicine (formerly known as the IOM) focuses on diagnostic errors, a significant but poorly addressed source of medical errors that was missing from the original 2000 report. Diagnostics errors are defined as (1) the failure to establish an accurate and timely diagnosis or (2) the failure to communicate the diagnosis to the patient. An estimated 5% of adults in the United States experience a diagnostic error each year. This equates to every American experiencing at least one error in diagnosis in their lifetime. A study by Tehrani et al. in 2013 analyzed 25 years of U.S. malpractice claims and found that the majority of paid claims were for diagnostic errors (28.6%). Diagnostic errors were nearly twice as likely as other types of claims to be associated with death. The estimated 2011 inflation adjusted payout for each diagnostic error claim was $386,849.
Medication Errors ( Fig. 39.2 )
Medication errors can be grouped into several categories: wrong patient, wrong drug, wrong dose, wrong route, or wrong frequency. These errors injure more than 1.5 million patients and result in billions of additional costs annually. Common medication errors in the past were related to illegible prescriptions and orders (see Fig. 39.2 ). Fortunately, the advent of electronic medical record systems has made a significant impact.
Other medication problems stem from the lack of standardization and presence of ambiguity in labeling of medications used in hospitals. For example, the epinephrine that is used in medical emergencies for cardiac arrest and anaphylaxis is packaged in the same vial with a similar label but in different concentrations. For anaphylaxis, a lower concentration of the medication should be given intramuscularly, but for cardiac arrest, a higher concentration should be given intravenously. Inadvertently giving the wrong concentration of the medication has led to fatal outcomes. In an effort to decrease the risk of this medical error, some hospitals are stocking prefilled intramuscular dose syringes for anaphylaxis on their crash carts. Efforts used at the development and manufacturing level, such as removing or limiting the number of drugs that look alike or sound alike (e.g., Celebrex and Cerebyx), are approaches that should reduce medical errors.
Another strategy designed to reduce medication errors is the ban on the use of certain words and abbreviations when ordering medications. The “do not use” list was developed by The Joint Commission in 2004 during a 1-day summit of representatives from more than 70 professional medical organizations and special interest group. The goal of the summit was to identify abbreviations, acronyms, and symbols that have the potential to cause errors and propose a method to eliminate or reduce the threat. The result was the official “do not use” list ( Table 39.1 ). The list applies to all orders and medication-related documents that are handwritten, free texted in the computer, or on preprinted forms.
|Do Not Use||Potential Problem||Use Instead|
|U, u (unit)||Mistaken for 0 (zero), the number 4 (four), or cc||Write “unit.”|
|IU (international unit)||Mistaken for IV (intravenous) or the number 10 (ten)||Write “international unit.”|
|Q.D., QD, q.d., qd (daily), Q.O.D., QOD, q.o.d, qod (every other day)||Mistaken for each other |
Period after the Q is mistaken for I, and the O is mistaken for I
|Write “daily.” |
Write “every other day.”
|Trailing zero (X.0 mg) |
Lack of leading zero (.X mg)
|Decimal point is missed||Write X mg |
Write 0.X mg
|MSMSO 4 and MgSO 4||Can mean morphine sulfate or magnesium sulfate |
Confused for each other
|Write “morphine sulfate.” |
Write “magnesium sulfate.”
Surgical Errors ( Fig. 39.3 )
The NQF, a nonprofit organization that sets national priorities and goals for health care quality and safety, lists surgical events as one of the six major categories of “never events.” Three of the top five sentinel events reported by The Joint Commission from 2004 to 2015 were surgical events (wrong-site surgery, unintended retention of foreign body, and operative or postoperative complications).
To address surgical errors, The Joint Commission developed a universal protocol for preventing wrong-site, wrong-procedure, and wrong-person surgery. Endorsed by more than 40 professional medical organizations, the protocol mandates active involvement and effective communication among all members of the surgical team. It involves a verification process, marking of the surgical site, and a time-out procedure ( Box 39.4 ).