Introduction
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 titled 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 had been 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. The list has undergone multiple revisions but as of 2019, there are 26 PSIs ( Box 44.1 ). These indicators are commonly used by health care organizations and governmental agencies to determine the magnitude of the problem. In addition to PSIs, the AHRQ has also developed other sets of quality indicators, including Prevention Quality Indicators, Inpatient Quality Indicators, Hospital Level Indicators, and Pediatric Quality Indicators (with a subset of Neonatal Quality Indicators).
From Agency for Healthcare Research and Quality. AHRQ Quality Indicators: Patient Safety Indicators, September 4, 2015. https://www.qualityindicators.ahrq.gov/Downloads/Modules/PSI/V50/PSI_Brochure.pdf .
Provider-level indicators
- ■
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 bloodstream 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 90 – Patient Safety for Selected Indicators
Area-level indicators
- ■
PSI 21 – Retained surgical item or unretrieved device fragment rate
- ■
PSI 22 – Iatrogenic pneumothorax rate
- ■
PSI 23 – Central venous catheter-related bloodstream 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
PSI, patient safety indicator.
Why errors occur
Historically, medical errors have been hidden from the public. The IOM reports, “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. 44.1 ). 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 the resulting error less likely to occur. It also emphasizes the need to identify the root causes that make the medical errors possible.
Human mistakes
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. Never events, now known as serious reportable events (SRE), can involve a variety of clinical settings, such as skilled nursing facilities, ambulatory surgery centers, and office-based practices, as well as inpatient settings.
As of 2019, the list of SREs are grouped into seven categories: surgical/invasive procedure, product or device, patient protection, care management, environmental, radiologic, and potentially criminal events ( Box 44.2 ).
From National Quality Forum. List of SREs. http://www.qualityforum.org/Topics/SREs/List_of_SREs.aspx .
1
Surgical or invasive procedure events
- 1A.
Surgery or other invasive procedure performed on the wrong site. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
- 1B.
Surgery or other invasive procedure performed on the wrong patient. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
- 1C.
Wrong surgical or other invasive procedure performed on a patient. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
- 1D.
Unintended retention of a foreign object in a patient after surgery or other invasive procedure. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
- 1E.
Intraoperative or immediately postoperative/postprocedure death in an ASA Class 1 patient. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices.
2
Product or device events
- 2A.
Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the health care setting. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
- 2B.
Patient death or serious injury associated with the use or function of a device in patient care, in which the device is used or functions other than as intended. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
- 2C.
Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a health care setting. Applicable in: hospitals, outpatient/office-based surgery centers, long-term care/skilled nursing facilities.
3
Patient protection events
- 3A.
Discharge or release of a patient/resident of any age who is unable to make decisions to anyone other than an authorized person. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
- 3B.
Patient death or serious injury associated with patient elopement (disappearance). Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
- 3C.
Patient suicide, attempted suicide, or self-harm that results in serious injury while being cared for in a health care setting. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities
4
Care management events
- 4A.
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). Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities
- 4B.
Patient death or serious injury associated with unsafe administration of blood products. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities
- 4C.
Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy while being cared for in a health care setting. Applicable in: hospitals, outpatient/office-based surgery centers.
- 4D.
Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy. Applicable in: hospitals, outpatient/office-based surgery centers.
- 4E.
Patient death or serious injury associated with a fall while being cared for in a health care setting. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
- 4F.
Any Stage 3, Stage 4, and unstageable pressure ulcers acquired after admission/presentation to a health care setting. Applicable in: hospitals, outpatient/office-based surgery centers, long-term care/skilled nursing facilities.
- 4G.
Artificial insemination with the wrong donor sperm or wrong egg. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices.
- 4H.
Patient death or serious injury resulting from the irretrievable loss of an irreplaceable biologic specimen. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities
- 4I.
Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
5
Environmental events
- 5A.
Patient or staff death or serious injury associated with an electric shock in the course of a patient care process in a health care setting. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
- 5B.
Any incident in which systems designated for oxygen or other gas to be delivered to a patient contain no gas, the wrong gas, or are contaminated by toxic substances. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
- 5C.
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. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
- 5D.
Patient death or serious injury associated with the use of physical restraints or bedrails while being cared for in a health care setting. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
6
Radiologic events
- 6A.
Death or serious injury of a patient or staff associated with the introduction of a metallic object into the MRI area. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices.
7
Potential criminal events
- 7A.
Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
- 7B.
Abduction of a patient/resident of any age. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
- 7C.
Sexual abuse/assault on a patient or staff member within or on the grounds of a health care setting. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
- 7D.
Death or serious 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. Applicable in: hospitals, outpatient/office-based surgery centers, ambulatory practice settings/office-based practices, long-term care/skilled nursing facilities.
MRI, magnetic resonance imaging.
More than 4000 surgical SREs occur in the United States every year and have resulted in malpractice payments totaling more than $1.3 billion over the last 20 years. Relative to the number of medical errors, SREs occur infrequently. When they do occur, however, they are very likely to be fatal. The AHRQ reported that during a 12-year period, 71% of SREs resulted in death.
The Joint Commission has also compiled a list of events that signal the need for immediate investigation. These so-called sentinel events (which include the aforementioned SREs) 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 list of sentinel events is shown in Box 44.3 .
- 1.
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
- 2.
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
- ■
In March 2019, the Joint Commission published a report of the top 10 sentinel events that occurred in 2018. The Joint Commission reviewed 801 sentinel events in 2018, the majority of which (87%) were voluntarily self-reported by health care organizations. The 10 most frequently reported sentinel events for 2018 were:
- 1.
Fall —111 events reported
- 2.
Unintended retention of a foreign body —111 events
- 3.
Wrong-site surgery —94 events
- 4.
Unassigned —68 events
- 5.
Unanticipated events such as asphyxiation, burn, choking on food, drowning, or being found unresponsive —59 events
- 6.
Suicide —50 events
- 7.
Delay in treatment —43 events
- 8.
Product or device event —29 events
- 9.
Criminal event —28 events
- 10.
Medication error —24 events
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.
Diagnosis errors
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
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 ( Fig. 44.2 ). Fortunately, the advent of electronic medical record systems has made a significant impact in that area.
Other medication problems stem from the lack of standardization and the presence of ambiguity in the labeling of medications used in hospitals. For example, the epinephrine that is used in medical emergencies for cardiac arrest and the epinephrine for anaphylaxis are 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, which has remained unchanged since its creation ( Table 44.1 ). 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
The NQF, a nonprofit organization that sets national priorities and goals for health care quality and safety, lists surgical events as one of the seven major categories of SREs. 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). Unfortunately, surgical sentinel events, such as the one depicted in Figure 44.3 , continued to rank third in the top 10 events in the Joint Commission’s 2018 report.
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 44.4 ).
Conduct a preprocedure verification process.
Address missing information or discrepancies before starting the procedure.
- ■
Verify the correct procedure, for the correct patient, at the correct site.
- ■
When possible, involve the patient in the verification process.
- ■
Identify the items that must be available for the procedure.
- ■
Use a standardized list to verify the availability of items for the procedure. (It is not necessary to document that the list was used for each patient.) At a minimum, these items include:
- ■
relevant documentation (e.g., history and physical, signed consent form, preanesthesia assessment)
- ■
labeled diagnostic and radiology test results that are properly displayed (e.g., radiology images and scans, pathology reports, biopsy reports)
- ■
any required blood products, implants, devices, or special equipment
- ■
- ■
Match the items that are to be available in the procedure area to the patient.
Mark the procedure site.
At a minimum, mark the site when there is more than one possible location for the procedure and when performing the procedure in a different location could harm the patient.
- ■
For spinal procedures, mark the general spinal region on the skin. Special intraoperative imaging techniques may be used to locate and mark the exact vertebral level.
- ■
Mark the site before the procedure is performed.
- ■
If possible, involve the patient in the site marking process.
- ■
The site is marked by a licensed independent practitioner who is ultimately accountable for the procedure and will be present when the procedure is performed.
- ■
In limited circumstances, site marking may be delegated to some medical residents, physician assistants (PAs), or advanced practice registered nurses (APRNs).
- ■
Ultimately, the licensed independent practitioner is accountable for the procedure, even when delegating site marking.
- ■
The mark is unambiguous and is used consistently throughout the organization.
- ■
The mark is made at or near the procedure site.
- ■
The mark is sufficiently permanent to be visible after skin preparation and draping.
- ■
Adhesive markers are not the sole means of marking the site.
- ■
For patients who refuse site marking or when it is technically or anatomically impossible or impractical to mark the site (see examples below), use your organization’s written, alternative process to ensure that the correct site is operated on. Examples of situations that involve alternative processes:
- ■
mucosal surfaces or perineum
- ■
minimal access procedures treating a lateralized internal organ, whether percutaneous or through a natural orifice
- ■
teeth
- ■
premature infants, for whom the mark may cause a permanent tattoo
- ■
Perform a time-out.
The procedure is not started until all questions or concerns are resolved.
- ■
Conduct a time-out immediately before starting the invasive procedure or making the incision.
- ■
A designated member of the team starts the time-out.
- ■
The time-out is standardized.
- ■
The time-out involves the immediate members of the procedure team: the individual performing the procedure, anesthesia providers, circulating nurse, operating room technician, and other active participants who will be participating in the procedure from the beginning.
- ■
All relevant members of the procedure team actively communicate during the time-out.
- ■
During the time-out, the team members agree, at a minimum, on the following:
- ■
correct patient identity
- ■
correct site
- ■
procedure to be done
- ■
- ■
When the same patient has two or more procedures, if the person performing the procedure changes, another time-out needs to be performed before starting each procedure.
- ■
Document the completion of the time-out. The organization determines the amount and type of documentation.
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