Patient safety and quality of care

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).

Box 44.1

Patient Safety 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

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PSI 02 - Death rate in low-mortality diagnosis related groups (DRGs)
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PSI 03 - Pressure ulcer rate
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PSI 04 - Death rate among surgical inpatients with serious treatable conditions
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PSI 05 - Retained surgical item or unretrieved device fragment count
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PSI 06 - Iatrogenic pneumothorax rate
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PSI 07 - Central venous catheter–related bloodstream infection rate
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PSI 08 - Postoperative hip fracture rate
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PSI 09 - Perioperative hemorrhage or hematoma rate
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PSI 10 - Postoperative physiologic and metabolic derangement rate
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PSI 11 - Postoperative respiratory failure rate
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PSI 12 - Perioperative pulmonary embolism or deep vein thrombosis rate
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PSI 13 - Postoperative sepsis rate
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PSI 14 - Postoperative wound dehiscence rate
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PSI 15 - Accidental puncture or laceration rate
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PSI 16 - Transfusion reaction count
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PSI 17 - Birth trauma rate – injury to neonate
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PSI 18 - Obstetric trauma rate – vaginal delivery with instrument
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PSI 19 - Obstetric trauma rate – vaginal delivery without instrument
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PSI 90 - Patient Safety for Selected Indicators

Area-level indicators

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PSI 21 - Retained surgical item or unretrieved device fragment rate
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PSI 22 - Iatrogenic pneumothorax rate
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PSI 23 - Central venous catheter-related bloodstream infection rate
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PSI 24 - Postoperative wound dehiscence rate
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PSI 25 - Accidental puncture or laceration rate
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PSI 26 - Transfusion reaction rate
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PSI 27 - Postoperative hemorrhage or hematoma rate
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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.

Fig. 44.1, Swiss cheese model of medical errors.

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 ).

Box 44.2

National Quality Forum’s List of Serious Reportable Events

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.

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