The Scale of Harm from Medical Error

Even conservative estimates indicate that each year in the United States, medical error causes tens of thousands of deaths, and many more serious but non-lethal injuries. In 2022, the US Department of Health and Human Services published a major study of the scope of harm from medical error. That study indicated that annually more than 1.7 million hospital patients in the United States suffer serious harm (including both lethal and non-lethal harm) from medical error.

I’ve written a summary of the major studies or articles on the scale of harm from medical error (as of late 2023). For a copy of that summary, click here.

Not all medical error constitutes negligence. In healthcare as in the rest of life, some mistakes occur despite reasonable efforts by all involved. But a lot of medical error does arise from negligence. And if we are to make healthcare as safe as it can be, we should create accountability for negligence when it occurs.

The Main Cause: Negligent Administration

The causes of medical error have been studied, and it is commonly known within the healthcare industry that medical errors usually arise from a combination of two general factors: (a) system or culture problems that create unreasonable potential for error, and (b) failings by individual clinicians within that system or culture.

Healthcare administrators have a critical role in preventing medical error.

The healthcare system is large and complex. In a hospital, for example, care of a patient typically involves multiple people in varying roles and varying specialties — for example, physicians, “mid-level” providers, nurses and nursing assistants, “allied health” staff (e.g., X-ray technicians), and support staff including secretarial, housekeeping, food service, and so on. Typically, care of a multi-day hospital patient is handed off multiple times from one physician to another, and from one nurse to another. 

The complexity of hospital care creates potential for medical errors of various kinds — for example, inattention, failures of communication, lack of preparedness, mistaken assumptions that someone else is addressing a problem, and others. 

Human error is inevitable. That is true as a general matter of human life, and it is true in healthcare. Any healthcare institution that relies solely on humans performing perfectly is doomed to fail — and to hurt patients.

Clinicians treating patients typically are not in a position to fix problems with the systems and organizational culture in a healthcare organization. A healthcare organization’s leadership thus plays an essential role in protecting patients from medical error.

To prevent inevitable human error from causing harm to patients, healthcare institutions must design and implement systems and work cultures that catch errors in time. One primary role of healthcare administrators is to anticipate vulnerabilities in the systems of care, and to put guardrails in place to prevent errors that hurt patients.

Human error can be reduced by well-designed systems. System failures in healthcare organizations can be reduced by a culture of safety and a program of continuous improvement. Errors that cause serious harm can be reduced or eliminated by managing the systems and culture of the healthcare facility.

Many types of healthcare system failures are known and predictable — for example, miscommunication during patient hand-offs, silo-ing of responsibilities, cognitive biases, overwork or understaffing, organizational cultures that discourage raising concerns about patient safety, etc.

While all this has been widely known in the healthcare industry for decades, healthcare administrators have been slow to act. For example, one of the most obvious causes of medical error is failure of communication at patient hand-offs — when a patient is handed off from one physician to another, or from one nurse to another. Even now, patients suffer serious injury, sometimes death, because of this simple, known, predictable failing. But even now, in case after case, we see hospitals that have taken little or no actions to make sure that proper communication takes place at handoffs.

Negligence by administrators promotes medical error and contributes to patient harm.

Physicians and nurses who act negligently should be held accountable for their own negligence. But it would be wrong to hold them accountable, while exempting non-clinician administrators from accountability for their own negligence.Indeed, it would be dangerous to exempt non-clinician administrators from accountability for their own negligence. That would remove an important incentive for them to work diligently to create systems that protect patients.

If we want to stop the torrent of medical errors that maim and kill people, then we have to hold healthcare administrators accountable.

The Most Common Types of Medical Error

The most common types of medical errors are:

  1. Medication events (including adverse drug events/reactions): Medication errors can occur at any stage of the medication-use process, such as when prescribing, entering information into a computer system, preparing or dispensing the drug, or administering it to the patient. Common causes include poor communication, ambiguous product names or directions, and lack of training or knowledge.

  2. Healthcare-associated infections (HAIs): Infections that patients acquire while receiving medical treatment in a healthcare setting, such as hospitals or long-term care facilities. These can be caused by poor infection control practices.

  3. Diagnostic errors: Misdiagnosis, delayed diagnosis, or failure to diagnose.

  4. Surgical errors: Mistakes that occur during surgical procedures, such as operating on the wrong body part or leaving surgical instruments inside the patient.

  5. Laboratory errors: Mistakes in laboratory testing, such as mix-ups of patient samples or inaccurate test results.

  6. Patient Falls: Falls that occur while a patient is under the care of a healthcare facility, which can lead to serious injuries.

  7. Pressure sores: Skin and tissue damage caused by prolonged pressure on the skin, often in bedridden or immobilized patients.

  8. Documentation/computer errors: Mistakes in recording patient information or data entry errors in electronic health records.

For more on this topic, see:

“Root Cause Analysis and Medical Error Prevention.”

Statistical Brief #237. Healthcare Cost and Utilization Project (HCUP).

The Most Common Root Causes of Medical Error

The most common root causes of medical errors are:

  1. Communication problems: Breakdowns in verbal or written communication between healthcare providers, or between providers and patients, are the most common cause of medical errors.

  2. Inadequate information flow: Insufficient transfer of crucial patient information, such as test results or medication orders, when patients are transferred between different healthcare settings can lead to errors.

  3. Human errors: Mistakes made by healthcare staff when they do not properly follow standards of care, policies, or procedures. This includes poor documentation, labeling errors, and knowledge-based errors.

  4. Patient-related issues: Problems such as inadequate patient assessment, failure to obtain consent, inappropriate patient identification, and insufficient patient education can contribute to errors.

  5. Organizational transfer of knowledge: Inadequate training, inconsistent education, and loss of experienced staff can lead to knowledge gaps that increase the risk of errors.

  6. Staffing patterns and workflow: Understaffing and high patient-to-caregiver ratios can create conditions more prone to mistakes.

  7. Technical failures: Issues with medical devices, equipment, or technology can directly cause errors or contribute to them.

  8. Inadequate policies: Lack of clear documentation, procedures, and protocols within healthcare organizations can enable errors to occur.

For more on this topic, see:

“Root Cause Analysis and Medical Error Prevention”

“Medical Error Reduction and Prevention”

The Importance of Administrative Leaders and a Culture of Safety

Leaders play a crucial role in developing and maintaining a strong safety culture within healthcare organizations. A safety culture is characterized by open communication, mutual trust, and a shared commitment to prioritizing patient safety above all else.

Effective leaders demonstrate their commitment to safety through their actions and decisions. They establish transparent, non-punitive reporting systems that encourage staff to identify and report adverse events, close calls, and unsafe conditions without fear of retaliation.1 Leaders must also draw clear distinctions between human error and reckless behavior, ensuring that mistakes are viewed as opportunities for improvement rather than grounds for punishment.

To build trust and accountability, leaders should model respectful behaviors, participate in safety initiatives, and provide feedback to staff who report safety concerns. They should also establish and enforce policies that support the safety culture, recognize staff who identify safety issues, and regularly assess the organization's safety culture using validated tools like the AHRQ Hospital Survey on Patient Safety Culture.

When safety culture survey results reveal opportunities for improvement, leaders should develop and implement targeted quality and safety initiatives at the unit level. Successful strategies include team training, safety briefings, huddles, and debriefs to learn from errors.

Improving safety culture has been linked to positive outcomes, such as reduced infection rates, fewer readmissions, and decreased adverse events and mortality. By prioritizing safety culture and leading by example, healthcare leaders can create an environment where staff feel empowered to identify and address safety issues, ultimately enhancing patient outcomes and organizational performance.

For more on this topic, see “Sentinel Event Alert 57: The essential role of leadership in developing a safety culture.”

The Diagnostic Process & Diagnostic Errors

Overview

Improving the diagnostic process is a critical priority in healthcare. Diagnostic errors — inaccurate or delayed diagnoses — are pervasive and can have devastating consequences for patients. Some key facts:

  • A conservative estimate found that 5% of U.S. adults seeking outpatient care each year experience a diagnostic error.

  • Diagnostic errors contribute to approximately 10% of patient deaths based on postmortem examination research.

  • Diagnostic errors account for 6-17% of hospital adverse events according to medical record reviews.

  • Diagnostic errors are the leading type of paid medical malpractice claims and are almost twice as likely to result in patient death compared to other claims.

A 2015 report by the U.S. Institute of Medicine — Improving Diagnosis in Healthcare — emphasizes that most people will experience at least one diagnostic error in their lifetime. Diagnostic errors stem from a variety of causes, including inadequate collaboration among clinicians, patients, and families, a healthcare system not well-designed to support the diagnostic process, limited feedback to clinicians, and a culture that discourages transparency.

To improve diagnosis, the report recommends eight key goals, including facilitating more effective teamwork among healthcare professionals, patients, and families; enhancing education and training; ensuring health IT supports the diagnostic process; developing approaches to identify and learn from diagnostic errors; and establishing a work culture and payment system that supports high-quality diagnosis. Achieving these goals will require a significant reenvisioning of the diagnostic process and a widespread commitment to change across the healthcare system.1Ultimately, improving diagnosis represents a moral, professional, and public health imperative. By focusing on this critical issue, healthcare can reduce patient harm and improve outcomes.

The Diagnostic Process: Differential Diagnosis & “Worst First”

The diagnostic process is how doctors figure out what is wrong with a patient. The diagnostic process is a matter of thinking like a physician. It is not necessarily the way we normally think. It requires discipline and diligence.

The diagnostic process is a back-and-forth process of gathering information, analyzing it, and coming up with a working diagnosis. First, the patient describes their symptoms and medical history to the doctor. The doctor also does a physical exam. This provides important clues to help determine the diagnosis. Doctors then consider a list of possible conditions that could be causing the patient's symptoms. This is called a "differential diagnosis." They work to narrow down this list and confirm or rule out the most likely diagnoses.

It's especially important for the doctor to quickly check for any serious, life-threatening conditions that could be causing the symptoms. This "worst first" approach ensures the doctor doesn't miss something dangerous.

The doctor gathers more information through tests like blood work or imaging scans. As they get more data, they can either confirm the working diagnosis or revise it. They share the working diagnosis with the patient and explain any uncertainty.

The goal is for the doctor to reduce uncertainty enough to make the best decisions for the patient's care, not necessarily to achieve complete certainty about the diagnosis.

A Common Diagnostic Error: Failure to Investigate the Worst First

One common type of error is the failure to consider less likely but still serious diagnoses. When a patient presents with symptoms, clinicians often focus on the most obvious or likely diagnosis based on the initial information. However, this can lead them to prematurely "seize" on that diagnosis and overlook other less likely but potentially catastrophic conditions that require urgent treatment.

This is a problem because many serious, time-sensitive conditions can have atypical or non-specific presentations, making them easy to miss. For example, a patient with an aortic dissection may initially present with only back pain, rather than the classic "ripping" chest pain. If the clinician fixates on a more common back pain diagnosis and fails to consider the aortic dissection, the delay in diagnosis can be fatal.

Similarly, certain infections and cancers can also have vague early symptoms that don't clearly point to the underlying disease. If the clinician doesn't maintain a broad differential diagnosis and explore less likely but still plausible possibilities, the patient may suffer severe consequences from a delayed or missed diagnosis.

Estimates suggest that diagnostic errors, including failure to consider critical diagnoses, are the leading cause of preventable harm in healthcare, exceeding deaths from other safety issues like medication errors or hospital-acquired infections. The impact can be catastrophic, with patients potentially losing decades of life or suffering permanent disability due to a missed or delayed diagnosis.

Addressing this problem requires changes at multiple levels — improving clinician education, developing better diagnostic decision support tools, and fostering a culture where clinicians feel empowered to keep an open mind and thoroughly evaluate all diagnostic possibilities, even the less likely ones.