Disclosure of adverse events has become the expectation in medicine and is widely regarded as the appropriate path when medical errors occur. Although data are limited on adverse events in pediatrics, that they occur frequently is uncontested. Types and rates of errors vary depending on the care setting and patient population. Patients with complex medical conditions or from historically marginalized groups or minoritized communities likely suffer disparate health and safety outcomes. Systemic factors, including nonpunitive safety cultures and supportive environments within institutions, are essential to promoting disclosure. State laws protecting apologies from use in legal proceedings can also help to encourage open communication. Some states have adopted laws to advance disclosure, and governmental agencies provide materials encouraging open communication and early resolution after adverse events occur. Many programs emphasize the importance of supporting health care workers involved in adverse events. Shame, fear of professional and legal repercussions, and lack of training remain barriers to disclosure. Education for health care clinicians, support in health care settings, additional research on programs and disparities, and governmental and regulatory initiatives can support disclosure of adverse events.

Over the last 2 decades, there has been increased recognition of the frequency and impact of adverse events in health care, accompanied by a transformation in how disclosure of such events takes place. Patients and their families expect such disclosure in a timely fashion. Additionally, data suggest that prompt and accurate disclosure of adverse events may be associated with decreased legal liability for the health care clinician. This policy statement updates a previous version1; discusses the current state of disclosure in pediatrics and issues surrounding it, including legal and ethical implications; and provides recommendations for pediatricians.

Patient safety is the prevention of patient harm and freedom from accidental injury in the health care setting.2 An adverse event (AE) occurs when patient harm is caused by medical care.3 A medical error (ME) is an act of commission or omission that increases risk of an unintended patient outcome. AEs may be preventable (when patient harm is related to an ME) or nonpreventable (when patient harm occurs in the absence of an ME). An ME that causes patient harm becomes a preventable AE. An ME that has the potential to cause patient harm but does not do so is referred to as a potential AE or “near miss.”4 These concepts and their relationships are explained in Table 1 and illustrated in Figure 1.

Table 1.

Definitions

TermDefinition
Patient safety Prevention of patient harm and freedom from accidental injury in health care setting 
Adverse event Patient harm caused by medical care 
Medical error Act of commission or omission that unreasonably increases risk of an undesirable patient outcome 
Preventable adverse event Patient harm related to a medical error 
Nonpreventable adverse event Patient harm in absence of medical error 
Potential adverse event (near miss) Medical error with potential to cause patient harm that does not do so 
Disclosure Communication from health care personnel to affected patient and/or family about an adverse event 
Reporting Exchange of information about adverse events among clinicians and regulators 
Just culture/safety culture An organization’s shared perceptions, beliefs, values, and attitudes that promote safety and minimize harm 
TermDefinition
Patient safety Prevention of patient harm and freedom from accidental injury in health care setting 
Adverse event Patient harm caused by medical care 
Medical error Act of commission or omission that unreasonably increases risk of an undesirable patient outcome 
Preventable adverse event Patient harm related to a medical error 
Nonpreventable adverse event Patient harm in absence of medical error 
Potential adverse event (near miss) Medical error with potential to cause patient harm that does not do so 
Disclosure Communication from health care personnel to affected patient and/or family about an adverse event 
Reporting Exchange of information about adverse events among clinicians and regulators 
Just culture/safety culture An organization’s shared perceptions, beliefs, values, and attitudes that promote safety and minimize harm 
Figure 1.

Graphical Depiction of Adverse Events and Medical Errors

Figure 1.

Graphical Depiction of Adverse Events and Medical Errors

Close modal

Estimates of total annual mortality in the United States attributable to preventable AEs vary widely, from 22 0005 to as high as 250 000 deaths.6 It is estimated that 6% of patients have experienced preventable harm.7 The American Academy of Pediatrics (AAP) has called attention to the importance of pediatric patient safety since 20018 and has recommended improved identification and reporting of MEs and AEs to improve the culture of safety in pediatric care.9 

The economic cost of AEs in the United States is substantial, although estimates have varied. In 2006, costs of AEs were estimated between $393 and $958 billion, equal to 18% to 45% of total US health care spending.10 In 2008, an estimate of the cost of MEs in the United States based on claims data was $17.1 billion.11 Another study estimated that MEs in the United States cost $985 million in 2008 and over $1 billion in 2009, with median costs per error of $892 in 2008 and $939 in 2009.12 Specific costs for AEs involving children and adolescents have not been quantified.

While the exact magnitude of harm to pediatric patients from AEs is not well established, pediatric AEs occur frequently, with significant morbidity and mortality. Among Canadian inpatient pediatric AEs, the overall rate was 9.2%, and those related to surgery were most frequent13; almost half of these AEs were determined to be preventable. There are wide variations in estimates of the incidence of AEs among pediatric inpatients.9,14,15 Error rates related to medications in pediatrics have been noted to be 3 times higher than in adult patients.16 

Types and rates of MEs vary depending on the health care setting and patient population. The majority of research to date has focused on errors in inpatient or emergency department settings. Emergency care settings involve high risks for errors, given the often busy, high-volume environment with frequent interruptions and transitions in care; complex patients who may not be well-known to staff; boarding; and commonly, a lack of standardized dosing, formulary, or information technology systems with pediatric safety features.17–19 Most pediatric care occurs in ambulatory settings, and studies have reported significant numbers of errors related to medications, vaccines, diagnoses, and coordination and transition of care.20,21 Medication administration errors account for the majority of preventable adverse drug events in the outpatient pediatric setting.21–24 Although diagnostic errors occur frequently in pediatrics, relatively little research has been performed on their incidence and epidemiology.25,26 

Children with special health care needs and/or medical complexity likely have higher rates of AEs than the general population because of frequent interactions with the health care system, clinicians in multiple settings, and medical needs. They are particularly vulnerable to medical errors during care transitions.24,27–32 Families are an underused resource for detecting and reporting safety events in these populations and can provide valuable perspectives, including in ambulatory settings.33–36 

Although research is limited on rates of AEs in historically marginalized or minoritized populations, evidence shows that these communities are more likely to suffer disparate health and safety outcomes.37,38 Recent data have shown higher rates of AEs in hospitalized Latino children and publicly insured children, including serious AEs.39,40 Hospitalized children of parents with limited comfort with English were twice as likely to experience AEs from medical care.41 Language barriers have been associated with increased rates of AEs42,43; underreporting of AEs in hospitals relying on voluntary event reports44; and less willingness to question health care clinicians, which may contribute to increased safety events.45 

The Institute of Medicine (IOM) noted that most MEs are attributable to flaws in systems rather than individuals and called for a “dramatic improvement in the reliability and safety” of the health care process.3 For this improvement to occur, AEs must first be identified and analyzed to understand their preventable causes and to allow for systematic safety improvements. Disclosure and open communication with patients and their families after an AE may benefit the patient and health care clinicians, reduce consequential harms, allow for better follow-up, and promote a safety culture.

Safety culture refers to an environment that facilitates open and honest communication to promote safety and minimize harm46 and is particularly important when potentially uncomfortable topics such as MEs or preventable harm are being addressed. A growing body of literature, including subspecialty publications in pediatrics, demonstrate that safer culture is associated with safer care. Increasingly, the culture of pediatrics, and health care in general, is to promptly disclose to patients and families after an AE has taken place. Multiple factors are considered when disclosing MEs, including safety culture, clinician and patient level factors, and the type of error itself (see Figure 2).

Figure 2.

Influences on the Decision to Disclose a Medical Error (adapted from Fein et al91 [https://www.ahrq.gov/downloads/pub/advances/vol2/Fein.pdf])

Figure 2.

Influences on the Decision to Disclose a Medical Error (adapted from Fein et al91 [https://www.ahrq.gov/downloads/pub/advances/vol2/Fein.pdf])

Close modal

The concepts of reporting and disclosure of AEs should be distinguished. Reporting refers to the exchange of information among clinicians and regulators. Reporting systems may be internal to health care organizations or may be required by licensing boards and governmental regulations. These systems may be voluntary or mandatory, depending on state and institutional policies, and some organizations may use automated AE reporting. Prior reporting systems often focused on punitive consequences, which was found to deter further reporting. More recent trends emphasize the adoption of “just culture,” promote reporting of AEs by all clinicians and staff, and utilize reports to develop systematic improvements and a safer patient care environment.47,48 Additionally, there is emerging evidence that including family reports in safety surveillance systems, which is not typical in many health care institutions, may help to identify more AEs.34 

Historically, physicians were not often advised to disclose MEs to patients and their families, but early disclosure and resolution is now routinely encouraged. A variety of programs have been initiated around the United States, including the CANDOR (communication and optimal resolution) approach (https://www.ahrq.gov/patient-safety/settings/hospital/candor/index.html).49 The CANDOR program consists of 2 main components:

  1. Prompt and accurate disclosure to families

  2. Care for the caregiver (see “Effects on Health Care Clinicians” section)

Clinicians involved are expected to notify their malpractice attorney(s) or institutional legal and risk management contacts as soon as possible. It is important for trainees to immediately notify appropriate supervisors and involve them, whenever possible, in conversations with families. Additional personnel, such as office managers, unit directors, and social workers, can aid in responding and provide support and guidance. Prompt and accurate discussion is encouraged, and whenever possible, a care team should have an organized plan, including predisclosure huddles and checklists, such as those available through the AHRQ, prior to meeting with families. In the immediate aftermath of a serious event, and when there may not be time to involve additional resources, conversations with families are usually limited to statements that something went wrong and that a formal investigation—usually in the form of a “root cause analysis” or “apparent cause analysis”—is forthcoming. At the initial discussion, clinicians can advise families that not all the facts are known and can assure them that additional meetings will be scheduled as more information is available. Apologies, including statements of sympathy with or without expressions of fault, may be included in initial conversations depending on the institutions and clinicians involved as well as the legal landscape around disclosures and protections for apologies and statements of fault in the local jurisdiction.50,51 A more formal disclosure is usually done after an investigation has been conducted, and at times in conjunction with an early offer for resolution. Attorneys or risk management staff usually direct such discussions. Veracity, meaning that communication should be honest, is one of the guiding principles of bioethics and a moral foundation of disclosure. The principle of truth is deeply rooted in the practice of medicine and is essential for building trust between clinicians and patients or families. Although in the past, patients and their families were often “shielded” from the truth by paternalistic physicians, they should be viewed as partners in shared decision making. Families cannot make informed decisions for their loved ones if they have not been given relevant facts.

Children and adolescents, including those with chronic illnesses, have expressed their desire to be involved in disclosures of errors affecting their care,52 and consideration should be given to involving them in such discussions when appropriate. Disclosure to children should be individualized and should not be determined simply by age and developmental parameters. Koller et al53 have suggested that the development of policies on disclosure “must begin by examining children’s understanding of medical errors and what they expect from their health care clinicians when errors occur.”

There may be circumstances when AEs occur during the confidential treatment of adolescents, including conditions involving behavioral health, substance use, or sexual activity. Although state laws vary depending on exact age and condition, adolescents are usually legally entitled to seek treatment without needing consent from a parent or guardian for these conditions.54 In such cases, disclosures are limited to the adolescent alone. Clinicians need to remain cognizant that subsequent care for medical consequences of the AE may fall outside adolescent confidentiality protections, and state laws protecting parental rights may impose further complications. Consultation with legal and/or risk management advisors in the relevant jurisdiction is recommended because of the complexity and variety of these protections.

Disclosure practices may vary depending on setting, type of error, and patient population. Important aspects of disclosure include an explanation of what happened, acknowledgment that something has gone wrong and of responsibility, expression of sincere regret and apology, and commitment to preventing recurrences.55 These should be conducted with the involvement of appropriate parties in each practice setting. Participants may include leaders, risk managers, and possibly attorneys. Immediately after an AE occurs, clinicians can follow recommended steps such as involving team members, practice or unit leaders, risk managers, or attorneys; apologizing when appropriate; and communicating with the involved patient and/or family. Resources for responding to AEs are provided in the Toolkit Appendix.

AEs and MEs not only affect patients and their families but also may have devastating effects on health care clinicians, who may suffer emotional consequences both from preventable AEs and from subsequent malpractice litigation.56–58 Affected clinicians may feel guilt, shame, and isolation, and these feelings may be exacerbated by negative reactions from their colleagues. They may experience depression, anxiety, and/or posttraumatic stress disorder.59 Anticipated or actual punitive consequences can add further emotional and financial burdens on clinicians. Although the terminology is evolving, the concepts of “second victims” or more recently “care for the caregiver” acknowledge that clinicians often experience significant personal turmoil if an AE occurs and focus on the important need to support health care clinicians involved in these events. Support systems for affected clinicians may reduce distress among health care clinicians.60–62 The tragedy in 2011 of a pediatric intensive care unit nurse’s suicide following a medication error highlights the devastating effects that MEs can have on the health care workers as well.59 

Numerous barriers to disclosure have been identified, including shame, fear of litigation and punishment, concern about the impact on professional reputation, decreased patient trust, situational complexity, lack of training or confidence in how to disclose, inconsistent guidelines on disclosure, and the lack of a nonpunitive patient safety culture.63 Language and cultural barriers may hinder communication about AEs. Even with institutional policies advocating for disclosure, errors may not always be disclosed. In some cases, failure to disclose may impact patients at other institutions. For example, an outbreak of carbapenem-resistant Enterobacter infections related to duodenoscope contamination at one institution was associated with later deaths in other hospitals and states.64 

Factors that promote disclosure include a safe setting for reporting AEs and availability of guidelines and education on how to disclose errors.65,66 Peer support for disclosure, just-in-time disclosure coaching, refresher trainings, medical school and residency disclosure training and modeling, and organizational and national policies supporting disclosure also influence the likelihood and implementation of disclosure.55 

Patients and caregivers most often desire complete disclosure of AEs.67,68 Yet historically, lawyers advised their physician-clients not to disclose MEs and did so with sound legal justification, because of the risk of statements of apology being used against physicians if an AE should result in a lawsuit.51,69,70 Physicians were trained that admitting fault would increase the risk of being sued.

However, studies suggest that affected patients and families may be less likely to pursue litigation against their health care clinicians if such disclosure is provided.71–76 Lack of such communication may make patients feel worse and may erode the sense of trust in their caregivers that is key to healing and to optimal health care. Although there is some disagreement in the legal literature on the impact of apologies and admissions of fault,77–79 the preponderance of the data, as well as the guiding ethical principles, support prompt and accurate disclosure.80 Patients and families expect information about the error, sincere remorse, and a pledge of improvement.66 

Numerous states have passed so-called “apology laws,” which protect statements of apologies from being used in court against health care clinicians. As of 2022, 39 states and the District of Columbia have such statutes.81 Most of these states protect only sympathetic statements, such as saying “I’m sorry for your suffering” or “I regret that this happened,” while 9 states also protect statements of fault.50 These apology laws, along with institutional, state, and federal efforts to implement disclosure programs, may help to encourage candid discussions after AEs.74 More recently, several states have developed “candor laws” that provide a process for investigating and communicating openly about AEs. Under the Colorado Candor Act, for example, discussions and offers of compensation held in the process are privileged and confidential, meaning they cannot be used against clinicians if the injured party later decides to file a lawsuit.82 

A case in which a nurse was convicted of negligent homicide after a medication error highlights the need for broader legal protections for statements about AEs. In this case in Tennessee, which was decided in 2022, the nurse’s words to state investigators were used against her in court. Widespread concern has been expressed that health care workers will be hesitant to disclose errors if their cooperation will be used as part of criminal prosecutions.83,84 Although this type of legal case is extremely rare, the potential deterring effect on self-reporting could not only undermine the disclosure of AEs but also reverse gains in establishing a culture of safety and other patient safety initiatives.85 

In 2019, disclosure of AEs was included as a common program requirement for resident education and experience, highlighting the importance of disclosure as a patient safety skill by the Accreditation Council for Graduate Medical Education (ACGME) (https://www.acgme.org/What-We-Do/Accreditation/Common-Program-Requirements). With increased focus on experiential learning, trainees have been involved in real or simulation scenarios, including disclosure of AEs.86,87 Disclosure practices are also included as one of 13 core professional activities for medical school graduates by the Association of American Medical Colleges, as part of identifying system failures and contributing to a culture of safety and improvement.88,89 Continued education in patient safety and developing communication skills for effective disclosure is needed at all training and career levels.55,90 

Progress has been made toward routine disclosure of adverse events over the past decades. Further efforts to better understand adverse events in pediatrics, focusing on risks, different health care settings, and inequitable practices that disproportionately impact historically marginalized or minoritized populations, may help to improve trends in disclosure. Support from institutions and legal protections can facilitate a culture of safety, reduce fear of disclosure, and provide enhanced education and support for health care clinicians involved in adverse events.

  1. Develop and implement policies and procedures for identifying and disclosing AEs to patients and families in an honest and empathetic manner as part of a nonpunitive safety culture.

  2. Develop policies and procedures and provide resources to support clinicians and other staff involved in AEs.

  3. Encourage a culture of safety, just culture, and reporting by all staff as well as by patients and families.

  4. Identify populations and situations with higher risk for AEs, such as patients with chronic illnesses and those from historically marginalized or minoritized communities, and partner with families and care teams to help prevent them.

  • 5. Develop and implement educational programs regarding identification and prevention of MEs and communication about AEs with patients and their families as part of a comprehensive patient safety curriculum.

  • 6. Investigate the consequences of various approaches to disclosure as well as of the effectiveness of disclosure education.

  • 7. Further explore and address disparities in AEs and disclosure. More data are needed on trends in AEs and disclosure by race, ethnicity, chronic conditions, and preferred language; impact of AEs and disclosure on historically marginalized or minoritized communities; structural factors related to disclosure; and impact on clinicians underrepresented in medicine.

  • 8. Encourage states and the federal government to adopt laws protecting apologies, programs supporting disclosure, and other mechanisms to reduce liability risks associated with disclosure in order to avoid detrimental effects on health care clinicians’ reactions to AEs.

For more information about advocating for these issues, contact the AAP state advocacy team at [email protected].

This document is copyrighted and is property of the American Academy of Pediatrics and its Board of Directors. All authors have filed conflict of interest statements with the American Academy of Pediatrics. Any conflicts have been resolved through a process approved by the Board of Directors. The American Academy of Pediatrics has neither solicited nor accepted any commercial involvement in the development of the content of this publication.

Policy statements from the American Academy of Pediatrics benefit from expertise and resources of liaisons and internal (AAP) and external reviewers. However, policy statements from the American Academy of Pediatrics may not reflect the views of the liaisons or the organizations or government agencies that they represent.

The guidance in this statement does not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate.

All policy statements from the American Academy of Pediatrics automatically expire 5 years after publication unless reaffirmed, revised, or retired at or before that time.

Laura Sigman, MD, JD, FAAP

Robert Turbow, MD, JD, FAAP

Daniel Neuspiel, MD, MPH, FAAP

Julia M. Kim, MD, MPH, FAAP

Steven A. Bondi, JD, MD, FAAP, Chairperson

Craig Howard Gosdin, MD, FAAP

David A. Horowitz, MD, FAAP

Kajal Khanna, MD, JD, FAAP

Jonathan Muraskas, MD, FAAP

Alan L. Nager, MD, MHA, FAAP

Sarah W. Northrop, MD, FAAP

Preethi Srinivasakumar, MD, FAAP

Michelle Terry, MD, FAAP

Ryan Earl Alanzalon, MD, FAAP

James Peter Scibilia, MD, FAAP, Immediate Past Chairperson

Laura Sigman, MD, JD, FAAP

Robert Turbow, MD, JD, FAAP

Julie Kersten Ake

Sunnah Kim

Ulfat Shaikh, MD, FAAP Chairperson

Francisco Javier Alvarez, MD, FAAP

John Chuo, MD, FAAP

Meghan Drayton Jackson, DO, FAAP

Julia M. Kim, MD, FAAP

Mary Beth Miotto, MD, FAAP

Raina Paul, MD, FAAP

Corinna Rea, MD, FAAP

Sandra Spencer, MD, FAAP

Amy Tyler, MD, FAAP

Joyee Vachani, MD, FAAP

Cathleen Guch

All authors contributed substantially to the conception and design; review and interpretation of relevant literature; drafting and revisions; and final approval of the version to the published.

CONFLICT OF INTEREST DISCLOSURE: The authors have indicated they have no potential conflicts of interest to disclose.

FUNDING: No external funding.

AAP

American Academy of Pediatrics

AEs

adverse events

AHRQ

Agency for Healthcare Research and Quality

IOM

Institute of Medicine

MEs

medical errors.

1
McDonnell
WM
,
Altman
RL
,
Bondi
SA
, et al;
COMMITTEE ON MEDICAL LIABILITY AND RISK MANAGEMENT; COUNCIL ON QUALITY IMPROVEMENT AND PATIENT SAFETY
.
Disclosure of adverse events in pediatrics
.
Pediatrics.
2016
;
138
(
6
):
e20163215
. PubMed doi: 10.1542/peds.2016-3215
2
Institute of Medicine, Committee on Quality of Health Care in America
.
Crossing the Quality Chasm: A New Health System for the 21st Century
.
National Academy Press
;
2001
.
3
Institute of Medicine, Committee on Quality of Health Care in America
.
To Err Is Human: Building a Safer Health System
.
Kohn
LT
,
Corrigan
JM
,
Donaldson
MS
, eds.
National Academies Press
;
2000
.
4
Rodziewicz
TL
,
Houseman
B
,
Hipskin
J
.
Medical Error Reduction and Prevention
.
StatPearls Publishing
;
2022
.
5
Rodwin
BA
,
Bilan
VP
,
Merchant
NB
, et al
.
Rate of preventable mortality in hospitalized patients: a systematic review and meta-analysis
.
J Gen Intern Med.
2020
;
35
(
7
):
2099
2106
. PubMed doi: 10.1007/s11606-019-05592-5
6
Makary
MA
,
Daniel
M
.
Medical error-the third leading cause of death in the US
.
BMJ.
2016
;
353
:
i2139
. PubMed doi: 10.1136/bmj.i2139
7
Panagioti
M
,
Khan
K
,
Keers
RN
, et al
.
Prevalence, severity, and nature of preventable patient harm across medical care settings: systematic review and meta-analysis
.
BMJ.
2019
;
366
:
l4185
. PubMed doi: 10.1136/bmj.l4185
8
Lannon
CM
,
Coven
BJ
,
Lane France
F
, et al;
National Initiative for Children’s Health Care Quality Project Advisory Committee
.
Principles of patient safety in pediatrics
.
Pediatrics.
2001
;
107
(
6
):
1473
1475
. PubMed doi: 10.1542/peds.107.6.1473
9
Mueller
BU
,
Neuspiel
DR
,
Fisher
ERS
, et al;
COUNCIL ON QUALITY IMPROVEMENT AND PATIENT SAFETY, COMMITTEE ON HOSPITAL CARE
.
Policy Statement. Principles of pediatric patient safety: reducing harm due to medical care
.
Pediatrics.
2019
;
143
(
2
):
e20183649
. PubMed doi: 10.1542/peds.2018-3649
10
Goodman
JC
,
Villarreal
P
,
Jones
B
.
The social cost of adverse medical events, and what we can do about it
.
Health Aff (Millwood).
2011
;
30
(
4
):
590
595
. PubMed doi: 10.1377/hlthaff.2010.1256
11
Van Den Bos
J
,
Rustagi
K
,
Gray
T
,
Halford
M
,
Ziemkiewicz
E
,
Shreve
J
.
The $17.1 billion problem: the annual cost of measurable medical errors
.
Health Aff (Millwood).
2011
;
30
(
4
):
596
603
. PubMed doi: 10.1377/hlthaff.2011.0084
12
David
G
,
Gunnarsson
CL
,
Waters
HC
,
Horblyuk
R
,
Kaplan
HS
.
Economic measurement of medical errors using a hospital claims database
.
Value Health.
2013
;
16
(
2
):
305
310
. PubMed doi: 10.1016/j.jval.2012.11.010
13
Matlow
AG
,
Baker
GR
,
Flintoft
V
, et al
.
Adverse events among children in Canadian hospitals: the Canadian Paediatric Adverse Events Study
.
CMAJ.
2012
;
184
(
13
):
E709
E718
. PubMed doi: 10.1503/cmaj.112153
14
Gates
PJ
,
Meyerson
SA
,
Baysari
MT
,
Lehmann
CU
,
Westbrook
JI
.
Preventable adverse drug events among inpatients: a systematic review
.
Pediatrics.
2018
;
142
(
3
):
e20180805
. PubMed doi: 10.1542/peds.2018-0805
15
Schroeder
L
,
Stockwell
DC
.
The persistent challenge of understanding preventable adverse drug events
.
Pediatrics.
2018
;
142
(
3
):
e20181841
. PubMed doi: 10.1542/peds.2018-1841
16
Kaushal
R
,
Bates
DW
,
Landrigan
C
, et al
.
Medication errors and adverse drug events in pediatric inpatients
.
JAMA.
2001
;
285
(
16
):
2114
2120
. PubMed doi: 10.1001/jama.285.16.2114
17
Benjamin
L
,
Frush
K
,
Shaw
K
, et al;
AMERICAN ACADEMY OF PEDIATRICS Committee on Pediatric Emergency Medicine; AMERICAN COLLEGE OF EMERGENCY PHYSICIANS Pediatric Emergency Medicine Committee; EMERGENCY NURSES ASSOCIATION Pediatric Emergency Medicine Committee
.
Pediatric medication safety in the emergency department
.
Pediatrics.
2018
;
141
(
3
):
e20174066
. PubMed doi: 10.1542/peds.2017-4066
18
Gross
TK
,
Lane
NE
,
Timm
NL
, et al;
COMMITTEE ON PEDIATRIC EMERGENCY MEDICINE
.
Crowding in the emergency department: challenges and best practices for the care of children
.
Pediatrics.
2023
;
151
(
3
):
e2022060972
. PubMed doi: 10.1542/peds.2022-060972
19
Joseph
MM
,
Mahajan
P
,
Snow
SK
,
Ku
BC
,
Saidinejad
M
;
AMERICAN ACADEMY OF PEDIATRICS COMMITTEE ON PEDIATRIC EMERGENCY MEDICINE, AMERICAN COLLEGE OF EMERGENCY PHYSICIANS PEDIATRIC EMERGENCY MEDICINE COMMITTEE, and EMERGENCY NURSES ASSOCIATION PEDIATRIC COMMITTEE
.
Optimizing pediatric patient safety in the emergency care setting
.
Pediatrics.
2022
;
150
(
5
):
e2022059673
. PubMed doi: 10.1542/peds.2022-059673
20
Neuspiel
DR
,
Stubbs
EH
.
Patient safety in ambulatory care
.
Pediatr Clin North Am.
2012
;
59
(
6
):
1341
1354
. PubMed doi: 10.1016/j.pcl.2012.08.006
21
Huth
K
,
Hotz
A
,
Starmer
AJ
.
Patient safety in ambulatory pediatrics
.
Curr Treat Options Pediatr.
2020
;
6
(
4
):
350
365
. PubMed doi: 10.1007/s40746-020-00213-4
22
Kaushal
R
,
Goldmann
DA
,
Keohane
CA
, et al
.
Adverse drug events in pediatric outpatients
.
Ambul Pediatr.
2007
;
7
(
5
):
383
389
. PubMed doi: 10.1016/j.ambp.2007.05.005
23
Yin
HS
,
Parker
RM
,
Sanders
LM
, et al
.
Liquid medication errors and dosing tools: a randomized controlled experiment
.
Pediatrics.
2016
;
138
(
4
):
e20160357
. PubMed doi: 10.1542/peds.2016-0357
24
Yin
HS
,
Neuspiel
DR
,
Paul
IM
, et al;
American Academy of Pediatrics, Council on Quality Improvement and Patient Safety, Committee on Drugs
.
Policy statement. Preventing home medication administration errors
.
Pediatrics.
2021
;
148
(
6
):
e2021054666
. PubMed doi: 10.1542/peds.2021-054666
25
Rinke
ML
,
Singh
H
,
Heo
M
, et al
.
Diagnostic errors in primary care pediatrics: Project RedDE
.
Acad Pediatr.
2018
;
18
(
2
):
220
227
. PubMed doi: 10.1016/j.acap.2017.08.005
26
Marshall
TL
,
Rinke
ML
,
Olson
APJ
,
Brady
PW
.
Diagnostic error in pediatrics: a narrative review
.
Pediatrics.
2022
;
149
(
suppl 3
):
e2020045948D
. PubMed doi: 10.1542/peds.2020-045948D
27
Rinke
ML
,
Bundy
DG
,
Shore
AD
,
Colantuoni
E
,
Morlock
LL
,
Miller
MR
.
Pediatric antidepressant medication errors in a national error reporting database
.
J Dev Behav Pediatr.
2010
;
31
(
2
):
129
136
. PubMed doi: 10.1097/DBP.0b013e3181ce6509
28
Taylor
JA
,
Winter
L
,
Geyer
LJ
,
Hawkins
DS
.
Oral outpatient chemotherapy medication errors in children with acute lymphoblastic leukemia
.
Cancer.
2006
;
107
(
6
):
1400
1406
. PubMed doi: 10.1002/cncr.22131
29
Walsh
KE
,
Mazor
KM
,
Stille
CJ
, et al
.
Medication errors in the homes of children with chronic conditions
.
Arch Dis Child.
2011
;
96
(
6
):
581
586
. PubMed doi: 10.1136/adc.2010.204479
30
Stone
BL
,
Boehme
S
,
Mundorff
MB
,
Maloney
CG
,
Srivastava
R
.
Hospital admission medication reconciliation in medically complex children: an observational study
.
Arch Dis Child.
2010
;
95
(
4
):
250
255
. PubMed doi: 10.1136/adc.2009.167528
31
Feinstein
JA
,
Feudtner
C
,
Kempe
A
.
Adverse drug event-related emergency department visits associated with complex chronic conditions
.
Pediatrics.
2014
;
133
(
6
):
e1575
e1585
. PubMed doi: 10.1542/peds.2013-3060
32
Huth
K
,
Vandecruys
P
,
Orkin
J
,
Patel
H
.
Medication Safety for children with medical complexity. Canadian Pediatric Society
.
Paediatr Child Health.
2020
;
25
(
7
):
473
474
. doi: 10.1093/pch/pxaa105
33
Khan
A
,
Baird
J
,
Kelly
MM
, et al
.
Family safety reporting in medically complex children: parent, staff, and leader perspectives
.
Pediatrics.
2022
;
149
(
6
):
e2021053913
. PubMed doi: 10.1542/peds.2021-053913
34
Khan
A
,
Furtak
SL
,
Melvin
P
,
Rogers
JE
,
Schuster
MA
,
Landrigan
CP
.
Parent-reported errors and adverse events in hospitalized children
.
JAMA Pediatr.
2016
;
170
(
4
):
e154608
. PubMed doi: 10.1001/jamapediatrics.2015.4608
35
Daniels
JP
,
Hunc
K
,
Cochrane
DD
, et al
.
Identification by families of pediatric adverse events and near misses overlooked by health care providers
.
CMAJ.
2012
;
184
(
1
):
29
34
. PubMed doi: 10.1503/cmaj.110393
36
Lang
S
,
Garrido
MV
,
Heintze
C
.
Patients’ views of adverse events in primary and ambulatory care: a systematic review to assess methods and the content of what patients consider to be adverse events
.
BMC Fam Pract.
2016
;
17
:
6
. PubMed doi: 10.1186/s12875-016-0408-0
37
Jean-Pierre
P
.
Medical error and vulnerable communities
.
Boston Univ Law Rev.
2022
;
102
:
327
392
.
38
Raman
J
,
Johnson
TJ
,
Hayes
K
,
Balamuth
F
.
Racial differences in sepsis recognition in the emergency department
.
Pediatrics.
2019
;
144
(
4
):
e20190348
. PubMed doi: 10.1542/peds.2019-0348
39
Stockwell
DC
,
Landrigan
CP
,
Toomey
SL
, et al;
GAPPS Study Group
.
Racial, ethnic, and socioeconomic disparities in patient safety events for hospitalized children
.
Hosp Pediatr.
2019
;
9
(
1
):
1
5
. PubMed doi: 10.1542/hpeds.2018-0131
40
Lion
KC
,
Rafton
SA
,
Shafii
J
, et al
.
Association between language, serious adverse events, and length of stay among hospitalized children
.
Hosp Pediatr.
2013
;
3
(
3
):
219
225
. PubMed doi: 10.1542/hpeds.2012-0091
41
Khan
A
,
Yin
HS
,
Brach
C
, et al;
Patient and Family Centered I-PASS Health Literacy Subcommittee
.
Patient and Family Centered I-PASS Health Literacy Subcommittee. Association between parent comfort with English and adverse events among hospitalized children
.
JAMA Pediatr.
2020
;
174
(
12
):
e203215
. PubMed doi: 10.1001/jamapediatrics.2020.3215
42
Cohen
AL
,
Rivara
F
,
Marcuse
EK
,
McPhillips
H
,
Davis
R
.
Are language barriers associated with serious medical events in hospitalized pediatric patients?
Pediatrics.
2005
;
116
(
3
):
575
579
. PubMed doi: 10.1542/peds.2005-0521
43
Divi
C
,
Koss
RG
,
Schmaltz
SP
,
Loeb
JM
.
Language proficiency and adverse events in US hospitals: a pilot study
.
Int J Qual Health Care.
2007
;
19
(
2
):
60
67
. PubMed doi: 10.1093/intqhc/mzl069
44
Halvorson
EE
,
Thurtle
DP
,
Easter
A
,
Lovato
J
,
Stockwell
D
.
Disparities in adverse event reporting for hospitalized children
.
J Patient Saf.
2022
;
18
(
6
):
e928
e933
. PubMed doi: 10.1097/PTS.0000000000001049
45
Khan
A
,
Parente
V
,
Baird
JD
, et al;
Patient and Family Centered I-PASS SCORE Scientific Oversight Committee
.
Association of patient and family reports of hospital safety climate with language proficiency in the US
.
JAMA Pediatr.
2022
;
176
(
8
):
776
786
. PubMed doi: 10.1001/jamapediatrics.2022.1831
46
Weaver
SJ
,
Lubomksi
LH
, et al
.
Promoting a culture of safety as a patient safety strategy: a systematic review
.
Ann Int Med.
2013
;
158
(
5.2
):
369
374
. PubMed doi: 10.7326/0003-4819-158-5-201303051-00002
47
Boysen PG II
.
Just culture: a foundation for balanced accountability and patient safety
.
Ochsner J.
2013
;
13
(
3
):
400
406
. PubMed
48
Marx
D
.
Patient safety and the just culture
.
Obstet Gynecol Clin North Am.
2019
;
46
(
2
):
239
245
. PubMed doi: 10.1016/j.ogc.2019.01.003
49
Agency for Healthcare Research and Quality
.
Communication and Optimal Resolution (CANDOR).
Accessed July 19, 2024. https://www.ahrq.gov/patient-safety/settings/hospital/candor/index.html
50
Ross
NE
,
Newman
WJ
.
The role of apology laws in medical malpractice
.
J Am Acad Psychiatry Law.
2021
;
49
(
3
):
406
414
. PubMed
51
Mastroianni
AC
,
Mello
MM
,
Sommer
S
,
Hardy
M
,
Gallagher
TH
.
The flaws in state ‘apology’ and ‘disclosure’ laws dilute their intended impact on malpractice suits
.
Health Aff (Millwood).
2010
;
29
(
9
):
1611
1619
. PubMed doi: 10.1377/hlthaff.2009.0134
52
Koller
D
,
Binder
MJ
,
Alexander
S
,
Darch
J
.
“Everybody makes mistakes”: children’s views on medical errors and disclosure
.
J Pediatr Nurs.
2019
;
49
:
1
9
. PubMed doi: 10.1016/j.pedn.2019.07.014
53
Koller
D
,
Rummens
A
,
Le Pouesard
M
, et al
.
Patient disclosure of medical errors in paediatrics: A systematic literature review
.
Paediatr Child Health.
2016
;
21
(
4
):
e32
e38
. PubMed doi: 10.1093/pch/21.4.e32
54
Chung
RJ
,
Lee
JB
,
Hackell
JM
, et al;
COMMITTEE ON ADOLESCENCE; COMMITTEE ON PRACTICE & AMBULATORY MEDICINE
.
Confidentiality in the care of adolescents: policy statement
.
Pediatrics.
2024
;
153
(
5
):
e2024066326
. PubMed doi: 10.1542/peds.2024-066326
55
Wu
AW
,
Boyle
DJ
,
Wallace
G
,
Mazor
KM
.
Disclosure of adverse events in the United States and Canada: an update, and a proposed framework for improvement
.
J Public Health Res.
2013
;
2
(
3
):
e32
. PubMed doi: 10.4081/jphr.2013.e32
56
Wu
AW
.
Medical error: the second victim
.
The doctor who makes the mistake needs help too
.
BMJ.
2000
;
320
(
7237
):
726
727
. PubMed doi: 10.1136/bmj.320.7237.726
57
Seys
D
,
Wu
AW
,
Van Gerven
E
, et al
.
Health care professionals as second victims after adverse events: a systematic review
.
Eval Health Prof.
2013
;
36
(
2
):
135
162
. PubMed doi: 10.1177/0163278712458918
58
Coughlan
B
,
Powell
D
,
Higgins
MF
.
The second victim: a review
.
Eur J Obstet Gynecol Reprod Biol.
2017
;
213
:
11
16
. PubMed doi: 10.1016/j.ejogrb.2017.04.002
59
Grissinger
M
.
Too many abandon the “second victims” of medical errors
.
P&T.
2014
;
39
(
9
):
591
592
. PubMed
60
Edrees
H
,
Connors
C
,
Paine
L
,
Norvell
M
,
Taylor
H
,
Wu
AW
.
Implementing the RISE second victim support programme at the Johns Hopkins Hospital: a case study
.
BMJ Open.
2016
;
6
(
9
):
e011708
. PubMed doi: 10.1136/bmjopen-2016-011708
61
Busch
IM
,
Moretti
F
,
Campagna
I
, et al
.
Promoting the psychological well-being of healthcare providers facing the burden of adverse events: a systematic review of second victim support resources
.
Int J Environ Res Public Health.
2021
;
18
(
10
):
5080
. PubMed doi: 10.3390/ijerph18105080
62
Shapiro
J
,
Galowitz
P
.
Peer support for clinicians: a programmatic approach
.
Acad Med.
2016
;
91
(
9
):
1200
1204
. PubMed doi: 10.1097/ACM.0000000000001297
63
Edwards
MT
.
An assessment of the impact of just culture on quality and safety in US hospitals
.
Am J Med Qual.
2018
;
33
(
5
):
502
508
. PubMed doi: 10.1177/1062860618768057
64
Centers for Disease Control and Prevention
.
Los Angeles County/UCLA investigation of CRE transmission and duodenoscopes
. July 10,
2015
. Accessed July 19, 2024. https://archive.cdc.gov/www_cdc_gov/hai/outbreaks/cdcstatement-la-cre.html#:∼:text=In%20this%20investigation%2C%20exposure%20to,associated%20with%20transmission%20of%20CRE
65
Ock
M
,
Lim
SY
,
Jo
MW
,
Lee
SI
.
Frequency, expected effects, obstacles, and facilitators of disclosure of patient safety incidents: a systematic review
.
J Prev Med Public Health.
2017
;
50
(
2
):
68
82
. PubMed doi: 10.3961/jpmph.16.105
66
Sattar
R
,
Johnson
J
,
Lawton
R
.
The views and experiences of patients and health-care professionals on the disclosure of adverse events: A systematic review and qualitative meta-ethnographic synthesis
.
Health Expect.
2020
;
23
(
3
):
571
583
. PubMed doi: 10.1111/hex.13029
67
Coffey
M
,
Espin
S
,
Hahmann
T
, et al
.
Parent preference for medical error disclosure: a qualitative study
.
Hosp Pediatr.
2017
;
7
(
1
):
24
30
. PubMed doi: 10.1542/hpeds.2016-0048
68
Hobgood
C
,
Tamayo-Sarver
JH
,
Elms
A
,
Weiner
B
.
Parental preferences for error disclosure, reporting, and legal action after medical error in the care of their children
.
Pediatrics.
2005
;
116
(
6
):
1276
1286
. PubMed doi: 10.1542/peds.2005-0946
69
Hyman
DA
.
When and why lawyers are the problem
.
Depaul L Rev.
2008
;
57
(
2
):
267
280
.
70
Tabler
N
.
Should physicians apologize for medical errors?
Health Lawyer.
2007
;
19
:
23
30
.
71
Helmchen
LA
,
Richards
MR
,
McDonald
TB
.
How does routine disclosure of medical error affect patients’ propensity to sue and their assessment of provider quality? Evidence from survey data
.
Med Care.
2010
;
48
(
11
):
955
961
. PubMed doi: 10.1097/MLR.0b013e3181eaf84d
72
Kachalia
A
,
Kaufman
SR
,
Boothman
R
, et al
.
Liability claims and costs before and after implementation of a medical error disclosure program
.
Ann Intern Med.
2010
;
153
(
4
):
213
221
. PubMed doi: 10.7326/0003-4819-153-4-201008170-00002
73
Adams
MA
,
Elmunzer
BJ
,
Scheiman
JM
.
Effect of a health system’s medical error disclosure program on gastroenterology-related claims rates and costs
.
Am J Gastroenterol.
2014
;
109
(
4
):
460
464
. PubMed doi: 10.1038/ajg.2013.375
74
Mello
MM
,
Kachalia
A
,
Roche
S
, et al
.
Outcomes in two Massachusetts hospital systems give reason for optimism about communication-and-resolution programs
.
Health Aff (Millwood).
2017
;
36
(
10
):
1795
1803
. PubMed doi: 10.1377/hlthaff.2017.0320
75
Kachalia
A
,
Sands
K
,
Niel
MV
, et al
.
Effects of a communication-and-resolution program on hospitals’ malpractice claims and costs
.
Health Aff (Millwood).
2018
;
37
(
11
):
1836
1844
. PubMed doi: 10.1377/hlthaff.2018.0720
76
Gallagher
TH
,
Mello
MM
,
Sage
WM
,
Bell
SK
,
McDonald
TB
,
Thomas
EJ
.
Can communication-and-resolution programs achieve their potential? Five key questions
.
Health Aff (Millwood).
2018
;
37
(
11
):
1845
1852
. PubMed doi: 10.1377/hlthaff.2018.0727
77
McMichael
BJ
,
Van Horn
RL
,
Viscusi
WK
.
“Sorry” is never enough: how state apology laws fail to reduce medical malpractice liability risk
.
Stanford Law Rev.
2019
;
71
(
2
):
341
409
. PubMed
78
Berlin
L
.
Will “sorry” make things worse?
Radiology.
2020
;
294
(
1
):
239
240
. PubMed doi: 10.1148/radiol.2019192231
79
Painter
LM
,
Kidwell
KM
,
Kidwell
RP
, et al
.
Do written disclosures of serious events increase risk of malpractice claims? One health care system’s experience
.
J Patient Saf.
2018
;
14
(
2
):
87
94
. PubMed doi: 10.1097/PTS.0000000000000178
80
Phillips-Bute
B
.
Transparency and disclosure of medical errors: it’s the right thing to do, so why the reluctance?
Campbell Law Rev.
2013
;
35
(
3
):
332
354
.
81
National Conference of State Legislatures
.
Medical Professional Apologies Statutes
. Accessed July 19, 2024. https://www.ncsl.org/research/financial-services-and-commerce/medical-professional-apologies-statutes.aspx
82
Martin
J
.
An Overview of the Colorado Candor Act
.
Colorado Med.
2019
;
116
(
4
):
53
54
.
83
Dolansky
MA
,
Barg-Walkow
L
,
Barnsteiner
J
, et al
.
A call to action following the Radonda Vaught case
.
J Nurses Prof Dev.
2022
;
38
(
6
):
329
332
. PubMed doi: 10.1097/NND.0000000000000945
84
Harrington
L
.
The RaDonda Vaught case: a critical conversation on nursing practice and technology
.
AACN Adv Crit Care.
2023
;
34
(
1
):
11
15
. PubMed doi: 10.4037/aacnacc2023873
85
Institute for Safe Medication Practices
.
Criminalization of Human Error and a Guilty Verdict: A Travesty of Justice that Threatens Patient Safety
. April 7,
2022
. Accessed July 19, 2024. https://psnet.ahrq.gov/issue/criminalization-human-error-and-guilty-verdict-travesty-justice-threatens-patient-safety
86
Aubin
J
,
Rivolet
O
,
Taunay
AL
,
Ragot
S
,
Ghazali
DA
,
Oriot
D
.
Benefit of simulation-based training in medical adverse events disclosure in pediatrics
.
Pediatr Emerg Care.
2022
;
38
(
2
):
e622
e627
. PubMed doi: 10.1097/PEC.0000000000002454
87
Stroud
L
,
Wong
BM
,
Hollenberg
E
,
Levinson
W
.
Teaching medical error disclosure to physicians-in-training: a scoping review
.
Acad Med.
2013
;
88
(
6
):
884
892
. PubMed doi: 10.1097/ACM.0b013e31828f898f
88
Amiel
JM
,
Andriole
DA
,
Biskobing
DM
, et al;
Association of American Medical Colleges Core EPAs for Entering Residency Pilot Team
.
Revisiting the core entrustable professional activities for entering residency
.
Acad Med.
2021
;
96
(
7S
):
S14
S21
. PubMed doi: 10.1097/ACM.0000000000004088
89
AAMC
.
Core Entrustable Professional Activities for Entering Residency Curriculum Developers’ Guide.
AAMC
;
2014
. Accessed April 5, 2024. https://store.aamc.org/downloadable/download/sample/sample_id/63/%20
90
Lin
M
,
Famiglietti
H
.
Closing the disclosure gap: medical errors in pediatrics
.
Pediatrics.
2019
;
143
(
4
):
e20190221
. PubMed doi: 10.1542/peds.2019-0221
91
Fein
S
,
Hilborne
L
,
Kagawa-Singer
M
, et al
. A conceptual model for disclosure of medical errors. In:
Henriksen
K
,
Battles
JB
,
Marks
ES
, et al
, eds.
Advances in Patient Safety: From Research to Implementation (Volume 2: Concepts and Methodology)
.
Agency for Healthcare Research and Quality
;
2005
.