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Disclosing adverse events and near misses to parents of neonates
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Seminars in Perinatology www.seminperinat.com
Disclosing adverse events and near misses to parents of neonates Brian S. Cartera,*, and John D. Lantosb a
University of Missouri-Kansas City School of Medicine, Children’s Mercy Bioethics Center, 2401 Gillham Road, Kansas City, MO 64108, USA b University of Missouri-Kansas City School of Medicine, Children’s Mercy Bioethics Center, 2401 Gillham Road, Kansas City, MO 64108, USA
A R T I C L E I N F O
AB STR ACT
Keywords:
Critically ill newborns receiving intensive and complex care may be subject to medical
Error disclosure
errors and adverse events. Like most physicians, neonatologists do not feel comfortable
Neonatology
disclosing their errors and may need assistance in learning how to do so. Understanding
Neonatal ICU
useful models of error disclosure, and communication training, will likely be beneficial.
NICU
Ó 2019 Elsevier Inc. All rights reserved.
Medical error Safety
Introduction As in all clinical environments, medical errors occur often in neonatal intensive care units (NICUs). Errors occur more often when fragile patients are critically ill, decisions must be made quickly, and multiple healthcare professionals (HCPs) are involved in any given neonate’s care. There are plentiful opportunities for miscommunication among various healthcare professionals (HCPs). There are also protocols and systems of care that don’t always fit together seamlessly. The convergence of both human communication ambiguities and errors related to overlapping responsibilities make it difficult to eliminate error completely.1,2 But we try. In most NICUs today, clinicians and administrators have implemented a multi-tiered safety culture. The goal of such a culture is to reduce ambiguity, eliminate “workarounds” that can short-circuit error-reduction efforts, and thus mitigate both human and systems-based error.3,4 A key element of all systems that are designed to reduce error is that people must communicate effectively and be willing to disclose errors so that the causes can be identified and better * Corresponding author. E-mail address: [email protected] (B.S. Carter). https://doi.org/10.1053/j.semperi.2019.08.011 0146-0005/Ó 2019 Elsevier Inc. All rights reserved.
prevention strategies implemented.4 In NICUs, parents must be part of safety promotion and error reduction efforts.5 A key component of a culture of safety is trust. HCPs must trust each other. They must earn the trust of parents. Parents may be more trusting if clinicians prove themselves trustworthy by disclosing errors that have occurred. Parents report that such transparency increases their levels of trust.6 After all, they are often aware of medical errors even before the physicians and nurses are.7
Talking about errors, adverse events and near misses Physicians, generally, do not like to disclose errors not to themselves, to colleagues, or to patients and parents. Mendonca and colleagues reported on the variability of the overall response to medical error across a number of countries.8 They showed that, in some countries, there is an expectation that physicians will never commit errors and, as a result, the
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barriers to disclosure of error are high. The very instruction in error disclosure also varies across cultural contexts, perhaps not even entering into a physician’s training, leaving him or her to the expectation that they must be infallible. In such an environment, physicians are ill prepared to constructively approach error when it occurs errors are simply not supposed to occur. Such a posture will make error disclosure very difficult. This group found that some Brazilian physicians realize that in a culture of blame and punishment for mistakes “. . .they will be tried and convicted, both socially and judicially.”8 In recent years there have been a number of considerations in equipping physicians-in-training and other clinicians with the skills necessary for error disclosure. These efforts have involved training interdisciplinary team members,9 medical students,10,11 and pediatric residents.12 National leadership workshops for neonatology fellows have been organized to improve their knowledge of error disclosure and to do it successfully.13,14 How do physicians in the NICU speak about medical error? Some may be influenced by their spiritual or religious affiliations and the values they have accepted,15 whereas others rely solely on the role models that they may or may not have had.10 The overall culture of a NICU can also influence the physician’s inclination to discuss and disclose medical error. In some NICUs, physicians who report errors are treated harshly and in a punitive manner. It is reasonable to expect that, in such NICUs, there will be not much discussion of error among colleagues or disclosure of error to parents.16 Such a NICU culture may even lead to more iatrogenic errors because of the stress that rudeness and secrecy place on HCPs.17 In the context of rudeness, team function may decline, which may leave certain clinicians less apt to be inclined to carry on important, yet stressful, conversations. Neonatal units should focus on the development of a culture of safety that encourages and facilitates ready and open discussion of medical error within the unit, its teams and its individual members. Trainees need mentors and role models for error disclosure, and constructive, positive and not punitive environments in which they train. Such environments embedded in highly reliable organizations have been well described.18 20 How best can physicians discuss and disclose medical error? Is full disclosure possible?21 Does it yield beneficial results?
Models of disclosure Medical error disclosure is but one part of an integrated culture of quality and safety.4,22 As stated by Liang, “Systems concepts, the patient-provider partnership, and overall quality of care. . .may foster and solidify a team approach to reducing errors and promoting patient safety.”23 It is clear that such a culture requires deliberate action and includes such things as creating an environment that allows staff to feel comfortable reporting errors, mistakes, and adverse events without fear of punitive responses.16,19 There are number of theoretical models of best practices in error disclosure. Boyle et al. describe a method of error disclosure in the adult ICU that explicitly attends to the timing, benefits,
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and potential problems associated with the process.2 They begin suggesting criteria for deciding when an error has occurred and needs to be disclosed. They recommend disclosure only when a patient has been harmed by the error and when peer colleagues would have recognized the actions (or inactions) in question as erroneous, or if those peer colleagues would have acted differently in ways that would have averted or reduced the harm. In such a system, one must recognize the difference between error and harm, and perhaps ask if you would like to know if a similar event occurred in the care provided to your own child, or if you’d rather find out directly from your child’s doctor or someone else? These same authors admit that this approach leaves open to interpretation just what constitutes harm.2 In the NICU questions might arise about a physician’s omission in discontinuing a sedative prior to extubation, such that an additional day of assisted ventilation is required. Is the baby harmed by an extra day of ventilation? And should that error be disclosed to parents? While certain risks for harm may accrue while intubated and receiving mechanical ventilation in the absence of ventilator associated pneumonia, pneumothorax or hypoxemia (this is only a partial list of such potential sequelae), it seems difficult to call this error of omission a ‘medical error’ that requires reporting because no specific harm has taken place. Should an explanation to the parents follow? An explanation, yes, but not a formal process of error disclosure. The following case clearly illustrates a medical error that resulted in significant patient harm. A seven-day old 28-week gestation newborn who was diagnosed with a grade II intraventricular hemorrhage (IVH) one day ago develops a clot in his central venous line. Responding to the line occlusion and clot practice guideline, the neonatologist orders tissue thromboplastin activator (TPA). However, it was used to flush the line rather than simply instilled in the line and later removed before flushing with normal saline, thus delivering a systemic dose of TPA. Subsequently the IVH expanded into the lateral ventricle and nearby parenchyma. Hydrocephalus developed and ultimately the patient required a ventriculo-peritoneal (VP) shunt. Here, an oversight has occurred a failure to consider a recent hemorrhage before ordering TPA in a patient at continued risk for hemorrhage, in addition to faulty administration of the TPA. A root cause analysis (RCA) determined that the error did contribute to further harm (extension of the grade II IVH to a grade IV) and that continued medical care that would not otherwise have been necessary was required. This case demonstrates at least two benefits of error disclosure. First, disclosure assists families in receiving necessary additional care for their child and in making financial arrangements for such care. Second, it can build or maintain parental trust in clinicians and the hospital.2 That said, it is recognized that the ICU environment is not necessarily conducive to error disclosure: families are under stress and the attending neonatologist is frequently a ‘new’ face to them. In addition to these factors, guilt, fear, and a sense of inadequacy on the part of the HCPs involved often play a role. Boyle et al. note that disclosing errors takes courage. It also requires training, support, and practice. It is challenging to know that an error has occurred, communicate it and do so
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effectively in a well-composed manner.2 These activities occur only within a system that undertakes objective inquiry, pursues RCA, embraces transparency and engages with parents using an established framework. A case that illustrates this process follows.
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You: “Thank you for saying that. I do have some things to tell you that can explain just what transpired, not all of which was good. Are you able to talk about it now?” (Providing a warning of a difficult discussion to follow) Mother: “Yes, please go ahead doctor.”
A case-study of error and error disclosure A 6-week old 25-week gestation premature female infant with chronic lung disease is recovering from necrotizing enterocolitis (NEC); feedings were reintroduced and advanced over the past week and her parenteral nutrition is gradually diminished. On the last day of her parenteral nutrition (a Saturday), her nurse asks the resident who was covering that weekend if the patient still needs her central line. Unsure, the resident keeps the line in place even though there is no continuous infusion or medications ordered to be delivered through that line. The line is left in the femoral vein throughout the weekend and is only re-evaluated on Monday when the primary team rounds again. You decide to remove the line and it is discontinued after rounds. Shortly thereafter the nurse tells you that the patient’s leg is mottled, swollen and purple in color. After examining the leg, you order an ultrasound that reveals an iliofemoral and inferior venous cava thrombus. You request a Pediatric Hematology consult and low molecular weight (LMW) heparin is prescribed. When the parents come to the bedside that evening they are shocked to hear of the development and concerned when they are told that after discharge they will have to give LMW heparin injections for weeks. You are on-call and go to speak with them, trying to be reassuring, but telling them that a formal investigation will be conducted. After the investigation is completed there will be an appointed time to meet again with them, within the week, once all of the facts are known. They accept your plan. You and the staff conduct an inquiry and RCA, determining that the presence of the line for 2 days without an infusate more likely than not contributed to the thrombus. The orders written on Saturday asked for only a heparin flush of 2 mL every 12 h, which was not consistent with practice guidelines, and it was determined that the proper thing to do would have been to remove the central line on Saturday. The resident physician who was on Saturday was called in and you tell him, “We missed something here, we will need to schedule a meeting with the family.” The family agrees to meet with you the next day; you have told the resident that you will lead the discussion.
You: “I know that it seems that every few days or weeks something new gets in the way of your baby’s progress; lung disease, NEC, and now this blood clot. I’m sure this is stressful for you. (Empathy, admitting the truth) I must admit that this is a bit difficult for me to say, and maybe hard for you to hear, but I think part of the reason for your baby’s blood clot was because we made a mistake in her care. I’m very sorry and we feel badly, but I think you’re entitled to know what happened.” (Apologizing and admitting the truth) Mother: “What kind of mistake causes a blood clot?” You: “The day your little girl finished her IV nutrition and antibiotics, her central line should have been removed. Leaving it in for two more days was unnecessary. The clot is a foreseeable complication of the line, but one way we minimize that and other complications is to remove it when it’s not being used anymore. We did not do it right, and should have known better.” (Again, admitting the truth and apologizing) Mother: “But you weren’t even here this past weekend. I think it was Dr. R, this young resident with you today, right?” You: “That’s correct. But as his supervisor, and the managing attending neonatologist, it was my responsibility to make the plan of care clear at hand-off on Friday afternoon. I’m sorry that the line wasn’t removed in a timely manner, and the clot formed. And now your baby will need 12 weeks of LMW heparin injections because of our error. We have revisited and clarified our clinical practice guidelines, circulated them by email, and held a teaching session for all of the nurses and the residents to make sure that this problem doesn’t happen again.” (Apology and explaining corrective action) Mother: “Okay, I think I understand. You’re saying that if Dr. R had removed the line on Saturday, that the blood clot would likely not have formed, and I wouldn’t have to give my baby LMW injections every day when I take her home in the next couple of weeks?”
You (to the mother): “I am glad we can meet again as I have more to tell you about your baby’s current condition and about the blood clot in her leg. I know this has been concerning you.” (Empathy)
You: “Yes, Dr. R and I both feel badly about that. I want you to know that I have already spoken with the hospital administrators and you won’t be charged for your baby’s care after the line was removed. Do you have any questions?” (Apology, and corrective action)
Mother: “Thank you, doctor, I appreciate all that you’ve done for her these past 2 months. I just don’t understand what happened, she was getting better and eating, and everything looked so positive.”
Mother: “Thank you for telling me all of this. I know everyone here has certainly meant well and helped so much with my little girl’s care her very survival. I appreciate you being honest with me about all of this.”
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Box 1. One approach to error disclosure. Hold a pre-disclosure meeting. - Perform a RCA with the HCPs who were involved in the event. - Include a representative from Risk Management and/or an appropriate hospital administrator who can speak to financial implications. - Determine what changes are necessary to prevent similar events. Implement these changes. - Discuss and determine who will be involved in the disclosure with the patient/family. Always have a second person present at the disclosure. - Anticipate questions that may arise and practice answering them in addition to the disclosure itself. Schedule the disclosure meeting as soon as possible at a time that is convenient for the patient/family, ask them to invite a support person, and choose a quiet place. At the disclosure: - Sit, lean in, and listen intently; be mindful of your own body language; be empathetic. - Provide a warning before voicing bad news: “We have some bad news to share today.” - Admit the error and apologize for the specific cause: “I’m sorry that your baby has had a complication and requires extended care.” (Not, “I’m sorry about what happened.”) - Discuss the event, what systems errors you discovered in your investigation, and what steps have been taken to prevent the same or similar events in the future. - Allow time, invite questions, answer questions honestly and inquire of understanding. Adapted from Boyle et al., 2006
Key elements of effective error disclosure In a report of patient and family interviews addressing their own experience with clinicians’ error disclosure, Iedema et al. provides a number of keys to effective disclosure.24 First, they note the value of preparing both patient/family and those HCPs involved in the error prior to disclosure. Second, the disclosure should follow an investigation of what went wrong. Third, the patient/family should have a support person present. Fourth, the family should be asked to present their own account of what transpired and ask questions. Fifth, the physicians should apologize for specific events and tell the family how any harm to their baby will be redressed. Sixth, the family should be told what measures will be taken to prevent such an event from recurring. They should also be told if other agencies, including other hospitals, the medical examiner, or law enforcement personnel need to be informed. Seventh, only after the patient/family have asked all of their questions should the involved physicians bring the meeting to a close. Patients and families need to be heard, taken seriously and have all of their questions answered. Physicians need to set aside ample time for this discussion and not convey (verbally or nonverbally) impatience or a sense of urgency to conclude the process. Finally, the physicians need to reassure the patient/family that they have learned from the mistake and that steps have been taken to ensure that it doesn’t happen again.
Communication matters: A potential contributor to medical error and its effective disclosure A third error disclosure model is described by Pichert et al. in their chapter within the Handbook of Human Factors and Ergonomics in Healthcare and Patient Safety.25 Their model grew out of work investigating why parents chose to file a lawsuit after an adverse event that involved their newborn infant.26 These
authors highlight the role played by poor communication among HCPs and between HCPs and patients/families as a contributor to medical error and a barrier to error disclosure. Poor communication also makes lawsuits more likely.
Barriers to error disclosure It may seem odd that neonatologists, who frequently convey bad news to families regarding clinical issues, test results, or even prognosis would have difficulty with medical error disclosure. Some of the contributing factors might include the aforementioned complexity of care and convergence of system and individual caregiver factors within the NICU. Additionally, it is not always immediately clear what particular event or omission is the cause of the patient’s harm. When there are obvious errors that result in obvious harm, Pichert et al. recommend full disclosure.26 But when the cause of the harm, or other unexpected outcome, is not immediately known, a process of inquiry, investigation, and root cause analysis is advised. Clearly, parents need to be told that the facts are not yet clear and that such an inquiry is being pursued. This may be done in any of several ways no one of which is correct in every instance: a) give only ‘safe’ facts but do not disclose reason(s) for error at this time (“Well yes, the IV infiltrated.”); b) state all known facts but pursue additional facts to be revealed later from which a determination of harm, and causation may come (“It’s clear that she received another mother’s breastmilk. But we will investigate why that happened, and if there is any potential harm to be considered.”); c) fully disclose the error right away (“The ventilator tubing became disconnected and the oxygen delivery was interrupted causing hypoxemia.”), and d) disclose the error and assign responsibility (“Your daughter’s central line was retained for two days longer than
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necessary, and a blood clot formed in a large vein in her groin and lower abdomen. After a thorough investigation, including every step of the process and all involved parties, it is clear that we collectively have a systems problem and have had to revise our procedural guidelines to prevent this from happening again. Dr. X ordered the line to be pulled, but as his supervising attending neonatologist I also bear responsibility here, as do other members of the team for not doing better. I’m sorry this happened. This is why your daughter needs to be given the heparin for the next twelve weeks”). As one can see, these all may come with attendant pros, cons and parental questions, and/or raw emotions. When not all facts are apparent it may be premature, even misleading or wrong, to assign responsibility. Such assignment of blame, while appearing expedient on the surface, cannot be easily reversed when an inquiry or RCA reveals other cause(s) and hurt feelings among colleagues or families leave additional scars. The balance beam approach takes these four options and weights them with what is known about what happened, when it became known, and how it explains the error.26 In Fig. 1a and b, two approaches to error disclosure are modeled. In Fig. 1a, the error is obvious, but its cause not necessarily so. In this situation the response to an error includes being supportive to all parties involved, parents and their concerns as well as the HCP staff, through a process of inquiry, fact finding, and root cause analysis (RCA). This may initially appear as equivocating to either party, but acknowledging that something has happened, and stating that you are committed to understanding what has transpired, and why, without rushing to judgment is generally accepted by parents. In Fig. 1b, when dealing with more complex cases, and those in which the cause of an unexpected outcome is not known, it is important to pursue the “what, when, and how” of the event. On this balance beam there are numerous approaches to an adverse event, and HCPs have taken any of them for most any given situation. But each approach has its pros and cons, and
a Support Involved Staff, Reassure Parent
Support Equivocate
Parent Concern
Support Involved Staff,
Support Paent
Some Reassurance
Inquiry
b No disclosure;
Fully disclose error
“safe” facts
right away
Facts, limited disclosure;
Disclose error, assign responsibility
More later
Fig. 1 – (a) Response strategies balance beam (adapted from Pichert et al.24 (b) Response strategies balance beam in cases of uncertainty (adapted from Pichert et al.24).
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the HCP must take time to ascertain the “best” approach in an individual case. Starting at the left-side of the balance beam the approach of no disclosure and only discussing “safe” facts may be taken well by some families, but others might see it as deceptive, or that HCPs are hiding something even operating under a code of silence. Obviously, this may breakdown any previous trust with the family. Still other parents might insist on knowing all the details and not disclosing anything appears as stalling. Closer to the fulcrum on the left side of the balance beam is an approach of affirming facts that are known and providing a still somewhat limited disclosure. This may appear to be more honest and allows for an impartial review to take place without appearing to cover up or stall. Still, it may come across to some parents as less than honest should they believe that you know more or if your disclosures are premature and viewed as speculative, even to the point of parents having unrealistic expectations, especially if there are misunderstandings of facts shared and what they mean. To the right of the fulcrum, the approach of full disclosure of an apparent error is often appealing as it conveys open, transparent, and honest communication. However, rushing in to disclose an apparent error may be difficult to retract if an RCA leads to a different premise for the error. Finally, error disclosure with an assignment of responsibility is a reasonable approach when the facts are known, and certainly appropriate after an RCA. It demonstrates honesty, and that you are on the parent’s/patient’s side. But no HCP likes to be on the receiving end of a pointed finger and both personal and systems matters must be taken into consideration. There may be times when an error that seems apparent, or discovered during an inquiry, can be unrelated to a patient’s ultimate outcome. At other times, the cause of an error or adverse event is frankly disputed. This may have to do with unwarranted assumptions, incomplete facts, and a desire to please parents or even dismiss personal responsibility. Even a RCA can leave participants with uncertainty about what caused a particular error. In such circumstances, HCPs need to avoid being rude or inflammatory. Sometimes no one can absolutely explain an event. That doesn’t mean that someone has to be wrong. HCPs can agree to disagree. Finally, there may be times when a neonatologist believes that an error has occurred but that it occurred when another neonatologist was the attending physician. Often, in such cases, the family does not know about it. Multiple choices exist in what to disclose when you discover an error in this fashion. Options might include (a) a nonspecific discussion of the reason the patient is in your NICU without disclosure of the error, (b) disclosing partial facts and conveying to the parents that you want to review all the records, and requesting the parent’s authorization to do so, (c) partial disclosure with a comment that you’d like to discuss your findings with the previous neonatologist, or (d) full disclosure with some explanation of the meaning of the findings. All choices have pros, cons, and likely consequences in how parents will respond. But once again a balanced response will consider time, expediency versus thoroughness, an intention of kindness but also a consideration of honesty and living up to one’s ethical duty. In this situation it is clear that on occasion, disclosure-related duties may rest with a subsequent-treating physician. It is hoped that the response strategy will be informed by the balance beam approach.
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Summary Error disclosure is but part of a culture of quality and safety within the NICU (and the hospital). It should happen in a systematic way. If an error is suspected, the family should be told, and they should be informed that an investigation will take place to determine the cause. There should then be an objective investigation and RCA. It is important to let this process play out and not to rush to judgment about blame. Disclosure should be frank. It should be done with empathy. Physicians should apologize for specific errors and explain why they happened. This may seem paradoxical to some as one’s instinct may be to keep errors secret or to never apologize. But transparency and remorse build trust. Families should be given time to explain their views and raise concerns. Successful error disclosure may lead to parental satisfaction and an appreciation of physician honesty and transparency.
R E F E R E N C E S
1. Silas R, Tibballs J. Adverse events and comparison of systematic and voluntary reporting from a paediatric intensive care unit. Qual Saf Health Care. 2010;19(6):568–571. 2. Boyle D, O’Connell D, Platt FW, Albert RK. Disclosing errors and adverse events in the intensive care unit. Crit Care Med. 2006;34(5):1532–1537. 3. Spear SJ, Schmidhofer M. Ambiguity & workarounds as contributors to medical error. Annals Intern Med. 2005;142(8):627–630. 4. McDonald TB, Helmchen LA, Smith KM, Centomani N, Gunderson A, Mayer D, Chamberlin WH. Responding to patient safety incidents: the “seven pillars”. Qual Saf Health Care. 2010;19:e11. https://doi.org/10.1136/qshc.2008.031633. 5. Fritz Z, Holton R. Too much medicine, not enough trust? J Med Ethics. 2019;45(1):31–35. 6. Lyndon A. Parents’ perspectives on safety in neonatal intensive care: a mixed-methods study. BMJ Qual Saf. 2014;23 (11):902–909. 7. McBride DL. Parents find medical errors and safety incidents that hospitals miss. J Pediatr Nurs. MayJune 2017;34( ):94–95. 8. Mendonca VS, Gallagher TH, de Oliviera RA. The function of disclosing medical errors: new cultural challenges for physicians. HEC Forum. 2018 epub ahead of print https://doi.org/ 10.1007/s10730-018-9362-7] Accessed 3 March 2019. 9. Smith JR, Cole FS. Patient safety: effective interdisciplinary teamwork through simulation and debriefing in the neonatal ICU. Crit Care Nurs Clin N Am. 2009;21:163–179.
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10. Martinez W, Hickson GB, Miller BM, Doukas DJ, Buckley JD, Song J, et al. Role-modeling and medical error disclosure: a national survey of trainees. Acad Med. 2014;89(3):482–489. 11. Sorokin R, Riggio JM, Hwang C. Attitudes about patient safety: a survey of physicians-in-training. Am J Med Qual. 2005;20(2):70–77. 12. Deonandan R, Khan H. Ethics education for pediatric residents: a review of the literature. Can Med Educ J. 2015;6(1):e61–e67. 13. Raju TNK, Suresh G, Higgins RD. Patient safety in the context of neonatal intensive care: research and educational opportunities. Pediatr Res. 2011;70:109–115. 14. Donn SM, McDonnell WM. When bad things happen: adverse event reporting and disclosure as patient safety and risk management tools in the neonatal intensive care unit. Am J Perinatol. 2012;29(1):65–70. 15. Berlinger N, Wu AW. Subtracting insult from injury: addressing cultural expectations in the disclosure of medical error. J Med Ethics. 2005;31:106–108. 16. Martinez W, Lehmann LS. The ‘hidden curriculum” and residents’ attitudes about medical error disclosure: comparison of surgical and nonsurgical residents. J Am Coll Surg. 2013;217(6):1145–1150. 17. Riskin A, Erez A, Foulk TA, et al. Rudeness and team performance. Pediatrics. 2017;139(2):e20162305. 18. Henry L. Disclosure of medical error: ethical considerations for the development of a facility policy and organizational change. Policy Polit Nurs Pract. 2005;6(2):127–134. 19. Chatziionnidis I, Mitsiakos G, Vouzas F. Focusing on patient safety in the neonatal intensive care unit environment. J Pediatr Neonat Individ Med. 2017;6(1):e060132. 20. Kaplan HC, Ballard J. Changing practice to improve patient safety and quality of care in perinatal medicine. Am J Perinatol. 2012;29(1):35–42. 21. Simons SL. Full disclosure when bad things happen. Neonat Netw. 2007;26(2):131–132. 22. American Medical Association, Code of Medical Ethics: Opinion 8.6, Promoting Patient Safety. https://www.ama-assn.org/ delivering-care/ethics/promoting-patient-safety. Accessed 3 March 2019. 23. Liang BA. A system of medical error disclosure. Qual Saf Health Care. 2002;11:64–68. 24. Iedema R, Allen S, Britton K, Piper D, Baker A, Grbich C, et al. Patients’ and family members’ views on how clinicians enact and how they should enact incident disclosure: the “100 patient stories” qualitative study. BMJ. 2011;343:d4423. https://doi.org/10.1136/bmj.d4423. 25. Pichert JW, Hickson GB, Pinto A, Vincent C. Communicating about unexpected outcomes, adverse events, and errors. In: Carayon P, ed. Handbook of Human Factors and Ergonomics in Healthcare and Patient Safety, 2nd ed. Boca Raton, FL: CRC Press; 2017. 401–422. 26. Hickson GB, Clayton EW, Githens PB, Sloan FA. Factors that prompted families to file medical malpractice claims following perinatal injuries. J Am Med Assoc. 1992;267(10):1359–1363.
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Available online at www.sciencedirect.com
Seminars in Perinatology www.seminperinat.com
Disclosing adverse events and near misses to parents of neonates Brian S. Cartera,*, and John D. Lantosb a
University of Missouri-Kansas City School of Medicine, Children’s Mercy Bioethics Center, 2401 Gillham Road, Kansas City, MO 64108, USA b University of Missouri-Kansas City School of Medicine, Children’s Mercy Bioethics Center, 2401 Gillham Road, Kansas City, MO 64108, USA
A R T I C L E I N F O
AB STR ACT
Keywords:
Critically ill newborns receiving intensive and complex care may be subject to medical
Error disclosure
errors and adverse events. Like most physicians, neonatologists do not feel comfortable
Neonatology
disclosing their errors and may need assistance in learning how to do so. Understanding
Neonatal ICU
useful models of error disclosure, and communication training, will likely be beneficial.
NICU
Ó 2019 Elsevier Inc. All rights reserved.
Medical error Safety
Introduction As in all clinical environments, medical errors occur often in neonatal intensive care units (NICUs). Errors occur more often when fragile patients are critically ill, decisions must be made quickly, and multiple healthcare professionals (HCPs) are involved in any given neonate’s care. There are plentiful opportunities for miscommunication among various healthcare professionals (HCPs). There are also protocols and systems of care that don’t always fit together seamlessly. The convergence of both human communication ambiguities and errors related to overlapping responsibilities make it difficult to eliminate error completely.1,2 But we try. In most NICUs today, clinicians and administrators have implemented a multi-tiered safety culture. The goal of such a culture is to reduce ambiguity, eliminate “workarounds” that can short-circuit error-reduction efforts, and thus mitigate both human and systems-based error.3,4 A key element of all systems that are designed to reduce error is that people must communicate effectively and be willing to disclose errors so that the causes can be identified and better * Corresponding author. E-mail address: [email protected] (B.S. Carter). https://doi.org/10.1053/j.semperi.2019.08.011 0146-0005/Ó 2019 Elsevier Inc. All rights reserved.
prevention strategies implemented.4 In NICUs, parents must be part of safety promotion and error reduction efforts.5 A key component of a culture of safety is trust. HCPs must trust each other. They must earn the trust of parents. Parents may be more trusting if clinicians prove themselves trustworthy by disclosing errors that have occurred. Parents report that such transparency increases their levels of trust.6 After all, they are often aware of medical errors even before the physicians and nurses are.7
Talking about errors, adverse events and near misses Physicians, generally, do not like to disclose errors not to themselves, to colleagues, or to patients and parents. Mendonca and colleagues reported on the variability of the overall response to medical error across a number of countries.8 They showed that, in some countries, there is an expectation that physicians will never commit errors and, as a result, the
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barriers to disclosure of error are high. The very instruction in error disclosure also varies across cultural contexts, perhaps not even entering into a physician’s training, leaving him or her to the expectation that they must be infallible. In such an environment, physicians are ill prepared to constructively approach error when it occurs errors are simply not supposed to occur. Such a posture will make error disclosure very difficult. This group found that some Brazilian physicians realize that in a culture of blame and punishment for mistakes “. . .they will be tried and convicted, both socially and judicially.”8 In recent years there have been a number of considerations in equipping physicians-in-training and other clinicians with the skills necessary for error disclosure. These efforts have involved training interdisciplinary team members,9 medical students,10,11 and pediatric residents.12 National leadership workshops for neonatology fellows have been organized to improve their knowledge of error disclosure and to do it successfully.13,14 How do physicians in the NICU speak about medical error? Some may be influenced by their spiritual or religious affiliations and the values they have accepted,15 whereas others rely solely on the role models that they may or may not have had.10 The overall culture of a NICU can also influence the physician’s inclination to discuss and disclose medical error. In some NICUs, physicians who report errors are treated harshly and in a punitive manner. It is reasonable to expect that, in such NICUs, there will be not much discussion of error among colleagues or disclosure of error to parents.16 Such a NICU culture may even lead to more iatrogenic errors because of the stress that rudeness and secrecy place on HCPs.17 In the context of rudeness, team function may decline, which may leave certain clinicians less apt to be inclined to carry on important, yet stressful, conversations. Neonatal units should focus on the development of a culture of safety that encourages and facilitates ready and open discussion of medical error within the unit, its teams and its individual members. Trainees need mentors and role models for error disclosure, and constructive, positive and not punitive environments in which they train. Such environments embedded in highly reliable organizations have been well described.18 20 How best can physicians discuss and disclose medical error? Is full disclosure possible?21 Does it yield beneficial results?
Models of disclosure Medical error disclosure is but one part of an integrated culture of quality and safety.4,22 As stated by Liang, “Systems concepts, the patient-provider partnership, and overall quality of care. . .may foster and solidify a team approach to reducing errors and promoting patient safety.”23 It is clear that such a culture requires deliberate action and includes such things as creating an environment that allows staff to feel comfortable reporting errors, mistakes, and adverse events without fear of punitive responses.16,19 There are number of theoretical models of best practices in error disclosure. Boyle et al. describe a method of error disclosure in the adult ICU that explicitly attends to the timing, benefits,
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and potential problems associated with the process.2 They begin suggesting criteria for deciding when an error has occurred and needs to be disclosed. They recommend disclosure only when a patient has been harmed by the error and when peer colleagues would have recognized the actions (or inactions) in question as erroneous, or if those peer colleagues would have acted differently in ways that would have averted or reduced the harm. In such a system, one must recognize the difference between error and harm, and perhaps ask if you would like to know if a similar event occurred in the care provided to your own child, or if you’d rather find out directly from your child’s doctor or someone else? These same authors admit that this approach leaves open to interpretation just what constitutes harm.2 In the NICU questions might arise about a physician’s omission in discontinuing a sedative prior to extubation, such that an additional day of assisted ventilation is required. Is the baby harmed by an extra day of ventilation? And should that error be disclosed to parents? While certain risks for harm may accrue while intubated and receiving mechanical ventilation in the absence of ventilator associated pneumonia, pneumothorax or hypoxemia (this is only a partial list of such potential sequelae), it seems difficult to call this error of omission a ‘medical error’ that requires reporting because no specific harm has taken place. Should an explanation to the parents follow? An explanation, yes, but not a formal process of error disclosure. The following case clearly illustrates a medical error that resulted in significant patient harm. A seven-day old 28-week gestation newborn who was diagnosed with a grade II intraventricular hemorrhage (IVH) one day ago develops a clot in his central venous line. Responding to the line occlusion and clot practice guideline, the neonatologist orders tissue thromboplastin activator (TPA). However, it was used to flush the line rather than simply instilled in the line and later removed before flushing with normal saline, thus delivering a systemic dose of TPA. Subsequently the IVH expanded into the lateral ventricle and nearby parenchyma. Hydrocephalus developed and ultimately the patient required a ventriculo-peritoneal (VP) shunt. Here, an oversight has occurred a failure to consider a recent hemorrhage before ordering TPA in a patient at continued risk for hemorrhage, in addition to faulty administration of the TPA. A root cause analysis (RCA) determined that the error did contribute to further harm (extension of the grade II IVH to a grade IV) and that continued medical care that would not otherwise have been necessary was required. This case demonstrates at least two benefits of error disclosure. First, disclosure assists families in receiving necessary additional care for their child and in making financial arrangements for such care. Second, it can build or maintain parental trust in clinicians and the hospital.2 That said, it is recognized that the ICU environment is not necessarily conducive to error disclosure: families are under stress and the attending neonatologist is frequently a ‘new’ face to them. In addition to these factors, guilt, fear, and a sense of inadequacy on the part of the HCPs involved often play a role. Boyle et al. note that disclosing errors takes courage. It also requires training, support, and practice. It is challenging to know that an error has occurred, communicate it and do so
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effectively in a well-composed manner.2 These activities occur only within a system that undertakes objective inquiry, pursues RCA, embraces transparency and engages with parents using an established framework. A case that illustrates this process follows.
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You: “Thank you for saying that. I do have some things to tell you that can explain just what transpired, not all of which was good. Are you able to talk about it now?” (Providing a warning of a difficult discussion to follow) Mother: “Yes, please go ahead doctor.”
A case-study of error and error disclosure A 6-week old 25-week gestation premature female infant with chronic lung disease is recovering from necrotizing enterocolitis (NEC); feedings were reintroduced and advanced over the past week and her parenteral nutrition is gradually diminished. On the last day of her parenteral nutrition (a Saturday), her nurse asks the resident who was covering that weekend if the patient still needs her central line. Unsure, the resident keeps the line in place even though there is no continuous infusion or medications ordered to be delivered through that line. The line is left in the femoral vein throughout the weekend and is only re-evaluated on Monday when the primary team rounds again. You decide to remove the line and it is discontinued after rounds. Shortly thereafter the nurse tells you that the patient’s leg is mottled, swollen and purple in color. After examining the leg, you order an ultrasound that reveals an iliofemoral and inferior venous cava thrombus. You request a Pediatric Hematology consult and low molecular weight (LMW) heparin is prescribed. When the parents come to the bedside that evening they are shocked to hear of the development and concerned when they are told that after discharge they will have to give LMW heparin injections for weeks. You are on-call and go to speak with them, trying to be reassuring, but telling them that a formal investigation will be conducted. After the investigation is completed there will be an appointed time to meet again with them, within the week, once all of the facts are known. They accept your plan. You and the staff conduct an inquiry and RCA, determining that the presence of the line for 2 days without an infusate more likely than not contributed to the thrombus. The orders written on Saturday asked for only a heparin flush of 2 mL every 12 h, which was not consistent with practice guidelines, and it was determined that the proper thing to do would have been to remove the central line on Saturday. The resident physician who was on Saturday was called in and you tell him, “We missed something here, we will need to schedule a meeting with the family.” The family agrees to meet with you the next day; you have told the resident that you will lead the discussion.
You: “I know that it seems that every few days or weeks something new gets in the way of your baby’s progress; lung disease, NEC, and now this blood clot. I’m sure this is stressful for you. (Empathy, admitting the truth) I must admit that this is a bit difficult for me to say, and maybe hard for you to hear, but I think part of the reason for your baby’s blood clot was because we made a mistake in her care. I’m very sorry and we feel badly, but I think you’re entitled to know what happened.” (Apologizing and admitting the truth) Mother: “What kind of mistake causes a blood clot?” You: “The day your little girl finished her IV nutrition and antibiotics, her central line should have been removed. Leaving it in for two more days was unnecessary. The clot is a foreseeable complication of the line, but one way we minimize that and other complications is to remove it when it’s not being used anymore. We did not do it right, and should have known better.” (Again, admitting the truth and apologizing) Mother: “But you weren’t even here this past weekend. I think it was Dr. R, this young resident with you today, right?” You: “That’s correct. But as his supervisor, and the managing attending neonatologist, it was my responsibility to make the plan of care clear at hand-off on Friday afternoon. I’m sorry that the line wasn’t removed in a timely manner, and the clot formed. And now your baby will need 12 weeks of LMW heparin injections because of our error. We have revisited and clarified our clinical practice guidelines, circulated them by email, and held a teaching session for all of the nurses and the residents to make sure that this problem doesn’t happen again.” (Apology and explaining corrective action) Mother: “Okay, I think I understand. You’re saying that if Dr. R had removed the line on Saturday, that the blood clot would likely not have formed, and I wouldn’t have to give my baby LMW injections every day when I take her home in the next couple of weeks?”
You (to the mother): “I am glad we can meet again as I have more to tell you about your baby’s current condition and about the blood clot in her leg. I know this has been concerning you.” (Empathy)
You: “Yes, Dr. R and I both feel badly about that. I want you to know that I have already spoken with the hospital administrators and you won’t be charged for your baby’s care after the line was removed. Do you have any questions?” (Apology, and corrective action)
Mother: “Thank you, doctor, I appreciate all that you’ve done for her these past 2 months. I just don’t understand what happened, she was getting better and eating, and everything looked so positive.”
Mother: “Thank you for telling me all of this. I know everyone here has certainly meant well and helped so much with my little girl’s care her very survival. I appreciate you being honest with me about all of this.”
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Box 1. One approach to error disclosure. Hold a pre-disclosure meeting. - Perform a RCA with the HCPs who were involved in the event. - Include a representative from Risk Management and/or an appropriate hospital administrator who can speak to financial implications. - Determine what changes are necessary to prevent similar events. Implement these changes. - Discuss and determine who will be involved in the disclosure with the patient/family. Always have a second person present at the disclosure. - Anticipate questions that may arise and practice answering them in addition to the disclosure itself. Schedule the disclosure meeting as soon as possible at a time that is convenient for the patient/family, ask them to invite a support person, and choose a quiet place. At the disclosure: - Sit, lean in, and listen intently; be mindful of your own body language; be empathetic. - Provide a warning before voicing bad news: “We have some bad news to share today.” - Admit the error and apologize for the specific cause: “I’m sorry that your baby has had a complication and requires extended care.” (Not, “I’m sorry about what happened.”) - Discuss the event, what systems errors you discovered in your investigation, and what steps have been taken to prevent the same or similar events in the future. - Allow time, invite questions, answer questions honestly and inquire of understanding. Adapted from Boyle et al., 2006
Key elements of effective error disclosure In a report of patient and family interviews addressing their own experience with clinicians’ error disclosure, Iedema et al. provides a number of keys to effective disclosure.24 First, they note the value of preparing both patient/family and those HCPs involved in the error prior to disclosure. Second, the disclosure should follow an investigation of what went wrong. Third, the patient/family should have a support person present. Fourth, the family should be asked to present their own account of what transpired and ask questions. Fifth, the physicians should apologize for specific events and tell the family how any harm to their baby will be redressed. Sixth, the family should be told what measures will be taken to prevent such an event from recurring. They should also be told if other agencies, including other hospitals, the medical examiner, or law enforcement personnel need to be informed. Seventh, only after the patient/family have asked all of their questions should the involved physicians bring the meeting to a close. Patients and families need to be heard, taken seriously and have all of their questions answered. Physicians need to set aside ample time for this discussion and not convey (verbally or nonverbally) impatience or a sense of urgency to conclude the process. Finally, the physicians need to reassure the patient/family that they have learned from the mistake and that steps have been taken to ensure that it doesn’t happen again.
Communication matters: A potential contributor to medical error and its effective disclosure A third error disclosure model is described by Pichert et al. in their chapter within the Handbook of Human Factors and Ergonomics in Healthcare and Patient Safety.25 Their model grew out of work investigating why parents chose to file a lawsuit after an adverse event that involved their newborn infant.26 These
authors highlight the role played by poor communication among HCPs and between HCPs and patients/families as a contributor to medical error and a barrier to error disclosure. Poor communication also makes lawsuits more likely.
Barriers to error disclosure It may seem odd that neonatologists, who frequently convey bad news to families regarding clinical issues, test results, or even prognosis would have difficulty with medical error disclosure. Some of the contributing factors might include the aforementioned complexity of care and convergence of system and individual caregiver factors within the NICU. Additionally, it is not always immediately clear what particular event or omission is the cause of the patient’s harm. When there are obvious errors that result in obvious harm, Pichert et al. recommend full disclosure.26 But when the cause of the harm, or other unexpected outcome, is not immediately known, a process of inquiry, investigation, and root cause analysis is advised. Clearly, parents need to be told that the facts are not yet clear and that such an inquiry is being pursued. This may be done in any of several ways no one of which is correct in every instance: a) give only ‘safe’ facts but do not disclose reason(s) for error at this time (“Well yes, the IV infiltrated.”); b) state all known facts but pursue additional facts to be revealed later from which a determination of harm, and causation may come (“It’s clear that she received another mother’s breastmilk. But we will investigate why that happened, and if there is any potential harm to be considered.”); c) fully disclose the error right away (“The ventilator tubing became disconnected and the oxygen delivery was interrupted causing hypoxemia.”), and d) disclose the error and assign responsibility (“Your daughter’s central line was retained for two days longer than
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necessary, and a blood clot formed in a large vein in her groin and lower abdomen. After a thorough investigation, including every step of the process and all involved parties, it is clear that we collectively have a systems problem and have had to revise our procedural guidelines to prevent this from happening again. Dr. X ordered the line to be pulled, but as his supervising attending neonatologist I also bear responsibility here, as do other members of the team for not doing better. I’m sorry this happened. This is why your daughter needs to be given the heparin for the next twelve weeks”). As one can see, these all may come with attendant pros, cons and parental questions, and/or raw emotions. When not all facts are apparent it may be premature, even misleading or wrong, to assign responsibility. Such assignment of blame, while appearing expedient on the surface, cannot be easily reversed when an inquiry or RCA reveals other cause(s) and hurt feelings among colleagues or families leave additional scars. The balance beam approach takes these four options and weights them with what is known about what happened, when it became known, and how it explains the error.26 In Fig. 1a and b, two approaches to error disclosure are modeled. In Fig. 1a, the error is obvious, but its cause not necessarily so. In this situation the response to an error includes being supportive to all parties involved, parents and their concerns as well as the HCP staff, through a process of inquiry, fact finding, and root cause analysis (RCA). This may initially appear as equivocating to either party, but acknowledging that something has happened, and stating that you are committed to understanding what has transpired, and why, without rushing to judgment is generally accepted by parents. In Fig. 1b, when dealing with more complex cases, and those in which the cause of an unexpected outcome is not known, it is important to pursue the “what, when, and how” of the event. On this balance beam there are numerous approaches to an adverse event, and HCPs have taken any of them for most any given situation. But each approach has its pros and cons, and
a Support Involved Staff, Reassure Parent
Support Equivocate
Parent Concern
Support Involved Staff,
Support Paent
Some Reassurance
Inquiry
b No disclosure;
Fully disclose error
“safe” facts
right away
Facts, limited disclosure;
Disclose error, assign responsibility
More later
Fig. 1 – (a) Response strategies balance beam (adapted from Pichert et al.24 (b) Response strategies balance beam in cases of uncertainty (adapted from Pichert et al.24).
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the HCP must take time to ascertain the “best” approach in an individual case. Starting at the left-side of the balance beam the approach of no disclosure and only discussing “safe” facts may be taken well by some families, but others might see it as deceptive, or that HCPs are hiding something even operating under a code of silence. Obviously, this may breakdown any previous trust with the family. Still other parents might insist on knowing all the details and not disclosing anything appears as stalling. Closer to the fulcrum on the left side of the balance beam is an approach of affirming facts that are known and providing a still somewhat limited disclosure. This may appear to be more honest and allows for an impartial review to take place without appearing to cover up or stall. Still, it may come across to some parents as less than honest should they believe that you know more or if your disclosures are premature and viewed as speculative, even to the point of parents having unrealistic expectations, especially if there are misunderstandings of facts shared and what they mean. To the right of the fulcrum, the approach of full disclosure of an apparent error is often appealing as it conveys open, transparent, and honest communication. However, rushing in to disclose an apparent error may be difficult to retract if an RCA leads to a different premise for the error. Finally, error disclosure with an assignment of responsibility is a reasonable approach when the facts are known, and certainly appropriate after an RCA. It demonstrates honesty, and that you are on the parent’s/patient’s side. But no HCP likes to be on the receiving end of a pointed finger and both personal and systems matters must be taken into consideration. There may be times when an error that seems apparent, or discovered during an inquiry, can be unrelated to a patient’s ultimate outcome. At other times, the cause of an error or adverse event is frankly disputed. This may have to do with unwarranted assumptions, incomplete facts, and a desire to please parents or even dismiss personal responsibility. Even a RCA can leave participants with uncertainty about what caused a particular error. In such circumstances, HCPs need to avoid being rude or inflammatory. Sometimes no one can absolutely explain an event. That doesn’t mean that someone has to be wrong. HCPs can agree to disagree. Finally, there may be times when a neonatologist believes that an error has occurred but that it occurred when another neonatologist was the attending physician. Often, in such cases, the family does not know about it. Multiple choices exist in what to disclose when you discover an error in this fashion. Options might include (a) a nonspecific discussion of the reason the patient is in your NICU without disclosure of the error, (b) disclosing partial facts and conveying to the parents that you want to review all the records, and requesting the parent’s authorization to do so, (c) partial disclosure with a comment that you’d like to discuss your findings with the previous neonatologist, or (d) full disclosure with some explanation of the meaning of the findings. All choices have pros, cons, and likely consequences in how parents will respond. But once again a balanced response will consider time, expediency versus thoroughness, an intention of kindness but also a consideration of honesty and living up to one’s ethical duty. In this situation it is clear that on occasion, disclosure-related duties may rest with a subsequent-treating physician. It is hoped that the response strategy will be informed by the balance beam approach.
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Summary Error disclosure is but part of a culture of quality and safety within the NICU (and the hospital). It should happen in a systematic way. If an error is suspected, the family should be told, and they should be informed that an investigation will take place to determine the cause. There should then be an objective investigation and RCA. It is important to let this process play out and not to rush to judgment about blame. Disclosure should be frank. It should be done with empathy. Physicians should apologize for specific errors and explain why they happened. This may seem paradoxical to some as one’s instinct may be to keep errors secret or to never apologize. But transparency and remorse build trust. Families should be given time to explain their views and raise concerns. Successful error disclosure may lead to parental satisfaction and an appreciation of physician honesty and transparency.
R E F E R E N C E S
1. Silas R, Tibballs J. Adverse events and comparison of systematic and voluntary reporting from a paediatric intensive care unit. Qual Saf Health Care. 2010;19(6):568–571. 2. Boyle D, O’Connell D, Platt FW, Albert RK. Disclosing errors and adverse events in the intensive care unit. Crit Care Med. 2006;34(5):1532–1537. 3. Spear SJ, Schmidhofer M. Ambiguity & workarounds as contributors to medical error. Annals Intern Med. 2005;142(8):627–630. 4. McDonald TB, Helmchen LA, Smith KM, Centomani N, Gunderson A, Mayer D, Chamberlin WH. Responding to patient safety incidents: the “seven pillars”. Qual Saf Health Care. 2010;19:e11. https://doi.org/10.1136/qshc.2008.031633. 5. Fritz Z, Holton R. Too much medicine, not enough trust? J Med Ethics. 2019;45(1):31–35. 6. Lyndon A. Parents’ perspectives on safety in neonatal intensive care: a mixed-methods study. BMJ Qual Saf. 2014;23 (11):902–909. 7. McBride DL. Parents find medical errors and safety incidents that hospitals miss. J Pediatr Nurs. MayJune 2017;34( ):94–95. 8. Mendonca VS, Gallagher TH, de Oliviera RA. The function of disclosing medical errors: new cultural challenges for physicians. HEC Forum. 2018 epub ahead of print https://doi.org/ 10.1007/s10730-018-9362-7] Accessed 3 March 2019. 9. Smith JR, Cole FS. Patient safety: effective interdisciplinary teamwork through simulation and debriefing in the neonatal ICU. Crit Care Nurs Clin N Am. 2009;21:163–179.
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10. Martinez W, Hickson GB, Miller BM, Doukas DJ, Buckley JD, Song J, et al. Role-modeling and medical error disclosure: a national survey of trainees. Acad Med. 2014;89(3):482–489. 11. Sorokin R, Riggio JM, Hwang C. Attitudes about patient safety: a survey of physicians-in-training. Am J Med Qual. 2005;20(2):70–77. 12. Deonandan R, Khan H. Ethics education for pediatric residents: a review of the literature. Can Med Educ J. 2015;6(1):e61–e67. 13. Raju TNK, Suresh G, Higgins RD. Patient safety in the context of neonatal intensive care: research and educational opportunities. Pediatr Res. 2011;70:109–115. 14. Donn SM, McDonnell WM. When bad things happen: adverse event reporting and disclosure as patient safety and risk management tools in the neonatal intensive care unit. Am J Perinatol. 2012;29(1):65–70. 15. Berlinger N, Wu AW. Subtracting insult from injury: addressing cultural expectations in the disclosure of medical error. J Med Ethics. 2005;31:106–108. 16. Martinez W, Lehmann LS. The ‘hidden curriculum” and residents’ attitudes about medical error disclosure: comparison of surgical and nonsurgical residents. J Am Coll Surg. 2013;217(6):1145–1150. 17. Riskin A, Erez A, Foulk TA, et al. Rudeness and team performance. Pediatrics. 2017;139(2):e20162305. 18. Henry L. Disclosure of medical error: ethical considerations for the development of a facility policy and organizational change. Policy Polit Nurs Pract. 2005;6(2):127–134. 19. Chatziionnidis I, Mitsiakos G, Vouzas F. Focusing on patient safety in the neonatal intensive care unit environment. J Pediatr Neonat Individ Med. 2017;6(1):e060132. 20. Kaplan HC, Ballard J. Changing practice to improve patient safety and quality of care in perinatal medicine. Am J Perinatol. 2012;29(1):35–42. 21. Simons SL. Full disclosure when bad things happen. Neonat Netw. 2007;26(2):131–132. 22. American Medical Association, Code of Medical Ethics: Opinion 8.6, Promoting Patient Safety. https://www.ama-assn.org/ delivering-care/ethics/promoting-patient-safety. Accessed 3 March 2019. 23. Liang BA. A system of medical error disclosure. Qual Saf Health Care. 2002;11:64–68. 24. Iedema R, Allen S, Britton K, Piper D, Baker A, Grbich C, et al. Patients’ and family members’ views on how clinicians enact and how they should enact incident disclosure: the “100 patient stories” qualitative study. BMJ. 2011;343:d4423. https://doi.org/10.1136/bmj.d4423. 25. Pichert JW, Hickson GB, Pinto A, Vincent C. Communicating about unexpected outcomes, adverse events, and errors. In: Carayon P, ed. Handbook of Human Factors and Ergonomics in Healthcare and Patient Safety, 2nd ed. Boca Raton, FL: CRC Press; 2017. 401–422. 26. Hickson GB, Clayton EW, Githens PB, Sloan FA. Factors that prompted families to file medical malpractice claims following perinatal injuries. J Am Med Assoc. 1992;267(10):1359–1363.