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Errors, Mistakes, Mishaps, Failures

Although in practice we accept that adverse events may occur for severalcauses, we do not accept that these incidents occur repeatedly for the same reasons.

When an adverse event occurs, like any other critical situation, different focal points require attention and timely response. The comprehensive management of adverse events and their impact requires the almost simultaneous approach of the multiple agents and levels affected (patient and family, healthcare professionals, institution). It implies tasks such as incident notification and analysis, frank communication with the first victim, or crisis communication if the adverse event has a media impact.

Listed below are a set of recommendations that guide the analysis of the incident, the communication of what happened to the patient or their family, and the protection of the reputation of the healthcare institution and the professionals.

  1. Detailed analysis of the incident
    • Ensure that information is reported in an appropriate context and through an appropriate medium addressing all questions as openly and honestly as possible as they arise.
    • Activate the team responsible for conducting the root cause analysis (as appropriate).
    • Arrange a meeting of the Safety Committee to analyse the results of the case analysis or root cause analysis (as appropriate) and propose measures to increase patient safety.
    • Establish the information required and a deadline for reporting it, minimising delays.
    • Decide whether it is appropriate to invite representatives of registered patient associations to participate in the case analysis or root cause analysis (as appropriate).
    • When needed, inform the patient who has experienced the adverse event (or his/her family) of the results of the analysis. This could be useful in some cases.
    • Introduce measures to increase patient safety and assess their effectiveness.
    • With the appropriate confidentiality, hold clinical sessions to discuss medical errors and how to decrease the risk of them occurring in the future.
    • Reflecting on the experience of an adverse event, review procedures for ensuring that personal information disclosed about patients and health professionals after an adverse event with media impact respect their rights to confidentiality and personal privacy. Consider that once agreement has been reached on measures to improve procedures and avoid adverse events due to a similar cause in the future, it is not relevant or necessary to provide further information, remembering also that relevant information has been noted in the patient’s medical record.
  2. Open disclosure with patients and/or family members
    When an AE occurs, it is needed to inform the patient (or his/her family) about what occurred, its foreseeable consequences, and the alternatives to correct it. There are ethical and clinical reasons for disclosing AEs to patients. Spite of, patients expect to be informed, the attitude of professionals is of excessive caution due to fear that disclosing such information will result in a lawsuit. In practice, only one-quarter of patients receive information after an error that causes them harm. Most healthcare professionals are not properly trained to undertake this communication with a patient. The way a show of grief should be exhibited for what has happened (an apology) has also been subject to controversy, especially in without apology laws. In recent years, consensus about how to deal with this communication has grown and help tools have been developed. Nonetheless, disclosing an AE to a patient is a complex and distressing situation that requires the following: adequate organizational framework, support from the organization and its management, knowing what to disclose, communication skills, ethical commitment, and a positive attitude that predisposes being open with the patient.
    • Ensure that there is a suitable place to talk with the patient and/or his/her family members without interruptions.
    • With the available information well organized, arrange for a senior medical practitioner (it is not always a good idea that the health professional involved in the 2 incident informs the patient), together with another health professional known to the patient (or his/her family) to provide honest information to the patient, and show empathy with their suffering, including making an apology. If various patients are involved, the information should be provided privately to each one. In some cases, the health professional involved, if willing and capable of doing so, may participate in this meeting to inform the patient (though never on their own).
    • Consider setting up an information team depending on the characteristics and magnitude of the adverse event.
    • Ensure that the communication does not intimidate the patient. The amount of information given the frequency and the number of professionals who inform should be carefully controlled.
    • Place importance on supplying information fast, even though it may initially be incomplete, making patients aware of this limitation.
    • Assess whether there are intrinsic patient related factors (personality, emotional situation, etc.) that weigh against informing the patient directly. This will occur in isolated cases. Assess what the patient(s) and family members know and what they want to know.
    • Decide, by consensus between a team of professionals, what information is to be given, in what order, and how to apologise with empathy. Confine the discussion strictly to facts and objective data.
    • Do not make judgements about causality or responsibility, confining the conversation to what is known about the incident and objective clinical data. Avoid speculation. Do not use jargon or words that the patient does not understand. As a rule, avoid terms that could be confusing or have legal implications that go beyond the goal of providing honest information to the patient. In relation to this, it is not recommended to use terms such as error or mistake; rather explain that the outcome has been unexpected. The way this process is carried out should reflect the fact that most adverse events have systemic causes, which are not directly attributable to a specific health professional.
    • Strive to reduce uncertainty without entering detailed analysis. Pay attention to nonverbal communication, ensuring that the patient and family members feel that the concern and respect shown by the health professional are genuine. Health professionals should talk to each other about the adverse event before informing the patient to reduce the emotional stress and create a climate of trust among healthcare team members.
    • Meet any special needs of the patient in terms of communication, considering their age, family situation, and language in which they are most comfortable, among other factors.
    • Record the meeting for informing the patient and/or family members if they give their consent. In such cases, a copy must be made available to the patient on request.
    • Check whether the patient will or would like to be accompanied by a family member, in the case of patients under 18 years of age.
    • Request written consent from the patient to share information with specialists in other centres or health services, as appropriate. In such cases, do not supply the name of the patient or other personal details, sharing only the minimum necessary information with third parties.
    • Have and make available information a legal advice about when and how to proceed with an asset of financial compensation.
    • Inform the patient and/or family not only about the incident but also about the steps being taken to determine what happened and how to prevent similar events in the future. See the algorithm for providing honest information to the patient.
    • Make sure that the patient and/or family members understand the information given and that they do not have any outstanding queries.
    • Keep a line of communication open between the patient and the contact health professional. Update the information regarding the incident as more details become available.
    • Make a note in the patient’s medical record specifying the information given to the patient/family with details of their questions and level of understanding of the information.
    • Plan follow-up to support the patient through the course of their illness and with paperwork, in such cases.
    • When needed, offer to the patient the option of changing his/her healthcare team.
  3. Protecting the reputation of health professionals and the organization
    • Review the communication plan in the light of experience, to ensure that in the months following the incident positive news about the care work are disseminated, to help to generate trust in the centre and its staff among the public.
    • Regularly update information on new interventions in the field of clinical safety underway in the centre.
    • Disseminate news on the therapeutic achievements and training activities carried out, to help strengthen confidence of patients, and the public in general, in the organization and its staff.


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