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FAQs About Adverse Events


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Q: What should I do after a serious adverse event?


When a serious adverse event occurs, sincere sympathy and compassion expressed to the patient and/or family is often the most important response to help diffuse a potentially volatile situation. Rather than taking a defensive stance against accusations of substandard care, the health care team should refrain from castigation or infighting and immediately begin the following positive measures:

Assess the situation and communicate with the patient and family

  • Determine who from the health care team will discuss the event, with whom (the patient and/or responsible family member), and when.
  • Achieve consensus among team members as to the factual details and sequence of what occurred and what needs to be done in response.
  • Discuss how the details of the event, the outcome, and the treatment plan will be explained.
  • Maintain contact with each other and the patient/family for questions. Repeated requests for an explanation of the event is a common reaction of angry or anxious patients and family members.
  • Organize a family meeting if several relatives are involved in the patient's care or if treatment decisions are complicated.
  • Contact the institutional risk manager and complete any institutional reporting requirements (potential claim, medical device failure, etc.) if indicated.
  • Empathize with the patient and family; offer emotional support. If appropriate, apologize for the patient's distress,without admitting liability.
  • Attempt to reconcile opposing perceptions of what has occurred.
  • Accept responsibility for follow up of serious complaints, but do not accept or assign blame, or criticize the care or response of other providers.

The Medical Record

  • Assign the most involved and knowledgeable staff member(s) to record factual statements of the event in the patient's record and any follow-up needed or done as a result of the incident.
  • Avoid writing in the record any information unrelated to the care of the patient (e.g., “incident report filed,” “legal office notified”).

Additional Resources

  1. Guidelines for Disclosure After an Adverse Event [PDF]

Q: Is an apology after an adverse event treated as an admission of negligence?



In Massachusetts, any statements, writings, or benevolent gestures relating to the suffering of patients involved in an unexpected outcome are inadmissible as evidence of liability. Even so, some types of apologies are better than others. An apology that includes such words as "I am so sorry that my treatment caused you harm" is inappropriate.

A sincere expression of regret following a poor outcome or upsetting experience, such as "I am sorry this happened" coupled with a discussion about future treatment options can demonstrate an empathetic and caring attitude. Apologies can help to mitigate any anger the patient may feel, and communicate that you will work with the patient to improve the outcome.

Q: What are the pros and cons of using an addendum in a medical record after an adverse event?


While information in the medical record should never be deleted, obliterated, or altered after the fact, the judicious use of an addendum in a medical record is reasonable, as long as the addendum is designated as such and dated. Accepted rationale for including an addendum would be for the correction of facts (i.e., persons involved, time of event, sequence of events) and for the addition of facts or clarifying information. Individuals who participated in the care, but were unable to access the record until a later date, may also provide added information. Addenda should not be used to state opinions, perceptions, or defenses.

Arguments Supporting Addenda

Accuracy: The witness to the event may not be the person who documents it. Inaccuracies, even those that appear minor, should be corrected by someone who did witness the event.

Recall: Recording everything that is happening during an emergency situation is often impossible. Witnesses to an event may recall details at a later time, in which case, an addendum is appropriate.

Clarification: Information previously thought irrelevant may be deemed pertinent upon review of the case by an objective clinician. In this case, clarifying comments should be added to the record if they are pertinent to future care.

Arguments Against Addenda

Perception: The major argument against writing addenda is the potential that they may be perceived as attempts to falsify or change the record of fact. Inappropriately phrased, an addendum may appear to be "self-serving" rather than providing information important in the course of a patient's recovery. For example, following an adverse event, individuals may attempt to explain their own particular role (or lack of one) in addenda. This appears defensive, does not contribute to the care of the patient, and should be avoided.

Vulnerability: An addendum will be interpreted by plaintiff counsel as an attempt to alter the medical record and, if at all possible, used to support his or her client's claim. Seemingly insignificant record details are often magnified and used effectively to emphasize a plaintiff's point.

Q: Is free servicing accounts to try to avoid claims a good idea?


Yes, in some cases.

The majority of patients who experience an adverse event or an unexpectedly bad outcome do not sue the institution or their physicians, or even lodge a complaint. In those cases where a patient or family member does express anger, dissatisfaction with care, or even their intent to seek legal advice, questions about the bill often arise.

One reasonable approach to resolving patient dissatisfaction on a case-by-case basis is to consider "free servicing" or "writing off" all or a portion of the patient's bill. However, no one guarantees that this practice prevents or avoids future claims. Supporters of this approach say it promotes good will and improves customer satisfaction, and may thereby avert a claim. Others believe that patients who are inclined to sue will do so regardless of this assistance. In court, adjustments to a patient's bill are not considered an admission of liability. Free servicing is not recommended if doing so is unlikely to satisfy the patient.

The decision to not charge or to reimburse a patient when something goes wrong is based on a multitude of factors that change with every case.

  • Is the adverse event or poor outcome due to an error?
  • Is a provider at fault?
  • Could the event have been prevented?
  • What is the magnitude of the injury and amount of billings involved?
  • Is this a one-time write off, or an open-ended clinical situation?
  • In the opinion of the providers involved, the risk manager, and administrator, will the free care resolve the patient's complaint, anger, and frustration with his or her care?

A corollary to "free servicing" is the practice of providing reimbursement for lost personal articles, such as dentures and glasses, stolen or lost valuables, and repair of dental injury occurring during intubation.

The ability to provide free service is an important tool in handling patient concerns at an administrative level. Involving caregivers in risk management decisions and communicating to them any action taken on behalf of a patient is also important.

Q: What responsibilities does my office practice have for reporting medical device adverse events?


What responsibilities does my office practice have for reporting medical device adverse events?

The Safe Medical Devices Act (SMDA) requires that any "device user facility" report certain types of medical device-related events to the Food and Drug Administration (FDA). Besides a hospital, a device user facility includes:

  • an ambulatory surgical facility,
  • a nursing home, or
  • an outpatient diagnostic or treatment facility (such as a mammography unit or home health agency).

The requirements do not apply to a physician's office, which is defined as one used for the primary purpose of examination, evaluation, and treatment/referral of patients.

All qualifying device user facilities have the same reporting responsibilities, regardless of size or complexity. Medical device-related deaths must be reported directly to the FDA and the manufacturer (if known), while events meeting the definition of device-related serious illness and serious injury are reported only to the manufacturer. (In the event a manufacturer is unknown, these reports go to the FDA.)

Device user facilities are also required to have written procedures for identifying and evaluating events that might be reportable. These facilities must also comply with documentation requirements, and provide employees with training and education about their obligations under the institution's program. Programs in all settings are subject to FDA auditing for compliance with the mandatory reporting requirements.

Copies of the mandatory reporting form, instructions, and the coding manual can be obtained from the FDA by calling 1.800.638.2041. Or visit the FDA's website.

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