Communication of Medical Errors with Harm and Unexpected Adverse Events to Patients and Families - PR.55

Content Applies To

Rochester

Scope

Mayo Clinic's campus in Rochester

Purpose

To outline a process for informing the patient of medical errors and unexpected adverse events that cause serious harm to the patient.

Key Terms

Medical error with harm:A mistake or omission in medical treatment that causes serious harm to the patient. Example: a surgical procedure performed on the wrong body part.

Serious harm:Includes (1) death, (2) prolonged or permanent loss of function, (3) prolonged or permanent pain, or (4) harm that requires medical intervention to prevent the progression of harm or return the patient to the baseline condition that existed before the occurrence of the adverse event. Example: the patient experiences respiratory depression due to the administration of an excessive dose of pain medication and requires medical intervention to restore normal respiratory function.

Primary staff physician:The staff physician who is responsible for directing and coordinating the patient’s overall medical treatment plan. In the outpatient setting, the primary staff physician is the supervising physician responsible for the outpatient care in which the medical error or unexpected adverse event occurred.

Unexpected adverse event:Serious harm sustained by a patient that differs significantly from the anticipated outcome of treatment. This does not include known complications of treatment disclosed to the patient prior to treatment. An unexpected adverse event may occur with or without an identifiable error in treatment. Example: the patient experiences a significant adverse reaction to a contrast material to which the patient had no known allergy.

Policy Statements

  1. The primary staff physician informs the patient, and when appropriate, the patient’s family, of medical errors and unexpected adverse events that cause serious harm to the patient. Mayo does additional internal and external reporting as required by applicable laws and Mayo policy.

Procedure Statements

  1. Treat the patient.Following the occurrence of a medical error or unexpected adverse event that causes serious harm to a patient, the first priority is to treat the patient and obtain assistance from other care providers to address the patient’s immediate needs.
  1. Notify the primary staff physician.The patient’s primary staff physician is immediately notified of the medical error or unexpected adverse event.
  1. Report the event to the Event Reporting Pager.The primary staff physician ensures that the medical error or unexpected adverse event is reported to the Event Reporting Pager (seeEvent Reporting: Patient, Visitor, and Volunteer – OF.1b).
  1. Communicate with the patient and/or family, as follows:
  1. The primary staff physician informs the patient of the medical error or unexpected adverse event. If the medical error or unexpected adverse event involved a physician or care provider other than the primary staff physician, the other physician or care provider may accompany the primary staff physician in meeting with the patient.
  1. The primary staff physician informs the patient of the medical error or unexpected adverse event as soon as practicable, depending on the patient’s medical condition and treatment needs. Depending on the patient’s wishes and/or medical condition, the primary staff physician should include the patient’s family in these discussions.
  1. The primary staff physician provides the patient with accurate, objective information regarding the medical error or unexpected adverse event. The physician should not speculate about any aspect of the patient’s medical condition or treatment, including care rendered by another provider. Communication regarding a medical error or unexpected adverse event is an ongoing process, and the primary staff physician should inform the patient of additional facts as they become known. The primary staff physician should inform the patient that the events surrounding his or her medical care will be carefully reviewed and the results of this review will be shared with the patient. The primary staff physician should inform the patient of his or her current status and plans for ongoing care.
  1. If the patient’s primary staff physician is unavailable, the physician who is covering for him or her identifies a suitable alternative physician to communicate with the patient and/or family. Depending on the specific situation, it may be appropriate for departmental or institutional leaders to participate in ongoing discussions with the primary staff physician, the patient and/or family.
  1. Document the event and the communication with the patient and/or family.

The primary staff physician documents the medical error or unexpected adverse event accurately and objectively in the patient’s medical record. The primary staff physician also documents all discussions with the patient and/or family regarding the medical error or unexpected adverse event.

Related Documents

Event Reporting: Patient, Visitor, and Volunteer – OF.1b.

References

N/A

Contact

Secretary, Mayo Clinic Rochester Clinical Practice Committee

Approved by

Mayo Clinic Clinical Practice Committee – 07/27/2011

Mayo Clinic Rochester Clinical Practice Executive Committee – 01/02/2008

Mayo Clinic Rochester Health Information Policy Committee – 03/05/2008

Content Information

Contact: Smith, Naomi
Content ID: DOCMAN-0000055924
Release Date: 07/27/2011
Site(s): Rochester

Workflow Reviewer Name(s): Smith, Naomi
Workflow Approver Name(s): Smith, Kenneth M. (Ken)
Next Review Date: 07/25/2013

Comments: Original effective date 12/04/2008; Date of last IPC review 07/25/2011

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