Adverse Event Protocol

Updated November 24, 2014
Author: Anesthesia Patient Safety Foundation

Description: General Plan for Immediate Management of a Critical Event; guidelines for Documentation, Communication, & Followup: Excerpted from the APSF.org website

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When to Initiate the Protocol:

The application of the protocol is particularly intended for sudden patient-injury accidents in the OR, especially when the anesthesia care may be involved in the causation. Further, a completely unexplained sudden cardiac arrest may well be revealed the next morning at autopsy to have been the result of an unavoidable massive pulmonary embolus, but with that fact being unknown at the time, activation of the protocol during the arrest is certainly appropriate.


The Basic Plan

Upon recognition that a major adverse anesthesia event is in progress or has occurred:

  1. Get help and mobilize according to this protocol
  2. The primary caregiver(s) should continue patient care.
    Except in the very unusual circumstance that the anesthesia provider becomes ill or disabled or is so shocked by the realization of the accident that s/he cannot function, s/he should devote full attention to direct clinical care rather than to the necessary organizational and administrative considerations.
  3. Designate immediately an Incident Supervisor (e.g., a senior practitioner, department leader, or the floorwalker) who:
    1. Assumes overall direction and control of the event.
    2. Organizes help and assigns tasks in the OR.
    3. Verifies incident has ended and there is no immediate recurrence (e.g. correct intubation and ventilation in the prototype example, continued availability of tank oxygen after a central oxygen supply failure, etc.).
    4. Involves consultants and advisors as indicated, including specifically the chief/chair of anesthesiology or appropriate designee, and any others who may help with care or recovery, such as neurologists, cardiologists, etc.
  4. Close that OR for that day;
    1. do not turn off or unplug anything;
    2. access any memory in any monitor or device used (especially the vital signs stored in many OR patient monitors) and print this out or photograph the screen(s) if there is no printing capacity;
    3. sequester all involved equipment and supplies (and the trash and needle buckets) and then:
    4. Alter nothing
        1. (no cleaning, no disassembly, no repair);
        2. if it appears likely or even possible that an equipment failure (anesthesia machine ventilator, bubble detector on a rapid infuser, or whatever) contributed to an accident, it may be indicated to conduct an inspection/testing session involving the real-time participation of representatives of the involved practitioners, the equipment manufacturers, the equipment maintenance personnel, facility administration, and involved insurance companies/attorneys.
    5. Discard nothing; sometimes the solution to a mystery can later be discovered in unexpected tiny details, such as an empty or missing or extra medication vial that suggests an accidental wrong drug administration may have caused the accident.
    6. Lock away all of the above (this may be difficult in a busy facility; be reasonable; for example, if it is accepted by all involved that there was an unrecognized esophageal intubation involving apparent human error, it would be possible to release the OR and its equipment for use the next day and dispose of the trash).
  5. Contact the care facility's administrator and risk manager (possibly also the practitioner's insurance company and attorney if indicated).
  6. Arrange immediate comfort and support for patient and/or family. Share as much information as possible. [Discussion of the concept of immediate full disclosure is beyond the scope of this article because of the administrative, risk management, and potential medical-legal implications; however, this concept is currently the subject of widespread attention and discussion. Good reprint from Annals of Int Medicine HERE]
  7. Designate a Follow-up Supervisor (who may or may not be the same as Incident Supervisor) who will:
    1. Verify that the elements of this protocol have been applied.
    2. Consider whether to organize a group debriefing (e.g., the day of the event or the following day) involving all those present during the event and function as scribe if indicated (note that there may be medical-legal implications of this and appropriate advice of counsel may be indicated). [Suggested protocols for such a debriefing exist in the literature involving the transportation, infrastructure, and technology industries; relevant medical examples are cited in the protocol's original journal article (reference below).]
    3. Maintain ongoing communications with all involved caregivers and patient representatives, coordinating and facilitating as much integration as possible.
    4. Pursue the accident investigation in conjunction with involved quality assurance and risk management systems and personnel; eventually prepare a report as indicated, particularly focusing on lessons learned and actions needed to help prevent similar accidents in the future; participate in any peer-review activities conducted regarding the event.
    5. File reports as indicated, such as with the FDA and ECRI if it appears that a medical device or medication hazard was involved in the cause of the accident.
  8. Document everything:
    1. Put strictly objective narrative entries in the medical record and incident report (but these can include background details on the involved thinking, such as, for example, the indication for invasive monitoring based on symptoms and signs of congestive heart failure).
    2. When writing about the events:
      1. State only the facts as you know them.
      2. Do not make judgments about causality or responsibility.
      3. Do not use judgmental terms or phrases.
    3. (Possibly) make additional detailed (including subjective impressions or value judgments) personal notes for later usecreated specifically while sitting with an attorney (personal or from the practitioner's insurance carrier) who keeps them as attorney-client work product.
  9. Try to review formal reports submitted by the institution to the authorities (state department of health/licensing body or the National Practitioner Data Bank) both in order to know what they contain and also add your observations or commentary if indicated.
  10. Continue involvement after the event when the patient survives:
    1. Talk to surgeons and consultants about care; make suggestions as indicated.
    2. Be visible, supportive, and not defensive with all involved.
    3. Communicate as much as possible (see G.3. above).

Summary of Responsibilities for Adverse Event Protocol

Primary Anesthetist/Anesthesiologist: Concentrate on continuing care; notify Anesthesia OR Administrator (or attending first if resident or CRNA); Do NOT discard supplies or apparatus or tamper with equipment; document events in the patient's record; Do NOT alter the record; stay involved with follow-up care; contact consultants as needed; submit a follow-up report; document continuing care in the patient's record.

Incident supervisor, e.g., Anesthesia Clinical Director, OR Administrator, Team Leader: Advise primary anesthetist/anesthesiologist and other personnel involved; verify close contact with the surgeon and other consultants; contact the hospital Risk Manager; contact manager for anesthesia equipment or alternate.

Department Chairman or Clinical Director: Directly supervise or delegate responsibility for incident investigation.

Anesthesia equipment manager or alternate: Assure impounding of equipment, if necessary, and determine appropriate disposition of equipment; if pharmaceuticals or supplies were involved which may create hazard to other patients, contact pharmacy, materials management, nursing or other departments; supervise continuing investigation of equipment or supplied-related issues; contact FDA, ECRI or manufacturer if appropriate.

Follow-up Supervisor: Notify the individuals involved of their responsibilities as defined in this documents; be responsible for assuring that procedures are followed to the extent necessary, reasonable and possible; maintain communication with those who are providing continuing anesthesia care, providing guidance and advice as needed; ensure that information regarding the adverse event is communicated through the proper channels to the department quality assurance program.


References

  1. The full text of the Anesthesia Patient Safety Foundation Critical Events Protocol
  2. The Detailed Original Protocol (Cooper, Cullen, Eichorn, 1993)

Reprinted from: Cooper JB, Cullen DJ, Eichhorn JH, Philip JH, Holzman RS. Administrative guidelines for response to an adverse anesthesia event. J Clin Anesth 1993; 5:79-84.

Guidelines for Action Following an Adverse Anesthesia Event

Objectives: To limit patient injury from a specific adverse event associated with anesthesia and to ensure that the causes of the events are identified so that a recurrence can be prevented.

Protocol: When a patient has died or has been injured from causes suspected to be related to anesthesia management, the following should occur:

Immediate

1. The primary anesthetist/anesthesiologist should concentrate on continuing patient care. The primary anesthetist/anesthesiologist should notify a physician responsible for supervision of anesthesia activities in the relevant patient care area, e.g., Anesthesia Clinical Director, Anesthesia OR Administrator, Team Leader, as soon as possible (at least before the anesthetist transfers direct responsibility for that patient). The person so contacted will direct the process of immediate prevention of recurrence (if necessary), events documentation and continued investigation or will delegate responsibility to someone other than the primary anesthetist or anesthesiologist. The individual performing these tasks is designated as the incident supervisor.

Rationale: Information vital to reconstructing events may be accidentally discarded. The highest priority for the primary caregivers must be the care of the patient, so responsibility for administrative and investigate activities must be assigned to others. Typically, an anesthesiologist supervising a primary anesthetist/anesthesiologist should not be the incident supervisor. However, out of normal working hours, a primary or supervising anesthesiologist may choose to act as incident supervisor and may exercise discretion in calling for assistance or advice.

2. Anesthesia equipment or supplies associated with the case, whether thought to be materially involved or not, should be sequestered before subsequent use. Nothing must be altered or discarded. The primary anesthetist/anesthesiologist or incident supervisor shall immediately contact the hospital individual responsible for management of anesthesia equipment and supplies (equipment supervisor). The equipment supervisor or his designee shall supervise the impoundment of involved supplies and equipment (including the anesthesia machine) in consultation with the hospital Risk Manager. A preliminary decision to continue use of urgently needed equipment may be made, following a safety inspection, at the discretion of the incident supervisor in consultation with the hospital Risk Manager.

Rationale: Equipment or supplies involved in the event may be accidentally altered or discarded, preventing determination of cause.

3. The incident supervisor or attending anesthesiologist should contact the hospital Risk Manager immediately following the anesthetic for additional administrative support.

Rationale: Individual caregivers will rarely be experienced in dealing with an adverse occurrence. The Risk Manager can advise on the ways to communicate information to the patient or to the patient's family in a way that is forthright and comforting, but which does not unintentionally alarm, misinform, or render judgment.

4. The primary anesthetist/anesthesiologist and other individuals involved must document relevant information about the incident.

5. The primary anesthetist/anesthesiologist, after discussion with the incident supervisor, must write on the patient's medical record relevant information about what happened and what actions were taken. Do not erase or obscure information on the record. If a correction is necessary, lightly cross out the original; initial and date changes. Additions to and explanations of notations on the record can be made, for example, to explain issues where professional judgment was involved.

6. The primary anesthetist/anesthesiologist must complete and file an incident report as soon as practical.

7. Others individuals involved in the incident should document their observations soon after the event. The documentation should be returned to the hospital Patient Care Assessment Coordinator or other appropriately designated individual. (List designated individual for hospital here.)

8. When writing about the events.

9. Give the highest priority to continued involvement in follow-up care of the patient.

1. Consult early and frequently with the surgeon.

2. Immediately call upon other consultants who may help improve long term care or recovery.

Follow-up Investigations

1. The Clinical Directory and/or Department Chairman shall be informed of each adverse event and will designate who shall supervise the event follow-up and investigation beyond the immediate actions. The follow-up supervisor shall:

1. notify the individuals involved of their responsibilities as defined in this document.

2. be responsible for assuring that procedures are followed to the extent necessary, reasonable and possible.

3. maintain communication with those who are providing continuing anesthesia care, providing guidance and advice as needed.

4. ensure that information regarding the adverse event is communicated through the proper channels to the departmental quality assurance program.

2. The need to maintain equipment sequestration shall be determined by the incident follow-up supervisor and the individual responsible for managing anesthesia technology.

1. If it is unlikely the equipment was related to the event, the equipment can be returned to service after routine inspection.

2. If it is possible that the equipment was related to the event, the following procedures should be implemented and supervised by the individual responsible for managing anesthesia technology or his designee:

1. Store the equipment in a secure location. Label it DO NOT DISTURB.

2. Document its physical condition and notable features as received and record its identification, e.g., serial number.

3. Do not alter or inspect the equipment in any way that could affect further investigation.

4. Conduct a thorough inspection of the equipment in the presence of the primary anesthetist/ anesthesiologist, the insurance carrier, hospital Risk Manager, equipment manufacturers or any of their designees.

3. If an equipment problem or failure is discovered or strongly suspected, the equipment supervisor, after consultation with the hospital Risk Manager, shall consider contacting the Food and Drug Administration (via the Device Experience Network @800-638-6725) and/or the Emergency Care Research Institute (ECRI) if it is believed necessary to warn other users. Alternatively, the manufacturer can communicate that information to the appropriate authorities, which may be required by law depending upon the circumstances.

4. Under the Safe Medical Devices Act, the hospital may be required to report the event to the manufacturer and FDA if a serious injury or death occurred.

5. Continue to verify and document medical care provided to the patient following the event.