General Information

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  Age unit (ASC, Nursing Facility, Pharmacy)
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  Contact email address
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  Contact extension
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  Contact name
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  Contact phone
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  Date discovered
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  Event date
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  Event time
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  Event time unknown
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  Form ID
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  Last modified date
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  Patient age
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  Patient ethnicity
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  Patient gender (ASC, Hospital, Nursing Facility)
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  Patient race
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  Select your facility (ASC)
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  Submission date
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  Who should we contact for clarification or feedback?

Harm Category

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  Did an actual adverse event occur?
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  Did the event contribute to or result in patient death?
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  Did the event reach the patient?
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  Did the event require any of the following significant interventions? (ASC)
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  The Harm Category for this event is
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  Was an intervention necessary to sustain life required?
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  Was extra monitoring or an intervention to preclude harm required?
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  Was the harm permanent?
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  Was the harm temporary?
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  Was the patient harmed?
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  What prevented the event from reaching the patient? (ASC, Hospital, Nursing Facility)
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  What was the extent of harm to the patient?
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  Which intervention to preclude harm was required? (ASC)

Event Information

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  Admitting diagnosis
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  Event location (ASC)
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  Event type (ASC)
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  How preventable was the incident?
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  Relevant comorbidities
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  Relevant surgeries or procedures
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  Was the event associated with HIT (Health Information Technology)?
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  What was the patient’s documented ASA Class?

HIT Questions

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  Type of EHR involved
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  Type of HIT device involved
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  Was the event associated with HIT (Health Information Technology)?
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  Which human/device interface or ergonomics issue(s) were involved?
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  Which of the following describes the circumstances involving the HIT in the event?
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  Which problem(s) resulted from the HIT function problem?

Event Type-Specific Questions

Anesthesia Event-Specific Questions

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  Anesthesia event type
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  Type of airway management problem
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  Type of physical injury
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  Was a briefing conducted prior to the induction of anesthesia?

Blood or Blood Product Event-Specific Questions

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  During which stage did the event originate (regardless of the stage when it was discovered)?
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  Type of blood product involved
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  Was an independent double-check documented?
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  Which best describes the blood or blood product event?

Contaminated Drug, Device or Biologic Event-Specific Questions

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  Was the event reported to MedWatch?

Device, Equipment or Supply Event-Specific Questions

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  Specific device
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  Type of device or supply involved (ASC, Hospital)
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  Was the event reported to MedWatch?
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  Which best describes the event?

Fall Event-Specific Questions

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  Did any physical device contribute to the fall?
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  Did the patient sustain a physical injury as a result of the fall? (ASC, Hospital)
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  Prior to the fall, what was the patient doing or trying to do? (ASC)
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  Was the fall assisted or unassisted?
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  Was the fall observed? (ASC and Hospital)
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  Was the medication considered to have contributed to the fall?
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  Was the patient on medication known to increase fall risk at the time of the fall? (ASC, Hospital)
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  What type of injury was sustained?
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  What was the patient’s goal? (ASC, Hospital)
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  What was the physical or environmental cause of the fall?

HAI Event-Specific Questions

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  SSI site
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  Type of central line involved
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  Type of healthcare-associated infection (HAI) (ASC)
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  Type of pathogen
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  Was the infection determined to be present or incubating on admission?

Medication or Other Substance Event-Specific Questions

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  At what stage in the process did the event originate, regardless of the stage at which it was discovered? (ASC, Hospital, Nursing Facility)
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  Generic name or investigational drug name
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  Type of medication or other substance event (ASC, Hospital, Nursing Facility)
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  Type of other substance (ASC)
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  Was this medication/substance given to this patient?
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  Was this medication/substance prescribed for this patient?
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  Were any of the following involved? (ASC, Hospital)
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  What type of medication/substance was involved? (ASC, Hospital, Nursing Facility)
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  What was the actual route of administration? (ASC)
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  What was the contraindication (potential or actual interaction)?
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  What was the intended route of administration? (ASC)

Surgical or Other Invasive Procedure Event-Specific Questions

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  Number of staff changes (after timeout)
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  Type of surgical or other invasive procedure event (ASC)
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  Was a safe surgery/procedure checklist used?
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  Was the patient’s death directly attributable to the surgery or procedure?

Unintended Retained Foreign Object Event-Specific Questions

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  Did the surgeon perform a cavity sweep?
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  Number of staff changes (after timeout)
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  Type of retained object
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  Was a safe surgery/procedure checklist used?
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  Was the patient’s death directly attributable to the surgery or procedure?
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  Was the retained object identifiable by any of the following means?
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  Were counts performed for the type of object that was retained?

Contributing Factors

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  Communication factors (ASC, Hospital)
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  Contributing Factor Category: Communication
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  Contributing Factor Category: Device, Equipment, or Supply
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  Contributing Factor Category: Human or Environmental
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  Contributing Factor Category: Organizational
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  Contributing Factor Category: Patient (ASC, Hospital, Pharmacy)
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  Contributing Factor Category: Patient Management (ASC, Hospital)
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  Contributing Factor Category: Policy or Procedure
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  Device, equipment, or supply factors (ASC, Hospital)
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  Human or environmental factors (ASC, Hospital, Nursing Facility)
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  Organizational factors (ASC, Hospital)
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  Patient factors (ASC, Hospital, Pharmacy)
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  Patient management factors (ASC)
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  Policy or procedure factors (ASC, Hospital, Nursing Facility)

Review and Analysis Information

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  Date review and analysis completed
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  Did the review and analysis team have a post-analysis briefing with senior management? (ASC, Hospital)
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  Members of the review and analysis team (ASC)
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  Person hours spent in review
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  Please specify why no written notification was given
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  Who was given written notification? (ASC, Hospital, Pharmacy)
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  Who was notified of this event? (ASC)
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  Why was your facility unable to provide written notification?

Summary, Cause and Action Plan Information

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  Action plans
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  Causes
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  Event Summary
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  Is this a root cause?