Table 1.

Content validity findings

Trigger Tool Items	I-CVI	S-CVI
Documentation Triggers
Missing, incomplete, or unclear documentation for the following: chief complaint, physical assessment, vital signs, hemodynamic monitoring (e.g., ETC02), allergies, pertinent history or medications, patient condition at handoff of facility.	0.80
Operational & Patient Movement Triggers
Change in transport mode or destination due to change in weather or patient condition.	0.70
Time from dispatch to initial patient contact exceeds accepted standards.	0.50
Time from initial patient contact to transfer of care exceeds accepted standards.	0.90
Injury to patient or team member during patient encounter / transport (e.g., stretcher drop, needle stick, or other).	1.00
Request for additional resources, personnel, or supervisor due to change in patient condition.	1.00
Patient Condition Triggers
A worsening trend (deterioration) in patient hemodynamic or mental status indicators (e.g., vital signs, LOC, GCS score).	1.00
Cardiac arrest during transport.	1.00
Intervention and Medication Triggers
Use of any of the following interventions during patient care: (cardioversion, defibrillation, transcutaneous pacing, advanced airway attempt, surgical airway, Intraosseous (IO), chest decompression, chest tube).	0.80
Failure of any intervention or procedure during patient care (some examples include: inability to obtain vascular access after a reasonable amount of time or number of attempts, failed IO, failed Nasogastric Tube (NG) placement, failed Foley placement, failed cardioversion, failed defibrillation, failed transcutaneous pacing, failed advanced airway or rescue airway, failed surgical airway, failed chest decompression).	1.00
Use of following medications or fluids: (blood products, vasopressors or inotrope [e.g., dobutamine, dopamine], naloxone, RSI medications [e.g., succinylcholine]).	0.80
Suggestive evidence of deviation from standard of care by performing an intervention or administering a medication that appears to be outside of protocol, or failure to perform an intervention or provide a medication that is within the standard of care.	1.00
Medication error (e.g., administering wrong or unapproved dose, administering wrong or unapproved medication, administering medication via wrong or unapproved route).	1.00
Other
No trigger directly applies, but I have suspicion that an AE may be present.	0.70
Trigger S-CVI (The average I-CVI for trigger items)		0.94*

Determination of Proximal Cause	I-CVI	S-CVI
Proximal Cause – Actions by Patient
Definition: The AE was the result of action(s) by the patient.	1.00
(A) Patient with capacity refuses transport to a specialty care facility.	0.80	0.94
(B) Patient with capacity refuses treatment specified in protocol.	0.90
(C) Patient with capacity discontinues ongoing therapy.	1.00
(D) Patient takes action that results or may result in harm to themselves or others.	1.00
Proximal Cause – Actions by Provider
Definition: The AE was the result of action(s) or inaction(s) by the crew.	1.00
HEMS Crew		0.93
(A) Medication errors	1.00
(B) Procedural errors (i.e., esophogeal intubation)	1.00
(C) Failure to zero the A-line prior to vehicle / aircraft moving.	0.70
(D) Failure to confirm orders from medical command.	0.80
(E) Failure to activate cath-lab for STEMI patient	0.90
(F) Failure to treat pain (e.g., extremity pain or treatment as indicated by protocol or medical oversight)	0.90
(G) Documentation error	0.40
(H) Inability to establish vascular access after a reasonable amount of time or number of attempts	0.50
(I) Failure to administer 02 to a hypoxic patient	1.00
(J) Failure to physically or chemically restrain a patient that is perceived to be at risk of harm to themselves or the crew	0.90
Non-HEMS
(A) Delay in patient care due to delays by the referring or receiving facility (e.g., patient in CT scanner, patient receiving dialysis).	0.60
Proximal Cause – Medical or Vehicle Equipment
Definition: Failure of the equipment, failure to troubleshoot and correct common problems with the equipment, or failure to remove defective equipment from service.	1.00
HEMS Crew
(A) Suctioning device malfunctioned during use.	0.90	0.98*
(B) An unanticipated malfunction with transport vehicle.	0.60
(C) Nasal capnography not available or 02 supply diminished during transport.	0.90
(D) All or any stretcher drop, tip, or malfunction.	1.00
(E) Malfunction of laryngoscope or ET tube (e.g., bulb failure or balloon failure)	1.00
(F) Fluid or medication pump failure or malfunction.	1.00
(G) Ventilator malfunction	1.00
(H) Failure of cardiac monitor	1.00
(I) Missing equipment that is needed for use.	1.00
Non-HEMS
(A) Delay in transport due to patient’s weight	0.40
(B) Delay in transport due to lack of appropriate equipment (non-hems)	0.40
Proximal Cause – Environmental/Scene Factors
Definition: Factors that may result from weather conditions or factors on the ground/scene (or other). This includes temperature, light, and scene safety.	0.60
(A) Cold causing fogging of optics on a Video laryngoscope system.	0.40	0.80*
(B) Freezing of fluids or drugs (e.g., mannitol).	0.70
(C) Diversion to a non-trauma center due to weather conditions for a trauma patient.	0.60
(D) Scene not safe delaying landing or take-off, prolonging on-scene time or pre-arrival (e.g., a remote landing zone).	0.60
(E) Delay in managing patient’s airway due to prolonged extrication.	0.80
(F) Delay due to prolonged arrival by ground or intercepting crew.	0.70
(G) A delay in patient packaging and transport due to weather.	0.30
Proximal Cause – Undetermined by Chart Review
Definition: The proximal cause of the AE (regardless of severity) cannot be determined by the information available in the chart.	0.60
Proximal Cause S-CVI (The average I-CVI for proximal cause items)		0.95*

Judgment of Severity	I-CVI	S-CVI
No Adverse Event
Definition: A case where a Trigger was selected (e.g., cardiac arrest during transport), but no AE identified after full review.	0.70
(A) Cardiac arrest during transport, but all documentation supports the crews committed no error and followed protocol(s) as prescribed.	0.70	0.80*
(B) Trigger selected due to administration of a medication (e.g., naloxone). However, the use of naloxone was indicated for patient overdose of opiate and is not related to delivery of care (e.g., the crewmembers did not overdose the patient).	0.60
(C) The time to transport the patient was delayed for necessary care, diagnostic procedures, or interventions outside control of medical crew (e.g. the patient was in the CT scanner at the referring facility or the patient requires a balloon pump, which will require longer time at bedside during the transition of care).	0.80
(D) Missing, incomplete, or unclear documentation.	0.60
AE Present – Potential for Harm
Definition: An action that may lead to injury or harm but there is NO evidence that an injury or harm occurred.	0.89
(A) A medication error in which one type of medication (e.g., ketamine) was administered to an intubated patient for sedation in place of more appropriate medication or medication listed as the standard of care (off- line protocols e.g., Versed).	1.00	0.92
(B) A 22kg pediatric burn patient received 0.2mg/kg of morphine (4.4mg total) for pain rather than 0.1mg/kg (2.2mg total). The pediatric patient may exhibit no adverse reactions (i.e. hypotension and reduced respirations).	1.00
(C) Administration of 500cc of saline when 300cc bolus was ordered by medical oversight.	0.78
(D) Patient received 4mg of Midazolam when the oversight physician ordered 2mg.	0.89
(E) Failure to administer ASA for a patient with chest pain for suspected cardiac etiology.	1.00
(F) Failure to check vital signs before and after medication administration (i.e., Nitroglycerin).	0.89
(G) Not adequately protecting patient’s airway. For example, no airway adjunct utilized for an unconscious patient with normal vital signs and no evidence of desaturation.	1.00
(H) Stretcher dropped or tipped, but no evidence the patient or crew member(s) were injured.	1.00
(I) Failure to immobilize a fracture in a trauma patient.	0.78
(J) Failure to control hemorrhage in a hemodynamically stable patient.	1.00
(K) Administration of Nitroglycerin to patient with documented use of phosphodiesterase inhibitors (e.g., Viagra). No evidence of hypotension is found.	0.89
(L) Immediately recognized and quickly corrected missed intubation with no evidence of patient deterioration.	0.78
AE Present – Harm Identified
Definition: An action or omission that led to injury or harm regardless of severity.	1.00
(A) Delay in recognition of missed intubation with evidence of patient deterioration; or failure to control airway within a reasonable amount of time or number of attempts with evidence of patient deterioration.	1.00	0.97
(B) A seizure patient administered 4mg Midazolam when medical oversight gave orders for 2mg. The patient lost spontaneous respirations. Crewmembers responded by use of BVM ventilations and intubation.	1.00
(C) Crew member intends to administer amiodarone for treatment of wide complex tachycardia at rate of 160. Crew member administers 10 mg Diltiazem and patient suffers a v-fib arrest.	1.00
(D) Stretcher drop with injury to patient.	1.00
(E) Failure to administer eclamptic patient Magnesium Sulfate and then seizes for a period of time.	1.00
(F) Patient with a GCS ≤8 and evidence of respiratory compromise (i.e., SPO2 <90) but no airway intervention by crewmembers.	1.00
(G) Crewmembers fail to activate specialty team where indicated (i.e. trauma team, cath lab, stroke alert).	0.89
(H) Failure to decompress a tension-pneumothorax	1.00
(I) Failure to adequately sedate a patient that was intubated as evidenced by follow-up from receiving facility that documented patient recall of events.	0.89
(J) Administration of Nitroglycerin to patient with documented use of phosphodiesterase inhibitors (e.g., Viagra). Hypotension results.	1.00
(K) A patient suffering from anaphylatic reaction is administered 0.3mg of Epinephrine 1:1000 Intravenous (IV) instead of Intramuscular (IM) and develop acute chest pain and change on EKG monitor.	1.00
(L) Use of unsynchronized cardioversion in a patient with unstable Atrial Fibrillation (Afib) that results in Ventricular Fibrillation (Vfib) or asystole.	0.89
Severity S-CVI (The average I-CVI for severity items)		0.95*
Overall S-SVI (The average I-CVI for all items in the tool)		0.95*

^*The S-CVI with the items highlighted in grey removed.