Critical Failure Reporting

Section 2 - EMERGENCY OPERATIONS

PURPOSE:

To establish a procedure to report instances where a potential adverse event such as medication errors, vehicle failure, malfunction or failure of durable medical equipment or other related medical equipment occurs during patient care.

PROCEDURE:

Medical Director Notification and Involvement:

• The Medical Director shall be notified on incidents where a potential adverse outcome, medication error category D or greater as listed on appendix 4547 takes place during patient care activities.
• The Medical Director shall participate in all investigations pertaining to adverse patient outcomes and medication errors as listed in appendix 4547 above.
• The Deputy Chief or designee is responsible for the notification and coordination with the Medical Director whenever an adverse outcome, medication error category D or greater or any significant adverse event takes place requiring the Medical Director’s involvement.
  

Medication Error, Equipment Malfunction or Failure Reporting:

• All personnel are required to report all incidents where there is a failure of a medical device (equipment), medication error(s) or vehicle malfunction/failure during patient care activities.
• After all patient care has been completed; the crew involved in the event will complete the Adverse Event, Equipment or Vehicle Malfunction/Failure Report form located on the City of Maitland network K drive according to the instructions on the form.
  

Equipment Disposition/Replacement:

• Any equipment involved in an event or suspected to be malfunctioning will be removed from service immediately and a replacement unit obtained through EMS supply.
• All equipment involved in a patient related event must be tagged and secured for inspection/investigation purposes by the Deputy Chief or their designee.
  • If the medical device is contaminated, the device must be encased in a biohazard bag.
  • The equipment must not be cleansed, reset, or tampered with before it is inspected.
• Upon further inspection by the manufacture etc. the Deputy Chief or their designee will make the necessary arrangements to repair or replace the defective medical device.
• Events involving medications, the crew must secure in an appropriate container any syringe, vials and packaging from the medication. Do not place any needles or sharps in the container.
• Events involving a transport vehicle will require the removal of the unit from service, replacement of said unit with a spare until such time that an inspection has been completed, the necessary repair work completed and the unit authorized to return to service by fleet maintenance.
  

Equipment Malfunction or Failure Investigation:

• All reports of equipment malfunction or failure will be investigated by the Assistant Chief.
  • Investigations requiring equipment evaluation from an independent agency will be coordinated through the Deputy Chief.
  • The Assistant Chief will coordinate with the Safety Committee on all investigations.
• Results of the investigation will be submitted to the Deputy Chief, Assistance Chief and Fire Chief for review.
  

Event Reporting to Local/State/Federal Agencies:

• Incidents requiring reporting to any Local, State and/or Federal agencies will be coordinated through the Fire Chief and completed in accordance to the respective agency reporting process.
• Report to the Food and Drug Administration will be completed through the MedWatch process. Forms can be obtained at http://www.fda.gov/medwatch/getforms.htm
  

Tracking and Documenting of Equipment Malfunction or Failures:

• All equipment malfunction or failure reports will be collected and tracking log completed by Assistant Chief.
  • All supporting documentation, investigation materials and disposition of the report will also be included in the report packet.
  • These reports will be archived for the time period as required by the laws governing the maintenance and disposal of records.
    

Definitions:

Medical Equipment or Devices: The Food and Drug Administration (FDA) defines a medical device as any instrument, apparatus or other article that is used to prevent, diagnose, mitigate or treat a disease or to affect the structure or function of the body, with the exception of medications. This means that the FDA classifies common hospital products such as catheters, thermometers, patient restraints and syringes as medical devices.

Medications: Any chemical, compound, fluid, tablet, spray or pharmaceutical product of any type used to alter a function, treat or otherwise affect an action upon a body’s system in an effort to correct a medical condition.

Medication Use Error: Any situation where a medication is incorrectly used. It includes events where the wrong medication, wrong dose or route, wrong patient, or medication was given when a known sensitivity or allergy is noted regardless of patient involvement or outcome.

Adverse Event: Any incident where the use of a medication or medical device is suspected to have resulted in an adverse outcome for the patient.

Product Problem: Any event where the medical device in question did not perform as designed. This includes reporting performance problems, safety concerns, questionable stability, defects, contamination or any event where the equipment did not perform as intended.

Medical Device Use Error: Any situation where the medical device was operated in a manner differently than intended by the manufacturer.

Vehicle Malfunction or Failure: Any condition or event where the transport unit had any type of mechanical or warning device failure that delayed or prevented the rapid transport of the patient to the initial receiving facility.

Appendices: 4547

• Medication Reporting Index
  • United States Pharmacopeia (USP) and National Coordinating Council for Mediation Error Reporting and Prevention (NCC MERP):

Type of Error	Category Result
No Error
Category A	Circumstances or events that have the capacity to cause error
Error/No Harm
Category B	An error occurred but the medication did not reach the patient
Category C	An error occurred that reached the patient but did not cause the patient harm
Category D	An error occurred that resulted in the need for increased patient monitoring but no patient harm
Error/Harm
Category E	An error occurred that resulted in the need for treatment or intervention and caused temporary patient harm
Category F	An error occurred that resulted in initial or prolonged hospitalization and caused temporary patient harm
Category G	An error occurred that resulted in permanent patient harm
Category H	An error occurred that resulted in a near-death event (e.g., anaphylaxis, cardiac arrest)
Error/Death
Category I	An error occurred that resulted in patient death