1. Medical Equipment Failure/Reporting Process
Brandy Shannon, RN, MSN, DSD
Educator CCC and NCU
October 2014

2. Purpose
To educate the health care provider on the correct process of reporting patient care equipment failure and the process of reporting unanticipated adverse outcomes following the chain of command organization model.

3. Objectives Knowledge of how to report patient equipment malfunctions.
Understand their role in withdrawing malfunctioning equipment from the patient service area, tagging and reporting to Biomedical Services for evaluation.
Have a better understanding of the importance of NOT trying to repair or change any settings on the equipment.

4. Patient Care Equipment Failure
Medical Device: FDA defines a medical device as an instrument, apparatus or other article that is used to prevent, diagnose , mitigate or treat a disease or to affect the structure of function of the body, with the exception of drugs. For example, a medical device includes but is not limited to ventilators, monitors, dialyzes, and any other electronic equipment, implants, thermometers, patient restraints, syringes, catheters, in vitro diagnostic test kits and reagents, disposable, components, parts, accessories and related software.

5. Policy No:
If a medical device malfunctions or is not working property, the employee/staff member must act immediately.
This policy applies to any medical personnel who discovers, witnesses, or are notified of a suspected medical device incident.

6. Responsibility of Medical Personnel
Attend to the patient’s needs.
Report the incident immediately to the attending physician, immediate supervisor, Biomedical Manager, and Risk Management Coordinator.
Remove the device from service, out of the patient area. Impound relevant supplies, accessories, and packaging. Do not change any settings or attempt to repair the equipment.
Request that hospital security assist in securing the device until the Biomedical personnel arrives to examine it.

7. Occurrence Reporting:
Submit an occurrence report directly to the Risk Management Coordinator within 24 hours of the incident. Include in the occurrence report the following information:
Patient name and medical record number
Room and bed number
Name of attending physician notified
Name of supervisor and Biomed Engineer notified
Product name
Location of the product
Model Number
Name of manufacturer, if known
Brief description of incident, including date and time

8. Occurrence Reporting (Cont.):
Within twenty-four (24) hours of being notified of a suspected medical device incident, the Risk Management Coordinator in conjunction with the Manager of Biomedical Department will conduct an investigation and initiate appropriate follow-up action.

9. Supplemental Form/Medical Device Incidents:

10. Reporting of Unanticipated Adverse Events
Brandy Shannon, RN, MSN, DSD
Educator CCC and NCU
October 2014

11. Purpose
To educate the health care provider on the correct process of reporting unanticipated adverse outcomes.

12. Objectives Identify when to report an unanticipated adverse event
Describe how to report an unanticipated adverse event

13. Definition
Adverse Event – any unanticipated happening that is not consistent with the routine care of a particular patient and/or the routine operation of the facility. An adverse event may also involve a visitor, employee, volunteer, student or Physician.

14. When to Report an Unanticipated Adverse Event
Examples of unanticipated adverse event:
Falls
Medication Related (wrong dose)
IV (wrong solution)
Pressure Ulcers
Leaving Against Medical Advice (AMA)
Elopement
Disruptive Behavior
Patient Self Injury
Loss of Property
Unanticipated event involving a patient.

15. How to Report an Unanticipated Adverse Event
If an unanticipated adverse event is
detected the following should be
followed:
Contact the attending physician, manager and house supervisor immediately.
Complete an Event Report via the iVOS Event Reporting System located in the Clinical Tunnel.
Only the physician, risk manager, nurse manager or designee will be responsible to disclose the event to patient or legal representative.
An appointed hospital designee will be responsible to report the event to the appropriate regulatory agencies.

16. Where to Find iVOS Event Reporting System (ERS)
ERS is located in the following:
Clinical Tunnel
Starfish Folder

17. A paper Event Report form may be used and must be delivered to the Risk Management or Patient Relations Department.
If you have any questions completing an event report, contact your charge nurse, manager, supervisor or the risk management

18. Chain of Command The Line of Authority
Brandy Shannon, RN, MSN, DSD
Educator CCC and NCU
October 2014

19. Purpose
This module will provide instruction on the importance of observing proper reporting process, good communication and initiating the chain of command as indicated.

20. Objectives At the end of this module, the learner will be able to:
Review clinical staff responsibilities and expectations on who to notify if an unusual occurrence takes place.
Review and reiterate “Chain of Command” policy and procedure as indicated.

21. Introduction
It is the policy of Neurological Care Unit to establish guidelines to define the chain of command when patient care personnel need assistance, clarification or direction in any situation, or when medical staff wish to escalate concerns about patient care or nursing services.

22. Definition
A chain of command is an aspect of organizational structure that is meant to show a clear line of responsibility from the top position in an organization all the way down to the bottom.
A chain of command is established so that everyone knows whom they should report to and what responsibilities are expected at their own level.

23. RN or Other Healthcare Provider
Charge RN
Manager
Director
VP of Neuro/Behavioral Services
Hospital President
take it to the next level.
If the RN or other healthcare provider faces any circumstances
that may constitute a threat to the health or safety of the patient
and needs assistance, clarification or direction, he or she must
take it to the next level.

24. RN or other healthcare provider VP of Neuro/Behavioral Services
Charge Nurse
RN or other healthcare provider
Charge RN
Manager
Director
Hospital President
VP of Neuro/Behavioral Services
If the Charge RN does not resolve or no resolution is met,
he or she will contact the Manager.

25. RN or other healthcare provider VP of Neuro/Behavioral Services
Director
RN or other healthcare provider
Charge RN
Manager
Director
Hospital President
VP of Neuro/Behavioral Services
The Manager will be notified if resolution does not occur
at level of the Charge RN. If no resolution is met, the
Director will notify the Director.

26. RN or other healthcare provider VP of Neuro/Behavioral Services
Administrator
RN or other healthcare provider
Charge RN
Manager
Director
Hospital President
VP of Neuro/Behavioral Services
The Director will be notified if resolution does
not occur at the level of the Manager. If no resolution
is met, the Director will notify the VP of Neuro/Behavioral
Health Services.

27. VP Neuro/Behavioral Services
RN or other healthcare provider
Charge RN
Manager
Director
Hospital President
VP of Neuro/Behavioral Services
The VP of Neuro/Behavioral Services will be notified if
resolution does not occur at the level of the Administrator.
If no resolution is met, the VP of Neuro/Behavioral Health
Services will notify the Hospital President

28. RN or other healthcare provider VP of Neuro/Behavioral Services
Hospital President
RN or other healthcare provider
Charge RN
Manager
Director
Hospital President
VP of Neuro/Behavioral Services
The final person to be notified is the
the Hospital President if resolution
does not occur at the level of the
VP of Neuro and Behavioral Services.

29. A Case Study This is the case of Ms. M.R. that occurred May 2007:
Sometime during the first week of May, Ms. M.R. presented multiple times at the Emergency Room of X Hospital, complaining of abdominal pain. It has been reported that on at least three occasions she was examined, provided pain medication, and then released. A mere six hours after her last visit she returned to the same ER complaining again of severe abdominal pain. The triage nurse on duty at the time informed her that there was nothing more that could be done. As she writhed in pain in the hallway, her boyfriend went around frantically trying to get help, going so far as to call 911. Since she had become a disturbance, hospital police were called.

30. A Case Study Con’t
They ran a background check, found that the patient had an outstanding warrant, and she was arrested! As she was wheeled out to the waiting patrol car, she became unresponsive, and was taken back to the ER where she died. An autopsy later discovered that she died of a perforated bowel. It was determined that if she had received treatment for this condition within the 24 hours prior to her death, there would have, in all likelihood, been a different outcome.
The triage nurse on duty that evening resigned and has been reported to the California Board of Registered Nursing, along with several other nurses. One wonders, what could have gone so terribly wrong?

31. What Could Have Been Done?
One possible scenario is that the triage nurse—who informed the patient that she had been seen six hours earlier and there was nothing more that could be done—could have turned to her superiors for guidance, advice, or to move the patient’s request up the chain of command. The nurse could have requested that the ER physician examine or reexamine the patient.

32. What Could Have Been Done?
If she had employed the chain of command she would in all likelihood, not have been held guilty. She failed to call and seek help from the head nurse or the charge nurse who were both in the position to advance her request. If she had contacted them and informed them of the situation then they would have been in the position to use their skills, position, and power to get the appropriate care for the patient.
In short, the nurse could have advocated more strongly
for her patient.

33. Asking for help is NOT a sign of weakness
Be A Patient Advocate

34. Thank You: Please take Post-test