In health care, an adverse event can be known by many different names. Patient harm event, serious safety event, unusual occurrence, never event, and sentinel event are a few examples. The Office of Inspector General (OIG) defines an adverse event as “An event, preventable or nonpreventable, that caused harm to a patient as a result of medical care.” Adverse events may cause temporary or permanent harm or even death. Examples include a wrong procedure performed or administering a medication to a patient, with a documented allergy, that results in anaphylactic reaction.
Equipment sequestering
Sometimes a device or piece of equipment is known or suspected to have malfunctioned while being used on a patient, which could cause or contribute to an adverse event. When this occurs, staff should preserve all equipment involved in the event, including accessories, disposable parts, and any associated packaging. All items should then be sequestered until a decision can be made regarding the need for inspection. For example, an infusion pump, along with the IV tubing and packaging, should be sequestered when an accident occurs, and all pieces should be labeled with the patient’s name, date and time, notation that the items are being sequestered as part of an investigation, and the name of the responsible individual. All items should be placed in locked storage so the equipment or device cannot inadvertently be used on another patient.
The equipment should be photographed and should not be cleaned. Settings and alarms on the device should not be changed. Batteries should not be removed or changed. The equipment and accessories should be interrogated and inspected by someone who is trained to do a thorough examination. This may be clinical engineering, the manufacturer, or a third-party investigator. Data essential to a thorough investigation would include device settings, error codes, alarm history, and other downloadable data.
No equipment should be placed back in use until the equipment has been tested and cleared of any possible cause of patient injury. The Safe Medical Device Act may require you to report to the FDA device-related deaths, serious injuries, and other reportable malfunctions.
Investigating an adverse event
Once you have been made aware of an adverse event, you will need to investigate what transpired. Your job is to conduct a fact-finding mission to create a clear picture of the order of events. This will allow improvements to be made to the system to prevent future harm from occurring. This knowledge can also be used to inform the patient and/or family of what happened. Also, it is important to assess the situation for potential future liability and litigation.
A key place to start your investigation is reading the incident report for details. You can also review the patient’s medical record to familiarize yourself with the episode of care in question and to determine which health care personnel participated in the care. Once you have this basic information, you can move on to interviewing the staff that was present or aware of the event.
Basic interviewing tips
Interviews should be set up as soon as possible after the adverse event so memories of the details are still fresh. Once your interview is scheduled, utilizing a few simple interview techniques can help achieve the best outcome possible. As risk manager, it is important to remain objective and open minded throughout the interview process. Healthcare staff may feel apprehensive about being questioned regarding the care they provided or witnessed. It is vital to make them feel they are in a safe environment. Start by explaining that the purpose of the interview is to obtain the facts of what occurred. Care should be taken to explain that the interview process is not about placing blame and that information gathered during the interview process can potentially illuminate needed system changes to prevent future recurrences.
To conduct your interviews, it is recommended to choose a private location with open space where you will not be interrupted. You may want to think about going to the healthcare staff member’s location out of respect for their time and schedule. A familiar location versus a strange office may also facilitate an easier conversation. During the interview, be aware of body language. Try to maintain an open posture versus crossed arms. Maintain neutral facial expressions to put the interviewee at ease instead of demonstrating surprise or judgment. Displaying empathy and concern for the healthcare worker’s wellbeing will also ease any potential tension. Explain to the interviewee that you will be taking notes to record an accurate picture of the events as they are described. It may also help alleviate fears if you reassure the worker that the notes from the adverse event investigation will not become part of their employee file.
Interviews should be conducted individually. It is not a good idea to interview multiple individuals at one time as problems with interpersonal relationships may surface. For example, if an employee and supervisor are at the same interview, the employee may not provide forthcoming responses out of concern for potential discipline. As you move along with interviewing the different individuals identified, note any discrepancies in knowledge of the event. Follow-up discussions with the interviewees can provide additional insight and information. Do not draw any final conclusions until you have read over any pertinent medical records or documents and have interviewed everyone involved in the incident.
Each interviewee is advised to limit conversations with others about this adverse event until after all the interviews have been completed and the investigation is closed. It is not helpful for speculative or erroneous information to be shared during the investigation process. Additionally, if this adverse event is likely to become a claim, or does become a claim, we recommend you reach out to your malpractice insurance carrier for guidance on limiting conversations to ensure quality protections are maintained.
Interview questions
You will need a list of broad, open- and closed-ended questions to begin your interview. When possible, begin the interview using the open-ended questions. The goal of these questions should be to paint a clear chronological picture of what occurred. There are many techniques and tools for investigating. Classic fact-finding questions include asking who, what, when, where, why, and how. Using the “Five Whys” is a technique to get to the root cause of the problem by repeating the question “Why?” multiple times, until the cause has been determined.
As you move through the broad and open-ended interview questions, you can then switch to asking more closeended or specific questions to ensure a clear, precise picture and a timeline of events. For example, if the adverse event was a patient fall, a more specific question might be, “What did you do next after the patient fell?” You want to avoid leading questions, such as, “After the patient fell, did you get the doctor to assess the patient?”
Sometimes the adverse event may involve a process or procedure you are not very familiar with. To understand the proper sequence or expectations, you may need to do some research. If research does not clarify the process, ask an employee to explain the process or demonstrate use of a piece of equipment. Most often employees appreciate the opportunity to demonstrate their knowledge and skills. A thorough understanding of the events that took place will help form the corrective action items as follow-up to the event. A final question to ask all interviewees is if there is anything else they want to discuss, or feel was not addressed during the interview. Make sure to end on a positive note and thank the interviewee for their time and cooperation.
Examples of interview questions:
• Could you please describe to me, in your own words, what happened?
• Was this the expected sequence of events?
• How did the sequence of events differ from what was expected?
• What other things did you notice?
• Was the activity carried out by regular staff familiar with the activity?
• Was the activity carried out in the usual location?
• Was there any defect, malfunction, misuse of, or absence of equipment that contributed to the event?
• Did an individual’s actions or inactions contribute to the adverse event?
• Did inaccurate or ambiguous information contribute to the event?
• Did a lack of communication contribute to the event?
• Did leadership factors contribute to the event?
• Did environmental factors contribute to the event?
• Did staffing factors contribute to the event?
Documentation
Interview notes should clearly portray who was interviewed along with the date and time of the interview. All notes should be based upon facts or direct observations and not based on judgments. Use quotation marks to capture an exact statement from an interviewee, as appropriate. All interview notes should be kept in a secure file or secure electronic system with the original incident report and maintained as part of your quality improvement program, so that any statutory protections afforded per your state can be maintained. Consider consultation with legal counsel to ensure the laws of discoverability are followed correctly. All documents created for the purposes of quality improvement or peer review should contain quality protection language in the footer of the document. If your state offers state-specific quality protections, these should be added to the document. An example of suggested Federal wording is provided for your convenience:
CONFIDENTIAL – This document and the quality improvement/peer review data contained herein are privileged and protected under the Federal Health Care Quality Improvement Act of 1986, and other applicable law.
When an adverse event occurs, it is important to document the facts in the medical record, such as provider notification, any provider orders and any actions taken, and the patient’s response. It is never a good idea to document in the patient’s medical record that an adverse event occurred, or an incident report was filed. You also do not want to include investigation notes in the patient’s medical record. Along this same line, you do not want to add any interview notes to an employee’s personnel file. Adding this information to the medical record or employee file may destroy any discoverability protections allowed by the state, therefore permitting these documents to be viewed by a plaintiff’s attorney, if requested.
Action plan
Now that the interviews have been concluded, you have determined how the adverse event occurred. The next important step is preventing future recurrences. The adverse event findings should be shared with a team of key staff members and organizational leadership who should address system failures or missed opportunities by assigning corrective action items to individuals. An example of an action item would be to review any policies or procedures related to the adverse event to determine if changes need to be made to improve clarification or meet practice standards. Once any needed changes are made, staff should be educated on the updated policy or procedure. Another example would entail verifying if staff involved in the adverse event were trained, credentialed, or had competency to perform the specific task involved in the event. If training was found to be outdated or inadequate, a new training and competency process should be developed and implemented prior to staff reengaging in that specific task. Many other possible corrective actions could come out of an adverse event investigation. The goal is to implement as many corrective actions as needed to prevent future adverse event recurrence.
All Action Plan notes should be documented and kept as part of your quality improvement program or as guided by your state to be afforded any discoverability protections allowed. If your state has specific laws allowing for protections from discoverability, include reference to those laws in the footer of all your documents created for the purposes of quality improvement.
Reporting obligations
Senior leadership and management notification should have already taken place, as their involvement in the Action Plan is key. Reporting obligations to state licensing bodies such as the Department of Health, the Board of Medicine or Nursing, or to external regulatory agencies such as the Joint Commission or DNV, may need to be considered, depending on the nature and severity of the adverse event. Consider notification to your malpractice insurance carrier to trigger coverage for potential future litigation. If there is potential for a state or regulatory survey, properly filed documentation and corrective action items on the Action Plan to prevent recurrence will be a focus of the survey.
Conclusion
Prompt response to an adverse event and the development of a quality Action Plan may decrease the likelihood of future adverse events, thus benefiting everyone involved. Proper investigative note taking and filing within your incident reporting system with state and Federal protections applied can help prevent document discoverability from plaintiff attorneys in situations of potential litigation.
This information should be modified based on individual circumstances, professional judgment, and local resources. This document is provided for educational purposes and is not intended to establish guidelines or standards of care. Any recommendations contained within the document is not intended to be followed in all cases and does not provide any medical or legal advice.
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