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Medication Errors

Including Patients on Root Cause Analysis Teams: Pros and Cons

Matthew Grissinger RPh, FASCP

Problem: How do patients and their family members feel after a serious medical error has affected them? A wide range of emotions can ensue, including confusion, anger, frustration, a feeling of vengeance and betrayal, and grief, especially if the injury caused death or permanent harm.

Although these reactions to an error are rather predictable, patients and families have repeatedly described three emotions that are rarely discussed in the health care literature: guilt, fear, and a sense of being alone.1 Similar to the feelings often experienced by health care professionals who make mistakes, patients and family members often exhibit strong feelings of guilt, believing they could have done more to prevent the error or harmful outcome; they may also fear further harm or retribution for voicing their opinions about the event.1,2 They also feel totally alone, as clinicians tend to avoid contact with victims of error, isolating them at a time when they are most vulnerable and in need of support.

How can health care providers help patients and families move beyond these understandable but detrimental responses to an error?

Honest, direct communication is the best antidote.1 Although disclosure of an error and an apology from the health care provider are crucial, patients and families need more.1,2 They want to understand how and why the error happened, and they need to know that the event has resulted in a learning process by the organization that will prevent future occurrences. Not content with being kept at arm’s length,3 patients and families want more visible roles in analyzing problems and identifying solutions.

Involving patients in the problem-solving process is not a new concept in health care; in fact, organizations have included patients and consumers on quality, safety, and education committees. Some organizations now include patients and their families when conducting root cause analyses (RCAs) of adverse events (AEs) or near-misses.2,4

Benefits of Including Patients In the Analysis

When properly conducted, RCAs can be rewarding for patients, their families, and clinicians. For patients, the experience often:

  • dispels any misconceptions about the staff’s degree of response to the error.
  • helps to alleviate their feelings of isolation, helplessness, and confusion about how and why the error occurred.
  • reduces self-blaming and blaming of individual staff members as the system-based causes of errors are revealed and described.
  • minimizes their frustration and anger.13
  • demonstrates the organization’s commitment to learning and change.
  • increases their comfort in knowing that some good will come from the event.14
  • facilitates the healing process.2,3
  • promotes forgiveness through honest interaction with the health care team.14

Benefits to Health Care Providers When Patients Are Included In the Analysis

For health care professionals, sharing the RCA process with patients can also be beneficial because it:

  • demonstrates the organization’s transparency regarding errors and its responsiveness to patients who have been affected by an error.
  • improves fact-finding by revealing information that might be known only by patients.2
  • facilitates their own healing.2,3
  • promotes forgiveness through direct, honest interaction with the patient.14
  • improves the outcome of the RCA and the actions selected for improvement.
  • helps the organization re-establish trust with the patient.2,4

Although little has been published about involving patients in RCAs,24 Exempla Lutheran Medical Center in Colorado provided an example of one parent’s response to being included in an RCA of medication mistakes that occurred during the treatment of her daughter:

“You have exceeded my expectations and have done far more than I anticipated you would. Thank you for taking this seriously.”4

Risks of Including Patients In the Analysis

Even though the benefits of including patients and families in RCAs are clear, negative consequences that could affect them or the health care team should be carefully considered before they are invited to participate.

Risk to the Patient

If the AE resulted in death or significant loss, having patients or family members participate in the RCA could lead to more harm by causing them to relive the trauma.2,4 If the patient died, the family must deal with the consequences of life without their loved one as well as cope with acute grief. Participating in the RCA may exacerbate the normal grieving process and may affect objectivity, which is necessary to improve the organization’s medication-use system.2 If the patient requires ongoing care as a result of the error, the family’s mental and emotional energy will be focused on care of the patient. Participation in the RCA could worsen the patient’s feelings of vulnerability and concerns about the potential for another error. Thus, the emotional impact on the patient or family may outweigh the benefit of participation.2

Risk to the Organization

Legal risks: Involving patients in the RCA exposes organizations to legal risks, primarily the loss of confidentiality and the possible waiver of federal, state, or local protections of information pertaining to the analysis of the event.2 Covert actions by the patient, such as using hidden recorders or cameras to capture information discussed at the meeting, may also be a concern.2 Although victims of medical errors tend to seek a legal remedy primarily if they feel they have been deceived, sharing confidential information, communications, and the existence of potential evidence with patients may expose organizations to a greater risk of an adverse outcome if a lawsuit is filed.

Staff discomfort: Including patients and family members in RCAs may also be an uncomfortable, emotional experience for the hospital staff, and it may inhibit staff dialogue during the analysis. The patient’s presence could cause clinicians to be overly cautious when speaking or to become defensive and confrontational when responding to the patient’s comments. Under these conditions, open and honest dialogue, which is necessary to perform a thorough, impartial, and credible RCA, might not be possible.

A recent example involved the death of a 29-week-old child. Within a week of the incident, the organization invited the child’s parents to a meeting at which the medical team explained what had happened and what had gone wrong. Within a year, the couple filed suit, citing the meeting.5

Safe Practice Recommendations. Despite the risks of involving patients and families in RCAs, the entire experience can be an enriching one if appropriate safeguards are in place. Some suggestions follow.

Reducing legal risks. Clinicians should assess how federal and state statutes might be affected by including patients in RCAs, and they should determine whether their organization can handle the process securely. If a decision is made to proceed, policies should be in place to involve patients for purposes of fact-finding while protecting the integrity of the RCA.2

Screening patients. A screening process should be developed to determine whether patients are psychologically, emotionally, and intellectually able to participate in the RCA.2 Screenings should take place before anyone discusses the possibility of participation in the RCA with the patient to avoid an expectation that cannot be met if the patient is considered unsuitable.

If necessary, patient participation could be limited to the opening meeting of the RCA team to allow introductions and to obtain important details from the patient. If this meeting takes place, the team should be dismissed at the same time that the patient leaves the meeting; this helps to avoid feelings of separateness or a perception on the part of patients that the team is talking about them behind closed doors.2 Patients could also be brought back to the meeting at the end of the RCA to learn about the planned changes.

Preparing patients and health care providers. Patients should be given details about the RCA, their role in the process, and the organization’s expectations of the patient and family during and after the RCA.2 The RCA team members should also be screened to ensure that they understand and agree with the value of patient participation and that they feel they can speak honestly in the patient’s presence. It may be necessary to meet with all potential team members individually to allow them to express opinions without others present.4

All health care providers selected for the team should then be informed about the patient’s role in the process as well as what to expect of the patient’s behavior. Zimmerman and Amori2 provide an excellent tool to guide patient and staff preparation.

Using trained facilitators. RCA facilitators must be skilled in creating a safe environment in which an open exchange of ideas can occur for meaningful change.4 Facilitators should be prepared to address divisiveness, defensiveness, and other behaviors that might inhibit analysis.

Supporting the patient after the RCA. After the RCA is completed, open lines of communication should be maintained to keep patients apprised of positive changes that have occurred as a result of their input.2

Inviting patients and families to contribute to the RCA of an AE in which they or their loved ones have been involved holds great promise to promote shared understanding, rekindled trust, and healing. Patients will undoubtedly bring important ideas to the table that otherwise would not be considered. The outcome could be positive, supporting the patient’s emotional needs during a difficult time and identifying ways to prevent similar harm in the future.

References

  1. Delbanco T, Bell SK. Guilty, afraid, and alone—struggling with medical error. N Engl J Med 2007;357;(17):1682–1683.
  2. Zimmerman T, Amori G. Including patients in root cause and system failure analysis: Legal and psychological implications. J Healthcare Risk Manage 2007;27;(2):27–33.
  3. HCPro, Inc. Mother: Patients want to help after errors. Briefings Patient Saf (Patient Saf Monit) 2007;8;(10):1–2.
  4. Munch DM. Patients and families can offer key insights in root cause analysis. Focus Patient Saf 2004;7;(4):6–7.
  5. For doctors, divulging errors can invite suits. The Philadelphia Inquirer November 62011;