Essay

JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 27, NUMBER 2 27

Enterprise Risk Management

Including patients in root cause and system failure analysis: Legal and psychological implications

The act of open disclosure of an adverse event alone may not be enough for patients or their families. Patients and patient advocates are asking for increased transparency and a greater role in the process of change. When properly handled, involving patients in post-event analysis allows risk management professionals to further improve their organization’s systems analysis process while empowering patients to be part of the solution. This article examines the legal and psychological considerations surrounding the involvement of patients in system failure analysis and provides tools for selecting patients who are able to benefit from this process and for adequately preparing patients and caregivers for what lies ahead.

INTRODUCTION

Incorporating patient perspectives into the problem solving process is not a new concept. Healthcare organizations have included patients on special committees for some time.(1)

Organizations have also begun to accept patients and families (hereafter referred to as patients) opening the doors to the failure mode and effects analysis (FMEA) and root cause analysis (RCA) processes to patients.(2)

Participation in system failure analysis (SFA) permits patients to understand the high level of importance that organizations place on patient safety and the seriousness of the event that adversely affected them.

However, including every patient involved in an adverse event or near miss analysis is not appropriate. In some instances, it can cause further distress or harm.(3)

Legal considerations

While offering an exciting opportunity to healthcare providers and patients alike, patient participation in root cause analysis can be legally risky.

A proactive assessment of all potential consequences must be performed. Issues surrounding sharing of confidential communications, information and the existence of potential evidence must be explored. State and/or federal privilege may exist to protect quality assurance and performance improvement activities.

By Theresa M. Zimmerman, RN, BSN, JD, ARM, CPHRM, FASHRM, and Geraldine Amori, Ph.D., ARM, CPHRM, DFASHRM

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Federal statutes, state statutes and case law may strongly influence any organization’s decision whether to open the QA/PI process to patients.

It is also important to ensure that actions taken do not waive any available privilege by including people not typically considered protected under the quality privilege, or by conducting these meetings hastily without careful thought and preparation. In instances where privilege should not be waived, it remains imperative that the proceeding be handled with confidentiality and under stringent guidelines to protect the integrity of the QA/PI process. Instituting a policy that addresses ways to include patients as part of the quality process for purposes of fact-finding would be beneficial for preserving the integrity of the analysis.

Alternative methods of encouraging patient involvement without compromising the confidential nature of the QA/PI process may also be available. These include placing limitations on the involved patient’s participation in the system failure analysis process, or involving a patient who received similar treatments but was not directly involved in the adverse event currently under review.(4)

Another way of including the patient while preserving the quality privilege granted by law is to ask the patient to deliver an opening statement at the RCA or FMEA and limiting their participation to that level. This practice both allows the committee members to meet the patient and the patient to see that a process change is underway.

Psychological considerations

An adverse medical event is traumatic for both the provider and the patient. The risk management professional has an ethical duty to ensure that no additional or unnecessary trauma is experienced by any of the parties in the process of fact-finding and development of corrective actions.(5) Consequently, care must be taken to screen all individuals carefully prior to the SFA meeting.

Care should be taken to consider the psychological concerns of any patient who is invited to participate in an SFA. One major issue centers on the vulnerable trust that the patient has in the healthcare system following an adverse event. Prior beliefs about the system and caregivers’ ability to heal have been compromised. Fear of retribution for speaking out about the error and the failure of the system are strongest when the error results in a need for further care.

The healthcare system is a comfortable environment for those who work in it. This is not necessarily the case for patients. Some patients believe they can make a contribution

based on their knowledge base to improve healthcare processes. More often, however, they are intimidated and feel they have nothing to offer because they do not under- stand the medical field. In either situation, the disparity of experience and knowledge between the patient coming into the SFA and the other members of the team can negatively affect the team’s cohesiveness if not properly managed by a skilled facilitator. The facilitator must be prepared to use conflict resolution skills to avert non-verbal divisiveness, verbal defensiveness, and other behavior destructive to patient and caregiver participants and the overall process.

When there has been a death from an adverse event, those families involved should be considered for participation

in a systems analysis carefully and on a case-by-case basis. By its nature, the analysis should take place soon after the event when facts and details are fresh in everyone’s minds. During this critical time, however, the family is managing post-mortem details as well as dealing with acute grief. Examining the care that may have contributed to the death is likely to exacerbate normal grieving processes and affect objectivity which is necessary to improve the system.

In cases where the adverse event has not resulted in death but in the need for significant ongoing care, the family’s mental and emotional energy

will be focused on the care of the patient. Discussion of the details of the adverse event can heighten the family’s awareness of the patient’s vulnerability and raise concern over the potential for another medical error. The emotional impact on the family of reviewing the details of what occurred to determine the causes of the adverse outcome may outweigh the benefit of participation in the SFA.

Screening for appropriateness

The appropriateness of patient participation in the analysis should be a consideration during all discussions held with the patient following an adverse event. However, a formal screening should be avoided to limit the possibility of creating an expectation with the patient which may then change because the patient is not suitable.

Once the determination has been made that the patient is psychologically, emotionally, intellectually and attitudinally ready and able, the direct question of participation can be broached during a follow-up conversation.

The risk manager or whoever is responsible for inviting participants to the SFA should be sensitive to the existing emotional state of all potential participants. If the patient’s primary focus is expressing anger or a desire to litigate,

The disparity of experience and

knowledge between the patient and the other members of the team

can negatively affect the team’s cohesiveness if not

properly managed.

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he or she may not a good candidate. The art of assessing emotional suitability requires an understanding of human nature. Awareness of culturally defined responses to emotional trauma and cultural beliefs about healthcare is essential.

Furthermore, the skill required to engage people who are in distress and move them along emotionally is necessary for assessing patient and staff readiness to participate in process improvement activities.

In addition to ensuring emotional and psychological readiness to participate, a determination should be made as to whether patients understand what is being asked of them and whether they are able to participate without becoming confused. They should be able to handle what may be an emotionally charged situation for all involved. Most importantly, it is essential that patients understand the valuable role they play and how critical their per- spective is to the process.

The skilled risk management profes- sional should be able to ascertain whether a patient is interested solely in punishing the providers or truly has a desire to ensure that the injury he or she experienced does not happen to someone else. The potential participant should also be able to exhibit the emotional and intellectual readiness necessary to deal with the root cause process, the other attendees and the limitations that will be part of the process.

Preparing patients

The patient’s well-being must be a primary concern if he or she is to be involved in the analysis. The patient must be prepared for the experience and supported during and after the formal process is concluded. Additionally, efforts should be made to keep the lines of communication open and make patients aware of the positive changes that have resulted from their input.

At a minimum, the patient preparation must include the following elements (See Patient Preparation Guide for expanded information):

• Information about the root cause analysis process;

• Information about the patient’s role in the process;

• Information about the organization’s expectations for the patient during and after the process.

Preparing the healthcare organization

The committee must be carefully coached in preparation for the patient’s participation. They must understand that their role is not to challenge the patient but to be supportive and seek additional information that will support the process. Any staff participant who is unable to appreciate the value of the patient’s contribution may not be a welcome attendee and should be asked to send a more amenable representative. Prior to the first meeting, the facilitator should be aware of conflicts and issues that may arise.

It is essential that caregivers, just like patient participants, be screened for psychological readiness. Strong beliefs that cannot be overcome – e.g., that patients add no value to the process or should not be involved because of legal

implications – can have a chilling effect on the interactions. Provider guilt about the cause of the event or conclusions regarding fault arrived at without thorough investigation can lead to inappropriate admissions of liability before the root cause can be determined.

Conversely, if a provider communicates the belief that the event would have happened regardless of the care given, they can come across as uncaring or callous to a patient who has experi- enced a medical error.

At a minimum, the preparation of caregivers must contain the following elements (See Caregiver Preparation Guide for details):

• Information about the patient’s role in the process; • Information about expectations for caregiver behavior.

For both patients and caregivers, concerns and questions must be addressed promptly and with respect and sensitivity to the vulnerabilities created when both sides begin to explore unanticipated events jointly.

Alternatives to patient participation

Healthcare institutions that have substituted patients undergoing similar treatments, but who were not directly involved in the event being analyzed, have reported positive experiences. The non-involved patients’ treatment ought to be completed before including them in this process.(6) This will prevent the participants from experiencing any additional anxiety associated with knowledge of possible serious adverse outcomes that could occur.

Other alternatives include having the patient meet with the team at a date following completion of the formal SFA process. A patient meeting with the team may bring addi- tional insights and a valuable perspective to the evaluation of the improvement plans implemented. Surrogate patient

It is essential that patients understand the valuable role they play and how critical their perspective is to the

process.

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SFA participants who have had similar services without an adverse event may also be able to contribute information on how patients experience the process. Patient participants on standing committees can offer constructive insight into the patient experience. Finally, creating carefully supportive and sensitively handled processes permitting patients and those involved in their care to debrief together after an adverse event can facilitate the healing essential for all involved parties.

Keys for success

Keys for success include:

• careful screening;

• structuring the process to optimize patient involvement without jeop- ardizing the potential for success;

• adequate preparation of participants;

• follow-up with patients.

The process must be supervised to ensure that patients and caregivers have the greatest opportunity for positive interactions. Furthermore, the legal implications must be con- sidered and accommodated in the meeting structure. Issues such as the extent of the patient’s role must be addressed in advance.

When possible, consideration should be given to compen- sating providers and caregivers for time spent outside of their normal work hours to participate in a SFA. This reflects the value you place on their willingness to improve care.

If the patient is to provide an opening statement only at the beginning of the process, the entire meeting should be dismissed so that patient and caregivers leave the meeting together. Experience has shown that having participants leave at different times sets in motion a feeling of separateness and concerns about “are they talking about me now?”

Preparation is essential for success, as well. Patients must understand what they are being asked to do and what it means. The meeting organizer (whether risk management or quality management) must make efforts to establish a trusting relationship with the patient prior to the meeting.

If necessary, patients need to be made aware that their involvement will be limited. However, the information that they deliver will be taken seriously and used as part of the action plan and problem resolution process. Post- meeting communication and follow-up is crucial to maintaining the positive relationship. Patients need to have a sense that changes have been made and that the process was not a sham.

Although careful selection of participants is essential, that alone is insufficient to assure success. Equally important is careful preparation of all participants in the process and facilitation of meetings to permit the open and honest exchange of ideas necessary for meaningful change.

RISK MANAGEMENT IMPLICATIONS

Confidentiality constraints

One risk concern that must be considered before permitting patients to participate is their ability to understand and comply with the confidentiality constraints that will be imposed on all those attending. This includes recognition

that the patient might share confidential information outside of the confines of the meeting room. One possible scenario might involve the patient discussing the meeting with a reporter.

Covert patient conduct

Another important risk to be mindful of is the possibility of covert conduct by the patient. (There have been instances during disclosure meetings and other discussions following adverse events in which patients and/or their family members have hidden recorders and cell phones to record discussions, or have used digital technology to capture some of the material presented

or discussed at meetings unbeknown to the other attendees.) While this possibility alone should not prohibit patient inclusion, it should be anticipated and dealt with if possible (e.g., having all participants leave their cell phones at the door).

Legal considerations, organizational policies

The risk management professional must be aware of statutes, regulations and case law that can have an impact on the decision to include patients in system analysis processes or other meetings. A review of legal considerations and organizational policies should be completed in advance to assess if involvement of outside participants is something that the organization can handle securely.

Before inviting a patient participant, work with legal counsel to assure that all proper protections are in place. Assure that each patient is evaluated for appropriateness prior to inclusion in the system analysis process and that expectations of conduct are expressed and understood by all parties. Most importantly, assist with the preparation of patients and healthcare providers alike to help create a “safe” environment and a positive learning experience.

Patients need to have a sense that changes have been made and that the process was

not a sham.

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Positive attitude toward change

If a healthcare organization is unable or unwilling to include patients in the process of systems analysis, it is important for risk management professionals to be agents for positive change. Systems are typically resistant to change and slow to respond once they recognize that it is the right thing to do. Maintaining a positive attitude toward the patient inclusion process and continuing to advocate for and educate regarding this important topic may lead to a success for the organization at a later time.

CONCLUSION

Despite the potential for emotional interactions requiring well developed group facilitation skills, the psychological benefits of including patients in SFA when appropriate, can be profound.

In group situations where caregivers are willing and able to listen, express vulnerability and concern, and patients can express feelings openly, a bond of experience can develop, permitting individuals to heal through shared understanding and empathy. Patients, who have long expressed the desire to ensure that adverse events they experience are not experienced by others(7) are given the opportunity to share in the process of improving the system.

Encouraging participation by patients is the essence of true partnering in care. It empowers patients to truly be members of the healthcare team benefiting the organization, which learns what its patients actually experience in their care.

After an adverse event, many patients are able to understand the vulnerability of healthcare processes and although upset by their experience, wish to help improve the system. These may be candidates for participation in the SFA process.

In order to take the next step to improve the integrity of risk investigations and understanding system errors, the inclusion of patients in the problem-solving process must be considered. Essential to the successful implementation of this initiative is recognition of the risk manager’s role as leader and role model. Risk management professionals, as advocates of open disclosure and patient safety, have a particularly important role in influencing an organization’s position on this issue.

Strong commitment to involving patients in process improvement, combined with careful examination of the legal, psychological and risk management implications, can lead to significant organizational change. In order to be an effective advocate in that regard, a risk management professional must be cognizant of the laws and regulations that afford certain quality privilege and protections and assure that procedures are in place to foster those.

It is equally important for the risk management professional to understand the psychological impact that involvement can have on patients, families and the healthcare providers and administrators, and be prepared to educate and support the people that will be involved in the process.

If done well, patient inclusion in the system analysis process will not only encourage more accurate investigative findings, but can also help involved health care providers and patients and their families to begin the healing process in a positive and effective manner.

REFERENCES

1. Conner, M, Ponte, P., Conway, J. “Multidisciplinary approaches to reducing error and risk in a patient care setting.” Critical Care Nursing Journal.Clinics of North America. 14: 359-367, December 2002.

2. Van Tilburg, C., Leistikow, I., Rademaker, C., Bierings, M., Van Dijk, A. “Health care failure mode and effect analysis: a useful proactive risk analysis in a pediatric oncology ward.” Quality and Safety in Healthcare. 15: 58-64, Spring 2006.

3. Vincent, C. “Understanding and responding to adverse events.” The New England Journal of Medicine 348(11):1051-1056, March 13, 2003.

4. Id.

5.http://www.ashrm.org/ashrm/aboutus/pdf/codeconduct. pdf

6. Van Tilburg, C., Leistikow, I., Rademaker, C., Bierings, M., Van Dijk, A. “Health care failure mode and effect analysis: a useful proactive risk analysis in a pediatric oncology ward.” Quality and Safety in Healthcare. 15: 58-64, Spring 2006.

7. Vincent, C., Young, M., Phillips, A. “Why do people sue doctors? A study of patients and relatives taking legal action.” Lancet. 343(8913):1609-13, June 25, 1994.

ABOUT THE AUTHORS

Geraldine Amori, Ph.D., ARM, CPHRM, DFASHRM, is senior director, Education and Professional Development, The Risk Management and Patient Safety Institute, Shelburne, VT. Theresa M. Zimmerman, RN, BSN, JD, ARM, CPHRM, FASHRM, is division patient safety officer, Catholic Healthcare Partners, Cincinnati, OH.

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A S H R M P A T I E N T P R E P A R A T I O N G U I D E

Minimum Elements for Discussion:

Information about the root cause analysis process:

Description of the process

Goals of the meeting

Reason the organization uses RCA for process improvement

What the organization hopes to learn

What the organization will do with the information

How the organization will ensure that change occurs

A description of the types of people who will participate

Information about the patient’s role in the process:

The unique contributions of the patient to the process

• Perspective that naturally may be different from the those of the caregivers

• Value of their closeness to the event

• Their desire to ensure that whatever happened to them will not re-occur if there is a way to prevent it

The nature of the patient’s participation

• Level of participation – whether for an opening statement or the entire process

• Who will be present

• The expectation for the patient’s contribution

• The expectation for the activity and behavior of the other participants during the patient’s involvement

• What will be done with the patient’s information

• What the patient can expect after the meeting

• What the patient should do if they feel the meeting has not gone as planned, they are uncomfortable, or they change their mind

The organization’s expectations of the patient during and after the process

Open and honest communication from both the patient and the organization

Honoring the process

• Promise on both sides not to tape or photograph secretly

• Promise on both sides not to use the meeting as a way to gather information to be used “against” the other party

Recognition that the caregivers are sad and upset

• Not using the meeting as an opportunity to lash out at providers

• Not using the meeting as an opportunity to blame or argue about care.

Note: This guide may be freely reproduced for hospital use.

Information Prepared:

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A S H R M P R O V I D E R / C A R E G I V E R P R E PA R AT I O N G U I D E

Minimum Elements for Discussion:

Information about the patient’s role in the process:

The value brought by patient perspective

The psychology of patient commitment to improving the process

The nature and level of patient participation in the process

The legal considerations which have been addressed through planning for the patient participation

How the patient has been prepared for participation

Information about the caregiver behavior expectations:

How the group will need to behave to preserve the faltering trust and concerns of the patient

Non-verbal and verbal strategies to ensure that individuals do not inadvertently create tension for the patient

How the meeting will be structured to ensure the patient feels welcomed and comfortable

Note: This guide may be freely reproduced for hospital use.

Information Prepared:

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Do the applicable by-laws, policies, regulations or statutes prohibit participation by patients or others in Peer Review or Quality activities?

no

Does the organization's culture recognize that competent professionals can make errors, and that often those errors are related to system failures?

yes

Does the organization evaluate situations for actual or potential system failures before it addresses human error?

yes

Was the event so catastrophic that any/all of the healthcare participants are extremely psychologically fragile?

no

Are the individual, specific healthcare participants emotionally and psychologically able to provide a safe environment for the patient/family participant (i.e., behaving in an open and respectful manner; avoiding sarcasm intimidating actions or words, or disruptive and threatening behavior)?

yes

Was the injury so significant that the patient/family may need to focus all their attention on immediate patient/family needs?

no

Is the patient/family psychologically or emotionally affected such that they are unable or unwilling to participate?

no

Is the patient/family potentially violent, or obviously adversarial?

no

Is the patient/family willing and able to participate?

yes

Begin process of education; make commitment to patient/family to share results?

Need to work towards changing by-laws and policies to reflect organization willingness to have patients participate; ensure compliance

Need to work on developing a just culture prior to involving patients or families

Need to work on developing a just culture prior to involving patients or families

Consider having a healthcare participant with similar experience, education, and background participate in lieu of upset individual; get support for the individual

Are the healthcare participants able to work emotionally/psychologically with any patient/family participant?

Consider substitute patient/family who has/have the same treatment; must meet patient & family criteria for suitability

Consider a substitute patient/family who has/have experienced similar treatment; must meet all other patient/family criteria for suitability

Consider substitute patient/family who has/have experienced similar treatment; must meet all other patient/family criteria for suitability

Consider substitute patient/family who has/have experienced similar treatment; offer patient/family professional psychological support

Consider substitute patient/family who has/have experienced similar treatment; must meet all other patient/family criteria for suitability

yes

no

no

yes

no

yes

yes

yes

no

no Do not include patients/families until the culture is more supportive

yes

A L G O R I T H M : I N V O L V I N G PAT I E N T S I N R O O T C A U S E A N A L Y S I S A N D S Y S T E M F A I L U R E A N A L Y S I S

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