Reviews within hospitals/institutions

While it is important to report patient safety incidents and near misses, what is done with these reports is equally significant. Thorough reviews of patient safety incidents and near-misses, when properly structured, are considered one of the more effective approaches to improving the safety of care in a hospital/institution.

Within the context of hospital or institutional care, there are two categories of reviews of patient safety incidents and near misses:

1. Quality improvement reviews, where the focus is on system issues
2. Accountability reviews, where the focus is on the conduct or performance of an individual healthcare professional

Peer review

The term peer review is used with varied meanings. For the purposes of this guide, peer review refers to a retrospective review by peers, or subject matters experts, of an individual or groups of individuals looking at specific indicators of quality of care. The goal is to identify, within a confidential process, areas for practice improvement. Under certain conditions, a peer review may be undertaken to assess the clinical competency of an individual; such reviews should be considered under a properly constituted accountability framework.

Quality improvement reviews

Quality improvement reviews are designed to identify the causes of patient safety incidents or near misses by looking at the system in which healthcare is provided. The results of quality improvement reviews can lead to system improvements that will prove beneficial to all future patients.

How is a quality improvement review structured?

To ensure confidentiality and to promote frank discussion, quality improvement reviews should operate under the guise of a properly constituted quality improvement committee. The name of these committees can vary by province or territory (e.g., Quality of Care Committee, Quality Assurance Committee, Risk Management Committee, etc.)

The structure and procedure for a quality improvement committee should be prescribed in hospital/institution policies based on the relevant provincial/territorial legislation. A properly constituted quality improvement committee will usually have terms of reference outlining its purpose, reporting structure, scope of activities and membership. Hospital/institutional policies may also provide guidance on sources or triggers for event analysis, the content and retention of committee documents and minutes, and instructions on access to and distribution of committee documents, minutes and recommendations.

Once established within the boundaries of a quality improvement committee, the review structure promotes candid and detailed assessment of patient safety incidents by the healthcare professionals involved. In reviewing known facts, it is often helpful to consider what could have happened or what the participants wished had happened. Discussion may include hypothesizing about weaknesses in system processes, which can be a useful way to identify reasons for clinical outcomes and to develop strategies to try to prevent re-occurrences.

Important: Physicians should determine whether their hospital’s quality improvement committee is properly constituted under the relevant legislation and seek assurances that quality improvement reviews will be conducted in a confidential manner. If such is not the case, physicians should promote the use of properly constituted quality improvement committees. CMPA members may contact the CMPA for advice in this area.

Who conducts the quality improvement review?

Reviewers should be chosen for their skills and knowledge in how to analyze unexpected outcomes, patient safety incidents and near misses, their clinical expertise and/or their ability to effect change in response to recommendations from the review.

Leadership/management must be careful of possible conflict of interest. It is generally inappropriate for those who play a role in annual performance reviews, and accountability and disciplinary matters (for example, a chief of department) to be involved in a quality improvement review involving healthcare professionals for whom they have responsibility.

When should the review take place?

The review should be done as soon as reasonably practical, ideally within days of an event. This optimizes recall of the facts and allows actions to be taken promptly to deal with any identified system failures.

Who should participate in the review?

Participants may include any of the healthcare professionals involved in the care of the patient, selected experts, and others who can contribute to the analysis of the event and to the development of practical recommendations to improve patient safety. Inter-professional participation provides a broader perspective of what happened, and when conducted in a respectful manner, may strengthen professional collaborative relationships. All participants must commit to the established conditions for participation, including keeping confidential all information and marking documents as being prepared for quality improvement review.

The attendance of the healthcare professionals involved in the patient safety incident may be required by law or institution/hospital policies and/or bylaws. Other individuals, including patients (and/or their substitute decision makers or selected family members), clinical experts, and equipment manufacturers may be invited to attend the review to clarify details from their perspective or area of expertise, but should not sit in on all of the discussions.

Important: Even if participation is not mandatory, physicians are encouraged to participate in properly structured quality improvement reviews in the interest of improving patient safety.

If a quality improvement review is not structured in accordance with the legislation protecting quality improvement records and information, physicians should seek assurances in writing that the review process is intended to remain confidential and discussions and disclosure of information will be restricted. If uncertain how to proceed, CMPA members should contact CMPA for advice.

How is information analyzed?

Many accepted methods and tools may be employed, such as incident analysis (reactive) and failure mode effect analysis (proactive), to identify the possible reasons for the occurrence of patient safety incidents and near misses. To gain a broader perspective it may also be helpful to review a group of related cases or institution/hospital processes. Trends can be identified by collecting aggregated data without identifying information pertaining to the patient or provider.

When reviewing system factors in an individual patient case, or a cluster of similar cases, the following questions could be explored:

• What were the reasons for the outcomes, patient safety incidents or near misses?
• Were the existing relevant policies clear, realistic, known and available?
• Were current clinical guidelines and up-to-date care maps used in the system?
• Was access to care or resource availability an issue?
• Were bias and discrimination contributing factors in the incident?
• Were appropriate diagnostics available, and was the interpretation of these facilitated?
• Was the healthcare team appropriately trained?
• Was communication among team members an issue?
• Are there recommendations for changes to the system, and has it been established who would likely be responsible for implementing them?

It may also be useful to explore what normally happens in similar circumstances in comparison to what should happen. Answers to these questions may help identify whether existing standards of care and supporting policies and procedures achieve their intended purpose and where they might be improved to reflect the realities of care.

What if performance issues surface during a quality improvement review?

If serious concerns regarding a healthcare provider's performance or conduct are discovered in the course of a quality improvement review, the quality improvement committee should suspend its analysis so these issues may be appropriately reviewed in a separate and independent accountability process.

How should the review be documented?

Information gathered for quality improvement reviews should be treated in a consistently confidential manner, and direct access to that information should be limited to those involved in the review process. It is helpful, wherever possible, to use headers and/or footers marking the material as being prepared for a quality improvement review pursuant to the relevant legislation. The working documents should be retained only for as long as needed by the committee to generate its report or to meet legislated requirements, following which the information should be properly disposed. To the extent possible, the final report should not name individuals and should avoid other identifying information.

For more information see the Healthcare Insurance Reciprocal of Canada (HIROC)’s Critical Incidents & Multi-Patient Events Risk Resource Guide [PDF].

Will the documentation related to the review be protected?

To foster continuous quality improvement and to encourage the participation of healthcare professionals, the legislation in each province/territory generally protects the information and documents prepared for or generated by a quality improvement committee from being used in subsequent legal, regulatory or other proceeding. This does not protect the fact that the review itself was conducted, nor protects information in incident reports and the patient’s medical record. The extent to which any quality improvement information can be disclosed varies among the jurisdictions.⁴

Depending on the applicable provincial/territorial legislation, a properly constituted quality improvement committee may be able to delegate functions to subcommittees. In order for this protection to extend to the work of a subcommittee, the subcommittee must comply with the legislative requirements for a properly constituted quality improvement committee. Delegated functions to appropriately structured subcommittees might include, but are not limited to, reviews of incident/occurrence reports, critical incident investigations, case reviews, care audits, morbidity and mortality rounds, and utilization reviews.

Important: In most jurisdictions, the legislation that protects quality improvement records and information from being disclosed in legal actions extends to other proceedings such as regulatory authority (College) investigations. However, the legislation does not generally preclude a hospital/institution from reporting to the College any suspected incompetence or unprofessional conduct uncovered by the quality improvement process.

What should be done with the review findings?

Review findings should generally be wide-ranging and may confirm that the unexpected poor clinical outcome resulted from the patient’s underlying medical condition, the risks inherent to an investigation or treatment or from healthcare delivery. The review may identify system vulnerabilities or failures that can be addressed through quality improvement measures.

Review findings, including recommendations on quality improvement changes, should be transmitted to those in leadership/management. The legislation in some jurisdictions explicitly prohibits the sharing of findings, conclusions or recommendations of quality improvement committees to anyone other than those in leadership/management. Quality improvement shared with leadership/management from a quality improvement review should be limited to the following:

• new facts, if any, related to a patient’s care that were discovered during the review and that are not already contained in the medical record of an individual patient;
• the final conclusions as to the reasons for an unexpected outcome, patient safety incident or a series of events, focusing on the “system” contributors; and
• the recommendations of the committee on how to improve the system of care.

Leadership/management has a responsibility for prioritizing any recommendations and implementing any appropriate changes. Importantly, leadership/management may also have a responsibility to further report the findings and recommendations to an appropriate health or regulatory authority.

How should the review findings be shared with patients/families?

To maintain fairness and objectivity, the quality improvement committee should not be responsible for the disclosure of facts and recommendations directly to a patient or their representative (post-analysis stage of disclosure).

It is up to the leadership/management to decide, on a case-by-case basis, preferably in consultation with legal counsel and the professionals involved, what information should be disclosed to a patient and by whom. Typically, leadership/management should be responsible for and involved in the post-analysis disclosure to patients/families. Depending on the circumstances, professionals involved in the patient’s care at the time of the incident should be offered an opportunity, with the patient’s permission, to be involved in these discussions.

A patient should be informed of new facts identified in the analysis of the event and the conclusions (but not the opinions leading to the conclusion) as to the reasons for the clinical outcome. The review may have confirmed the clinical outcome resulted from the patient’s underlying medical condition or the risks inherent in an investigation or treatment. Conversely, the review may have identified system vulnerabilities or failures. When the facts are shared with patients, speculations should not be provided and blaming should be avoided. An apology may be warranted.

Harmed patients, particularly those who have experienced discrimination or racism in healthcare, may have lost trust in the system. Further interactions and communications with the hospital/institution may be triggering and result in further psychological hardship. Understandably, patients often want to learn of any steps that have been implemented to prevent similar harm to others. In some cases, it may be appropriate to share with the patient information about actual system changes/improvements implemented by the hospital/institution as a result of the quality improvement review.

For more information, see the “Post-analysis disclosure” section of the CMPA handbook “Disclosing harm from healthcare delivery: Open and honest communication with patients”.

How should “lessons learned” be shared with other health professionals?

It is important to communicate the findings of the review to those involved in the event or to those who had identified and reported a potential vulnerability—thus closing the loop in communication and providing reassurance that reports on acted upon.

A culture of safety and learning will leverage insights gained from incident reviews to disseminate recommendations and educate other healthcare professionals. When sharing improvements to processes, policies or procedures that arise out of a quality improvement review, it is inappropriate to reveal information that can easily be tied back to a particular event. Maintaining patient and provider confidentiality is necessary to meet privacy obligations, will promote a just culture and demonstrate a commitment to learning and improvement.

Accountability reviews

The separation of quality improvement and accountability reviews is based on the premise that patient safety incidents and near misses may involve system and provider-related elements and that learning to improve the system can occur independently from the management of provider performance.

An accountability review focuses on the conduct or performance of an individual healthcare provider but does not preclude the identification of system failures and improvements. This type of review generally occurs in response to a concern that a provider’s performance may have been a significant contributor of a patient safety incident.

CMPA members who are asked to participate in accountability reviews should contact CMPA for assistance.

How should an accountability review be structured?

The procedure for an accountability review is usually prescribed in hospital/institution bylaws and policies and may also be set out in legislation. There may be a number of stages in the process, including rights of appeal or review. It is important that such reviews be conducted in a manner that is fair to all involved parties, and that any relevant policies, bylaws or legislation are respected.

Who conducts the review?

The leadership and management of the provider’s department are usually responsible for the review. Their role is to ensure that during the review process, all parties are treated fairly and that all applicable institution/hospital bylaws, policies and legislation are followed.

In Québec, department leadership and management can refer a matter to the medical examiner, typically a physician appointed by the healthcare institution to examine concerns about the care or conduct of a physician (i.e. conduct an accountability review).

When should the review take place?

The review should be done as soon as reasonably practical. This increases the likelihood of accurate recall of the facts and allows action to be taken promptly.

Who should participate in the review?

The healthcare provider is usually obliged by institution/hospital bylaws and/or policies to cooperate with an accountability review. Patients, substitute decision makers and selected family members may be asked to contribute to the review by providing information about their knowledge of the facts. Contributors might also include other providers involved in the care of the patient. On occasion, independent peer experts may participate in an accountability review.

Participants in the accountability review process should limit their comments to facts of which they have first-hand knowledge. They should answer questions factually and should not speculate, hypothesize, self-blame or blame others.

How is the information analyzed?

An accountability review may or may not identify or confirm concerns about the competency or conduct of an individual provider. During an accountability review, the challenge is to understand the reasonableness of a provider’s decision at the time of a patient safety incident, taking into account all the circumstances in the working environment.

A just culture approach to information analysis can play a crucial role in the establishment and maintenance of a healthy workplace culture that prioritizes the safety of care while treating providers fairly and respectfully. The just culture model conceptualizes the role of a provider in an event as being the result of three possible situations:

• human error, which is inevitable and unintentional,
• at-risk behaviour, which arises as a result of an unconscious drift away from safe practices, and
• reckless behaviour, which is the result of a conscious choice to disregard an acknowledged risk.

If, in the course of an accountability review, system issues are identified and a quality improvement review is not already underway, these should be referred to the quality improvement committee.

Will the documentation related to the review be protected?

The information generated in an accountability review is not collected for or produced by a quality improvement committee and therefore is not protected by quality improvement legislation. The process and records of such a review should nonetheless be treated as confidential. The participants in an accountability review should be informed that it is an accountability review and to what extent information generated will be shared with others and the circumstances under which it will be shared.

In Québec, the legislation provides that the medical examiner’s investigation record must remain confidential.

Important: The information generated in an accountability review will not be protected by quality improvement legislation. Physicians participating in such a review should ask to what extent information generated will be shared with others and the circumstances under which it will be shared.

What should be done with the review findings?

As mentioned previously, an accountability review may not necessarily identify concerns about the conduct or performance of a provider. However, if concerns are identified, organizations are encouraged to consider an approach that favours appropriate remedial action and education, and limits disciplinary measures and sanctions only to appropriate situations.

In Québec, the medical examiner will decide whether the matter raises sufficient concern to be referred for consideration by a disciplinary committee within the institution, or whether to dismiss the matter (with or without recommendations to the physician).

In the just culture model, the determination of which situation was at play in the event dictates the appropriate management intervention. Healthcare professionals who made a human error are consoled, those who engaged in at-risk behaviour are coached, and those who exhibited reckless behaviour are disciplined.

Neither consoling, coaching nor disciplining preclude learning from the event and identifying what system factors can be improved to promote safety.

Important: If a physician’s privileges are restricted, cancelled or suspended as a result of any review, the hospital/institution may also be required by law to report this information to the College.⁵

How should the review findings be shared with patients/families?

Once an accountability review has taken place, it is appropriate to reassure the patient the event has been fully examined and that appropriate actions have been taken. It is up to leadership/management to decide, on a case-by-case basis, whether additional information should be disclosed to patients and families. Despite a patient’s appeal for additional information, the provider’s right to privacy must be respected. For example, it would be improper for leadership/management to disclose personal health information about a healthcare provider without the provider’s permission. The decision to share the review findings with patients/families will typically require prior consultation with hospital/institution legal counsel.

Choosing the best type of review

Prior to determining which type of review should be initiated, the suitability and the ensuing benefits of a review process must be established. This initial assessment is contingent on the collection of preliminary facts as they relate to the unexpected clinical outcome, patient safety incident or near miss. An examination of the salient facts will help determine whether further analysis is required. If such is the case, the next step is to select the best type of review.

Step 1: Collecting all the facts

To determine if a review is indicated,⁶ a preliminary collection of salient facts will be required. This will support an initial understanding of the event and assist in determining whether a review will be beneficial.

Step 2: Determine if further analysis/review is required

In general, a review should be considered when a serious unexpected clinical outcome or patient safety incident has occurred. The legal framework of each province and territory may dictate what types of events (e.g., critical incidents in Ontario) require a formal review. Consideration should also be given to quality improvement review of less serious clinical outcomes, near misses and, on a case-by-case basis, concerns or complaints (associated with unexpected outcomes and/or patient safety incidents) from patients or healthcare professionals.

Each hospital/institution must decide, preferably using pre-established and objective criteria, which events should be reviewed, the type of review and the extent of the analysis.

While most patient safety incidents are related to the inherent risks of an investigation or treatment, harm should not be prematurely attributed to being simply “a complication” of an investigation or treatment. An examination of some of these events should be considered to determine whether system issues were contributing factors.

Step 3: Determine what type of review should be initiated

Recognizing patient safety incidents most often originate from system failures, quality improvement reviews are generally preferred. The systems theory of patient safety emphasizes that focusing on the system rather than on the individual will prevent more patient safety incidents. However, an accountability review should be considered when the performance of an individual healthcare provider appears to be the dominant factor that contributed to the patient safety incident or near miss. The just culture model of review aims to strike a balance between system and provider contributions to incidents.

The following three questions will assist leadership in determining whether an accountability review is appropriate:

• Is it alleged there was a deliberate violation of a policy by an individual provider?
• Is there a concern about the health of the provider?
• Is the dominant concern in this case about a clear lack of knowledge or skills or significant unprofessional conduct by an individual provider? (Note: Unprofessional conduct in this context refers only to behaviour that may have significantly contributed to the patient safety incident or near miss.)

Unless the answer to any of these questions is positive, a quality improvement review is the most suitable starting point, recognizing that it effectively identifies potential system improvements and may still allow for the identification of less obvious performance issues of healthcare providers.

The importance of an information firewall

Recognizing the differing focuses and purposes of the quality improvement and accountability reviews, occasionally it may be necessary to conduct both. These should be done independently with a strict information firewall between the two. By separating the two processes, healthcare professionals in a quality improvement review will be more likely to contribute their opinions and advance their perspectives on possible system improvements.

Important: CMPA members should contact CMPA for advice if:

• Asked to participate in an accountability review;
• Obligated to participate in a quality improvement review structured outside the parameters of the relevant provincial/territorial legislation;
• Privileges are threatened;
• A coroner/medical examiner (i.e. a medically qualified public officer who investigates deaths occurring under unusual or suspicious circumstances) is requesting information from a review;
• A disciplinary proceeding by a College and/or litigation is threatened or has already begun; or
• Uncertainty exists on how to proceed.

Triage process

The use of the triage process will help determine whether a review will be beneficial and if so, what type of review is required. The triage of information must be done objectively by leaders who are knowledgeable in clinical practice and patient safety, and who understand the distinct goals of the two types of reviews.

The following diagram (Figure 1) illustrates the recommended triage process for unexpected outcomes, patient safety incidents and near misses, and the two types of reviews generally available at the hospital/institution level.

Figure 1: Choosing the best type of review in hospitals/healthcare institutions

Notes

1. 4. 
   Each Canadian jurisdiction has enacted legislation that protects quality improvement information from being disclosed in legal proceedings. However, each jurisdiction is different in its categorization of what constitutes a quality improvement committee, quality improvement activity and quality improvement information. Furthermore, the extent of the protection that is afforded to quality improvement information differs among jurisdictions. Members are encouraged to familiarize themselves with the relevant legislation in their respective jurisdictions.
2. 5. 
   A mandatory reporting requirement of hospital disciplinary measures is imposed by legislation in British Columbia, Alberta, Ontario, Québec, New Brunswick, Nova Scotia, Prince Edward Island, and Newfoundland and Labrador.
3. 6. 
   The quality improvement review process may also be used to examine groups of other clinical outcomes, not just those triggered by a single patient’s outcome or experience.