Healthcare practitioners are expected to speak up about patient safety concerns to help intercept errors and avoid adverse patient outcomes. By ‘speaking up,’ we mean raising concerns for the benefit of patient safety and quality of care upon recognizing or becoming aware of a risk or a potential risk.¹ Such risks may include concerns about the safety of an order or treatment modality, a possible missed diagnosis, questionable clinical judgment, rule breaking, dangerous shortcuts, incompetence, and disrespect. Healthcare practitioners, especially frontline staff, are well positioned to observe unsafe conditions and bring them to the attention of those who can remediate them.

Speaking up is a behavioral choice under every healthcare practitioners’ control, but this is quite different than simply voicing a suggestion. A practitioner who bravely expresses a patient safety concern may cause the recipient to become defensive and set themselves up for negative repercussions. In deciding whether to speak up, the practitioner typically engages in a deliberate decision process whereby he or she considers both the positive and negative consequences, as well as the anticipated effectiveness and safety of voicing the concern.² It is a balancing act of trying to be proactive and constructive while at the same time considering the possible personal costs of speaking up. As a result, all too often, practitioners will hesitate to voice their concerns, choosing the “safe” response of silence.^3,4 On the other hand, they may speak up and be ignored or easily convinced that their concerns are unfounded.5 Silence and dismissed concerns are especially dangerous types of communication breakdowns.

“Safe” Response of Silence

While there are numerous studies² and anecdotes that demonstrate the positive relationship between speaking up and patient safety, hesitancy to speak up is an important contributing factor in errors and adverse events.¹ Most practitioners, regardless of their position and specialty, have some experience with hesitating to voice a concern related to patient safety, even when they are aware of the risks and their moral obligation to report their concern.^1,4,6 Silence can be caused by a variety of factors, including fear of reprisal, low perceived effectiveness, low motivation, clinical factors, individual factors, normative and social pressures, lack of confidence, fear of embarrassment if wrong, a disproportionate authority gradient, and many others (Table 1). In fact, raising patient safety concerns may be perceived as a high-risk, low-benefit proposition for many practitioners.^1,7

**_{Table 1.}**_{Influencing Factors that Reduce and Enable Speaking Up Behaviors^1-4,6,7}
Influencing Factors	Factors that Reduce Speaking Up Behaviors	Factors that Enable Speaking Up Behaviors
Perceived effectiveness of speaking up	Lack of response and impact Ignoring practitioner concerns Sweeping concerns under the rug No improvement in safety Lack of managerial support Lack of transparency and follow-up	Receptiveness and impact Listening to and valuing concerns Acting on practitioner concerns Active managerial/leadership support/ approachability Providing feedback about reported concerns, safety data to units
Motivation to speak up	Low index of suspicion Low perceived patient harm Feeling of helplessness, intimidation Tolerance of risk No social motivation to speak up Belief that speaking up is an annoyance	High index of suspicion High perceived patient harm Empowered to voice concerns Fierce intolerance of risk Coworkers, leaders encourage and model speaking up behavior Belief that speaking up is a moral obligation
Clinical factors	Ambiguity of the clinical situation Uncertainty about patient harm	Clarity of the clinical situation Perceived risk of patient harm
Individual factors	Distracted Prior repercussions Prior experiences with disrespect Inadequate coping skills Unassertive Diffident cultural background Insufficient knowledge and skills Low confidence, prior unfavorable experiences Fear of damaging collegial relationships Adaptive conformer (see Table 2)	Keen situational awareness Joy in work, job satisfaction Feels responsibility towards patients Assertive Knowledge of human factors Understanding of best practices Good interpersonal communication skills High confidence, prior favorable experiences Trusting collegial relationships Observant questioner (see Table 2)
General contextual factors	Feeling rushed Cumbersome reporting process Lack of teamwork No input into policy making No policy to speak up No established procedure for resolving conflicts about safety	Adequate time to consider potential errors Streamlined reporting process Effective teamwork Interdisciplinary policy making Organizational edict to speak up Clear procedure for resolving conflicts about safety not dependent on hierarchical structures Speaking up included in performance reviews
Perceived safety of speaking up	Psychologically unsafe work environment Culture of blame, reprisal Fear of appearing incompetent Prior negative outcomes Presence of an audience (e.g., patient) Lack of manager/coworker coaching before, and support after, speaking up	Psychologically safe work environment Fair and just culture, culture of safety Leadership approachable and visible Certainty about the positive consequences of speaking up Privacy when speaking up Managers/coworkers offer coaching and advice before, and support after, speaking up
Tools and training	No formal training on: Patient safety theory Effective communication strategies Working in teams No tools provided to help gather and communicate critical concerns	Formal training provided in regular intervals (e.g., patient safety theory, crew resource management, TeamSTEPPS) Having a speaking up rubric (e.g., SBAR) or structured communication technique (e.g., critical language) Established opportunities for speaking up (e.g., surgical time outs, SBAR handoffs)
Measurement	No aggregation or analysis of voiced concerns	Measures the frequency of voiced safety concerns, responses, impact on the messenger and others, and outcomes Uses these measures for improvement

A study conducted with nurses several years ago found that more than half had been in situations where they felt it was unsafe to speak up.⁴ Almost 1 in 5 nurses said they were in this situation at least a few times a month. One in 3 nurses had shared concerns with their coworkers about dangerous shortcuts they had observed, and only 1 in 4 had confronted a previously disrespectful colleague to share their patient safety concerns. Although nurses in the study were more likely to take their safety concerns to their managers than to speak directly to the practitioner, fewer than half of these managers followed through and spoke up about the reported safety issue; thus, taking safety concerns to a manager may not produce reliable results.

Several studies have identified the factors that influence and enable practitioners to voice their patient safety concerns (summarized in Table 1).^1-4,6,7 For example, many studies emphasized the importance of:

The perceived effectiveness of speaking up, such as managerial/leadership support/approachability and feedback
Motivation to speak up, such as a high index of suspicion, a high perceived risk, and clarity of the situation
Individual factors, such as job satisfaction, situational awareness, confidence, and communication skills
Contextual factors, such as effective teamwork and a nonhierarchical process for resolving conflicts
Perceived safety of speaking up, such as a psychologically safe work environment and managerial/coworker support
Tools and training, including a standardized rubric for speaking up (e.g., SBAR [situation, background, assessment, recommendation])
Measurement of the frequency, responses, and outcomes of voiced safety concerns

Awareness of the factors that influence and enable speaking up behaviors can help leaders create a workforce who can candidly and effectively discuss their patient safety concerns without fear. The goal is to help practitioners feel comfortable and competent with being an observant questioner who speaks up about patient safety concerns, not an adaptive conformer who quietly remains silent (Table 2).⁸

**_{Table 2.}**_{Adaptive Conformer vs. Observant Questioner⁸}
Worker Faces	Adaptive Conformer (undesired)	Observant Questioner (desired)
Obstacles	Adjusts, improvises without bothering managers or others; fixes it and forgets it	Noisy complainer: Remedies immediate situation but also lets managers and others know when the system has failed
Others’ risky behaviors (e.g., dangerous shortcuts)	Does not intervene; if it is clear the patient is at risk of serious harm, may report it to a manager	Eager coach: Coaches peers and others to see the risk associated with their behavioral choice, regardless of actual harm, and suggests a safer choice; reports the behavior for learning purposes only
Own risky behaviors	Rationalizes their behavioral choice to cut corners as required under the circumstances; does not report the behavior	Concerned drifter: Lets manager and others know that they have drifted away from the way processes are designed, and reports the underlying (often system-based) causes so they can be remedied
Potentially unsafe orders	Defers to experts and gives the prescriber the benefit of the doubt; does not clarify the order unless it is clear that a mistake has been made	Persistent clarifier: Makes no assumptions and clarifies all potentially unsafe orders with the prescriber
Others’ errors	Seamlessly corrects errors of others, without confronting them	Curious interrupter: Asks what others are doing and lets others know they have made a mistake, for learning purposes only
Own errors	Creates an impression of never making errors	Self-aware error maker: Lets manager and others know they have made a mistake so everyone can learn; communicates openness to hearing about his or her own errors discovered by others
Subtle opportunities for improvement	Understands the “way things work around here”	Disruptive questioner: Asks: Why do we do things this way? Is there a better way of providing care?

_{Adapted from Tucker & Edmondson}⁸

Dismissed Concerns

When a practitioner voices a concern, there may be an explanation from competent practitioners that dispels the initial concern too quickly, before it has been given sufficient consideration. A pharmacist reassures a technician that the compounding directions are correct when questioned about an unusual volume of ingredients; a pharmacist assures a nurse that the strength of an infusion is correct when questioned about the final volume; a nurse reassures a patient that the medication is correct when questioned about its appearance; a physician convinces a pharmacist that the prescribed dose is correct when questioned because it differs from what he found during investigation. These are real, all-too-frequent examples of backing away from an initial concern that subsequently led to fatal adverse drug events. Those who questioned the patients’ care were easily convinced that others knew more than they did, particularly if the provider who was questioned had an otherwise stellar reputation.

Is this a form of intimidation? Perhaps, but it may be more akin to a logical deference to expertise, meaning it is natural and often reasonable for people to defer final judgment to those they perceive to be more “qualified.” The person questioning the patient’s care has been easily convinced that their concern is unfounded, and the person being questioned has not perceived the voiced concern as a possible, credible patient threat. Neither the questioner nor the person being questioned possess a required element to safeguard patients: an appropriately high index of suspicion for errors. A low index of suspicion is particularly problematic in a healthcare system that is often reluctant to acknowledge human error or value the contributions from every person, regardless of rank, who interacts with the patient.

An index of suspicion is defined as “awareness and concern for potentially serious underlying and unseen injuries or illness.”⁹ Suspicion is defined as “the act or an instance of suspecting something wrong without proof or on slight evidence, or a state of mental uneasiness and uncertainty.”¹⁰ A high index of suspicion requires consideration of a large differential so that a serious possibility is not accidentally discounted; a potential medical error should always be considered one of the possibilities. An appropriately high index of suspicion should lead a person with a concern to pursue it until it’s proven to not be a credible patient threat, even when met with opposition from experts. It should also prompt the provider to be responsive to voiced concerns and to initiate a suitable investigation to determine if there is a credible threat to the patient.

ISMP has previously discussed the need to maintain a high index of suspicion for errors in our newsletters, including an article about mindfulness, a defining characteristic of organizations with highly reliable outcomes.¹¹ Mindfulness refers to the deep and chronic sense of unease and preoccupation with failure that arises from admitting the possibility of error, even with well-designed, stable processes. People in organizations with highly reliable outcomes worry about system failures and human errors. They ask, “What will happen when an error occurs?” not “What will happen if an error occurs?” They are wary of complacency and naturally suspicious, so they expect people to speak up about any concerns they may have. Their high index of suspicion is a predominant factor in achieving laudable safety records. Furthermore, position and experience do not necessarily dictate who is an important contributor or decision maker.

To diminish unconvincing threats, healthcare needs to raise the index of suspicion for errors, always anticipating and investigating the possibility when any person, regardless of experience or position, voices concern, or when patients are not responding to treatment as anticipated. Staff need to be trained and mentored to resolve potential concerns and to trust in their own experiences to augment the expertise of others. All healthcare practitioners need to encourage, and be receptive to, practitioners who ask questions, even if they just have a sense that “something” is wrong or can’t articulate the concern well. When concerns are met with quick responses that initially appear to be “evidence” of safety (Table 3), caution is recommended. These quick responses should be viewed as “red flags” that require more reliable answers and actual proof.

**_{Table 3.}**_{Examples of “Red Flag” Responses to Voiced Concerns}
That will never happen here
That doesn’t apply to me (us)
The patient says that’s how he takes it at home
It’s just a nuisance alert; it alarms all the time
That’s the way we always do it
This is how we get the work done here
Everyone else is doing the same thing
No one ever says anything, so it can’t be too wrong
Just do it
You must be new here; I’ve been doing this for years
It’s not your job to question that

Conclusion

ISMP is not discounting the fact that many complex factors influence whether healthcare practitioners speak up about patient safety concerns. We also do not discount the extraordinary courage it may take for many to step up to these conversations. However, tolerance of risk that goes unchallenged is a serious patient safety concern, and to combat that, all who interact with patients must become an observant questioner and raise their index of suspicion of errors. Healthcare practitioners need to ensure that patient safety concerns are not only raised but also properly investigated and addressed. You can be sure that those involved in serious and fatal errors wish that they had taken the opportunity to do just that.

References

Okuyama A, Wagner C, Bijnen B. Speaking up for patient safety by hospital-based health care professionals: a literature review. BMC Health Serv Res. 2014;14:61.
Nacioglu A. As a critical behavior to improve quality and patient safety in health care: speaking up! Safety in Health. 2016;2(10):1-25.
Morrison EW, Milliken FJ. Speaking up, remaining silent: the dynamics of voice and silence in organizations. J Manage Stud. 2003;40(6):1353-8.
Maxfield D, Grenny J, Lavandero R, Groah L. The silent treatment: why safety tools and checklists aren’t enough to save lives. Report: VitalSmarts, AORN, AACN.
Institute for Safe Medication Practices (ISMP). Raising the index of suspicion: red flags that represent credible threats to patient safety. ISMP Medication Safety Alert! 2012;17(15):1-3.
Lyndon A, Sexton JB, Simpson KR, Rosenstein A, Lee KA, Wachter RM. Predictors of likelihood of speaking up about safety concerns in labour and delivery. BMJ Qual Saf. 2012;21(9):791-9.
Attree M. Factors influencing nurses’ decisions to raise concerns about care quality. J Nurs Manag. 2007;15(4):392-402.
Tucker AL, Edmondson AC. Why hospitals don’t learn from failures: organizational and psychological dynamics that inhibit system change. Calif Manage Rev. 2003;45(2):55-72.
Pollak, AN, ed. Emergency Care and Transportation of the Sick and Injured, 10th ed. Sudbury, MA: Jones and Bartlett Publishers; 2011.
Merriam-Webster. Online dictionary. www.merriam-webster.com/dictionary/suspicion
ISMP. Safety requires a state of mindfulness (part I). ISMP Medication Safety Alert! 2006;11(5):1-2.

Speaking Up About Patient Safety Requires an Observant Questioner and a High Index of Suspicion

“Safe” Response of Silence

Dismissed Concerns

Conclusion