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Some red rules shouldn't rule in hospitals

From the April 24, 2008 issue

As healthcare strives to create a culture of safety, many organizations are successfully incorporating safety practices utilized in highly reliable industries, including failure mode and effects analysis, root cause analyses, redundancies with technology, and crew resource management. These strategies have been adopted to help organizations reduce the risk of patient harm from preventable adverse events. Recently, another safety practice used by highly reliable industries—red rules—has sparked interest in healthcare, and some organizations have attempted to adopt this strategy, too.  

Defining red rules. Red rules are rules that cannot be broken. In highly reliable industries, red rules are few in number, easy to remember, and associated only with processes that can cause serious harm to employees, customers, or the product line. The red rule must be followed exactly as specified except in rare or urgent situations. Every worker, regardless of rank or experience in the company, is expected to stop the work or production line if the red rule is violated. This is the most important aspect of a red rule: to empower any worker to speak up when the rule is not being followed and to stop the line, regardless of rank or seniority. Foremost, management always supports the work stoppage when a red rule is violated, regardless of how inconvenient, financially costly, or disruptive to the company it might be. Furthermore, all violations of a red rule are mediated through a Just Culture approach in which the workers' behavioral choice—in this case, breaking a red rule—is evaluated to determine if it was caused by human error, at-risk behavior, or reckless behavior, regardless of staff member's rank, popularity, and importance to the company. This is not to say that red rules should be used as a means to discipline workers for breaking particular rules, but rather to empower the entire workforce to take action if a critical rule is broken. As with any rule, repeated violations of a red rule should spur an evaluation of internal systems that might make it difficult to follow the rule.
     
Example of a red rule in industry. In a company that uses a production line to assemble a product, a red rule might be associated with a particularly crucial component that, if defective, could lead to significant employee or customer harm. Inspection of this component before placing it on the assembly line would be the red rule, and anyone who notices that the component has not been inspected or has not passed the inspection according to specifications would be given the authority and responsibility to “stop the line” until the component has been inspected or replaced, regardless of the inconvenience and financial cost to the company. The company’s adoption of this red rule conveys the message that safety is of utmost importance.

Example of a red rule in everyday life. The use of seatbelts while riding in an automobile could serve as an example of a red rule that everyone should follow in everyday life. If an individual is not ‘buckled up’ when the automobile pulls out, any driver or passenger in the car—child, spouse, friend—should be empowered to speak up, tell the individual who is not wearing his seatbelt to buckle up, and cause the vehicle to stop until the action is completed. Maybe the individual was preoccupied and forgot this important step (human error), or had slid into the habit of failing to follow this safety rule (at-risk behavior); this doesn’t mean he must be punished or expelled from the car for breaking the rule. If the individual made a decision to purposely refuse to wear a seatbelt for personal convenience, knowing full well the risk, disciplinary action might be warranted. 

Misuse of red rules in healthcare. Some healthcare organizations have adopted red rules for the purpose of improving compliance with a rule that is often broken for a variety of reasons, many rooted in inadequate system support for following the rule. For example, a red rule that practitioners should always follow the 5 rights would not be appropriate. Most important, red rules should not be confused with organizational policies or standard operating procedures—even crucial ones like handwashing that call for strict adherence.(1) While compliance with policies and procedures is always expected, there will inevitably be circumstances when practitioners cannot abide by the rules, or circumstances where violating a rule may be the best course of action. For instance, in an environment where bar-coding technology is available, policies and procedures that call for practitioners to scan all medications before dispensing or administering them would certainly be considered crucial. However, circumstances will arise when scanning is not possible due to technology glitches, product idiosyncrasies, or emergency situations. Thus, compliance with bar-coding technology cannot be considered a red rule unless the organization has processes in place to ensure that not scanning a medication is a very rare event, and anyone can “stop the line” when it doesn’t occur.

Implementing too many red rules is another problem, which makes it difficult for staff to remember the rules, follow them at all times, and stop the line at all times if the rule is broken. Red rules will be meaningless and fail to achieve the goal of safety if applied to situations that are more appropriate for standard operating procedures.(1) Relying on too many red rules can also lead to rule-dependent behavior in which practitioners do not feel obligated or permitted to think critically about patient care and safety outside the established rules.(2)

Red rule criteria. So what makes a red rule different than other crucial rules (policies and procedures) in an organization? Consider the following:

  • It must be possible and desirable for everyone to follow a red rule every time in a process under all circumstances (red rules should not contain verbiage such as “except when…” or “each breach will be assessed for appropriateness”) 
  • Anyone who notices that the red rule has been breached has the authority and responsibility to stop further progress of the patient care associated with the red rule while protecting the patient or employee from harm
  • Managers and other leaders (including the board of trustees) always support the work stoppage and immediately begin rectifying the problem and addressing the underlying reason for breaking the rule
  • The people who breached the red rule are given an opportunity to support their behavioral choices and then judged fairly based on the reasons for breaking the rule, regardless of rank and experience
  • The red rules are few, well understood, and memorable.
Red rules in healthcare. In any workplace, there are a few rules that are well understood by all and never intended to be broken under any circumstance by anybody in the organization.(2) These rules often stem from well-established societal norms, such as not causing harm to others. In healthcare, this can be translated into strict avoidance of patient abuse, sexual harassment, or working under the influence of alcohol or drugs. Certainly, these norms and other societal norms like these can be considered red rules in any organization, as there are no reasonable circumstances under which the rules can be broken. But beyond these societal norms, appropriate use of red rules in healthcare should be limited to those that can always be followed and, if broken, can cause significant harm. Consider the following examples.   

Reconciliation of sponge count. During a surgical procedure, reconciling a sponge and instrument count before closure of an incision may be under consideration as a red rule. Thus, if a surgeon starts to close the incision before reconciliation of the count (breach the red rule), everyone in the room would be permitted to, and held responsible for, halting the process until reconciliation occurs, without exception. Thus, leaders must gain consensus from clinical staff, particularly surgeons, that closure of an incision despite an incorrect count puts patients at greater risk than failing to close the incision while reconciling an incorrect count. Also, leaders must be willing to hold the physician who breached the red rule accountable for his behavioral choice, judge the physician fairly based on the reason for breaking the rule, and support staff who halted the process of closure, under all circumstances.    

Time out before an invasive procedure. If holding a time out to verify the patient and site of surgery before the start of a procedure is under consideration as a red rule, a consensus of clinicians must agree that such action would always be expected. Again, leaders must be willing to hold clinicians who breach the red rule accountable for their behavioral choices and support staff who halted progression of the procedure. Other examples of red rules in the operating room include using sterile surgical instruments in open incisions (as you would not condone picking up an instrument that dropped on the floor and using it again) and the wearing of masks, gowns, and gloves during a surgical procedure.

Organizations must also hold staff accountable for their behavioral choices and fairly assess the reason they chose not to “stop the line” when a red rule was breached. 

Summary. If your organization is considering red rules, an interdisciplinary team, including representation from senior leadership and medical staff, should carefully consider each suggested rule to ensure that it meets the criteria listed above. If properly implemented, red rules have the potential to promote an organizational culture of safety that shares accountability for the safe delivery of patient care. But if misused or poorly supported by organizational leadership and the workforce, red rules will not be effective and may even increase patient risk if systems and processes are not in place to facilitate staff adherence to the rules.

References: 1) Scharf WR, Red rules: an error-reduction strategy in the culture of safety. Focus on Patient Safety. 2007;10(1):1-2. 2) Griffith S. An examination of red rules in a just culture. November 28, 2007. The Just Culture Community administered by Outcome Engineering, LLC. Accessed at: www.justculture.org.
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