Critical Order Set Change and Critical Limb Ischemia
Approach to Improving Safety
Setting of Care
A 72-year-old woman with a history of severe peripheral vascular disease presented with acute limb ischemia secondary to thrombosis of her left superficial femoral artery. Catheter-directed thrombolysis was performed almost immediately upon arrival to the hospital. The patient was subsequently admitted to the intensive care unit with the catheter device in place.
Per protocol, the admitting resident ordered a heparin drip to prevent thrombosis of the catheter and sheath site. The resident was unaware that the heparin drip order set in the electronic medical record had undergone significant revision and now contained dosing and monitoring options. Because of this change, the resident inadvertently ordered a heparin dose that was too low. The bedside nurse and the pharmacist noticed the low dose, but they assumed that the resident had purposefully selected the dose from the range of options provided in the order set.
As a result, the patient was inadequately anticoagulated. Twelve hours later, she developed extensive thrombosis associated with the catheter and sheath site that extended to the bifurcation of the aorta. The patient ultimately required surgical intervention for critical limb ischemia, including amputation of the contralateral leg above the knee, due to prolonged time without adequate blood flow.
Commentary by Brian Clay, MD
Order sets have become a mainstay of provider workflow within modern electronic health record (EHR) systems, serving as both a tool to increase the efficiency of order entry and a means of clinical decision support. Order sets are used in a wide variety of clinical situations and can be categorized based on their intended purpose, which include facilitating standard clinical workflows (e.g., hospital admission, transfer, and discharge), supporting specific clinical conditions or tasks (e.g., managing heart failure, transfusing blood products, or arranging for central line placement), or simply making order entry more convenient (e.g., an order set for frequently utilized laboratory tests).(1)
Creating order sets represents a substantial investment of time and resources on the part of health care organizations.(2) Such investment facilitates efficiency and accuracy of provider order entry, which may increase provider satisfaction with computer-based order entry overall.(3) Optimal design and implementation of an order set may also improve the quality of care and adherence to established clinical guidelines. Reported examples include order sets designed for relatively simple scenarios such as standardizing the use of potassium binding resins when treating patients with hyperkalemia (4), or those intended for more complex clinical situations such as standardizing the care for ICU patients with diabetic ketoacidosis.(5) Order sets can also serve to avoid waste and lower costs, for example by reducing the use of unnecessary red blood cell transfusions.(6)
In the case described above, the order set in question was developed to support a relatively complex clinical workflow: administration of therapeutic anticoagulation treatment with unfractionated heparin. A well-designed order set would support selection of proper bolus dosing, correct rate of maintenance infusion, and appropriate timing of anticoagulation monitoring at scheduled intervals. The case indicates that the heparin infusion order set in question "now contained dosing and monitoring options," which suggests that the resident using the order set was prompted to make a decision that wasn't previously required.
The use of order sets is not without risks. The design, implementation, and maintenance of order sets all require careful attention to the potential of harm to patients and of unintended consequences. The Institute for Safe Medication Practices has published guidelines for order set management (7), outlining best practices for design, implementation, and maintenance. Content development for a given order set is ideally achieved through consensus among all clinical areas impacted. Such consensus is usually accomplished through numerous meetings of standing interdisciplinary committees composed of providers, nurses, pharmacists, and information services. Every order set needs a clinical champion—someone who is a content expert who can also facilitate ongoing review and revision of the design. Order sets should be reviewed regularly every few years to ensure that content has not become outdated; EHR-based analysis of order set use can help to inform review for frequency of use by providers.(8) If substantial changes are made to an order set, communication of those changes must go to all users who could potentially use the order set and be affected by the change, such as the resident (described in the case above) who was likely unaware of the new heparin order set.
Order sets are a form of clinical decision support and can contribute to patient harm when not properly designed. Published examples of adverse patient outcomes related to order sets include one order set designed to support continuous bladder irrigation that resulted in clinical complications for patients from overly high irrigation rates (9) and another order set intended to facilitate N-acetylcysteine administration that resulted in hyponatremia due to lack of ability to adjust the base intravenous solution.(10) More generally, widespread use of order sets in the EHR may lead to a degree of complacency on the part of providers. A provider may wrongly assume that the order set content represents the best practice for a particular clinical scenario or fail to recognize when an order set is not appropriate for a given patient due to specific aspects of that patient's medical situation. Finally, order sets that are designed for the convenience of the provider (such as an order set for frequently used morning laboratory tests in the hospital) might lead to orders for inappropriate and unnecessary tests, a form of overuse known to cause harm and increase costs. In any case where a significant change is made to an order set, it is also best practice, during the planning stages, to determine metrics that can be used to detect whether the change resulted in the desired effect. In the case described, one such metric might have been time from initiation of heparin to the first therapeutic activated partial thromboplastin time level.
This case involved a substantial change to an existing order set for therapeutic heparin: The ordering provider (the resident) was faced with a new requirement to select a specific dose. To optimize clinical decision support, the order set should have been designed to provide guidance as to how to select the proper dose, perhaps by using an indication-based ordering approach, which has been shown to be successful with insulin-based order sets.(11) Such an approach would have prompted the resident to select a clinical indication (i.e., arterial thrombosis) instead of a heparin infusion rate. The selection of the correct clinical indication would then result in ordering the appropriate infusion rate. Without such guidance, the resident was left to select a dose and an infusion rate based on his limited clinical knowledge base and experience.
This case also illustrates a failure of communication by the health care organization regarding a significant change in an order set. Communicating system changes like this can be challenging, especially when targeting providers—emails alone are not highly effective, and it is often difficult to gather all providers that might potentially use a heparin order set, for example, in one place for an in-person presentation. Therefore, a best practice in such a situation would be to augment such electronic communications and reference material with a real-time reminder of the change to the order set that could pop up as an alert when a provider uses the new order set. While such an alert could be easily constructed, the well-known risk of alert fatigue and interruption of attention makes this approach suboptimal. A better approach might be to edit the order set itself to display—perhaps with larger font and bold colors at the top of the screen—the specifics of the recent changes to the order set, and to leave this bold text in place for several months after the changes are made. Communication to nursing and pharmacy would also have been appropriate in this case, as the requirement for providers to make decisions on heparin dosing was new, and close scrutiny of the ordered heparin dose on the part of both nursing and pharmacy would be helpful in order to ensure safety.
In summary, a comprehensive process for design, implementation, and maintenance of order sets, including effective communication of key changes, is needed for order sets to remain valuable tools for providers. This is especially true when substantial changes are made to order sets related to potentially high-risk clinical workflows such as therapeutic anticoagulation.
- Order sets are important tools to improve ordering efficiency for providers and can serve as an effective means of clinical decision support.
- There are established best practices for order set design, implementation, and maintenance, including having a clinical champion and performing regular review of order set content. Adherence to these best practices can minimize risks associated with the use of order sets.
- Communication of significant changes to order sets to the potentially impacted users is essential. Consider multiple modes of communication when substantial changes are made to order sets, especially for high-risk clinical workflows.
Brian Clay, MD
Health Sciences Clinical Professor of Medicine, Department of Medicine
Chief Medical Information Officer
University of California San Diego Health
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