A shout is heard from the patient’s room – “Someone help – he’s turning blue!” The frantic call is answered quickly by the nursing staff. Assessment and treatment happen in seconds. A slow respiration rate, low oxygenation, and a morphine PCA are noted. Administration of naloxone does the trick — the patient responds, and everyone breathes a sigh of relief. The RN notes an error in the pump settings for narcotic administration, and makes the needed corrections. After communicating with other medical personnel and documenting the events in the patient’s chart, the nurse moves on to other duties. This crisis was averted, but what about the next one? Although this RN does not know it, it is the third time this scenario has occurred this month. Who will know? Unreported events allow the weaknesses in the system to lurk in the shadows waiting for another chance to introduce error and adversely affect patient care. To play on a catch-phrase made popular in the 1980’s: “Where’s the data?”
Voluntary reporting is one of the keystones of a comprehensive medication error assessment program, and is the topic of this article. Although it captures only a tiny fraction of actual events, voluntary reporting allows front-line workers to report, describe, and offer insight into misadventures. Trigger tools, performance reports from electronic medication management systems, observation-based data, prospective assessments (such as FMEA), and prospective monitoring of the literature are other methods which may round out your error management program. Whether or not the hypothetical occurrence above is captured in the hospital’s medication error reporting system depends on the following factors: the organization’s safety culture, its reporting process, and how the data is used.
Although it is often overlooked when discussing error-reporting programs, the values, beliefs and behaviors of the workplace have an overwhelming influence on how actively that reporting system is used. Consider our hypothetical case above: if the RN knew that the person who made the pump-setting error would be punished if discovered, do you think the error would ever be reported? What if that RN knew a reprimand would be the result of even reporting it? Not likely. However, if the RN knew that the report would be welcomed, researched, and used to improve patient care — how would this change your answer? A “just culture” marries the best parts of a blame-free environment with a well-established system of accountability. It is in this environment that a voluntary reporting system can flourish. The “data” will fill up the bun!
Because each medication error is considered to be an opportunity for improving patient care, all personnel should be actively encouraged to report errors and near-misses, and those reports must be welcomed by leadership. Without such reports, how can we reduce or eliminate the chance a similar event will happen again? Mark Twain is credited with saying “If you do what you’ve always done, you’ll get what you always got.”
Whether paper or electronic, a successful reporting system should possess the five characteristics listed in table 1. This information also applies if you are evaluating a commercial system for medication error reporting and evaluation. Confidentiality protections are essential for patients, reporters, health care professionals, and the organization. A risk manager or legal consultant should assist with the appropriate privileging and restrictions to allow for using the data for quality improvement while protecting from disclosure in potential legal proceedings.
The reporting system must be easy to access so it may be completed near the time of the event when details are fresh in the reporter’s mind. Copies of paper forms should be stored in a consistent, labeled location in every patient care area. Placement of an icon on an intranet home page or on an established safety location is effective for computer access to a reporting system. Don’t forget that the computer itself must be accessible! The decision to allow anonymous reports is organization specific, and should consider the current level of safety culture, technology factors, and process for follow-up of events.
Review your form for data collection: can it be completed without further instruction or minimal explanation? If not, it may be time to revise it! It is well worth the time and effort to collaborate with representatives from risk management, pharmacy, nursing, medical staff and performance improvement. During the design phase, pay close attention to your headings, terminology, spacing, and flow. Test the form with different disciplines to ensure verbiage is clear enough to elicit the information you seek to collect. Allow adequate space in the field for the reporter to complete the information. Include definitions where needed for clarity. To avoid clutter, the back of a paper form may be utilized. An electronic system may employ dropdown or hover-over options. Do not underestimate the value of the report’s appearance: users will appreciate a form that is “pleasing to the eye” and easy-to-follow. The form should follow a sequence of events that incorporates the workflow of the reporter. In our example, locating the space for drug name (morphine) before the narrative means the RN won’t have to repeat it in the next section.
Now that we have staff willing and able to report, we can again ask “where’s the data?” – just what is it we need to collect? Here, we must begin with the end in mind. The question of what to collect depends on what you will want to look at to make the data useful. The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) has created a taxonomy which can be used to develop your error reporting system.1 The magic word here is: balance. During my experience with the redesign process at four organizations, the number one reason I heard for users not reporting was “time.” Differentiate between the essential and the “nice-to-have” data, and contemplate the difference in time needed to fill out the reports.
What you need to know + minimal time for the reporter = success.
It may not be wise to include every single piece of information you might ever want to refer to, as this may significantly reduce the number of reports. A suggested list of data elements is presented in table 2. Limit paper forms to one page, and minimize the number of screens needed to complete an electronic form (a maximum of five is suggested.) Measure the time needed to complete a report, and make sure it is acceptable to potential reporters in your organization.
A word about field type: both free text and defined category fields are desirable in medication error reporting. Defined fields are best used when you intend to “track and trend” those elements of information, or use them during research of particular events. As an example, patient outcome is presented in Table 3. A free text field will allow the user to state in their own words what happened. While users should be taught to include only the facts during reporting, the narrative description can often provide insight which would not otherwise be available.
Using the Data
It must be emphasized that the purpose of submitting data to an error reporting system is for quality improvement. The NCC MERP says it best:
“Use of medication error rates to compare health care organizations is of no value. The goal of every health care organization should be to continually improve systems to prevent harm to patients due to medication errors. Health care organizations should monitor actual and potential medication errors that occur within their organization, and investigate the root cause of errors with the goal of identifying ways to improve the medication use system to prevent future errors, and potential patient harm. The value of medication error reports and other data gathering strategies is to provide the information that allows an organization to identify weaknesses in its medication use system and to apply lessons learned to improve the system.”3
Once the error report is completed, it needs to be transmitted or transported to its next stop. Although reporting systems may be paper or electronic, use of an electronic database is critical for evaluating data. Think about who is asking: “where’s the data?” when determining routing of reports. While you will have one person charged with maintaining the database, follow-up to each report should be performed by a leadership person involved with the area of occurrence in collaboration with pharmacy. Key questions that should be addressed during follow-up include:
This information should be linked to the report in the database. In addition to narrative, defined fields for topics such as contributing factors and actions may be strong indicators when evaluating possibilities for systems improvements.Aggregate data may be used to identify and focus improvement efforts to reduce error. You should be able to create reports using any field in the report, and trend these findings over time. Some of the most common report types are listed in table 4. Report functionality with drilldown, often found in commercial products, can be particularly powerful to help identify systems concerns at the click of a mouse.
Let’s come back to our opening case involving morphine. If the event remains unreported, we have not made any impact on potential recurrence for future patients. (This does not rule out identification by another method in your error-management program, such as through administration technology quality reports or trigger tools.) Once reported, however, it interacts with other records to form the aggregate data. A report by drug category reveals narcotics in the top 3 by frequency of occurrence; drilldown shows morphine at the top of this list; drilldown further exposes I.V. administration by PCA of morphine as a problem. Another report discloses of all errors involving morphine, the majority result in patient harm (categories E-H). These data are indicators that a systems related problem exists with the use of PCA morphine. You may use the individual report narratives and follow-up to help you focus your efforts on reviewing the processes used with morphine PCA, perhaps resulting in a change to the formulary product, labeling, I.V. pump, order set, nursing process, or other components. The result: reduced potential for error, and safe patient care.
Lastly, remember to share your journeys, challenges, and successes associated with the error management program with all levels of staff and administration. Where’s the data? With a safety culture, a well-designed program, and a process for data evaluation — you will not have far to go looking for it!
Deb Saine, MS, RPh, is the Medication Safety Manager at Valley Health/Winchester Medical Center in Winchester, Virginia. The chair of ASHP’s Section Advisory Group on Medication Safety, she received her BS in pharmacy from the University of Toledo and an MS in management from Antioch University. Deb has extensive experience in both community and academic medical centers, and for the past 17 years, her practice has focused on medication safety.
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