Force, Mary VanOyen BSN, RN; Deering, Linda MSN, RN; Hubbe, John PharmD, JD; Andersen, Marcy RHIA; Hagemann, Barbara RPh; Cooper-Hahn, Michelle BA; Peters, William MS
Making mistakes is part of being human. A key factor to minimizing risks and improving patient safety in the hospital is a better understanding of the precursors of medication errors. Compared to other high-risk industries, hospitals score poorly on safety issues. Greene1 reported that patients have a 1 in 200 chance of dying from medical errors occurring during their hospital stay. This is a shocking statistic when compared to the aviation industry that reports a 1 in 2,000,000 chance that a passenger will die during an airline flight. The Institute of Medicine (IOM) startled healthcare administrators with a report that stated the healthcare industry is 10 years behind the aviation industry in preventing errors.2 Leape,3 a Harvard researcher on medical errors, attributed the success of the airline industry to their emphasis on safety designs and improved processes that prevent errors. System failures, not individual mistakes, usually create an opportunity for accidents to occur.2-8
The IOM supported patient safety systems that focused on avoidance of blaming individuals. Human errors occur when systems rely on memory. Through designing simplified systems that include safety nets for errors, mistakes may be minimized or avoided. Data derived from medication error reporting can be used to improve medication processes and reduce the risks of future system failures. By creating a nonthreatening environment where staff is comfortable reporting medication errors, all staff and physicians can contribute to improving processes for patient safety.3,4
A nonpunitive culture that promotes patient safety must be a lived experience and integral to every clinical activity and decision in healthcare. This culture requires staff members to trust, value and feel supported by administration and colleagues. Culture is "the invisible force behind the tangibles and observables in any organization, a social energy that moves people to act. Culture is to an organization what personality is to the individual-a hidden, yet unifying theme that provides meaning, direction and mobilization."5(p48) To achieve this institutional shift to a blame-free culture, healthcare administrators must embrace a commitment built on trust that reporting medication errors will not evoke punitive action.
Although the actual frequency of medication errors is undetermined, medication error rates are wide-ranging in American healthcare organizations.2-4,7,8 In a United States Pharmacopeia (USP) report, medication errors were classified by outcomes. These data were collected from a study of voluntary, anonymous, and confidential reporting through the nationally recognized USP MEDMARX database system of 154,816 records from 500 healthcare organizations. These medication errors were reported from January 1, 1999 to December 31, 2001 through several mechanisms: "spontaneous reporting, retrospective chart reviews, computer triggers and/or direct observations."7(p761) A medication error was defined as "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer."7(p761)
Generally, nurses are the professionals who administer medications in healthcare facilities. But administration of medication is the final step of a complex medication administration process. Errors may occur at any step of the process and involve the prescribers, pharmacists, pharmacy technicians, and unit clerks. Determining the type of error is the starting point for further investigation into system failures. USP reported that the 10 most commonly reported medication errors were performance deficit (38%), policy/procedure not followed (20%), transcription inaccurate/omitted (15%), documentation (12), computer entry (11%), knowledge deficit (10%), communication (10%), written order (6%), drug distribution system (4%), and illegible handwriting (3%). The most common error of performance deficit refers to mistakes that occur when the individual empowered with the responsibility failed to complete the task competently.7
Organizational attributes contribute substantially to causes of errors regarding performance deficit, communication, computer entry, and drug distribution issues. The cause of errors is seldom limited to one simple reason. Contributing factors include: noisy work setting causing distractions, increased work loads, staffing shortages, agency staffing, lack of 24-hour pharmacy, code situations, lack of patient information, "floating" to different units, shift change, poor lighting, and inexperienced staff. Distractions were the most frequently cited contributing factor to performance deficit.8
Medication errors are either potential or actual, with actual errors analyzed by the extent of harm they cause. In the USP study of Santell et al,7 potential errors were 9.7% of the total submitted errors, leaving a remaining 91.3% being actual medication errors. Patients were not harmed by 97% of the actual errors. Three percent of errors did cause significant harm or death. Eighty-three percent of errors causing harm did not result in permanent harm or death. Death resulted from medication errors at a rate of 0.01% (n = 19). This is comparable to 19 airplane crashes out of 154,816 flights.
Medication administration is a complex system that requires diligent strategies and safety nets to prevent errors. When medication errors are reported, including those that do not cause actual harm, interventions can be implemented to correct the processes that lead to the mistakes.8 A comprehensive analysis of the healthcare organization's medication error reports may be used for systematic performance improvement changes. Because reporting is a voluntary program for staff, a culture of trust and nonblame must be prevalent in the organization.5,9
Patient safety is the primary reason for developing a program to minimize errors within the medication administration process, but the leading national regulatory agency requires implementation of an interdisciplinary process to monitor critical processes associated with medication management. Beginning January 1, 2006, the Joint Commission of Accreditation of Healthcare Organizations mandates continuous compliance with the national patient safety goal of improving the safety of using medications.10 "An effective medication management system includes mechanism for reporting potential and actual errors and a process to improve medication management processes and patient safety based on this information."11(p175) The Joint Commission of Accreditation of Healthcare Organizations is supportive of a nonpunitive culture that encourages staff to give feedback to management as defined through established performance improvement procedures.11
Medication Event Team
At Delnor-Community Hospital, an interdepartmental team was created for the purpose of increasing reporting of medication errors, analysis of the reports, and implementing action plans to improve medication administration and patient safety. The medication event team (METs) was co-chaired by the Director of Quality Management (health information professional) and the Team Leader of Research and Performance Improvement (nurse). METs consisted of staff nurses, quality department personnel, public relations representative, and pharmacists. In order for the team to study where errors occur, the medication process was broken into 4 categories: ordering, transcription, dispensing, and administration/monitoring. Utilizing published research, the team defined and wrote criteria to classify medication errors into each category for consistency and accuracy (Table 1).
The central problem was that staff (pharmacists and nurses) were not reporting medication errors. Although the hospital quality personnel had a long history of consistently tracking medication event reports per 1,000 doses administered, the monthly average was only 14 written reports per month. Although staff expressed support for the theory of medication error reporting, they did not report mistakes. Inherent fear of retribution, punitive actions, and professional humiliation prevented self-reporting of medication errors.
To solve the problem of low medication error reporting, the METs team developed a hospital-wide performance improvement project called "LifeSavers: Report Medication Events." The first step of LifeSavers was to organize small group forums with staff nurses and pharmacists to learn more how medication errors actually occurred within the hospital. The METs team chairpersons met with staff to ask why medication process failures are unreported and to open dialog about possible solutions to these problems. Emphasis was placed on the medication process and not on individual errors. These forums provided a wealth of practical information to build resources, tools, training, and an environment where reporting was easy, blame-free, and accessible to staff. Feedback from staff was discussed at METs meetings and strategies to correct the problem of low error reporting were initiated. The issues and solutions are presented in Table 2.
The METs formulated a strong communication strategic plan with the public relations department to promote a nonblame, nonpunitive culture at Delnor-Community Hospital. A logo was designed as a colorful hallmark of the LifeSavers program. This logo appeared on all communications regarding LifeSavers. LifeSavers' plan began with letters sent to the homes of all clinical staff identifying the problem of low medication error reporting. The letter informed staff that the intention of LifeSavers was to identify and correct medication system failures and not to punish individuals. This letter was signed by the Chief Nursing Officer, the Chief Operating Officer, and the Chief Executive Officer. This initial step established an administrative direction for a change in culture and sought employee "buy-in" as the foundation for a success.
Ongoing frequent communication about the LifeSavers program encouraged blame-free medication error reporting and was aimed at all levels of the organization. Managers and staff were provided with information regarding current research in medication error analysis, high-risk conditions, and why medication errors occur. Research-based information regarding a nonpunitive culture was provided through newsletters, flyers, bulletin boards, safety themes, screensavers, colorful buttons, banners, Lifesavers® candies, reward and recognition of staff reporting events, and involvement of the nursing-shared decision-making quality councils. The "Introduction to LifeSavers Program" with new hires occurred every month. Frequent and intense staff education was ongoing regarding the importance of reporting medication events to provide data for analysis to correct flaws in the medication process. Slowly, the culture evolved and employees began to trust that administrators wanted to learn and gain insights into medication administration for patient safety, and not punish the individual.
The main barrier to medication event reporting was the hospital reporting form. Staff stated during the forums that the form was punitive because it was called a "medication error report" and required a physician's signature. The staff felt that the reports would be included in their personal files and negatively affect their merit evaluations. Staff stated the word "error" immediately implied harmful consequences. They also felt the forms were difficult to find and complete, and lacked a feedback mechanism. Without a feedback mechanism, staff felt that no action would be taken regarding their report and that it was a waste of time. Generally, staff responses reflected attitudes of fear and a punitive reporting culture.
Medication reporting forms required staff to sign their names, shifts, and dates. Some staff had requested "anonymous reporting," but METs decided that the valuable follow-up procedures would be lost with anonymous reporting. When a medication event occurred, the staff and managers were instructed to say "report it," instead of the traditional negative statement of "write her/him up." This small change of daily language by staff and leaders encouraged the nonblame culture to emerge.
The METs developed 2 new user-friendly reporting tools: the long "medication event" and short "near-miss" form. Both forms emphasized contributing system factors leading to the medication event instead of individual responsibility. The word "error" was eliminated from the forms and replaced with the word "event" in all LifeSavers communications. The newly printed forms were simple and objective with a feedback mechanism built into the forms. Using these reports, technical and operational processes regarding medication administration were reviewed with the objective of providing improved patient safety.
The long medication event form went into more details of the event and how it could have been avoided (Figure 1). This form required a physician to be notified, but did not require the physician's signature. A section was designated for "feedback to staff" regarding actions taken to correct the event. Example of an actual long form medication event: A nurse prepared an injection of Imitrex to be given to her patient for treatment of a migraine headache. The order read "Imitrex 6 mg SQ now for headache." The nurse carried the medication record to the patient's bedside, matched the medication with the patient's identifiers, and pushed the medication intravenously. Immediately, the patient began to experience severe chest pain, elevated blood pressure, rapid pulse, and anxiety. The physician was "stat" paged and the patient was transferred to the intensive care unit for treatment of new symptoms. The patient's hospital stay was extended and required monitoring and interventions to control the side effects from an intravenous administration of Imitrex. The nurse was distraught knowing she had caused harm to her patient. She completed, signed, and submitted the medication event form to METs. The actions taken from evaluation of this report were: pharmacy department provided educational in-services on Imitrex to all nursing staff; pharmacy added a "pop-up" screen to Imitrex in the Pyxis which stated "give subcutaneously only" as a warning and safety net to remind nursing staff that Imitrex may not be given intravenously or intramuscularly; the nurse received additional education on medication administration, but did not receive disciplinary action.
During forums, staff had requested a quick short form to write their opinions about issues that may lead to medication events (Figure 2). The LifeSavers' Program included a new "near-miss" initiative to identify, interrupt, and correct potential medication events before they happened. The "near-miss" form simply asked what happened and how could this event have been avoided. Immediate actions were taken to solve simple system failures on a daily basis. The new "near-miss" half-page forms were designed to be easy, fast, and simple. The "near-miss" form did not require a physician's signature. These forms encouraged staff to report their opinions of medication processes and how to improve the system. Example: a staff nurse reported that 2 female patients with very similar names shared the same semi-private room. Both women were prescribed high-risk oral medication that are very different but have similar sounding names: Cytotec and Cytoxan. Because of the look-alike/sound-alike patient names, room number, and medications, the nurse "almost" gave one patient the wrong medication. The nurse completed a "near-miss" form immediately. When the form was retrieved and the issue addressed, the patients were immediately separated into different rooms with high-alert signage applied to their medication records and Pyxis.
To provide easy access to all medication forms, a rack was mounted on the wall of each nursing unit to hold the "medication event long forms" and "near-miss short forms." Racks were decorated with the colorful LifeSavers logo. Staff was informed to place the completed medication event forms in clear decorated plastic boxes that were conveniently placed next to the racks. Ongoing education was provided to staff on how to complete the forms, where to return them, how they would be triaged with follow-up, and the rationale for increasing medication event reporting for patient safety.
In the past, nurse managers received medication reports directly from staff but did not have a procedure for action to correct complicated hospital medication processes. Reports would be filed on the manager's desks for months without actions to improve the problems. LifeSavers' education was specifically directed at nurse managers to correct this barrier. Managers were encouraged to immediately forward any reports to the METs' chairpersons after recording their immediate staff follow-up on the report. Medication reports were not allowed to be filed, copied, or placed into employee records. This provided staff reassurance against punitive action at employee evaluation time.
The chairpersons, or designee, of the METs team did daily rounds to collect all medication event reports and immediately triage for possible corrective actions. The triage system involved reading the report, discussing the event with the appropriate nursing leader or pharmacists, and implementing a corrective action. Staff submitting reports received a personal thank-you note from the METs team with a gift card in recognition of participation in the new LifeSavers program promoting reporting medication events. This daily rounding by the chairpersons encouraged engagement with the nursing staff to discuss any medication process problems.
Collectively, original medication events were analyzed at the weekly METs meetings. In an hour-long meeting, usually 7 to 10 reports could be effectively analyzed for cause and possible solutions initiated of the system failure. METs classified the events into 4 categories: ordering, dispensing, transcription, and administration/monitoring (see Table 2). The team looked for trending of events and frequency, contributing factors, and solutions to the problems. Because the METs team was interdepartmental, meetings were active and lively with discussion over solutions to events. Soon it became apparent that more meetings were necessary to review the great number of reports submitted every week. Small task teams of one nurse and one pharmacist were formed to meet separately to categorize the events and then return the difficult forms back to the general METs meetings for solutions.
For more complicated medication process failures, task teams were formed to develop strategies to implement organizational/departmental changes to solve the problems. More and more leaders and staff were getting involved in analysis and solutions of medication administration process failures. Frequent ongoing communications to staff and leadership promoted the work of the METs team. Monthly medication event reports were counted and filed with the quality improvement department and reported to the Board of Directors. Investigations of every report were thorough, respectful, and system-focused without emphasis on personal failures. The METs utilized aggregate data to inform and shape patient safety action plans to reduce medication errors. The strong campaign for promoting the important work of the METs team was essential to maintain staff buy-in and continued support of reporting of medication events.
Medication event reports were collected and aggregated every month for 1 year before and after the LifeSavers program was implemented. Results were matched by months for 1 year preceding and following the implementation to control for seasonal variation in staffing and patient caseloads. During the 12 months before LifeSavers was implemented, the mean rate of collected medication reports was 14.3. In the 12 months after LifeSavers was implemented, the mean rate of collected reports increased to 72.5. A paired-samples t-test analysis indicated that the LifeSavers program was associated with increased medication error reporting significantly more than would be expected by chance, t(11) = 13.598, P <.001.
The LifeSavers program implementation was associated with an increase in reporting of medication events. The intense educational program provided staff with a solid rationale for reporting medication events as they occurred in the current medication processes. When staff understood how medication event reporting would be used to analyze system failures and not for individual punitive actions, the reporting increased. The growth of the organizational nonblame culture of safety coincided with the growth in numbers of medication event reports. As more employees were praised, thanked, and recognized as valued participants in LifeSavers, more staff felt comfortable contributing to the reporting process.
These results suggested that educational programming aimed at changing the way staff perceived medication errors significantly impacted medication event reporting. The LifeSavers program was very successful in the essential first step of patient safety where staff can freely report events. Future plans are to invite representatives from each nursing unit to all weekly METs meetings to increase awareness of medication events and solutions. METs will continue to utilize information collected from these reports to improve the complex medication administration system.
© 2006 Lippincott Williams & Wilkins, Inc.