Procedings from the Quality Colloquim: Culture Improves Safety Reducing Adverse Drug Events


November / December 2005

Procedings from the Quality Colloquim

Culture Improves Safety Reducing Adverse Drug Events

OSF St. Joseph Medical Center began its journey to patient safety by focusing on reduction of adverse drug events (ADE). For help in this venture, the medical center became involved with the Institute for Healthcare Improvement’s (IHI) ADE Reduction Collaborative. This collaboration, with hundreds of facilities and systems across the country, facilitated an organized structure in promoting change.

OSF St. Joseph Medical Center is located in Bloomington, Illinois — a community of approximately 100,500 people. The medical center is licensed for 157 beds, provides open heart services, started a “beating heart” program in 1999, is licensed as a level II Trauma Center, and has 5 hospital-owned physician office practices and 2 urgent care centers.

The objectives of this article are to provide information regarding our experiences at OSF St. Joseph’s with various tools and process changes that contributed to a change in culture and reduction of adverse drug events.

The goals of IHI’s ADE Reduction Collaborative include:


  • Improve the cultural climate of the organization.
  • Conduct 3 phases of medication reconciliation.
  • Decrease the dispensing and ordering FMEA score.
  • Deploy pharmacy-based order sets.
  • Involve patients with safety.
  • Comply with JCAHO Patient Safety Goals.
  • Use of safety tool kit (RCA, FMEA, human factors, complex adaptive systems, and team resource management).


Our initial efforts were to identify key areas for design of an ideal process for medication use: culture, reconciliation, ordering, dispensing, and high-risk medications.

The basis for any performance improvement project is cultural transformation with a priority on safety, which was promoted at OSF St. Joseph through integration of safety into the organization’s strategic management plan. A cultural transformation began by improving the safety climate. Baseline measurements were obtained through a cultural survey that measured the staff’s perception of the safety and teamwork climate. Second, the organization began focusing on harm as opposed to errors by analyzing events to obtain meaningful information regarding failure modes rather than using the “blame game.” This led to a focus on process and systems, which identified that most events are a result of poor processes and not “bad people.” No one has employees who come into work and think, “I am going to make three mistakes today.” Rather, poor processes enable these mistakes. As 70% of sentinel events have communication as a contributing factor, a focus on communication and teamwork is felt to be crucial in the cultural transformation.

The ultimate aim of any facility is to become a high reliability organization. When evaluating core processes, such as the medication process, you must detect adverse events before you can prevent them. In the real world, we know that we cannot eliminate all such events, so in restructuring processes, it is important to incorporate mechanisms to mitigate harm should an adverse event occur. This can be achieved through use of tools such as root cause analysis (RCA); failure mode effects analysis (FMEA); simulation, complex adaptive system thinking (CAS); crew resource management (CRM); and consideration of human factors in system design and analysis. Team efforts are driven by collaboration, systems thinking, a focus on change, and the use of evidence-based information. Finally, the foundation of a high reliability organization is a leadership-driven focus on the culture of safety.

Characteristics of a high reliability organization include:


  • A preoccupation with failure. Even five years ago, healthcare professionals would be pleased with achieving 80% compliance of a given indicator, but in today’s world, is 80% good enough? Would we be satisfied with 80% of the flights landing safely at any of our airports? Would we want our family member to be in the 20% that did not get the recommended care?
  • Deference to expertise. The most knowledgeable staff should take charge in their area of expertise regardless of their role. Examples of this are the pharmacist’s involvement in anticoagulation dosing or the dietician in determining the nutrition needs of the patient.
  • A culture that encourages everyone to ask, “What have I missed today? What should I have seen that I didn’t?”


The journey to culture change begins with systems thinking. In evaluating processes, it is important to identify the influence of patient condition, tasks, staff, environment, teamwork, and management on the process. As most healthcare facilities do not have unlimited resources, collaboration is important to promote friendly competition and to accomplish more, faster. This prevents “recreating the wheel” and promotes learning from others about which changes worked successfully and which were failures. A commitment to change will aid in the cultural transformation. This can be the most difficult aspect of the transformation as change puts us out of our comfort zone. Leadership support is necessary for testing new ways of doing things. Change can be facilitated through the use of evidence-based processes such as order sets and protocols.

There are three key populations to address in the cultural transformation: staff, physicians, and patients. To involve staff, a non-punitive reporting policy was established to promote reporting of safety concerns. Staff members were encouraged to report and reassured that there would not be disciplinary action taken if an error was reported. The first concern about an event is to provide the needed patient care and second, to investigate the cause of the event. This leads to systems thinking, where the focus is on harm and processes, not on blaming the care provider.

Safety briefings with employee feedback is another tool we used at St. Joseph’s to encourage knowledge of safety concerns. The patient safety officer and executives make rounds on a routine basis. During these rounds, staff members are asked:


  • What have you seen today that caused harm?
  • What have you seen today that could cause harm?
  • What did you have to do today to prevent harm?


Feedback is provided monthly to staff on the status of concerns they have shared during rounds. Staff members serve on Unit Councils to identify and address safety concerns specific to their area. This involves staff in development of processes to resolve safety concerns. Recently, a safety hotline has been established as another mechanism to promote reporting of safety concerns.

Physician Involvement
Physician engagement is crucial to any performance improvement project. The buy-in and cooperation of the medical staff will hasten efforts and the success of the changes or revisions. To involve physicians, we took the following actions:


  • Patient safety is a standing agenda item at all medical staff meetings.
  • Safety briefings and feedback are provided to communicate identified concerns and resolutions.
  • Monthly updates of project improvement projects.
  • Root cause analyses include physician input.
  • Human factors are included in peer review.
  • Expectations and goals of the organization are shared.
  • Efforts are made to obtain input while being mindful of the physician’s time.


The following are some examples of physician input into our safety projects:


  • Ad-hoc team developed process and protocol for peri-operative beta blockade.
  • Anesthesiologists developed epidural protocol.
  • Pediatricians requested a medication safety brochure for their offices.
  • Internists and CV surgeons assisted in development of IV insulin infusion protocol.
  • Medical Executive Committee approved a surgical antibiotic prophylaxis protocol.


The Patient’s Role
Patients also have a responsibility to be involved in their care and can be an asset in promoting safety. Patient input is obtained through satisfaction survey questions regarding safety. A poster hangs in each patient room, encouraging the patient and visitors to check that staff is verifying patient identification prior to medication administration or completion of procedures, to ask the staff if a medication looks unfamiliar, and to empower them to encourage hand washing. A brochure about medication safety is given to all new admissions and is distributed by physician offices. Recently, a community-wide project was started to promote a consistent tool for patients to create a current medication list. A patient education channel is available in the hospital 24/7 with information about diseases, physicians, and more.

Medication Reconciliation
Medication reconciliation is key to reducing adverse drug events. It is a process of creating an accurate list of all the medications a patient is taking and using this list as a resource when providing care in any setting. It requires comparing the patient’s list of current medications against the physician’s admission, transfer, and discharge orders. Medication reconciliation provides the following advantages:


  • Accurate comparison of home medications to those ordered during hospitalization.
  • Promotes continuity of care between different levels of care.
  • Prevents the wrong dose, route or frequency from being prescribed.
  • Prevents important medicines from being omitted.


In the medication reconciliation process, the medication history is completed and is compared with admission medication orders. Transfer reconciliation is conducted when the patient moves to a different level of care, and discharge reconciliation compares the medicines ordered during hospitalization with those ordered for use at home. Variances between medication history and hospital orders are clarified with the physician. Current home medications, over-the-counter drugs, and herbals are included on the medication list and include the dose, route, frequency, and time of the last dose. This information can be obtained from the patient or family, the patient’s pharmacy, from previous medical records, from the primary care physician’s office, or from the patient’s medication bottles. Obtaining a “perfect” list may not be possible and should not delay this process. Barriers to obtaining a list include:


  • Complexity of communication — interruptions.
  • Accountability — staff too busy.
  • Lack of teamwork — office does not have updated list or nursing home list is confusing.
  • Patient brings in incorrect list.
  • Patient does not take what is marked on the bottle.
  • Patient does not know names of meds.
  • Patient is unable to communicate with staff.



A second key process in our ADE reduction efforts was the completion of failure modes effects analysis (FMEA) on the ordering and dispensing phases of the medication administration process. During an FMEA, sub-processes are flowcharted, and the point of failure is identified as well as the frequency, probability, and severity of each failure mode. A subjective number is assigned to each point of failure. This provides a mechanism to prioritize change or improvement efforts. Some of the changes we made, which reduced the dispensing FMEA score by 70%, were:


  • Pharmacy reduction/standardization of unit stock medications.
  • Pharmacy preparation of all non-standard doses.
  • Labels on all IV pumps encouraging caution when stopping the pump to make rate or dose/changes.
  • A matrix called the IV Drug Administration Reference directs dosages, guidelines, and monitoring information.
  • Installation of an automated dispensing system.
  • Renovation of nursing and pharmacy workspaces to improve process flow and efficiency.


The same process was followed with the ordering phase of medication use. The FMEA score was reduced by 40%. Changes included:


  • Peri-operative beta blocker protocol initiated.
  • Surgical prophylaxis antibiotic protocol was developed.
  • Pharmacists were assigned to a nursing unit/enter orders.
  • Renal dosing review based on creatinine clearance.
  • Abbreviations — unapproved abbreviations are on orders sheets.
  • Illegibility — pharmacists call with any question of the order.
  • Read-backs — nurses read back 95% of all telephone orders and sign with “TORB” or telephone order repeat back.


Multiple changes were made to address high-risk medications, including:


  • Standardized heparin nomogram.
  • PCA protocol with default orders.
  • TPN protocol.
  • IV insulin infusion protocol.
  • Chemotherapy order set.
  • Coumadin dosing service.
  • DVT assessment and intervention protocol.
  • Review of all INRs above 4 to identify opportunities in dosing regimens.
  • Renal dosing program.


Medical simulation was also used to reduce the occurrence of ADEs. Through leadership support and an emphasis on safety, we were able to purchase “Sim Man,” a computerized manikin that uses either “canned” or created scenarios for staff training. Depending on staff response, the condition of “Sim Man” will either improve or deteriorate. This tool is used to sharpen staff skill, competence, and confidence in a safe setting rather than through the use of a “real” patient. A simulation lab was created where staff can observe a simulation and review the videotape of the simulation for debriefing purposes. Simulation is used for clinical orientation for RNs, LPNs, unit secretaries, and certified nurse assistants for annual skills validation and for root cause analysis. All staff members, including medical staff, are encouraged to use the simulation lab.

Root cause analysis (RCA) is used to investigate causative and contributing factors in events. Although RCA is time consuming and labor intensive, it has proved invaluable in understanding process failures. Human-factor triage questions have been incorporated into the RCA tool, which has been approved and applauded by JCAHO. Initially staff members were hesitant to speak freely in the RCA process. Continued encouragement and assurance that this process is non-punitive and used solely for learning purposes has helped to overcome this hesitancy. Currently, staff members from a variety of departments are requesting RCAs when an event occurs.

SBAR is an acronym that stands for situation, background, assessment, and recommendation. SBAR is a tool used to improve communication between parties. Often the “listener” is not “hearing” what is being said. Also, nurses tend to be narrative and may not get to the point, where physicians are more detailed oriented. To promote the use of this tool, laminated pocket cards including the acronym have been distributed to all nurses. Posters explaining SBAR have been posted in clinical areas and stickers have been placed on phones. Use of SBAR is spreading to non-clinical areas as well as clinical areas for communication of any safety issue, staff concern, email, meeting minutes, staff hand-off, etc.

Finally, team resource management (TRM) is being spread to members in the organization, including medical staff. TRM was adapted from crew or cockpit resource management (CRM), which was developed by the airline industry. TRM improves team efficiency and effectiveness through use of multiple communication tools: SBAR, staff assertion, situational awareness, briefings, debriefings, and red flags. Initial and refresher training was provided to staff members and physicians.

The success of our ADE reduction efforts did not occur overnight. Time and continued effort are needed to pursue the cultural transformation, which is the basis of these efforts. Barriers to change can include limited resources, lack of organizational or leadership support, lack of physician buy-in, resistance to change, starting too big, moving too quickly, reluctance to share safety concerns or a lack of transparency, multiple projects, and the feeling of added work instead of replacement processes.

Some keys to success in overcoming barriers are leadership support, involving the right people, simplifying processes, networking with others, making change a “win-win” situation, using rapid cycle tests of change, rewarding and recognizing staff, building relationships, communicating progress, and reinforcing successes through ongoing feedback.

Kathy Haig ( is a registered nurse and has worked at OSF St. Joseph Medical Center for the past 25 years. During that time, Kathy has worked on the medical unit as an admission/utilization review nurse, risk manager, and assistant director of the Quality Resource Management Department. Currently, Kathy is the director of quality resource management, the risk manager, and the patient safety officer. Kathy has also served as a facilitator for the Institute for Healthcare Improvement (IHI) and the Illinois Hospital Association for Medication Reconciliation mini-collaboratives, as well as for IHI’s Surgical Infection Prevention project.