Introduction
In response to the Institute of Medicine report, To Err Is Human, that medical mistakes kill 98,000 patients each year, healthcare facilities throughout the country were given a wake-up call to evaluate the safety of their environment and processes that touch each of us at some time in our lives. To this end, OSF St. Joseph Medical Center began their journey towards a cultural evolution of making patient safety a priority.
OSF St. Joseph Medical Center is one of six facilities operated by OSF Healthcare System. The hospital is licensed for 165 beds and is a non-profit facility that serves a community of 110,000 in central Illinois. The facility provides open-heart services, including the "Beating Heart" program since 1999, is licensed as a Level II Trauma Center, has an Urgent Care Center and five hospital-owned physician office practices.
With culture defined as, "The predominating attitudes and behavior that characterize the functioning of a group or organization", a comprehensive redesign of the culture and care systems was initiated to reduce the potential rate of harm to patients. In evaluating areas for improvement, reduction of events involving medications was identified as an opportunity that impacted the largest population of patients. Flowcharting of the medication process proved it to be complicated, labor intensive and involving multiple caregivers from the time the order is written until the patient receives the medication. Common sources of errors include unavailable patient information, unavailable drug information, miscommunication of medication orders, problems with labeling or packaging, drug standardization, storage, stocking and process flaws.
To facilitate improvement in this project, OSF St. Joseph Medical Center entered into a collaborative with the Institute of Healthcare Improvement (IHI) as one of 50 international hospitals to participate in a program addressing Reduction of Adverse Drug Event’s (ADE’s). Leadership provided both human and financial resources to participate in the year long collaborative. A team of early-adopters representing administration, medical staff, nursing and pharmacy was established. This core group was sent to three, two-day training sessions provided by the IHI. Aims and goals were established including maintaining a cultural survey score above 4, use of the medication reconciliation process, reduction in the Dispensing Failure Mode Effect Analysis and reduction of events occurring with high-risk medications.
Adverse Drug Events
Reduction of Adverse Drug Events is the result of multifaceted changes in process. An initial review of twenty medical records selected at random using an ADE trigger tool provided by the IHI indicated our rate to be 5.8 ADE’s per 1000 doses dispensed. The same methodology and trigger tool continues to be used to monitor monthly progress in reduction of the ADE rate.
In order to measure ADEs, one must be aware of when these events occur. As the team perceived the incident occurrence report to be only the "tip of the iceberg" in identifying events, an ADE Hotline was established.
This provided another mechanism for staff to anonymously report a medication event. The information provided includes the date of the event, patient name, medication involved, and the nature of the event. As the Hotline is located in the pharmacy, a pharmacist checks the Hotline daily for reported events and proceeds with an investigation into potential causes. This is a "win-win" situation as the event is identified for evaluation and trending, and the staff can report easily, quickly, anonymously and save time by avoiding paperwork associated with completion of an occurrence report.
Our ADE rate has improved from 5.8 per 1,000 doses dispensed in June of 2001 to 0.50 per 1,000 doses dispensed in May of 2003, thus achieving a ten-fold reduction.
A key tool used in the reduction of ADE’s is the medication reconciliation process. There appears to be a direct correlation between use of the reconciliation process and the ADE rate. This hypothesis arose when a slight increase in the ADE rate was noted with decreased usage of the reconciliation process immediately following implementation of a computerized medical record. Medication reconciliation is the act of comparing the medications the patient has been taking with the medications currently ordered. This allows the caregiver to identify medications that may need to be continued/discontinued or require dose/frequency adjustments based on the patient’s changing condition. The comparison is conducted in three phases: admission, transfer and discharge. On admission reconciliation, the home medications are compared to the initial physician orders; on transfer reconciliation, the meds the patient was taking are compared from the previous nursing unit to the orders on the current unit; and discharge reconciliation compares all current meds taken in the hospital with those the physician orders for the patient upon discharge. Any variances between the two lists should be "reconciled" by the nurse or the pharmacist with the physician within four or twenty-four hours depending on the type of medication. By adding a physician signature line, this tool can also save staff time and potential transcription errors by serving as the physician order sheet.
Admission reconciliation usage is ranges from 85-95 percent, transfer reconciliation is at 70 percent and discharge reconciliation is at 95 percent.
As standardization of orders is believed to be an important factor in reducing variance, Pharmacy Based Services and Order Sets has aided efforts in reduction of ADE’s. To address high-risk medications, a single, weight-based Heparin Nomogram was developed and is used throughout the medical center.
Additionally, both inpatient and outpatient Coumadin dosing services are offered by the pharmacy. A Patient Controlled Analgesia (PCA) order set is used 93 percent of the time in pain management and offers default doses on selected medications.
A TPN Order Set and dosing service is used 100 percent of the time. Renal Dosing Services are conducted on all patients having a creatinine clearance of less than 50 ml.
One of the most popular changes is the availability of pharmacists on the nursing units to review and enter medication orders. This provides the double benefit of saving nursing time in addition to providing the pharmacist a first-hand look at the orders to identify potential dosing errors, drug interactions, etc. Because of these efforts, the Ordering Failure Mode Effects Analysis hazard vulnerability score has decreased from 157 to 103 for a 34 percent reduction.
The Dispensing Failure Mode Effect Analysis score has been reduced a total of 66 percent in the past two years as a result of multiple action steps. Medications of discharged patients are retrieved hourly as pharmacy techs make their rounds to deliver medications. Nursing unit stock medications have been reduced by 45 percent, adult IV medications have been standardized, and all non-standard doses are prepared by the pharmacy. An IV Drug Administration Reference matrix directing dosage, guidelines and monitoring information has been developed for nursing staff. The pharmacist compares lab values to orders to identify potentially inappropriate dosing. Anesthesia staff has contributed to reducing potential dispensing events by assisting in standardization of epidural-safe pumps with use of colored tubing. Automated medication dispensing machines are scheduled for implementation November 5, 2003.
Cultural changes
To promote Patient Safety throughout the environment, safety must be a priority in the culture of the organization. To measure the cultural climate of the staff, cultural surveys were conducted every six months to determine the willingness of staff to report. The survey was obtained from the Institute for Healthcare Improvement and is a modified version of the Brian Sexton/Robert Helmreich Aviation cultural survey. Respondents include ten percent of each hospital and medical staff. The survey includes nine statements using a Lichert scoring scale from one to five indicating agreement or disagreement. The survey is used as a tool for measuring the effectiveness of promoting a non-punitive culture of reporting safety concerns. Survey results in the first year improved from a baseline score of 3.96 to 4.28 from a maximum score of five.
One of the lessons learned from the cultural survey is that changing the culture is a very slow process. We are currently testing a new survey tool that addresses teamwork concepts as well as attitudes regarding the safety culture of the organization and will conduct them annually.
One of the first steps in our journey to establish a culture of safety included the development of a non-punitive reporting policy that encourages self-reporting of an adverse event without fear of reprisal.
Ongoing education is provided in annual and new orientation sessions to communicate the importance of reporting for two primary reasons: first, to provide immediate and appropriate care to the patient; and second, to evaluate the process with the intent of reducing the potential for error. It is our belief that errors are unintentional and the result of poor systems or processes, complicated by human factors.
One of the most valuable tools in promoting the culture of safety has been the use of Safety Briefings. Safety Briefings is short meeting with staff to raise awareness and identify concerns witnessed by front-line staff. In these brief, five to ten minutes meetings, staff is asked what they have seen that DID cause harm, COULD cause harm, or steps taken to PREVENT harm. Over the past year, safety concerns involving process, equipment, medication, etc. have been identified from both clinical and non-clinical areas and have ranged from simple hazards to serious clinical issues. The Patient Safety Officer assigns the reported issue to the appropriate personnel for investigation and resolution. A summary of the issue and the resolution is provided monthly to management team and front-line staff to present feedback.
Physician and Patient Involvement
To involve the physicians as partners in the culture of safety, Patient Safety has been added as a standing agenda item in all Medical Staff quality meetings. Feedback of safety concerns identified through Safety Briefings and results of any root cause analysis of near misses is also shared with Medical Staff in their quality management meetings.
Root Cause Analysis of near misses includes input from physicians directly involved, as well as input from associated departments, committees, or sections. To promote the belief that events are the cause of poor processes, human factor components including communication, environment, staffing, equipment, competency, etc. have been incorporated into the Medical Staff peer review process. This has been instrumental in trying to eliminate a perception of "blame" in evaluation of clinical concerns.
Multiple cycles of improvement have been taken to involve the patient in their safety. Interviews are conducted with ten patients monthly and include questions pertaining to staff and physician concern, education provided about medications, needs being met promptly and the safety of the environment. Questions pertaining to patient safety from the hospital patient satisfaction survey are also used to identify those areas scoring highest in order to share their approaches or "best practice" with other areas throughout the facility. Each new inpatient admission is given a Medication Safety Brochure that provides tips to the patient, as well as a form to list their current medications. This form can be removed from the brochure to carry with them, thus enabling availability of medication information for the physician or consultants the patient may see. These brochures have also been distributed to physician office practices and are place in waiting areas throughout the medical center.
Information is provided to patients that recognizes the patient’s responsibility as an active partner in the safety of their care. A poster has been placed in each room reminding the patient to check with staff if they are given an unfamiliar medication, to ensure they have an armband and to promote the importance of handwashing by staff and visitors.
Care conferences involving patients, family, physicians and hospital staff are another means of gaining the patient/family perspective of their care and opportunities for improvement. Other tools include a patient accessed TV channel that provides information about multiple medical conditions and use of the Community Board in a dual role as the Patient Advisory Council.
Other Tools
One concept that has proved to be a valuable tool in establishing proximal causes of an event is the use of Root Cause Analysis (RCA). Incorporation of human factor components into the RCA tool has assisted in promoting a non-punitive culture as staff and physicians observe the depth of the analysis and how contributing factors can ultimately impact a process. Root Cause Analysis has led to improved processes by identifying the need for additional rapid sequence intubation equipment in the ED/Trauma setting, adjustment of software protocols for CT scanning, tests conducted in evaluation of spinal neurosurgical cases, changes to dosing parameters and intubation practices in pediatric emergencies and enhancements to provide MRI safety.
Simulation is a mechanism used to recreate quality concerns, investigate process failures, complete an RCA, and identify failure modes. In their commitment to promote safety, leadership approved the purchase of a simulation manikin. A simulation lab was developed to imitate a hospital setting and includes video equipment to tape the simulation for the "debriefing" process that follows every exercise. While avoiding risk to actual patients, the simulation lab allows practice in team and rapid response; evaluation of critical thinking, assessment and technical skills and the ability to "visualize" and learn from errors through the debriefing session. The manikin software allows educators to use either "canned" scenarios or to program a scenario that mimics a real event. Based upon the reactions of the staff in the simulation exercise, the manikin’s condition can either improve or continue to deteriorate. Simulation with the manikin is used in clinical orientation of new employees and for skills validation of current employees. Use of this tool is expected to improve the quality of clinical training and to reduce the length of the learning sessions.
Team Resource Management is a technique commonly called "Crew Resource Management" that has been used by the airline industry for several years. This tool promotes staff assertion, briefings and situational awareness among team members to improve the communication, efficiency and effectiveness of teams. Examples of teams impacted by TRM are the ED, OB and OR staff. A training module for TRM has been developed and will be presented to the ED staff in November 2003.
Surgical Safety
In April 2003, efforts in Patient Safety moved to Surgical Site Infections and later, to Surgical Safety. The overall aim is to reduce Periop Adverse Events by 50 percent in this coming year.
Initial efforts focused on a Surgical Site Infection Prevention Bundle. This incorporated using an appropriate prophylaxis antibiotic and ensuring the prophylaxis antibiotic is infused within 60 minutes of the incision. The team developed a Prophylaxis Antibiotic Order Protocol noting the most effective antibiotic depending on the type of procedure being performed. A FMEA of the PreOp process revealed opportunities for improvement and standardization in obtaining the appropriate lab work and the prophylaxis antibiotic order. To this end, the team incorporated the Prophylaxis Antibiotic Order Protocol into a PreOp Order sheet based on procedure type. This order sheet is currently being tested with the third group of surgeons and revisions to internal pre-admission processes are also being tested. Changes in process to insure the antibiotic is given in a timely manner (within 60 minutes of incision) include the Pharmacy sending the antibiotic to the Pre-op Holding Area, the Pre-op Holding staff hang the IV antibiotic mixture, and finally, the OR Circulator starts the IV antibiotic mixture. The team is investigating using IV antibiotic in syringes for "push" administration and working with Anesthesia staff to identify if they should be administering the med rather than the circulator. The OR staff notifies the unit nurse of when to start administration of Vanco and/or Tequin as these meds should be started within 1-2 hours prior to the incision.
A second piece of the SSI Prevention Bundle includes normothermia or maintaining the patient’s body temperature of 36 degrees upon arrival to the PACU. To achieve this goal, Baer Huggers are available for use in every OR room, warming blankets are used, IV and irrigation fluids are warmed, the OR room temperature was increased 4-5 degrees and insulated head covers are being purchased for patients weighing 50-60 Kg.
The third component of the SSI Prevention Bundle is to increase the FiO2 of the patient to 80 percent for 1-2 hours postoperatively. A Selected population was defined as patients with general anesthesia and the procedure lasts for more than one hour. Non-rebreather masks are used on that population to increase the FiO2. Scripting noting the benefits of this practice in preventing infection is encouraged by PACU staff when the patient complains about the non-rebreather mask. Following this action, the PACU staff noted a decrease in the amount of narcotics required in the PACU particularly in neurosurgical cases. The Neurosurgeons have changed their standing orders so that all craniotomy patients have a non-rebreather for 3 hours post op as they believe the increased FiO2 reduces nausea and vomiting.
Development of a Periop Beta Blocker Protocol has resulted in no occurrence of periop MI’s for over 257 days and has realized an unexpected benefit of reduced narcotic usage in the PACU in those patients receiving a periop Beta Blocker.
Other actions taken to date for Surgical Safety include testing 2 types of clippers to eliminate shaving, testing an Insulin Drip Protocol for tighter hypoglycemic control of diabetic CABG patients, development of a policy and performance of surgical pauses to insure the correct surgical site, purchase of fire blankets, competency testing of OR fire safety for all staff, simulation of fire drills in the OR, revision of the OR process regarding light sources for prevention of fire, implementation of a "no artificial nails" for all caregivers to reduce the potential for infection, and development and testing of a DVT Prophylaxis Protocol. In addition, 20 charts will be selected at random for review using a Perioperative Adverse Event trigger tool.
(Permission must be obtained from the IHI for provision of the Perioperative Adverse Event Trigger Tool. )
Infection Control
Several changes are being made to prevent infections from a variety of sources. Ventilator Bundles are being used to prevent complications associated with ventilator management. These bundles include raising the head of the bed 30 degrees, awakening the patient daily, and use of both DVT and Peptic Ulcer Disease prophylaxis. These four components are to be completed simultaneously for each day the patient is on a ventilator. Data is not yet available as to the impact of this practice.
To assist in the fight against infection, alcohol gel dispensers have been installed in each patient room and in public areas such as wing rooms, the cafeteria, etc. Posters have been developed to remind staff and physicians, but also to educate the public in the importance of handwashing in prevention of infection.
Coated urinary catheters and antibiotic impregnated lines are being used to prevent device infections. To reduce the transmission of MRSA, selected populations of patients, i.e. transferred from another facility, admitted from a nursing home, admitted into ICU, are being screened. Positive screening for MRSA results in initiation of MRO (Multi-Resistant Organism) isolation that mandates the use of gown, gloves and masks in addition to special cleaning techniques. Outcome data collection is in the early stages.
Lessons Learned
As with any change, barriers have been encountered. Some of the barriers include resistance to change, multiple projects, and starting too big. An important lesson we learned that technology in itself, is not the solution to all problems; but instead, seems to highlight poor processes.
Keys to success include leadership support through their visibility and communication of safety as a priority, as well as emotional and financial support for safety projects. Administrative participation was also helpful in promoting safety efforts through their reinforcement of expectations when progress was sluggish. We found using "tests of change" provides some early successes that serve to motivate staff to push forward. Tests of change can best be described by trying a solution on a very small basis, i.e. one patient of one physician for one day. This allows the staff the opportunity to analyze the test, make adjustments and retest on a slightly larger scale.
Other keys to success include making the resolution or change a "win-win" situation in order to gain staff and physician buy-in. Providing feedback of progress and rewarding success also serve to motivate teams. Sharing strategies with others is helpful as it prevents time being spent on solutions that others have tried and found to have failed.
Within our system, the following saying in regards has been created, "Safety is like peeling an onion; the more you look, the more you find, and each layer makes you cry."
