AHRQ Innovations Exchange | Patient Safety Alert System That Uses Principles From Auto Manufacturing Increases Reporting and Improves Safety in a Medical Center

Patient Safety Alert System That Uses Principles From Auto Manufacturing Increases Reporting and Improves Safety in a Medical Center

Snapshot
Summary
Virginia Mason Medical Center instituted a patient safety alert system that requires all staff who encounter a situation likely to harm a patient to make an immediate report and "stop the line" (i.e., cease any activity that could cause further harm). Reports are received and assessed by a patient safety specialist, who decides patient safety is at risk, based on factors including the likelihood of harm and probability of recurrence. The patient safety specialist immediately notifies the accountable leadership and launches an investigation, with the goal of correcting the problem or faulty process as quickly as possible. As a result of this system, a culture of safety and reporting has emerged in which many more safety problems are identified and efficiently addressed; patient safety has increased; and potential claims are detected earlier, leading to early resolution when appropriate.

See the Results section for updated evaluation data on error reporting, processing, corrections, and claims (updated May 2009).
begin doxml
Developing Organizations
Virginia Mason Medical Center

Virginia Mason Medical Center is located in Seattle, WA. end dobegin pp
Patient Population
Geographic Location > City


What They Did
Problem Addressed
Medical errors are a common problem in medical centers, due to the complexity of contemporary health care, human error, and other factors. Medical errors cause unnecessary injuries, illnesses, and death, and they also contribute to the high cost of health care:
Common problem with severe consequences: In 1999, the Institute of Medicine estimated that 44,000 to 98,000 people die in medical centers each year as the result of medical errors.1 In 2004, an independent quality health care company estimated that the number of such deaths was 195,000.2 Preventable medical accidents cost the United States $17 to $29 billion a year.3
Reluctance to report: Medical center employees often fail to report problems and errors because of fears of retribution and because the culture of blame creates the presumption that errors occur because of incompetence. In addition, the hierarchical culture discourages subordinates from pointing out the mistakes of more powerful colleagues.3
Delays that make problems difficult to address: Ideally, medical centers should fix error-prone processes as soon as possible, but conventional tools for quality improvement tend to be slow and inefficient. At Virginia Mason Medical Center, like many other medical centers throughout the country, it often took months or more to review and address quality incident reports, a delay that made it hard to understand all the facts and root causes that led to the original problem.3
Culture of secrecy: At many medical centers, a culture of secrecy limits knowledge of medical errors to as few people as possible. Before instituting the patient safety alert system, Virginia Mason Medical Center did not broadly apply safety lessons, and the organization had no clear sense of which processes were broken or dangerous. The long delays and lack of feedback contributed to the prevalent cultural belief that a certain frequency of medical errors was inevitable and tolerable.3
Description of the Innovative Activity
Virginia Mason Medical Center uses a patient safety alert system that is modeled after a Toyota manufacturing plant at which any employee can stop the assembly line if he or she sees a problem that might affect product quality or worker safety, and the line does not restart until the faulty process that led to the problem is identified and corrected. Key features of the patient safety system include:
Reporting system: Any employee who encounters a situation that he or she believes is likely to/may harm a patient is required to make a report to the department of patient safety immediately, using a 24-hour hotline or an online reporting system. Such reports are known as patient safety alerts. Staff members involved in the incident must cease any activity that they believe could cause further harm.
Classification system: The investigation process and corrective action begins when an employee files a patient safety alert, which one of four patient safety specialists immediately review and classify. (A patient safety specialist is available 24 hours a day.) The medical center uses a three-tier policy that differentiates between high-, moderate-, and low-risk harm and likelihood of recurrence:
Red: Red patient safety alerts are events that caused or can cause serious harm or have the potential to occur frequently. Red alerts require immediate investigation and resolution within 24 hours. In addition, the accountable executive holds the authority to pull a process, piece of equipment, or staff member offline while investigating the incident to ensure patient safety until the problem is corrected.
Orange: Orange patient safety alerts are events that have a lower, moderate level of risk of causing harm or are less likely to recur. Near misses typically are addressed as orange patient safety alerts but may be handled as red patient safety alerts if there is greater potential harm to patients. Orange alerts require investigation and resolution of the immediate issues identified within 72 hours.
Yellow: Yellow patient safety alerts have the lowest potential for harm. Previously called quality incidents, yellow alerts are usually resolved within 1 week.
Investigation process and corrective action: When a red patient safety alert occurs, the patient safety specialist contacts the accountable senior executive, or the administrator on call if in nonbusiness hours, who helps coordinate the investigation in cooperation with the relevant supervisor (e.g., the chief of surgery for surgical errors, the pharmacy director for pharmacy errors). The executive goes to the scene of the incident to determine whether it is necessary to "stop the line" immediately and/or temporarily or permanently remove the involved staff members from the workforce. The investigative team uses the technique of asking "why" five times to get to the root cause of the problem. Examples of corrective action taken include the following:
After a pharmacist and a nurse both misinterpreted an illegible pharmacy order, leading to patient harm, the medical center developed a step-by-step protocol that eliminates the likelihood of such incidents occurring.
After a newly admitted patient received a color-coded wristband signifying "do not resuscitate" instead of one indicating drug allergies (as a result of a nurse being color blind), the medical center added text to the wristbands.
After an incident in which an oncologist verbally abused a nurse who refused to follow his instruction to start a patient on chemotherapy because the patient's ejection fraction had not been assessed, the medical center placed the oncologist on administrative leave and temporarily suspended his admission privileges. Before reinstatement, the oncologist had to apologize to the nurse, review the literature on relevant chemotherapy standards, agree to complete anger management counseling, and commit to a follow up plan documenting improved behavior.
Other common problems identified and corrected by the patient safety alert process include fatigue due to oncall duties, conflicts between operating room and clinic schedules, and difficulties adjusting to computerized medical systems.
Executive involvement: Senior medical center executives take an active role in the patient safety alert process:
Incident review: The medical center chief executive officer, chief operating officer, and senior vice president of quality (a registered nurse) review each patient safety alert. If the relevant executive does not believe that the incident is a patient safety concern, the chief executive officer and the senior vice president of quality must agree with that determination, and without unanimous agreement the review process moves forward. The senior vice president of quality participates in each patient safety alert review to remove barriers and aid in resolution if needed.
Oversight: The Board Quality Oversight Committee (which includes the medical center's chief executive officer, chief operating officer, and several members of the Board of Directors with expertise in safety issues) closely monitor the patient safety alert system. All red patient safety alerts must be reviewed by the Quality Oversight Committee before closure. Sometimes, the board-level committee sends the executive back to do more work to reduce chance of reoccurrence.
Executive walkarounds: All 28 members of the medical center's executive team walk around the medical center for at least 1 hour a month, talking to patients and all levels of staff. During walkarounds, executives hold question-and-answer sessions and distribute printed business cards to staff that include the patient safety alert hotline telephone number.
Monthly safety meeting: Each month, patient safety alert program staff meet with the Quality Oversight Committee and other senior medical center executives to review errors that occurred the previous month and what actions were taken to correct them. The committee reviews patient safety alert data and specific corrective action plans, holding participants accountable for timely, effective actions. In addition, accountable executives present case studies of actual patient safety alerts.
Documentation and reporting: When a report is made, staff enter each case into a database used for analysis and aggregate reporting, including the following information:
number of patient safety alerts reported, by type and role function
number of days elapsed from first report to resolution
number of staff, processes, and equipment taken offline.
Annual culture of safety survey: An annual culture of safety survey provides the following information:
percentage of staff aware of the patient safety alert policy
percentage of staff who feel comfortable reporting errors
percentage of staff who believe Virginia Mason Medical Center treats patient safety as a high priority
Closing the loop: Once a patient safety alert investigation is completed, the accountable leader contacts the employee who filed the report to thank and inform him or her of the resolution.
Informing patients: In the event of an unanticipated outcome, a physician informs the patient and explains what corrective action is being taken to prevent the problem from recurring.
References/Related Articles
Furman C, Caplan R. Applying the Toyota Production System: using a patient safety alert system to reduce error. Jt Comm J Qual Patient Saf. 2007 July;33(7):376-86. [PubMed]
Contact the Innovator
Cathie Furman, RN, MHA
Senior Vice President, Quality and Compliance
Virginia Mason Medical Center
1100 Ninth Ave.
Seattle, WA 98101
(206) 223-6600
E-mail: cathie.furman@vmmc.org

Did It Work?
Results
The patient safety alert system significantly increased the number of medical problems reported at Virginia Mason Medical Center while reducing the time it takes to resolve them, leading to significant improvements in patient safety:
Increased reporting of patient safety alerts: From the system's inception in September 2002 through September 2007, workforce members, including affiliated care providers and outside groups such as the blood bank, reported 8,112 patient safety alerts. Updated data indicate that between inception and April 2009, workforce members reported 12,713 patient safety alerts. The number of patient safety alerts have risen each year from 100 in 2002 to more than 2,000 in 2005 and more than 3,300 in 2006. Updated data indicate that although reports decreased in 2007 and 2008, reporting has trended upward in 2009, with an average of 259 patient safety alerts filed per month.
Broad safety awareness and participation: The safety system has broad awareness and participation. By 2004, 100 percent of staff was aware of the patient safety alert system. A range of staff members report patient safety alerts: nurses (who reported 44 percent), nonclinical support personnel (23 percent), managers (20 percent), physicians (8 percent), and pharmacists (5 percent).
Quick processing and resolution: Staff processed most reports within 24 hours. The average time until resolution was 33 through 2006 but by 2009 had decreased to 22 days. Investigation of a safety concern through the patient safety alert system often uncovers additional operational improvements needed; therefore, a patient safety alert may stay open longer to ensure that employees can design and implement the necessary improvements. Before the patient safety alert system's implementation, it typically took months or years to correct problems that led to medical errors.
Correction of numerous behavioral and system problems that threaten safety: Fifty-six providers (physicians, nurses, and other health care workers) were taken offline from the system's inception through September 2007; between September 2007 and April 2009, an additional 26 were taken offline. Approximately one-third of these individuals returned to work after appropriate remedial plans were developed; the rest were terminated or left voluntarily. Numerous systems and other problems that threaten safety have been identified and corrected.
Reductions in serious incidents and liability claims: The number of professional liability claims combined with potential claims classified by the hospital as "potentially compensable events" has dropped steadily, from about 129 open cases a month at the outset of the safety system to 72 to 83 each month currently (as of April 2009). The system has also led to a decline in the number of claims filed against the hospital. This has not translated into lower liability costs in every year since the inception of the patient safety alert system, because the average cost per lawsuit has risen in recent years (due to the trend toward larger jury awards). Even so, hospital officials believe the patient safety alert system has lowered the hospital's legal liability, and they are optimistic that over the long term legal costs will decrease.
Evidence Rating (What is this?)
Moderate: The evidence consists of a before and after comparison of key indicators.

How They Did It
Context of the Innovation
Virginia Mason Medical Center is a private, nonprofit organization that includes a 336-bed acute care medical center and a large, multispecialty group practice of more than 480 physicians. Searching for management method ideas, an executive team consisting of the hospital's Board of Directors and 32 administrators and physician executives toured several manufacturing plants in Japan in 2002. Impressed by the efficiency in identifying and solving safety problems at a Toyota plant, the executive team decided to apply Toyota's Production System to the medical center. A key tool of Toyota's Production System is the "stop the line" approach to errors and safety problems. A goal was to create a new culture of safety with three tenets:
It is safe to report mistakes.
When mistakes are reported, they will be corrected.
Those who report mistakes will be praised.
Planning and Development Process
The planning and development process consisted of the following steps:
Reorganization and creation of new role: The medical center consolidated its risk management and quality assessment functions into a newly created patient safety department and created the new role of patient safety specialist. These individuals serve as liaisons to medical center executives, coordinate documentation of analytical tools when needed, review the patient safety alert documentation for completeness, track key performance indicators, and generate and distribute data for the Quality Oversight Committee. Patient safety specialists come from varied clinical practices (e.g., nurses, pharmacists, and laboratory staff).
Development of reporting system: The medical center established the 24-hour telephone reporting hotline. In 2005, an online reporting system was added.
Raising awareness: To make all employees aware of the safety system and how it works, patient safety specialists briefed workers at staff meetings, and medical center executives promoted the safety system during walkarounds. The medical center shared information about patient safety and the patient safety alert system with staff and patients in online and printed newsletters, e-mail notifications, and in several annual reports. Patient safety specialists also shared key safety information at the monthly managers meeting and the monthly professional staff meeting, where they reviewed case studies each month to increase awareness.
Training: The medical center incorporated information about the safety system into the orientation program for new employees. Other training included coaching for physicians and patient safety specialists to ensure that they feel comfortable explaining medical errors/unanticipated outcomes to affected patients and can do so in a way that does not increase the medical center's legal liability.
Resources Used and Skills Needed
Personnel: The patient safety department's staff includes a manager, five patient safety specialists, and a safety coordinator. All other medical center staff members participate as part of their regular jobs.
Resources: Program resources include the 24-hour telephone hotline, the online computer reporting system, and the Web-based database.
begin fsxml
Funding Sources
Funding for the patient safety alert system comes from the medical center's internal operating budget. end fs

Adoption Considerations
Getting Started with This Innovation
Obtain high-level buy-in: A patient safety alert system requires strong support from the medical center's senior management, or it will collapse. For example, if prominent doctors are able to have patient safety alerts stemming from their conduct overlooked because of their reputation or connections, the system will lose credibility, and staff members will become reluctant to report errors.
Prepare to make tough choices: Early on, a medical center implementing a patient safety alert system has to make important definitional decisions about what constitutes a medical error (requiring corrective action) and what is considered an unavoidable complication of patient care. Often, the line is not well-defined. Early decisions will set the tone for future decisions, and, as time goes on, there are fewer difficult calls.
Make reporting easy: To encourage employees to raise safety issues, make reporting patient safety alerts as easy as possible through multiple avenues.
Do not judge patient safety alerts: Employees should not have to worry about someone judging their reports' significance, so avoid questioning them in a skeptical way that will discourage further reports.

Sustaining This Innovation
Be prepared and willing to change practices and processes: Patient safety alert investigations will reveal numerous practices that need improvement, so the medical center should be prepared to devote time and resources to developing safer processes.
Educate nonclinical staff about the system: Because a patient safety alert system brings to light medical errors that previously were kept secret, it is a good idea to spend some time making sure that all staff members understand that mistakes can and do occur, even in a safety-conscious medical center. Pay special attention to staff members who have little or no contact with patients, because they may not understand the day-to-day realities of health care.
Additional Considerations and Lessons
Virginia Mason Medical Center officials believe the patient safety alert system is the single most important tool available for improving patient safety. It provides a quick, timely process for improvement, along with a mechanism for showing employees that their concerns are being heard and taken seriously.
Use By Other Organizations
Several medical centers have consulted with Virginia Mason Medical Center about ways to improve patient safety. However, none currently use a patient safety alert system in the same way that Virginia Mason Medical Center does (i.e., using an across-the-board employee reporting system with the potential to immediately stop the relevant health care process until it is corrected).


Disclaimer: The inclusion of an innovation in the Innovations Exchange does not constitute or imply an endorsement by the U.S. Department of Health and Human Services, the Agency for Healthcare Research and Quality, or Westat of the innovation or of the submitter or developer of the innovation. Read more.
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1 Institute of Medicine. To err is human: building a safer health system. Washington, DC: National Academy Press; 2000.
2 Patient safety in American hospitals: HealthGrades quality study. Lakewood, CO: HealthGrades; 2004. Available at: http://www.healthgrades.com/media/english/pdf/HG_Patient_Safety_Study_Final.pdf
3 Furman C, Caplan R. Applying the Toyota Production System: using a patient safety alert system to reduce error. Jt Comm J Qual Patient Saf. 2007 July;33(7):376-86. [PubMed]


Innovation Profile Classification Patient Population: Geographic Location > City
Stage of Care: Acute care
Setting of Care: Hospital Inpatient - Hospital Type > Tertiary care hospital
Patient Care Process: Active Care Processes: Diagnosis and Treatment > Patient safety; Population Health Processes > Error reporting
IOM Domains of Quality: Safety
Organizational Processes: Organizational culture change; Policies and procedures; Staffing; Training, knowledge management
Developer: Virginia Mason Medical Center


Original publication: April 14, 2008.
Last updated: August 05, 2009.
Date verified by innovator: May 28, 2009.



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AHRQ Innovations Exchange | Patient Safety Alert System That Uses Principles From Auto Manufacturing Increases Reporting and Improves Safety in a Medical Center