True Patient Safety Begins at the Top.

Leaders at one large health system rally around safety, avoid blame game

IN THIS ARTICLE...

Making patient safety the No. 1 priority at a hospital or clinic sounds like a easy task. It isn't. At one Oklahoma health system, an improved patient safety program is a massive effort requiring input and participation from every member of the staff. Figuring out how to convince employees that patient safety is their first priority means developing an extensive communication and education program.

MEDICAL ERRORS CARRY high costs-both human and financial.

In human terms, consider not only the suffering for patients and their families but also the impact on health care workers who often get the brunt of blame.

The financial costs are significant. The November 1999 report from the Institute of Medicine (TOM) estimates that medical errors cost the nation approximately $37.6 billion each year.[1] About $17 billion of those costs are linked to preventable errors.

While the IOM report was criticized and its numbers disputed by another recent study, health care organizations still must strive to provide care to patients in the safest manner possible. Since long before the recent public attention, quality of care and patient safety were high priorities in most hospitals, particularly those accredited by the Joint Commission on Accreditation of Healthcare Organizations.

Historical efforts typically included:

* Fall prevention.

* Improvement in medication processes.

* Operative site identification.

* Prevention of hospital-acquired infection.

* Investigation of near misses.

INTEGRIS Health in Oklahoma is working to identify and coordinate expanded patient safety efforts and to sharpen its focus on this large and nebulous subject. To help simplify the complex issue, INTEGRIS developed "A Framework for Approaching Patient Safety."[2]

The framework opens with a vision of:

* Committing to patient safety at all levels.

* Engaging all employees in ensuring the safety of every patient.

* Achieving zero defects in clinical care.

* Becoming a high reliability organization that's preoccupied with the possibility of failure.

* Being perceived as the community leader in patient safety.

According to the experts, leadership is an essential ingredient of success in the search for safety.[3] So our first step in establishing a culture of safety is to be sure that leadership and the entire organization understand the rationale for a focus on patient safety.

Leaders must understand why errors are so difficult to reduce-that health care errors occur as a function of flawed systems, not individuals, and that health care systems are increasingly complex.[4]

This complexity of modern medical care is a major risk factor in medical errors, according to patient safety guru Lucian Leape. "We perform many interventions during hospital care. Each of them presents many opportunities for error. Indeed, the wonder is that there are not many more injuries," Leape said. [5]

However, as Leape also notes, even an error rate nearing perfection can have serious consequences in a modern hospital.

Even if the medication ordering, dispensing, and administration system were 99.9 percent error free, in a hospital the size of INTEGRIS Baptist Medical Center, there might still be almost 5,000 errors a year. If only 1 percent of those result in a serious adverse event, 45 to 50 patients might be harmed. [5]

It's your fault

The reliability of our health care delivery system rests on people, [6] but unfortunately, systems that rely on perfect performance by individuals to prevent errors are doomed to fail. The reason is simple: all humans, even our best and brightest and even our most experienced, make mistakes.

Physicians and other hospital leaders must understand that only when human mistakes are accepted as inevitable will it be possible to shift away from a punitive frame of mind and focus on identifying underlying systems failures. [7]

The traditional approach of fixing blame, imposing discipline, retraining, and writing new policies will not prevent human error. It will stifle discussion and discovery of the causes of error.

Instead, we need involvement at the grassroots level. We need our staffs to speak freely, to talk about errors that happen and those that almost happen. We need them to identify where mistakes are likely and where our systems allow mistakes to get through. They can help us learn where we need to focus our attention.

We have used several models of error to illustrate these issues for leadership, including modified "Blunt End/Sharp End" models and the "Swiss Cheese" model:

In the Blunt End/Sharp End Model, hospitals and their policies, procedures and systems are in the blunt end of this large object pointed at the patient.

Practitioners--physicians and nurses in particular--are at the sharp end, affected by resources and constraints. Most of the time they use their knowledge, training, attention and skill to directly interact with the patient, who benefits from correct diagnoses, tests and treatment decisions and skilled surgeries. Healing occurs.

However, there are times when human frailties come into play at the same sharp end--stress, fatigue, and distraction are among the contributors to human errors. They invite missed diagnoses, misjudgment, treatment errors, or inappropriate interventions sometimes causing harm to the patient.

Blaming individuals at the sharp end--though natural and convenient--has virtually no remedial value.

Hindsight bias--our tendency to judge the quality of a process by its outcome--reinforces our tendency to blame failures on those involved. [8] Blaming only focuses our attention on the least remedial link in the chain of error and leads to ineffective countermeasures such as disciplinary action, retraining and writing new procedures. [9]

Instead, we must focus on our systems and their flaws (latent failures)--"accidents waiting to happen." [7]

According to human error expert James Reason, latent failures are the delayed-action consequences of decisions taken in the upper echelons of the organization (the "blunt end"), such as:

* Design and construction of plan and equipment.

* Structure of the organization.

* Planning and scheduling.

* Training and selection.

* Forecasting, budgeting and allocating resources.

The adverse safety effects of these decisions may lie dormant for a very long time, but latent failures are inevitable. Reason recommends making the system resistant to chance combinations of latent failures, human fallibility and hazards. His "Swiss Cheese" model illustrates how these flaws line up to allow mistakes to get through our defenses and reach the patient.

We must find and try to close these holes in the Swiss cheese by strengthening our system defenses. The goal is to design a system without latent failures and make management decisions with an understanding of where failure is likely.

Systems and processes should make it difficult for staff to make mistakes and easy for them to do things correctly. In other words, we need to 'human-proof' our systems.

What will it take to get there? It will take leadership and commitment, persistent attention and time. It will also take involvement of all our doctors, nurses and pharmacists--a grassroots effort. Caregivers need to understand the issues and know they are not the problem but part of the solution. They must believe in leadership's commitment to this effort, avoiding blame and focusing on our system flaws. We must change our culture to one of accountability without blame--a "just culture."

To begin to accomplish these things at INTEGRIS Health, we are asking all leaders in our organization to commit to patient safety.

* Members of all our boards of directors were educated on safety issues and endorsed our patient safety initiative. They will monitor progress regularly.

* Patient safety is a priority in our strategic plan.

* Management accountability and measures of success for patient safety were clarified.

* A dedicated position of patient safety officer was created.

* A multidisciplinary patient safety steering committee was organized to provide oversight and prioritize issues.

* Patient safety is a priority for each facility's quality program, working in coordination with risk management and existing performance improvement structures and processes.

The starting point 

Establishing and maintaining a culture of safety is a long-term proposition. We are just beginning. Senior leaders are meeting face-to-face with clinical staff on all units to talk about patient safety and their involvement. We need staff to talk about safety, to feel comfortable discussing errors or hazards with colleagues and to report problems without fear of blame.

As we move ahead, our organizations must learn more about errors and potential hazards, improve our reporting systems and gain knowledge about how to create a safer environment.

The ultimate goal is, of course, correction and prevention, which will require more effective analysis and improvement processes.

All of us need to:

* Understand more about human errors and latent failures in our systems.

* Avoid blaming someone when mistakes occur.

* Support our physicians, nurses and pharmacists.

* Lead our hospitals' efforts to strengthen our defenses.

We must help our medical staffs understand their responsibility to improve communication with other members of the care team, ensure that their orders are written or stated clearly and that their intentions are well understood. Administrative and medical staff physician leaders play a critical role in improving patient safety.

James P. White, MD, is chief medical officer and managing director for medical affairs at INTEGRIS Health, a health system headquartered in Oklahoma City. Certified by the American Board of Internal Medicine, White practiced full-time from 1981 until January 2001, when he became the CMO. He still maintains a part-time practice. Leading the patient safety effort for INTEGRIS is currently his first priority.

Susan D. Ketring, MSM, is vice president for quality and medical staff services at INTEGRIS Health. Ketring is a biostatistician and helps to lead the patient safety effort while overseeing the organization's quality efforts, medical staff support functions and accreditation activities.

References

(1.) Kohn, L.T., Corrigan, J.M., Donaldson, MS. (Ed.) (1999), To Err Is Human: Building a Safer Health System, (p. 1), Washington, DC: National Academy Press.

(2.) White, J.P., and Ketring, S.D. (2001) Framework For Approaching Patient Safety, Oklahoma City, OK: INTEGRIS Health.

(3.) Leape, L.L., and Berwick, D.M. (2000) Safe health care: are we up to it?, British Medical Journal. Vol 320, 18 March 2000, pp. 725-726.

(4.) van Leeuwen, D, Cholewka, PA., and Grube, JA. (2001) Do no harm, Journal for Healthcare Quality, Vol 23, No. 1, January/February 2001, p. 2, 24.

(5.) Leape, L. L. (1994) The preventability of medical injury, In M, S. Bogner (Ed.), Human Error in Medicine, (pp. 13-25), Hillsdale, NJ: Lawrence Erlbaum Associates.

(6.) Van Cott, H. (1994) Human errors: their causes and reduction, In M. S. Bogner (Ed.), Human Error in Medicine, (pp. 53-66), Hillsdale, NJ: Lawrence Erlbaum Associates.

(7.) Leape, L. L. (1999) A systems analysis approach to medical error, In M. Cohen (Ed)., Medication Errors, (pp. 2.1-2.13) Washington DC: American Pharmaceutical Association.

(8.) Cook, R.I., and Woods, D. D. (1994) Operating at the sharp end: The complexity of human error, In M. S. Bogner (Ed.), Human Error in Medicine, (pp. 255-310), Hillsdale, NJ: Lawrence Erlbaum Associates.

(9.) Reason, J. T. (1994) Foreword, In M. S. Bogner (Ed.), Human Error in Medicine, (pp. vii-xv), Hillsdale, NJ: Lawrence Erlbaum Associates.

Safety Program Requires Staff-wide Effort

James P. White

"Our staff helped us identify multiple 'accidents waiting to happen'."

At INTEGRIS, we talk with clinical staff about human proofing when we meet face-to-face to engage them in our culture change. Since February, about 750 caregivers have been involved in these meetings in our two large metropolitan facilities.

At our meetings, we discuss avoiding blame, looking for "accidents waiting to happen," and the importance of effective communication.

We show a video, "Beyond Blame," and talk about how the medical accidents in the video could be prevented with system fixes. Examples from the video include restricting access to concentrated potassium chloride and other dangerous drugs, and improving medication labeling.

We also tell stories of our own. We talk about a series of mistakes that occurred in one of our own facilities, how these mistakes led to an error and how the error might have been prevented.

The staff's reaction is generally positive, although some are skeptical. Staff members are sobered by the video. They're aghast when we tell some of our stories. Our staff has seen many programs come and go. To gain their confidence, we must be effective in making change and really improving patient safety.

As part of our staff meetings, we administered a survey to assess the current thinking about medical errors, reporting and blame. We will re-administer the survey later to determine the effectiveness of our efforts to change the culture.

Our staff helped us identify multiple "accidents waiting to happen." An anesthesiologist at one of our large hospitals brought us a list of safety issues immediately after hearing our presentation. Interestingly, several of the items on his list represent conflicts created by stringent interpretation of JCAHO's standards on control of medications.

A nurse reported four identically packaged suppositories--all with very different effects--located in the same compartment in a dispensing machine. The solution to this one was fairly easy. A greater challenge is to disseminate concerns and solutions throughout all of our hospitals. Many such system flaws were identified as a result of our discussions.

Human proofing is complex. Our clinical information system has decision support capability, so we create rules and dosage range modules to help us protect patients from medication errors.

For example, after a near miss involving a neuromuscular blocker we developed a computerized rule to alert caregivers if an order for a neuromuscular blocker is placed without an active ventilator order.

As we learned more about our medication processes and information systems, we recognized several challenges:

1. It's important to have complete information entered into the computer so that rules and dosage range modules work. We consistently have difficulty with availability of height and weight information.

2. We also need enough programmers to create our rules and dosage range modules.

3. We must find ways to discourage short cuts--working around the safeguards in the system for the sake of expediency. At the same time, we need to make the information system user-friendly so that users are not tempted to take short cuts.

In April, the patient safety steering committee for our Oklahoma City facilities met and designated task forces to address several high priority issues, including two medication processes for which the goal is zero defects.

In May, we rolled the patient safety effort out to our rural facilities, where the challenges are different--fewer resources, less computerization, different cultures. Our work involves:

1. Keeping patient safety highly visible and demonstrating progress in our implementation.

2. Getting staff to think about safety and feel like they are seeing effective solutions to real safety issues. We want them to continuously look for accidents waiting to happen."

3. Sorting through, prioritizing and resolving the myriad safety issues that we identify with our staff's help.

4. Developing effective mechanisms for communicating safety solutions and making sure they are implemented in all of our facilities.

5. Figuring out how to measure success in a meaningful way. We developed a patient safety scorecard as a first step.

While pleased with our progress, we are anxious to keep it moving forward. We want everyone in the organization to be as passionate as we are about the safety of our patients. There is nothing more important.