Patient Safety: A Special Issue -- January 2005
By Ken Ortolon
"First, do no harm."
It is a phrase well known to all physicians. It is a tenet of the medical profession that dates back to Hippocrates, who wrote, "As to diseases, make a habit of two things -- to help, or at least to do no harm."
But an Institute of Medicine (IOM) report in November 1999 suggested that physicians, nurses, hospitals, and other health care professionals were doing harm. The IOM concluded that as many as 98,000 Americans die each year as a result of medical errors in our nation's hospitals.
That report, To Err Is Human: Building a Safer Health System , was highly controversial, and many health care professionals raised objections to the quality of the IOM data and the methodology the group used to reach its conclusions. (A " Constructive Response to the Institute of Medicine Report on Medical Errors" is on the TMA Web site.)
But the report garnered considerable news coverage and brought the patient safety issue front and center on the public stage. Since the report was published, a wide array of organizations (ranging from state and national medical societies to hospital accreditation organizations and the hospitals they govern) and Medicare have focused considerable attention and resources on improving the quality of health care being provided in hospitals and doctors offices and increasing patient safety.
Their goal is to change the culture within the health care system and create an environment of safety. Experts believe the effort is succeeding, although they admit that hard data are not always available to quantify how much improvement is being made.
Getting Off the Dime
The health care industry actually was moving on patient safety issues well before the IOM released its report. Nancy W. Dickey, MD, president of The Texas A&M University System Health Science Center, says groups such as the American Medical Association already had recognized that the increasing complexity of health care delivery was creating opportunities for error.
"The decade before the IOM report was a time of recognizing that there were measurable substantive problems in health care delivery and that the very complexity of modern medicine meant that we couldn't ignore that," Dr. Dickey said. "I think the IOM report gave it a substantive kick in the fanny or push from behind. It made headlines. It was no longer an issue simply talked about by the profession. It was on the public's mind and lips."
In 1996 -- three years before the IOM released its report -- AMA founded the National Patient Safety Foundation (NPSF) to develop a core body of knowledge on patient safety and identify ways to apply that knowledge, says Dr. Dickey, a member of the NPSF board.
Since its inception, the foundation has been involved in a number of initiatives, including its Stand Up for Safety campaign launched in 2002. The program, in which hundreds of hospitals and health systems across the country are participating, provides educational tools and programs, conferences on safety topics, forums for sharing best practices, and materials for internal and external communication.
Another NPSF initiative is a research fellows project for mid- to senior-level hospital administrators. Participating administrators spend a year on a series of research projects, including asking and answering questions about safety issues at their own institutions.
Medical specialty societies also addressed patient safety before the IOM report. Among those is the American Academy of Orthopaedic Surgeons (AAOS), which in 1998 launched a campaign called "Sign Your Site" designed to reduce wrong-side surgeries. The program encourages surgeons in all specialties to mark the operative site as part of their pre-surgery routine.
"Wrong site surgery is not just an orthopedic problem that occurs because a surgeon operates on the wrong limb; it's a system problem that affects other surgical specialties," AAOS said in a 1999 article posted on its Web site. "The academy believes operating on the wrong anatomical site is the result of poor preoperative planning, lack of institutional controls, failure by the surgeon to exercise due care, or a simple mistake in communication between the patient and surgeon."
But the level of attention being paid to patient safety has definitely increased since the IOM report's release. Among the most aggressive organizations is the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Nearly 50 percent of JCAHO's hospital accreditation standards relate directly to patient safety, including issues such as medication use, infection control, and staffing. And, the organization encourages, but does not require, hospitals accredited by JCAHO to report sentinel events.
But the organization imposed additional safety requirements on hospitals in 2001. It implemented similar standards for behavioral health care and long-term care facilities in 2003 and ambulatory care and home care organizations in 2004. Those new standards addressed issues such as the responsibility of hospital administrators to create a culture of safety, the implementation of patient safety programs, the response to adverse events when they occur, the prevention of accidental harm through prospective analysis and redesign of vulnerable systems, and the organization's responsibility to tell patients about the outcomes of care whether good or bad.
Dr. Dickey says informing patients when errors occur may not help prevent mistakes, but it does improve the environment in which care is provided.
"Many of today's physicians were trained in an era when you were told not to ever identify an error -- certainly not to a patient, maybe not to colleagues," she said. "And, in fact, one of the things that research has shown us is the importance of identifying errors in order to then create solutions so the same error doesn't occur in 47 different places."
Star West, director of health care quality for the Texas Hospital Association, says JCAHO is being pretty tough when scoring hospitals on compliance with their new patient safety goals.
"For example, on health care-associated infections, hospitals must comply with the CDC [Centers for Disease Control and Prevention] hand-washing guidelines, and they have to manage as sentinel events all cases of unanticipated death or loss of function associated with a health-care associated infection," Ms. West said. "If JCAHO comes in and sees even one health care worker not washing his or her hands or using [sanitizing] gels, then that can be a ding on their hospital and it can jeopardize their accreditation."
JCAHO recently revised its national patient safety goals and requirements to include measures to avoid the interchange of sound-alike and look-alike drugs, reduce risk of harm from patient falls, and develop a process for obtaining, documenting, and communicating a list of all medications a patient is taking to every health care worker involved in the patient's care. Those new goals and requirements take effect this year.
In March 2004, JCAHO also took on wrong-site surgery. Working with AAOS, the agency developed a universal protocol for eliminating wrong-site surgery. The protocol was created to standardize pre-surgery procedures for verifying the correct patient, the correct procedure, and the correct surgical site. Modeled in part after the "Sign Your Site" initiative, it entails marking the surgical site, involving the patient in the marking process, and taking a final "time out" in the operating room to double-check information among all members of the surgical team.
Cutting Errors of Omission
While the JCAHO standards and other efforts have focused on errors of commission, other organizations have focused their attention on eliminating errors of omission.
Over the past several years, the Centers for Medicare & Medicaid Services (CMS) has worked to make sure that patients receive medications or treatment that is proven to improve patient outcomes. Working through the state quality improvement organizations -- such as the Texas Medical Foundation (TMF) -- CMS ranks states' performance on a number of quality indicators for both acute and chronic care.
For hospitals, 22 different clinical indicators measure performance on such things as administering aspirin on arrival for a patient with acute myocardial infarction, administering antibiotics early for pneumonia patients, and using angiotensin-converting enzyme (ACE) inhibitors for congestive heart failure.
Physician offices are ranked on six indicators involving chronic care issues, such as making sure women get mammograms, patients with diabetes receive lipids tests and annual eye exams, and all elderly patients are offered flu and pneumonia shots.
While these measures may not fit a narrow definition of patient safety, they do address the goal of improving the quality of care patients are receiving. "In a broad sense, they are about patient safety because they are about creating systems that bring about the best outcomes," said TMF spokesperson Karen Leach.
Texas initially ranked extremely low nationally on these quality indicators, coming in 49th in a combined ranking for both the inpatient and outpatient indicators. Adonica Benesh, TMF project manager for hospital quality improvement, says Texas has moved up some but still ranks in the bottom quarter of states.
"Looking at the overall ranking, we may have moved up some, but we haven't made any transformational change," she said.
The problem, says Tara Frease, TMF project manager for physician office quality improvement, is that while Texas hospitals and physicians have improved their performance, so have hospitals and physicians in most other states.
"Hospitals and physicians in Texas have done well," said Kevin Warren, director of quality improvement for TMF. "We can do better."
The CMS quality improvement initiative is about to move into its 8th Scope of Work this year, and much emphasis will be placed on introducing information technology both in physician offices and in hospitals.
"For hospitals, the expectation is that we'll work with providers on the implementation of bar coding or computerized physician order entry systems," said Mr. Warren. "The big kicker for physicians' offices is working with providers in implementation of electronic health records. This goes in support of the national initiative."
President Bush has set a goal of getting the majority of physicians to convert to electronic medical records within 10 years.
The Texas Angle
While all of this is going on at the federal level, much is happening here in Texas to improve patient safety. TMA -- in cooperation with representatives of the nursing, hospital, and pharmacy communities -- created the Texas Patient Safety Alliance. Houston neonatalogist Michael Speer, MD, who chairs the alliance, says the group's mission is to track research, legislation, and advances in patient safety and educate the various stakeholders.
Working through its HeartCare Partnership, TMA also has developed an electronic tool that helps physicians improve their care for heart patients by making sure they adhere to evidence-based practice guidelines. The Texas Department of State Health Services -- working with the American Heart Association, the American College of Cardiology, and other stakeholders -- has launched a similar cardiovascular initiative that stresses use of evidence-based practice guidelines.
Dallas cardiologist Allan Anderson, MD, who has been involved with both projects, says these are important steps to prevent errors of omission.
"Omission, I think, means failure of physicians to adhere to evidence-based practice guidelines," he said. "Tools like HeartCare Partnership and electronic medical records with prompts and guidelines built in certainly are ways to overcome that."
While JCAHO-accredited hospitals are required to report sentinel events and analyze them to prevent future errors, many smaller, nonaccredited hospitals lack the resources to do that kind of analysis.
Josie R. Williams, MD, director of the Rural and Community Health Institute at Texas A&M , has been helping a dozen or more rural hospitals across the state conduct root cause analysis for the past two years. She says root cause analysis shows that medical errors are usually at least partially system problems rather than simple human mistakes.
"When you do root cause analysis, you try to recreate the entire situation and then you try to say what it is in our process that allowed the error to happen," Dr. Williams said. "You usually don't find a who. You normally find three or four events that in and of themselves probably are minor, but when they come together allow an error or a catastrophe."
Among problems recently identified at some of the hospitals she works with are such seemingly minor problems as storing three different sizes of insulin syringes in the same cup in the emergency room, and storing two different doses of potassium chloride -- one 10 milliequivalents and one 40 milliequivalents -- in the same bin and in packages that virtually are identical.
"It doesn't take a rocket scientist to realize that if you're in a really big hurry or you're getting bombarded or somebody's yelling at you to do something, picking out that 10 or 40 [on a label] is a very small difference," Dr. Williams said. "And yet, 40 milliequivalents of potassium when you're wanting 10 might be a critical error."
Dr. Williams says that fixing these types of problems may seem like a simple step, but it requires a change in culture to get nurses, physicians, and hospital administrators to focus attention on them.
"It's not rocket science, but it is does require an understanding that the tiny little process and structural things contribute up to 65 percent of the errors," she said.
Another effort under way in Texas is attempting to see if a "close call" reporting system modeled after that of the aviation industry can be implemented in health care. The University of Texas System received a $7.5 million grant from the Agency for Healthcare Research and Quality to carry out the study. It is led by UT M.D. Anderson Cancer Center and involves nine facilities in Houston's Texas Medical Center.
Sherry Martin, vice president for performance improvement and chief quality officer at M.D. Anderson, says the program will look at "system flaws that are creating an environment conducive to errors."
The project got a slow start because of fear of reporting errors or near misses, particularly among the nursing staff.
"When we started the close call project, we realized that the nurses were really frightened of their own [licensing] board," Ms. Martin said. "Nurses are actually required to turn in one another."
Under Texas State Board of Nurse Examiners (BNE) rules, nurses involved in minor incidents -- including close calls or near misses -- must be reported to the board. If they are found responsible for three minor incidents, they can lose their licenses, Ms. Martin says.
"Now, in reality, there's really very little of that [reporting]," she said. "But it doesn't matter, they're not about to report anything. They're scared to death."
To solve that problem, the UT System persuaded the legislature in 2003 to allow pilot projects to challenge the reporting requirements. M.D. Anderson is finalizing a contract with the BNE that will allow the study to go forward.
When up and running, the chief nursing officer at an institution where a close call occurs will work with a staff nurse and a BNE member to determine whether it was a human error or systems issue. Then a directive will be issued to devise measures to prevent similar events.
"The first question should not be 'Who did it?' It should be 'What happened?' Is this a systems issue that might be masquerading as a practitioner error?" Ms. Martin said. "I think we're moving toward that."
Hospital officials and others say they believe progress has been made on improving patient safety both before and since the release of the IOM report. But they say definitive data are still hard to come by.
"I don't think we have the data to show that yet, and I'm not sure if it's because we don't know how to measure it or if we're not measuring the right things," Ms. West said.
Dr. Speer says there is change in attitude on the part of physicians, hospitals, and others. He says physicians have gotten over the shock of the IOM report and are concentrating on fixing safety problems.
"The medical community sort of got drop-kicked when the IOM report came out," he said. "Most of us didn't know it was coming out, most of us didn't know what it was going to say, and most of us had utterly no idea of the data. It was a shock to many and the immediate reaction was a kneejerk defensive attitude.
"But I think it's come full circle from a knee-jerk, defensive posture to an advocacy posture. We're getting away from the numbers and getting into the essence of what the message is, and that is that hospitals are potentially dangerous places and there are things that one can do to make them less dangerous."
Dr. Dickey says she believes the United States leads the world in addressing patient safety. "I think we've made a good start," she said. "There's still a long way to go."
is can be reached by telephone at (800) 880-1300, ext. 1392, or (512) 370-1392; by fax at (512) 370-1629; or by email at Ken Ortolon.