Patient safety in the era of healthcare reform

Many would agree that the patient safety movement, defined as a concerted effort in health care to reduce treatment-caused injuries, if not always a well-organized one, began with the release of the Institute of Medicine (IOM) report “To Err Is Human” in late 1999 [5]. Basing its conclusions on work done a decade earlier, the IOM took a clear position that the level of unintended harm in medicine is unacceptably high and that something can, and must, be done about it. It proclaimed for medicine what experts in other fields had long recognized: Errors and harm are far more likely to result from faulty systems than from careless or incompetent people. The IOM laid down the challenge: Launch a major effort to change our poorly designed and harmful systems to make them safe. This concept, that harm results from bad systems not bad people, is literally transforming, since it stands on its head what most of us instinctively believe — that errors result from carelessness or incompetence and that those who make them should be punished so they will be more careful in the future. Physicians and nurses, who have been taught how to “do it right” through long and arduous training, are especially unforgiving of themselves and others when things go wrong. So, it has been a hard sell. Yet, it works. Application of systems theory, particularly the use of human factors concepts, such as standardization, simplification, reducing reliance on memory, to change the processes of care to make it easy to do it right and hard to do it wrong has resulted in some stunning successes. One of the most striking successes has been the work of Peter Pronovost MD, PhD, FCCM and his colleagues at Johns Hopkins Medicine. Pronovost and colleagues completely eliminated central line infections in an intensive care unit by standardizing the process of catheter insertion and working effectively in teams [1]. The generalizability of this approach was later proved in Michigan, where 65 hospitals were able to drive their central line infection rates to zero for more than a year [8]. Less dramatic, but still impressive reductions have been made in medication errors through computerizing prescriptions, the use of bar coding, and elimination of nurses measuring doses of medications. Many hospitals have substantially reduced the rate of falls in their inpatient population by applying systems changes in identifying patients at risk and improving monitoring. But some errors have not yielded readily to systems change, most noticeably wrong-site surgery, and even the most successful systems changes, eg, central line protocols, have not been adopted by all hospitals. Lay observers legitimately ask why, and we have no good answer. Even when systems changes are implemented widely, the results often fall far short of those achieved in pilot studies. A recent multistate study [3] of central line protocol adoption, for example, showed only a 40% drop in infections. While achieving that rate of reduction nationwide would save 20,000 lives, an impressive gain, one can reasonably question why they fell short and suspect that many of the institutions did not really implement the protocol 100% perfectly, 100% of the time. Anecdotal evidence strongly suggests that a similar failure to scrupulously implement timeouts and site identification protocols underlies the disappointing results in preventing wrong-site surgery. These issues are very much front and center for improving safety in orthopaedic surgery, which continues to be dogged with wrong-site errors and wound infections that are particularly disastrous after joint arthroplasty. Another relevant issue that is not typically thought of as a patient safety concern is overuse, the application of a diagnostic measure or treatment that is not indicated. It has been estimated that at least 30% of care is unnecessary or inappropriate, with even higher estimates in some procedures and operations [2, 4]. Assuming that these patients suffer preventable harm at the same 10% to 20% rate as other inpatients, 3% to 6% of all hospital patients suffer preventable harm from receiving care that was not indicated in the first place. It is estimated that 1.2 million patients undergo back surgery annually. If 30% of these are unnecessary, then 360,000 of these patients are also exposed to the risk of errors and preventable harm.