Patient Safety Concern Research Articles

Is there a “July phenomenon” in pediatric neurosurgery at teaching hospitals?

Concern for patient safety, among other reasons, recently prompted sweeping changes in resident work policies in the US. Some have speculated that the arrival of new interns and residents at teaching hospitals each July might cause an annual transient increase in poor patient outcomes and inefficient care. Data were analyzed for 4323 craniotomies for tumor resection and 22,072 shunt operations performed in pediatric patients between 1988 and 2000 in US nonfederal hospitals (Nationwide Inpatient Sample, Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality, Rockville, MD). In-hospital mortality rates, discharge outcome, complications, and efficiency measures (length of stay [LOS] and hospital charges) for patients treated in July and August were compared with similar data for patients in other months. There were no significant increases in any adverse end point for either tumor or shunt operations in July and August. Odds ratios (95% confidence interval [CI]) for outcome of tumor craniotomies performed in July and August compared with outcome for tumor craniotomies performed in other months were as follows: for mortality rate, 0.43 (0.14-1.32); for adverse discharge disposition, 1.03 (0.71-1.51); for neurological complications, 1.00 (0.63-1.59); for transfusion, 0.70 (0.41-1.19). Hospital charges were 0.5% lower (range -6 to 5%) in July and August, and LOS was 3% shorter (range -8 to 3%). Odds ratios (95% CI) for July or August shunt surgery compared with shunt surgery performed in other months were as follows: for mortality rate, 0.96 (0.58-1.60); for adverse discharge disposition, 0.85 (0.66-1.11); for neurological complications, 1.27 (0.75-2.16); for transfusion, 0.81 (0.48-1.37). Hospital charges were 0.2% higher in July and August (range -3 to 3%), and LOS was 3% shorter (range -5 to 0.5%). Although moderate increases in some adverse end points could not be excluded, there was no evidence that brain tumor or shunt surgery performed in pediatric patients at US teaching hospitals during July and August is associated with more frequent adverse patient outcome or inefficient care than similar surgery performed during other months.

Clinical simulators: applications and implications for rural medical education

Medical education has undergone significant changes globally. Calls for the revitalisation of centuries old pathways of learning have resulted in innovative medical curricula. Didactic modes of teaching which involved the learning of copious amounts of facts have given way to curricula that focus on the horizontal and vertical integration of basic and clinical sciences. Increasing concern for patient care and safety has led to a 'gap' between the needs of medical students to acquire necessary psychomotor skills and the safety and wellbeing of the patient. This has resulted in alternate teaching methods that include non-patient based training for the acquisition of clinical skills. The use of computerised, full-sized human simulators provides medical students with the necessary psychomotor and clinical reasoning skills in a realistic learning environment, while remaining risk free to patients. These clinical simulators are powerful learning tools that have applications at all levels of medical education across multiple disciplines, emphasising the multidisciplinary approach required in many medical situations. This article reviews the literature on medical simulation and provides the contextual basis for the establishment of a Clinical Simulation Learning Centre (CSLC) in a rural clinical school in Australia. The educational program, as well as the design, layout and equipment of the CSLC are described, as well as implications for rural practitioners. The CSLC has been a major capital investment in a relatively under-resourced part of regional Australia and has provided opportunities for ongoing education across a range of healthcare professionals in the community.

Patient Safety and Quality Improvement Act of 2005

To review Public Law (PL) 109-41-the Patient Safety and Quality Improvement Act of 2005 (PSQIA)-and summarize key medication error research that contributed to congressional recognition of the need for this legislation. Relevant publications related to medication error research, patient safety programs, and the legislative history of and commentary on PL 109-41, published in English, were identified by MEDLINE, PREMEDLINE, Thomas (Library of Congress), and Internet search engine-assisted searches using the terms healthcare quality, medication error, patient safety, PL 109-41, and quality improvement. Additional citations were identified from references cited in related publications. All relevant publications were reviewed. Summarization of the PSQIA was carried out by legal textual analysis. PL 109-41 provides privilege and confidentiality for patient safety work product (PSWP) developed for reporting to patient safety organizations (PSOs). It does not establish federal mandatory reporting of significant errors; rather, it relies on existing state reporting systems. The Act does not preempt stronger state protections for PSWP. The Agency for Healthcare Research and Quality is directed to certify PSOs and promote the establishment of a national network of patient safety databases. Whistleblower protection and penalties for unauthorized disclosure of PSWP are among its enforcement mechanisms. The Act protects clinicians who report minor errors to PSOs and protects the information from disclosure, but providers must increasingly embrace a culture of interdisciplinary concern for patient safety if this protection is to have real impact on patient care.

Follow-up of Outpatient Test Results: A Survey of House-Staff Practices and Perceptions

Failure to follow up outpatient test results is a potential patient safety concern; however, data about how house-staff physicians follow up on tests are sparse. The authors sought to assess internal medicine house-staff practices and perceptions regarding the follow-up of outpatient tests and identified barriers to timely follow-up. Seventy-five of 111 eligible house staff at a large urban teaching hospital (68%) completed the survey. Seventy-four percent reported they were sometimes unable to follow up on test results, 78% were at least somewhat worried about inadequate follow-up, and 46% stated that they have seen a patient's medical condition worsen due to a delay in test result follow-up at least a few times a year. Barriers to timely follow-up included lack of a reminder system (40%), difficulty accessing results (24%), too many competing demands on time (27%), and uncertainty about who should follow up on results (16%).

Patient Safety in the Office-Based Setting

After studying this article, the participant should be able to: 1. Discern the importance of the physician's office administrative capacity. 2. Recognize the necessity of a system for quality assessment. 3. Assess which procedures are safe in the office-based setting. 4. Know the basic steps to properly evaluate patients for office-based plastic surgery. At least 44,000 Americans die annually as a result of preventable medical errors. Medical mistakes are the eighth leading cause of death in the United States, costing between $54.6 billion and $79 billion, or 6 percent of total annual national health care expenditures. Office-based procedures comprise a 10-fold increase in risk for serious injury or death as compared with an ambulatory surgical facility. This article reviews the literature on office-based patient safety issues. It places special emphasis on the statements and advisories published by the American Society of Plastic Surgeons' convened Task Force on Patient Safety in Office-Based Settings. This article stresses areas of increased patient safety concern, such as deep vein thrombosis prophylaxis and liposuction surgery. The article divides patient safety in health care delivery into three broad categories. First, patient safety starts with emphasis at the administrative level. The physician or independent governing body must develop a system of quality assessment that functions to minimize preventable errors and report outcomes and errors. Second, the clinical aspects of patient safety require that the physician evaluate whether the procedure(s) and the patient are proper for the office setting. Finally, this article gives special attention to liposuction, the most frequently performed office-based plastic surgery procedure. Patient safety must be every physician's highest priority, as reflected in the Hippocratic Oath: primum non nocere ("first, do no harm"). In the office setting, this priority requires both administrative and clinical emphasis. The physician who gives the healing touch of quality care must always have patient safety as the foremost priority.

Cardiac Devices and Electromagnetic Interference Revisited: New Radiofrequency Technologies and Implications for Dermatologic Surgery

As the number of patients with implantable cardiac devices escalates, inadvertent electromagnetic interference (EMI) by electrosurgery carries increasing concern for patient safety. Given the trend for dermatologic care delivery by nonphysician providers, supervising physicians must carefully consider the adequacy of perioperative evaluation in elective or cosmetic settings. Rapidly evolving technology also calls into question potential EMI of new therapeutic modalities (radiofrequency resurfacing, electrochemotherapy, and endovenous ablation). The most recently published recommendations (1998) for care of dermatologic patients with cardiac devices do not differ significantly from guidelines proposed in 1975. These recommendations, based on complications experienced during noncutaneous surgery, are exceedingly conservative and do not take into consideration the different electrosurgical modalities and varying degrees of EMI risk. In addition, modern cardiac devices have evolved significantly with increased sophistication in protection from EMI. A survey of dermatologic surgeons demonstrated low compliance with these existing guidelines. Based on a review of the literature and current electrosurgical and cardiac devices, we discuss the potential impact of conventional dermatologic electrosurgery and new technologies. We propose that new perioperative guidelines are needed to provide appropriate safety, facile implementation, and cost-effective care for patients with modern implantable cardiac devices.

A Web-based Tool for the Comprehensive Unit-based Safety Program (CUSP)

An organization's ability to change is driven by its culture, which in turn has a significant impact on safety. The six-step Comprehensive Unit-Based Safety Program (CUSP) is intended to improve local culture and safety. A Web-based project management tool for CUSP was developed and then pilot tested at two hospitals. HOW ECUSP WORKS: Once a patient safety concern is identified (step 3), a unit-level interdisciplinary safety committee determines issue criticality and starts up the projects (step 4), which are managed using project management tools within eCUSP (step 5). On a project's completion, the results are disseminated through a shared story (step 6). OSF St. Joseph's Medical Center-The Medical Birthing Center (Bloomington, Illinois), identified 11 safety issues, implemented 11 projects, and created 9 shared stories--including one for its Armband Project. The Johns Hopkins Hospital (Baltimore) Medical Progressive Care (MPC4) Unit identified 5 safety issues and implemented 4 ongoing projects, including the intravenous (IV) Tubing Compliance Project. The eCUSP tool's success depends on an organizational commitment to creating a culture of safety.

Follow-up of Markedly Elevated Serum Potassium Results in the Ambulatory Setting: Implications for Patient Safety

Failure to follow up outpatient test results in a timely manner is a growing patient safety concern. To investigate the follow-up of markedly elevated serum potassium levels in the ambulatory setting, the authors reviewed the medical records of all patients seen in a large primary care practice between September 1, 2003, and August 31, 2004, with potassium levels > or = 5.8 mEq/L. Of the 12,914 serum potassium tests performed, there were 109 cases of markedly elevated serum potassium levels in 86 patients. The median potassium level was 5.9 mEq/L (range, 5.8-7.3). More than half the patients were recalled to the clinic specifically for repeat testing; however, 25% of patients had no repeat tests until they were seen at routine follow-up visits. The median time to a repeat potassium level was 6 days (range, 0-445). Patients > or = 65 years old had a lower likelihood of having repeat testing within 1 week (odds ratio = 0.38, P = .03).

Effective Strategies to Increase Reporting of Medication Errors in Hospitals

A major concern for patient safety in hospitals is accurate medication administration. To improve the medication administration process, nurses and pharmacists must report system problems. Although staff supported the concept of medication error reporting, they did not report errors. Inherent fear of retribution, punitive actions, and professional humiliation prevented self-reporting of medication errors. Our hospital's quality improvement department developed, implemented, and evaluated a program called LifeSavers. Its purpose was to build a nonpunitive culture and to increase medication error reporting by staff. In one year, the LifeSavers program increased medication error disclosures from 14 to 72 reports per month. The successful development of a nonblame culture of medication error reporting led to identified sources of problems and improvement of the medication administration system.

Airway management before, during and after extubation: a survey of practice in the United Kingdom and Ireland

Summary Complications at extubation remain an important risk factor in anaesthesia. A postal survey was conducted on extubation practice amongst consultant anaesthetists in the United Kingdom and Ireland. The use of short acting drugs encourages anaesthetists to extubate the trachea at lighter levels of anaesthesia. The results show that oxygen (100%) is not routinely administered either before extubation or en route to the recovery area. A trend towards a head up or sitting position at extubation is emerging. However, further research into the use of these positions is required. Airway related complications at extubation are relatively frequent but are usually dealt with by simple basic measures. The role of drugs such as propofol in decreasing the incidence of these complications needs further evaluation. Some of these results give concern for patient safety and for training. The importance of teaching and adherence to continued oxygenation until complete recovery is strongly emphasised. Nerve stimulators should be used continually as standard monitoring throughout the anaesthetic period when muscle-relaxing drugs are part of the anaesthetic technique.

Cardiac Devices and Electromagnetic Interference Revisited

Background and Objective As the number of patients with implantable cardiac devices escalates, inadvertent electromagnetic interference (EMI) by electrosurgery carries increasing concern for patient safety. Given the trend for dermatologic care delivery by nonphysician providers, supervising physicians must carefully consider the adequacy of perioperative evaluation in elective or cosmetic settings. Rapidly evolving technology also calls into question potential EMI of new therapeutic modalities (radiofrequency resurfacing, electrochemotherapy, and endovenous ablation). The most recently published recommendations (1998) for care of dermatologic patients with cardiac devices do not differ significantly from guidelines proposed in 1975. These recommendations, based on complications experienced during noncutaneous surgery, are exceedingly conservative and do not take into consideration the different electrosurgical modalities and varying degrees of EMI risk. In addition, modern cardiac devices have evolved significantly with increased sophistication in protection from EMI. A survey of dermatologic surgeons demonstrated low compliance with these existing guidelines. Methods, Results, and Conclusions Based on a review of the literature and current electrosurgical and cardiac devices, we discuss the potential impact of conventional dermatologic electrosurgery and new technologies. We propose that new perioperative guidelines are needed to provide appropriate safety, facile implementation, and cost-effective care for patients with modern implantable cardiac devices.

Six sigma approach to improve surgical site infections: A key variable

BACKGROUND: Nationally, post-operative infections are a primary patient safety concern. Surgical site infections (SSIs) are not a rare outcome, occurring with 2%-5% of clean extra-abdominal and up to 20% of intra-abdominal surgeries. 1 www.ahrq.gov/clinic/ptsafety/pdf/ptsafety.pdf. Google Scholar Nationally, each SSI is estimated to increase length of stay by an average of 7 days and result in more than $3,000 in additional charges. 2 Surgical Infection Prevention Advisory Statement. Google Scholar Patients with an SSI are also five times more likely to be readmitted and two times as likely to expire. 2 Surgical Infection Prevention Advisory Statement. Google Scholar PROJECT: Through ongoing quality improvement and infection control monitoring, a trend in readmissions with post-operative infections was noted. A six sigma approach was used to determine contributing factors for SSI. In addition to educational and minor process changes, the primary change centered on the use of the forced air-warming device for abdominal hysterectomy procedures. In fact, after implementation, we found that this project built on the outcomes of a surgical site infection study conducted by Veterans Health Administration (VHA) in 2002. 3 VHA Surgical Infection Prevention Study, October 2002. Google Scholar RESULTS: After providing staff education for process changes, monitoring both process and outcome indicators continued for more than a year. As the process indicators improved, SSI rates declined. The number of physicians returning monthly surgical line listings increased from 78.7% in 2003, to 94.6% in 2004. The median first patient temperature after post-op admission to the medical-surgical nursing unit increased from a range of 96.4°F–96.8°F to 97.1°F–97.6°F. Total abdominal hysterectomy (TAH) infections were reduced from 14 in January-September 2003, to 7 in January-September 2004. Infection rate was reduced from 5.0 to 2.07 per 100 TAH surgeries (p = 0.045). CONCLUSIONS: The six sigma approach successfully improved infection rates and can be applied to other infection control efforts. This approach not only reduced infection rates and resulted in better patient care, but also substantiated research about patient temperature and SSIs. In particular, many organizations may find opportunities associated with the use of forced air-warming devices based on both our project results and the VHA study results. BACKGROUND: Nationally, post-operative infections are a primary patient safety concern. Surgical site infections (SSIs) are not a rare outcome, occurring with 2%-5% of clean extra-abdominal and up to 20% of intra-abdominal surgeries. 1 www.ahrq.gov/clinic/ptsafety/pdf/ptsafety.pdf. Google Scholar Nationally, each SSI is estimated to increase length of stay by an average of 7 days and result in more than $3,000 in additional charges. 2 Surgical Infection Prevention Advisory Statement. Google Scholar Patients with an SSI are also five times more likely to be readmitted and two times as likely to expire. 2 Surgical Infection Prevention Advisory Statement. Google Scholar PROJECT: Through ongoing quality improvement and infection control monitoring, a trend in readmissions with post-operative infections was noted. A six sigma approach was used to determine contributing factors for SSI. In addition to educational and minor process changes, the primary change centered on the use of the forced air-warming device for abdominal hysterectomy procedures. In fact, after implementation, we found that this project built on the outcomes of a surgical site infection study conducted by Veterans Health Administration (VHA) in 2002. 3 VHA Surgical Infection Prevention Study, October 2002. Google Scholar RESULTS: After providing staff education for process changes, monitoring both process and outcome indicators continued for more than a year. As the process indicators improved, SSI rates declined. The number of physicians returning monthly surgical line listings increased from 78.7% in 2003, to 94.6% in 2004. The median first patient temperature after post-op admission to the medical-surgical nursing unit increased from a range of 96.4°F–96.8°F to 97.1°F–97.6°F. Total abdominal hysterectomy (TAH) infections were reduced from 14 in January-September 2003, to 7 in January-September 2004. Infection rate was reduced from 5.0 to 2.07 per 100 TAH surgeries (p = 0.045). CONCLUSIONS: The six sigma approach successfully improved infection rates and can be applied to other infection control efforts. This approach not only reduced infection rates and resulted in better patient care, but also substantiated research about patient temperature and SSIs. In particular, many organizations may find opportunities associated with the use of forced air-warming devices based on both our project results and the VHA study results.

The Current Concept of Cell Therapy for Heart Failure

Cardiac repair is a dream in the field of medical science. The biological limitations to human cardiac regenerative growth require the creation of new strategies for cardiac regeneration using cells, genes and protein. Recent experimental studies and early-phase clinical trials showed stem cells have the potential to enhance myocardial perfusion and contractile performance in patients with acute myocardial infarction, advanced coronary artery disease and chronic heart failure. Overall clinical experience also suggests that stem cell therapy can be safely performed if the right cell protocol is used within the correct clinical setting. Some experimental data have shown stable stem cell engraftment due to fusion or transdifferentiation into cardiomyocyte or vascular cell lineages, which could be likely explanations for these beneficial effects. Others have proposed that transient cell retention may be sufficient to promote functional effects, e.g., by release of paracrine mediators. We should proceed cautiously with carefully designed clinical trials, and concern for patient safety must remain the key issue. The translational basic research will be required to elucidate the mechanism of stem cell therapy. (Korean Circulation J 2005;35:415-423)

“I Wish I Had Seen This Test Result Earlier!”

Failure to review and follow up on outpatient test results in a timely manner represents a patient safety and malpractice concern. Therefore, we sought to identify problems in current test result management systems and possible ways to improve these systems. We surveyed 262 physicians working in 15 internal medicine practices affiliated with 2 large urban teaching hospitals (response rate, 64%). We asked physicians about systems they used and the amount of time they spent managing test results. We asked them to report delays in reviewing test results and their overall satisfaction with their management of test results. We also asked physicians to rate features they would find useful in a new test result management system. Overall, 83% of respondents reported at least 1 delay in reviewing test results during the previous 2 months. Despite reporting that they spent on average 74 minutes per clinical day managing test results, only 41% of physicians reported being satisfied with how they managed test results. Satisfaction was associated with fewer self-reported delays in reviewing test results. Physicians who actively tracked their test orders to completion were also more likely to be satisfied. The most highly desired features of a test result management system were tools to help physicians generate result letters to patients, prioritize their workflow, and track test orders to completion. Delays in test result review are common, and many physicians are not satisfied with how they manage test results. Tools to improve test result management in office practices need to improve workflow efficiency and track test orders to completion.

Anti-Vascular Endothelial Growth Factor Monoclonals in Non-Small Cell Lung Cancer

There is an urgent need for new therapies to treat non-small cell lung cancer (NSCLC) because current chemotherapy regimens are of limited effectiveness. The role of vascular endothelial growth factor in promoting tumor angiogenesis, in maintaining existing vasculature, and in resistance to traditional therapies, together with its negative prognostic significance in NSCLC, make it an appropriate target for therapy. Bevacizumab (Avastin), a monoclonal antibody directed against vascular endothelial growth factor, has shown promise in treating a number of different cancers. In a recent Phase II trial in patients with advanced metastatic NSCLC, the addition of bevacizumab to standard carboplatin/paclitaxel chemotherapy significantly increased the time to progression and increased the response rate when compared with chemotherapy alone. This was particularly impressive in the subset of patients with non-squamous histology. Bevacizumab is generally well tolerated and did not appear to increase the incidence or severity of nausea/vomiting, neuropathy and renal toxicity, which are typically associated with carboplatin/paclitaxel chemotherapy. Adverse events in Phase I and II studies included hypertension, thrombosis, proteinuria (with occasional nephrotic syndrome), and epistaxis. Serious tumor-related bleeding episodes (hemoptysis/hematemesis) seem to be the main safety concern in patients with NSCLC, with squamous cell histology as a possible risk factor. Present ongoing studies are under way in NSCLC including (a) a Phase II neo-adjuvant study in combination with paclitaxel and carboplatin in patients with stage IB-IIA NSCLC; (b) a Phase I/II study of bevacizumab in combination with the epidermal growth factor receptor tyrosine kinase inhibitor agent, Tarceva, in patients with previously treated NSCLC; and (c) an Eastern Cooperative Group randomized Phase III study of paclitaxel and carboplatin with/without bevacizumab in patients with previously untreated IIIB (malignant pleural effusion) or metastatic NSCLC. These studies will help to establish the role of bevacizumab in NSCLC.

Non-Small Cell Lung Cancer and Antiangiogenic Therapy: What Can Be Expected of Bevacizumab?

There is an urgent need for new therapies to treat non-small cell lung cancer (NSCLC), as progress with current chemotherapy regimens has been limited. The roles of vascular endothelial growth factor (VEGF) in promoting tumor angiogenesis, maintaining existing vasculature, and contributing to resistance to traditional therapies, together with its negative prognostic significance in NSCLC, make it an appropriate target for therapy. Bevacizumab (Avastin; Genentech Inc., South San Francisco, CA), a monoclonal antibody directed against VEGF, has shown promise in treating a number of different cancers. In a recent phase II trial in patients with advanced metastatic NSCLC, the addition of bevacizumab to standard carboplatin/paclitaxel chemotherapy produced a significantly longer time to progression (32.1 versus 18.4 weeks) and greater response rate (31% versus 19% [not significant]) than chemotherapy alone. In the subset of patients with nonsquamous histologies, response rates and survival were further enhanced, with a mean survival time of 17.9 months versus 12.3 months with chemotherapy alone. Bevacizumab was generally well tolerated and did not appear to increase the incidences or severities of the nausea/vomiting, neuropathy, and renal toxicity that are typically associated with carboplatin/paclitaxel chemotherapy. Adverse events in phase I and II studies included hypertension, thrombosis, proteinuria (with occasional nephrotic syndrome), and epistaxis. Serious tumor-related bleeding episodes (hemoptysis/hematemesis) appear to be the main safety concern in patients with NSCLC, with squamous cell histology as a possible risk factor. Further work is needed to identify the best way to use bevacizumab in NSCLC, including use in combination with other biologic agents and in the adjuvant setting.

The Role of Leadership in Instilling a Culture of Safety: Lessons from the Literature

The publication of To Err Is Human has highlighted concern for patient safety. Attention to date has focused primarily on micro issues such as minimizing medication errors and adverse drug reactions, improving select aspects of care, and reducing diagnostic and treatment errors. However, attention is also required to a macro issue--an organization's culture and the level of leadership required to create a culture. This article discusses the concepts of culture and leadership and summarizes two paradigms that are useful in understanding the precursors of medical errors and developing interventions to prevent them: normal accident theory and high-reliability organization theory. It also delineates approaches to instilling a safety culture. Normal accident theory asserts that errors result from system failures. An important element of this perspective is the need for a system that collects, analyzes, and disseminates information from incidents and near misses as well as regular proactive checks on the system's vital signs. Four subcultures are necessary to support such an environment: a reporting culture, a just culture, a flexible culture, and a learning culture. High-reliability organization theory posits that accidents occur because individuals who operate and manage complex systems are themselves not sufficiently complex to sense and anticipate the problems generated by the system. Lessons learned from high-reliability organizations indicate that a safety culture is supported by migrated distributed decision making, management by exception or negotiation, and fostering a sense of the "big picture." Lessons from other industries are also shared in this article.

National Institutes of Health's Clinical Center Sets New Policy on Use of Herbal and Other Alternative Supplements by Patients Enrolled in Clinical Trials

The nationwide concern over the escalating use of herbal and other alternative dietary supplements is prompting a call for action in health care organizations. Not only is there mounting evidence to support a strong concern for patient safety, but the use of these products by people participating in biomedical research protocols has an added impact on the integrity of the research design and data gathering. These issues are of increasing concern to the National Institutes of Health's hospital for biomedical research, the Warren Grant Magnuson Clinical Center. Surveys completed in 2000 showed that 25–45% of Clinical Center patients reported taking herbal and other alternative dietary supplements. In 2001, the Clinical Center moved forward to develop and implement a policy to guide hospital staff in the management of patient use of herbal and alternative supplements. The policy established the requirement for all patients to be screened for supplement use upon admission or outpatient visit. Continued use of supplement products during hospitalization and/or outpatient enrollment on protocol require a physician's authorizing order. The implementation of this policy has increased awareness and provided an important step forward in protecting patient safety and preserving the scientific integrity of the research at the NIH's Clinical Center.

Historical perspective on medical errors: Richard Cabot and the Institute of Medicine.

The November 1999 report from the Institute of Medicine (IOM), “To Err Is Human,” stated the surprising estimate that errors by the medical profession are the eighth leading cause of death in the United States. The report called for a nationwide directive to address patient safety. The Institute, which is composed largely of health care administrators, recommended mandatory reporting of adverse events, heightened standards by oversight organizations, and expansion of safety systems within health care organizations. To support these recommendations, the IOM report estimated that between 44,000 and 98,000 deaths occur annually in American hospitals as a result of medical error. This startling estimate aroused substantial government and public concern for patient safety and certainly seized the attention of the medical profession. Although the stated goal of the report was to show that a system, despite being wellintentioned, could produce significant errors and that such errors could and should be combated by addressing flaws within the system, many physicians condemned the report. Most rebuttals disputed the true incidence of error-related mortality, and virtually all challenges to the IOM emphasized the competency and dignity of the medical profession. Although the IOM report has had a significant impact, it was not the first attempt to confront medical errors in American medicine. Nearly 100 years ago, Richard Clark Cabot, a Harvard physician, published two studies that examined the rates of error in clinical diagnosis. Although the science and technology of medicine have made remarkable progress since Cabot’s time, the fears and apprehensions of physicians in response to his work were remarkably similar to those recently expressed by many members of our profession. Such anxieties are, as they were then, a major impediment to improvement in health care. The purpose of this discussion is briefly to compare and contrast the response of the medical profession to the Cabot reports from the early 1900s with the current response to the IOM report. Around the turn of the last century, Richard Cabot was a practicing physician prominent in the Harvard hospital system. Cabot’s first article on medical errors, “A Study of Mistaken Diagnosis Based on the Analysis of 1,000 Autopsies and a Comparison with the Clinical Findings,” appeared in JAMA in 1910. This report recounted his personal review of 1,000 clinical records of patients who had recently died in the Massachusetts General Hospital. For each patient, he compared his clinical diagnosis, which he obtained on review of the medical records, with the postmortem findings evident at autopsy. Any disparity between his clinical diagnosis and the autopsy findings was categorized as a diagnostic error. Cabot found significant error in the premortem diagnoses, especially in such areas as cardiovascular disease and acute nephritis. He concluded not with a condemnation of physicians or their motivation. Instead, Cabot considered his report compelling evidence that the medical profession of his day held a multitude of false assumptions that flawed the diagnostic acumen of physicians. In 1912 Cabot published a second report, in which he reviewed an additional 2,000 cases. Again he identified significant disagreement between the premortem diagnosis and the postmortem findings. The tone of this second report was considerably bolder. Where Cabot had made only nonthreatening observations about diagnostic inconsistencies in 1910, he now described grave systemic errors in the practice of medicine. He was careful to point out that such errors were not the result of incompetence:

The use of economic modeling to determine the hospital costs associated with nosocomial infections.

Hospital-associated infection is well recognized as a patient safety concern requiring preventive interventions. However, hospitals are closely monitoring expenditures and need accurate estimates of potential cost savings from such prevention programs. We used a retrospective cohort design and economic modeling to determine the excess cost from the hospital perspective for hospital-associated infection in a random sample of adult medical patients. Study patients were classified as being not infected (n=139), having suspected infection (n=8), or having confirmed infection (n=17). Severity of illness and intensive unit care use were both independently associated with increased cost. After controlling for these confounding effects, we found an excess cost of $6767 for suspected infection and $15,275 for confirmed hospital-acquired infection. The economic model explained 56% of the total variability in cost among patients. Hospitals can use these data when evaluating potential cost savings from effective infection-control measures.