Mark A. Callahan

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

EXECUTIVE SUMMARY 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 organizations 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 systems 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.

Influence of Surgical Subspecialty Training on in-Hospital Mortality for Gastrectomy and Colectomy Patients

Objective: This study examined the relationship of surgeon subspecialty training and interests to in-hospital mortality while controlling for both hospital and surgeon volume. Summary Background Data: The relationship between volume of surgical procedures and in-hospital mortality has been studied and shows an inverse relationship. Methods: A large Statewide Planning and Research Cooperative System was used to identify all 55,016 inpatients who underwent gastrectomy (n = 6434) or colectomy (n = 48,582) between January 1, 1998 and December 31, 2001. Surgical subspecialty training and interest was defined as surgeons who were members of the Society of Surgical Oncology (training/interest; n = 68) or the Society of Colorectal Surgery (training; n = 61) during the study period. The association of in-hospital mortality and subspecialty training/interest was examined using a logistic regression model, adjusting for demographics, comorbidities, insurance status, and hospital and surgeon volume. Results: Overall mortality for colectomy patients was 4.6%; the adjusted mortality rate for subspecialty versus nonsubspecialty-trained surgeons was 2.4% versus 4.8%, respectively (adjusted odds ratio [OR] = 0.45; 95% confidence interval [CI] = 0.34, 0.60; P < 0.0001). Gastrectomy patients experienced an overall mortality rate of 8.4%; the adjusted mortality rate for patients treated by subspecialty trained surgeons was 6.5%, while the adjusted mortality rate for nonsubspecialty trained surgeons was 8.7% (adjusted OR = 0.70; 95% CI = 0.46, 1.08; P = 0.10). Conclusions: For gastrectomies and colectomies, risk-adjusted mortality is substantially lower when performed by subspecialty interested and trained surgeons, even after accounting for hospital and surgeon volume and patient characteristics. These findings may have implications for surgical training programs and for regionalization of complex surgical procedures.

Modeling the Public Health Response to Bioterrorism: Using Discrete Event Simulation to Design Antibiotic Distribution Centers:

Background Post-exposure prophylaxis is a critical component of the public health response to bioterrorism. Computer simulation modeling may assist in designing antibiotic distribution centers for this task. Methods The authors used discrete event simulation modeling to determine staffing levels for entry screening, triage, medical evaluation, and drug dispensing stations in a hypothetical antibiotic distribution center operating in low, medium, and high disease prevalence bioterrorism response scenarios. Patient arrival rates and processing times were based on prior mass prophylaxis campaigns. Multiple sensitivity analyses examined the relationship between average staff utilization rate (UR) (i.e., percentage of time occupied in patient contact) and capacity of the model to handle surge arrivals. Results Distribution center operation required from 93 staff for the low-prevalence scenario to 111 staff for the high-prevalence scenario to process approximately 1000 people per hour within the baseline model assumptions. Excess capacity to process surge arrivals approximated (1-UR) for triage staffing. Conclusions Discrete event simulation modeling is a useful tool in developing the public health infrastructure for bioterrorism response. Live exercises to validate the assumptions and outcomes presented here may improve preparedness to respond to bioterrorism.

Physicians' Attitudes Towards Copy and Pasting in Electronic Note Writing

BACKGROUNDThe ability to copy and paste text within computerized physician documentation facilitates electronic note writing, but may affect the quality of physician notes and patient care. Little is known about physicians’ collective experience with the copy and paste function (CPF).OBJECTIVESTo determine physicians’ CPF use, perceptions of its impact on notes and patient care, and opinions regarding its future use.DESIGNCross-sectional survey.PARTICIPANTSResident and faculty physicians within two affiliated academic medical centers currently using a computerized documentation system.MEASUREMENTSResponses on a self-administered survey.RESULTSA total of 315 (70%) of 451 eligible physicians responded to the survey. Of the 253 (80%) physicians who wrote inpatient notes electronically, 226 (90%) used CPF, and 177 (70%) used it almost always or most of the time when writing daily progress notes. While noting that inconsistencies (71%) and outdated information (71%) were more common in notes containing copy and pasted text, few physicians felt that CPF had a negative impact on patient documentation (19%) or led to mistakes in patient care (24%). The majority of physicians (80%) wanted to continue to use CPF.CONCLUSIONSAlthough recognizing deficits in notes written using CPF, the majority of physicians used CPF to write notes and did not perceive an overall negative impact on physician documentation or patient care. Further studies of the effects of electronic note writing on the quality and safety of patient care are required.

Economic impact of hyponatremia in hospitalized patients: a retrospective cohort study.

Abstract Background: Hyponatremia is the most common electrolyte abnormality seen in general hospital patients, with an incidence of 1% to 6% in the United States. Objective: We aimed to evaluate the impact of varying levels of hyponatremia at admission on length of stay (LOS) and cost of care in adult hospitalized patients. Methods: A retrospective cohort study was conducted using an existing clinical database from a large academic-setting hospital. All adult admissions from January 2004 through May 2005 with serum sodium level at admission of ≤ 134 mEq/L were separated into 2 cohorts: patients with moderate-to-severe hyponatremia (serum sodium level at admission of ≤ 129 mEq/L, n = 547) and patients with mild-to-moderate hyponatremia (serum sodium level of 130–134 mEq/L, n = 1500). ICD-9 diagnosis codes for these 2047 admissions with hyponatremia were used to identify a cohort of 7573 admissions with the same principal admitting diagnoses and a serum sodium level of 135 to 145 mEq/L. Differences in hospital LOS, intensive care unit (ICU) admission rate, and median total costs per admission between cohorts were examined using multiple linear regression, logistic, and quantile regression models. Results: Admissions with hyponatremia had significantly longer hospital LOS than those admitted without hyponatremia (median LOS: moderate-to-severe hyponatremia, 8 days; mild-to-moderate hyponatremia, 8 days; normal, 6 days; P < 0.001). Patients with more severe hyponatremia were also more likely to be admitted to the ICU during the hospital stay (moderate-to-severe hyponatremia, 32%; mild-to-moderate hyponatremia, 26%; normal, 22%; P < 0.001). These trends were also reflected in the total costs per admission, with median costs of

Value of serum antisperm antibodies in diagnosing obstructive azoospermia.

16 606 for moderate-to-severe hyponatremia cases,

Accuracy of Screening for Inhalational Anthrax after a Bioterrorist Attack

14 266 for mild-to-moderate hyponatremia cases, and

Costeffectiveness of diagnostic tests

13 066 for normal admissions (P < 0.001). Conclusions: Hyponatremia at admission was associated with increased LOS and cost of care for hospitalized patients. Interventions or pharmacotherapies for the prompt treatment of hyponatremia could potentially reduce morbidity and LOS, thereby reducing the utilization of health care resources.

Outcomes of Telephone Medical Care

PURPOSE The requisite presence of active spermatogenesis for antisperm antibody production may be useful in identifying obstructive azoospermia. The diagnostic performance of serum antisperm antibody was evaluated as a test for obstructive azoospermia. MATERIALS AND METHODS A total of 484 men with male infertility who had undergone antisperm antibody testing were evaluated. Demographic data, patient history, and followup were recorded. Obstruction was confirmed by surgical exploration. Sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios were calculated to quantify diagnostic performance. ROC curves were calculated and compared. RESULTS Of 484 men 272 possessed documented obstruction of the vas or epididymis and 212 had documented infertility without azoospermia. The obstructed group had significantly increased antisperm antibody levels compared to the nonobstructed group. IgG, IgA, and IgM were analyzed as diagnostic tests for obstruction. The AUC for IgG, IgA and IgM ROC curves was 0.92, 0.85 and 0.67, respectively. The AUC for serum IgG against sperm tails was 0.92, 0.87 against sperm heads and 0.79 against sperm midpieces. IgG demonstrated the highest sensitivity (85%) with a specificity of 97% (chi-square test p <0.01). IgA possessed the highest specificity (99%), positive predictive value (99%) and positive likelihood ratio (70.0). CONCLUSIONS The presence of serum antisperm antibody was highly accurate in predicting obstructive azoospermia, particularly after vasectomy. It can obviate the need for testis biopsy, the current but more invasive and costly gold standard of detection. This allows the surgeon to proceed directly to surgical reconstruction or sperm retrieval after a simple blood test.

Electronic Result Viewing and Quality of Care in Small Group Practices

Context In the event of a bioterrorist attack, it may be difficult to distinguish inhalational anthrax from viral respiratory tract disease. Contribution This synthesis compares reported symptoms of 28 patients with inhalational anthrax and 4694 patients with viral respiratory tract illnesses. Fever and cough were common in both infections. Mental confusion or loss of consciousness, shortness of breath, and nausea and vomiting more often indicated anthrax, whereas sore throat and runny nose more often indicated viral infection. Implications Several symptoms, including neurologic and gastrointestinal symptoms and shortness of breath, may help distinguish inhalational anthrax from respiratory viral illness. The Editors The 2001 anthrax attacks in the United States, in which 11 people developed the inhalational form of the disease and 5 died, exposed a weakness in the U.S. medical response to bioterrorism (1). Despite heroic efforts on behalf of the victims, physicians were largely unprepared to recognize the early symptoms and signs of this extremely rare and rapidly progressive infection in ambulatory patients (2). Initially, 4 of the 11 patients were sent home after being seen as outpatients or in an emergency department with diagnoses that included viral syndrome, bronchitis, and gastroenteritis (3, 4). Physicians first considered a diagnosis of anthrax in 2 of these patients (both postal workers) on their second visits to the emergency department and then only after hearing media reports of illness among other postal employees (3). Inhalation of anthrax spores leads to clinical disease from elaboration of two toxins, a calmodulin-dependent adenylate cyclase known as edema factor and a zinc metalloproteinase called lethal factor, by phagocytosed bacteria in the mediastinal lymph nodes and bloodstream (5). Classic pathologic findings include hemorrhagic mediastinitis and hemorrhagic meningitis; primary anthrax pneumonia is rare (6, 7). Without prompt treatment, death occurs rapidly from a combination of shock and respiratory compromise. Anthrax has been classified by the U.S. Centers for Disease Control and Prevention as one of six category A bioterrorist agents posing the greatest risk to civilian populations (8). A large-scale anthrax attack has the potential to cause casualties on a scale that would quickly overwhelm local and regional health care treatment capacity (6). The emergency response to such an attack would probably include the establishment of multiple mass prophylaxis centers physically distinct from hospital emergency departments (to prevent overcrowding and potential contamination) for rapid dispensing of prophylactic antibiotics to exposed populations and for identifying individuals suspected of having inhalational anthrax (9). Presumptive cases would be transferred to established or temporary medical care facilities for rapid definitive testing and initiation of combination antimicrobial treatment, which may improve outcomes (10-12). Efficient management of this limited medical care capacity is an important secondary goal of outpatient triage during a bioterrorism response (13, 14). Screening and triage protocols used in these settings would need to rely on presenting symptoms and signs because laboratory or radiographic testing will probably not be feasible in high-volume mass prophylaxis centers (15). We sought to establish an evidence base for developing a screening protocol for inhalational anthrax. The utility of such a protocol, which improves both case detection and case exclusion, would also extend beyond the immediate mass prophylaxis setting because large numbers of individuals outside the exposure zone will probably seek reassurance from health care providers for symptomatic illnesses in the aftermath of a major attack. Providing scientific evidence on which to base these discussions may decrease postattack anxiety and inappropriate utilization of health care resources (16). Methods Clinical data on the 11 inhalational anthrax cases of 2001 are now widely available (3, 4, 17-20). Because of the small number of cases in the contemporary attack, we performed a systematic literature review to identify additional original case reports of inhalational anthrax in the English-language medical literature. We searched two computerized databases (MEDLINE and Web of Science) for adult human case reports of anthrax infection between 1960 and 2000 using the keywords anthrax and case report. This yielded 44 references; 4 contained sufficient clinical data on inhalational anthrax to permit comparison with the 11 contemporary cases (21-24). Tracing bibliographies of these articles and a recent review article (25) produced an additional 7 articles that were appropriate for inclusion, for a total of 11 reports on 17 cases (26-32). Two of the cases involved patients from outside of the United States (22, 24). We interpreted lack of mention of a specific symptom or abnormal sign in these reports as indicating the absence of that finding from the patients clinical presentation. We compared proportions of symptoms and signs in historical and contemporary cases using the Fisher exact test; clinical features that had consistent prevalence rates in earlier and contemporary cases were candidates for comparison with viral respiratory tract disease. Viral respiratory tract infections, such as with influenza, respiratory syncytial virus (RSV), parainfluenza, and rhinoviruses or coronaviruses, are appropriate comparison conditions for this study because of their prevalence and potential similarity to inhalational anthrax (15, 33). We searched MEDLINE for descriptive epidemiologic reports of presenting clinical features of laboratory-confirmed influenza and noninfluenza viral respiratory illnesses in ambulatory adults; we found five published studies that met the search criteria (34-38). We did not include studies that describe samples of mixed influenza and noninfluenza cases (39-42) or that present data already reported in these five studies (43). We did not compare anthrax cases with asymptomatic persons (because they would not present a screening dilemma) or with acutely ill patients (because they would probably not participate in mass screening). Since there are no reports of inhalational anthrax in pediatric patients, we limited our comparison sample to adult patients. Finally, we also compared anthrax cases to ambulatory patients with community-acquired pneumonia to highlight the difficulty of distinguishing these two conditions (44). We calculated positive likelihood ratios with 95% CIs for the presence of selected signs and symptoms in inhalational anthrax versus influenza, influenza-like illness, and ambulatory community-acquired pneumonia. The positive likelihood ratio is defined here as the prevalence of a symptom or sign among inhalational anthrax cases divided by the prevalence of the same symptom or sign in the influenza, influenza-like illness, or pneumonia comparison groups. The positive likelihood ratio is the multiplicative factor that increases or decreases the odds of having inhalational anthrax as opposed to one of these comparison diseases, given the presence of a clinical finding (45). Therefore, the post-test probability of having inhalational anthrax is influenced by both the magnitude of the positive likelihood ratio and the pretest probability of having the disease (46). In the appropriate clinical setting (that is, when the pretest probability of having the target disease is not zero), likelihood ratios greater than 3 or less than 0.3 are considered clinically important (47). The general approach used heredeveloping diagnostic algorithms for rare diagnoses by using likelihood ratios and by establishing hypothetical comparison groups populated by common medical conditionshas been previously described (46, 48, 49). The study sponsors had no role in the design, conduct, and reporting of the data or in the decision to submit the manuscript for publication. Results Presenting symptoms and signs and radiographic results for the 11 deliberately infected contemporary cases and 17 occupationally or environmentally infected historical cases were similar, although contemporary patients reported significantly more fever/chills and fatigue or malaise (Table 1). All but 1 of the 28 patients (including 100% of the contemporary patients) had fever, chills, or cough on presentation. (The single exception was a patient who presented with impending shock, which limited the ability to record a complete history.) Other symptoms that affected more than half of all patients included dyspnea (68%), chest discomfort or pain (61%), and nausea or vomiting (61%). More than half of current case-patients and 43% of the combined sample presented with neurologic symptoms other than headache, including confusion, blurred vision, and dizziness. Only a few patients with inhalational anthrax reported sore throat (18%) or rhinorrhea (14%). Table 1. Summary of Symptoms and Signs at Initial Presentation: Historical versus Contemporary Patients with Inhalational Anthrax Eighty-one percent of patients presented with abnormalities on lung auscultation, including rales or rhonchi (65%) and dullness or decreased breath sounds (58%). Respiratory symptoms often did not match findings on lung physical examination. Four of the five patients with no respiratory symptoms had positive findings (rales), whereas 8 of the 23 patients with respiratory symptoms had no abnormality on lung examination. Outcomes differed significantly between historical and contemporary patients: 16 of the 17 historical patients died compared with only 5 of the 11 contemporary patients. The presenting clinical features of the 28 patients can be divided into nine symptom complexes involving respiratory; gastrointestinal; ear, nose, and throat; and nonheadache neurologic problems (Figure 1). The single most common presentation was a combination of respirato