Role of Patient Safety Organizations in Improving Patient Safety.

Research into the incidence of harm and death resulting from medical error has continued after the release of "To Err Is Human." Although debate of the incidence of harm from medical errors continues, patient safety experts agree that medical errors still occur at considerable and unacceptable rates. Continued attention and examination of medical errors are required. Patient Safety Organizations are a federal program that enables providers across the health care delivery system to analyze and learn from errors with the protection of privilege and confidentiality.

Missed Diagnosis of Cardiovascular Disease in Outpatient General Medicine: Insights from Malpractice Claims Data.

BACKGROUND: Diagnostic errors are an underrecognized source of patient harm, and cardiovascular disease can be challenging to diagnose in the ambulatory setting. Although malpractice data can inform diagnostic error reduction efforts, no studies have examined outpatient cardiovascular malpractice cases in depth. A study was conducted to examine the characteristics of outpatient cardiovascular malpractice cases brought against general medicine practitioners. METHODS: Some 3,407 closed malpractice claims were analyzed in outpatient general medicine from CRICO Strategies' Comparative Benchmarking System database-the largest detailed database of paid and unpaid malpractice in the world-and multivariate models were created to determine the factors that predicted case outcomes. RESULTS: Among the 153 patients in cardiovascular malpractice cases for whom patient comorbidities were coded, the majority (63%) had at least one traditional cardiac risk factor, such as diabetes, tobacco use, or previous cardiovascular disease. Cardiovascular malpractice cases were more likely to involve an allegation of error in diagnosis (75% vs. 47%, p <0.0001), have high clinical severity (86% vs. 49%, p <0.0001) and result in death (75% vs. 27%, p <0.0001), as compared to noncardiovascular cases. Initial diagnoses of nonspecific chest pain and mimics of cardiovascular pain (for example, esophageal disease) were common and independently increased the likelihood of a claim resulting in a payment (p <0.01). CONCLUSION: Cardiovascular malpractice cases against outpatient general medicine physicians mostly occur in patients with conventional risk factors for coronary artery disease and are often diagnosed with common mimics of cardiovascular pain. These findings suggest that these patients may be high-yield targets for preventing diagnostic errors in the ambulatory setting.

Effects of the I-PASS Nursing Handoff Bundle on communication quality and workflow.

BACKGROUND AND OBJECTIVE: Handoff communication errors are a leading source of sentinel events. We sought to determine the impact of a handoff improvement programme for nurses. METHODS: We conducted a prospective pre-post intervention study on a paediatric intensive care unit in 2011-2012. The I-PASS Nursing Handoff Bundle intervention consisted of educational training, verbal handoff I-PASS mnemonic implementation, and visual materials to provide reinforcement and sustainability. We developed handoff direct observation and time motion workflow assessment tools to measure: (1) quality of the verbal handoff, including interruption frequency and presence of key handoff data elements; and (2) duration of handoff and other workflow activities. RESULTS: I-PASS implementation was associated with improvements in verbal handoff communications, including inclusion of illness severity assessment (37% preintervention vs 67% postintervention, p=0.001), patient summary (81% vs 95%, p=0.05), to do list (35% vs 100%, p<0.001) and an opportunity for the receiving nurse to ask questions (34% vs 73%, p<0.001). Overall, 13/21 (62%) of verbal handoff data elements were more likely to be present following implementation whereas no data elements were less likely present. Implementation was associated with a decrease in interruption frequency pre versus post intervention (67% vs 40% of handoffs with interruptions, p=0.005) without a change in the median handoff duration (18.8 min vs 19.9 min, p=0.48) or changes in time spent in direct or indirect patient care activities. CONCLUSIONS: Implementation of the I-PASS Nursing Handoff Bundle was associated with widespread improvements in the verbal handoff process without a negative impact on nursing workflow. Implementation of I-PASS for nurses may therefore have the potential to significantly reduce medical errors and improve patient safety.

Changes in medical errors after implementation of a handoff program.

BACKGROUND: Miscommunications are a leading cause of serious medical errors. Data from multicenter studies assessing programs designed to improve handoff of information about patient care are lacking. METHODS: We conducted a prospective intervention study of a resident handoff-improvement program in nine hospitals, measuring rates of medical errors, preventable adverse events, and miscommunications, as well as resident workflow. The intervention included a mnemonic to standardize oral and written handoffs, handoff and communication training, a faculty development and observation program, and a sustainability campaign. Error rates were measured through active surveillance. Handoffs were assessed by means of evaluation of printed handoff documents and audio recordings. Workflow was assessed through time-motion observations. The primary outcome had two components: medical errors and preventable adverse events. RESULTS: In 10,740 patient admissions, the medical-error rate decreased by 23% from the preintervention period to the postintervention period (24.5 vs. 18.8 per 100 admissions, P<0.001), and the rate of preventable adverse events decreased by 30% (4.7 vs. 3.3 events per 100 admissions, P<0.001). The rate of nonpreventable adverse events did not change significantly (3.0 and 2.8 events per 100 admissions, P=0.79). Site-level analyses showed significant error reductions at six of nine sites. Across sites, significant increases were observed in the inclusion of all prespecified key elements in written documents and oral communication during handoff (nine written and five oral elements; P<0.001 for all 14 comparisons). There were no significant changes from the preintervention period to the postintervention period in the duration of oral handoffs (2.4 and 2.5 minutes per patient, respectively; P=0.55) or in resident workflow, including patient-family contact and computer time. CONCLUSIONS: Implementation of the handoff program was associated with reductions in medical errors and in preventable adverse events and with improvements in communication, without a negative effect on workflow. (Funded by the Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, and others.).

Rates of medical errors and preventable adverse events among hospitalized children following implementation of a resident handoff bundle.

IMPORTANCE: Handoff miscommunications are a leading cause of medical errors. Studies comprehensively assessing handoff improvement programs are lacking. OBJECTIVE: To determine whether introduction of a multifaceted handoff program was associated with reduced rates of medical errors and preventable adverse events, fewer omissions of key data in written handoffs, improved verbal handoffs, and changes in resident-physician workflow. DESIGN, SETTING, AND PARTICIPANTS: Prospective intervention study of 1255 patient admissions (642 before and 613 after the intervention) involving 84 resident physicians (42 before and 42 after the intervention) from July-September 2009 and November 2009-January 2010 on 2 inpatient units at Boston Children's Hospital. INTERVENTIONS: Resident handoff bundle, consisting of standardized communication and handoff training, a verbal mnemonic, and a new team handoff structure. On one unit, a computerized handoff tool linked to the electronic medical record was introduced. MAIN OUTCOMES AND MEASURES: The primary outcomes were the rates of medical errors and preventable adverse events measured by daily systematic surveillance. The secondary outcomes were omissions in the printed handoff document and resident time-motion activity. RESULTS: Medical errors decreased from 33.8 per 100 admissions (95% CI, 27.3-40.3) to 18.3 per 100 admissions (95% CI, 14.7-21.9; P < .001), and preventable adverse events decreased from 3.3 per 100 admissions (95% CI, 1.7-4.8) to 1.5 (95% CI, 0.51-2.4) per 100 admissions (P = .04) following the intervention. There were fewer omissions of key handoff elements on printed handoff documents, especially on the unit that received the computerized handoff tool (significant reductions of omissions in 11 of 14 categories with computerized tool; significant reductions in 2 of 14 categories without computerized tool). Physicians spent a greater percentage of time in a 24-hour period at the patient bedside after the intervention (8.3%; 95% CI 7.1%-9.8%) vs 10.6% (95% CI, 9.2%-12.2%; P = .03). The average duration of verbal handoffs per patient did not change. Verbal handoffs were more likely to occur in a quiet location (33.3%; 95% CI, 14.5%-52.2% vs 67.9%; 95% CI, 50.6%-85.2%; P = .03) and private location (50.0%; 95% CI, 30%-70% vs 85.7%; 95% CI, 72.8%-98.7%; P = .007) after the intervention. CONCLUSIONS AND RELEVANCE: Implementation of a handoff bundle was associated with a significant reduction in medical errors and preventable adverse events among hospitalized children. Improvements in verbal and written handoff processes occurred, and resident workflow did not change adversely.

Primary care closed claims experience of Massachusetts malpractice insurers.

IMPORTANCE: Despite prior focus on high-impact inpatient cases, there are increasing data and awareness that malpractice in the outpatient setting, particularly in primary care, is a leading contributor to malpractice risk and claims. OBJECTIVE: To study patterns of primary care malpractice types, causes, and outcomes as part of a Massachusetts ambulatory malpractice risk and safety improvement project. DESIGN, SETTING, AND PARTICIPANTS: Retrospective review of pooled closed claims data of 2 malpractice carriers covering most Massachusetts physicians during a 5-year period (January 1, 2005, through December 31, 2009). Data were harmonized between the 2 insurers using a standardized taxonomy. Primary care practices in Massachusetts. All malpractice claims that involved primary care practices insured by the 2 largest insurers in the state were screened. A total of 551 claims from primary care practices were identified for the analysis. MAIN OUTCOMES AND MEASURES: Numbers and types of claims, including whether claims involved primary care physicians or practices; classification of alleged malpractice (eg, misdiagnosis or medication error); patient diagnosis; breakdown in care process; and claim outcome (dismissed, settled, verdict for plaintiff, or verdict for defendant). RESULTS: During a 5-year period there were 7224 malpractice claims of which 551 (7.7%) were from primary care practices. Allegations were related to diagnosis in 397 (72.1%), medications in 68 (12.3%), other medical treatment in 41 (7.4%), communication in 15 (2.7%), patient rights in 11 (2.0%), and patient safety or security in 8 (1.5%). Leading diagnoses were cancer (n = 190), heart diseases (n = 43), blood vessel diseases (n = 27), infections (n = 22), and stroke (n = 16). Primary care cases were significantly more likely to be settled (35.2% vs 20.5%) or result in a verdict for the plaintiff (1.6% vs 0.9%) compared with non-general medical malpractice claims (P < .001). CONCLUSIONS AND RELEVANCE: In Massachusetts, most primary care claims filed are related to alleged misdiagnosis. Compared with malpractice allegations in other settings, primary care ambulatory claims appear to be more difficult to defend, with more cases settled or resulting in a verdict for the plaintiff.

Return on investment for vendor computerized physician order entry in four community hospitals: the importance of decision support.

BACKGROUND: In-hospital adverse events are a major cause of morbidity and mortality and represent a major cost burden to health care systems. A study was conducted to evaluate the return on investment (ROI) for the adoption of vendor-developed computerized physician oder entry (CPOE) systems in four community hospitals in Massachusetts. METHODS: Of the four hospitals, two were under one management structure and implemented the same vendor-developed CPOE system (Hospital Group A), while the other two were under a second management structure and implemented another vendor-developed CPOE system (Hospital Group B). Cost savings were calculated on the basis of reduction in preventable adverse drug event (ADE) rates as measured previously. ROI, net cash flow, and the breakeven point during a 10-year cost-and-benefit model were calculated. At the time of the study, none of the participating hospitals had implemented more than a rudimentary decision support system together with CPOE. RESULTS: Implementation costs were lower for Hospital Group A than B ($7,130,894 total or $83/admission versus $19,293,379 total or $113/admission, respectively), as were preventable ADE-related avoided costs ($7,937,651 and $16,557,056, respectively). A cost-benefit analysis demonstrated that Hospital Group A had an ROI of 11.3%, breaking even on the investment eight years following implementation. Hospital Group B showed a negative return, with an ROI of -3.1%. CONCLUSIONS: Adoption of vendor CPOE systems in community hospitals was associated with a modest ROI at best when applying cost savings attributable to prevention of ADEs only. The modest financial returns can beattributed to the lack of clinical decision support tools.

1,3,8-Triazaspiro[4.5]decane-2,4-diones as efficacious pan-inhibitors of hypoxia-inducible factor prolyl hydroxylase 1-3 (HIF PHD1-3) for the treatment of anemia.

The discovery of 1,3,8-triazaspiro[4.5]decane-2,4-diones (spirohydantoins) as a structural class of pan-inhibitors of the prolyl hydroxylase (PHD) family of enzymes for the treatment of anemia is described. The initial hit class, spirooxindoles, was identified through affinity selection mass spectrometry (AS-MS) and optimized for PHD2 inhibition and optimal PK/PD profile (short-acting PHDi inhibitors). 1,3,8-Triazaspiro[4.5]decane-2,4-diones (spirohydantoins) were optimized as an advanced lead class derived from the original spiroindole hit. A new set of general conditions for C-N coupling, developed using a high-throughput experimentation (HTE) technique, enabled a full SAR analysis of the spirohydantoins. This rapid and directed SAR exploration has resulted in the first reported examples of hydantoin derivatives with good PK in preclinical species. Potassium channel off-target activity (hERG) was successfully eliminated through the systematic introduction of acidic functionality to the molecular structure. Undesired upregulation of alanine aminotransferese (ALT) liver enzymes was mitigated and a robust on-/off-target margin was achieved. Spirohydantoins represent a class of highly efficacious, short-acting PHD1-3 inhibitors causing a robust erythropoietin (EPO) upregulation in vivo in multiple preclinical species. This profile deems spirohydantoins as attractive short-acting PHDi inhibitors with the potential for treatment of anemia.

Impact of robotic antineoplastic preparation on safety, workflow, and costs.

PURPOSE: Antineoplastic preparation presents unique safety concerns and consumes significant pharmacy staff time and costs. Robotic antineoplastic and adjuvant medication compounding may provide incremental safety and efficiency advantages compared with standard pharmacy practices. METHODS: We conducted a direct observation trial in an academic medical center pharmacy to compare the effects of usual/manual antineoplastic and adjuvant drug preparation (baseline period) with robotic preparation (intervention period). The primary outcomes were serious medication errors and staff safety events with the potential for harm of patients and staff, respectively. Secondary outcomes included medication accuracy determined by gravimetric techniques, medication preparation time, and the costs of both ancillary materials used during drug preparation and personnel time. RESULTS: Among 1,421 and 972 observed medication preparations, we found nine (0.7%) and seven (0.7%) serious medication errors (P = .8) and 73 (5.1%) and 28 (2.9%) staff safety events (P = .007) in the baseline and intervention periods, respectively. Drugs failed accuracy measurements in 12.5% (23 of 184) and 0.9% (one of 110) of preparations in the baseline and intervention periods, respectively (P < .001). Mean drug preparation time increased by 47% when using the robot (P = .009). Labor costs were similar in both study periods, although the ancillary material costs decreased by 56% in the intervention period (P < .001). CONCLUSION: Although robotically prepared antineoplastic and adjuvant medications did not reduce serious medication errors, both staff safety and accuracy of medication preparation were improved significantly. Future studies are necessary to address the overall cost effectiveness of these robotic implementations.

Genomic testing and therapies for breast cancer in clinical practice.

PURPOSE: Given the likely proliferation of targeted testing and treatment strategies for cancer, a better understanding of the utilization patterns of human epidermal growth factor receptor 2 (HER2) testing and trastuzumab and newer gene expression profiling (GEP) for risk stratification and chemotherapy decision making are important. STUDY DESIGN: Cross-sectional. METHODS: We performed a medical record review of women age 35 to 65 years diagnosed between 2006 and 2007 with invasive localized breast cancer, identified using claims from a large national health plan (N = 775). RESULTS: Almost all women received HER2 testing (96.9%), and 24.9% of women with an accepted indication received GEP. Unexplained socioeconomic differences in GEP use were apparent after adjusting for age and clinical characteristics; specifically, GEP use increased with income. For example, those in the lowest income category (< $40,000) were less likely than those with an income of $125,000 or more to receive GEP (odds ratio, 0.34; 95% CI, 0.16 to 0.73). A majority of women (57.7%) with HER2-positive disease received trastuzumab; among these women, differences in age and clinical characteristics were not apparent, although surprisingly, those in the lowest income category were more likely than those in the high-income category to receive trastuzumab (P = .02). Among women who did not have a positive HER2 test, 3.9% still received trastuzumab. Receipt of adjuvant chemotherapy increased as GEP score indicated greater risk of recurrence. CONCLUSION: Identifying and eliminating unnecessary variation in the use of these expensive tests and treatments should be part of quality improvement and efficiency programs.

Genomic testing and therapies for breast cancer in clinical practice.

OBJECTIVE: Given the likely proliferation of targeted testing and treatment strategies for cancer, a better understanding of the utilization patterns of human epidermal growth factor receptor 2 (HER2) testing and trastuzumab and newer gene expression profiling (GEP) for risk stratification and chemotherapy decision making are important. STUDY DESIGN: Cross-sectional. METHODS: We performed a medical record review of women aged 35 to 65 years diagnosed between 2006 and 2007 with invasive localized breast cancer, identified using claims from a large national health plan (N = 775). RESULTS: Almost all women received HER2 testing (96.9%), and 24.9% of women with an accepted indication received GEP. Unexplained socioeconomic differences in GEP use were apparent after adjusting for age and clinical characteristics; specifically, GEP use increased with income. For example, those in the lowest income category (<$40,000) were less likely than those with an income of $125,000 or more to receive GEP (odds ratio, 0.34; 95% confidence interval, 0.16 to 0.73). A majority of women (57.7%) with HER2-positive disease received trastuzumab; among these women, differences in age and clinical characteristics were not apparent, although surprisingly, those in the lowest income category were more likely than those in the high-income category to receive trastuzumab (P = .02). Among women who did not have a positive HER2 test, 3.9% still received trastuzumab. Receipt of adjuvant chemotherapy increased as GEP score indicated greater risk of recurrence. CONCLUSION: Identifying and eliminating unnecessary variation in the use of these expensive tests and treatments should be part of quality improvement and efficiency programs.

Tradeoffs of using administrative claims and medical records to identify the use of personalized medicine for patients with breast cancer.

BACKGROUND: Administrative claims and medical records are important data sources to examine healthcare utilization and outcomes. Little is known about identifying personalized medicine technologies in these sources. OBJECTIVES: To describe agreement, sensitivity, and specificity of administrative claims compared with medical records for 2 pairs of targeted tests and treatments for breast cancer. RESEARCH DESIGN: Retrospective analysis of medical records linked to administrative claims from a large health plan. We examined whether agreement varied by factors that facilitate tracking in claims (coding and cost) and that enhance medical record completeness (records from multiple providers). SUBJECTS: Women (35 to 65 y of age) with incident breast cancer diagnosed in 2006 to 2007 (n=775). MEASURES: Use of human epidermal growth factor receptor 2 (HER2) and gene expression profiling (GEP) testing, trastuzumab, and adjuvant chemotherapy in claims and medical records. RESULTS: Agreement between claims and records was substantial for GEP, trastuzumab, and chemotherapy, and lowest for HER2 tests. GEP, an expensive test with unique billing codes, had higher agreement (91.6% vs. 75.2%), sensitivity (94.9% vs. 76.7%), and specificity (90.1% vs. 29.2%) than HER2, a test without unique billing codes. Trastuzumab, a treatment with unique billing codes, had slightly higher agreement (95.1% vs. 90%) and sensitivity (98.1% vs. 87.9%) than adjuvant chemotherapy. CONCLUSIONS: Higher agreement and specificity were associated with services that had unique billing codes and high cost. Administrative claims may be sufficient for examining services with unique billing codes. Medical records provide better data for identifying tests lacking specific codes and for research requiring detailed clinical information.

Integrating incident data from five reporting systems to assess patient safety: making sense of the elephant.

BACKGROUND: A study was conducted to examine and compare information gleaned from five different reporting systems within one institution: incident reporting, patient complaints, risk management, medical malpractice claims, and executive walk rounds. These data sources vary in the timing of the reporting (retrospective or prospective), severity of the events, and profession of the reporters. METHODS: A common methodology was developed for classifying incidents. Data specific to each incident were abstracted from each system and then categorized using the same framework into one of 23 categories. RESULTS: Overall, there was little overlap, although each reporting system identified important safety issues. Communication problems were common among patient complaints and malpractice claims; malpractice claims' leading category was clinical judgement. Walk rounds identified issues with equipment and supplies. Adverse event reporting systems highlighted identification issues, especially mislabelled specimens. The frequency of contributions of reports by provider group varied substantially by system. Physicians accounted for 50% of risk management reports, but in adverse event reporting, where nurses were the main reporters, physicians accounted for only 2.5% of reports. Complaints and malpractice claims come primarily from patients. CONCLUSIONS: The five reporting systems each identified different yet complementary patient safety issues. To obtain a comprehensive picture of their patient safety problems and to develop priorities for improving safety, hospitals should use a broad portfolio of approaches and then synthesize the messages from all individual approaches into a collated and cohesive whole.

Leading in crisis: lessons for safety leaders.

OBJECTIVE: The National Quality Forum (NQF) Safe Practices are a group of 34 evidence-based Safe Practices that should be universally used to reduce the risk of harm to patients. Four of these practices specifically address leadership. A recently published book, 7 Lessons for Leading in Crisis, offers practical advice on how to lead in crisis. An analysis of how concepts from the 7 lessons could be applied to the Safe Practices was presented nationally by webinar to assess the audience's reaction to the information. The objective of this article was to present the information and the audience's reaction to it. METHOD: Recommendations for direct actions that health care leaders can take to accelerate adoption of NQF Safe Practices were presented to health care leaders, followed by an immediate direct survey that used Reichheld's "Net Promoter Score" to assess whether the concepts presented were considered applicable and valuable to the audience. In a separate presentation, the challenges and crises facing nursing leaders were addressed by nursing leaders. RESULTS: Six hundred seventy-four hospitals, with an average of 4.5 participants per hospital, participated in the webinar. A total of 272 safety leaders responded to a survey immediately after the webinar. A Net Promoter Score assessment revealed that 58% of those surveyed rated the value of the information at 10, and 91% scored the value of the webinar to be between 8 and 10, where 10 is considered a strong recommendation that those voting would recommend this program to others. CONCLUSIONS: The overwhelmingly high score indicated that the principles presented were important and valuable to this national audience of health care leadership. The 2010 environment of uncertainty and shrinking financial resources poses significant risk to patients and new challenges for leaders at all levels. A values-grounded focus on personal accountability for leading in crisis situations strongly resonates with those interested in or leading patient safety initiatives.

Evaluation of the contributions of an electronic web-based reporting system: enabling action.

BACKGROUND: Incident reporting represents a key tool in safety improvement. Electronic voluntary reporting systems have been perceived as advantageous compared to paper approaches and are increasingly being implemented. OBJECTIVES: To evaluate the rate, content, ease of use, reporters' profile, and the follow-up and actions resulting from reports submitted to a Web-based electronic reporting system. METHODS: Analysis of the submitted reports to a commercial Web-based reporting system at a tertiary care academic hospital for 31 months between May 2004 and November 2006. RESULTS: During the study period, 14,179 reports were submitted. The leading incident categories were labs (30%), followed by medication issues (17%), falls (11%), and blood bank (10%). Of the reported incidents, 24% were near misses, 61% were adverse events that caused no harm, 14% caused temporary harm, 0.4% caused permanent harm, and 0.1% caused death. Of the eligible staff, 29% submitted a report during the study period. Physicians submitted only 2.9% of the reports; most reports were submitted by nurses, pharmacists, and technicians. Physicians tended to report on more severe cases and focused on different topics than other professionals. Overall, 84% of the reports came from the inpatient setting. On average, it took 14 minutes to submit a report. In following up on reports, first manager review was completed within a median of 22 hours, and a mean of 4 people reviewed each report. A large array of actions followed the reports. CONCLUSIONS: This application effectively captured incidents, actions, and follow-up. Ease of data manipulation facilitated descriptive statistical analysis, and the ability to use branching algorithms may have helped in decision making about actions and follow-up.

Risks of complications by attending physicians after performing nighttime procedures.

CONTEXT: Few data exist on the relationships between experienced physicians' work hours and sleep, and patient safety. OBJECTIVE: To determine if sleep opportunities for attending surgeons and obstetricians/gynecologists are associated with the risk of complications. DESIGN, SETTING, AND PATIENTS: Matched retrospective cohort study of procedures performed from January 1999 through June 2008 by attending physicians (86 surgeons and 134 obstetricians/gynecologists) who had been in the hospital performing another procedure involving adult patients for at least part of the preceding night (12 am-6 am, postnighttime procedures). Sleep opportunity was calculated as the time between end of the overnight procedure and start of the first procedure the following day. Matched control procedures included as many as 5 procedures of the same type performed by the same physician on days without preceding overnight procedures. Complications were identified and classified by a blinded 3-step process that included administrative screening, medical record reviews, and clinician ratings. MAIN OUTCOME MEASURES: Rates of complications in postnighttime procedures as compared with controls; rates of complications in postnighttime procedures among physicians with more than 6-hour sleep opportunities vs those with sleep opportunities of 6 hours or less. RESULTS: A total of 919 surgical and 957 obstetrical postnighttime procedures were matched with 3552 and 3945 control procedures, respectively. Complications occurred in 101 postnighttime procedures (5.4%) and 365 control procedures (4.9%) (odds ratio, 1.09; 95% confidence interval [CI], 0.84-1.41). Complications occurred in 82 of 1317 postnighttime procedures with sleep opportunities of 6 hours or less (6.2%) vs 19 of 559 postnighttime procedures with sleep opportunities of more than 6 hours (3.4%) (odds ratio, 1.72; 95% CI, 1.02-2.89). Postnighttime procedures completed after working more than 12 hours (n = 958) compared with 12 hours or less (n = 918) had nonsignificantly higher complication rates (6.5% vs 4.3%; odds ratio, 1.47; 95% CI, 0.96-2.27). CONCLUSION: Overall, procedures performed the day after attending physicians worked overnight were not associated with significantly increased complication rates, although there was an increased rate of complications among postnighttime surgical procedures performed by physicians with sleep opportunities of less than 6 hours.

Sphingosine 1-phosphate receptor agonist FTY720-phosphate causes marginal zone B cell displacement.

FTY720 is an immunosuppressive agent that modulates lymphocyte trafficking. It is phosphorylated in vivo to FTY720-phosphate (FTY-P) and binds to a family of G protein-coupled receptors recognizing sphingosine 1-phosphate (S1P) as the natural ligand. It has previously been reported that FTY-P blocks egress of lymphocytes from the thymus and lymph nodes, resulting in peripheral blood lymphopenia. We now report that FTY-P also causes displacement of marginal zone (MZ) B cells to the splenic follicles, an effect that is similar to that observed after in vivo administration of lipopolysaccharide. This effect is specific to B cells in the MZ, as treatment with FTY-P does not cause redistribution of the resident macrophage population. A small but statistically significant decrease in the expression of beta1 integrin on MZ B cells was observed with FTY-P treatment. The redistribution of MZ B cells from the MZ sinuses does not abolish the ability of these cells to respond to the T-independent antigen, trinitrophenol-Ficoll. It has been proposed that the displacement of MZ B cells to the follicles is an indication of cell activation. Consistent with this, FTY-P caused an increase in percentage of MZ B cells expressing activation markers CD9, CD1d, and CD24. These results suggest that S1P receptors on MZ B cells are responsible for their mobilization to follicles.

A controlled trial of smart infusion pumps to improve medication safety in critically ill patients.

OBJECTIVE: Intravenous medications are vital during inpatient management. Errors associated with the administration of medications through intravenous infusion pumps to critically ill patients can result in adverse drug events. We sought to assess the impact of smart pumps with integrated decision support software on the incidence and nature of medication errors and adverse drug events. DESIGN: We performed a prospective, randomized time-series trial and compared the serious medication error rate between intervention (decision support on) and control (decision support off) periods. Serious medication errors included both near-misses and preventable adverse drug events. Pump software produced log reports to help identify potential events. Events were presented to physicians for rating of event type, preventability, and severity. SETTING: Cardiac surgical intensive care and step-down units between February and December 2002. PATIENTS: Pump data were available for 744 cardiac surgery admissions. INTERVENTIONS: Decision support during medication administration provided feedback including alerts, reminders, and unit-specific drug rate limits. MEASUREMENTS AND MAIN RESULTS: We found a total of 180 serious medication errors, including 14 and 11 preventable adverse drug events and 73 and 82 nonintercepted potential adverse drug events in the control and intervention periods, respectively. The serious medication error rates in the control and intervention periods were 2.03 and 2.41 per 100 patient-pump-days, respectively (p = .124). We also found numerous opportunities for safety improvement. Violations of infusion practice during the intervention periods included 571 (25%) bypasses of the drug library. Medications were also frequently administered without documentation of physician orders in both periods (n = 823; 7.7%). CONCLUSION: Intravenous medication errors and adverse drug events were frequent and could be detected using smart pumps. We found no measurable impact on the serious medication error rate, likely in part due to poor compliance. Although smart pumps have great promise, technological and nursing behavioral factors must be addressed if these pumps are to achieve their potential for improving medication safety.