Partnering With a Medical Malpractice Insurer to Improve Patient Safety and Decrease Risk.

Implementing evolving science into clinical practice remains challenging. Assimilating new scientific evidence into clinical protocols and best practice recommendations, in a timely manner, can be difficult. In this article, we examine the value of partnering with a captive medical malpractice insurance company and its Patient Safety Organization to use data and convening opportunities to build upon the principles of implementation science and foster efficient and widespread adoption of the most current evidence-based interventions. Analyses of medical malpractice and root-cause analysis data set the context for this partnership and acted as a catalyst for creating best practice guidelines for adopting therapeutic hypothermia in the treatment of neonatal encephalopathy. What follows is a powerful example of successfully leveraging the collective wisdom of healthcare providers across specialties and institutional lines to move patient safety forward while managing risk.

Randomized Trial of Reducing Ambulatory Malpractice and Safety Risk: Results of the Massachusetts PROMISES Project.

OBJECTIVE: Evaluate application of quality improvement approaches to key ambulatory malpractice risk and safety areas. STUDY SETTING: In total, 25 small-to-medium-sized primary care practices (16 intervention; 9 control) in Massachusetts. STUDY DESIGN: Controlled trial of a 15-month intervention including exposure to a learning network, webinars, face-to-face meetings, and coaching by improvement advisors targeting "3+1" high-risk domains: test result, referral, and medication management plus culture/communication issues evaluated by survey and chart review tools. DATA COLLECTION METHODS: Chart reviews conducted at baseline and postintervention for intervention sites. Staff and patient survey data collected at baseline and postintervention for intervention and control sites. PRINCIPAL FINDINGS: Chart reviews demonstrated significant improvements in documentation of abnormal results, patient notification, documentation of an action or treatment plan, and evidence of a completed plan (all P<0.001). Mean days between laboratory test date and evidence of completed action/treatment plan decreased by 19.4 days (P<0.001). Staff surveys showed modest but nonsignificant improvement for intervention practices relative to controls overall and for the 3 high-risk domains that were the focus of PROMISES. CONCLUSIONS: A consortium of stakeholders, quality improvement tools, coaches, and learning network decreased selected ambulatory safety risks often seen in malpractice claims.

Unrealized potential and residual consequences of electronic prescribing on pharmacy workflow in the outpatient pharmacy.

INTRODUCTION: Electronic prescribing systems have often been promoted as a tool for reducing medication errors and adverse drug events. Recent evidence has revealed that adoption of electronic prescribing systems can lead to unintended consequences such as the introduction of new errors. The purpose of this study is to identify and characterize the unrealized potential and residual consequences of electronic prescribing on pharmacy workflow in an outpatient pharmacy. METHODS: A multidisciplinary team conducted direct observations of workflow in an independent pharmacy and semi-structured interviews with pharmacy staff members about their perceptions of the unrealized potential and residual consequences of electronic prescribing systems. We used qualitative methods to iteratively analyze text data using a grounded theory approach, and derive a list of major themes and subthemes related to the unrealized potential and residual consequences of electronic prescribing. RESULTS: We identified the following five themes: Communication, workflow disruption, cost, technology, and opportunity for new errors. These contained 26 unique subthemes representing different facets of our observations and the pharmacy staff's perceptions of the unrealized potential and residual consequences of electronic prescribing. DISCUSSION: We offer targeted solutions to improve electronic prescribing systems by addressing the unrealized potential and residual consequences that we identified. These recommendations may be applied not only to improve staff perceptions of electronic prescribing systems but also to improve the design and/or selection of these systems in order to optimize communication and workflow within pharmacies while minimizing both cost and the potential for the introduction of new errors.

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.

Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system.

IMPORTANCE: Health care-associated infections (HAIs) account for a large proportion of the harms caused by health care and are associated with high costs. Better evaluation of the costs of these infections could help providers and payers to justify investing in prevention. OBJECTIVE: To estimate costs associated with the most significant and targetable HAIs. DATA SOURCES: For estimation of attributable costs, we conducted a systematic review of the literature using PubMed for the years 1986 through April 2013. For HAI incidence estimates, we used the National Healthcare Safety Network of the Centers for Disease Control and Prevention (CDC). STUDY SELECTION: Studies performed outside the United States were excluded. Inclusion criteria included a robust method of comparison using a matched control group or an appropriate regression strategy, generalizable populations typical of inpatient wards and critical care units, methodologic consistency with CDC definitions, and soundness of handling economic outcomes. DATA EXTRACTION AND SYNTHESIS: Three review cycles were completed, with the final iteration carried out from July 2011 to April 2013. Selected publications underwent a secondary review by the research team. MAIN OUTCOMES AND MEASURES: Costs, inflated to 2012 US dollars. RESULTS: Using Monte Carlo simulation, we generated point estimates and 95% CIs for attributable costs and length of hospital stay. On a per-case basis, central line-associated bloodstream infections were found to be the most costly HAIs at $45,814 (95% CI, $30,919-$65,245), followed by ventilator-associated pneumonia at $40,144 (95% CI, $36,286-$44,220), surgical site infections at $20,785 (95% CI, $18,902-$22,667), Clostridium difficile infection at $11,285 (95% CI, $9118-$13,574), and catheter-associated urinary tract infections at $896 (95% CI, $603-$1189). The total annual costs for the 5 major infections were $9.8 billion (95% CI, $8.3-$11.5 billion), with surgical site infections contributing the most to overall costs (33.7% of the total), followed by ventilator-associated pneumonia (31.6%), central line-associated bloodstream infections (18.9%), C difficile infections (15.4%), and catheter-associated urinary tract infections (<1%). CONCLUSIONS AND RELEVANCE: While quality improvement initiatives have decreased HAI incidence and costs, much more remains to be done. As hospitals realize savings from prevention of these complications under payment reforms, they may be more likely to invest in such strategies.

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.

Off the hamster wheel? Qualitative evaluation of a payment-linked patient-centered medical home (PCMH) pilot.

CONTEXT: Many primary care practices are moving toward the patient-centered medical home (PCMH) model and increasingly are offering payment incentives linked to PCMH changes. Despite widespread acceptance of general PCMH concepts, there is still a pressing need to examine carefully and critically what transformation means for primary care practices and their patients and the experience of undergoing such change in a practice. METHODS: We used a qualitative case study approach to explore the underlying dynamics of change at five practices participating in PCMH transformation efforts linked to payment reform. The evaluation consisted of structured site visits, interviews, observations, and artifact reviews followed by a structured review of transcripts and documents for patterns, themes, and insights related to PCMH implementation. FINDINGS: We describe both the detailed components of each practice's transformation efforts and a grounded taxonomy of eight insights stemming from the experiences of these medical homes. We identified specific contextual factors related to wide variations in change tactics. We also observed widely varying approaches to catalyzing change using (or not) external consultants, specific challenges regarding health information technology implementation, team and staff role restructuring, compensation, and change fatigue, and several unexpected potential confounders or alternative explanations for practice success. CONCLUSIONS: Our evaluation affirms the value and necessity of qualitative methods for understanding primary care practice transformation, and it should encourage ongoing and future pilots to include assessments of the PCMH change process beyond clinical markers and claims data. The results raise insights into the heterogeneity of medical home transformation, the central but complex role of payment reform in creating a space for change, the ability of small practices to achieve substantial change in a short time period, and the challenges of sustaining it.

Adverse drug events caused by serious medication administration errors.

OBJECTIVE: To determine how often serious or life-threatening medication administration errors with the potential to cause harm (potential adverse drug events) result in actual harm (adverse drug events (ADEs)) in the hospital setting. DESIGN: Retrospective chart review of clinical events following observed medication administration errors. BACKGROUND: Medication errors are common at the medication administration stage for inpatients. While many errors can cause harm, it is unclear exactly how often. METHODS: In a previous study where 14 041 medication administrations were directly observed, 1271 medication administration errors were discovered, of which 133 had the potential to cause serious or life-threatening harm and were considered serious or life-threatening potential adverse drug events. As a follow-up, clinical reviewers conducted detailed chart review of serious or life-threatening potential ADEs to determine if they caused an ADE. Reviewers assessed severity of the ADE and attribution to the error. RESULTS: Ten (7.5% (95% CI 6.98 to 8.01)) actual ADEs resulted from the 133 serious and life-threatening potential ADEs, of which 6 resulted in significant, three in serious, and one life threatening injury. Therefore 4 (3% (95% CI 2.12 to 3.6)) of serious or life threatening potential ADEs led to serious or life threatening ADEs. Half of the ADEs were caused by dosage or monitoring errors for anti-hypertensives. CONCLUSIONS: Unintercepted potential ADEs at the medication administration stage can cause serious patient harm. At hospitals where 6 million doses are administered per year, about 4000 preventable ADEs would be attributable to medication administration errors annually.

The costs of adverse drug events in community hospitals.

BACKGROUND: Adverse drug events (ADEs) occur often in hospitals, causing high morbidity and a longer length of stay (LOS), and are costly. However, most studies on the impact of ADEs have been conducted in tertiary referral centers, which are systematically different than community hospitals, where the bulk of care is delivered, and most available data about ADE costs in any setting are dated. Costs in community settings are generally lower than in academic hospitals, and the costs of ADEs might be as well. To assess the additional costs and LOS associated with patients with ADEs, a multicenter retrospective cohort study was conducted in six community hospitals with 100 to 300 beds in Massachusetts during a 20-month observation period (January 2005-August 2006). METHODS: A random sample of 2,100 patients (350 patients per study site) was drawn from a pool of 109,641 patients treated within the 20-month observation period. Unadjusted and adjusted cost of ADEs as well as LOS were calculated. RESULTS: ADEs were associated with an increased adjusted cost of $3,420 and an adjusted increase in length of stay (LOS) of 3.15 days. For preventable ADEs, the respective figures were +$3,511 and +3.37 days. The severity of the ADE was also associated with higher costs--the costs were +$2,852 for significant ADEs (LOS +2.77 days), +$3,650 for serious ADEs (LOS +3.47 days), and +$8,116 for life-threatening ADEs (LOS +5.54 days, all p < .001). CONCLUSIONS: ADEs in community hospitals cost more than $3,000 dollars on average and an average increase of LOS of 3.1 days--increments that were similar to previous estimates from academic institutions. The LOS increase was actually greater. A number of approaches, including computerized provider order entry and bar coding, have the potential to improve medication safety.

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.

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.

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.

Occurrence of adverse, often preventable, events in community hospitals involving nephrotoxic drugs or those excreted by the kidney.

Medication errors in patients with reduced creatinine clearance are harmful and costly; however, most studies have been conducted in large academic hospitals. As there are few studies regarding this issue in smaller community hospitals, we conducted a multicenter, retrospective cohort study in six community hospitals (100 to 300 beds) to assess the incidence and severity of adverse drug events (ADEs) in patients with reduced creatinine clearance. A chart review was performed on adult patients hospitalized during a 20-month study period with serum creatinine over 1.5 mg/dl who were exposed to drugs that are nephrotoxic or cleared by the kidney. Among 109,641 patients, 17,614 had reduced creatinine clearance, and in a random sample of 900 of these patients, there were 498 potential ADEs and 90 ADEs. Among these ADEs, 91% were preventable, 51% were serious, 44% were significant, and 4.5% were life threatening. Of the potential ADEs, 54% were serious, 44% were significant, 1.6% were life threatening, and 96.6% were not intercepted. All 82 preventable events could have been intercepted by renal dose checking. Our study shows that ADEs were common in patients with impaired kidney function in community hospitals, and many appear potentially preventable with renal dose checking.

Adverse drug events and medication errors in psychiatry: methodological issues regarding identification and classification.

Abstract Adverse drug events and medication errors have received extensive study recently in a variety of clinical populations, though compared to many other areas relatively little work has focused on this area in psychiatry, especially with respect to the contribution of error to harm. The goal of this paper is to discuss methodological issues around measurement of medication safety in psychiatric patients. Against the background of a systems approach, a modern perspective of error management is discussed, and a multidimensional procedure for detection and classification of incidents related to the medication process is presented. This method has proven successful in non-psychiatric settings yielding the current best estimate of error rates and providing insight into the underlying causes. While this general approach can be adapted to the psychiatric setting, a number of issues make measurement especially challenging in psychiatry. These include the fluctuating course of psychiatric disorders, reduced patient adherence to the medication process, adverse effects which are often similar to symptoms of the underlying disorder, the frequent use of wide dose intervals depending on the clinical situation, and the presence of many drug-drug interactions. Data collected by means of the presented approach provide a basis for the development of effective strategies to reduce the risk of medication errors and thus improve patient safety in psychiatric care.