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author:("Singh, hardee")
1.  Resilient Actions in the Diagnostic Process and System Performance 
BMJ quality & safety  2013;22(12):10.1136/bmjqs-2012-001661.
Systemic issues can adversely affect the diagnostic process. Many system-related barriers can be masked by ‘resilient’ actions of frontline providers (ie, actions supporting the safe delivery of care in the presence of pressures that the system cannot readily adapt to). We explored system barriers and resilient actions of primary care providers (PCPs) in the diagnostic evaluation of cancer.
We conducted a secondary data analysis of interviews of PCPs involved in diagnostic evaluation of 29 lung and colorectal cancer cases. Cases covered a range of diagnostic timeliness and were analyzed to identify barriers for rapid diagnostic evaluation, and PCPs’ actions involving elements of resilience addressing those barriers. We rated these actions according to whether they were usual or extraordinary for typical PCP work.
Resilient actions and associated barriers were found in 59% of the cases, in all ranges of timeliness, with 40% involving actions rated as beyond typical. Most of the barriers were related to access to specialty services and coordination with patients. Many of the resilient actions involved using additional communication channels to solicit cooperation from other participants in the diagnostic process.
Diagnostic evaluation of cancer involves several resilient actions by PCPs targeted at system deficiencies. PCPs’ actions can sometimes mitigate system barriers to diagnosis, and thereby impact the sensitivity of ‘downstream’ measures (eg, delays) in detecting barriers. While resilient actions might enable providers to mitigate system deficiencies in the short run, they can be resource intensive and potentially unsustainable. They complement, rather than substitute for, structural remedies to improve system performance. Measures to detect and fix system performance issues targeted by these resilient actions could facilitate diagnostic safety.
PMCID: PMC3833904  PMID: 23813210
patient safety; systems resilience; quality and safety measurements; test results; care delays
2.  How context affects electronic health record-based test result follow-up: a mixed-methods evaluation 
BMJ Open  2014;4(11):e005985.
Electronic health record (EHR)-based alerts can facilitate transmission of test results to healthcare providers, helping ensure timely and appropriate follow-up. However, failure to follow-up on abnormal test results (missed test results) persists in EHR-enabled healthcare settings. We aimed to identify contextual factors associated with facility-level variation in missed test results within the Veterans Affairs (VA) health system.
Design, setting and participants
Based on a previous survey, we categorised VA facilities according to primary care providers’ (PCPs’) perceptions of low (n=20) versus high (n=20) risk of missed test results. We interviewed facility representatives to collect data on several contextual factors derived from a sociotechnical conceptual model of safe and effective EHR use. We compared these factors between facilities categorised as low and high perceived risk, adjusting for structural characteristics.
Facilities with low perceived risk were significantly more likely to use specific strategies to prevent alerts from being lost to follow-up (p=0.0114). Qualitative analysis identified three high-risk scenarios for missed test results: alerts on tests ordered by trainees, alerts ‘handed off’ to another covering clinician (surrogate clinician), and alerts on patients not assigned in the EHR to a PCP. Test result management policies and procedures to address these high-risk situations varied considerably across facilities.
Our study identified several scenarios that pose a higher risk for missed test results in EHR-based healthcare systems. In addition to implementing provider-level strategies to prevent missed test results, healthcare organisations should consider implementing monitoring systems to track missed test results.
PMCID: PMC4244393  PMID: 25387758
Elecronic Health Records; Missed Test Results; Patient Follow-up; Social-Technical Model; Patient Safety; Diagnostic Errors
3.  Root Cause Analysis Reports Help Identify Common Factors In Delayed Diagnosis And Treatment Of Outpatients 
Health affairs (Project Hope)  2013;32(8):10.1377/hlthaff.2013.0130.
Delays in diagnosis and treatment are widely considered to be threats to outpatient safety. However, few studies have identified and described what factors contribute to delays that might result in patient harm in the outpatient setting. We analyzed 111 root cause analysis reports that investigated such delays and were submitted to the Veterans Affairs National Center for Patient Safety in the period 2005–12. The most common contributing factors noted in the reports included coordination problems resulting from inadequate follow-up planning, delayed scheduling for unspecified reasons, inadequate tracking of test results, and the absence of a system to track patients in need of short-term follow-up. Other contributing factors were team-level decision making problems resulting from miscommunication of urgency between providers and providers' lack of awareness of or knowledge about a patient's situation; and communication failures among providers, patients, and other health care team members. Our findings suggest that to support care goals in the Affordable Care Act and the National Quality Strategy, even relatively sophisticated electronic health record systems will require enhancements. At the same time, policy initiatives should support programs to implement, and perhaps reward the use of, more rigorous interprofessional teamwork principles to improve outpatient communication and coordination.
PMCID: PMC3822525  PMID: 23918480
4.  An analysis of electronic health record-related patient safety concerns 
A recent Institute of Medicine report called for attention to safety issues related to electronic health records (EHRs). We analyzed EHR-related safety concerns reported within a large, integrated healthcare system.
The Informatics Patient Safety Office of the Veterans Health Administration (VA) maintains a non-punitive, voluntary reporting system to collect and investigate EHR-related safety concerns (ie, adverse events, potential events, and near misses). We analyzed completed investigations using an eight-dimension sociotechnical conceptual model that accounted for both technical and non-technical dimensions of safety. Using the framework analysis approach to qualitative data, we identified emergent and recurring safety concerns common to multiple reports.
We extracted 100 consecutive, unique, closed investigations between August 2009 and May 2013 from 344 reported incidents. Seventy-four involved unsafe technology and 25 involved unsafe use of technology. A majority (70%) involved two or more model dimensions. Most often, non-technical dimensions such as workflow, policies, and personnel interacted in a complex fashion with technical dimensions such as software/hardware, content, and user interface to produce safety concerns. Most (94%) safety concerns related to either unmet data-display needs in the EHR (ie, displayed information available to the end user failed to reduce uncertainty or led to increased potential for patient harm), software upgrades or modifications, data transmission between components of the EHR, or ‘hidden dependencies’ within the EHR.
EHR-related safety concerns involving both unsafe technology and unsafe use of technology persist long after ‘go-live’ and despite the sophisticated EHR infrastructure represented in our data source. Currently, few healthcare institutions have reporting and analysis capabilities similar to the VA.
Because EHR-related safety concerns have complex sociotechnical origins, institutions with long-standing as well as recent EHR implementations should build a robust infrastructure to monitor and learn from them.
PMCID: PMC4215044  PMID: 24951796
Electronic Health Records; sociotechnical; reporting systems; medical errors; human factors; patients safety
5.  Information Overload and Missed Test Results in EHR-based Settings 
JAMA internal medicine  2013;173(8):10.1001/2013.jamainternmed.61.
PMCID: PMC3822526  PMID: 23460235
diagnostic errors; patient safety; test results; care delays; health information technology; primary care; electronic health records; usability
6.  Types and Origins of Diagnostic Errors in Primary Care Settings 
JAMA internal medicine  2013;173(6):418-425.
Diagnostic errors are an understudied aspect of ambulatory patient safety.
To determine the types of diseases missed and the diagnostic process involved in the cases of confirmed diagnosis errors in primary care settings and to determine whether record reviews could shed light on potential contributory factors to inform future interventions.
We reviewed medical records of diagnostic errors detected at two sites through electronic health records-based triggers. Triggers were based on patterns of patients’ unexpected return visits after an initial primary care “index” visit.
A larger urban Veterans Affairs facility and a large integrated private health care system.
Our study focused on 190 unique instances of diagnostic errors detected in primary care visits between October 1, 2006, and September 30, 2007.
Main Outcome Measures
Through medical record reviews, we collected data on presenting symptoms at the index visit, types of diagnoses missed, process breakdowns, potential contributory factors, and potential for harm from errors.
In 190 cases, a total of 68 unique diagnoses were missed. Most missed diagnoses were common conditions in primary care, with pneumonia (6.7%), decompensated congestive heart failure (5.7%), acute renal failure (5.3%), cancer (primary) (5.3%), and urinary tract infection or pyelonephritis (4.8%) being most common. Process breakdowns most frequently involved the patient-practitioner clinical encounter (78.9%) but were also related to referrals (19.5%), patient-related factors (16.3%), follow-up and tracking of diagnostic information (14.7%), and performance and interpretation of diagnostic tests (13.6%). A total of 43.7% of cases involved more than one of these processes. Patient- practitioner encounter breakdowns were primarily related to problems with history-taking (56.3%), examination (47.4%), and/or ordering diagnostic tests for further work-up (57.4%). Most errors were associated with potential for moderate-to-severe harm.
Conclusions and Relevance
Diagnostic errors identified in our study involved a large variety of common diseases and had significant potential for harm. Most errors were related to process breakdowns in the patient-practitioner clinical encounter. Preventive interventions should target common contributory factors across diagnoses, especially those that involve data gathering and synthesis in the patient- practitioner encounter.
PMCID: PMC3690001  PMID: 23440149
diagnostic errors; patient safety; follow-up; primary care; electronic health records
7.  Effectiveness of an Electronic Health Record-Based Intervention to Improve Follow-up of Abnormal Pathology Results: a Retrospective Record Analysis 
Medical care  2012;50(10):898-904.
Background and Objective
On March 11, 2009, the Veterans Health Administration (VA) implemented an electronic health record (EHR)-based intervention that required all pathology results to be transmitted to ordering providers via mandatory automated notifications. We examined the impact of this intervention on improving follow-up of abnormal outpatient pathology results.
Research Design and Subjects
We extracted pathology reports from the EHR of two VA sites. From 16,738 pre- and 17,305 post-intervention reports between 09/01/2008 and 09/30/2009, we randomly selected about 5% and evaluated follow-up outcomes using a standardized chart review instrument. Documented responses to the alerted report (e.g., ordering follow-up tests or referrals, notifying patients, and prescribing/changing treatment) were recorded.
Primary outcome measures included proportion of timely follow-up responses (within 30 days) and median time to direct response for abnormal reports.
Of 816 pre- and 798 post-intervention reports reviewed, 666 (81.6%) and 688 (86.2%) were abnormal. Overall, there was no apparent intervention effect on timely follow-up (69% vs. 67.1%;p=0.4) or median time to direct response (8 days vs. 8 days; p=0.7). However, logistic regression uncovered a significant intervention effect (pre-intervention OR, 0.7; 95%CI 0.5-1.0) after accounting for site-specific differences in follow-up, with a lower likelihood of timely follow-up at one site (OR,0.4; 95%CI 0.2-0.7).
An electronic intervention to improve test result follow-up at two VA institutions using the same EHR was found effective only after accounting for certain local contextual factors. Aggregating the effect of EHR interventions across different institutions and EHRs without controlling for contextual factors might underestimate their potential benefits.
PMCID: PMC3444625  PMID: 22929995
Anatomic pathology; electronic health record; communication; follow-up; post-analytic phase
9.  Post-Referral Colonoscopy Delays in Diagnosis of Colorectal Cancer: A Mixed-Methods Analysis 
Quality management in health care  2012;21(4):252-261.
Delays in colorectal cancer (CRC) diagnosis are one of the most common reasons for malpractice claims and lead to poor outcomes. However, they are not well studied.
We used a mixed quantitative-qualitative approach to analyze post-referral colonoscopy delays in CRC patients and explored referring physician’s perception of processes surrounding these delays.
Two physician-raters conducted independent electronic health record reviews of new CRC cases in a large integrated safety-net system to determine post-referral colonoscopy delays, which we defined as failures to perform colonoscopy within 60 days of referral for an established indication(s). To explore perceptions of colonoscopy processes, we conducted semi-structured interviews with a sample of primary care physicians (PCPs) and used a content analysis approach.
Of 104 CRC cases that met inclusion criteria, reviewers agreed on the presence of post-referral colonoscopy delays in 35 (33.7%) cases; κ = 0.99 (95% CI, 0.83–0.99). The median time between first referral and completion of colonoscopy was 123.0 days (range 62.0–938.0; IQR=90.0 days). In about two-thirds of instances (64.8%), the reason for delay was a delayed future appointment with the gastroenterology service. On interviews, PCPs attributed long delays in scheduling to reduced endoscopic capacity and inefficient processes related to colonoscopy referral and scheduling, including considerable ambiguity regarding referral guidelines. Many suggested that navigation models be applied to streamline CRC diagnosis.
Post-referral delays in CRC diagnosis are potentially preventable. A comprehensive mixed-methods methodology might be useful for others to identify the steps in the diagnostic process that are in most need for improvement.
PMCID: PMC3702372  PMID: 23011072
Diagnostic delays; colorectal cancer; primary care; referrals; practice patterns
10.  Rights and responsibilities of users of electronic health records 
PMCID: PMC3447016  PMID: 22331971
11.  Impact of Resident Duty Hour Limits on Safety in the ICU: A National Survey of Pediatric and Neonatal Intensivists 
Resident duty-hour regulations potentially shift workload from resident to attending physicians. We sought to understand how current or future regulatory changes might impact safety in academic pediatric and neonatal intensive care units (ICUs).
Web-based survey
US academic pediatric and neonatal ICUs
Attending pediatric and neonatal intensivists
We evaluated perceptions on four ICU safety-related risk measures potentially affected by current duty-hour regulations: 1) Attending physician and resident fatigue, 2) Attending physician work-load, 3) Errors (self-reported rates by attending physicians or perceived resident error rates), and 4) Safety culture. We also evaluated perceptions of how these risks would change with further duty hour restrictions.
Measurements and Main Results
We administered our survey between February and April 2010 to 688 eligible physicians, of which 360 (52.3%) responded. Most believed that resident error rates were unchanged or worse (91.9%) and safety culture was unchanged or worse (84.4%) with current duty-hour regulations. Of respondents, 61.9% believed their own work-hours providing direct patient care increased and 55.8% believed they were more fatigued while providing direct patient care. Most (85.3%) perceived no increase in their own error rates currently, but in the scenario of further reduction in resident duty-hours, over half (53.3%) believed that safety culture would worsen and a significant proportion (40.3%) believed that their own error rates would increase.
Pediatric intensivists do not perceive improved patient safety from current resident duty hour restrictions. Policies to further restrict resident duty hours should consider unintended consequences of worsening certain aspects of ICU safety.
PMCID: PMC3427401  PMID: 22614570
Resident duty hours; graduate medical education; Patient Safety; Intensive Care; Pediatrics; Medical Errors
12.  Challenges of Making a Diagnosis in the Outpatient Setting: A Multi-Site Survey of Primary Care Physicians 
BMJ quality & safety  2012;21(8):641-648.
Although misdiagnosis in the outpatient setting leads to significant patient harm and wasted resources, it is not well studied. We surveyed primary care physicians (PCPs) about barriers to timely diagnosis in the outpatient setting and assessed their perceptions of diagnostic difficulty.
We conducted a survey of general internists and family physicians practicing in an integrated health system across 10 geographically dispersed states in 2005. The survey elicited information on key cognitive failures (such as in clinical knowledge or judgment) for a specific case, and solicited strategies for reducing diagnostic delays. Content analysis was used to categorize cognitive failures and strategies for improvement. We examined the extent and predictors of diagnostic difficulty, defined as reporting >5% patients difficult to diagnose.
Of 1817 physicians surveyed, 1054 (58%) responded; 848 (80%) respondents primarily practiced in outpatient settings and had an assigned patient panel (inclusion sample). Inadequate knowledge (19.9%) was the most commonly reported cognitive factor. Half reported >5% of their patients were difficult to diagnose; more experienced physicians reported less diagnostic difficulty. In adjusted analyses, problems with information processing (information availability and time to review it) and the referral process, were associated with greater diagnostic difficulty. Strategies for improvement most commonly involved workload issues (panel size, non-visit tasks).
PCPs report a variety of reasons for diagnostic difficulties in primary care practice. In our study, knowledge gaps appear to be a prominent concern. Interventions that address these gaps as well as practice level issues such as time to process diagnostic information and better subspecialty input may reduce diagnostic difficulties in primary care.
PMCID: PMC3680371  PMID: 22626738
diagnostic error; missed and delayed diagnosis; primary care; cognitive errors; patient safety
13.  Primary care and communication in shared cancer care: A Qualitative Study 
To explore perceptions of primary care physicians’ (PCPs) and oncologists’ roles, responsibilities, and patterns of communication related to shared cancer care in three integrated health systems that used electronic health records (EHRs).
Study design
Qualitative study.
We conducted semi-structured interviews with ten early stage colorectal cancer patients and fourteen oncologists and PCPs. Sample sizes were determined by thematic saturation. Dominant themes and codes were identified and subsequently applied to all transcripts.
Physicians reported that EHRs improved communication within integrated systems, but communication with physicians outside their system was still difficult. PCPs expressed uncertainty about their role during cancer care, even though medical oncologists emphasized the importance of co-morbidity control during cancer treatment. Both patients and physicians described additional roles for PCPs, including psychological distress support and behavior modification.
Integrated systems that use EHRs likely facilitate shared cancer care through improved PCP-oncologist communication. However, strategies to facilitate a more active role for PCPs in managing co-morbidities, psychological distress and behavior modification, as well as to overcome communication challenges between physicians not practicing within the same integrated system, are still needed to improve shared cancer care.
PMCID: PMC3693186  PMID: 21615196
14.  Exploring Situational Awareness in Diagnostic Errors in Primary Care 
BMJ quality & safety  2011;21(1):30-38.
Diagnostic errors in primary care are harmful but poorly studied. To facilitate understanding of diagnostic errors in real-world primary care settings using electronic health records (EHRs), this study explored the use of the Situational Awareness (SA) framework from aviation human factors research.
A mixed-methods study was conducted involving reviews of EHR data followed by semi-structured interviews of selected providers from two institutions in the US. The study population included 380 consecutive patients with colorectal and lung cancers diagnosed between February 2008 and January 2009. Using a pre-tested data collection instrument, trained physicians identified diagnostic errors, defined as lack of timely action on one or more established indications for diagnostic work-up for lung and colorectal cancers. Twenty-six providers involved in cases with and without errors were interviewed. Interviews probed for providers' lack of SA and how this may have influenced the diagnostic process.
Of 254 cases meeting inclusion criteria, errors were found in 30 (32.6%) of 92 lung cancer cases and 56 (33.5%) of 167 colorectal cancer cases. Analysis of interviews related to error cases revealed evidence of lack of one of four levels of SA applicable to primary care practice: information perception, information comprehension, forecasting future events, and choosing appropriate action based on the first three levels. In cases without error, the application of the SA framework provided insight into processes involved in attention management.
A framework of SA can help analyze and understand diagnostic errors in primary care settings that use EHRs.
PMCID: PMC3692739  PMID: 21890757
diagnostic error; decision-making; patient safety; primary care; medical errors; human factors; cancer; electronic health records; diagnostic delays
15.  Electronic Health Records and National Patient-Safety Goals 
The New England journal of medicine  2012;367(19):1854-1860.
PMCID: PMC3690003  PMID: 23134389
16.  Electronic Health Record-Based Surveillance of Diagnostic Errors in Primary Care 
BMJ quality & safety  2011;21(2):93-100.
Diagnostic errors in primary care are harmful but difficult to detect. We tested an electronic health record (EHR)-based method to detect diagnostic errors in routine primary care practice.
We conducted a retrospective study of primary care visit records “triggered” through electronic queries for possible evidence of diagnostic errors: Trigger 1: A primary care index visit followed by unplanned hospitalization within 14 days; and Trigger 2: A primary care index visit followed by ≥ 1 unscheduled visit(s) within 14 days. Control visits met neither criterion. Electronic trigger queries were applied to EHR repositories at two large healthcare systems between October 1, 2006 and September 30, 2007. Blinded physician-reviewers independently determined presence or absence of diagnostic errors in selected triggered and control visits. An error was defined as a missed opportunity to make or pursue the correct diagnosis when adequate data was available at the index visit. Disagreements were resolved by an independent third reviewer.
Queries were applied to 212,165 visits. On record review, we found diagnostic errors in 141 of 674 Trigger 1-positive records (PPV=20.9%, 95% CI, 17.9%-24.0%) and 36 of 669 Trigger 2-positive records (PPV=5.4%, 95% CI, 3.7%-7.1%). The control PPV of 2.1% (95% CI, 0.1%-3.3%) was significantly lower than that of both triggers (P ≤ .002). Inter-rater reliability was modest, though higher than in comparable previous studies (κ = 0.37 [95% CI=0.31-0.44]).
While physician agreement on diagnostic error remains low, an EHR-facilitated surveillance methodology could be useful for gaining insight into the origin of these errors.
PMCID: PMC3680372  PMID: 21997348
diagnostic errors; primary care; patient safety; electronic health records; triggers; automated surveillance; error detection
17.  Creating an Oversight Infrastructure for Electronic Health Record-Related Patient Safety Hazards 
Journal of patient safety  2011;7(4):169-174.
Electronic health records (EHRs) have potential quality and safety benefits. However, reports of EHR-related safety hazards are now emerging. The Office of the National Coordinator (ONC) for Health Information Technology (HIT) recently sponsored an Institute of Medicine committee to evaluate how HIT use affects patient safety. In this paper, we propose the creation of a national EHR oversight program to provide dedicated surveillance of EHR-related safety hazards and to promote learning from identified errors, close calls, and adverse events. The program calls for data gathering, investigation/analysis and regulatory components. The first two functions will depend on institution-level EHR safety committees that will investigate all known EHR-related adverse events and near-misses and report them nationally using standardized methods. These committees should also perform routine safety self-assessments to proactively identify new risks. Nationally, we propose the long-term creation of a centralized, non-partisan board with an appropriate legal and regulatory infrastructure to ensure the safety of EHRs. We discuss the rationale of the proposed oversight program and its potential organizational components and functions. These include mechanisms for robust data collection and analyses of all safety concerns using multiple methods that extend beyond reporting; multidisciplinary investigation of selected high-risk safety events; and enhanced coordination with other national agencies in order to facilitate broad dissemination of hazards information. Implementation of this proposed infrastructure can facilitate identification of EHR-related adverse events and errors and potentially create a safer and more effective EHR-based health care delivery system.
PMCID: PMC3677059  PMID: 22080284
18.  System Related Interventions to Reduce Diagnostic Error: A Narrative Review 
BMJ quality & safety  2011;21(2):160-170.
Diagnostic errors (missed, delayed, or wrong diagnosis) have gained recent attention and are associated with significant preventable morbidity and mortality. We reviewed the recent literature to identify interventions that have been, or could be, implemented to address systems-related factors that contribute directly to diagnostic error.
We conducted a comprehensive search using multiple search strategies. We first identified candidate articles in English between 2000 and 2009 from a PubMed search that exclusively evaluated for articles related to diagnostic error or delay. We then sought additional papers from references in the initial dataset, searches of additional databases, and subject matter experts. Articles were included if they formally evaluated an intervention to prevent or reduce diagnostic error; however, we also included papers if interventions were suggested and not tested in order to inform the state-of-the science on the topic. We categorized interventions according to the step in the diagnostic process they targeted: patient-provider encounter, performance and interpretation of diagnostic tests, follow-up and tracking of diagnostic information, subspecialty and referral-related; and patient-specific.
We identified 43 articles for full review, of which 6 reported tested interventions and 37 contained suggestions for possible interventions. Empirical studies, though somewhat positive, were non-experimental or quasi-experimental and included a small number of clinicians or health care sites. Outcome measures in general were underdeveloped and varied markedly between studies, depending on the setting or step in the diagnostic process involved.
Despite a number of suggested interventions in the literature, few empirical studies have tested interventions to reduce diagnostic error in the last decade. Advancing the science of diagnostic error prevention will require more robust study designs and rigorous definitions of diagnostic processes and outcomes to measure intervention effects.
PMCID: PMC3677060  PMID: 22129930
19.  Defining Health Information Technology-related Errors: New Developments Since To Err is Human* 
Archives of internal medicine  2011;171(14):1281-1284.
Despite its promise, recent literature has revealed possible safety hazards of health information technology (HIT) use. The Office of the National Coordinator for HIT recently sponsored an Institute of Medicine committee to synthesize evidence and experience from the field on how HIT affects patient safety. To lay the groundwork for defining, measuring, and analyzing HIT-related safety hazards, we propose that Health information technology-related error occurs anytime HIT is unavailable for use, malfunctions during use, is used incorrectly by someone, or when HIT interacts with another system component incorrectly, resulting in data being lost or incorrectly entered, displayed, or transmitted. These errors, or the decisions that result from them, significantly increase the risk of adverse events and patient harm. In this paper, we describe how a socio-technical approach can be used to understand the complex origins of HIT errors, which may have roots in rapidly evolving technological, professional, organizational, and policy initiatives.
PMCID: PMC3677061  PMID: 21788544
Electronic Health Records; Health Information Technology; Patient Safety; Errors
20.  Safety Assurance Factors for Electronic Health Record Resilience (SAFER): study protocol 
Implementation and use of electronic health records (EHRs) could lead to potential improvements in quality of care. However, the use of EHRs also introduces unique and often unexpected patient safety risks. Proactive assessment of risks and vulnerabilities can help address potential EHR-related safety hazards before harm occurs; however, current risk assessment methods are underdeveloped. The overall objective of this project is to develop and validate proactive assessment tools to ensure that EHR-enabled clinical work systems are safe and effective.
This work is conceptually grounded in an 8-dimension model of safe and effective health information technology use. Our first aim is to develop self-assessment guides that can be used by health care institutions to evaluate certain high-risk components of their EHR-enabled clinical work systems. We will solicit input from subject matter experts and relevant stakeholders to develop guides focused on 9 specific risk areas and will subsequently pilot test the guides with individuals representative of likely users. The second aim will be to examine the utility of the self-assessment guides by beta testing the guides at selected facilities and conducting on-site evaluations. Our multidisciplinary team will use a variety of methods to assess the content validity and perceived usefulness of the guides, including interviews, naturalistic observations, and document analysis. The anticipated output of this work will be a series of self-administered EHR safety assessment guides with clear, actionable, checklist-type items.
Proactive assessment of patient safety risks increases the resiliency of health care organizations to unanticipated hazards of EHR use. The resulting products and lessons learned from the development of the assessment guides are expected to be helpful to organizations that are beginning the EHR selection and implementation process as well as those that have already implemented EHRs. Findings from our project, currently underway, will inform future efforts to validate and implement tools that can be used by health care organizations to improve the safety of EHR-enabled clinical work systems.
PMCID: PMC3639028  PMID: 23587208
Electronic health records; Health information technology; Patient safety; Risk assessment; Resilience
21.  Primary care practitioners’ views on test result management in EHR-enabled health systems: a national survey 
Failure to notify patients of test results is common even when electronic health records (EHRs) are used to report results to practitioners. We sought to understand the broad range of social and technical factors that affect test result management in an integrated EHR-based health system.
Between June and November 2010, we conducted a cross-sectional, web-based survey of all primary care practitioners (PCPs) within the Department of Veterans Affairs nationwide. Survey development was guided by a socio-technical model describing multiple inter-related dimensions of EHR use.
Of 5001 PCPs invited, 2590 (51.8%) responded. 55.5% believed that the EHRs did not have convenient features for notifying patients of test results. Over a third (37.9%) reported having staff support needed for notifying patients of test results. Many relied on the patient's next visit to notify them for normal (46.1%) and abnormal results (20.1%). Only 45.7% reported receiving adequate training on using the EHR notification system and 35.1% reported having an assigned contact for technical assistance with the EHR; most received help from colleagues (60.4%). A majority (85.6%) stayed after hours or came in on weekends to address notifications; less than a third reported receiving protected time (30.1%). PCPs strongly endorsed several new features to improve test result management, including better tracking and visualization of result notifications.
Despite an advanced EHR, both social and technical challenges exist in ensuring notification of test results to practitioners and patients. Current EHR technology requires significant improvement in order to avoid similar challenges elsewhere.
PMCID: PMC3721157  PMID: 23268489
missed test results; medical errors; diagnostic errors; lack of follow-up; health information technology; electronic health records
22.  Safer electronic health records: Using the science of informatics to develop safety assessment guides 
Following the IOM report, “Health IT and Patient Safety: Building Safer Systems for Better Care,” the Office of the National Coordinator for Health Information Technology sponsored a project to address safety concerns in electronic health record-enabled (EHR) healthcare systems. To address the complexity of EHR-related errors and the difficulty in eliminating them, we designed the SAFER project (Safety Assurance Factors for EHR Resilience) to proactively identify potential safety issues and best practices for addressing them. We take into account the full sociotechnical context of EHR implementation and use. Our iterative work is grounded in several recently developed informatics-based scientific methods including: Review of scientific clinical informatics literatureUse of Rapid Assessment Process mixed-methods approaches developed for evaluating EHR-enabled healthcare systems in contextA semantic wiki for asynchronous collaborationAn 8-dimension socio-technical model of safe and effective EHR use
We are developing and piloting self-assessment “checklist-type” tools using a unique mix of methods based on the science of biomedical informatics. As the country continues its rapid EHR deployment, we believe that these tools are essential to ensure that the safety of the “EHR-enabled healthcare system” continues to improve.
PMCID: PMC3540559
23.  Rethinking Resident Supervision to Improve Safety: From Hierarchical to Interprofessional Models 
Inadequate supervision is a significant contributing factor to medical errors involving trainees but supervision in high-risk settings such as the Intensive Care Unit (ICU) is not well studied.
We explored how residents in the ICU experienced supervision related to medication safety not only from supervising physicians but also from other professionals.
Design, Setting, Measurements
Using qualitative methods, we examined in-depth interviews with 17 residents working in ICUs of three tertiary-care hospitals. We analyzed residents' perspectives on receiving and initiating supervision from physicians within the traditional medical hierarchy and from other professionals, including nurses, staff pharmacists and clinical pharmacists (“interprofessional supervision”).
While initiating their own supervision within the traditional hierarchy, residents believed in seeking assistance from fellows and attendings and articulated rules of thumb for doing so; however, they also experienced difficulties. Some residents were concerned that their questions would reflect poorly on them; others were embarrassed by their mistaken decisions. Conversely, residents described receiving interprofessional supervision from nurses and pharmacists, who proactively monitored, intervened in, and guided residents' decisions. Residents relied on nurses and pharmacists for non-judgmental answers to their queries, especially after-hours. To enhance both types of supervision, residents emphasized the importance of improving interpersonal communication skills.
Residents depended on interprofessional supervision when making decisions regarding medications in the ICU. Improving interprofessional supervision, which thus far has been under-recognized and underemphasized in graduate medical education, can potentially improve medication safety in high-risk settings.
PMCID: PMC3201712  PMID: 21990173
medical errors; housestaff; supervision; communication; teamwork; patient safety; medication errors
24.  Improving the Effectiveness of Electronic Health Record-Based Referral Processes 
Electronic health records are increasingly being used to facilitate referral communication in the outpatient setting. However, despite support by technology, referral communication between primary care providers and specialists is often unsatisfactory and is unable to eliminate care delays. This may be in part due to lack of attention to how information and communication technology fits within the social environment of health care. Making electronic referral communication effective requires a multifaceted “socio-technical” approach. Using an 8-dimensional socio-technical model for health information technology as a framework, we describe ten recommendations that represent good clinical practices to design, develop, implement, improve, and monitor electronic referral communication in the outpatient setting. These recommendations were developed on the basis of our previous work, current literature, sound clinical practice, and a systems-based approach to understanding and implementing health information technology solutions. Recommendations are relevant to system designers, practicing clinicians, and other stakeholders considering use of electronic health records to support referral communication.
PMCID: PMC3492108  PMID: 22973874
25.  Fenretinide metabolism in humans and mice: utilizing pharmacological modulation of its metabolic pathway to increase systemic exposure 
British Journal of Pharmacology  2011;163(6):1263-1275.
High plasma levels of fenretinide [N-(4-hydroxyphenyl)retinamide (4-HPR)] were associated with improved outcome in a phase II clinical trial. Low bioavailability of 4-HPR has been limiting its therapeutic applications. This study characterized metabolism of 4-HPR in humans and mice, and to explore the effects of ketoconazole, an inhibitor of CYP3A4, as a modulator to increase 4-HPR plasma levels in mice and to increase the low bioavailability of 4-HPR.
4-HPR metabolites were identified by mass spectrometric analysis and levels of 4-HPR and its metabolites [N-(4-methoxyphenyl)retinamide (4-MPR) and 4-oxo-N-(4-hydroxyphenyl)retinamide (4-oxo-4-HPR)] were quantified by high-performance liquid chromatography (HPLC). Kinetic analysis of enzyme activities and the effects of enzyme inhibitors were performed in pooled human and pooled mouse liver microsomes, and in human cytochrome P450 (CYP) 3A4 isoenzyme microsomes. In vivo metabolism of 4-HPR was inhibited in mice.
Six 4-HPR metabolites were identified in the plasma of patients and mice. 4-HPR was oxidized to 4-oxo-4-HPR, at least in part via human CYP3A4. The CYP3A4 inhibitor ketoconazole significantly reduced 4-oxo-4-HPR formation in both human and mouse liver microsomes. In two strains of mice, co-administration of ketoconazole with 4-HPR in vivo significantly increased 4-HPR plasma concentrations by > twofold over 4-HPR alone and also increased 4-oxo-4-HPR levels.
Mice may serve as an in vivo model of human 4-HPR pharmacokinetics. In vivo data suggest that the co-administration of ketoconazole at normal clinical doses with 4-HPR may increase systemic exposure to 4-HPR in humans.
PMCID: PMC3144539  PMID: 21391977
fenretinide; metabolism; ketoconazole; paediatric cancers

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