Venous Access: National Guideline and Registry Development (VANGUARD): Advancing Patient-Centered Venous Access Care Through the Development of a National Coordinated Registry Network.

There are over 8 million central venous access devices inserted each year, many in patients with chronic conditions who rely on central access for life-preserving therapies. Central venous access device-related complications can be life-threatening and add tens of billions of dollars to health care costs, while their incidence is most likely grossly mis- or underreported by medical institutions. In this communication, we review the challenges that impair retention, exchange, and analysis of data necessary for a meaningful understanding of critical events and outcomes in this clinical domain. The difficulty is not only with data extraction and harmonization from electronic health records, national surveillance systems, or other health information repositories where data might be stored. The problem is that reliable and appropriate data are not recorded, or falsely recorded, at least in part because policy, payment, penalties, proprietary concerns, and workflow burdens discourage completeness and accuracy. We provide a roadmap for the development of health care information systems and infrastructure that address these challenges, framed within the context of research studies that build a framework of standardized terminology, decision support, data capture, and information exchange necessary for the task. This roadmap is embedded in a broader Coordinated Registry Network Learning Community, and facilitated by the Medical Device Epidemiology Network, a Public-Private Partnership sponsored by the US Food and Drug Administration, with the scope of advancing methods, national and international infrastructure, and partnerships needed for the evaluation of medical devices throughout their total life cycle.

A qualitative study of prevalent laboratory information systems and data communication patterns for genetic test reporting.

PURPOSE: The availability of genetic test data within the electronic health record (EHR) is a pillar of the US vision for an interoperable health IT infrastructure and a learning health system. Although EHRs have been highly investigated, evaluation of the information systems used by the genetic labs has received less attention-but is necessary for achieving optimal interoperability. This study aimed to characterize how US genetic testing labs handle their information processing tasks. METHODS: We followed a qualitative research method that included interviewing lab representatives and a panel discussion to characterize the information flow models. RESULTS: Ten labs participated in the study. We identified three generic lab system models and their relevant characteristics: a backbone system with additional specialized systems for interpreting genetic results, a brokering system that handles housekeeping and communication, and a single primary system for results interpretation and report generation. CONCLUSION: Labs have heterogeneous workflows and generally have a low adoption of standards when sending genetic test reports back to EHRs. Core interpretations are often delivered as free text, limiting their computational availability for clinical decision support tools. Increased provision of genetic test data in discrete and standard-based formats by labs will benefit individual and public health.

A qualitative investigation of biomedical informatics interoperability standards for genetic test reporting: benefits, challenges, and motivations from the testing laboratory's perspective.

PURPOSE: Genetic laboratory test reports can often be of limited computational utility to the receiving clinical information systems, such as clinical decision support systems. Many health-care interoperability (HC) standards aim to tackle this problem, but the perceived benefits, challenges, and motivations for implementing HC interoperability standards from the labs' perspective has not been systematically assessed. METHODS: We surveyed genetic testing labs across the United States and conducted a semistructured interview with responding lab representatives. We conducted a thematic analysis of the interview transcripts to identify relevant themes. A panel of experts discussed and validated the identified themes. RESULTS: Nine labs participated in the interview, and 24 relevant themes were identified within five domains. These themes included the challenge of complex and changing genetic knowledge, the motivation of competitive advantage, provided financial incentives, and the benefit of supporting the learning health system. CONCLUSION: Our study identified the labs' perspective on various aspects of implementing HC interoperability standards in producing and communicating genetic test reports. Interviewees frequently reported that increased adoption of HC standards may be motivated by competition and programs incentivizing and regulating the incorporation of interoperability standards for genetic test data, which could benefit quality control, research, and other areas.

Building a robust, scalable and standards-driven infrastructure for secondary use of EHR data: the SHARPn project.

The Strategic Health IT Advanced Research Projects (SHARP) Program, established by the Office of the National Coordinator for Health Information Technology in 2010 supports research findings that remove barriers for increased adoption of health IT. The improvements envisioned by the SHARP Area 4 Consortium (SHARPn) will enable the use of the electronic health record (EHR) for secondary purposes, such as care process and outcomes improvement, biomedical research and epidemiologic monitoring of the nation's health. One of the primary informatics problem areas in this endeavor is the standardization of disparate health data from the nation's many health care organizations and providers. The SHARPn team is developing open source services and components to support the ubiquitous exchange, sharing and reuse or 'liquidity' of operational clinical data stored in electronic health records. One year into the design and development of the SHARPn framework, we demonstrated end to end data flow and a prototype SHARPn platform, using thousands of patient electronic records sourced from two large healthcare organizations: Mayo Clinic and Intermountain Healthcare. The platform was deployed to (1) receive source EHR data in several formats, (2) generate structured data from EHR narrative text, and (3) normalize the EHR data using common detailed clinical models and Consolidated Health Informatics standard terminologies, which were (4) accessed by a phenotyping service using normalized data specifications. The architecture of this prototype SHARPn platform is presented. The EHR data throughput demonstration showed success in normalizing native EHR data, both structured and narrative, from two independent organizations and EHR systems. Based on the demonstration, observed challenges for standardization of EHR data for interoperable secondary use are discussed.

Computer clinical decision support that automates personalized clinical care: a challenging but needed healthcare delivery strategy.

How to deliver best care in various clinical settings remains a vexing problem. All pertinent healthcare-related questions have not, cannot, and will not be addressable with costly time- and resource-consuming controlled clinical trials. At present, evidence-based guidelines can address only a small fraction of the types of care that clinicians deliver. Furthermore, underserved areas rarely can access state-of-the-art evidence-based guidelines in real-time, and often lack the wherewithal to implement advanced guidelines. Care providers in such settings frequently do not have sufficient training to undertake advanced guideline implementation. Nevertheless, in advanced modern healthcare delivery environments, use of eActions (validated clinical decision support systems) could help overcome the cognitive limitations of overburdened clinicians. Widespread use of eActions will require surmounting current healthcare technical and cultural barriers and installing clinical evidence/data curation systems. The authors expect that increased numbers of evidence-based guidelines will result from future comparative effectiveness clinical research carried out during routine healthcare delivery within learning healthcare systems.

Logical Observation Identifiers Names and Codes (LOINC®) Applied to Microbiology: A National Laboratory Mapping Experience in Taiwan.

BACKGROUND AND OBJECTIVE: Logical Observation Identifiers Names and Codes (LOINC) is a universal standard for identifying laboratory tests and clinical observations. It facilitates a smooth information exchange between hospitals, locally and internationally. Although it offers immense benefits for patient care, LOINC coding is complex, resource-intensive, and requires substantial domain expertise. Our objective was to provide training and evaluate the performance of LOINC mapping of 20 pathogens from 53 hospitals participating in the National Notifiable Disease Surveillance System (NNDSS). METHODS: Complete mapping codes for 20 pathogens (nine bacteria and 11 viruses) were requested from all participating hospitals to review between January 2014 and December 2016. Participating hospitals mapped those pathogens to LOINC terminology, utilizing the Regenstrief LOINC mapping assistant (RELMA) and reported to the NNDSS, beginning in January 2014. The mapping problems were identified by expert panels that classified frequently asked questionnaires (FAQs) into seven LOINC categories. Finally, proper and meaningful suggestions were provided based on the error pattern in the FAQs. A general meeting was organized if the error pattern proved to be difficult to resolve. If the experts did not conclude the local issue's error pattern, a request was sent to the LOINC committee for resolution. RESULTS: A total of 53 hospitals participated in our study. Of these, 26 (49.05%) used homegrown and 27 (50.95%) used outsourced LOINC mapping. Hospitals who participated in 2015 had a greater improvement in LOINC mapping than those of 2016 (26.5% vs. 3.9%). Most FAQs were related to notification principles (47%), LOINC system (42%), and LOINC property (26%) in 2014, 2015, and 2016, respectively. CONCLUSIONS: The findings of our study show that multiple stage approaches improved LOINC mapping by up to 26.5%.

Interoperable genetic lab test reports: mapping key data elements to HL7 FHIR specifications and professional reporting guidelines.

OBJECTIVE: In many cases, genetic testing labs provide their test reports as portable document format files or scanned images, which limits the availability of the contained information to advanced informatics solutions, such as automated clinical decision support systems. One of the promising standards that aims to address this limitation is Health Level Seven International (HL7) Fast Healthcare Interoperability Resources Clinical Genomics Implementation Guide-Release 1 (FHIR CG IG STU1). This study aims to identify various data content of some genetic lab test reports and map them to FHIR CG IG specification to assess its coverage and to provide some suggestions for standard development and implementation. MATERIALS AND METHODS: We analyzed sample reports of 4 genetic tests and relevant professional reporting guidelines to identify their key data elements (KDEs) that were then mapped to FHIR CG IG. RESULTS: We identified 36 common KDEs among the analyzed genetic test reports, in addition to other unique KDEs for each genetic test. Relevant suggestions were made to guide the standard implementation and development. DISCUSSION AND CONCLUSION: The FHIR CG IG covers the majority of the identified KDEs. However, we suggested some FHIR extensions that might better represent some KDEs. These extensions may be relevant to FHIR implementations or future FHIR updates.The FHIR CG IG is an excellent step toward the interoperability of genetic lab test reports. However, it is a work-in-progress that needs informative and continuous input from the clinical genetics' community, specifically professional organizations, systems implementers, and genetic knowledgebase providers.

Enabling a learning healthcare system with automated computer protocols that produce replicable and personalized clinician actions.

Clinical decision-making is based on knowledge, expertise, and authority, with clinicians approving almost every intervention-the starting point for delivery of "All the right care, but only the right care," an unachieved healthcare quality improvement goal. Unaided clinicians suffer from human cognitive limitations and biases when decisions are based only on their training, expertise, and experience. Electronic health records (EHRs) could improve healthcare with robust decision-support tools that reduce unwarranted variation of clinician decisions and actions. Current EHRs, focused on results review, documentation, and accounting, are awkward, time-consuming, and contribute to clinician stress and burnout. Decision-support tools could reduce clinician burden and enable replicable clinician decisions and actions that personalize patient care. Most current clinical decision-support tools or aids lack detail and neither reduce burden nor enable replicable actions. Clinicians must provide subjective interpretation and missing logic, thus introducing personal biases and mindless, unwarranted, variation from evidence-based practice. Replicability occurs when different clinicians, with the same patient information and context, come to the same decision and action. We propose a feasible subset of therapeutic decision-support tools based on credible clinical outcome evidence: computer protocols leading to replicable clinician actions (eActions). eActions enable different clinicians to make consistent decisions and actions when faced with the same patient input data. eActions embrace good everyday decision-making informed by evidence, experience, EHR data, and individual patient status. eActions can reduce unwarranted variation, increase quality of clinical care and research, reduce EHR noise, and could enable a learning healthcare system.

Achieving "meaningful use" of electronic health records through the integration of the Nursing Management Minimum Data Set.

OBJECTIVE: To update the definitions and measures for the Nursing Management Minimum Data Set (NMMDS). BACKGROUND: Meaningful use of electronic health records includes reuse of the data for quality improvement. Nursing management data are essential to explain variances in outcomes. The NMMDS is a research-based minimum set of essential standardized management data useful to support nursing management and administrative decisions for quality improvement. METHODS: The NMMDS data elements, definitions, and measures were updated and normalized to current national standards and mapped to LOINC (Logical Observation Identifier Names and Codes), a federally recognized standardized data set for public dissemination. RESULTS: The first 3 NMMDS data elements were updated, mapped to LOINC, and publicly disseminated. CONCLUSIONS: Widespread use of the NMMDS could reduce administrative burden and enhance the meaningful use of healthcare data by ensuring that nursing relevant contextual data are available to improve outcomes and safety measurement for research and quality improvement in and across healthcare organizations.

Logical Observation Identifiers Names and Codes for Laboratorians.

CONTEXT.­: The Logical Observation Identifiers Names and Codes (LOINC) system is supposed to facilitate interoperability, and it is the federally required code for exchanging laboratory data. OBJECTIVE.­: To provide an overview of LOINC, emerging issues related to its use, and areas relevant to the pathology laboratory, including the subtleties of test code selection and importance of mapping the correct codes to local test menus. DATA SOURCES.­: This review is based on peer-reviewed literature, federal regulations, working group reports, the LOINC database (version 2.65), experience using LOINC in the laboratory at several large health care systems, and insight from laboratory information system vendors. CONCLUSIONS.­: The current LOINC database contains more than 55 000 numeric codes specific for laboratory tests. Each record in the LOINC database includes 6 major axes/parts for the unique specification of each individual observation or measurement. Assigning LOINC codes to a laboratory's test menu should be a defined process. In some cases, LOINC can aid in distinguishing laboratory data among different information systems, whereby such benefits are not achievable by relying on the laboratory test name alone. Criticisms of LOINC include the complexity and resource-intensive process of selecting the most correct code for each laboratory test, the real-world experience that these codes are not uniformly assigned across laboratories, and that 2 tests that may have the same appropriately assigned LOINC code may not necessarily have equivalency to permit interoperability of their result data. The coding system's limitations, which subsequently reduce the potential utility of LOINC, are poorly understood outside of the laboratory.

Lessons Learned in Creating Interoperable Fast Healthcare Interoperability Resources Profiles for Large-Scale Public Health Programs.

OBJECTIVE: This article describes lessons learned from the collaborative creation of logical models and standard Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) profiles for family planning and reproductive health. The National Health Service delivery program will use the FHIR profiles to improve federal reporting, program monitoring, and quality improvement efforts. MATERIALS AND METHODS: Organizational frameworks, work processes, and artifact testing to create FHIR profiles are described. RESULTS: Logical models and FHIR profiles for the Family Planning Annual Report 2.0 dataset have been created and validated. DISCUSSION: Using clinical element models and FHIR to meet the needs of a real-world use case has been accomplished but has also demonstrated the need for additional tooling, terminology services, and application sandbox development. CONCLUSION: FHIR profiles may reduce the administrative burden for the reporting of federally mandated program data.

Evaluating the accuracy of existing EMR data as predictors of follow-up providers.

In order to evaluate the accuracy of existing EMR data in predicting follow-up providers, a retrospective analysis was performed on six months of data for inpatient and ED encounters occurring at two hospitals, and on related outpatient data. Sensitivity and Positive Predictive Value (PPV) were calculated for each of eight predictors, to determine their effectiveness in predicting follow-up providers. Our findings indicate that access to longitudinal patient care records can improve prediction of which providers a patient is likely to see post-discharge compared to simply using Primary Care Provider data from admissions records. Of the predictors evaluated, a patient's past appointment history was the best predictor of which providers they would see in the future (PPV = 48% following inpatient visits, 35% following emergency department visits). However, even the best performing predictors failed to predict more than half of the follow-up providers and might generate many "false" alerts.

Computerized alerts improve outpatient laboratory monitoring of transplant patients.

Authors evaluated the impact of computerized alerts on the quality of outpatient laboratory monitoring for transplant patients. For 356 outpatient liver transplant patients managed at LDS Hospital, Salt Lake City, this observational study compared traditional laboratory result reporting, using faxes and printouts, to computerized alerts implemented in 2004. Study alerts within the electronic health record notified clinicians of new results and overdue new orders for creatinine tests and immunosuppression drug levels. After implementing alerts, completeness of reporting increased from 66 to >99 %, as did positive predictive value that a report included new information (from 46 to >99 %). Timeliness of reporting and clinicians' responses improved after implementing alerts (p <0.001): median times for clinicians to receive and complete actions decreased to 9 hours from 33 hours using the prior traditional reporting system. Computerized alerts led to more efficient, complete, and timely management of laboratory information.

System analysis and improvement in the process of transplant patient care.

Clinical information concerning transplant patients is voluminous and difficult to manage using paper records. A system analysis was performed to assess information system needs of the liver, kidney, and pancreas transplant program at LDS Hospital in Salt Lake City, Utah. After evaluating workflow, decision support needs, and requirements, we designed and implemented an extendable information system to support care following liver transplantation. We developed and implemented a standardized operative note, forms to enter external laboratory results and transplant-related information into the electronic health record, and computerized alerts to notify the transplant nurses when liver transplant patients had new, abnormal, or overdue laboratory results. The information system has improved the quality of clinical data available in the EHR, clinician satisfaction, and efficiency with management of laboratory results. The components developed for this project can be extended to meet other transplant program needs.

The Pluripotent Rendering of Clinical Data for Precision Medicine.

Health care and biomedical research are awash in data. Traditional data warehouse methodologies do not scale to this challenge; nor do their schema match the variety of analytic use cases. An alternative model, which shreds data into well-formed constituent data elements, conformant with the emerging CIMI-FHIR standards and stored together with the complete, raw, source data using modern and scalable data utilities such as Hadoop and its derivatives, affords the creation of pluripotent data repositories. Such repositories can be leveraged to generate any number of data marts, registries, and analytic data sets, each of which "just in time" binds an appropriate use-case specific data model. We call this notion PiCaRD: Pluripotent Clinical Repository of Data. We believe such nimble biomedical data management strategies are crucial for Precision Medicine discovery and application.

A case for manual entry of structured, coded laboratory data from multiple sources into an ambulatory electronic health record.

Laboratory results provide necessary information for the management of ambulatory patients. To realize the benefits of an electronic health record (EHR) and coded laboratory data (e.g., decision support and improved data access and display), results from laboratories that are external to the health care enterprise need to be integrated with internal results. We describe the development and clinical impact of integrating external results into the EHR at Intermountain Health Care (IHC). During 2004, over 14,000 external laboratory results for 128 liver transplant patients were added to the EHR. The results were used to generate computerized alerts that assisted clinicians with managing laboratory tests in the ambulatory setting. The external results were sent from 85 different facilities and can now be viewed in the EHR integrated with IHC results. We encountered regulatory, logistic, economic, and data quality issues that should be of interest to others developing similar applications.

Profiling Fast Healthcare Interoperability Resources (FHIR) of Family Health History based on the Clinical Element Models.

In this study we developed a Fast Healthcare Interoperability Resources (FHIR) profile to support exchanging a full pedigree based family health history (FHH) information across multiple systems and applications used by clinicians, patients, and researchers. We used previously developed clinical element models (CEMs) that are capable of representing the FHH information, and derived essential data elements including attributes, constraints, and value sets. We analyzed gaps between the FHH CEM elements and existing FHIR resources. Based on the analysis, we developed a profile that consists of 1) FHIR resources for essential FHH data elements, 2) extensions for additional elements that were not covered by the resources, and 3) a structured definition to integrate patient and family member information in a FHIR message. We implemented the profile using an open-source based FHIR framework and validated it using patient-entered FHH data that was captured through a locally developed FHH tool.

Clinical element models in the SHARPn consortium.

OBJECTIVE: The objective of the Strategic Health IT Advanced Research Project area four (SHARPn) was to develop open-source tools that could be used for the normalization of electronic health record (EHR) data for secondary use--specifically, for high throughput phenotyping. We describe the role of Intermountain Healthcare's Clinical Element Models ([CEMs] Intermountain Healthcare Health Services, Inc, Salt Lake City, Utah) as normalization "targets" within the project. MATERIALS AND METHODS: Intermountain's CEMs were either repurposed or created for the SHARPn project. A CEM describes "valid" structure and semantics for a particular kind of clinical data. CEMs are expressed in a computable syntax that can be compiled into implementation artifacts. The modeling team and SHARPn colleagues agilely gathered requirements and developed and refined models. RESULTS: Twenty-eight "statement" models (analogous to "classes") and numerous "component" CEMs and their associated terminology were repurposed or developed to satisfy SHARPn high throughput phenotyping requirements. Model (structural) mappings and terminology (semantic) mappings were also created. Source data instances were normalized to CEM-conformant data and stored in CEM instance databases. A model browser and request site were built to facilitate the development. DISCUSSION: The modeling efforts demonstrated the need to address context differences and granularity choices and highlighted the inevitability of iso-semantic models. The need for content expertise and "intelligent" content tooling was also underscored. We discuss scalability and sustainability expectations for a CEM-based approach and describe the place of CEMs relative to other current efforts. CONCLUSIONS: The SHARPn effort demonstrated the normalization and secondary use of EHR data. CEMs proved capable of capturing data originating from a variety of sources within the normalization pipeline and serving as suitable normalization targets.

Development of an information model for storing organ donor data within an electronic medical record.

OBJECTIVE: To develop a model to store information in an electronic medical record (EMR) for the management of transplant patients. The model for storing donor information must be designed to allow clinicians to access donor information from the transplant recipient's record and to allow donor data to be stored without needlessly proliferating new Logical Observation Identifier Names and Codes (LOINC) codes for already-coded laboratory tests. DESIGN: Information required to manage transplant patients requires the use of a donor's medical information while caring for the transplant patient. Three strategies were considered: (1) link the transplant patient's EMR to the donor's EMR; (2) use pre-coordinated observation identifiers (i.e., LOINC codes with *(wedge)DONOR specified in the system axes) to identify donor data stored in the transplant patient's EMR; and (3) use an information model that allows donor information to be stored in the transplant patient's record by allowing the "source" of the data (donor) and the "name" of the result (e.g., blood type) to be post-coordinated in the transplant patient's EMR. RESULTS: We selected the third strategy and implemented a flexible post-coordinated information model. There was no need to create new LOINC codes for already-coded laboratory tests. The model required that the data structure in the EMR allow for the storage of the "subject" of the test. CONCLUSION: The selected strategy met our design requirements and provided an extendable information model to store donor data. This model can be used whenever it is necessary to refer to one patient's data from another patient's EMR.

Completing Death Certificates from an EMR: Analysis of a Novel Public-Private Partnership.

With the objective of increasing electronic death registration, Intermountain Healthcare and the Utah Office of Vital Records and Statistics have developed a system enabling death certification from within Intermountain's electronic medical record (EMR), consisting of an EMR module and an HL7 interface. Comparison of post-intervention death certification at Intermountain Healthcare against a baseline study found a slight increase in the percentage of deaths certified electronically (73% pre vs. 77% post). Analysis of deaths certified using the EMR-module found that they were completed significantly sooner than those certified on paper or using the state's web-based electronic death registration system (EDRS) (Mean time: Paper = 114.72 hours, EDRS = 81.84 hours, EMR = 43.92 hours; p < 0.0001). EMR-certified deaths also contained significantly more causes of deaths than either alternative method (Mean number of causes: Paper = 3.9 causes, EDRS = 4.0 causes, EMR = 5.5 causes; p < 0.0001).