Fieran Mason-Blakley

On the safety of electronic medical records

Information and communication technology is rapidly transforming modern health care systems. Electronic Medical Records (EMRs) systems have replaced traditional forms of storing, processing, interpreting and exchanging patient health information in many health care organizations. However, an increasing number of concerns are raised about the quality of EMR systems and industry regulators are pondering ways to ensure safer health information technologies. This paper discusses fundamental concepts associated with the safety of EMR systems, describes current approaches to regulating the industry, and discusses limitations of traditional safety engineering methods with respect to their application to EMR systems. We then present a domain-specific adaptation of Levesons system-theoretic model STAMP for safety engineering of EMR systems and demonstrate its application with a real-world case study.

The safety of Electronic Medical Record (EMR) systems: what does EMR safety mean and how can we engineer safer systems?

Information and communication technology is rapidly transforming modern health care systems. Electronic Medical Records (EMRs) systems have replaced traditional forms of storing, processing, interpreting and exchanging patient health in many health care organizations. However, an increasing number of concerns are raised about the quality of EMR systems and industry regulators are pondering ways to ensure safer health information technologies. This paper discusses fundamental concepts associated with the safety of EMR systems, describes current approaches to regulating the industry, and discusses limitations of traditional safety engineering methods with respect to their application to EMR systems. We then present a domain-specific adaptation of Levesons system-theoretic model STAMP for safety engineering of EMR systems and demonstrate its application with a real-world case study.

Prospective Hazard Analysis for Information System

Clinical Information Technology (CIT) literature expresses a wide variety of hazards and unintended consequences which these technologies manifest. Literature review, field study, sample survey and experimental simulation have all been applied in an effort to understand the nature of these hazards, however, systematic hazard analysis techniques of systems which implement these technologies have been sparsely reported. In this article, we report on a synthesis of such methodologies which have been derived from the Failure Modes and Effects Analysis (FMEA) method. The synthesis revealed three central weaknesses of the qualitative aspects of the techniques which compromise reproducibility: consistent analysis scoping, consistent process modeling, and model comprehensiveness. We address the consistency of scoping and modeling by suggesting a hybridization of the event-centric FMEA techniques with another prospective technique - Levesons control loop centric system theoretic process analysis (STPA). We call this methodology Information Systems Hazard analysis (ISHA). We then address the weakness in comprehensiveness by suggesting the use of an information systems domain specific safety objectives taxonomy during the application of the hybridized technique.

CIS system hazards derived from literature using systems and human factors perspectives

The FDA and other national regulatory agencies have expressed their intentions to begin enforcement of medical device regulations on Health Informatics Technology (HIT) vendors. A mechanism which might be employed to achieve this enforcement in the US is the Quality Systems Regulations (QSR), while similar legislation might be employed elsewhere. In order for vendors to achieve conformance with QSR regulations, they must first identify hazards which their products may pose. In order to identify these hazards we have undertaken a literature review from which we have extracted taxonomies of Clinical Informatics Systems (CIS) devices, systems and hazards. We present these three taxonomies, and a discussion of contemporary risk classfication strategies which are being applied to HIT. The taxonomies which have been developed provide actionable hazards for HIT vendors, and provide a potential basis for best practices in the engineering of HIT systems.

Assessing STAMP EMR with Electronic Medical Record Related Incident Reports: Case Study: Manufacturer and User Facility Device Experience Database

At the turn of the millennium the institute of medicine (IOM) discovered that medical error was responsible for the deaths of as many as 98000 Americans each year. In response to this discovery they recommended the implementation of a wide range of Health Information and Communication Technology (HICT) including electronic medical records (EMRs). In spite of the broad based adherence of practitioners to these recommendation, the Agency for Healthcare Research and Quality (AHRQ) has not only failed to observe an improvement in the rate of errors, they have in fact observed the opposite. We propose that this failing arises from a fundamental misunderstanding of error which may be remedied by the application of a system theoretic framework. We propose a previously evaluated system model developed using the principles of the System Theoretic Accidents Models and Process (STAMP) framework for this purpose. In this work we aim to further assess the value of our model, STAMP EMR, by investigating the degree to which it aligns with the hazards and accidents reported in incident reports. We perform an initial coding of a corpus of incident reports against STAMP EMR as an a priori model. We analyze the raw results and further provide a multiple coordination analysis (MCA). We find firstly that no reports in the MAUDE could not be coded using the STAMP EMR model. We find secondly that four primary clusters of contributing factors are represented for the reports - validation, verification, engineering management and clinical management issues.

Information System Hazard Analysis and Mitigation

Health information and communication technology (HICT) poses technology specific hazards to patient safety. The FDAs MAUDE database is one source among many which reports on HICT related patient injuries and deaths. The stagnancy of the safety of these technologies in the ten years following Institute of Medicine warnings indicates a lack understanding of the nature of these hazards. As we have remedied the issues in existing technology, a pandemic of similar issues will soon be on us as more HICT will be deployed in the next ten years than has been in the history of medicine. To address this gap, we have adapted Levesons work on socio-technical safety engineering to develop a system theoretic model of information systems that re-imagines them as traditional control systems. We call this model System Theoretic Accidents Models and Processes for Information Systems (STAMP-IS). We have incorporated the model into a systematic safety engineering process we call information system hazard analysis and mitigation (ISHAM). ISHAM consists of an iterative four step process which includes team selection, modelling, analysis, and mitigation. It requires a process under investigation (PUI) as input, and retrospective accident data (RAD) ideally about the PUI itself, though RAD about a substantially similar process can be substituted.

Applying Information System Hazard Analysis to an Episodic Document Context

In spite of wide spread knowledge in the Clinical Information Technology (CIT) community about the unintended and sometimes hazardous consequences of the implementation and use of this technology, the application of systematic hazard analysis techniques in the domain for implementation projects, change management operations, or even prospective or retrospective static analysis have been sparsely reported. We report on the application of the Information Systems Hazard Analysis (ISHA) process to a conceptual architecture based on implementations of an electronic medical document exchange standard which was recently prescribed in British Columbia, Canada. The application of the technique with a focus on control coordination hazards identified a number of well known CIT hazards as well as a variety of less known hazards which the context presents.

Visual coder: clinical coding in translational research

As the fields of translational research and personalized medicine evolve, the need clinicians and scientists have to exchange experimental results is growing. As different terminologies are used to describe research results in different fields, a tool which could provide assistance in the automated integration of scientific and medical experimental results would be facilitated by semantic tagging using terminology sourced from a domain spanning thesaurus[5]. We present Visual Coder, a visualization tool for performing clinical coding of anatomic pathology structured reports (APSR) for the purpose of multidisciplinary knowledge exchange. The tool provides a visualization of a translational research terminology server and a graphical user interface which provides a set of visual tools to facilitate clinical coding.