Assurance Case Research Articles

Software Assurance Using Structured Assurance Case Models.

Software assurance is an important part of the software development process to reduce risks and ensure that the software is dependable and trustworthy. Software defects and weaknesses can often lead to software errors and failures and to exploitation by malicious users. Testing, certification and accreditation have been traditionally used in the software assurance process to attempt to improve software trustworthiness.In this paper, we examine a methodology known as a structured assurance model, which has been widely used for assuring system safety, for its potential application to software assurance. We describe the structured assurance model and examine its application and use for software assurance. We identify strengths and weaknesses of this approach and suggest areas for further investigation and testing.

Virtual slide telepathology for an academic teaching hospital surgical pathology quality assurance program

Virtual slide telepathology is an important potential tool for providing re-review of surgical pathology cases as part of a quality assurance program. The University of Arizona pathology faculty has implemented a quality assurance program between 2 university hospitals located 6 miles apart. The flagship hospital, University Medical Center (UMC), in Tucson, AZ, handles approximately 20 000 surgical pathology specimens per year. University Physicians Healthcare Hospital (UPHH) at Kino Campus has one tenth the volume of surgical pathology cases. Whereas UMC is staffed by 10 surgical pathologists, UPHH is staffed daily by a single part-time pathologist on a rotating basis. To provide same-day quality assurance re-reviews of cases, a DMetrix DX-40 ultrarapid virtual slide scanner (DMetrix, Inc, Tucson, AZ) was installed at the UPHH in 2005. Since then, glass slides of new cases of cancer and other difficult cases have been scanned the same day the slides are produced by the UPHH histology laboratory. The pathologist at UPHH generates a provisional written report based on light microscopic examination of the glass slides. At 2:00 pm each day, completed cases from UPHH are re-reviewed by staff pathologists, pathology residents, and medical students at the UMC using the DMetrix Iris virtual slide viewer. The virtual slides are viewed on a 50-in plasma monitor. Results are communicated with the UPHH laboratory by fax. We have analyzed the results of the first 329 consecutive quality assurance cases. There was complete concordance with the original UPHH diagnosis in 302 (91.8%) cases. There were 5 (1.5%) major discrepancies, which would have resulted in different therapy and/or management, and 10 (3.0%) minor discrepancies. In 6 cases (1.8%), the diagnosis was deferred for examination of the glass slides by the reviewing pathologists at UMC, and the diagnosis of another 6 (1.8%) cases were deferred pending additional testing, usually immunohistochemistry. Thus, the quality assurance program found a small number of significant diagnostic discrepancies. We also found that implementation of a virtual slide telepathology quality assurance service improved the job satisfaction of academic subspecialty pathologists assigned to cover on-site surgical pathology services at a small, affiliated university hospital on a rotating part-time basis. These findings should be applicable to some community hospital group practices as well.

Quality Assurance Case of the Day

Quality Assurance Case of the Day

Special issue on applications and advances in problem frames

Special issue on applications and advances in problem frames

The essential synthesis of problem frames and assurance cases

Abstract: Problem frames and assurance cases are two current research areas that can improve – and have improved – system dependability, in critical and noncritical systems alike. While these two techniques are effective separately, their synthesis is much more powerful. This paper describes the synthesis of these two techniques and the rationale behind the synthesis, the particular pieces that influence each other, and the beginning of a process to integrate the two in software system development. A detailed example of the application of the synthesis is also provided.

Financial Times Business School Rankings: A Nontraditional Assurance Case in Three Parts*

ABSTRACTThe Financial Times of London (FT) is a business newspaper, with daily editions published in the United Kingdom, continental Europe, the United States, and Asia, and an estimated daily readership of 10 million people. In 1999 the FT began to publish a ranking of what it considered to be the top business schools in the world. Since their inception, these rankings have become increasingly relied upon by potential students and business school administrators worldwide. The FT's ranking is unique compared with other rankings because of its special international focus. Given the prominence of these rankings and the FT's position as a well‐respected business newspaper, the question of providing assurance over the business school rankings that the FT provides is particularly challenging.

Causes of Mortality on a University Hospital Neurology Service

The mortality rate for all patients cared for by inpatient neurology services has not been described. Quality assurance case discussions of all patients (n = 6012) admitted to a neurology service from 1996 to 2003 were reviewed to determine frequency and causes of mortality. All cases of mortality were reviewed in detail. The majority of patients (98%) survived their admission; 118 patients died. In 95/118 cases, care had been withdrawn at the time of death. In 11 cases, adverse events occurred during the patients' hospital stay and may have impacted outcome. Few patients (18%) had clear advance directives. Most mortality in this acute care neurology setting occurs in the course of stroke, epilepsy, or complicated tumor management and is managed through withdrawal of care with family participation.

International Working Group on Assurance Cases (for Security)

Critical systems are aptly named - from electric power to water and gas to the telephone system and the Internet, they're all critical to some aspect of our daily lives. We're a networked society and as such, it's important to both know whether critical systems are trustworthy and be able to communicate, review, and debate the level of trust achieved in them. In the safety domain, explicit safety cases are increasingly required by law, regulations, and standards. In this article, we outline what a small, international group of experts, spanning various disciplines in safety, security, reliability, and critical infrastructure, been doing with the International Working Group on Assurance Cases (for Security), what we hope to achieve, and where we go next

A descriptive model of preventability in maternal morbidity and mortality

To develop a descriptive model of preventability for maternal morbidity and mortality that can be used in quality assurance and morbidity and mortality review processes. This descriptive study was part of a larger case–control study conducted at the University of Illinois at Chicago in which maternal deaths were cases and women with severe maternal morbidity served as controls. Morbidities and mortalities were classified by a team of clinicians as preventable or not preventable. Qualitative analysis of data was conducted to identify and categorize different types of preventable events. Of 237 women, there were 79 women with preventable events attributable to provider or system factors. The most common types of preventable events were inadequate diagnosis/recognition of high-risk (54.4%), treatment (38.0%), and documentation (30.7%). A descriptive model was illustrated that can be used to categorize preventable events in maternal morbidity and mortality and can be incorporated into quality assurance and clinical case review to enhance the monitoring of hospital-based obstetric care and to decrease medical error.

Emergency Medicine Resident Errors Identification and Educational Utilization

To evaluate the error management systems emergency medicine residency directors (EMRDs) use to identify and report clinical errors made by emergency medicine residents and their satisfaction with error-based teaching as an educational tool. All 112 EMRDs listed by the Accreditation Council for Graduate Medical Education in 1996 were sent a 15-item survey. Five areas of error evaluation and management were assessed: 1) systems for tracking and reporting clinical errors; 2) resident participation in the systems; 3) resident remediation; 4) EMRD-perceived satisfaction with current error-reporting mechanisms, their educational value, and their ability to identify and prevent errors; and 5) EMRDs' perceptions of faculty and resident satisfaction with the systems. The response rate was 86%. All EMRDs indicated that methods are in place to track and report errors at their institutions. These include morbidity and mortality conference (94%), quality assurance case review conference (76%), and continuous quality improvement audits (60%). A majority of programs (58%) present resident cases anonymously in order to enhance teaching (39%), to avoid embarrassment (28%), and to avoid individual blame (24%). While mandated resident remediation is not required at 48% of the programs, 24% require lectures, 17% require written reports, and 6% require extra clinical shifts. The EMRDs rated the educational value of morbidity and mortality conference as outstanding (11%) or excellent (53%), and rated their systems for identifying key resident errors as outstanding (0%), excellent (14%), or good (47%). All emergency medicine residency programs have systems to track and report resident errors. Resident participation varies widely, as does resident remediation processes. Most EMRDs are satisfied with their systems but few EMRDs rate them as excellent in the detection or prevention of clinical errors.

The Right Solution to the Right Problem – A Quality Assurance Case

Users of edp - management or staff - quite often demand edp solutions for tasks which they cannot solve even without edp. They do not know if a logical solution exists. This gives a high risk of future conflicts concerning the feasibility and quality of developed edp solutions. If edp is to be used properly users and edp specialists must be able to clarify: What are the tasks to be solved; What are the proper solutions; How to priority the solutions; How are the solutions integrated; How can information systems and technology be applied at best The paper describes some processes and documentation standards which can be used to answer these questions. Process Quality Assurance is used for project structuring. Entity Lifecycle Analyses is used for definition and quality assurance with respect to validity, completeness and consistency of the basic system design. The way documentation is used leads to higher job satisfaction for project participants on all levels.

Clinical Quality Assurance

The Quality Assurance section has the responsibility for assessing all clinical trials conducted by the Division of Medical Affairs (DMA) for compliance with applicable regulations and procedures, and adherence to the protocol. The Quality Assurance section reviews protocols and case report forms, audits internal study files, audits the clinical stockroom, audits data review and computer entry, participates in review of New Drug Applications (NDAs) and audits the sites of clinical studies. Workshops are also conducted to update Medical Monitors and Clinical Research Associates (CRAs) with results of audits, changes in federal regulations and in DMA procedures Auditing functions are performed in accordance with current and proposed regulations. The Food and Drug Administration (FDA) compliance Programs for Sponsors, Monitors and Clinical Investigators are used as guides in conducted audits. The mechanics of performing internal and external auditing will be examined.

Further Notes on some Legal Aspects of Life Assurance Practice

Introduction.—Increased interest in legal matters on the part of actuaries.—Practical nature of legal questions in Institute examinations.—Need for information not found in ordinary text-books.—Why particulars of decided cases are given.—Reporting assurance cases in Journal.—Recent papers dealing with legal subjects.Nature of the Contract of Life Assurance.—Assurances where a larger amount is payable on maturity than on death.—Are these contracts of life assurance?—Essentials of contract of assurance.—Accident policies with return of premium on death or attainment of fixed age.—Test of a double contract.Insurable Interest.—Must the interest be a pecuniary one ?— Has an employer an insurable interest in the life of his weekly servant ?—Policy assigned immediately after issue.—Who can plead absence of insurable interest?—Return of premiums when assurance is void.—Agent as expert in assurance law.The Proposal.—Agent's knowledge as to misstatements in proposal.—Agent as agent of proposer and not of company.—When the agent is the agent of the company.—Conflicting decisions.