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Evaluation of megakaryocyte morphology is difficult but can be essential for the diagnosis of myelodysplastic syndromes (MDS) and other myeloid neoplasms. We agreed upon descriptions and provided images of megakaryoblasts and of normal and dysplastic megakaryocytes, which were used as a basis for assessing the concordance of expert morphologists in their recognition. We showed a high rate of concordance for the recognition of micromegakaryocytes and confirmed their strong association with hematologic neoplasia, including MDS. Concordance was also found to be good for the recognition of multinucleated megakaryocytes, which showed a significant association with MDS. However cytoplasmic abnormalities were found not to be useful in MDS recognition. The occurrence of appreciable numbers of nonlobulated and hypolobulated megakaryocytes in individuals without a myeloid neoplasm was confirmed. We demonstrated that subjects without a myeloid neoplasm can have some megakaryocytes that are assessed as 'dysplastic' or 'possibly dysplastic' and that to avoid over diagnosis of dysplasia, 'possibly dysplastic' forms should be excluded from the count of dysplastic cells. Our results demonstrate that the nature as well as the presence of megakaryocyte dysplasia is important in the diagnosis of MDS; although evaluation of 30 megakaryocytes is strongly recommended, it may be possible to recognize diagnostically important dysplasia when fewer megakaryocytes are present but highly diagnostic forms are seen.

Increasingly medical devices are being designed to allow them to exchange information over an IT network. However incorporating a medical device into an IT network can introduce risks which can impact the safety, effectiveness and security of the medical device. Medical devices are stringently tested according to regulation during the design and manufacture process. However until the introduction of IEC 80001-1: Application of Risk Management for IT-Networks incorporating Medical Devices, no standard addressed the risks of incorporating a medical device into an IT network. In order to perform an assessment (which is compliant with ISO/IEC 15504-2) of an IT network against IEC 80001-1, a Process Assessment Model is required. Based on the relationship between IEC 80001-1 and ISO/IEC 20000-1, this paper examines how the TIPA transformation process developed by Public Research Centre Henri Tudor was used to develop a process assessment model (TIPA PAM) for ISO/IEC 20000-1. It also examines how a process assessment model can be developed following that transformation process to assess Medical IT networks against IEC 80001-1.

Industry recognizes that there are very small enterprises that develop parts which contain software components. These enterprises are very important to the world-wide economy, and the parts they develop are often integrated into products made by larger enterprises. Failure to deliver a quality product on time and within budget threatens the competitiveness of both organizations. One way to mitigate these risks is for all the suppliers in a product chain put in place recognized engineering practices. Many international standards have been developed to capture proven engineering practices. However, these standards were not written for very small development organizations, those with less than 25 employees, and are consequently difficult to apply in such settings. An ISO/IEC JTC1/SC71 Working Group has been established to address these difficulties.

CONTENTS: 1) CMMI V1.2: What Has Changed and Why by Mike Phillips: This article provides a view of what has been included - and not included - in Capability Maturity Model Integration Version 1.2 (CMMI V1.2), describing the major elements of change for each CMMI product. 2) Measure Twice and Cut Once by Rushby Craig: This article describes how the 309th Software Maintenance Group used Standard Capability Maturity Model Integration Appraisal Method for Process Improvement B to identify opportunities for additional improvements, educate key project personnel in the organization on best-practices, and obtain critical buy-in from project personnel. 3) CMMI Level 2 Within Six Months? No Way! by George Jackelen: The purpose of this article is to show that when an organization is already doing competent project management, the effort to benchmark that capability by using CMMI is almost straightforward, and it is possible to achieve a Level 2 CMMI appraised rating within six months. 4) Future Directions in Process Improvement by Watts S. Humphrey, Dr. Michael D. Konrad, James W. Over, and William C. Peterson: This article describes how and why development processes, methods, and management must change and the likely future directions of process-improvement evolution. 5) The ImprovAbility Model by Dr. Jan Pries-Heje, Joern Johansen, Mads Christiansen, and Morten Korsaa: This model helps users identify strengths and weaknesses that can be leveraged or avoided to help an organization get the most from its process improvement effort. 6) Applying International Software Engineering Standards in Very Small Enterprises by Claude Y. Laporte, Alain April, and Alain Renault: This article discusses the utilization of ISO/IEC JTC 1/SC7 in very small enterprises., CrossTalk,The Journal of Defense Software Engineering is co-sponsored by the Department of Defense Chief Information Office (DoD-CIO); the Office of the Secretary of Defense (OSD) Acquisition, Technology and Logistics (AT&L); U.S. Navy (USN); U.S. Air Force (USAF); and the U.S. Department of Homeland Security (DHS). DoD-CIO co-sponsor: Assistant Secretary of Defense (Networks and Information Integration). OSD (AT&L) co-sponsor: Software Engineering and System Assurance. USN cosponsor: Naval Air Systems Command. USAF cosponsors: Oklahoma City-Air Logistics Center (ALC) 76 Software Maintenance Group (SMXG); and Ogden-ALC 309 SMXG. DHS co-sponsor: National Cyber Security Division in the National Protection and Programs Directorate. The original document contains color images. All DTIC reproductions will be in black and white.

At a time when software quality is increasingly becoming a subject of concern, and process approaches are maturing and gaining acceptance in companies, the use of International Organization for Standardization (ISO) systems and software engineering standards remains limited to a few of the most popular ones. However, these standards were not written for enterprises with fewer than 25 employees in mind. As they are difficult to apply in such settings, a new international standardization project has been mandated to address some of those difficulties by developing profiles and by providing guidance for compliance with ISO software engineering standards in very small enterprises (VSEs). A survey was conducted to ask very small enterprises about their utilization of ISO/IEC JTC 1/SC71 information technology (IT) standards and to collect data to identify problems and potential solutions to help them apply standards.