Safety and Nonsafety Communications and Interactions in International Nuclear Power Plants

Current industry and NRC guidance documents such as IEEE 7-4.3.2, Reg. Guide 1.152, and IEEE 603 do not sufficiently define a level of detail for evaluating interdivisional communications independence. The NRC seeks to establish criteria for safety systems communications that can be uniformly applied in evaluation of a variety of safety system designs. This report focuses strictly on communication issues related to data sent between safety systems and between safety and nonsafety systems. Further, the report does not provide design guidance for communication systems nor present detailed failure modes and effects analysis (FMEA) results for existing designs. This letter report describes communications between safety and nonsafety systems in nuclear power plants outside the United States. A limited study of international nuclear power plants was conducted to ascertain important communication implementations that might have bearing on systems proposed for licensing in the United States. This report provides that following information: 1.communications types and structures used in a representative set of international nuclear power reactors, and 2.communications issues derived from standards and other source documents relevant to safety and nonsafety communications. Topics that are discussed include the following: communication among redundant safety divisions, communications between safety divisions and nonsafety systems, control of safety equipment from a nonsafety workstation, and connection of nonsafety programming, maintenance, and test equipment to redundant safety divisions during operation. Information for this report was obtained through publicly available sources such as published papers and presentations. No proprietary information is represented

Diversity Strategies for Nuclear Power Plant Instrumentation and Control Systems

This report presents the technical basis for establishing acceptable mitigating strategies that resolve diversity and defense-in-depth (D3) assessment findings and conform to U.S. Nuclear Regulatory Commission (NRC) requirements. The research approach employed to establish appropriate diversity strategies involves investigation of available documentation on D3 methods and experience from nuclear power and nonnuclear industries, capture of expert knowledge and lessons learned, determination of best practices, and assessment of the nature of common-cause failures (CCFs) and compensating diversity attributes. The research described in this report does not provide guidance on how to determine the need for diversity in a safety system to mitigate the consequences of potential CCFs. Rather, the scope of this report provides guidance to the staff and nuclear industry after a licensee or applicant has performed a D3 assessment per NUREG/CR-6303 and determined that diversity in a safety system is needed for mitigating the consequences of potential CCFs identified in the evaluation of the safety system design features. Succinctly, the purpose of the research described in this report was to answer the question, 'If diversity is required in a safety system to mitigate the consequences of potential CCFs, how much diversity is enough?' The principal results of this research effort have identified and developed diversity strategies, which consist of combinations of diversity attributes and their associated criteria. Technology, which corresponds to design diversity, is chosen as the principal system characteristic by which diversity criteria are grouped to form strategies. The rationale for this classification framework involves consideration of the profound impact that technology-focused design diversity provides. Consequently, the diversity usage classification scheme involves three families of strategies: (1) different technologies, (2) different approaches within the same technology, and (3) different architectures within the same technology. Using this convention, the first diversity usage family, designated Strategy A, is characterized by fundamentally diverse technologies. Strategy A at the system or platform level is illustrated by the example of analog and digital implementations. The second diversity usage family, designated Strategy B, is achieved through the use of distinctly different technologies. Strategy B can be described in terms of different digital technologies, such as the distinct approaches represented by general-purpose microprocessors and field-programmable gate arrays. The third diversity usage family, designated Strategy C, involves the use of variations within a technology. An example of Strategy C involves different digital architectures within the same technology, such as that provided by different microprocessors (e.g., Pentium and Power PC). The grouping of diversity criteria combinations according to Strategies A, B, and C establishes baseline diversity usage and facilitates a systematic organization of strategic approaches for coping with CCF vulnerabilities. Effectively, these baseline sets of diversity criteria constitute appropriate CCF mitigating strategies for digital safety systems. The strategies represent guidance on acceptable diversity usage and can be applied directly to ensure that CCF vulnerabilities identified through a D3 assessment have been adequately resolved. Additionally, a framework has been generated for capturing practices regarding diversity usage and a tool has been developed for the systematic assessment of the comparative effect of proposed diversity strategies (see Appendix A)

Diversity Strategies for Nuclear Power Plant Instrumentation and Control Systems

This report presents the technical basis for establishing acceptable mitigating strategies that resolve diversity and defense-in-depth (D3) assessment findings and conform to U.S. Nuclear Regulatory Commission (NRC) requirements. The research approach employed to establish appropriate diversity strategies involves investigation of available documentation on D3 methods and experience from nuclear power and nonnuclear industries, capture of expert knowledge and lessons learned, determination of best practices, and assessment of the nature of common-cause failures (CCFs) and compensating diversity attributes. The research described in this report does not provide guidance on how to determine the need for diversity in a safety system to mitigate the consequences of potential CCFs. Rather, the scope of this report provides guidance to the staff and nuclear industry after a licensee or applicant has performed a D3 assessment per NUREG/CR-6303 and determined that diversity in a safety system is needed for mitigating the consequences of potential CCFs identified in the evaluation of the safety system design features. Succinctly, the purpose of the research described in this report was to answer the question, 'If diversity is required in a safety system to mitigate the consequences of potential CCFs, how much diversity is enough?' The principal results of this research effort have identified and developed diversity strategies, which consist of combinations of diversity attributes and their associated criteria. Technology, which corresponds to design diversity, is chosen as the principal system characteristic by which diversity criteria are grouped to form strategies. The rationale for this classification framework involves consideration of the profound impact that technology-focused design diversity provides. Consequently, the diversity usage classification scheme involves three families of strategies: (1) different technologies, (2) different approaches within the same technology, and (3) different architectures within the same technology. Using this convention, the first diversity usage family, designated Strategy A, is characterized by fundamentally diverse technologies. Strategy A at the system or platform level is illustrated by the example of analog and digital implementations. The second diversity usage family, designated Strategy B, is achieved through the use of distinctly different technologies. Strategy B can be described in terms of different digital technologies, such as the distinct approaches represented by general-purpose microprocessors and field-programmable gate arrays. The third diversity usage family, designated Strategy C, involves the use of variations within a technology. An example of Strategy C involves different digital architectures within the same technology, such as that provided by different microprocessors (e.g., Pentium and Power PC). The grouping of diversity criteria combinations according to Strategies A, B, and C establishes baseline diversity usage and facilitates a systematic organization of strategic approaches for coping with CCF vulnerabilities. Effectively, these baseline sets of diversity criteria constitute appropriate CCF mitigating strategies for digital safety systems. The strategies represent guidance on acceptable diversity usage and can be applied directly to ensure that CCF vulnerabilities identified through a D3 assessment have been adequately resolved. Additionally, a framework has been generated for capturing practices regarding diversity usage and a tool has been developed for the systematic assessment of the comparative effect of proposed diversity strategies (see Appendix A)

Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial.

BACKGROUND: Continuous automatic optimisation of cardiac resynchronisation therapy (CRT), stimulating only the left ventricle to fuse with intrinsic right bundle conduction (synchronised left ventricular stimulation), might offer better outcomes than conventional CRT in patients with heart failure, left bundle branch block, and normal atrioventricular conduction. This study aimed to compare clinical outcomes of adaptive CRT versus conventional CRT in patients with heart failure with intact atrioventricular conduction and left bundle branch block. METHODS: This global, prospective, randomised controlled trial was done in 227 hospitals in 27 countries across Asia, Australia, Europe, and North America. Eligible patients were aged 18 years or older with class 2-4 heart failure, an ejection fraction of 35% or less, left bundle branch block with QRS duration of 140 ms or more (male patients) or 130 ms or more (female patients), and a baseline PR interval 200 ms or less. Patients were randomly assigned (1:1) via block permutation to adaptive CRT (an algorithm providing synchronised left ventricular stimulation) or conventional biventricular CRT using a device programmer. All patients received device programming but were masked until procedures were completed. Site staff were not masked to group assignment. The primary outcome was a composite of all-cause death or intervention for heart failure decompensation and was assessed in the intention-to-treat population. Safety events were collected and reported in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02205359, and is closed to accrual. FINDINGS: Between Aug 5, 2014, and Jan 31, 2019, of 3797 patients enrolled, 3617 (95·3%) were randomly assigned (1810 to adaptive CRT and 1807 to conventional CRT). The futility boundary was crossed at the third interim analysis on June 23, 2022, when the decision was made to stop the trial early. 1568 (43·4%) of 3617 patients were female and 2049 (56·6%) were male. Median follow-up was 59·0 months (IQR 45-72). A primary outcome event occurred in 430 of 1810 patients (Kaplan-Meier occurrence rate 23·5% [95% CI 21·3-25·5] at 60 months) in the adaptive CRT group and in 470 of 1807 patients (25·7% [23·5-27·8] at 60 months) in the conventional CRT group (hazard ratio 0·89, 95% CI 0·78-1·01; p=0·077). System-related adverse events were reported in 452 (25·0%) of 1810 patients in the adaptive CRT group and 440 (24·3%) of 1807 patients in the conventional CRT group. INTERPRETATION: Compared with conventional CRT, adaptive CRT did not significantly reduce the incidence of all-cause death or intervention for heart failure decompensation in the included population of patients with heart failure, left bundle branch block, and intact AV conduction. Death and heart failure decompensation rates were low with both CRT therapies, suggesting a greater response to CRT occurred in this population than in patients in previous trials. FUNDING: Medtronic