Safety Plan Development Considerations

The patient safety plan must direct actions to improve healthcare safety and reduce risk to patients through a culture that encourages 

Adverse events are untoward incidents, therapeutic misadventures, iatrogenic injuries, or other adverse occurrences directly associated with care or services provided. Adverse events may result from acts of commission or omission. Adverse events can include patient falls, medication errors, procedural errors or complications, suicides, and missing patients. An adverse event can also be categorized as either a sentinel event or near miss. 

Appendix Y Patient Safety Plan Development Considerations 

A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase or the risk thereof includes, any process variation for which a recurrence would carry a significant chance of serious adverse outcome. 

A near miss is an event or situation that could have resulted in an accident, injury, or illness, but did not, either by chance or through timely intervention. Near misses are opportunities for learning and afford the chance to develop preventive strategies and actions. Near misses should receive the same level of scrutiny as adverse events that result in actual injury. 

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Appendix Y Patient Safety Plan Development Considerations 453... 

An individual planning to work with carcinogenic material must be prepared to ensure that the laboratory hygiene plan developed to meet the performance standards implicit in 29 CFR 1910.1450, the laboratory safety standard, meets all of the criteria set forth in the standard in terms of quality of the facihty, training and information made available to the employee, operational procedures, and availability of personal protective equipment. These considerations should arise at least by the time of purchase of the research material or before. Therefore, the list of chemicals considered to be probable carcinogens was placed in the section on purchasing earlier in this chapter. 

Safety Considerations are the documented results of a process to identify, as soon as possible after a mature Operational Concept has been developed, the main safety issues associated with a Project and to help in deciding whether a full Safety Plan and Safety Case are required. 

Building on the Safety Considerations, the initial Safety Argument should be as complete as possible and at least sufficient to form the basis of the Safety Plan. It also provides the starting point, and framework, for the development of the Project Safety Case. 

The Safety Plan is produced to assist and contribute to the establishment of a safe, healthy and environmentally sound working environment, so as to benefit all workers and management personnel on site, neighbours and third parties, and to minimise the environmental impact of the work. It should include details of the project and its safety, health and environmental requirements, anticipated site hazards and conditions and their means of control. It will also contain rules developed following consideration of all significant hazards and their risks, and other items which are important for the safe and efficient conduct of the work. Significant hazards in this context refers to those hazards which a competent contractor could not be expected to identify in advance. 

Risk-based information provides a foundation for regulation of severe accidents. Early PRAs, with large uncertainties, indicated risk that was above or below the Safety Goals depending on containment performance. Consequently the NRC developed an Integration Plan for Closure of Severe Accident Issues (SECY-88-47) with six main elements to this plan 1) individual plant examinations (IPE), 2) containment performance improvements, 3) improved plant oper itions, 4) severe accident research, 5) external event considerations, and 6) accident management. 

H. Safety considerations. The Occupational Safety and Health Administration (OSHA), US Department of Labor, standard entitled Occupational Exposure to Hazardous Chemicals in Laboratories (29 CFR 1910.1450) makes it necessary to address safety issues in the SOP. The standard requires laboratories that use hazardous chemicals to maintain employee exposures at or below the permissible exposure limits specified for these chemicals in 29 CFR Part 1910, Subpart Z. Hazards associated with any specific chemicals used in a method must be addressed so that the user has the information needed to follow the Chemical Hygiene Plan for their laboratory. The method developer should limit the use of hazardous chemicals where feasible. The use of toxic and/or carcinogenic reagents should be avoided or eliminated as much as possible. Additionally, the cost of disposal is increasing and could impact the practicality of a method. Material Safety Data Sheets for the analyte(s) and any unusual or hazardous reagents should be provided for the user. 

There are no electrolyzers developed specifically for operation with wind turbines. However, the rapid response of electrochemical systems to power variations makes them suitable "loads" for wind turbines. Industrial electrolyzers are designed for continuous operation, mainly because their elevated investment cost requires high-capacity factors for reasonable payback times, but they are subject to a considerable number of current interruptions through their lifetime due to occasional power interruptions, accidental trips of safety systems, and planned stops for maintenance. Current interruptions are more frequent in specialty applications, where electrolyzers supply hydrogen "on demand." Therefore, the discontinuous use of the equipment is not new, and most commercial electrolyzers may be used in intermittent operation although a significant performance decrease is expected with time. In fact, it is not power variation, but current interruptions that may cause severe corrosion problems to the electrodes, if the latter are not protected by the application of a polarization current when idle. 

Develop and implement a plan of action, including safety considerations, consistent with Standard Operating Procedures and within the capability of the available personnel, personal protective equipment, and control equipment. 

Recommendation 3 The committee recommends that DOE make a significant effort to address safety issues, and it supports DOE s plans to incorporate safety considerations into its various hydrogen research, development, and deployment programs. 

Overall, even in early drug development, a consideration of the excipient profile of the final product is important. If use of the established excipients is planned, an awareness of potential adverse effects in humans is necessary. Development should use pharmacopoeia-listed materials. For new excipients, this information is not available, and safety will be assessed in the preclinical evaluation. Extrapolation may only be possible if the new excipient is in the same class or is structurally similar to established materials, but such a comparison would not necessarily be reliable. 

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