4.1 This guide serves three purposes:4.1.1 To serve as a guide for developers of computer software providing, or interacting with, electronic signature processes,4.1.2 To serve as a guide to healthcare providers who are implementing electronic signature mechanisms, and4.1.3 To be a consensus standard on the design, implementation, and use of electronic signatures.1.1 This guide covers:1.1.1 Defining a document structure for use by electronic signature mechanisms (Section 4),1.1.2 Describing the characteristics of an electronic signature process (Section 5),1.1.3 Defining minimum requirements for different electronic signature mechanisms (Section 5),1.1.4 Defining signature attributes for use with electronic signature mechanisms (Section 6),1.1.5 Describing acceptable electronic signature mechanisms and technologies (Section 7),1.1.6 Defining minimum requirements for user identification, access control, and other security requirements for electronic signatures (Section 9), and1.1.7 Outlining technical details for all electronic signature mechanisms in sufficient detail to allow interoperability between systems supporting the same signature mechanism (Section 8 and Appendix X1-Appendix X4).1.2 This guide is intended to be complementary to standards under development in other organizations. The determination of which documents require signatures is out of scope, since it is a matter addressed by law, regulation, accreditation standards, and an organization's policy.1.3 Organizations shall develop policies and procedures that define the content of the medical record, what is a documented event, and what time constitutes event time. Organizations should review applicable statutes and regulations, accreditation standards, and professional practice guidelines in developing these policies and procedures.

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This specification prescribes airworthiness design requirements for the establishment of operating limitations and information for the operation of aeroplanes. It addresses the general limitations and information to be contained in the aeroplane flight manual. The applicant for a design approval shall seek the individual guidance of their respective civil aviation authority (CAA) body concerning the use of this specification as part of a certification plan.The requirements described in this specification cover: airspeed limitations, operating maneuvering speed, flap extended speed, minimum control speed, weight and center of gravity, auxiliary power unit limitations, minimum flight crew, maximum passenger seating configuration, kinds of operation, and maximum operating altitude.1.1 This specification covers airworthiness requirements for establishing general limitations and information to be contained in the aeroplane flight manual. This specification specifies what information shall be provided and does not state how such information shall be presented unless this is necessary for the clarity of the purpose of the specification. Refer to Specification F3117/F3117M for means and methods of presentation. The material was developed through open consensus of international experts in general aviation. This information was created by focusing on Level 1, 2, 3, and 4 Normal Category aeroplanes. The content may be more broadly applicable; it is the responsibility of the applicant to substantiate broader applicability as a specific means of compliance. The topics covered within this specification are: Limitations for Airspeed, Weight and Center of Gravity, Auxiliary Power Units, Minimum Flight Crew, Maximum Passenger Seating Configuration, Kinds of Operation, and Maximum Operating Altitude.1.2 An applicant intending to propose this information as Means of Compliance for a design approval must seek guidance from their respective oversight authority (for example, published guidance from applicable CAAs) concerning the acceptable use and application thereof. For information on which oversight authorities have accepted this specification (in whole or in part) as an acceptable Means of Compliance to their regulatory requirements (hereinafter “the Rules”), refer to the ASTM Committee F44 web page (www.astm.org/COMMITTEE/F44.htm). Annex A1 maps the Means of Compliance described in this specification to EASA CS-23, amendment 5, or later, and FAA 14 CFR Part 23, amendment 64, or later.1.3 Units—This specification may present information in either SI units, English Engineering units, or both; the values stated in each system may not be exact equivalents. Each system shall be used independently of the other; combining values from the two systems may result in nonconformance with the standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 A nano-object at any specific time can be considered well-defined.5.2 The life-cycle of a nano-object can be viewed as a series of production processes that transforms starting materials or a well-defined nano-object into a new, equally well-defined nano-object.5.3 Each step of the life-cycle can be considered a separate production action and can be described by the information categories and descriptors within this guide.5.4 The following are examples of nano-object productions that can be described by this guide.5.4.1 The creation of carbon nanotubes by arc discharge.5.4.2 The coating of a nano-object in a random or controlled manner when placed in a liquid.NOTE 1: The reactivity of nano-objects makes it likely that even with the utmost precautions, various features and characteristics may change over time, for example, when a nano-object is placed in a liquid and coated. Such a coating can significantly change the properties, functionalities, and reactivity of the nano-object. This change can be considered one step of a life-cycle and is a production process.NOTE 2: A nano-object may have more than one coating. For example, titania nano-objects are often coated by alumina by manufacturers to control certain properties. When these previously coated nano-objects are placed in liquid containing biological molecules, they can acquire a second coating. It can require very careful administration of test procedures to ensure the test results can meaningfully be ascribed to characteristics and features of the “initial” nano-objects.5.4.3 A nano-object experiences changes to its size, shape, physical structure, and other characteristics.NOTE 3: Events such as shock (unexpected forces), temperature and pressure changes, humidity changes, shipping, dissolution, and exposure to acids and bases can result in a changed nano-object with significantly different properties, functionalities, and reactivity. These events can be considered a production process.5.4.4 Unless care is taken to carefully control potential changes to a nano-object before testing, measurement results should be carefully examined for unintended changes through good laboratory practices, statistical analysis of all data, and verification that test samples maintain their integrity throughout the testing process.5.5 A nano-object can be subjected to a series or sequence of production steps. The steps can be fully planned and controlled or some steps can happen due to random events. This guide is applicable to describe one, many, or all steps in detail.NOTE 4: For example, the testing of a nano-object for potential toxic effects may involve a sequence of steps as shown in Table 1. As can be seen, steps such as storage, insertion into biological media, or sampling can possibly involve random changes to the resulting nano-object.5.6 Use of this guide to describe the individual production steps leading to the creation of a tested nano-object can be important in ascertaining the cause-effect relationship between a test result and a nano-object that was made in one of the sequence production steps prior to creation of the tested nano-object.5.7 The reactivity of individual and collections of nano-objects gives rise to questions about their stability under “non-reactive” conditions such as movement, temperature changes, exposure to heat, and shock. These occurrences are frequent enough in the life cycle of nano-objects that additional information categories and descriptors should be used as detailed in 6.2.5.8 ISO TC 229 has produced ISO/TS 80004-1:2010(en) that defines terminology applicable to nanomanufacturing.5.9 Information on quality control with respect to the production process or production results is covered by ASTM and ISO quality control guides.1.1 This guide provides guidelines for describing the production of one or more individual nano-objects. It establishes essential and desirable information categories and descriptors important to specify the production process, including the starting materials, the process itself, and the resulting nano-objects.1.2 This guide is designed to be directly applicable to reporting production information and data for nano-objects in most circumstances, including but not limited to reporting original research results in the archival literature, developing of ontologies, database schemas, data repositories and data reporting formats, specifying regulations, and enabling commercial activity.1.3 This guide is applicable to an individual nano-object and a collection of nano-objects.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 During the process of calibration of a groundwater flow model, each simulation is compared to site-specific information to ascertain the success of previous calibration efforts and to identify potentially beneficial directions for further calibration efforts. Procedures described herein provide guidance for making comparisons between groundwater flow model simulations and measured field data.5.2 This guide is not meant to be an inflexible description of techniques comparing simulations with measured data; other techniques may be applied as appropriate and, after due consideration, some of the techniques herein may be omitted, altered, or enhanced.1.1 This guide covers techniques that should be used to compare the results of groundwater flow model simulations to measured field data as a part of the process of calibrating a groundwater model. This comparison produces quantitative and qualitative measures of the degree of correspondence between the simulation and site-specific information related to the physical hydrogeologic system.1.2 During the process of calibration of a groundwater flow model, each simulation is compared to site-specific information such as measured water levels or flow rates. The degree of correspondence between the simulation and the physical hydrogeologic system can then be compared to that for previous simulations to ascertain the success of previous calibration efforts and to identify potentially beneficial directions for further calibration efforts.1.3 By necessity, all knowledge of a site is derived from observations. This guide does not address the adequacy of any set of observations for characterizing a site.1.4 This guide does not establish criteria for successful calibration, nor does it describe techniques for establishing such criteria, nor does it describe techniques for achieving successful calibration.1.5 This guide is written for comparing the results of numerical groundwater flow models with observed site-specific information. However, these techniques could be applied to other types of groundwater related models, such as analytical models, multiphase flow models, noncontinuum (karst or fracture flow) models, or mass transport models.1.6 This guide is one of a series of guides on groundwater modeling codes (software) and their applications.1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.1.8 This guide offers an organized collection of information or a series of options and does not recommend a specific course of action. This document cannot replace education or experience and should be used in conjunction with professional judgment. Not all aspects of this guide may be applicable in all circumstances. This ASTM standard is not intended to represent or replace the standard of care by which the adequacy of a given professional service must be judged, nor should this document be applied without consideration of a project's many unique aspects. The word “Standard” in the title of this document means only that the document has been approved through the ASTM consensus process.

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This specification covers the minimum requirements for information that shall be provided by the manufacturer or seller of new amusement rides or devices as a part of the initial sale or transfer to the first end user. It does not apply to the sale or transfer of used amusement rides and devices. A manufacturer issued information plate, printed in English, shall be permanently affixed to the ride or device in a visible location and shall be designed to remain legible for the expected life of the ride or device. The plate shall include, but not be restricted to, all applicable items such as ride serial number, ride name and manufacturer, ride model number, date of manufacture, ride speed, travel direction, passenger capacity by weight, and passenger capacity by number. Other information required to be provided by manufacturer shall include the following: ride duration, recommended balance of passenger loading or unloading, environmental restrictions, recommended passenger restrictions, electrical power requirements, mechanical power requirements, water flow, static information, dynamic information, trailering information, fastener schedule, load distribution per footing, and elements and structures.1.1 This specification covers the minimum requirements for information that shall be provided by the manufacturer or seller of new amusement rides or devices as a part of the initial sale or transfer to the first end user.1.2 This specification does not apply to the sale or transfer of used amusement rides and devices.

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4.1 Implantable medical device labeling often results in a variety of label formats and information prioritization. This variability can be seen not only across different manufacturers but also across different implant types.3 At present label design and layout is developed by a given manufacturer and represents balancing internal needs (such as manufacturing, distribution, and marketing), regulatory requirements within various markets, and end user needs (as identified by individual manufacturers performing “voice of the consumer” feedback on their label designs).4.2 At no fault to any given manufacturer, this process, along with the manner in which label information competes for available “real estate” on a package, often leads to variable prioritization of label information and highly variable label designs. The impact of this variability on patient care is not well documented within the published literature. An article from AAOS Now in 2009 described potential issues around label variability and gave anecdotal evidence of its impact.34.3 No published literature demonstrating a clear and conclusive impact on patient safety resulting from implant label variability was identified. Despite this lack of evidence, anecdotal observations and input from various involved individuals and organizations (surgeons, operating room nurses, hospital administrators, product representatives, and manufacturers) suggests a potential, although unproven, benefit for an increased standardization of implant labeling.4.4 The authors of this guide believe it is important to highlight that no universally accepted method for validation of a label’s effectiveness exists. Current validation methods consist of varying methods of customer feedback on an existing label design using formal customer questionnaires, informal customer feedback through individual polling, and internal manufacturer-driven studies. The label recommendations presented within this guide have not been validated as more or less effective than other existing implant labels currently in use.4.5 These recommendations have been developed through the collaboration of an ASTM-sponsored task group with representation from large and small orthopedic implant manufacturers, orthopedic surgeons (specifically the Biomedical Engineering Committee from the American Academy of Orthopedic Surgeons), healthcare facility administrators, operating room nurses, the U.S. Food and Drug Administration (FDA), and the Canadian Healthcare System. The task group utilized “voice of consumer” feedback from previous manufacturer label initiatives combined with input from various end users on the task group. This process did not identify any given implant label format as being more or less effective but only attempts to prioritize information and recommend a universal format for this information. A manufacturer may determine that an alternative format may be more effective for its internal processes and elect not to follow these recommendations.1.1 The goal of this guide is to recommend a universal label format (across manufacturers and various implants) of content and relative location of information necessary for final implant selection within an implant’s overall package labeling.1.2 This guide recommends package labeling for musculoskeletal based implants individually processed and packaged with the intent of being opened at the point of use, typically in the operating room.1.3 This guide identifies the necessary, “high priority” label content and recommendations for the layout and location of information for accurate implant identification by the end users in the operating room environment.1.4 This goal is achieved by creating a partitioned, secondary area of an implant’s package label or a separate label to present this information uniformly.1.5 The authors of this guide identified the competing needs of regulatory requirements, manufacturing/distribution, and implant identification. It is recognized through our task group’s efforts that, if a manufacturer elects to implement these recommendations, balancing these competing needs may necessitate changing a manufacturer’s internal processes, relabeling their entire inventory (either at a single point in time or over a defined time period), or accepting duplicate information on an implant’s package label. No additional compromises that would allow the primary goal of uniform implant label design across manufacturers were identified.1.6 It is not the intent of this guide to limit or dictate overall package labeling content.1.7 It is not the intent of this guide to supplant existing regulatory requirements (only to augment or complement existing regulatory label requirements).1.8 The use or application of multiple languages is not prevented by this guide; however, use of more than one language is discouraged on the implant selection sublabel (ISSL) defined in this guide. The language of choice is left to the manufacturer and should be dictated by the end user and regulatory requirements in the jurisdictions where the device is marketed. International symbols should also be considered to avoid the need for multiple ISSLs where possible.1.9 Use and implementation of this guide is optional and at the sole discretion of the implant’s manufacturer. It shall be implemented with the following considerations:1.9.1 The content and layout of any orthopedic implant label should be influenced by risk management activities and all label formats should be validated.1.9.2 If internal risk management activities recommend deviation from this guide, the manufacturer is discouraged from implementing a hybrid label that partially applies the principles and recommendations in this guide.1.10 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.11 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.12 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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This practice identifies the method of presenting information on selected performance and physical characteristics of a vacuum cleaner. Information will be presented to consumers in the form of a buyer's guide, with cleaner characteristics as follows: brand, model number, weight of cleaner, bag capacity, maximum cleaning distance from outlet, cleaning ability, embedded dirt, maneuverability, maximum air power, quietness, and durability.1.1 This practice identifies the method of presenting information on selected performance and physical characteristics of a residential vacuum cleaner.1.2 This information is intended to assist the consumer in comparing selected characteristics of vacuum cleaner models.1.3 It is also intended that this information be presented in a manner that is meaningful and understandable to the consumer.1.4 The characteristics are selected from those for which ASTM test methods have been developed.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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2.1 This practice is intended for use by any technical investigator when investigating an incident that can be reasonably expected to be the subject of litigation. The intent is to obtain sufficient information and physical items to identify evidence associated with the incident and to preserve it for analysis.2.2 The quality of evidence may change with time, therefore, special effort should be taken to capture and preserve evidence in an expeditious manner. This practice sets forth guidelines for the collection and preservation of evidence for further analysis.2.3 Evidence that has been collected and preserved is identified with, and traceable to, the incident. This practice sets forth guidelines for such procedures.1.1 This practice covers guidelines for the collection and preservation of information and physical items by any technical investigator pertaining to an incident that can be reasonably expected to be the subject of litigation.1.2 This practice describes generally accepted professional principles and operations, although the facts and issues of each situation require consideration, and frequently involve matters not expressly dealt with herein. Deviations from this practice should be based on specific articulable circumstances.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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3.1 Electrochemical corrosion rate measurements often provide results in terms of electrical current. Although the conversion of these current values into mass loss rates or penetration rates is based on Faraday’s Law, the calculations can be complicated for alloys and metals with elements having multiple valence values. This practice is intended to provide guidance in calculating mass loss and penetration rates for such alloys. Some typical values of equivalent weights for a variety of metals and alloys are provided.3.2 Electrochemical corrosion rate measurements may provide results in terms of electrical resistance. The conversion of these results to either mass loss or penetration rates requires additional electrochemical information. Some approaches for estimating this information are given.3.3 Use of this practice will aid in producing more consistent corrosion rate data from electrochemical results. This will make results from different studies more comparable and minimize calculation errors that may occur in transforming electrochemical results to corrosion rate values.1.1 This practice covers the providing of guidance in converting the results of electrochemical measurements to rates of uniform corrosion. Calculation methods for converting corrosion current density values to either mass loss rates or average penetration rates are given for most engineering alloys. In addition, some guidelines for converting polarization resistance values to corrosion rates are provided.1.2 The values stated in SI units are to be regarded as standard. Other units of measurement are included in this standard because of their usage.1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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4.1 The Ship Safety Record is an electronic database of information pertaining to a specific vessel including information related to the safe operation of the vessel and the safety of it’s crew and the environment. The data is grouped and organized under the following key categories: vessel particulars, vessel status, crew requirements, crew status, voyage specific data, record of inspection, record of incidents, and corrective actions.4.2 The Ship Safety Record is created and maintained in each instance for the primary benefit of the owner, technical manager, or operator who is required through the implementation of the ISM Code to be cognizant of such information. The information in the database is at all times the property of the owner who will maintain and control the dissemination of any and all of the information. It is expected that operators will elect to make portions of their Ship Safety Record database available to other interested parties such as flag states, class societies, and port states.14 The Ship Safety Record should provide for the implementation of several levels of electronic database security as may be required by the vessel owner or operator. The data that becomes part of the Ship Safety Record can be thought of in a number of subsets:4.2.1 Data that is not subject to change, including particulars of the vessel, and so forth.4.2.2 Data that is subject to change but not normally by the ship’s crew.4.2.3 Data that will be updated periodically either manually or as a result of updates to other computer systems or applications. This would include, as an example, cargo information, ballast conditions, the names/identification of crew members, and passenger details. This would also include information relative to internal inspections, maintenance records, internal audits, safety audits, and so forth.4.3 Guides F1756 and F1757 may be used as the basis for implementation of a shipboard electronic database and ship safety record.AbstractThis guide provides a uniform format and definition of general vessel-related technical information, including ship safety data, to be used by ship owners and operators, at their option and to the extent that they consider beneficial to their operation. It is recognized that all of the data is already contained in various documents on the vessel, but normally not electronically and normally not in one location. The ship safety record is designed to provide an industry-accepted common method of identifying, maintaining, and subsequently communicating the safety-related information needed for maritime operations. The ship safety record is an electronic database of information pertaining to a specific vessel including information related to the safe operation of the vessel and the safety of its crew and the environment. The vessel particulars, vessel status, crew requirements, status of crew and persons other than passengers on board, voyage specific data, record of inspection, record of incidents and corrective actions are presented in details.1.1 This guide provides a uniform format and definition of general vessel-related technical information, including ship safety data, to be used by ship owners and operators, at their option and to the extent that they consider beneficial to their operation. It is recognized that all of the data is already contained in various documents on the vessel, but normally not electronically and normally not in one location. The Ship Safety Record is designed to provide an industry-accepted common method of identifying, maintaining, and subsequently communicating the safety-related information needed for maritime operations. It is recognized that many of the data fields are not applicable for every vessel. Appendix X1 and Appendix X2 provide examples of how data elements in this guide may be used for a specific purpose, that is, the USCG’s Automated Identification System (AIS) and the Advance Notice of Arrival.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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Validation is an important and mandatory activity for laboratories that fall under regulatory agency review. Such laboratories produce data upon which the government depends to enforce laws and make decisions in the public interest. Examples include data to support approval of new drugs, prove marketed drugs meet specifications, enforce environmental laws, and develop forensic evidence for trial. This also extends to LIMS used in environmental laboratories. In some cases these systems may need to be interoperable with CLIMS and computer-based patient records (CPR) for reporting environmental exposures and clinical laboratory testing for biologic measure of stressor exposure. The enormous financial, legal, and social impact of these decisions requires government and public confidence in laboratory data. To ensure this confidence, government agencies regularly review laboratories operating under their rules to confirm that they are producing valid data. Computer system validation is a part of this review. This guide is designed to aid users validating LIMS and incorporating the validation process into their LIMS life cycle.Validation must provide evidence of testing, training, audit and review, management responsibility, design control, and document control, both during the development of the system and its operation life (2).1.1 This guide describes an approach to the validation process for a Laboratory Information Management System (LIMS).1.2 This guide is for validation of a commercial LIMS purchased from a vendor. The procedures may apply to other types of systems, but this guide makes no claim to address all issues for other types of systems. Further, in-house developed LIMS, that is, those developed by internal or external programmers specifically for an organization, can utilize this guide. It should be noted that there are a number of related software development issues that this guide does not address. Users who embark on developing a LIMS either internally or with external programmers also should consult the appropriate ASTM, ISO, and IEEE software development standards.1.3 This guide is intended to educate individuals on LIMS validation, to provide standard terminology useful in discussions with independent validation consultants, and to provide guidance for development of validation plans, test plans, required standard operating procedures, and the final validation report.

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1.1 The Emergency Medical Services Management Information System (EMS-MIS) serves as a framework for the management and linkage of data documenting the complete emergency episode from onset through the pre-hospital, emergency department, and hospital phases to final discharge. This document establishes a standard guideline for the planning, development, and maintenance of an EMS-MIS framework, including linkage among pre-hospital, hospital, and other public safety or government agencies. The resultant EMS-MIS should be capable of monitoring the compliance of an EMS system with its established system standards, and provide an objective basis upon which different EMS systems can be comparatively evaluated.1.2 EMS-MIS Goals1.2.1 To manage data regarding response to a medical emergency.1.2.2 To provide a process for obtaining and documenting objective, reliable data.1.2.3 To provide information that can be used to affect operational changes in an EMS system leading to the delivery of better quality emergency medical care.1.2.4 To provide information to guide the rational investment of local, state, and national resources to improve and maintain EMS.1.3 This guide will standardize data needed for decision making at various levels of the EMS system, and offer suggestions as to the appropriate use of this information.1.4 This guide comments on several possible configurations for information flow and data processing, recognizing that no one configuration is best suited to all circumstances.1.5 This guide focuses on pre-hospital medical activities, including emergency responses, scheduled transports, and all interinstitutional transfers.1.6 This guide addresses EMS-MIS techniques applicable to the internal operations of outpatient and inpatient facilities as well as pre-hospital care providers.1.7 This guide will not address specialized data systems and applications such as trauma registries, but will allow for interfacing with such applications.1.8 This guide will not address computer-aided dispatch (CAD) systems, nor system status management (SSM) applications, but will allow for interfacing with such applications.

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Health information networks (HINs) have arisen in recent years as a way to share common information within organizational arrangements among those healthcare facilities that have been formed into large, more comprehensive integrated delivery systems (IDS) and managed care organizations (MCO) offering a full range of healthcare services, both inpatient and ambulatory.The specific organizational structures to which the MCO term was originally applied most probably have evolved into something quite different. Furthermore, IDS organizations are contracting with other organizations that have a market larger than a single IDS itself and are buying such services for themselves rather than offering them internally.These organizations will need a frame of reference for the global information needed to provide all of the services required during patient care. For a global Concept Model consult ADA Specification 1000.0–1000.18 and TR 1039.Pharmacotherapy will require a number of these services, including those of the clinical laboratory for therapeutic drug monitoring as well as pharmacy services of both resident and nonresident care organizations and stand-alone pharmacies to ensure freedom from medication errors and conduct ongoing investigations of both the outcomes of care and the management of resources related to pharmacotherapy.Pharmacotherapy functions include prescribing (clinical orders), dispensing, administering, and monitoring, which support “pharmaceutical care” defined as “provision of drug therapy to achieve desired therapeutic outcomes that improve a patient’s quality of life.” These functions address patients’ needs that require information support as noted in Table 1.Another aspect of the monitoring function is the development of instrumentation for testing at point of care (POCT) for high-value immediate-benefit services that support pharmacotherapy. POCT, however, needs supervision and training from skilled laboratorians for the actual performers, whether that supervision comes from within the IDS or outside of it. This range of operation is only achievable by distributed HIN structures that shall have the same quality of clinical and data services as offered by laboratories close at hand. Data management of POCT is documented separately (see CLSI POCT1, ASTP2), but such data management for support of pharmacotherapy shall be placed into the broader context of this practice and linked to CLSI LIS-9A. Thus, this practice should be used to first organize the global domain and then the interconnected subdomains.1.1 This practice applies to the process of defining and documenting the capabilities, logical data sources, and pathways of data exchange regarding pharmacotherapy information services within a given network architecture serving a set of healthcare constituents.1.2 This practice is not a technical implementation standard but, rather, describes how the implementation methods and techniques can be used to coordinate pharmacotherapy services logically within an electronic health record (EHR) systems environment involving participating organizations and sites connected by a networked communication system.1.3 This practice covers the content of the nodes and arcs of the resulting logical network involving EHR, pharmacy, and clinical laboratory-capable sites. This practice also considers the various purposes and organizational arrangements for coordinating pharmacotherapy services within the network boundaries and the considerations for connections among external networks.1.4 This practice refers to other standards for conventions within various data domains, such as pharmacy systems, clinical laboratory information management systems (CLIMS), and EHR systems, and for messaging conventions.1.5 This practice is intended to outline how integration of pharmacy, CLIMS, and EHR information systems can be undertaken to result in a transparent pharmacotherapy clinical decision support environment, regardless of the underlying implementation architecture, by describing the logical interoperability of information domains as facilitated by information and communications technology (ICT).1.6 This practice is directed at pharmacists, clinical pharmacologists, clinical laboratorians, information system managers, and information systems vendors for use in planning and implementing coordinated pharmacotherapy services through effective dialog.1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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2.1 The purpose of this specification is to provide to the new owner of an amusement ride or device, available information for the identification, placement, erection, operation, and maintenance of the amusement ride or device.1.1 This specification covers the requirements for information that shall supplement the sale or transfer of ownership of an amusement ride or device.1.2 This specification applies only to amusement rides and devices, which have previously been in operation, and which are beign sold or transferred as a used amusment ride or device.

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The purpose of this guide is to assure comparability between paper-based and computer-based amendments. Paper-based and computer-based amendments must have comparable methods, practices and policies, in order to assure an unambiguous representation of the sequence and timing of documented events. Original and amended health information entries and documents must both be displayed and must be consistent across both domains. Comparability does not rule out, however, the use of capabilities specific to the electronic world, which do not have paper-based counterparts, for example, displaying the amended text with a pop-up window, which can show the text prior to its amendment.Traditional paper-based health records and policies support the need of authorized authors of health information to amend entries and documents in the health record under appropriate circumstances. In a paper-based health record, amending entries is accomplished by drawing a line through the erroneous entry, writing in the correct information, and authenticating the amendment by signing and dating the change. Such corrections always display the original documentation along with the amendment. This procedure is used to assure an unambiguous representation of the sequence and timing of documented events and any appropriate amendments.Current and emerging technologies for health records, including, but not limited to, computer-based health records, employ different input and display methodologies than the traditional paper-based record and, therefore, different amendment alternatives for health record or health information entries, or both. Health information may be entered directly into an automated, electronic, or computer-based health record system, for example, by voice, keyboard (either by the care practitioner, transcriptionist, or other intermediary), mouse, pen, tablet, a personal digital assistant, or through the use of structured data entry. Unlike a written record, which essentially is always viewed in its original handwritten or typewritten form, the presentation and display of electronic and computer-based health information often is transformed. This transformation occurs when information is transferred from one computerized system to another system or filtered by different display characteristics or views of the data. In addition, in contrast to the paper-based record, computers and computer systems can modify display of the data directly, for example, in nonchronological order or filtering through queries. Amended electronic records should display a distinct and obvious notation of their amended state. Access to the original health information should be immediately available, that is, prior amendments back to and including the original record.1.1 This guide addresses the criteria for amending individually-identifiable health information. Certain criteria for amending health information is found in federal and state laws, rules and regulations, and in ethical statements of professional conduct. Although there are several sources for guidance, there is no current national standard on this topic.

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