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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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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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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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4.1 The maintenance of confidentiality in paper-based, electronic, or computer-based health information requires that policies and procedures be in place to protect confidentiality. Confidentiality of information depends on structural and explicit mechanisms to allow persons or systems to define who has access to what, and in what situation that access is granted. For guidelines on the development and implementation of privilege management infrastructures supporting these mechanisms, see Guide E2595.4.2 Confidential protection of data elements is a specific requirement. The classification of data elements into restrictive and specifically controlled categories is set by policies, professional practice, and laws, legislation, and regulations.4.3 There are three explicit concepts upon which the use of and access to health information confidentiality are defined. Each of these concepts is an explicit and unique characteristic relevant to confidentiality, but only through the combination (convergence) of all three concepts can appropriate access to an explicit data element at a specific point in time be provided, and unauthorized access denied. The three concepts are:4.3.1 The categorization and breakdown of data into logical and reasonable elements or entities.4.3.2 The identification of individual roles or job functions.4.3.3 The establishment of context and conditions of data use at a specific point in time, and within a specific setting.4.4 The overriding principle in preserving the confidentiality of information is to provide access to that information only under circumstances and to individuals when there is an absolute, established, and recognized need to access that data, and the information accessed should itself be constrained only to that information essential to accomplish a defined and recognized task or process. Information nonessential to that task or process should ideally not be accessible, even though an individual accessing that information may have some general right of access to that information.1.1 This guide covers the process of granting and maintaining access privileges to health information. It directly addresses the maintenance of confidentiality of personal, provider, and organizational data in the healthcare domain. It addresses a wide range of data and data elements not all traditionally defined as healthcare data, but all elemental in the provision of data management, data services, and administrative and clinical healthcare services. In addition, this guide addresses specific requirements for granting access privileges to patient-specific health information during health emergencies.1.2 This guide is based on long-term existing and established professional practices in the management of healthcare administrative and clinical data. Healthcare data, and specifically healthcare records (also referred to as medical records or patient records), are generally managed under similar professional practices throughout the United States, essentially regardless of specific variations in local, regional, state, and federal laws regarding rules and requirements for data and record management.1.3 This guide applies to all individuals, groups, organizations, data-users, data-managers, and public and private firms, companies, agencies, departments, bureaus, service-providers, and similar entities that collect individual, group, and organizational data related to health care.1.4 This guide applies to all collection, use, management, maintenance, disclosure, and access of all individual, group, and organizational data related to health care.1.5 This guide does not attempt to address specific legislative and regulatory issues regarding individual, group, and organizational rights to protection of privacy.1.6 This guide covers all methods of collection and use of data whether paper-based, written, printed, typed, dictated, transcribed, forms-based, photocopied, scanned, facsimile, telefax, magnetic media, image, video, motion picture, still picture, film, microfilm, animation, 3D, audio, digital media, optical media, synthetic media, or computer-based.1.7 This guide does not directly define explicit disease-specific and evaluation/treatment-specific data control or access, or both. As defined under this guide, the confidential protection of elemental data elements in relation to which data elements fall into restrictive or specifically controlled categories, or both, is set by policies, professional practice, and laws, legislation and regulations.

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1.1 This guide outlines the rights of individuals, both patients and providers, regarding health information and recommends procedures for the exercise of those rights.1.2 This guide is intended to amplify Guide E1869.

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1.1 This guide addresses the privacy, confidentiality, and security training of employees, agents and contractors who have access to health information. This access shall be authorized and required to meet job responsibilities. Training is essential to developing and understanding about, and sensitivity for, individually identifiable health infoamtion. Anyone in a setting that collects, maintains, transmits, stores or uses health information, or provides health services, or a combination thereof, shall provide privacy, confidentiality, and security awareness training to all staff and business partners. Training shall be based on job responsibilities.

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