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RADT Object Model as a Basis for Communication8212;The RADT object model is the first model used to create a common library of consistent entities (objects) and their attributes in the terminology of object analytical models as applied to the healthcare domain. These object models can be used to construct and refine standards relating to healt care information and its management. Since the RADT object model underpins the design and implementation of specific systems, it provides the framework for establishing the systematics of managing observations made during health care. The observations recorded during health care not only become the basis for managing an individual''s health care by practitioners but are also used for research and resource management. They define the common language for abstracting and codifying observations. The inconsistency and incompleteness of the data recorded in paper records is well known and has been noted by the Institute of Medicine''s study (4). The ability to build the recommended EHR begins with RADT, as noted in Practice E 1239. A more detailed specification of the RADT process and its specific functional domain shall begin with a formal model. Furthermore, following agreement on the initial model, that model shall evolve as knowledge accumulates and the initial view of the healthcare domain extends to other social and psychologic processes that link healthcare with other functional domains of society. The management of lifelong cases of care, such as those of birth defects in newborns, will involve interactions with social work and educational functional domains of experience. It has been recognized for some time (5) that a “healthcare team,” in the broader sense, is involved in dealing with these complex cases. The RADT model is the core to linking these functional domains together in a transparent way. For that reason, the object terminology is used to enable the most global view and vernacular that will facilitate communication among technical specialties that participate in managing some aspect of health care or that build systems to manage the required information. Common Terminology as a Basis for Education8212;The use of models and their associated terminology implies that education of the healthcare practitioners shall incorporate this view to a significant extent. While a detailed specification of systems requires extensive lexicons of carefully defined terms, a more understandable terminology shall evolve for the process of educating practitioners during their formal education as well as continuing to educate current practioners concerning how this new technology can be integrated with their existing practices. This challenge has yet to be met, but the objects and modeling concepts presented here are intended to be named with the most intuitive titles in order to promote clear understanding during their use in instruction. Nevertheless, relating these objects and their properties to everyday practice remains a significant challenge, for both the implementors of systems and educators. The perspectives cataloged here can be used in the creation of system documentation and curricula represented in a variety of media.1.1 This practice is intended to amplify Practice E 1239 and to complement Practice E 1384 by detailing the objects that make up the reservation, registration, admitting, discharge, and transfer (RADT) functional domain of the computer-based record of care (CPR). As identified in Practice E 1239, this domain is seminal to all patient record and ancillary system functions, including messaging functions u......

Standard Practice for An Object-Oriented Model for Registration, Admitting, Discharge, and Transfer (RADT) Functions in Computer-Based Patient Record Systems

ICS
35.240.80 (IT applications in health care technolo
CCS
C07
发布
2001
实施

1.1 Information models appropriately are used for analysis, design, and sharing a common understanding in health and healthcare information engineering, in healthcare process improvement, in building information systems, and in health informatics standards development.1.2 The purpose of this practice is to identify best practices for the creation, use, and assessment of information models in the health and healthcare domain.1.3 Included in this practice are recommended organizational policies and procedures, where modeling is best used in healthcare, and recommended modeling methods, best practices and evaluation criteria.1.4 Excluded from this practice are detailed specifications of modeling techniques that are specified or described in other sources.

Standard Practice for Modeling in Health Informatics

ICS
35.240.80 (IT applications in health care technolo
CCS
C07
发布
2001
实施

1.1 This specification is for the development and implementation of security audit/disclosure logs for health information. It specifies how to design an access audit log to record all access to patient identifiable information maintained in computer systems and includes principles for developing policies, procedures, and functions of health information logs to document all disclosure of health information to external users for use in manual and computer systems. The process of information disclosure and auditing should conform, where relevant, with the Privacy Act of 1974 (1).1.2 The first purpose of this specification is to define the nature, role, and function of system access audit logs and their use in health information systems as a technical and procedural tool to help provide security oversight. In concert with organizational confidentiality and security policies and procedures, permanent audit logs can clearly identify all system application users who access patient identifiable information, record the nature of the patient information accessed, and maintain a permanent record of actions taken by the user. By providing a precise method for an organization to monitor and review who has accessed patient data, audit logs have the potential for more effective security oversight than traditional paper record environments. This specification will identify functionality needed for audit log management, the data to be recorded, and the use of audit logs as security and management tools by organizational managers.1.3 In the absence of computerized logs, audit log principles can be implemented manually in the paper patient record environment with respect to permanently monitoring paper patient record access. Where the paper patient record and the computer-based patient record coexist in parallel, security oversight and access management should address both environments.1.4 The second purpose of this specification is to identify principles for establishing a permanent record of disclosure of health information to external users and the data to be recorded in maintaining it. Security management of health information requires a comprehensive framework that incorporates mandates and criteria for disclosing patient health information found in federal and state laws, rules and regulations and ethical statements of professional conduct. Accountability for such a framework should be established through a set of standard principles that are applicable to all health care settings and health information systems.1.5 Logs used to audit and oversee health information access and disclosure are the responsibility of each health care organization, data intermediary, data warehouse, clinical data repository, third party payer, agency, organization or corporation that maintains or provides, or has access to individually-identifiable data. Such logs are specified in and support policy on information access monitoring and are tied to disciplinary sanctions that satisfy legal, regulatory, accreditation and institutional mandates.1.6 Organizations need to prescribe access requirements for aggregate data and to approve query tools that allow auditing capability, or design data repositories that limit inclusion of data that provide potential keys to identifiable data. Inferencing patient identifiable data through analysis of aggregate data that contains limited identifying data elements such as birth date, birth location, family name, etc., is possible using software that matches data elements across data bases. This allows a consistent approach to linking records into longitudinal cases for research purposes. Audit trails can be designed to work with applications which use these techniques if the query functions are part of a defined retrieval application but often standard query tools are not easily audited. This specification applies to the disclosure or transfer of health information (records) i......

Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems

ICS
35.240.80 (IT applications in health care technolo
CCS
C05
发布
2001
实施

5.1 RADT Object Model as a Basis for Communication—The RADT object model is the first model used to create a common library of consistent entities (objects) and their attributes in the terminology of object analytical models as applied to the healthcare domain. These object models can be used to construct and refine standards relating to healt care information and its management. Since the RADT object model underpins the design and implementation of specific systems, it provides the framework for establishing the systematics of managing observations made during health care. The observations recorded during health care not only become the basis for managing an individual's health care by practitioners but are also used for research and resource management. They define the common language for abstracting and codifying observations. The inconsistency and incompleteness of the data recorded in paper records is well known and has been noted by the Institute of Medicine's study (4). The ability to build the recommended EHR begins with RADT, as noted in Practice E1239. A more detailed specification of the RADT process and its specific functional domain shall begin with a formal model. Furthermore, following agreement on the initial model, that model shall evolve as knowledge accumulates and the initial view of the healthcare domain extends to other social and psychologic processes that link healthcare with other functional domains of society. The management of lifelong cases of care, such as those of birth defects in newborns, will involve interactions with social work and educational functional domains of experience. It has been recognized for some time (5) that a “healthcare team,” in the broader sense, is involved in dealing with these complex cases. The RADT model is the core to linking these functional domains together in a transparent way. For that reason, the object terminology is used to enable the most global view and vernacular that will facilitate communication among technical specialties that participate in managing some aspect of health care or that build systems to manage the required information. 5.2 Common Terminology as a Basis for Education—The use of models and their associated terminology implies that education of the healthcare practitioners shall incorporate this view to a significant extent. While a detailed specification of systems requires extensive lexicons of carefully defined terms, a more understandable terminology shall evolve for the process of educating practitioners during their formal education as well as continuing to educate current practioners concerning how this new technology can be integrated with their existing practices. This challenge has yet to be met, but the objects and modeling concepts presented here are intended to be named with the most intuitive titles in order to promote clear understanding during their use in instruction. Nevertheless, relating these objects and their properties to everyday practice remains a significant challenge, for both the implementors of systems and educators. The perspectives cataloged here can be used in the creation of system documentation and curricula represented in a variety of media. 1.1 This practice is intended to amplify Practice E1239 and to ......

Standard Practice for An Object-Oriented Model for Registration, Admitting, Discharge, and Transfer (RADT) Functions in Computer-Based Patient Record Systems

ICS
35.240.80 (IT applications in health care technolo
CCS
C07
发布
2001
实施

4.1 Data that document health services in health care organizations are business records and must be archived to a secondary but retrievable medium. Audit logs should be retained, at a minimum, according to the statute governing medical records in the geographic area. 4.2 The purpose of audit access and disclosure logs is to document and maintain a permanent record of all authorized and unauthorized access to and disclosure of confidential health care information in order that health care providers, organizations, and patients and others can retrieve evidence of that access to meet multiple needs. Examples are clinical, organizational, risk management, and patient rights' needs. 4.3 Audit logs designed for system access provide a precise capability for organizations to see who has accessed patient information. Due to the significant risk in computing environments by authorized and unauthorized users, the audit log is an important management tool to monitor, access retrospectively. In addition, the access and disclosure log becomes a powerful support document for disciplinary action. Audit logs are essential components to comprehensive security programs in health care. 4.4 Organizations are accountable for managing the disclosure of health information in a way that meets legal, regulatory, accreditation and licensing requirements and growing patient expectations for accountable privacy practices. Basic audit trail procedures should be applied, manually if necessary, in paper patient record systems to the extent feasible. Security in health information systems is an essential component to making progress in building and linking patient information. Successful implementation of large scale systems, the use of networks to transmit data, growing technical capability to address security issues and concerns about the confidentiality, and security provisions of patient information drive the focus on this topic. (See Guide E1384.) 4.5 Consumer fears about confidentiality of health information and legal initiatives underscore disclosure practices. Patients and health care providers want assurance that their information is protected. Technology exists to incorporate audit functions in health information systems. Advances in security audit expert systems can be applied to the health care industry. Emerging off-the-shelf products will be able to use audit logs to enable the detection of inappropriate use of health information. Institutions are accountable for implementing comprehensive confidentiality and security programs that combine social elements, management, and technology. 1.1 This specification is for the development and implementation of security audit/disclosure logs for health information. It specifies how to design an access audit log to record all access to patient identifiable information maintained in computer systems and includes principles for developing policies, procedures, and functions of health information logs to document all disclosure of health information to external users for use in manual and computer systems. The process of information disclosure and auditing should conform, where relevant, with the Privacy Act of 1974 (1).2

Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems

ICS
35.240.80 (IT applications in health care technolo
CCS
发布
2001
实施

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.

Standard Guide for Validation of Laboratory Information Management Systems

ICS
35.240.80 (IT applications in health care technolo
CCS
N07
发布
2000
实施

1.1 Computed tomography (CT) may be used for new applications, or, in place of film radiography, provided that the capability to disclose physical features or indications that form the accept/reject criteria is fully documented and available for review. 1.2 The CT systems addressed in this practice utilize a set of transmission measurements made along a set of paths projected through the test object from many different directions. Each of the transmission measurements within these views is digitized and stored in a computer, where they are subsequently conditioned (for example, normalized and corrected) and reconstructed by one of a variety of techniques. An in-depth treatment of CT principles is given in Guide E1441. 1.3 Computed tomography (CT), as with conventional radiography and radioscopic examination, is broadly applicable to any material or test object through which a beam of penetrating radiation may be passed and detected, including metals, plastics, ceramics, metallic/nonmetallic composite material, and assemblies. The principal advantage of CT is that it provides densitometric (that is, radiological density and geometry) images of thin cross sections through an object. Because of the absence of structural superposition, images are much easier to interpret than conventional radiological images. The new user can quickly learn to read CT data because images correspond more closely to the way the human mind visualizes 3D structures than conventional projection radiology. Further, because CT images are digital, the images may be enhanced, analyzed, compressed, archived, input as data into performance calculations, compared with digital data from nondestructive evaluation (NDE) modalities, or transmitted to other locations for remote viewing, or a combination thereof. While many of the details are generic in nature, this practice implicitly assumes the use of penetrating radiation, specifically x ray and [gamma] ray. 1.4 This practice provides procedural information for performing CT examinations. The techniques and the applications associated with CT examination are diverse. This practice is not intended to be limiting or restrictive, but rather to address the general use of CT technology and thereby facilitate its use. 1.5 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. For specific safety statements, see Section 8, NBS Handbook 114, and Federal Standards 21 CFR 1020.40 and 29 CFR 1910.96.

Standard Practice for Computed Tomographic (CT) Examination

ICS
35.240.80 (IT applications in health care technolo
CCS
C43
发布
2000
实施

1.1 Computed tomography (CT) is a radiographic method that provides an ideal examination technique whenever the primary goal is to locate and size planar and volumetric detail in three dimensions. Because of the relatively good penetrability of X-rays, as well as the sensitivity of absorption cross sections to atomic chemistry, CT permits the nondestructive physical and, to a limited extent, chemical characterization of the internal structure of materials. Also, since the method is X-ray based, it applies equally well to metallic and non-metallic specimens, solid and fibrous materials, and smooth and irregularly surfaced objects. When used in conjunction with other nondestructive evaluation (NDE) methods, such as ultrasound, CT data can provide evaluations of material integrity that cannot currently be provided nondestructively by any other means.1.2 This guide is intended to satisfy two general needs for users of industrial CT equipment: (1) the need for a tutorial guide addressing the general principles of X-ray CT as they apply to industrial imaging; and (2) the need for a consistent set of CT performance parameter definitions, including how these performance parameters relate to CT system specifications. Potential users and buyers, as well as experienced CT inspectors, will find this guide a useful source of information for determining the suitability of CT for particular examination problems, for predicting CT system performance in new situations, and for developing and prescribing new scan procedures.1.3 This guide does not specify test objects and test procedures for comparing the relative performance of different CT systems; nor does it treat CT inspection techniques, such as the best selection of scan parameters, the preferred implementation of scan procedures, the analysis of image data to extract densitometric information, or the establishment of accept/reject criteria for a new object.1.4 Standard practices and methods are not within the purview of this guide. The reader is advised, however, that examination practices are generally part and application specific, and industrial CT usage is new enough that in many instances a consensus has not yet emerged. The situation is complicated further by the fact that CT system hardware and performance capabilities are still undergoing significant evolution and improvement. Consequently, an attempt to address generic examination procedures is eschewed in favor of providing a thorough treatment of the principles by which examination methods can be developed or existing ones revised.1.5 The principal advantage of CT is that it nondestructively provides quantitative densitometric (that is, density and geometry) images of thin cross sections through an object. Because of the absence of structural noise from detail outside the thin plane of inspection, images are much easier to interpret than conventional radiographic data. The new user can learn quickly (often upon first exposure to the technology) to read CT data because the images correspond more closely to the way the human mind visualizes three-dimensional structures than conventional projection radiography. Further, because CT images are digital, they may be enhanced, analyzed, compressed, archived, input as data into performance calculations, compared with digital data from other NDE modalities, or transmitted to other locations for remote viewing. Additionally, CT images exhibit enhanced contrast discrimination over compact areas larger than 20 to 25 pixels. This capability has no classical analog. Contrast discrimination of better than 0.1 % at three-sigma confidence levels over areas as small as one-fifth of one percent the size of the object of interest are common.1.6 With proper calibration, dimensional inspections and absolute density determinations can also be made very accurately. Dimensionally, virtually all CT systems provide a pixel resolution of rough......

Standard Guide for Computed Tomography (CT) Imaging

ICS
35.240.80 (IT applications in health care technolo
CCS
L81;C43
发布
2000
实施

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.

Standard Guide for Validation of Laboratory Information Management Systems

ICS
35.240.80 (IT applications in health care technolo
CCS
N07
发布
2000
实施

1.1 This guide identifies the minimum information capabilities needed by an ambulatory care system or a resident facility R-ADT system. This guide is intended to depict the processes of: patient registration, inpatient admission into health care institutions and the use of registration data in establishing and using the demographic segments of the electronic health record. It also identifies a common core of informational elements needed in this R-ADT process and outlines those organizational elements that may use these segments. Furthermore, this guide identifies the minimum general requirements for R-ADT and helps identify many of the additional specific requirements for such systems. The data elements described may not all be needed but, if used, they must be used in the way specified so that each record segment has comparable data. This guide will help answer questions faced by designers of R-ADT capabilities by providing a clear description of the consensus of health care professionals regarding a uniform set of minimum data elements used by R-ADT functions in each component of the larger system. It will also help educate health care professionals in the general principles of patient care information management as well as the details of the constituent specialty areas.1.2 This standard does not purport to address 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.

Standard Guide for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT) Systems for Electronic Health Record (EHR) Systems

ICS
35.240.80 (IT applications in health care technolo
CCS
C07
发布
2000
实施

1.1 This practice is intended to amplify Guide E 1239 and to complement Guide E 1384 by detailing the objects that make up the reservation, registration, admitting, discharge, and transfer (RADT) functional domain of the computer-based record of care (CPR). As identified in Guide E1239, this domain is seminal to all patient record and ancillary system functions, including messaging functions used in telecommunications. For example, it is applicable to clinical laboratory information management systems, pharmacy information management systems, and radiology, or other image management, information management systems. The object model terminology is used to be compatible with other national and international standards for healthcare data and information systems engineering or telecommunications standards applied to healthcare data or systems. This practice is intended for those familiar with modeling concepts, system design, and implementation. It is not intended for the general computer user or as an initial introduction to the concepts.

Standard Practice for An Object-Oriented Model for Registration, Admitting, Discharge, and Transfer (RADT) Functions in Computer-Based Patient Record Systems

ICS
35.240.80 (IT applications in health care technolo
CCS
C07
发布
1999
实施

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.

Standard Guide for Amendments to Health Information

ICS
35.240.80 (IT applications in health care technolo
CCS
C07
发布
1999
实施

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.

Standard Guide for Amendments to Health Information

ICS
35.240.80 (IT applications in health care technolo
CCS
C07
发布
1999
实施

This guide has three purposes: 4.1.1 To serve as a guide for developers of computer software that provides or makes use of authentication and authorization processes, 4.1.2 To serve as a guide to healthcare providers who are implementing authentication and authorization mechanisms, and 4.1.3 To be a consensus standard on the design, implementation, and use of authentication and authorization mechanisms. Additional standards will define interoperable protocols and message formats that can be used to implement these mechanisms in a distributed environment, using specific commercial technologies such as digital signatures.1.1 This guide covers mechanisms that may be used to authenticate healthcare information (both administrative and clinical) users to computer systems, as well as mechanisms to authorize particular actions by users. These actions may include access to healthcare information documents, as well as, specific operations on those documents (for example, review by a physician). 1.2 This guide addresses both centralized and distributed environments, by defining the requirements that a single system shall meet and the kinds of information which shall be transmitted between systems to provide distributed authentication and authorization services. 1.3 This guide addresses the technical specifications for how to perform user authentication and authorization. The actual definition of who can access what is based on organizational policy.

Standard Guide for User Authentication and Authorization

ICS
35.240.80 (IT applications in health care technolo
CCS
A00
发布
1998
实施

4.1 This guide has three purposes: 4.1.1 To serve as a guide for developers of computer software that provides or makes use of authentication and authorization processes, 4.1.2 To serve as a guide to healthcare providers who are implementing authentication and authorization mechanisms, and 4.1.3 To be a consensus standard on the design, implementation, and use of authentication and authorization mechanisms. 4.2 Additional standards will define interoperable protocols and message formats that can be used to implement these mechanisms in a distributed environment, using specific commercial technologies such as digital signatures. 1.1 This guide covers mechanisms that may be used to authenticate healthcare information (both administrative and clinical) users to computer systems, as well as mechanisms to authorize particular actions by users. These actions may include access to healthcare information documents, as well as specific operations on those documents (for example, review by a physician). 1.2 This guide addresses both centralized and distributed environments, by defining the requirements that a single system shall meet and the kinds of information which shall be transmitted between systems to provide distributed authentication and authorization services. 1.3 This guide addresses the technical specifications for how to perform user authentication and authorization. The actual definition of who can access what is based on organizational policy.

Standard Guide for User Authentication and Authorization

ICS
35.240.80 (IT applications in health care technolo
CCS
发布
1998
实施

1.1 This guide covers mechanisms that may be used to authenticate healthcare information (both administrative and clinical) users to computer systems, as well as mechanisms to authorize particular actions by users. These actions may include access to healthcare information documents, as well as, specific operations on those documents (for example, review by a physician). 1.2 This guide addresses both centralized and distributed environments, by defining the requirements that a single system shall meet and the kinds of information which shall be transmitted between systems to provide distributed authentication and authorization services. 1.3 This guide addresses the technical specifications for how to perform user authentication and authorization. The actual definition of who can access what is based on organizational policy.

Standard Guide for User Authentication and Authorization

ICS
35.240.80 (IT applications in health care technolo
CCS
A00
发布
1998
实施

1.1 This specification covers deterministic remote control of laboratory equipment in an automated laboratory. The labor-intensive process of integrating different equipment into an automated system is a primary problem in laboratory automation today. Hardware and software standards are needed to facilitate equipment integration thereby significantly reduce the cost and effort to develop fully automated laboratories. 1.2 This Laboratory Equipment Control Interface Specification (LECIS) describes a set of standard equipment behaviors that must be accessible under remote control to set up and operate laboratory equipment in an automated laboratory. The remote control of the standard behaviors is defined as standard interactions that define the dialogue between the equipment and the control system that is necessary to coordinate operation. The interactions are described with state models in which individual states are defined for specific, discrete equipment behaviors. The interactions are designed to be independent of both the equipment and its function. Standard message exchanges are defined independently of any specific physical communication links or protocols for messages passing between the control system and the equipment. 1.3 This specification is derived from the General Equipment Interface Definition developed by the Intelligent Systems and Robotics Center at Sandia National Laboratory, the National Institute of Standards Technologies'' Consortium on Automated Analytical Laboratory Systems (CAALS) High-Level Communication Protocol, the CAALS Common Command Set, and the NISTIR 6294 (1-4). This LECIS specification was written, implemented, and tested by the Robotics and Automation Group at Los Alamos National Laboratory. 1.4 Equipment Requirements-LECIS defines the remote control from a Task Sequence Controller (TSC) of devices exhibiting standard behaviors of laboratory equipment that meet the NIST CAALS requirements for Standard Laboratory Modules (SLMs) (5). These requirements are described in detail in Refs (3, 4). The requirements are: 1.4.1 Predictable, deterministic behavior, 1.4.2 Ability to be remotely controlled through a standard bidirectional communication link and protocol, 1.4.3 Maintenance of remote communication even under local control, 1.4.4 Single point of logical control, 1.4.5 Universal unique identifier, 1.4.6 Status information available at all times, 1.4.7 Use of appropriate standards including the standard message exchange in this LECIS, 1.4.8 Autonomy in operation (asynchronous operation with the TSC), 1.4.9 Perturbation handling, 1.4.10 Resource management 1.4.11 Buffered inputs an outputs, 1.4.12 Automated access to material ports, 1.4.13 Exception monitoring and reporting, 1.4.14 Data exchange via robust protocol, 1.4.15 Fail-safe operation, 1.4.16 Programmable configurations (for example, I/O ports), 1.4.17 Independent power-up order, and 1.4.18 Safe start-up behavior.

Standard Specification for Laboratory Equipment Control Interface (LECIS)

ICS
35.240.80 (IT applications in health care technolo
CCS
N04
发布
1998
实施

1.1 This guide covers the identification of the information that is necessary to document emergency medical care in a computerized patient record that is part of a paperless patient record system. The intent of a paperless patient record system will be to improve efficiency and cost-effectiveness. 1.2 This guide is a view of the data elements to document the types of emergency medical information that would be valuable if available in the computerized patient record. 1.2.1 The patient''s summary record and derived data sets will be described separately from this guide. 1.2.2 As a view of the computerized patient record, the information presented will conform to the structure defined in other ASTM standards for the computerized patient record. 1.3 This guide is intended to amplify Guides E1239, E1384, and F1629 and the formalisms described in Practice E1715. 1.3.1 This guide details the use of data elements already established in these standards for use during documentation of emergency care in the field or in a treatment facility and places them in the context of the object models for health care that will be the vehicle for communication standards for health care data. 1.3.1.1 The codes for the data elements referred to in this guide will be developed in consideration of national or professional guidelines whenever available. The EMS definitions are based on those generated from the national consensus conference sponsored by NHTSA and from ASTM F30.03.03 on EMS Management Information Systems. The Emergency Department (ED) definitions will consider those recommended by the CDC workshop on ED definitions scheduled for January 1996. The hospital discharge definitions will be developed in consideration of existing requirements for Medicare and Medicaid payment. 1.3.1.2 The ASTM process allows for the definitions to be updated as the national consensus changes. When national or professional definitions do not exist, or whenever there is a conflict in the definitions, the committee will recommend a process for resolving the conflict or present the various definitions within the document along with an explanation for the purpose of each definition. 1.3.2 This guide reinforces the concepts set forth in Guides E1239 and E1384 that documentation of care in all settings shall be seamless and be conducted under a common set of precepts using a common logical record structure and common terminology. 1.4 The computerized patient record focuses on the patient. 1.4.1 In particular, the computerized patient record sets out to ensure that the data document includes: 1.4.1.1 The occurrence of the emergency, 1.4.1.2 The symptoms requiring emergency medical treatment, 1.4.1.3 The medical/mental assessment/diagnoses established, 1.4.1.4 The treatment rendered, and 1.4.1.5 The outcome and disposition of the patient after emergency treatment. 1.4.2 The computerized patient record consists of subsets of the data computerized by multiple care providers at the time of onset/scene and enroute, in the emergency department, and in the hospital or other emergency health care settings. 1.4.3 The computerized patient record focuses on the documentation of information that is necessary to support patient care but does not define appropriate care.

Standard Guide for View of Emergency Medical Care in the Computer-Based Patient Record

ICS
35.240.80 (IT applications in health care technolo
CCS
发布
1998
实施

Principal Advantage of Compton Scatter Tomography8212;The principal advantage of CST is the ability to perform three-dimensional X-ray examination without the requirement for access to the back side of the examination object. CST offers the possibility to perform X-ray examination that is not possible by any other method. The CST sub-surface slice image is minimally affected by examination object features outside the plane of examination. The result is a radioscopic image that contains information primarily from the slice plane. Scattered radiation limits image quality in normal radiographic and radioscopic imaging. Scatter radiation does not have the same detrimental effect upon CST because scatter radiation is used to form the image. In fact, the more radiation the examination object scatters, the better the CST result. Low subject contrast materials that cannot be imaged well by conventional radiographic and radioscopic means are often excellent candidates for CST. Very high contrast sensitivities and excellent spatial resolution are possible with CST tomography. Limitations8212;As with any nondestructive testing method, CST has its limitations. The technique is useful on reasonably thick sections of low-density materials. While a 25 mm [1 in.] depth in aluminum or 50 mm [2 in.] in plastic is achievable, the examination depth is decreased dramatically as the material density increases. Proper image interpretation requires the use of standards and examination objects with known internal conditions or representative quality indicators (RQIs). The examination volume is typically small, on the order of a few cubic inches and may require a few minutes to image. Therefore, completely examining large structures with CST requires intensive re-positioning of the examination volume that can be time-consuming. As with other penetrating radiation methods, the radiation hazard must be properly addressed.1.1 Purpose8212;This guide covers a tutorial introduction to familiarize the reader with the operational capabilities and limitations inherent in X-ray Compton Scatter Tomography (CST). Also included is a brief description of the physics and typical hardware configuration for CST.1.2 Advantages8212;X-ray Compton Scatter Tomography (CST) is a radiologic nondestructive examination method with several advantages that include:1.2.1 The ability to perform X-ray examination without access to the opposite side of the examination object;1.2.2 The X-ray beam need not completely penetrate the examination object allowing thick objects to be partially examined. Thick examination objects become part of the radiation shielding thereby reducing the radiation hazard;1.2.3 The ability to image examination object subsurface features with minimal influence from surface features;1.2.4 The ability to obtain high-contrast images from low subject contrast materials that normally produce low-contrast images when using traditional transmitted beam X-ray imaging methods; and 1.2.5 The ability to obtain depth information for examination object features thereby providing three-dimensional examination. The ability to obtain depth information presupposes the use of a highly collimated detector system having a narrow angle of acceptance.1.3 Applications8212;This guide does not specify which examination objects are suitable, or unsuitable, for CST. As with most nondestructive examination techniques, CST is highly application specific thereby requiring the suitability of the method to be first demonstrated in the application laboratory. This guide does not provide guidance in the standardized practice or application of CST techniques. No guidance is provided concerning the acceptance or rejection of examination objects examined with CST.......

Standard Guide for X-Ray Compton Scatter Tomography

ICS
35.240.80 (IT applications in health care technolo
CCS
H26
发布
1997
实施

This test method allows specification of the density calibration procedures to be used to calibrate and perform material density measurements using CT image data. Such measurements can be used to evaluate parts, characterize a particular system, or compare different systems, provided that observed variations are dominated by true changes in object density rather than by image artifacts. The specified procedure may also be used to determine the effective X-ray energy of a CT system. The recommended test method is more accurate and less susceptible to errors than alternative CT-based approaches, because it takes into account the effective energy of the CT system and the energy-dependent effects of the X-ray attenuation process. This (or any) test method for measuring density is valid only to the extent that observed CT-number variations are reflective of true changes in object density rather than image artifacts. Artifacts are always present at some level and can masquerade as density variations. Beam hardening artifacts are particularly detrimental. It is the responsibility of the user to determine or establish, or both, the validity of the density measurements; that is, they are performed in regions of the image which are not overly influenced by artifacts. Linear attenuation and mass attenuation may be measured in various ways. For a discussion of attenuation and attenuation measurement, see Guide E 1441 and Practice E 1570. FIG. 1 Density Calibration Phantom1.1 This test method covers instruction for determining the density calibration of X- and 947;-ray computed tomography (CT) systems and for using this information to measure material densities from CT images. The calibration is based on an examination of the CT image of a disk of material with embedded specimens of known composition and density. The measured mean CT values of the known standards are determined from an analysis of the image, and their linear attenuation coefficients are determined by multiplying their measured physical density by their published mass attenuation coefficient. The density calibration is performed by applying a linear regression to the data. Once calibrated, the linear attenuation coefficient of an unknown feature in an image can be measured from a determination of its mean CT value. Its density can then be extracted from a knowledge of its mass attenuation coefficient, or one representative of the feature.1.2 CT provides an excellent method of nondestructively measuring density variations, which would be very difficult to quantify otherwise. Density is inherently a volumetric property of matter. As the measurement volume shrinks, local material inhomogeneities become more important; and measured values will begin to vary about the bulk density value of the material.1.3 All values are stated in SI units.1.4 This standard does not purport to address 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.

Standard Test Method for Calibrating and Meausring CT Density

ICS
35.240.80 (IT applications in health care technolo
CCS
H26
发布
1997
实施



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