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ASTM E1715-99

(Practice)

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

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

SCOPE
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.

General Information

Status
Historical
Publication Date
09-May-2001
ICS
35.240.80 - IT applications in health care technology
Technical Committee
E31 - Healthcare Informatics
Drafting Committee
E31.25 - Healthcare Data Management, Security, Confidentiality, and Privacy
Current Stage
Ref Project

Relations

Replaced By
ASTM E1715-01 - Standard Practice for An Object-Oriented Model for Registration, Admitting, Discharge, and Transfer (RADT) Functions in Computer-Based Patient Record Systems
Effective Date
10-May-2001

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ASTM E1715-99 - Standard Practice for An Object-Oriented Model for Registration, Admitting, Discharge, and Transfer (RADT) Functions in Computer-Based Patient Record SystemsASTM E1715-99 - Standard Practice for An Object-Oriented Model for Registration, Admitting, Discharge, and Transfer (RADT) Functions in Computer-Based Patient Record Systems
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ASTM E1715-99 - Standard Practice for An Object-Oriented Model for Registration, Admitting, Discharge, and Transfer (RADT) Functions in Computer-Based Patient Record Systems
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NOTICE: This standard has either been superseded and replaced by a new version or
withdrawn. Contact ASTM International (www.astm.org) for the latest information.
Designation: E 1715 – 99 An American National Standard
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Practice for
an Object-Oriented Model for Registration, Admitting,
Discharge, and Transfer (RADT) Functions in Computer-
1
Based Patient Record Systems
This standard is issued under the fixed designation E 1715; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 2.2 ANSI Standard:
3
ANSI X3.172 Dictionary of Information Systems
1.1 This practice is intended to amplify Guide E 1239 and to
2.3 IEEE Standard:
complement Guide E 1384 by detailing the objects that make
IEEE 1157.1 Trial Use Standard for Healthcare Information
up the reservation, registration, admitting, discharge, and
4
Interchange—Information Modelling (6 June 1994)
transfer (RADT) functional domain of the computer-based
2.4 Other Document:
record of care (CPR). As identified in Guide E 1239, this
5
HL-7 v2.2 Data Communication Standard
domain is seminal to all patient record and ancillary system
functions, including messaging functions used in telecommu-
3. Terminology
nications. For example, it is applicable to clinical laboratory
3.1 General terms are defined in ANSI X3.172.
information management systems, pharmacy information man-
3.2 Definitions of Terms Specific to This Standard:
agement systems, and radiology, or other image management,
3.2.1 functional domain—that area of activity that encom-
information management systems. The object model terminol-
passes a given function. (HL-7, v2.2)
ogy is used to be compatible with other national and interna-
3.2.2 health care domain—that functional domain encom-
tional standards for health care data and information systems
passing all aspects of the delivery of health care, both preven-
engineering or telecommunications standards applied to health
tive and corrective, to patients, and the management of
care data or systems. This practice is intended for those
resources enabling that care to be delivered. (HL-7, v2.2)
familiar with modeling concepts, system design, and imple-
mentation. It is not intended for the general computer user or as
4. Background
an initial introduction to the concepts.
4.1 Object Representation of RADT Processes—Guide
2. Referenced Documents E 1239 provides the experiential background of the functions
in RADT. These functions are common to all systems that deal
2.1 ASTM Standards:
with patient data. The minimal essential data elements for
E 1238 Specification for Transferring Clinical Observations
2 RADT were identified and characterized partly in Guide
Between Independent Computer Systems
E 1239. Table 1 of that guide identifies a logical data structure
E 1239 Guide for Description of Reservation/Registration-
for the data elements, but it does not relate these elements to
Admission, Discharge, Transfer (RADT) Systems for Au-
2
constituent “entities” or “objects” in the sense that they are
tomated Patient Care Information Systems
now used in analysis. Entity-relationship modeling is one
E 1384 Guide for Description for Content and Structure of
6
2 major technique used (1) to establish the conceptual “things”
an Automated Primary Record of Care
and their relationships involved in this overall functional
E 1633 Specification for Coded Values Used in Computer-
2 domain. “Objects” (2, 3) is another term for these things, and
Based Patient Record
the object concept involves very specific characteristics asso-
E 1639 Guide for Functional Requirements of Clinical
2 ciated with a defined object such as encapsulation and inher-
Laboratory Information Management Systems
itance. Common ground exists between entity and object
E 1744 Guide for a View of Emergency Medical Care in the
2 representations of models. However, the object terminology is
Computer-Based Patient Record
F 1629 Guide for Establishing and/or Operating Emergency
Medical Services Management Information Systems
3
Available from American National Standards Institute, 11 W. 42nd St., 13th
Floor, New York, NY 10036.
4
1
Available from IEEE, 445 Hoes Lane, P.O. Box 1331, Piscataway, NJ
This practice is under the jurisdiction of ASTM Committee E-31 on Healthcare
08855-1331.
Informatics and is the direct responsibility of Subcommittee E31.19 on Computer-
5
–Based Patient Record Content and Structure. Available from Health Level Seven, 900 Victors Way, Suite 122, Ann Arbor, MI
Current edition approved Jan. 10, 1999. Published March 1999. Originally 48108.
6
published as E 1744–95. Last previous editi
...

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ABSTRACT
This specification describes the security requirements involved in the development and implementation of audit and disclosure logs used in health information systems. 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 confidential health care information to external users for use in manual and computer systems. This specification provides for two main purposes, namely: 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; and 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.
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4.3 Audit reports designed for system access provide a precise capability for healthcare providers, organizations, patients, patient representatives, and advocates to see who has accessed and/or manipulated patient information. Because of the significant risk of medical information manipulation in computing environments by authorized and unauthorized users, the audit report is an important management tool to monitor access and any such manipulation retrospectively. In addition, the access and disclosure logs become powerful support documents for disciplinary and legal actions. Moreover, audit reports are essential components to comprehensive security programs in healthcare and vital for the privacy rights of the individual. A patient has a right to ...
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1.2 The first purpose of this specification is to defin...

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4.1 Purpose—Practices to be employed for the radiographic examination of materials and components with neutrons using digital neutron detectors are outlined herein. They are intended as a guide for the assessment of a digital neutron radiograph’s characteristics. For information on neutron beam lines for imaging and film neutron radiography, refer to Guide E748.  
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1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE) for Digital X-ray (DX) Test Methods

SIGNIFICANCE AND USE
5.1 Personnel that are responsible for the creation, transfer, and storage of digital X-ray test results will use this standard. This practice defines a set of information modules that, along with Practice E2339 and the DICOM standard, provides a standard means to organize digital X-ray test parameters and results. The digital X-ray test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any digital X-ray inspection data stored according to Practice E2339 may use this document to help them decode and display the data contained in the DICONDE-compliant inspection record.
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1.1 This practice covers the interoperability of digital X-ray imaging equipment using Digital Detector Arrays (DDA) as described in Practice E2698 by specifying image data transfer and archival methods in commonly accepted terms. A separate practice, Practice E2738, addresses this topic for digital X-ray imaging equipment using Computed Radiography (CR). This document is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of DICOM NEMA PS3 / ISO 12052 (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage, and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules, and a data dictionary that are specific to digital X-ray test methods.  
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1.3.2 The implementation details of any features of the standard on a device claiming conformance.  
1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance.  
1.4 Units—Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The SI units required by this practice are to be regarded as standard. No other units of measurement are included in this standard.  
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1.1 This guide provides a listing and description of the fields that are recommended for inclusion in a digital radiological examination data base to facilitate the transfer of such data. This guide sets guidelines for the format of data fields for computerized transfer of digital image files obtained from radiographic, radioscopic, computed radiographic, or other radiological examination systems. The field listing includes those fields regarded as necessary for inclusion in the data base: (1) regardless of the radiological examination method (as indicated by Footnote C in Table 1), (2) for radioscopic examination (as indicated by Footnote F in Table 1), and (3) for radiographic examination (as indicated by Footnote D in Table 1). In addition, other optional fields are listed as a reminder of the types of information that may be useful for additional understanding of the data or applicable to a limited number of applications.  
1.2 It is recognized that organizations may have in place an internal format for the storage and retrieval of radiological examination data. This guide should not impede the use of such formats since it is probable that the necessary fields are already included in such internal data bases, or that the few additions can easily be made. The numerical listing and its order indicated in this guide is only for convenience; the specific numbers and their order carry no inherent significance and are not part of the data file.  
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5.1 The purpose of this practice is to provide data that can be used for comparison and evaluation of the accuracy of different CAS systems.  
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1.3 All units of measure will be reported as millimeters for this standard.  
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5.1 The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems.  
5.2 The use of surgical navigation and robotic positioning systems is becoming increasingly common. In order to make informed decisions about the suitability of such systems for a given procedure, their accuracy capability needs to be evaluated under clinical application and compared to the requirements. As the performance of a whole system is constrained by those of its subparts, a preliminary step must be to objectively characterize the accuracy of the tracking subsystem in a controlled environment under controlled conditions.  
5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting accuracy is needed. Parameters such as coordinate system, units of measurement, terminology, and operational conditions must be standardized.
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1.1 This document provides procedures for measurement and reporting of basic static performance of surgical navigation and/or robotic positioning devices under defined conditions. They can be performed on a subsystem (for example, tracking only) or a full computer-aided surgery system as would be used clinically. Testing a subsystem does not mean that the whole system has been tested. The functionality to be tested based on this practice is limited to the performance (accuracy in terms of bias and precision) of the system regarding point localization in space by means of a pointer. A point in space has no orientation; only multidimensional objects have orientation. Therefore, orientation of objects is not within the scope of this practice. However, in localizing a point the different orientations of the pointer can produce errors. These errors and the pointer orientation are within the scope of this practice. The aim is to provide a standardized measurement of performance variables by which end users can compare within a system (for example, with different reference elements or pointers) and between different systems (for example, from different manufacturers). Parameters to be evaluated include (based upon the features of the system being evaluated):
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SIGNIFICANCE AND USE
5.1 Personnel that are responsible for the creation, transfer, and storage of X-ray tomographic NDE data will use this standard. This practice defines a set of information modules that along with Practice E2339 and the DICOM standard provide a standard means to organize X-ray tomography test parameters and results. The X-ray CT test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any tomographic inspection data stored according to Practice E2339 may use this document to help them decode and display the data contained in the DICONDE-compliant inspection record.
SCOPE
1.1 This practice facilitates the interoperability of X-ray computed tomography (CT) imaging equipment by specifying image data transfer and archival storage methods in commonly accepted terms. This document is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of the NEMA Standards Publication titled Digital Imaging and Communications in Medicine (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE test results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules and a data dictionary that are specific to X-ray CT test methods.  
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1.3 This practice does not specify:  
1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard.  
1.3.2 The implementation details of any features of the standard on a device claiming conformance.  
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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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 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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ASTM E2891-20(Guide)
Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

SIGNIFICANCE AND USE
4.1 A significant amount of data is generated during pharmaceutical development and manufacturing activities. The interpretation of such data is becoming increasingly difficult. Individual examination of the univariate process variables is relevant but can be significantly complemented by multivariate data analysis (MVDA). MVDA may be particularly appropriate for exploring and handling large sets of heterogenous data, mapping data of high dimensionality onto lower dimensional representations, exposing significant correlations among multivariate variables within a single data set or significant correlations among multivariate variables across data sets. MVDA may extract statistically significant information which may enhance process understanding, decision making in process development, process monitoring and control (including product release), product life-cycle management, and continuous improvement.  
4.2 MVDA is widely used in various industries including the pharmaceutical industry. To achieve a valid outcome, an MVDA model/application should incorporate the following:  
4.2.1 A predefined risk-based objective incorporating one or more relevant scientific hypotheses specific to the application;  
4.2.2 Sufficient relevant data of requisite quality covering the variance space encountered during intended use, that is, pharmaceutical development, or pharmaceutical manufacturing, or both;  
4.2.3 Appropriate data analysis and model utilization practices including considerations on testing, validation, and qualification of all new data prior to using a model to analyze it;  
4.2.4 Appropriately trained staff;  
4.2.5 Appropriate standard operating procedures; and  
4.2.6 Life-cycle management.  
4.3 This guide can be used to support data analysis activities associated with pharmaceutical development and manufacturing, process performance and product quality monitoring in manufacturing, as well as for troubleshooting and investigation events. Technical detai...
SCOPE
1.1 This guide covers the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities. MVDA is one of the key enablers for process understanding and decision making in pharmaceutical development, and for the release of intermediate and final products after being validated appropriately using a science and risk-based approach.  
1.2 The scope of this guide is to provide general guidelines on the application of MVDA in the pharmaceutical industry. While MVDA refers to typical empirical data analysis, the scope is limited to providing a high level guidance and not intended to provide application-specific data analysis procedures. This guide provides considerations on the following aspects:  
1.2.1 Use of a risk-based approach (understanding the objective requirements and assessing the fit-for-use status);  
1.2.2 Considerations on the data collection and diagnostics used for MVDA (including data preprocessing and outliers);  
1.2.3 Considerations on the different types of data analysis, model testing, and validation;  
1.2.4 Qualified and competent personnel; and  
1.2.5 Life-cycle management of MVDA model.  
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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  • Guide
    7 pages
    English language
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ASTM
ASTM E1935-97(2019)(Test Method)
Standard Test Method for Calibrating and Measuring CT Density

SIGNIFICANCE AND USE
5.1 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.  
5.2 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.
FIG. 1 Density Calibration Phantom  
5.3 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.  
5.4 Linear attenuation and mass attenuation may be measured in various ways. For a discussion of attenuation and attenuation measurement, see Guide E1441 and Practice E1570.
SCOPE
1.1 This test method covers instruction for determining the density calibration of X- and γ-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 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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