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ASTM E1715-01

(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

Replaces
ASTM E1715-99 - 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
Replaced By
ASTM E1715-01(2008) - Standard Practice for An Object-Oriented Model for Registration, Admitting, Discharge, and Transfer (RADT) Functions in Computer-Based Patient Record Systems
Effective Date
15-Sep-2008

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ASTM E1715-01 - Standard Practice for An Object-Oriented Model for Registration, Admitting, Discharge, and Transfer (RADT) Functions in Computer-Based Patient Record SystemsASTM E1715-01 - 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 E1715-01 - 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
An American National Standard
Designation: E 1715 – 01
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 F 1629 Guide for Establishing and/or Operating Emergency
3
Medical Services Management Information Systems
1.1 ThispracticeisintendedtoamplifyGuideE 1239andto
2.2 ANSI Standard:
complement Guide E 1384 by detailing the objects that make
4
ANSI X3.172 Dictionary of Information Systems
up the reservation, registration, admitting, discharge, and
2.3 IEEE Standard:
transfer (RADT) functional domain of the computer-based
IEEE 1157.1 Trial Use Standard for Healthcare Information
record of care (CPR). As identified in Guide E 1239, this
5
Interchange—Information Modelling (6 June 1994)
domain is seminal to all patient record and ancillary system
2.4 Other Document:
functions, including messaging functions used in telecommu-
6
HL-7 v2.4 Data Communication Standard
nications. For example, it is applicable to clinical laboratory
information management systems, pharmacy information man-
3. Terminology
agement systems, and radiology, or other image management,
3.1 Definitions—General terms are defined in accordance
information management systems. The object model terminol-
with ANSI X3.172.
ogy is used to be compatible with other national and interna-
3.2 Definitions of Terms Specific to This Standard:
tional standards for healthcare data and information systems
3.2.1 functional domain, n—that area of activity that en-
engineeringortelecommunicationsstandardsappliedtohealth-
compasses a given function. (HL-7, v2.4)
care data or systems. This practice is intended for those
3.2.2 healthcare domain, n—that functional domain encom-
familiar with modeling concepts, system design, and imple-
passing all aspects of the delivery of health care, both preven-
mentation.Itisnotintendedforthegeneralcomputeruseroras
tive and corrective, to patients, and the management of
an initial introduction to the concepts.
resources enabling that care to be delivered. (HL-7, v2.4)
2. Referenced Documents
4. Background
2.1 ASTM Standards:
4.1 Object Representation of RADT Processes—Guide
E 1238 Specification for Transferring Clinical Observations
2 E 1239 provides the experiential background of the functions
Between Independent Computer Systems
in RADT. These functions are common to all systems that deal
E 1239 Guide for Description of Reservation/Registration-
with patient data. The minimal essential data elements for
Admission, Discharge, Transfer (RADT) Systems for Au-
2 RADT were identified and characterized partly in Guide
tomated Patient Care Information Systems
E 1239. Table 1 of that guide identifies a logical data structure
E 1384 Guide for Content and Structure of the Electronic
2 for the data elements, but it does not relate these elements to
Health Record (EHR)
constituent “entities” or “objects” in the sense that they are
E 1633 Specification for Coded Values Used in the Elec-
2 now used in analysis. Entity-relationship modeling is one
tronic Health Record (EHR)
7
major technique used (1) to establish the conceptual“ things”
E 1639 Guide for Functional Requirements of Clinical
2 and their relationships involved in this overall functional
Laboratory Information Management Systems
E 1744 Guide for View of Emergency Medical Care in the
2
Computerized Patient Record
3
Annual Book of ASTM Standards, Vol 13.01.
4
Available from American National Standards Institute, 11 W. 42nd St., 13th
Floor, New York, NY 10036.
1 5
This practice is under the jurisdiction ofASTM Committee E31 on Healthcare Available from IEEE, 445 Hoes Lane, P.O. Box 1331, Piscataway, NJ
Informatics and is the direct responsibility of Subcommittee E31.25 on Healthcare 08855-1331.
6
Management, Security, Confidentiality, and Privacy. AvailablefromHealthLevelSeven,900VictorsWay,Suite122,AnnArbor,MI
Current edition approved May 10, 2001. Published July 2001. Originally 48108.
7
published as E 1744–95. Last previous edition E 1744–99. The boldface numbers in parentheses refer to the list of references at the end of
2
Annual Book of ASTM Standards, Vol 14.01. the standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
E1715–01
TABLE 1 Data Element Datatypes
agement.Thehospitalandemergencyroomdataareasubsetof
Type Standar
...

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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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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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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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1.3.1 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.  
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 values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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
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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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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