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ASTM E2369-05e2

(Specification)

Standard Specification for Continuity of Care Record (CCR)

Standard Specification for Continuity of Care Record (CCR)

ABSTRACT
The Continuity of Care Record (CCR) is a core data set of the most relevant administrative, demographic, and clinical information facts about a patient's healthcare, covering one or more healthcare encounters. It provides a means for one healthcare practitioner, system, or setting to aggregate all of the pertinent data about a patient and forward it to another practitioner, system, or setting to support the continuity of care. The primary use case for the CCR is to provide a snapshot in time containing the pertinent clinical, demographic, and administrative data for a specific patient. To ensure interchangeability of electronic CCRs, this specification specifies XML coding that is required when the CCR is created in a structured electronic format. Conditions of security and privacy for a CCR instance must be established in a way that allows only properly authenticated and authorized access to the CCR document instance or its elements. The CCR consists of three core components: the CCR Header, the CCR Body, and the CCR Footer.
SCOPE
1.1 The Continuity of Care Record (CCR) is a core data set of the most relevant administrative, demographic, and clinical information facts about a patient’s healthcare, covering one or more healthcare encounters. It provides a means for one healthcare practitioner, system, or setting to aggregate all of the pertinent data about a patient and forward it to another practitioner, system, or setting to support the continuity of care.
1.1.1 The CCR data set includes a summary of the patient’s health status (for example, problems, medications, allergies) and basic information about insurance, advance directives, care documentation, and the patient’s care plan. It also includes identifying information and the purpose of the CCR. (See 5.1 for a description of the CCR’s components and sections, and Annex A1 for the detailed data fields of the CCR.)
1.1.2 The CCR may be prepared, displayed, and transmitted on paper or electronically, provided the information required by this specification is included. When prepared in a structured electronic format, strict adherence to an XML schema and an accompanying implementation guide is required to support standards-compliant interoperability. The Adjunct to this specification contains a W3C XML schema and Annex A2 contains an Implementation Guide for such representation.
1.2 The primary use case for the CCR is to provide a snapshot in time containing the pertinent clinical, demographic, and administrative data for a specific patient.
1.2.1 This specification does not speak to other use cases or to workflows, but is intended to facilitate the implementation of use cases and workflows. Any examples offered in this specification are not to be considered normative.  
1.3 To ensure interchangeability of electronic CCRs, this specification specifies XML coding that is required when the CCR is created in a structured electronic format. This specified XML coding provides flexibility that will allow users to prepare, transmit, and view the CCR in multiple ways, for example, in a browser, as an element in a Health Level 7 (HL7) message or CDA compliant document, in a secure email, as a PDF file, as an HTML file, or as a word processing document. It will further permit users to display the fields of the CCR in multiple formats.
1.3.1 The CCR XML schema or .xsd (see the Adjunct to this specification) is defined as a data object that represents a snapshot of a patient’s relevant administrative, demographic, and clinical information at a specific moment in time. The CCR XML is not a persistent document, and it is not a messaging standard.
Note 1—The CCR XML schema can also be used to define an XML representation for the CCR data elements, subject to the constraints specified in the accompanying Implementation Guide (see Annex A2).
1.3.2 Using the required XML schema in the Adjunct to this specification or other XML schemas that may be authori...

General Information

Status
Historical
Publication Date
30-Sep-2005
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 E2369-05e1 - Standard Specification for Continuity of Care Record (CCR)
Effective Date
01-Oct-2005
Referred By
ASTM E1578-18 - Standard Guide for Laboratory Informatics
Effective Date
01-Oct-2005

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ASTM E2369-05e2 - Standard Specification for Continuity of Care Record (CCR)ASTM E2369-05e2 - Standard Specification for Continuity of Care Record (CCR)
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ASTM E2369-05e2 - Standard Specification for Continuity of Care Record (CCR)
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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
´2
Designation:E2369 −05 AnAmerican National Standard
Standard Specification for
1
Continuity of Care Record (CCR)
This standard is issued under the fixed designation E2369; 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 (´) indicates an editorial change since the last revision or reapproval.
1
´ NOTE—Section 2 was corrected editorially in August 2009.
2
´ NOTE—Footnote 1 was corrected editorially in October 2011
1. Scope of use cases and workflows. Any examples offered in this
4
specification are not to be considered normative.
1.1 The Continuity of Care Record (CCR) is a core data set
of the most relevant administrative, demographic, and clinical 1.3 To ensure interchangeability of electronic CCRs, this
information facts about a patient’s healthcare, covering one or specification specifies XML coding that is required when the
2 5
more healthcare encounters. It provides a means for one CCR is created in a structured electronic format. This speci-
healthcarepractitioner,system,orsettingtoaggregateallofthe fied XML coding provides flexibility that will allow users to
pertinent data about a patient and forward it to another prepare, transmit, and view the CCR in multiple ways, for
practitioner,system,orsettingtosupportthecontinuityofcare. example,inabrowser,asanelementinaHealthLevel7(HL7)
1.1.1 The CCR data set includes a summary of the patient’s message or CDA compliant document, in a secure email, as a
health status (for example, problems, medications, allergies) PDF file, as an HTML file, or as a word processing document.
andbasicinformationaboutinsurance,advancedirectives,care It will further permit users to display the fields of the CCR in
documentation, and the patient’s care plan. It also includes multiple formats.
identifying information and the purpose of the CCR. (See 5.1 1.3.1 TheCCRXMLschemaor.xsd(seetheAdjuncttothis
for a description of the CCR’s components and sections, and specification) is defined as a data object that represents a
Annex A1 for the detailed data fields of the CCR.) snapshot of a patient’s relevant administrative, demographic,
1.1.2 The CCR may be prepared, displayed, and transmitted andclinicalinformationataspecificmomentintime.TheCCR
on paper or electronically, provided the information required XML is not a persistent document, and it is not a messaging
by this specification is included.When prepared in a structured standard.
electronic format, strict adherence to an XML schema and an
NOTE 1—The CCR XML schema can also be used to define an XML
accompanying implementation guide is required to support
representation for the CCR data elements, subject to the constraints
3
standards-compliant interoperability. The Adjunct to this
specified in the accompanying Implementation Guide (see Annex A2).
specification contains a W3C XML schema and Annex A2
1.3.2 Using the required XMLschema in theAdjunct to this
contains an Implementation Guide for such representation.
specification or other XML schemas that may be authorized
1.2 The primary use case for the CCR is to provide a through joints efforts of ASTM and other standards develop-
snapshot in time containing the pertinent clinical, ment organizations, properly designed electronic healthcare
demographic, and administrative data for a specific patient. record (EHR) systems will be able to import and export all
1.2.1 This specification does not speak to other use cases or CCR data to enable automated healthcare information trans-
to workflows, but is intended to facilitate the implementation mission with minimal workflow disruption for practitioners.
Equally important, it will allow the interchange of the CCR
data between otherwise incompatible EHR systems.
1
This specification is under the jurisdiction of ASTM Committee E31 on
1.4 Security—The data contained within the CCR are pa-
Healthcare Informatics and is the direct responsibility of Subcommittee E31.25 on
tient data and, if those data are identifiable, then end-to-end
Healthcare Data Management, Security, Confidentiality, and Privacy.
Current edition approved July 17, 2006. Published December 2005. DOI: CCR document integrity and confidentiality must be provided
10.1520/E2369-05E02.
2
A CCR is not intended to be a medical-legal clinical or administrative
document entered into a patient’s record, but may in specific use cases be used in
4
such a manner, provided that accepted policies and procedures in adding such data Since the CCR is a core data set of selected, relevant information, it is not a
to a patient’s record are followed. A personal health record, with the information discharge summary, that is, it does not include all of a patient’s health information
under
...

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ABSTRACT
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SIGNIFICANCE AND USE
5.1 Personnel that are responsible for the creation, transfer, and storage of computed radiography NDE data will use this practice. This practice will define a set of information modules that along with the Practice E2339 and the DICOM standard will provide a standard means to organize CR inspection data. The CR inspection data may be displayed and analyzed on any device that conforms to the standard. Personnel wishing to view any CR inspection data stored in accordance with Practice E2339 may use this practice 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 computed radiography (CR) imaging and data acquisition equipment by specifying image data transfer and archival storage methods in commonly accepted terms. This practice 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 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 computed radiography test methods.  
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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.  
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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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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.  
1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from tomographic test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all the X-ray CT technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology.  
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.  
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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