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ASTM E1239-04

(Practice)

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

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

SCOPE
1.1 This practice identifies the minimum information capabilities needed by an ambulatory care system or a resident facility R-ADT system. This practice 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 practice 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 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 requirements prior to use.

General Information

Status
Historical
Publication Date
31-Oct-2004
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 E1239-00 - Standard Guide for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT) Systems for Electronic Health Record (EHR) Systems
Effective Date
01-Nov-2004
Replaced By
ASTM E1239-04(2010) - Standard Practice for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT) Systems for Electronic Health Record (EHR) Systems (Withdrawn 2017)
Effective Date
01-Mar-2010

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ASTM E1239-04 - Standard Practice for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT) Systems for Electronic Health Record (EHR) SystemsASTM E1239-04 - Standard Practice for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT) Systems for Electronic Health Record (EHR) Systems
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ASTM E1239-04 - Standard Practice for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT) Systems for Electronic Health Record (EHR) Systems
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Standards Content (Sample)

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:E1239–04
Standard Practice for
Description of Reservation/Registration-Admission,
Discharge, Transfer (R-ADT) Systems for Electronic Health
1
Record (EHR) Systems
This standard is issued under the fixed designation E1239; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope E1384 Practice for Content and Structure of the Electronic
Health Record (EHR)
1.1 This practice identifies the minimum information capa-
E1633 Specification for Coded Values Used in the Elec-
bilities needed by an ambulatory care system or a resident
tronic Health Record
facility R-ADT system. This practice is intended to depict the
E1714 Guide for Properties of a Universal Healthcare
processes of: patient registration, inpatient admission into
Identifier (UHID)
health care institutions and the use of registration data in
E1715 Practice forAn Object-Oriented Model for Registra-
establishing and using the demographic segments of the
tion, Admitting, Discharge, and Transfer (RADT) Func-
electronic health record. It also identifies a common core of
tions in Computer-Based Patient Record Systems
informational elements needed in this R-ADT process and
E1744 PracticeforViewofEmergencyMedicalCareinthe
outlines those organizational elements that may use these
Electronic Health Record
segments. Furthermore, this guide identifies the minimum
E1869 Guide for Confidentiality, Privacy,Access, and Data
general requirements for R-ADT and helps identify many of
Security Principles for Health Information Including Elec-
theadditionalspecificrequirementsforsuchsystems.Thedata
tronic Health Records
elements described may not all be needed but, if used, they
3
2.2 ANSI Standards:
must be used in the way specified so that each record segment
ANSX3.38 Identification of States of the United States for
has comparable data. This practice will help answer questions
Information Interchange
faced by designers of R-ADT capabilities by providing a clear
ANSX3.47 Structure of the Identification of Name Popu-
description of the consensus of health care professionals
lated Places and Related Entities of the States of the
regarding a uniform set of minimum data elements used by
United States
R-ADT functions in each component of the larger system. It
NCCLSLIS-5A Specification for Transferring Clinical Ob-
will also help educate health care professionals in the general
servations Between Independent Computer Systems
principles of patient care information management as well as
NCCLSLIS-8A Guide for Functional Requirements of
the details of the constituent specialty areas.
Clinical Laboratory Information Management Systems
1.2 This standard does not purport to address all of the
NCCLSLIS-9A Guide for Coordination of Clinical Labo-
safety concerns, if any, associated with its use. It is the
ratory Services within the Electronic Health Record En-
responsibility of the user of this standard to establish appro-
vironment and Networked Architectures
priate safety and health practices and determine the applica-
4
2.3 ISO Standards:
bility of regulatory requirements prior to use.
ISO 639 Names of Languages
2. Referenced Documents
ISO 3166 Names of Countries
2
ISO 5218 Representation of Human Sexes
2.1 ASTM Standards:
5
2.4 Federal Information Processing Standard Publication:
FIPSPUB 6-2 Counties of the States of the United States
FIPSPUB 5-1 States of the United States
1
This practice is under the jurisdiction ofASTM Committee E31 on Healthcare
Informatics and is the direct responsibility of Subcommittee E31.25 on Healthcare
3. Terminology
Data Management, Security, Confidentiality, and Privacy. This guide was prepared
in collaboration with the American Health Information Management Assn.
3.1 Definitions of Terms Specific to This Standard:
Current edition approved Nov. 1, 2004. Published November 2004. Originally
approved in 1988. Last previous edition approved in 2000 as E1239–00. DOI:
3
10.1520/E1239-04. Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 4th Floor, New York, NY 10036.
4
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from ISO.
5
Standards volume information, refer to the standard’s Document Summary page on Available from US Dept. of Commerce, Government Printing Office, Wash-
the ASTM website. ington, DC.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
E1239–04
3.1
...

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1.1 This specification is for the development and implementation of secure audit data and logs for electronically stored health information. It specifies how to design the audit log to record all activities impacting a medical record, for example, creating a new record, entering data into a record, changing or deleting an existing record, and all additional user access data (for example, identification, location, and date and time) to patient-identifiable information maintained in computer systems. Such audit logs shall track not only data entry and modifications, but also simple access and viewing of the patient record, and whether any modifications are made during that access. This specification also includes principles for developing policies, procedures, and functions of health information logs to document all actions regarding identifiable health information for use in both manually entered (paper record) and computer systems.  
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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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 standard will measure the effects on the accuracy of computer assisted surgery (CAS) systems of the environmental influences caused by equipment utilized for bone preparation during the intended clinical application for the system. The environmental vibration effect covered in this standard will include mechanical vibration from: cutting saw (sagittal or reciprocating), burrs, drills, and impact loading. The change in accuracy from detaching and re-attaching or disturbing a restrained connection that does not by design require repeating the registration process of a reference base will also be measured.  
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1.3 All units of measure will be reported as millimeters for this standard.  
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SIGNIFICANCE AND USE
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 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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