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ASTM E2344-04(2011)

(Guide)

Standard Guide for Data Capture through the Dictation Process (Withdrawn 2020)

Standard Guide for Data Capture through the Dictation Process (Withdrawn 2020)

SIGNIFICANCE AND USE
This document provides guidelines for dictation techniques and environments that contribute to quality documentation, that is:
Educational facilities for the purpose of introducing and training of dictation techniques, and
Healthcare professionals for preferred dictation techniques.
This document provides recommendations to help create quality documentation for the following reasons:
Correct Coding for Reimbursement
Reports that require no QA intervention increase efficiency of the reimbursement process and reduce discrepancies for the healthcare environment and healthcare provider.
Risk Management, Legal, and Peer Review
Reports that require no QA intervention reduce legal exposure for the healthcare environment and the healthcare provider.
Improved TAT
Reports that require no QA intervention reduce turnaround time, are more cost-effective, and possibly reduce delay in patient care.
Legislative and Regulatory Compliance
Dictation performed in preferred environments would not compromise patient confidentiality and the patient's right to privacy and would be compliant with legislative and regulatory requirements.
Continuity of Patient Care
Documents with missing text (blanks) compromise quality. These should be filled in or corrected as directed by the dictating author upon authentication of the report.
Improved Communication Between Healthcare Professionals
Timely quality documentation can enhance communication within the dynamic healthcare setting. Patient safety may also be improved when transcribed documents are used to replace handwritten documentation by healthcare professionals.
This document does not address security issues. Refer to Specification E1902.
SCOPE
1.1 This guide identifies ways to improve the quality of healthcare documentation through the dictation process. This guide will assist dictating authors (physicians, physician assistants, nurses, therapists, and other healthcare professionals) in facilitating their use of dictation in the healthcare environment, that is, hospital, clinic, physician practice, or multi-campus healthcare system.
1.2 This guide will aid in the continuity of patient care, privacy and confidentiality issues, risk management issues, optimal coding for reimbursement, compliance with legislative and regulatory requirements, and turnaround time.
1.3 The complexity of the language of medicine, the dynamics of the healthcare environment, and the sophistication of the dictation systems present a formidable challenge for dictating authors. This guide will facilitate a quality dictation message.
1.4 This guide does not address the medical transcription process.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.
WITHDRAWN RATIONALE
This guide identifies ways to improve the quality of healthcare documentation through the dictation process. This guide will assist dictating authors (physicians, physician assistants, nurses, therapists, and other healthcare professionals) in facilitating their use of dictation in the healthcare environment, that is, hospital, clinic, physician practice, or multi-campus healthcare system.
Formerly under the jurisdiction of Committee E31 on Healthcare Informatics, this guide was withdrawn in January 2020 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

Status
Withdrawn
Publication Date
30-Jun-2011
Withdrawal Date
08-Jan-2020
ICS
11.020 - Medical sciences and health care facilities in general
Technical Committee
E31 - Healthcare Informatics
Drafting Committee
E31.15 - Healthcare Information Capture and Documentation
Current Stage
Ref Project

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ASTM E2344-04(2011) - Standard Guide for Data Capture through the Dictation Process (Withdrawn 2020)ASTM E2344-04(2011) - Standard Guide for Data Capture through the Dictation Process (Withdrawn 2020)
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ASTM E2344-04(2011) - Standard Guide for Data Capture through the Dictation Process (Withdrawn 2020)
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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: E2344 − 04 (Reapproved 2011)
Standard Guide for
1
Data Capture through the Dictation Process
This standard is issued under the fixed designation E2344; 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. Scope E1902 Specification for Management of the Confidentiality
and Security of Dictation, Transcription, and Transcribed
1.1 This guide identifies ways to improve the quality of
3
Health Records (Withdrawn 2011)
healthcare documentation through the dictation process. This
E2117 Guide for Identification and Establishment of a Qual-
guide will assist dictating authors (physicians, physician
ity Assurance Program for Medical Transcription
assistants, nurses, therapists, and other healthcare profession-
E2184 Specification for Healthcare Document Formats
als) in facilitating their use of dictation in the healthcare
3
(Withdrawn 2011)
environment, that is, hospital, clinic, physician practice, or
multi-campus healthcare system.
3. Terminology
1.2 This guide will aid in the continuity of patient care,
3.1 Definitions:
privacy and confidentiality issues, risk management issues,
3.1.1 analog, n—of, relating to, or being a mechanism in
optimal coding for reimbursement, compliance with legislative
which data is represented by continuously variable physical
and regulatory requirements, and turnaround time.
quantities, that is, recording tape.
1.3 The complexity of the language of medicine, the dy-
3.1.2 blanks, n—missing text that must be filled in as
namicsofthehealthcareenvironment,andthesophisticationof
directed by the dictating author.
the dictation systems present a formidable challenge for
dictating authors. This guide will facilitate a quality dictation
3.1.3 confidential, adj—status accorded to data or informa-
message. tion indicating that it is sensitive, and therefore, it must be
protected against theft, disclosure, or improper use.
1.4 This guide does not address the medical transcription
process. 3.1.4 dictate workstation (or dictate station), n—location
with a device for input of voice dictation.
1.5 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
3.1.5 dictating author, n—one who dictates information to
responsibility of the user of this standard to establish appro-
be transcribed, that is, healthcare students and healthcare
priate safety and health practices and determine the applica-
professionals.
bility of regulatory requirements prior to use.
3.1.6 dictation message (or digital voice file), n—unit of
1.6 This international standard was developed in accor-
information that consists of both audio (voice) and its data
dance with internationally recognized principles on standard-
elements.
ization established in the Decision on Principles for the
3.1.7 document, n—report in any form (print, electronic, or
Development of International Standards, Guides and Recom-
voice file).
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
3.1.8 healthcare environment, n—any facility whose pri-
mary purpose is delivery of healthcare, that is, hospital, clinic,
2. Referenced Documents
physician practice, or multi-campus healthcare system.
2
2.1 ASTM Standards:
3.1.9 medical transcription, n—process of interpreting and
transcribing dictation by physicians and other healthcare pro-
1
fessionals regarding patient assessment, workup, therapeutic
This guide is under the jurisdiction of ASTM Committee E31 on Healthcare
Informatics and is the direct responsibility of Subcommittee E31.15 on Healthcare
procedures, clinical course, diagnosis, prognosis, and so forth
Information Capture and Documentation.
into readable text to document patient care and facilitate
CurrenteditionapprovedJuly1,2011.PublishedJuly2011.Originallypublished
delivery of healthcare services.
2004. Last previous edition approved 2004 as E2344–04. DOI: 10.1520/E2344-
04R11.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2344 − 04 (2011)
3.1.10 microphone, n—instrument whereby sound waves 4.1.1 Educational facilities for the purpose of introducing
are caused to generate or modulate an e
...

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ASTM E1633-08a(2013)(Specification)
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ABSTRACT
This specification covers all paper and automated systems related to the identification of the lexicons to be used for the data elements intended to unify the representations for: (1) primary record of care data elements; (2) the data elements identified in other standard statistical data sets; (3) data elements used in other healthcare data message exchange format standards, or (4) in data gathering forms for this purpose; and (5) in data derived from these elements in order that data recorded in the course of patient care be exchangeable and be the source of accurate statistical and resource management data.
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4.1 Purpose—The approval of Guide E1384, concerned with the structure and content of the computer-based patient record, now includes a formal indexing of data elements and a cataloging of the minimal essential value set for these elements. Indexing of these data elements with a unique identifier keyed to its position in the logical structure of Appendix X1 of Guide E1384 now provides a means of cataloging the value sets representing each data element (see Guide E1384). Specification E1238, coordinated with Guide E1239, describes conventions for representing many of the data values for data elements that are included in the more comprehensive listing in Guide E1384. A comprehensive listing of all of the value sets associated with Guide E1384 has not yet been assembled. This specification begins to catalog the representation conventions for a number of these elements and in particular to list the coded values. It is important that this catalog consider the traditionally assigned representations for each of these elements, and it must resolve differences in a manner that introduces systematics and consistency into the representation. The catalog must establish both a global framework consistent with international standardization and with long-term growth, while at the same time maximizing familiar or traditional representations. This standard has been developed with input from many organizations, including government agencies and other standards bodies and professional associations, and as a result of the effort to achieve consistency and comprehensiveness among the data dealt with by various standards efforts.  
4.2 General Values—Early in the coordination of healthcare information standards an informal body, the Healthcare Information Standards Coordinating Committee (HISCC), identified certain common data element types and agreed upon conventions for representing these data element types in a standard manner. This set the stage for the development of the value sets...
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Many U.S. healthcare and health information systems leaders believe that electronic health information systems that include computer-based patient records will improve health care. To achieve this goal these systems will need to protect individual privacy of patient data, provide appropriate access, and use adequate data security measures. Sound information policies and practices must be in place prior to the wide-scale deployment of health information systems. Strong enforceable privacy policies must shape the development and implementation of these systems.
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The maintenance of confidentiality in paper-based, electronic, or computer-based health information requires that policies and procedures be in place to protect confidentiality. Confidentiality of information depends on structural and explicit mechanisms to allow persons or systems to define who has access to what, and in what situation that access is granted. For guidelines on the development and implementation of privilege management infrastructures supporting these mechanisms, see Guide E2595.
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1.1 This guide covers the process of granting and maintaining access privileges to health information. It directly addresses the maintenance of confidentiality of personal, provider, and organizational data in the healthcare domain. It addresses a wide range of data and data elements not all traditionally defined as healthcare data, but all elemental in the provision of data management, data services, and administrative and clinical healthcare services. In addition, this guide addresses specific requirements for granting access privileges to patient-specific health information during health emergencies.
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3.1 These terms have particular application to forensic practice. Entries for Section A of E1732 are chosen variously from Webster’s Online Dictionary, international standards, textbooks, and the Compilation of ASTM Standard Definitions. The subcommittee develops definitions when conventional sources fail to yield suitable candidates. Reference citations include:  
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5.3 Leak test results that exceed the permissible threshold setting are indicated by audible or visual signal responses, or both, or by other means.  
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5.1 Harmful biological or particulate contaminants may enter the package through incomplete seals or imperfections such as pinholes or cracks in the trays.  
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5.1 This document will be of use to forensic laboratory personnel who are involved in the analysis of GSR samples by SEM/EDS (5).  
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1.1 This practice covers the analysis of gunshot residue (GSR) by scanning electron microscopy/energy-dispersive X-ray spectrometry (SEM/EDS). The analysis is performed using automated software control of both the SEM and EDS systems, to screen the sample for candidate particles that could be associated with GSR. Manual control of the instrument is then used to perform confirmatory analysis and classification of the candidate particles. This practice refers solely to the analysis of electron microscopy stubs (1).2  
1.2 Since software and hardware formats vary among commercial systems, guidelines will be offered in the most general terms possible. For proper terminology and operation, consult the SEM/EDS system manuals for each instrument.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard cannot replace knowledge, skills, or abilities acquired through education, training, and experience (Practice E2917), and is to be used in conjunction with professional judgment by individuals with such discipline-specific knowledge, skills, and abilities.  
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.  
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Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

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4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier, material and package performance attributes and characteristics, package integrity, visibility and appearance, processing, printed ink, distribution simulation, and conditioning.  
4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.
Note 1: Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Standards and Conformity Assessment Program at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program  
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4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide.
SCOPE
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.  
1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.  
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1.5 The units cited in the referenced standard should be used.  
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Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products

SIGNIFICANCE AND USE
5.1 Scaffolds potentially may be metallic, ceramic, polymeric, natural, or composite materials. Scaffolds are usually porous to some degree, but may be solid. Scaffolds can range from mechanically rigid to gelatinous and can be either absorbable/degradable or non-absorbable/non-degradable. The scaffold may or may not have a surface treatment. Because of this large breadth of possible starting materials and scaffold constructions, this guide cannot be considered as exhaustive in its listing of potentially applicable tests. A voluntary guidance for the development of tissue-engineered products can be found in Omstead, et al (1).15 Guide F2027 contains a listing of potentially applicable test methods specific to various starting materials. Guidance regarding the evaluation of absorbable polymeric materials and constructs can be found in Guide F2902. Guidance regarding the evaluation of collagen-based materials can be found in Guide F2212. Guidance regarding the evaluation of scaffolds composed of ceramic or mineral-based material is available in Guide F2883. Similarly, guidance for the assessment of unique aspects of scaffolds based on hydrogels (for example, gel kinetics, mechanical stability, and mass transport properties) may be found in Guide F2900.  
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SCOPE
1.1 This guide is a resource of currently available test methods for the characterization of the compositional and structural aspects of biomaterial scaffolds used in the development and manufacture of regenerative medicine and tissue-engineered medical products (TEMPs).  
1.2 The test methods contained herein guide characterization of the bulk physical, chemical, mechanical, and surface properties of a scaffold construct. Such properties may be important for the success of a TEMP, especially if the property affects cell retention, activity and organization, the delivery of bioactive agents, or the biocompatibility and bioactivity within the final product.  
1.3 This guide may be used in the selection of appropriate test methods for the generation of an original equipment manufacture (OEM) specification. This guide also may be used to characterize the scaffold component of a finished medical product.  
1.4 This guide is intended to be used in conjunction with appropriate characterization(s) and evaluation(s) of any raw or starting material(s) used in the fabrication of the scaffold, such as described in Guide F2027.  
1.5 This guide addresses natural, synthetic, or combination scaffold materials with or without bioactive agents or biological activity. This guide does not address the characterization or release profiles of any biomolecules, cells, drugs, or bioactive agents that are used in combination with the scaffold, but may be used to address the effects on other (e.g., structural) properties as a result of such release. A determination of the suitability of a particular starting material and/or finished scaffold structure to a specific cell type and/or tissue engineering application is essential, but will require additional  in vitro and/or in vivo evaluations considered to be outside the scope of this guide.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its...

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ASTM
ASTM E1732-19(Terminology)
Standard Terminology Relating to Forensic Science

SIGNIFICANCE AND USE
3.1 These terms have particular application to the forensic sciences. In addition, a hierarchy of sources of definitions were used in the development of this terminology. The hierarchy is as follows: Webster’s New Collegiate 7th Dictionary; technical dictionaries; and the Compilation of ASTM Standard Definitions  (1).11 The subcommittee developed a suitable definition after all of the sources in the hierarchy were found wanting.
SCOPE
1.1 This terminology standard includes definitions of terms used in the forensic sciences.  
1.2 Legal and scientific and terms in common use that are generally understood or defined adequately in other readily available sources may not be included, except when dictionaries show multiple definitions and it seems desirable to indicate the definitions recommended for forensic science use.  
1.3 Section A defines terms that are common to multiple areas of forensic science, whereas, the subsequent sections define terms pertaining to specific forensic science areas, as follows:    
Section A: General (Common) Forensic Science Terms  
The terms defined in Section A are the direct responsibility of Subcommittee E30.92, Terminology.  
Section B: Criminalistics  
The terms defined in Section B are the direct responsibility of Subcommittee E30.01, Criminalistics.  
Section B1: Terms for Seized Drug Analysis  
Section B2: Terms for Gunshot Residue (GSR) Analysis and Smokeless Powder Analysis  
Section B3: Terms for Paint Analysis  
Section B4: Terms for Textile, Fiber, Cord, and Tape Examination  
Section B5: Terms for Glass Examination  
Section C: Digital and Multimedia Evidence    
The terms defined in Section C are the direct responsibility of Subcommittee E30.12, Digital and Multimedia Evidence.  
Section C1: Terms for Computer Forensics  
Section C2: Terms for Digital Image Processing and Multimedia Evidence Examination  
Section C3: Terms for Magnetic Card Reader Examination  
Section C4: Terms for Facial Image Examination  
Section D: Interdisciplinary  
The terms defined in Section D are the direct responsibility of Subcommittee E30.11, Interdisciplinary Forensic Science Standards.  
Section E: Questioned Documents    
The terms defined in Section E were formerly the direct responsibility of Subcommittee E30.02, Questioned Documents, and are currently the direct responsibility of Subcommittee E30.90, Executive Committee.  
1.4 Entries listed in Sections B–E reflect only those existing in Committee E30 standards current with the date of a once yearly review of Committee E30 standards. Changes to standards or entries following this date will appear in Sections B–E after the following year’s review date.  
1.5 An alphabetical list of the terms defined in this standard is given in Appendix X1, which also identifies the section(s) in which each term is defined.  
1.6 Definitions identical to those published by another standards-developing organization or ASTM committee are identified with the abbreviation of the name of the organization or the identifying document and ASTM committee; for example, ASME is the American Society of Mechanical Engineers.  
1.7 In some cases different usage of a term in different fields has been noted.  
1.8 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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