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ASTM E2184-02

(Specification)

Standard Specification for Healthcare Document Formats (Withdrawn 2011)

Standard Specification for Healthcare Document Formats (Withdrawn 2011)

ABSTRACT
This specification addresses requirements for the headings, arrangement, and appearance of sections and subsections when used within an individual's healthcare documents. This specification will facilitate identification and retrieval of health information in a manner that will enhance the quality and efficiency of health services. Use of this specification in conjunction with XML DTDs (extensible markup language document type definitions) and the EHR (electronic health records) would further enhance efficiency in time and cost. In addition, this specification applies across multiple healthcare settings in which healthcare documents are generated, such as hospitals, clinics, skilled nursing facilities, ambulatory care facilities, outpatient surgery centers, and private healthcare providers' offices. The author of a healthcare document may choose to summarize subsection information within a general section rather than creating subsections.
SCOPE
1.1 This specification addresses requirements for the headings, arrangement, and appearance of sections and subsections when used within an individual's healthcare documents. This specification will facilitate identification and retrieval of health information in a manner that will enhance the quality and efficiency of health services. Use of this specification in conjunction with XML DTDs (extensible markup language document type definitions) and the EHR (electronic health records) would further enhance efficiency in time and cost. This specification applies across multiple healthcare settings in which healthcare documents are generated, such as hospitals, clinics, skilled nursing facilities, ambulatory care facilities, outpatient surgery centers, and private healthcare providers' offices.
1.2 This specification addresses the headings, arrangement, and appearance of sections and subsections of healthcare documents, however generated (dictation/transcription, speech recognition, touch-screen entry, and so forth) and whether displayed electronically or on paper. It does not address the titles of healthcare documents or the content of sections and subsections.
1.2.1 The author of a healthcare document may choose to summarize subsection information within a general section rather than creating subsections.
1.3 The format and content of patient-identifying data are addressed in Guide E 1384.
1.4 Issues of confidentiality and security are addressed in Guide E 1869, Guide E 1902, Guide E 1762, Guide E 1985, Guide E 1986, Guide E 1987, Guide E 1988, Specification E 2084, Guide E 2085, and Guide E 2086, as well as in Specification E 2147.
1.5 Issues of XML DTDs are addressed in Specification E 2182 and Guide E 2183.
WITHDRAWN RATIONALE
Formerly under the jurisdiction of Committee E31 on Healthcare Informatics, this Specification was withdrawn in 2011 in accordance with section 10.5.3.1 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
09-Jan-2002
Withdrawal Date
31-Dec-2010
ICS
35.240.80 - IT applications in health care technology
Technical Committee
E31 - Healthcare Informatics
Drafting Committee
E31.15 - Healthcare Information Capture and Documentation
Current Stage
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ASTM E2184-02 - Standard Specification for Healthcare Document Formats (Withdrawn 2011)ASTM E2184-02 - Standard Specification for Healthcare Document Formats (Withdrawn 2011)
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ASTM E2184-02 - Standard Specification for Healthcare Document Formats (Withdrawn 2011)
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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: E2184 – 02
Standard Specification for
1
Healthcare Document Formats
This standard is issued under the fixed designation E2184; 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.
2
1. Scope Health Record (EHR)
E1762 Guide for Electronic Authentication of Health Care
1.1 This specification addresses requirements for the head-
2
Information
ings, arrangement, and appearance of sections and subsections
E1869 Guide for Confidentiality, Privacy,Access, and Data
when used within an individual’s healthcare documents. This
Security Principles for Health Information Including Elec-
specification will facilitate identification and retrieval of health
2
tronic Health Records
information in a manner that will enhance the quality and
E1902 Specification for Management of the Confidentiality
efficiency of health services. Use of this specification in
and Security of Dictation, Transcription, and Transcribed
conjunction with XML DTDs (extensible markup language
2
Health Records
document type definitions) and the EHR (electronic health
2
E1985 Guide for User Authentication and Authorization
records) would further enhance efficiency in time and cost.
E1986 Guide for Information Access Privileges to Health
This specification applies across multiple healthcare settings in
2
Information
which healthcare documents are generated, such as hospitals,
E1987 Guide for Individual Rights Regarding Health Infor-
clinics, skilled nursing facilities, ambulatory care facilities,
32
mation
outpatient surgery centers, and private healthcare providers’
E1988 Guide for Training of Persons who have Access to
offices.
32
Health Information
1.2 This specification addresses the headings, arrangement,
E2084 Specification forAuthentication of Healthcare Infor-
and appearance of sections and subsections of healthcare
32
mation Using Digital Signatures
documents, however generated (dictation/transcription, speech
E2085 Guide on Security Framework for Healthcare Infor-
recognition, touch-screen entry, and so forth) and whether
32
mation
displayed electronically or on paper. It does not address the
3
E2086 Guide for Internet and Intranet Healthcare Security
titles of healthcare documents or the content of sections and
2
subsections.
E2147 Specification forAudit and Disclosure Logs for Use
1.2.1 The author of a healthcare document may choose to
2
in Health Information Systems
summarize subsection information within a general section
E2182 Specification for Clinical XML DTDs in Healthcare
rather than creating subsections.
2
1.3 The format and content of patient-identifying data are
E2183 Guide for XML DTD Design, Architecture and
addressed in Guide E1384.
Implementation
1.4 Issues of confidentiality and security are addressed in
Guide E1869, Guide E1902, Guide E1762, Guide E1985,
3. Terminology
Guide E1986, Guide E1987, Guide E1988, Specification
3.1 Definitions:
E2084, Guide E2085, and Guide E2086, as well as in Speci-
3.1.1 alias, n—heading synonymous with and which shall
fication E2147.
be replaced by the specified heading. No alias (synonym) shall
1.5 Issues of XML DTDs are addressed in Specification
be used in place of the specified heading.The aliases presented
E2182 and Guide E2183.
areexamplesonly,thatis,noattempthasbeenmadetoidentify
2. Referenced Documents all potential aliases.
2
3.1.2 amendment, n—a correction or addendum to a docu-
2.1 ASTM Standards:
ment.
E1384 Practice for Content and Structure of the Electronic
3.1.3 author, n—the person originating content for a health-
care document.
1
This specification is under the jurisdiction of ASTM Committee E31 on 3.1.4 document, n—see healthcare document.
Healthcare Informatics and is the direct responsibility of Subcommittee E31.15 on
Health Information Capture and Documentation.
Current edition approved Jan. 10, 2002. Published March 2002. DOI: 10.1520/
3
E2184-02. Withdrawn. The last approved version of this historical standard is referenced
2
Annual Book of ASTM Standards, Vol 14.01. on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
E2184 – 02
3.1.5 format, n—the arrangement of the content of a health- and among enterprises, and (4) promoting greater efficiency in
caredocumentfordisplay.Inthisspecification,formatrefersto transcription and other forms of data capture. Secondary
the sequencing of the sections and subsections used in a benefits include improved access to health information for
healthcare document, the appearance
...

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Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems

ABSTRACT
This specification describes the security requirements involved in the development and implementation of audit and disclosure logs used in health information systems. It specifies how to design an access audit log to record all access to patient identifiable information maintained in computer systems, and includes principles for developing policies, procedures, and functions of health information logs to document all disclosure of confidential health care information to external users for use in manual and computer systems. This specification provides for two main purposes, namely: to define the nature, role, and function of system access audit logs and their use in health information systems as a technical and procedural tool to help provide security oversight; and to identify principles for establishing a permanent record of disclosure of health information to external users and the data to be recorded in maintaining it.
SIGNIFICANCE AND USE
4.1 Data that document health services in health care organizations are business records and shall be archived to a secondary but retrievable medium, and readily accessible, such as data that would be archived in a server or cloud storage. Audit data shall be retained for as long as the medical record is maintained, and may not be destroyed before the medical record may legally be destroyed, and in any event, for at least 10 years or for two years after the legal age of majority, unless a longer period of record retention is prescribed by state, federal or other law or regulation.  
4.2 The purpose of audit data and disclosure logs is to document and maintain a permanent, trustworthy, and immutable record of all authorized and unauthorized activities of any nature whatsoever and disclosure of confidential health information {except exclusions per federal and state law [21 CFR 11 Subpart B(e)]}. This further facilitates the purpose that patients, healthcare providers, organizations, and others can obtain a verifiable, self-authenticating record documenting all activities with respect to that record. The process of information disclosure and auditing shall also conform, where relevant, with the Privacy Act of 1974 (3).  
4.3 Audit reports designed for system access provide a precise capability for healthcare providers, organizations, patients, patient representatives, and advocates to see who has accessed and/or manipulated patient information. Because of the significant risk of medical information manipulation in computing environments by authorized and unauthorized users, the audit report is an important management tool to monitor access and any such manipulation retrospectively. In addition, the access and disclosure logs become powerful support documents for disciplinary and legal actions. Moreover, audit reports are essential components to comprehensive security programs in healthcare and vital for the privacy rights of the individual. A patient has a right to ...
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1.1 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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ASTM E2147-01(2013)(Specification)
Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems (Withdrawn 2017)

ABSTRACT
This specification describes the security requirements involved in the development and implementation of audit and disclosure logs used in health information systems. It specifies how to design an access audit log to record all access to patient identifiable information maintained in computer systems, and includes principles for developing policies, procedures, and functions of health information logs to document all disclosure of confidential health care information to external users for use in manual and computer systems. This specification provides for two main purposes, namely: to define the nature, role, and function of system access audit logs and their use in health information systems as a technical and procedural tool to help provide security oversight; and to identify principles for establishing a permanent record of disclosure of health information to external users and the data to be recorded in maintaining it.
SIGNIFICANCE AND USE
4.1 Data that document health services in health care organizations are business records and must be archived to a secondary but retrievable medium. Audit logs should be retained, at a minimum, according to the statute governing medical records in the geographic area.  
4.2 The purpose of audit access and disclosure logs is to document and maintain a permanent record of all authorized and unauthorized access to and disclosure of confidential health care information in order that health care providers, organizations, and patients and others can retrieve evidence of that access to meet multiple needs. Examples are clinical, organizational, risk management, and patient rights' needs.  
4.3 Audit logs designed for system access provide a precise capability for organizations to see who has accessed patient information. Due to the significant risk in computing environments by authorized and unauthorized users, the audit log is an important management tool to monitor, access retrospectively. In addition, the access and disclosure log becomes a powerful support document for disciplinary action. Audit logs are essential components to comprehensive security programs in health care.  
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ASTM E1869-04(2010)(Guide)
Standard Guide for Confidentiality, Privacy, Access, and Data Security Principles for Health Information Including Electronic Health Records

SIGNIFICANCE AND USE
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.
The purposes of patient records are to document the course of the patient's illness or health status during each encounter and episode of care; to furnish documentary evidence of the course of the patient's health evaluation, treatment and change in condition; to document an individual's health status; to provide data for preventive care; to document communication between the practitioner responsible for the patient's care and any other healthcare practitioner who contributes to the patient's care; to assist in protecting the legal interest of the patient, the health care facility and the responsible practitioner; to provide continuity of care; to provide data to substantiate insurance claims; to provide a basis for evaluating the adequacy and appropriateness of care; and to provide data for use in continuing education and research.
Health information is a broad concept. It includes all information related to an individual's physical and mental health, the provision of health care generally, and payment for health care. The patient record is a major component of the health information system. The creation of electronic databases and communication protocols to transfer data between systems presents new opportunities to implement more effective systems for health information, to enhance patient care, reduce the cost of health care, and improve patient outcomes. National standards guide all that have responsib...
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1.1 This guide covers the principles for confidentiality, privacy, access, and security of person identifiable health information. The focus of this standard is computer-based systems; however, many of the principles outlined in this guide also apply to health information and patient records that are not in an electronic format. Basic principles and ethical practices for handling confidentiality, access, and security of health information are contained in a myriad of federal and state laws, rules and regulations, and in ethical statements of professional conduct. The purpose of this guide is to synthesize and aggregate into a cohesive guide the principles that underpin the development of more specific standards for health information and to support the development of policies and procedures for electronic health record systems and health information systems.

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ASTM E1986-09(Guide)
Standard Guide for Information Access Privileges to Health Information

SIGNIFICANCE AND USE
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.
Confidential protection of data elements is a specific requirement. The classification of data elements into restrictive and specifically controlled categories is set by policies, professional practice, and laws, legislation, and regulations.
There are three explicit concepts upon which the use of and access to health information confidentiality are defined. Each of these concepts is an explicit and unique characteristic relevant to confidentiality, but only through the combination (convergence) of all three concepts can appropriate access to an explicit data element at a specific point in time be provided, and unauthorized access denied. The three concepts are:
The categorization and breakdown of data into logical and reasonable elements or entities.
The identification of individual roles or job functions.
The establishment of context and conditions of data use at a specific point in time, and within a specific setting.
The overriding principle in preserving the confidentiality of information is to provide access to that information only under circumstances and to individuals when there is an absolute, established, and recognized need to access that data, and the information accessed should itself be constrained only to that information essential to accomplish a defined and recognized task or process. Information nonessential to that task or process should ideally not be accessible, even though an individual accessing that information may have some general righ...
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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.
1.2 This guide is based on long-term existing and established professional practices in the management of healthcare administrative and clinical data. Healthcare data, and specifically healthcare records (also referred to as medical records or patient records), are generally managed under similar professional practices throughout the United States, essentially regardless of specific variations in local, regional, state, and federal laws regarding rules and requirements for data and record management.
1.3 This guide applies to all individuals, groups, organizations, data-users, data-managers, and public and private firms, companies, agencies, departments, bureaus, service-providers, and similar entities that collect individual, group, and organizational data related to health care.  
1.4 This guide applies to all collection, use, management, maintenance, disclosure, and access of all individual, group, and organizational data related to health care.
1.5 This guide does not attempt to address specific legislative and regulatory issues regarding individual, group, and organizational rights to protection of privacy.
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ASTM E2147-01(2009)(Specification)
Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems

ABSTRACT
This specification describes the security requirements involved in the development and implementation of audit and disclosure logs used in health information systems. It specifies how to design an access audit log to record all access to patient identifiable information maintained in computer systems, and includes principles for developing policies, procedures, and functions of health information logs to document all disclosure of confidential health care information to external users for use in manual and computer systems. This specification provides for two main purposes, namely: to define the nature, role, and function of system access audit logs and their use in health information systems as a technical and procedural tool to help provide security oversight; and to identify principles for establishing a permanent record of disclosure of health information to external users and the data to be recorded in maintaining it.
SIGNIFICANCE AND USE
Data that document health services in health care organizations are business records and must be archived to a secondary but retrievable medium. Audit logs should be retained, at a minimum, according to the statute governing medical records in the geographic area.
The purpose of audit access and disclosure logs is to document and maintain a permanent record of all authorized and unauthorized access to and disclosure of confidential health care information in order that health care providers, organizations, and patients and others can retrieve evidence of that access to meet multiple needs. Examples are clinical, organizational, risk management, and patient rights' needs.
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ASTM E1762-95(2009)(Guide)
Standard Guide for Electronic Authentication of Health Care Information

SIGNIFICANCE AND USE
This guide serves three purposes:
To serve as a guide for developers of computer software providing, or interacting with, electronic signature processes,
To serve as a guide to healthcare providers who are implementing electronic signature mechanisms, and
To be a consensus standard on the design, implementation, and use of electronic signatures.
SCOPE
1.1 This guide covers:
1.1.1 Defining a document structure for use by electronic signature mechanisms (Section 4),
1.1.2 Describing the characteristics of an electronic signature process (Section 5),
1.1.3 Defining minimum requirements for different electronic signature mechanisms (Section 5),
1.1.4 Defining signature attributes for use with electronic signature mechanisms (Section 6),
1.1.5 Describing acceptable electronic signature mechanisms and technologies (Section 7),
1.1.6 Defining minimum requirements for user identification, access control, and other security requirements for electronic signatures (Section 9), and
1.1.7 Outlining technical details for all electronic signature mechanisms in sufficient detail to allow interoperability between systems supporting the same signature mechanism (Section 8 and Appendix X1-Appendix X4).
1.2 This guide is intended to be complementary to standards under development in other organizations. The determination of which documents require signatures is out of scope, since it is a matter addressed by law, regulation, accreditation standards, and an organization's policy.
1.3 Organizations shall develop policies and procedures that define the content of the medical record, what is a documented event, and what time constitutes event time. Organizations should review applicable statutes and regulations, accreditation standards, and professional practice guidelines in developing these policies and procedures.

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ASTM E1715-01(2008)(Practice)
Standard Practice for An Object-Oriented Model for Registration, Admitting, Discharge, and Transfer (RADT) Functions in Computer-Based Patient Record Systems

SIGNIFICANCE AND USE
RADT Object Model as a Basis for Communication—The RADT object model is the first model used to create a common library of consistent entities (objects) and their attributes in the terminology of object analytical models as applied to the healthcare domain. These object models can be used to construct and refine standards relating to healt care information and its management. Since the RADT object model underpins the design and implementation of specific systems, it provides the framework for establishing the systematics of managing observations made during health care. The observations recorded during health care not only become the basis for managing an individual's health care by practitioners but are also used for research and resource management. They define the common language for abstracting and codifying observations. The inconsistency and incompleteness of the data recorded in paper records is well known and has been noted by the Institute of Medicine's study (4). The ability to build the recommended EHR begins with RADT, as noted in Practice E 1239. A more detailed specification of the RADT process and its specific functional domain shall begin with a formal model. Furthermore, following agreement on the initial model, that model shall evolve as knowledge accumulates and the initial view of the healthcare domain extends to other social and psychologic processes that link healthcare with other functional domains of society. The management of lifelong cases of care, such as those of birth defects in newborns, will involve interactions with social work and educational functional domains of experience. It has been recognized for some time (5) that a “healthcare team,” in the broader sense, is involved in dealing with these complex cases. The RADT model is the core to linking these functional domains together in a transparent way. For that reason, the object terminology is used to enable the most global view and vernacular that will facilitate communication amo...
SCOPE
1.1 This practice is intended to amplify Practice E 1239 and to complement Practice 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 Practice E 1239, 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.

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ASTM E2171-02(2008)(Practice)
Standard Practice for Rating-Scale Measures Relevant to the Electronic Health Record

SIGNIFICANCE AND USE
The simplicity and practicality of Rasch's probabilistic scale-free measurement models have brought within reach universal metrics for educational and psychological tests, and for rating scale-based instruments in general. There are at least 3 implications to the application of Rasch's models to the health-related calibration of universal metrics for each of the variables relevant to the Electronic Health Record (EHR) that are typically measured using rating scale instruments.
First, establishing a single metric standard with a defined range and unit will arrest the burgeoning proliferation of new scale-dependent metrics.
Second, the communication of the information pertaining to patient status represented by these measures (physical, cognitive, and psychosocial health status, quality of life, satisfaction with services, etc.) will be simplified.
Third, common standards of data quality will be used to evaluate and improve instrument performance. The vast majority of test and survey data quality is currently almost completely unknown, and when quality is evaluated, it is via many different methods that are often insufficient to the task, misapplied, misinterpreted, or even contradictory in their aims.
Fourth, currently unavailable economic benefits will accrue from the implementation of measurement methods based on quality-assessed data and widely accepted reference standard metrics. The potential magnitude of these benefits can be seen in an assessment of 12 different metrological improvement studies conducted by the National Science and Technology Council (Subcommittee on Research, 1996). The average return on investment associated with these twelve studies was 147 %. Is there any reason to suppose that similar instrument improvement efforts in the psychosocial sciences will result in markedly lower returns?
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1.1 This standard addresses the identification of data elements from the EHR definitions in Practice E 1384 that have ordinal scale value sets and which can be further defined to have scale-free measurement properties. It is applicable to data recorded for the Electronic Health Record and its paper counterparts. It is also applicable to abstracted data from the patient record that originates from these same data elements. It is applicable to identifying the location within the EHR where the observed measurements shall be stored and what is the meaning of the stored data. It does not address either the uses or the interpretations of the stored measurements.

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ASTM E2553-07(Guide)
Standard Guide for Implementation of a Voluntary Universal Healthcare Identification System

SCOPE
1.1 This document describes the implementation principles needed to create a Voluntary Universal Healthcare Identification (VUHID) system. The purpose of this system is to enable unambiguous identification of individuals in order to facilitate the delivery of healthcare.
1.2 The VUHID system should be dedicated exclusively to the needs and functions of healthcare.
1.3 The VUHID system is designed to represent no, or at least minimal, increased risk to healthcare privacy and security.
1.4 The system should be as cost-effective as possible.
1.5 The system must be created and maintained in a way to provide sustained benefit to healthcare.
1.6 The system should be designed and implemented in a manner that ensures that it can operate indefinitely.
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 limitations prior to use.

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ASTM E2457-07(Terminology)
Standard Terminology for Healthcare Informatics

SCOPE
1.1 This terminology is intended to name and document the principal concepts, and their associated terms, that are utilized in the healthcare information domain and all of its specialized subdomains. It is applicable to all areas of healthcare about which information is kept or utilized. It is intended to complement and utilize those concepts already identified by other national and international standards bodies. It will identify alternate accepted terms for the same concept and its elected term. Its terms are intended to clarify and simplify usage in the dialog and documentation about the concepts, processes and data that are used to schedule, conduct and manage all phases of healthcare. This common usage will improve the quality and management of all facets of healthcare by means of explicit information used in referring to each of these facets. These health informatics terms have been collected here specifically in order to facilitate the consistent use of common concepts in informatics standards development and use throughout healthcare. A separate process from this standard that is described in ISO 15188 will manage the approval of biomedical and healthcare terms.
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 limitations prior to use.

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