ASTM E1029-01
Standard Guide for Documentation of Clinical Laboratory Computer Systems
- Standard No.
- ASTM E1029-01
- Release Date
- 2001
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Latest
- ASTM E1029-01
- Replace By
- ANSI/NCCLS
- Scope
1.1 This guide covers documentation for a computer system operating in a clinical laboratory.
1.2 Documentation is defined as the information needed to install, use, maintain, or modify the system. This information shall be in a reusable form, and may exist in other forms as well. These forms may include printed manuals, online help screens, prompts, computer readable text, computer assisted instruction, audio tapes, or equivalent media. As technology and software techniques change, the form of the documentation may also change. It is a central component of the processes by which system life cycles are managed. Hereafter, the term "documentation" shall encompass all such possible forms.
1.2.1 This documentation includes information that explains how the users interact with and operate the system. This may include a terminal operator's guide, training documentation, system operation descriptions, and database and file maintenance instructions.
1.2.2 Documentation also includes reference documents that describe functional and internal characteristics of the system, such as software reference manuals, source code, descriptions of file structures, hardware reference manuals, schematics, and flow charts. Paragraphs and might apply when some of this information is proprietary.
1.2.3 Documentation includes test procedures to establish whether the system is installed correctly and continues to operate properly. The frequency that the tests are to be performed, the test data sets to be used, and whether the results are to be compared to manual methods should be provided.
1.3 The computer systems under consideration are those designed to assist the general work flow of the laboratory. They typically include some or all of the following features: sample tracking, data gathering, report generation, record keeping, quality assurance, management aids, and hospital communications. They may range from very large to small computer systems. Computers dedicated only to a single instrument are not the primary focus.
1.4 This standard does not purport to address the safety problems 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.
ASTM E1029-01 Referenced Document
- ASTM E1239 Standard Practice for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT) Systems for Electronic Health Record (EHR) Systems *， 2024-04-19 Update
- ASTM E1246 Standard Practice for Reporting Reliability of Clinical Laboratory Computer Systems*， 2001-11-10 Update
- ASTM E1639 Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
- ASTM E1985 Standard Guide for User Authentication and Authorization
- ASTM E1986 Standard Guide for Information Access Privileges to Health Information
- ASTM E1987 Standard Guide for Individual Rights Regarding Health Information (Withdrawn 2007)*， 2017-08-16 Update
- ASTM E1988 Standard Guide for Training of Persons who have Access to Health Information (Withdrawn 2007)*， 2017-08-16 Update
- ASTM E2017 Standard Guide for Amendments to Health Information
- ASTM E2084 Standard Specification for Authentication of Healthcare Information Using Digital Signatures *， 2024-04-19 Update
- ASTM E2085 Standard Guide on Security Framework for Healthcare Information *， 2024-04-19 Update
- ASTM E2086 Standard Guide for Internet and Intranet Healthcare Security *， 2024-04-19 Update
- ASTM E2118 Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures
- ASTM E2147 Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems*， 2018-05-01 Update
- ASTM E792 Standard Guide for Selection of a Clinical Laboratory Information Management System
ASTM E1029-01 history
- 2001 ASTM E1029-01 Standard Guide for Documentation of Clinical Laboratory Computer Systems
- 1984 ASTM E1029-84(1997) Standard Guide for Documentation of Clinical Laboratory Computer Systems
