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This specification covers the format and content of digitally recorded voice data files and their identifying data. The object is to enable transfer between independent digital dictation systems and workstations, regardless of manufacturer and protocols for ensuring reliability. This specification is specifically targeted for the definition of a message encapsulating both the data elements and actual voice file encoded in a standard compression algorithm. The digital voice file format is Resource Interchange File Format (RIFF). Different digital voice file format shall be: PCM; ITU/CCITT A Law; ITU/CCITT mu Law; OKI ADPCM; IMA (DVI) ADPCM; TrueSpeech; and GSM 610. This specification is specifically targeted for the definition of a message encapsulating both the data elements and actual voice file encoded in a standard compression algorithm.1.1 This specification covers the format and content of digitally recorded voice data files and their identifying data. The object is to enable transfer between independent digital dictation systems and workstations, regardless of manufacturer and protocols for ensuring reliability. This specification does not cover the transmission of voice data files and their identifying data within digital dictation systems and workstations or their transcription into text files.1.2 This specification may be applied to either the transmission of data over medium- to high-speed data communication networks or to the transmission of data by recording on, and later playing back from, magnetic or optical digital storage media. It defines the blocked stream of data, called a message, which is transmitted over a network connection or recorded on a storage medium. It does not define the hardware or software network protocols or storage media formats needed for message transmission (for example, see ISO 8072-1986) or the formats used to store data internally by the sender or receiver.1.3 Since some standardization in storage media format and network protocols would help to promote the exchange of data between computer systems with diverse hardware and software, it is suggested that readily available universal media and formats be used for data exchange when possible.1.4 Any considerations regarding the security of the digital dictation file or its components as defined herein are outside the scope of this specification. Such measures as encryption of files (either at rest or in transit), authentication of users or originators, assignment and control of file access permissions, and backup or recovery of files which may be necessary to meet institutional policies or governmental regulations are not addressed in this specification. Guidance for security of dictated health records can be found in Guide E 1902.

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4.1 Many analytical laboratories comply with accepted quality system requirements such as NELAC, Chapter 5,5 (see Note 2) and ISO/IEC 17025. When using standard test methods, their test results on the same sample should agree with those from other similar laboratories within the reproducibility estimates (R2) published in the standard. Reproducibility estimates are generated during the standardization process as part of the interlaboratory studies (ILS). Many laboratories participate in proficiency tests to confirm that they perform consistently over time. In both ILS and proficiency testing protocols, it is generally assumed that only one workstation is used to generate the data (see 6.5.1).NOTE 2: NELAC, Chapter 5, allows the use of a Work Cell where multiple instruments/operators are treated as one unit: the performance of the Work Cell is tracked rather than each workstation independently. This guide is intended to go beyond the Work Cell to achieve the benefits of monitoring workstations independently.4.2 Many laboratories have workloads or logistical requirements, or both, that dictate the use of multiple workstations. Some have multiple stations in the same area (central laboratory format). Others’ stations are scattered throughout a facility (at-line laboratory format). Often, analysis reports do not identify the workstation used for the testing, even if workstations differ in their testing uncertainties. Problems can arise if clients mistakenly attribute variation in report values to process rather then workstation variability. These problems can be minimized if the laboratory organization sets, complies with, and reports a unified set of measurement quality objectives throughout.4.3 This guide can be used to harmonize calibration and control protocols for all workstations, thereby providing the same level of measurement traceability and control. It streamlines documentation and training requirements, thereby facilitating flexibility in personnel assignments. Finally, it offers an opportunity to claim traceability of proficiency test measurements to all included workstations, regardless on which workstation the proficiency test sample was tested. The potential benefits of utilizing this protocol increase with the number of workstations included in the laboratory organization.4.4 This guide can be used to identify and quantify benefits derived from corrective actions relating to under-performing workstations. It also provides means to track improved performance after improvements have been made.4.5 It is a prerequisite that all users of this guide comply with ISO/IEC 17025, especially including the use of documented procedures, the application of statistical control of measurement processes, and participation in proficiency testing.4.6 The general principles of this protocol can be adapted to other types of measurements, such as mechanical testing and on-line process control measurements such as temperature and thickness gauging. In these areas, users will likely need to establish their own models for defining measurement quality objectives. Proficiency testing may not be available or applicable.4.7 It is especially important that users of this guide take responsibility for ensuring the accuracy of the measurements made by the workstations to be operated under this protocol. In addition to the checks mentioned in 6.2.3, laboratories are encouraged to use other techniques, including, but not limited to, analyzing some materials by independent methods, either within the same laboratory or in collaboration with other equally competent laboratories. The risks associated with generating large volumes of data from carefully harmonized, but incorrectly calibrated multiple workstations are obvious and must be avoided.1.1 This guide describes a protocol for optimizing, controlling, and reporting test method uncertainties from multiple workstations in the same laboratory organization. It does not apply when different test methods, dissimilar instruments, or different parts of the same laboratory organization function independently to validate or verify the accuracy of a specific analytical measurement.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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.3 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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This guide provides recommended guidelines for the essential elements to be included in the design and implementation of an efficient, secure, risk-free work environment for medical transcription and health information documentation.Improve and increase production.Reduce healthcare costs by minimizing injury/illness.Increase retention and professional longevity.Ensure regulatory compliance with state and local government requirements as well as federal privacy and security regulations.1.1 This guide identifies ways to improve the medical transcription workstation, including, but not limited to, the work environment, which encompasses ergonomics and security issues, equipment, references, and tools.1.2 This guide will assist healthcare managers, vendors, medical transcription service owners, and individual medical transcriptionists to make informed decisions related to the design of an efficient medical transcription work environment compliant with federal regulatory agencies.1.3 This guide does not address the medical transcription process or training.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 and health practices and determine the applicability of regulatory limitations prior to use.

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