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4.1 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 E2595.4.2 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.4.3 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:4.3.1 The categorization and breakdown of data into logical and reasonable elements or entities.4.3.2 The identification of individual roles or job functions.4.3.3 The establishment of context and conditions of data use at a specific point in time, and within a specific setting.4.4 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 right of access to that information.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.1.6 This guide covers all methods of collection and use of data whether paper-based, written, printed, typed, dictated, transcribed, forms-based, photocopied, scanned, facsimile, telefax, magnetic media, image, video, motion picture, still picture, film, microfilm, animation, 3D, audio, digital media, optical media, synthetic media, or computer-based.1.7 This guide does not directly define explicit disease-specific and evaluation/treatment-specific data control or access, or both. As defined under this guide, the confidential protection of elemental data elements in relation to which data elements fall into restrictive or specifically controlled categories, or both, is set by policies, professional practice, and laws, legislation and regulations.

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4.1 Two general types of tables (Note 1) are given, one based on the concept of lot tolerance, LTPD, and the other on AOQL. The broad conditions under which the different types have been found best adapted are indicated below.4.1.1 For each of the types, tables are provided both for single sampling and for double sampling. Each of the individual tables constitutes a collection of solutions to the problem of minimizing the over-all amount of inspection. Because each line in the tables covers a range of lot sizes, the AOQL values in the LTPD tables and the LTPD values in the AOQL tables are often conservative.NOTE 1: Tables in Annex A1 – Annex A4 and parts of the text are reproduced by permission of John R. Wiley and Sons. More extensive tables and discussion of the methods will be found in that text.4.2 The sampling tables based on lot quality protection (LTPD) (the tables in Annex A1 and Annex A2) are perhaps best adapted to conditions where interest centers on each lot separately, for example, where the individual lot tends to retain its identity either from a shipment or a service standpoint. These tables have been found particularly useful in inspections made by the ultimate consumer or a purchasing agent for lots or shipments purchased more or less intermittently.4.3 The sampling tables based on average quality protection (AOQL) (the tables in Annex A3 and Annex A4) are especially adapted for use where interest centers on the average quality of product after inspection rather than on the quality of each individual lot and where inspection is, therefore, intended to serve, if necessary, as a partial screen for defective pieces. The latter point of view has been found particularly helpful, for example, in consumer inspections of continuing purchases of large quantities of a product and in manufacturing process inspections of parts where the inspection lots tend to lose their identity by merger in a common storeroom from which quantities are withdrawn on order as needed.4.4 The plans based on average quality protection (AOQL) consider the degree to which the entire inspection procedure screens out defectives in the product submitted to the inspector. Lots accepted by sample undergo a partial screening through the elimination of defectives found in samples. Lots that fail to be accepted by sample are completely cleared of defectives. Obviously, this requires a nondestructive test. The over-all result is some average percent defective in the product as it leaves the inspector, termed the average outgoing quality, which depends on the level of percent defective for incoming product and the proportion of total defectives that are screened out.4.5 Given a specific problem of replacing a 100 % screening inspection by a sampling inspection, the first step is to decide on the type of protection desired, to select the desired limit of percent defective lot tolerance (LTPD) or AOQL value for that type of protection, and to choose between single and double sampling. This results in the selection of one of the appended tables. The second step is to determine whether the quality of product is good enough to warrant the introduction of sampling. The economies of sampling will be realized, of course, only insofar as the percent defective in submitted product is such that the acceptance criteria of the selected sampling plan will be met. A statistical analysis of past inspection results should first be made, therefore, in order to determine existing levels and fluctuations in the percent defective for the characteristic or the group of characteristics under consideration. This provides information with respect to the degree of control as well as the usual level of percent defective to be expected under existing conditions. Determine a value from this and other information for the process average percent defective that should be used in applying the selected sampling table, if sampling is to be introduced.AbstractThis practice is primarily a statement of principals for the guidance of ASTM technical committees and others in the use of average outgoing quality limit, AOQL, and lot tolerance percent defective, LTPD, sampling plans for determining acceptable of lots of product. Two general types of tables are given, one based on the concept of lot tolerance, LTPD, and the other on AOQL. For each of the types, tables are provided both for single sampling and for double sampling. Each of the individual tables constitutes a collection of solutions to the problem of minimizing the over-all amount of inspection.1.1 This practice is primarily a statement of principals for the guidance of ASTM technical committees and others in the use of average outgoing quality limit, AOQL, and lot tolerance percent defective, LTPD, sampling plans for determining acceptable of lots of product.1.2 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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3.1 The cloud point temperature is a reproducible characteristic of certain pure nonionic surfactants. It is also characteristic of certain nonionic surfactant formulated systems. This test method is appropriate for both systems.NOTE 1: If the transition from a distinctly cloudy to a clear solution is not sharp, that is, if it does not take place within a range of 1 °C, this test method is not appropriate.1.1 This test method covers a procedure to determine the “cloud point” of nonionic surfactants or detergent systems. Cloud Point is the temperature at which dissolved components (solids or liquids) are no longer completely soluble, precipating as a second phase giving the fluid a cloudy appearance. It is limited to those surfactants and detergent systems for which the visible solubility change occurs over a range of 1 °C or less at concentrations of 0.5 % to 1.0 % in DI water between 30 °C and 95 °C.1.2 Chemical Limitations—Nonionic surfactants that exhibit a characteristic cloud point in general terms consist of a water-in-soluble moiety condensed with 50 % to 75 % by weight of ethylene oxide. If the level of ethoxylation is too low the surfactant may not be water soluble at temperatures less than 30 °C, and if it is too high no cloud point may exist.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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