ASTM E2538-06(2011)

Health information networks (HINs) have arisen in recent years as a way to share common information within organizational arrangements among those healthcare facilities that have been formed into large, more comprehensive integrated delivery systems (IDS) and managed care organizations (MCO) offering a full range of healthcare services, both inpatient and ambulatory.

The specific organizational structures to which the MCO term was originally applied most probably have evolved into something quite different. Furthermore, IDS organizations are contracting with other organizations that have a market larger than a single IDS itself and are buying such services for themselves rather than offering them internally.

These organizations will need a frame of reference for the global information needed to provide all of the services required during patient care. For a global Concept Model consult ADA Specification 1000.0–1000.18 and TR 1039.

Pharmacotherapy will require a number of these services, including those of the clinical laboratory for therapeutic drug monitoring as well as pharmacy services of both resident and nonresident care organizations and stand-alone pharmacies to ensure freedom from medication errors and conduct ongoing investigations of both the outcomes of care and the management of resources related to pharmacotherapy.

Pharmacotherapy functions include prescribing (clinical orders), dispensing, administering, and monitoring, which support “pharmaceutical care” defined as “provision of drug therapy to achieve desired therapeutic outcomes that improve a patient’s quality of life.” These functions address patients’ needs that require information support as noted in Table 1.

Another aspect of the monitoring function is the development of instrumentation for testing at point of care (POCT) for high-value immediate-benefit services that support pharmacotherapy. POCT, however, needs supervision and training from skilled laboratorians for the actual performers, whether that supervision comes from within the IDS or outside of it. This range of operation is only achievable by distributed HIN structures that shall have the same quality of clinical and data services as offered by laboratories close at hand. Data management of POCT is documented separately (see CLSI POCT1, ASTP2), but such data management for support of pharmacotherapy shall be placed into the broader context of this practice and linked to CLSI LIS-9A. Thus, this practice should be used to first organize the global domain and then the interconnected subdomains.

1.1 This practice applies to the process of defining and documenting the capabilities, logical data sources, and pathways of data exchange regarding pharmacotherapy information services within a given network architecture serving a set of healthcare constituents.

1.2 This practice is not a technical implementation standard but, rather, describes how the implementation methods and techniques can be used to coordinate pharmacotherapy services logically within an electronic health record (EHR) systems environment involving participating organizations and sites connected by a networked communication system.

1.3 This practice covers the content of the nodes and arcs of the resulting logical network involving EHR, pharmacy, and clinical laboratory-capable sites. This practice also considers the various purposes and organizational arrangements for coordinating pharmacotherapy services within the network boundaries and the considerations for connections among external networks.

1.4 This practice refers to other standards for conventions within various data domains, such as pharmacy systems, clinical laboratory information management systems (CLIMS), and EHR systems, and for messaging conventions.

1.5 This practice is intended to outline how integration of pharmacy, CLIMS, and EHR information systems can be undertaken to result in a transparent pharmacotherapy clinical decision support environment, regardless of the underlying implementation architecture, by describing the logical interoperability of information domains as facilitated by information and communications technology (ICT).

1.6 This practice is directed at pharmacists, clinical pharmacologists, clinical laboratorians, information system managers, and information systems vendors for use in planning and implementing coordinated pharmacotherapy services through effective dialog.

1.7 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.