What is ISO 18530 about?
ISO 18530 outlines the standards needed to identify and label the Subject of Care (SoC) and the Individual Provider on objects such as identification (wrist) bands, identification tags, or other objects, to enable automatic data capture using data carriers in the care delivery process.
ISO 18530 provides a unique SoC identification that can be used for other purposes, such as recording the identity of the SoC in individual health records.
ISO 18530 serves as a reference for any organization which plans to implement or improve Automatic Identification and Data Capture (AIDC) in their delivery of care process.
ISO 18530 describes good practices to reduce/avoid variation and workarounds which challenge the efficiency of AIDC at the point of care and compromise patient safety.
Who is ISO 18530 for?
ISO 18530 on automatic identification and data capture marking and labeling of health informatics is useful for:
- Hospitals
- Healthcare providers
- Medical laboratories
- Regulation authorities of the Healthcare sector
Why should you use ISO 18530?
Interoperability, where information is shared and used by different information systems, requires a common SoC and Individual Provider identification semantic to ensure that shared information is consistent and unambiguous. The same SoC and Individual Provider are accurately identified, referenced and cross-referenced in each system. Effective data capture systems and information sharing is the key to improving the care of SoCs and delivery by Individual Providers in terms of conformance, accuracy and integrity of the health data.
A considerable majority of supplies in healthcare around the world are identified in accordance to this multi-sectorial and global system of standards.
ISO 18530 helps you maintain interoperability that makes it easier to secure a single system of standards is used in the healthcare setting.
ISO 18530 empowers you to manage and clinically monitor the treatment plan for the SoC for safety and stock purposes.
In hospitals, a SoC (as in-patient) usually experiences a large number of care instances. Examples of these instances include: prescriptions and medicinal product administration, laboratory testing of SoC bio-samples and subsequent analysis and reporting. Each of these instances requires accurate reconciliation of the instance and delivery to the SoC. Healthcare providers (i.e., organizations that deliver healthcare to the SoC) have introduced AIDC technology-based barcodes to help capture the SoC's identity, as well as, identification of other related items such as biology samples, so that manual key entry can be replaced by AIDC. In the complex hospital environment with many care instances, the need for uniqueness of identifications is generally recognized, since this avoids identification conflicts, overlaps, uncertainty and risks.
According to BS EN ISO 18530, AIDC enables capture of the SoC’s identification, medicinal product, administration event, recording of relevant data about the medicinal product administered, and other data such as batch number, expiration information, and amount used.
BS EN ISO 18530 helps to capture data that can be used to efficiently manage and replenish stock.
BS EN ISO 18530 provides benefits from unique SoC Identification in AIDC can be documented from the following three examples:
- Patient, as well as, data can travel outside a provider's environment: Following a devastating tornado in Joplin, Missouri, USA, in 2011, 183 SoCs from St John's Hospital had to be swiftly evacuated to other regional hospitals. Under such “chaotic” conditions, a patient identifier that is truly unique would prevent replacing identification bands immediately for every SoC admitted to a different hospital.
- For regional referral laboratories, especially those performing blood bank testing: positively identifying SoCs and linking them to previous records, is essential for patient safety. Two different SoC with the same name, hospitalized at two different facilities using identical patient identification numbering schemes (perhaps because they use the same IT system), could lead to serious errors.
- A provider uses two identifiers for the management of care processes: the “patient identification” and the “case identification”. One provider organized the number banks for the two identifiers in such a way, that data collision was excluded. After years of use of that solution, number banks started overlapping without anyone noticing until two SoCs were having the same numbers, one of “patient identification”, the other for “care identification”. A mismatch with a serious incident occurred.
What’s changed since the last update?
BS EN ISO 18530:2021 supersedes ISO/TS 18530:2014. BS EN ISO 18530:2021
includes some technical changes with respect to ISO/TS 18530:2014. These include:
- New definitions added
- Use case and UML diagrams updated
- Bibliography expanded