POCT1-A/POCT1-A2

Interoperability Standards

Standards for Point-of-care Equipment

Advances in miniaturization, particularly in microfluidics, have enabled a new class of diagnostic equipment. “Point-of-care“ diagnostics allow a broad spectrum of diagnostic tests to be carried out at the patient´s bedside. Examinations that once required equipment located in centralized laboratories can now be conducted in a myriad of locations: at the hospital bedside, in primary- and secondary-care facilities or even at home. “Point-of-care“ diagnostic equipment provides faster examination results and can contribute to lower costs. In theory, diagnostic tests can be run regardless of the location.

However, a representative of the responsible institution must control and ensure that any governmental and institute-based quality and procedural guidelines and regulations are adhered to. It´s therefore imperative that “Point-of-care“ equipment providers incorporate mechanisms that make it possible to integrate their products into existing institute-wide systems for controlling quality and managing diagnostic information. The need for integration forms the starting point for standardization in this area.

For the descriptions that follow, “Point-of-care tests“ refers to all examinations carried out at the location where the patient is being cared for. This can involve a wide variety of locations ranging from the hospital bedside and physician´s office to any private or public environment in which the examinations are conducted automatically or carried out or initiated by the patient. “Point-of-care“ connectivity standards should have utility in all of these situations to the extent they are technically feasible.

Our Technology

Schnittstelle NCDS Standard
© Photo Fraunhofer IIS

Fig. 1

© Photo Fraunhofer IIS

Fig. 2

As illustrated in figure 1, the NCCLS POCT1-A/POCT1-A2 standard defines two interfaces: a “device interface“ for transmitting information between devices and so-called “observation reviewers“ (“Point-of-care“ data managers) and an “observation reporting interface“ (EDI) that serves as a message exchange between an observation reviewer and an observation recipient, usually a laboratory information system (LIS) or a clinical data repository (CDR). Brief extensible markup language (XML) messages are exchanged via the device interface.

Figure 2 depicts part of a so-called “observation message“ describing a hemoglobin measurement. The system encodes numerical values, value ranges and measurement units and sends them to an observation reviewer as attributes of an “observation“. The EDI (depicted on the left in fig. 1) defines messages in the Health Level 7 (HL7) format in order to send the validated information to the clinical information system.

Manufacturer Benefits

POCT1-A/POCT1-A2 offers clear benefits to medical equipment manufacturers:

  • Accelerated specification and development
  • Streamlined development of distributed applications (i. e. for data management systems)
  • Lower-cost product maintenance and care (life cycle management)
  • Lower-cost development and installation (fewer equipment-specific components required)
  • Less complex installations: easier troubleshooting and technical support

User Benefits

  • Cost-effective equipment connectivity, such as to data management or lab information systems
  • Re-usable network infrastructure and hardware (i. e. access points) if supplier change required
  • Faster implementation and installation (less need for expensive specialists)
  • Simpler and faster problem resolution (easier component swapping)
  • Purchase decision no longer oriented toward connectivity requirements and instead can focus on product functionality and innovation

Our Services

Fraunhofer Institute IIS offers a wide range of customer-specific services that help manufacturers of medical equipment and information systems develop and enhance connectivity and interoperability mechanisms for their products. We have modules compatible with the CEN/IEEE/ISO “VITAL“ and NCCLS POCT1-A standards, which can be acquired on a license basis. Our services include engineering and system integration, application development for standard platforms and embedded systems and also services and tools for conformity and interoperability testing. All of these services are backed by our extensive experience in the field of software and chip development.

Further Information

Brochure

Medical Communication and Biosignal Processing

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