chdegbus

IT solutions in diagnostic laboratories

IT systems improve efficiency and security of your work processes

PTA's expertise covers the entire value-added chain for IT solutions in diagnostic laboratories – from identifying requirements, through implementation and validation, to rolling out the software and support at all levels.

 

For an overview of our projects in this area, see our industry spotlight: diagnostics and pharmaceuticals.

What should a laboratory information system be capable of?

A laboratory information system (LIS) supports the operation and management of diagnostic and research laboratories.

 

Its main tasks are order management and consolidation of results in order to enable standardized and prompt dissemination of results to the doctor treating the patient. To provide this service, it must ensure a high level of data security, be intuitive, error-free and efficient to operate and be fail-safe and expandable. Given the increasing automation in laboratories, it is important that a modern LIS not only provides analytical services but also monitors and controls work processes in pre-analysis and post-analysis.

Laboratory information systems (LIS), work area managers (WAM)

The central, key element of any laboratory information (management) system is managing laboratory-related information. It both provides an interface to the outside world (doctors, laboratories, wards, etc.) and distributes information between the work areas or departments within a laboratory (clinical chemistry, hematology, microbiology, molecular diagnostics, endocrinology etc.).

 

Due to the varying conditions in the different departments, dedicated subsystems are often used for localized control of the departments.

 

A key element of the clinical/chemical laboratory is the work area manager, who is tasked with distributing patient samples and the corresponding orders and information to the relevant devices or workstations. The samples are prepared and distributed in the pre-analytics area in accordance with the tests to which they are to be subjected. The WAM controls how many parts of the sample (aliquots) have to be distributed to which devices in order to achieve the shortest possible sample dwell time before testing. A high degree of automation and the use of automatic identification systems, such as bar codes and RFID tags, means that a large number of patient samples can be tested as free from errors as possible in a short time.

 

The measured data are transferred from the measuring devices to the WAM or LIS; standard protocols like ASTM and HL7 are used here. Near patient testing instruments, which are used directly on the patient, can also be connected and managed.

  

In laboratory fields such as microbiology, automation is only possible to a limited extent, so LIS also has to support manual processes efficiently.

 

Once the analyses are complete, the results are validated medically. Here, the software supports the laboratory physicians by presenting the data clearly. The results are then transferred to the treating doctor or higher-level systems like the clinic information system, either as printed test reports or through automatic interfaces. Post-analytical modules and devices monitor and control storage of the samples.

Data security and regulatory requirements

When operating this kind of system, large quantities of data need to be managed securely over long periods of time. This can only be accomplished professionally with a database. A database also makes it possible to display reports on results specifically. In addition, the laboratory information system can also complete tasks of a non-analytical nature, such as managing blood reserves in a hospital.

 

Protection against incorrect or mixed up results is enormously important to patient safety. There are therefore standards that require compliance with rules and considerations in the software development process. One important standard, for example, is EN ISO 62304, which specifies what must be taken into account when creating medical software. Testing the software intensively is a key factor here. This starts at the smallest possible level, the individual modules (unit test), and proceeds to the component and system tests. Issues that were considered particularly critical in the risk assessment in accordance with EN ISO 14791 also need to be designed and tested with particular care. Complex systems of this kind can only be tested manually. Automated tests and stress tests help to continuously verify the quality of the software.

 

Once a system is live, it is crucial to ensure that the results are correct. Regular reference measurements and statistics create a set of information that can also be viewed by inspection authorities. Quality control is determined by two fundamental sets of procedural rules: the German RiliBäk (guidelines of the German Federal Medical Council on quality assurance in medical analysis laboratories) and the internationally applicable Westgard Rules.