Clinical Pathology Challenges

Dependence on Host Systems

When a Clinical Pathology system is embedded within a larger data management system it is invariably the case that ClinPath information is not immediately available for integration with data deriving from systems outside the Host system.

The PDS ClinPath system, with its open systems architecture, provides connectivity with external systems through purpose-built import/export data interfaces. Such interfaces, through connectivity standardization, have no impact on the kernel system. This avoids product customization and consequential expense. By developing specialized import/export processes, the system can be tailored to meet the requirements of individual clients in an economical and controlled way.

Most commercially available Clinical Pathology systems, by virtue of their close relationships with Host systems, are very good at managing Host-derived samples but are mediocre when managing external samples.

The PDS ClinPath system is designed to accept samples from any source, either manually (through Sample Registration) or automatically (via a data connectivity interface). The design ensures that no attribute associated with samples from a previously unsupported source will force a change in the structure of the kernel system.

The primary deliverable of any Clinical Pathology system is data of verifiable quality. The standard way in which this is achieved is through the use of Quality Control (QC) materials. Such materials have known properties and are placed at regular intervals within sample analysis sequences. However, many commercially available Clinical Pathology systems do not retain QC data either in a coherent format or in such a way as to demonstrate (e.g. during a quality assurance (QA) inspection) the QC results that were contemporaneous with the non-QC samples they were measured alongside.

The PDS ClinPath system archives all QC data and retains the relationships between QC and other samples within analysis sequences to deliver comprehensive quality auditing. Through the use of powerful QC data analysis tools, the monitoring and presentation of QC data adds significantly to the reliability of the data which ClinPath delivers to its clients.

Many Host-dependent Clinical Pathology systems do not retain the identities of samples or of their data after these have been supplied to the Host system. Consequently the ownership of, and responsibility for the data becomes ill-defined with possible regulatory implications.

The PDS ClinPath system archives sample information and all associated sample data. This ensures that no question of data ownership or of the responsibilities surrounding their capture and management can arise. Furthermore, by retaining data in structures which correspond to the data collection sequences, not only can individual data items be retrieved at any future time but that the relationship one sample has with another (where applicable) can also be retrieved. The retention of structure and format provides strong regulatory compliance.

The use of transaction logging for all instrument data traffic and user activity ensures that raw data can be explicitly defined and any system event can be reconstructed on demand at any time.