Management solutions

Quality management in the laboratory

Your all-round package for laboratory quality management

A key factor in the success of laboratories is an extremely accurate and structured way of working. The handling of medical specifications also demands standard-compliant and clearly defined document control – and this is particularly true of information from the LIS that affects diagnosis and analyses. This includes what are known as normal or reference ranges – these are values that describe the level of a particular analyte in the blood as of which the patient is considered to be ill. This data changes frequently and, in many cases, is still maintained manually in laboratory SOPs. These SOP documents are ultimately used as the basis for obtaining certifications and accreditations (DIN DAkkS).

Laboratory information systems do not enable such traceable and regulated document control. What's more, maintaining SOP document manually is prone to errors. If the values from the LIS do not match those of the SOPs, this can have negative ramifications that extend beyond a DAkkS audit.

With the integration of the NEXUS / CURATOR quality management system into the NEXUS / SWISSLAB laboratory information system, discrepancies like these are a thing of the past. The method SOPs are maintained in the form of data entry screens and automatically populated with the data stored in the LIS via an interface. Test descriptions can also be centrally created, maintained and added to a wide variety of SOP documents. MTAs, laboratory doctors and workplace managers can perform manual updates at any time. Any changes are reviewed and released in a transparent and traceable manner in review workflows based on the dual-control principle.  

NEXUS / CURATOR enables you to map the entire quality management process within your laboratory. All the way through to accreditation!

 

Risk management

Risk management in the laboratory: safe and clearly arranged

The NEXUS / CURATOR risk management module was originally created for use in laboratories. As is the case in other areas, the importance of such a system is beyond question. Dealing with risks and working out how they can be prevented, minimized and contained at an early stage and on an ongoing basis is a major factor in the success of a company.

Risk management with NEXUS / CURATOR enables the structured identification of risks based on catalogs and notification systems, for example the entry of CIRS, error and complaint information. Individual risks are assessed using FMEA (Failure Mode and Effects Analysis) forms, which are directly linked to the respective procedures, such method SOPs, and the workplace managers. This method of describing risks has proven itself in the systematic analysis of risks for complex processes. The action management feature integrated in NEXUS / CURATOR allows you to keep a constant eye on how these risks are being managed in direct conjunction with the SOPs.

 

Accreditation

Fit for accreditation!

Accreditation of a laboratory by the Deutsche Akkreditierungsstelle (DAkkS) ensures compliance with applicable quality assurance directives. Any laboratory seeking accreditation must have a documented quality management system.

This includes ensuring that all specifications are properly managed, regularly updated and verifiably communicated. NEXUS / CURATOR provides clearly defined read receipts, a multi-stage approval workflow and reminders for your procedural instructions, forms or method SOPs. Be ready for accreditation and certification with DIN-ISO-compliant document control.

NEXUS / CURATOR provides automated support in creating the service specifications required for accreditation and the provision of data for the appendices.

The system also helps you to translate the terms you use in your SOPs into the language and terminology used by DAkkS. This is because DAkkS has very precise expectations as to the terminology used in accredited procedures. The standard terms for analytes, materials, techniques, procedures and equipment types are stored in NEXUS / CURATOR as an alternative sorting option. This enables you to assign every specification and every method SOP or equipment SOP to these DAkkS-compliant terms.

What's more, NEXUS / CURATOR reliably and continuously reminds you about outstanding tasks, for example if DAkkS verification documents need to be updated.

This means you're well prepared at all times!

 

Laboratory equipment documentation

For enhanced safety, quality and availability.

Work in the laboratory is wholly dependent on the available equipment: microscopes, spectral photometers, centrifuges, gas-phase chromatographs, evaporators – to name but a few – require continuous and complete documentation. This requirement stems from the provisions of applicable laws (Ordinance on Medical Devices, Ordinance on Industrial Safety and Health, VDE regulations, etc.).

NEXUS / CURATOR maps the entire documentation for your laboratory equipment in a state-of-the-art and intuitive web interface. From managing a product master data sheet, documenting the persons responsible for the equipment, all the way through to the traceable recording of training plus conducted maintenance and error messages, the entire history of an item of equipment can be traced at any time. Changes to documents are logged and versioned.

Notifications reliably remind you about upcoming dates, for example for maintenance or training. Various search options make it considerably easier to find the information you need.

 

Do you have questions?

We will be happy to help! Whether you're already a customer or are interested in our solutions, our NEXUS / LAB experts have years of experience and expertise in all laboratories as well as pathology, cytology and genetics and will be happy to share their knowledge with you: