Quality control testing in Swiss medical practices: basics, responsibilities and real-world quality

Quality control testing is one of the key pillars of care in Swiss medical practices. Physicians cannot correctly interpret laboratory results or make responsible treatment decisions unless their diagnostic systems work reliably. QUALAB is an independent body that defines standards and monitors how external quality audits are performed. Its guidelines, along with the quality contract concluded between physicians and health insurers, serve as the legal and organisational basis for quality control testing. Parties to the contract include healthcare provider organisations such as the Swiss Medical Association (FMH) and the Swiss Association of Medical Laboratories (FAMH) on the one hand and health insurers and insurance organisations on the other. The latter include santésuisse, as well as state insurers for veterans and the disabled – organisations that require quality-assured diagnostic services. QUALAB, in turn, assumes the role of a control body, ensuring that the agreed quality standards have indeed been met. You may view the contract on the QUALAB.swiss website or by following the link below.

Go to contract: https://www.QUALAB.swiss/Vertraege.htm

Internal quality control – regular performance testing

In Switzerland, QUALAB regulates internal quality control requirements, and every practice is obliged to perform QC testing regularly and to document this work for tracking purposes. The aim here is to ensure that analytical instruments used every day work reliably and deliver correct results. Internal QC encompasses all of the laboratory analyses that you run in your practice and that you bill to social insurance. Exemptions apply to only a few tests, such as Strep A rapid tests, pregnancy tests or simple urine strips. We recommend reviewing QUALAB’s “Richtlinie interne Qualitätskontrolle” [Guidelines for internal quality control], which contain all the information you need regarding QC frequency (i.e., how often you need to test each system), how to document testing results and how long to keep them on file, etc. Maximum QUALAB tolerance ranges can be found in Appendix A. In addition, the Guidelines also offer practical explanations of how to assess quality control.

Using the same reagents and test systems for internal quality control that you would use for patients is important, as this gives you a realistic tool for determining whether system performance is stable under actual conditions in your practice. Test results must be documented and evaluated – simply recording control values is not enough. You should always assess the cause of deviations, either by repeating the measurement, conducting a technical inspection or adjusting your procedures. Doing so will result in a continuous quality process – one that reliably helps to keep your patients safe.

The document containing the latest Guidelines for Internal Quality Control is updated on a regular basis. We advise you to add it to your favourites in your browser and check it regularly for changes.

Why every practice needs a GLN

A global location number (GLN) is absolutely mandatory for any laboratory facility wishing to bill its analyses to social insurance – including state health insurance, accident insurance and insurance for veterans and the disabled. The GLN serves as a unique identifier, ensuring that laboratory services can be unambiguously assigned to an accredited, properly registered medical laboratory. That’s why it’s important for every medical practice to register with QUALAB early on, to use a GLN and to update changes (such as a new location or operator) in a timely manner. A GLN, in other words, is a key component of formal quality assurance – and a prerequisite for anyone wishing to bill services through social insurance programmes. You can apply for a laboratory GLN directly from QUALAB when you register your medical lab with QUALAB. Laboratories failing to comply with registration requirements will face consequences: Article 59 of Switzerland’s Federal Health Insurance Act (KVG) permits insurers to initiate sanctions, while Article 38 of the KVG describes actions that regulatory bodies may take.

External quality control – round-robin testing for objective comparisons

Whereas internal QC ensures day-to-day stability, external QC enables neutral testing through the use of round-robin studies. Medical practices in Switzerland must take part in these external QC studies four times each year. QUALAB contracts accredited providers such as the Quality Control Center Switzerland (CSCQ) and the Association for Medical Quality Control (MQZH) to send out the samples, which must be tested and submitted within a prescribed period of time. The target value with which your results will later be compared will be calculated based on the results of all participating laboratories, i.e., not until all submissions have been received. Statistical outliers will be eliminated to ensure that the comparison is robust and fair. Because different systems can naturally have slightly different measurement characteristics, results from each study will be assessed within the same group of instruments.

To ensure this process runs smoothly, we recommend noting the delivery and submission dates in your calendar early on and defining clear responsibilities within your team. Advance planning can be critical here, especially since holidays and changes in personnel can result in delays.

Why do the round-robin samples need to be tested quickly?
Although they could spoil, this is not the primary reason. More importantly, the stability of the analytes they contain is limited, and sample conditions need to be comparable for all participating laboratories. The longer the controls sit untested, the greater the risk that temperature differences, transport conditions or natural changes in the sample matrix can impact the test results. Plus, prompt analysis demonstrates that a given laboratory is organised and functional – a factor that cannot be understated in the overall quality assurance concept.

Self-declaration – your annual confirmation of quality

Medical practices are required to submit their annual self-declarations each spring. These confirm that you have reliably implemented quality control testing – both internally and externally – and that all relevant documentation is on hand in its entirety. You do not need to submit your control sample charts, however.

For many medical practices, this is an opportunity to take stock of their organisation: Where do things stand? Do our processes work? Are there areas in need of improvement? Seamless documentation throughout the entire year makes this job considerably easier.

CIP – the engine that drives lasting quality development

Quality management isn’t just about checking requirements off a to-do list – it’s an ongoing process. A continuous improvement process (CIP) ensures that errors, deviations and observations actually yield improvements. CIP means analysing every irregularity – whether it occurs during internal QC testing, during a round-robin test or in day-to-day operations – and defining, implementing and reviewing corrective actions. The method allows quality to develop one step at a time, anchoring it into the structure of your practice.

Conclusion

Quality controls are much more than just an administrative burden. They are the very foundation of reliable diagnostics, of medical decision-making and of your patients’ trust. Staying well-organised, defining clear responsibilities and pursuing an active CIP will do more than just prevent errors – they will also give the quality of your medical lab a long-term boost precisely where it is needed.

Quality happens where precision, responsibility and teamwork come together.

 

Sources:

QUALAB – the Swiss Commission for Quality Assurance in Medical Laboratories. Available online at: https://www.QUALAB.swiss, accessed 24 Dec 2025

QUALAB – Quality assurance guidelines for medical laboratories. Available online at: https://www.qualab.swiss/Aktuelle-Richtlinien.htm, accessed 24 Dec 2025

QUALAB – Quality assurance contracts for medical laboratories. Available online at: https://www.QUALAB.swiss/Vertraege.htm, accessed 24 Dec 2025