Modern laboratories – both hospital and veterinary – operate in an environment where the quality and safety of test results are of particular importance. To ensure their reliability, it is essential to maintain the right conditions for storing samples and reagents. More and more facilities are therefore opting for digital temperature and humidity monitoring systems that provide real-time control and compliance with quality standards.
Why are environmental conditions so important?
Excessively high or low temperatures and inappropriate humidity – even for a short period of time – can lead to the degradation of biological samples, loss of reagent activity or falsification of test results. As a consequence, the laboratory loses time, money and credibility.
For hospital laboratories, this poses a threat to patient safety, and for veterinary laboratories, to animal health and the reliability of diagnoses. In both cases, it is also necessary to comply with standards such as PN-EN ISO 15189 or PN-EN ISO/IEC 17025, which impose an obligation to document and control the storage conditions of biological materials.
Digital monitoring instead of manual records
The traditional method of control, based on manual readings and paper sheets, is becoming less and less effective.
It is time-consuming, prone to errors and does not allow for a quick response in the event of deviations.
Digital systems – such as CoolSens – eliminate these problems by offering continuous, automatic monitoring and immediate notifications when set values are exceeded.
How does the CoolSens system work?
CoolSens is a plug & play solution that can be implemented in any laboratory without complicated installation work. The system consists of three main components:
- CoolSens Node wireless sensors – recording temperature and humidity at selected points
- (e.g. refrigerators, freezers, incubators, storage rooms).
- CoolSens CloudHub data concentrator – which collects data from sensors
- and sends it to the cloud, additionally working as a sensor – it measures the conditions
- in the room where it is located and, optionally, atmospheric pressure
- CoolSens Cloud/App cloud platform and application – enabling real-time viewing of measurements, setting alarms, analysing measurements and generating reports in accordance with audit requirements.
If temperature or humidity thresholds are exceeded, the system sends an alert in the application, by text message or e-mail, allowing you to react immediately and prevent losses. All data is archived, which facilitates reporting during inspections or audits.
Implementation example – hospital laboratory
One of the hospital laboratories decided to digitise the process of monitoring environmental conditions. Previously, temperature and humidity measurements were performed manually – readings were recorded in notebooks, which was time-consuming, prone to errors and did not allow for quick response in case of deviations.
After implementing the CoolSens system, the laboratory gained:
- full control over the storage conditions of samples and reagents,
- time savings thanks to automatic data recording,
- reduction of material losses – the system immediately alerts when permissible values are exceeded,
- easier audits and maintenance of compliance with the requirements of the PN-EN ISO 15189 standard.
The PN-EN ISO 15189 standard specifies quality and competence requirements for medical laboratories. It covers both technical aspects (e.g. temperature control, equipment calibration, method validation) and the quality management system,
including monitoring of environmental conditions. In practice, this means that the laboratory must not only ensure the appropriate temperature and humidity in the storage areas, but also document each measurement, respond to deviations and have archival data available for inspection during audits.
Thanks to the CoolSens digital monitoring system, the laboratory fully meets these requirements – all data is automatically recorded, archived in the cloud and available in the form of ISO-compliant reports. This not only allows the laboratory to maintain its accreditation, but also ensures the stability and repeatability of test results, which directly translates into a higher level of safety and quality of patient diagnostics.
In the case of veterinary laboratories that perform tests on material of animal origin, the requirements of the PN-EN ISO/IEC 17025 standard – General requirements for the competence of testing and calibration laboratories – apply. This standard, like PN-EN ISO 15189, specifies principles for ensuring quality, reliability of results and supervision of environmental conditions. Digital monitoring systems, such as CoolSens, also support compliance with its requirements by automatically recording, archiving and reporting measurement data necessary for audits and quality control.
Attention: PN-EN ISO 15189:2023-02 and PN-EN ISO/IEC 17025:2018 are the official Polish translations of international ISO standards. The full text is protected by copyright and available exclusively from the Polish Committee for Standardisation.
Guidance for laboratories planning implementation:
- Identify critical measurement points – e.g. freezers, incubators, reagent storage rooms.
- Set alarm thresholds and response procedures for deviations.
- Ensure staff training and integration with the quality system.
- Choose a scalable and reliable system that can be easily expanded with additional sensors.
