Themes / Standardization

Normalization

In the laboratory industry, there are ongoing developments in standardization to ensure the quality, reliability and traceability of laboratory testing and analysis. With the ongoing digitization of society, more and more norms and standards have been developed in various sectors to regulate digital processes, information security and data exchange.

Digital processes

Information systems have become a critical part of laboratory operations. IT systems manage laboratory processes, including sample tracking, data capture, reporting and quality management. With the introduction of new measurement methods and the development of new technologies, such as dna research, laboratories are producing increasing amounts of data. In addition, more and more laboratories are opting for a cloud-based information system to be more flexible and effiencient with limited resources. It is becoming more important for software vendors to develop secure products and follow best practices for securing their systems.

With developments in robotics, routine operations on the laboratory shop floor can be increasingly automated. Suppliers of robotics are bundling hardware packages together with software to facilitate implementation. New generations of robots are easier to use, and there is a clear trend toward user interfaces that allow simple, icon-based programming and manual guidance of robots. Standards have been developed to ensure the interoperability and safety of automated laboratory equipment, as well as to ensure the safety of laboratory personnel. 

Information security

Information security is the set of preventive, detective, repressive and corrective measures that guarantee the availability, exclusivity and integrity of all forms of information within an organization. First, these are measures related to the organization itself, such as establishing policies, performing risk assessments, training employees and implementing procedures. Next, these measures relate to the technology used to process data, such as firewalls, antivirus software, and encryption. In addition, these are measures related to the physical security of data, such as securing servers and restricting access to sensitive areas.

Standards organizations have developed standards that focus on data security in laboratories, including guidelines for securely storing, transferring and processing laboratory data. Examples include ISO 27001 (information security) and ISO 27701 (privacy information management). In addition to these ISO standards, laboratories must comply with laws and regulations related to data protection and privacy, such as the AVG in the European Union. Standardization can help develop standards for compliance with such regulations. In addition, the sharing of anomalous measurement results to set standards has become increasingly important and is also legally enforced. There are standardization efforts aimed at sharing this information between laboratories and the broader community.

Data exchange

Standards-based data exchange is the process of exchanging data between different systems or applications using a common set of rules and guidelines. These rules and guidelines are defined in a standard. Using standards for data exchange offers several advantages:
  • It ensures interoperability between different systems and applications, making it easier to share and use data
  • There is consistency in the way data is stored and exchanged, reducing errors and inconsistencies
  • It increases efficiency by reducing the need for custom interfaces and conversions between different systems
For the exchange and analysis of laboratory data, the following 3 laboratory/sector specific standards, among others, are used:

  1. The Foundation for Infrastructure Quality Assurance Soil Management (SIKB) is a Dutch organization dedicated to improving the quality of soil management and soil use SIKB develops and manages guidelines, protocols and certification schemes for soil management and soil remediation. An example of a SIKB standard is the BRL SIKB 1000, which relates to the sampling of soil, dredged material and building materials. This standard describes the requirements that sampling must meet to ensure reliable and representative results.

  2. The Aquo standard is the Dutch standard for exchanging data within the water sector. It is a semantic standard that defines the meaning of concepts and data and their interrelationships. The Aquo standard consists of three parts: concepts, domain tables and information models. The glossary contains the meaning of terms and their interrelationships. The domain tables contain lists of domain values used in the information models. The information models contain data elements over which information can be exchanged and the relationships between those elements.

  3. LOINC is a coding system in the medical field and aims to standardize concepts of laboratory requisitions, laboratory results and clinical concepts. LOINC was developed in 1994 by the Regenstrief Institute to meet the growing demand for automation to process coded laboratory requests and results. Although every laboratory does use a coding system, when electronically exchanging data between multiple parties, it is essential that measurements and results can be unambiguously identified. LOINC stands for Logical Observation, Identifiers, Names and Codes. The scope of LOINC includes laboratory observations and other clinical observations. The laboratory part of LOINC consists of the following areas: chemistry, hematology, serology, microbiology, toxicology, parasitology and virology.