Background

Since the new EU-regulation (2017/746) for in-vitro-diagnostics came into effect, many healthcare institutions especially laboratories challenge to make their workflows ISO 15189 conform.

Blood banks often use "in house-tests" for donor or product testing, therefore they have to follow this special standard for medical laboratories to fulfill aspects of the EU-regulation. We aimed to implement the requirements and passed accreditation by national authority in 2023.

Methods

The implementation project of the ISO 15189:2012 standard started in August 2020. The project-members were all in-house employees of the laboratory, without external support.

The identified key-milestones of the project were: 1) kick-off 2) gap-analysis and implementation of appropriate measures 3) application for accreditation 4) inspection by national authority 5) resolve nonconformities 6) receipt of accreditation confirmation.

Employees of the laboratory were included in all phases of project work to internalize the relevant requirements for their units. The project leader was responsible for planning the project, conducting the application and was the contact person to the authority during the whole project.

Results

Net project time to implement the ISO 15189 was 30 months. 4 laboratory units and over 80 procedures where successfully accredited. Employees of the laboratory internalized new ISO 15189 requirements by continuously taking part in project work and they could transfer this knowledge instantly into routine. The advantages of an internal project leader are the increase of acceptance of the project and the minimization of external costs. Additionally, the expertise of the accreditation procedure itself remains in the organization.

Most important aspects are to take enough time to do the gap-analysis and to examine all documents recommended by national authority before starting implementation of the standard.

Conclusion

One successful way to implement the ISO 15189 in blood banks is through project work. Expected duration of such a project is medium term. The key to success is to involve internal staff from the beginning to use and retain know-how.

Blood banks have high quality standards, as they are obliged to implement the requirements of e.g. parts of the good practice guidelines of the EDQM guide or national law. This could be an advantage in the implementation of the ISO 15189.

Offenlegung Interessenkonflikt:

The authors have no conflicts of interest to declare.