Fully automated validations for clinical chemistry and molecular diagnostics
German laboratory diagnostics face the most demanding conditions worldwide concerning quality and efficiency. To achieve cost efficiency and the best possible competitive advantage, together with compliance with the regulatory requirements, it is necessary that method validations and verifications integrate well in the quality management process, and that they support high automation.
Labor Mönchengladbach, MVZ Dr.Stein + Kollegen, which is part of the nation-wide Limbach group, is one of largest and most modern medical laboratories in Germany. In 2017, this forerunner laboratory adopted Validation Manager™ with a goal of automating and digitalizing their method validation needs throughout the organization.
Thomas Berche, Quality Manager at MVZ Dr.Stein + Kollegen, explains the background of their needs. “Obtaining the highest quality is essential in all operations of our organization. We strictly follow the national RiliBÄK guidelines, and all our areas are accredited by DAkkS (Germany’s national accreditation body) according to DIN EN ISO 15189:2014.”
“Also, the lab relocation in spring 2016 and introducing one of the largest automated laboratory systems by Roche in Europe really challenged our capabilities to ensure the quality assurance activities required. We needed to find a solution that would automate the method validation process and reduce the manual hands-on work that was wasted on various data management and reporting steps,” Berche continues.
“After thorough evaluation of the options, it became obvious that the Validation Manager™ solution, provided by Finbiosoft, stood in a class of its own,” says Berche.
“None of the Excel-based solutions could provide anything near the same level of automation, traceability and ease of use we were looking for.”
André Frontzek, Senior Scientist from the Molecular Diagnostics department agrees with Berche: “We wanted to obtain a solution for the future and to follow our dream of a paperless laboratory. After my first encounter with Validation Manager™, I knew that I had found the right solution for us. None of the Excel-based solutions could provide anything near the same level of automation, traceability and ease of use we were looking for.”
During the early spring of 2017, Validation Manager™ was taken into use in close collaboration between the organizations. Customer requirements were mapped, analyzed, and required functionalities, such as supporting data transfer from the LIS, measurement uncertainty and total analytical error, were implemented.
“I must admit that I am very impressed with the forward-looking attitude of the people at MVZ Dr.Stein + Kollegen,” says Akseli Virtanen, R&D Director at Finbiosoft. “Introducing the very latest CLSI-based V&V protocols, fulfilling the national RiliBÄK requirements and other industry-leading ISO requirements has been a challenging but a rewarding journey. I especially value the close professional dialog and the feedback loop between the people we have had right from the beginning of the project,” Virtanen adds.
“I would say that Finbiosoft should think about increasing the 95% time saving rate on their product website.”
Berche expresses his satisfaction with the results obtained from the collaboration. “I am very pleased with the type of workflow that Validation Manager™ has enabled us to perform. In just a few minutes I can carry out a complete verification analysis and create corresponding documentation in parallel for thousands of samples from multiple instruments and hundreds of individual analytes. This enables me to conduct method validations more frequently than before, with significantly less work. I would say that Finbiosoft should think about increasing the 95% time saving rate on their product website. Of course, there are always a few things that could be improved, but it is not a problem since our requirements are heard and implemented really quickly,” says Berche.
“I would be happy to recommend Validation Manager™ to my colleagues so that they may see the benefits by themselves.”
During summer 2017, after streamlining and fine-tuning the organization-wide validation process, the rest of the users, such as technicians running the V&V samples, have been trained. The next focus for Berche will be managing the DAkkS re-accreditation in November 2017. “I can sleep well and confidently wait for the upcoming re-accreditation, after knowing that our validation and verification process with the related V&V data is now more comprehensive and better organized than ever before. I would be happy to recommend Validation Manager™ to my colleagues so that they may see the benefits by themselves.”
HUSLAB, the leading laboratory service provider nationally in Finland, paves the way for the introduction of new novel diagnostics methods. Evaluation and development of new diagnostics methods is particularly active in the department of clinical microbiology. Commercial test verifications and in-house test validations are a regular activity because of the rapidly evolving landscape, especially in the field of molecular diagnostics.
However, due to the insufficient tools to manage validations according to ever-strictening quality requirements, validation activities have been found extremely burdening and error-prone work. Moreover, validation related work is often fragmented and requires specific knowledge about quality requirements and statistics. Data management has required a lot of manual work and has been handled by using various informal Excel sheets. Furthermore, approaching relocation of the laboratory will require re-validations for all utilized diagnostic tests.
In 2014, Finbiosoft and department of virology and immunology started a collaboration with the aim to introduce a lean and standardized way of conducting validations. The deep needs of users were thoroughly collected, analyzed and a new lean process model was created to streamline validation activities. Validation Manager™ software was introduced into use and verified to address the various needs of users, all the way from validation planning to the data collection, calculation and final reporting of validations.
Implementation of Validation Manager™ yielded substantial benefits for HUSLAB.
Benefits for HUSLAB
- Measured time saving in validations up to 95 %
- Conducting validations is better managed and significantly easier than before
- Regulatory and accreditation requirements can be addressed effectively
- Increased result reliability due to process and data traceability
“Validation Manager significantly streamlines and brings visibility to the validation process.”
Maija Lappalainen, Department head
Clinical microbiology, HUSLAB
The results of the collaboration were published and presented in EMMD 2015 (Poster).
Thanks to the great results achieved, the use of Validation Manager™ was later further expanded to cover the whole HUSLAB laboratory chain with strong emphasis in molecular diagnostics, clinical chemistry, hematology, serology and immunology.
What is HUSLAB?
Leading laboratory service provider in Finland
More than 20 million analyses annually
Follows and applies LEAN principles in lab processes