When Lapin Sairaanhoitopiiri wanted to use the data from its data warehouse as part of a software program for assessing children’s symptoms, it turned out, according to the law, to be a medical device accessory. A quality management system had to be established for it. With Clinipower’s assistance, the audit was successfully completed on the first attempt.
Author: Minna Torppa
Lapin sairaanhoitopiiri aims for knowledge-based management
Lapin Sairaanhoitopiiri can justifiably be described as a pioneer: it was the second entity in Europe, following Helsinki and Uusimaa Hospital District (HUS), to implement a certified quality management system that governs the manufacturing of medical devices, based on the EU Medical Device Regulation’s ISO 13485 standard. Additionally, it introduced Europe’s first data warehouse, which, upon completion of the software, will be submitted to the medical device registry, potentially by the end of this year.
As early as 2014, a data-driven management unit was established at Lapin Sairaanhoitopiiri to promote a data-informed working model. According to this approach, employees at all levels of the organization are encouraged to consider how work could be done more intelligently, ensuring it is as productive, high-quality, and cost-effective as possible. This development work has borne fruit, as, among other recognitions, Lapin Sairaanhoitopiiri was awarded the title of Data-Driven Organization in 2019.
Matti Oikarainen
Matti Oikarainen, who works as a project manager for the data team, has been involved in developing his team’s quality management system. The creation of this system became necessary when the existing data warehouse was intended to be utilized for assessing children’s symptoms and treatment needs. Lapin Sairaanhoitopiiri spans a vast geographical area. For instance, the hospital journey from Utsjoki to Rovaniemi is 450 kilometers. Therefore, it would be beneficial to determine in advance whether a symptom requires a visit to the hospital emergency department or if treatment can be provided at the local health center.
With Clinipower’s assistance, the audit was successfully completed on the first attempt.
“When it was decided to retrieve comparative data from the data warehouse for a software program assessing treatment needs, it was determined that it would be classified as a medical device accessory, which requires an approved quality management system,” Oikarainen states. As a new employee, he was tasked in 2018 with building the quality management system alongside his other duties. While wading through the complex regulatory text, the limits of his own expertise soon became apparent.
“In September, we began close collaboration with Clinipower. We decided that by December, the project would be at the auditing stage. We received clear working instructions, schedules, and training on several occasions. We also got excellent guidance for the audit itself. Thanks to the professional expertise of Clinipower’s Hannele Toroi, the audit passed successfully on the first attempt!”
When Oikarainen evaluates the process in hindsight, he is convinced that without professional assistance, the timeline would have been delayed, and the audit would not have been passed immediately.
“We received clear working instructions and schedules, as well as training on several occasions. We also got excellent guidance for the audit.”
“In my opinion, companies waste energy trying to decipher legal texts on their own. An expert could clarify the essential points very quickly. At the moment, I think I understand some of the regulatory text, but the whole process involves a vast array of other matters as well. That’s why it’s difficult to proceed without a consultant.”
Currently, a significant portion of Oikarainen’s working time is spent on data management, but he still participates every other month in a peer support group for quality managers, which Clinipower initiated in the spring of 2019.
Through the group’s expert lectures, I’ve been able to update my knowledge. We have also received information about the topics covered by email, which has made it easy to revisit them,” says Matti Oikarainen appreciatively.
The COVID-19 pandemic affected knowledge work
Lapin sairaanhoitopiiri found itself on the front line when the coronavirus arrived in Finland. The country’s first case was confirmed on January 29, 2020, in a tourist who had arrived from Wuhan, China, and was placed in isolation at Rovaniemi Central Hospital.
We quickly realized that we needed information about the progress of the situation and about resources. We set up a Corona Situation Center environment on Microsoft’s SharePoint site. It contained training materials, guidelines, and above all, a real-time situational overview built with Power BI,” explains Matti Oikarainen.
“Information was needed, for example, on the sufficiency of masks and other supplies. Data from the systems of the Lapin sairaanhoitopiiri and the City of Rovaniemi’s primary health care were transferred directly to the data warehouse, but the challenge was obtaining information from other municipal organizations.
Lapland Central Hospital in the midst of expansion work in August 2021. According to Matti Oikarainen, the photo he took also symbolizes continuous improvement as well as knowledge-based leadership and decision-making.
We didn’t have a material management system, nor access to municipal information or laboratory systems. Using the Forms tool in the Office software suite, we built forms that enabled us to collect the necessary information from the region centrally, in a format that was useful to us.” According to Oikarainen, for example, border stations still report daily through forms the number of arrivals and how many of them are vaccinated or have been tested for COVID-19.
The software tools that were tested and proven effective during the corona crisis will continue to be used. According to Oikarainen, the goal is that department managers could report daily how much staffing levels deviate from planned levels and why. For example, has the intensive care unit staff been handling resuscitations in the hospital, or have nurses perhaps been transferred from there to the emergency department?
Such matters could not be brought up before. Now they can be used to examine the workload burden of the department.
Benefits of the Lean method also in healthcare
Many companies and production facilities have long utilized Lean thinking, which aims to improve work efficiency and quality while simultaneously increasing customer satisfaction and reducing costs. Lapin sairaanhoitopiiri also began considering years ago whether lean methods could be utilized in hospital work. At the same time, huddling was introduced. The term originates from American football, where team players gather together before the start to agree on game tactics.
Leaning and huddling were found to produce benefits, as they enable human resources and financial resources to be allocated in the best possible way.
In the hospital, each unit gathers quickly in the morning to check the day’s resource needs. Head nurses hold their own huddle regarding inter-departmental operations and assess nursing needs. The result areas also have their own gathering, which includes top management as well. So huddling is done at three different levels, allowing everyone to get a picture of the upcoming workday.
Matti Oikarainen says that already in 2019 it was observed that leaning and huddling produce benefits, as they enable human resources and financial resources to be allocated in the best possible way. This is also conducive to improving the quality of patient care.
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