WP2 - Task 1: Pilot report - Denmark | UNITED4Surveillance

UNITED4Surveillance Grant Agreement Number 101102070 WP2 Outbreak detection – Task 1: Improving Laboratory Based-Reporting Milestone 35: Pilot report Denmark Disclaimer Copyright message This document was produced under the terms and conditions of Grant Agreement No. 101102070 for the European Commission. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the granting authority can be held responsible for them. © UNITED4Surveillance Consortium, 2025 This deliverable contains original unpublished work except where clearly indicated otherwise. Acknowledgement of previously published material and of the work of others has been made through appropriate citation, quotation or both. Reproduction is authorized provided the source is acknowledged. UNITED4Surveillance Grant Agreement Number 101102070 1.1 Background & objectives A more elaborate background of this pilot is described in Deliverable 2.1 “Review of existing i) laboratory surveillance systems and ii) outbreak detection systems or methods of participating countries”. 1 In short, the Danish National Microbiology Database (MiBa) forms the cornerstone of the digital infectious disease surveillance system in Denmark. 2 MiBa comprises microbiology test results from (i) all ten clinical microbiology laboratories (CMLs) from across the five regions of Denmark and (ii) SSI (including selected results from Whole Genome Sequencing, WGS). During the COVID-19 epidemic, also TestCenter Danmark (established in early 2020 to meet the high demand for SARS-CoV-2 testing) 3 and private laboratories reported SARS-CoV-2 results to MiBa. During the COVID-19 epidemic, a specific gap that was identified, was that not yet all CMLs had the technical basis to report microbial properties and molecular level information in a structured way to MiBa, which hampered timely data analysis. The reason for this challenge was that CMLs have different laboratory ITsystems, use local codes and often reported properties in free text fields. At SSI, local codes are centrally harmonized through dynamic mapping to common codes in MiBa. To improve structured reporting of microbial properties and molecular level information to MiBa, the objectives of the Danish pilot were: 1) To achieve harmonization by establishing consensus on the classification of molecular characteristics for SARS-CoV-2 variants and microbial properties of Shiga-toxin producing E. Coli (STEC) as model organisms. Core questions that were addressed were: a. By pathogen, which properties are relevant and which terminology should be used for them? b. How should the new data model be structured to accommodate properties? c. Which codes should be used for the properties? 2) To revise the existing national xml data standard XRPT06 30M to reflect the agreed-on principles in the new xml standard XRPT06 32M 3) To technically integrate the revised xml data standard XRPT06 32M in the majority of CMLs 1.2 Outcome/delivered product The development of the data standard XRPT06 32M (Figure 2) has been completed through joint collaboration of SSI, IT vendors, CMLs and disease specialists. XRPT06 32M, as an official national standard, is publicly available on the website of MedCom 4 , 5 , a publicly-funded, non-profit organization that supports the digitalization of the Danish health sector by developing, testing and certifying data standards. The pilot milestone (MS35), defined as the technical integration of the national standard data transfer protocol in the majority of CMLs, has thereby been achieved. 1 D2.1 Review of existing i) laboratory surveillance systems and ii) outbreak detection systems or methods of participating countries 2 Electronic reporting of diagnostic laboratory test results from all healthcare sectors is a cornerstone of national preparedness and control of COVID-19 in Denmark - PubMed 3 Testcenter Danmark 4 Releases - MedCom 5 MedCom in English UNITED4Surveillance Grant Agreement Number 101102070 Figure 2. Model of the revised data standard XRPT06 32M. Green boxes reflect elements that have been developed in the revised standard compared to the previous version XRPT06 30M. 1.3 Impact The following points have been achieved during the pilot period: • Development and integration of a scalable, official, national data standard: The pilot has resulted in a robust and scalable national data standard, which has officially been published by MedCom 6 . The infrastructure of the Danish surveillance system is now better prepared to respond to emerging health threats, including new potential pandemics, as well as reporting of antimicrobial resistance data. • Improved standardization: The pilot enhanced Denmark’s infectious disease surveillance by enabling structured, standardized reporting of microbial properties to MiBa, improving data quality and analysis. • Agreement on reporting of STEC properties: Consensus has been reached regarding which properties of STEC are relevant and how they should be entered in the revised standard. This enhanced the consistency of reporting. • Improved data sharing: Compared to the COVID-19 epidemic period, when sharing molecular-level data on SARS-CoV-2 was difficult, the revised standard enables significantly faster exchange of SARSCoV-2 variant data. However, some issues remain, such as how to manage the evolving nomenclature of SARS-CoV-2 variants, which will be topic of future discussions. • Strengthened collaboration: This pilot strengthened the core “principle” working group (principarbejdsgruppe), which provided expertise on how the data standard should be used in practice. Their work will continue under the national project “UpSurvDK”, co-funded by the EU (Grant Agreement No. 101180540). The pilot also improved communication with relevant expert groups (faglige grupper), fostering closer collaboration between disease specialists across CMLs and Statens Serum Institut (SSI). Expert groups deliberated which properties are relevant for the respective model pathogens. Involving all relevant levels within each stakeholder in the process, from disease 6 MedCom in English UNITED4Surveillance Grant Agreement Number 101102070 and IT specialists to system administrators, proved valuable in creating common understanding and achieving the pilot objectives. 1.4 Evaluation The evaluation was conducted in three parts “Evaluation of the pilot implementation process”, “Evaluation of the pilot product” and “Evaluation of sustainability”. The first two parts were conducted via separate online questionnaires implemented in the EU Survey platform. The respective target groups comprised persons involved in the implementation process (n=34) and persons assessing the pilot product (n=40). We used single choice questions, including Likert scales from 1 to 5 ranging from “strongly disagree” to “strongly agree”, as well as multiple choice and free text questions. Both survey invitations were sent on 9 April and – after sending reminders – closed on 9 May 2025. Sustainability was assessed by the SSI project team and reflects the status as of mid-June 2025. 1.4.1. Evaluation of pilot implementation process The aim of this survey was to assess how effectively the pilots were executed and to identify areas for improvement. Seven out of 34 responded to the survey (20,6%). If not otherwise indicated, the following results are based on seven responses. • Pilot objectives, acceptability and process of pilot implementation: The respondents rated clear communication regarding the pilot objectives with a median score of 4 (range: minimum 3-maximum 5) and the meaningfulness of the objectives with 5 (range 4-5), respectively. The level of satisfaction with the overall pilot implementation process was 4 (range 3-5). • Timeline: The median score for executing the pilot within the agreed-on timeline was 4 (range 2-5). A median score of 4 reflected whether the timeline for the pilot was realistic and achievable (range 35). Five respondents reported a median score of 4, regarding whether any delays from the pilot project team were promptly communicated to them (range 4-5). Two reported “not applicable” (NA). A median score of 4, based on five responses, described whether they, as stakeholders, reported delays timely to the project team (range 1-4). Again, two reported NA. A median score of 4 reflected whether adjustments to the pilot implementation plan were made efficiently by the project team (range 3-5). • Budget: One respondent stated that the pilot was executed within the allocated budget (14,3%). Three reported unknown and three NA, (42,9% each), respectively. • Challenges: Of the respondents, two (28,6%) reported that they faced challenges during the pilot implementation phase. The challenges comprised that certain parts of the pilot that were planned have not been accomplished, insufficient human resources and outside parties not meeting deadlines. 1.4.2. Evaluation of the pilot product XRPT06 32M The purpose of this evaluation was to assess selected attributes of the pilot product, the revised data standard XRPT06 32M. 7 Eleven respondents participated in this survey (response rate 27,5%). 7 Updated Guidelines for Evaluating Public Health Surveillance Systems UNITED4Surveillance Grant Agreement Number 101102070 • Usefulness: Nine respondents rated the usefulness of XRPT06 32M in terms of improving laboratorybased reporting, in particular the reporting of microbial properties, with a median score of 5 (range minimum 4 – maximum 5). Two reported unknown. • Simplicity: Seven respondents scored the ease of use of XRPT06 32M with a median of 4 (range 2-5) on a scale from 1 (not at all easy) to 5 (very easy). One reported unknown and three NA. Based on 11 ratings, the clarity of the documentation of XRPT06 32M scored a median of 3 (range 1-5). • Flexibility: The flexibility of XRPT06 32M in terms of how easily it can adapt to changes in data requirements of new emerging diseases was scored with a median of 4 (range 3-5) on a scale from 1 (not very easily) to 5 (very easily). Two reported unknown. • Timeliness: Based on eight ratings, the extent as to which XRPT06 32M has improved timeliness of laboratory-based surveillance, in particular sharing of microbial properties, was scored with a median of 3,5 (range 2-5) on a scale from 1 (very little extent) to 5 (very large extent). Three reported unknown. • Data quality: A median score of 5 (range 3-5) reflected the extent to which XRPT06 32M improved data quality of the laboratory-based surveillance data, in particular data on microbial properties. Two reported unknown. • Completeness: Nine respondents rated the extent to which XRPT06 32M improved completeness of the reporting of laboratory-based surveillance data, in particular data on microbial properties, with a median score of 5 (range 3-5). Two reported unknown. • Acceptability: The burden of implementing (n=10) and maintaining (n=8) XRPT06 32M was rated with a median score of 5 (range 3-5) and 4 (range 2-4) on a scale from 1 (very low) to 5 (very high), respectively. One and three reported “Unknown”, respectively. The evaluation of XRPT06 32M revealed strong perceived usefulness among respondents, particularly in enhancing the reporting of microbial properties, with a high median score of 5. Simplicity received slightly mixed feedback: while the ease of use was generally positive (median 4), clarity of documentation was rated lower (median 3), indicating room for improvement in supporting materials. XRPT06 32M was viewed as flexible to respond to new health threats (median 4). Timeliness was moderately rated (median 3.5), pointing to potential improvements, but also some limitations in the speed of data sharing. However, it has to be noted that it is unclear, whether respondents rated timeliness of XRPT06 32M at the time of the survey response, when XRPT06 32M was not yet widely used, or whether they evaluated expected timeliness in the future, once XRPT06 32M is more widely integrated in production environments of CMLs. This requires closer investigation. Importantly, the data standard was considered highly valuable in improving data quality and completeness, both scoring a median of 5. Finally, while implementation was seen as highly burdensome (median 5), the maintenance burden was viewed as somewhat less demanding (median 4), highlighting a need for follow-up with stakeholders to better understand which aspects were particularly demanding. Although XRPT06 32M is not yet implemented in the production environments of all CMLs, it is – once widely integrated – expected to reap benefits in the future by providing structured and standardized data for laboratory-based surveillance purposes. 1.4.3. Evaluation of sustainability • Long-term sustainability: XRPT06 32M is technically integrated in the Danish surveillance system and is thereby sustainable in the long term. However, work of the “principle” working group and UNITED4Surveillance Grant Agreement Number 101102070 other disease expert groups will continue in the future, as every pathogen/disease requires their own discussion in terms of how to report to the revised data standard. Parts of these efforts will continue under UpSurvDK. 8 • Adoption of the data standard: As of mid-June 2025, all Clinical Microbiology Laboratories (CMLs) have adopted the revised data standard XRPT06 32M, and are now capable of transmitting test data on STEC in test environments. Additionally, five CMLs have successfully integrated the standard into their production environments and are actively sharing STEC data. The revised standard is able to share SARS-CoV-2 variant data in a more structured way, however, the challenge of changing nomenclature remains to be addressed • Strong partnerships: Since the pilot was embedded within existing structures – such as the MiBa Board of Representatives and the working groups of the Danish Society for Clinical Microbiology – collaboration and engagement had already been well-established and will continue beyond this pilot. Key Challenges Encountered During the pilot implementation, several challenges emerged: • Dependence on external stakeholders: The progress of the development and implementation largely depended on the availability of external stakeholders. From a project management side, this required to flexibly respond to changing priorities and adjust work plans accordingly. • Variation in technical setups and operation between stakeholders: The difference in IT infrastructure among IT vendors required tailored implementation approaches. For example, one vendor operated with only two annual release windows, which restricted the timing of technical implementation of the revised data standard and impacted the pilot timeline. • Staff Turnover: Staffing changes within a key external stakeholder delayed the publication of the revised data standard, contributing to project delays. • Communication Gaps: Limited communication from stakeholders posed a challenge for the pilot implementation at times. 1.5 Recommendations To ensure the successful implementation of such projects, it is recommended that stakeholders have test systems in place that allow full end-to-end testing. In this pilot, one IT system vendor had such test environments in place, whereas this has been a gap for another vendor and thereby posed a dependency for the successful implementation of the pilot. Risk management proved an important part of the process, particularly in light of competing priorities across stakeholders. The pilot was proactively managed and implemented through an iterative process, reviewing progress throughout the implementation phase. However, one learning point included that the pilot implementation would have benefitted from earlier involvement of higher management levels to support mitigation of risks. 8 UpSurvDK UNITED4Surveillance Grant Agreement Number 101102070 The success of such a complex and interdisciplinary project depends on strong collaboration with a diverse group of stakeholders, including IT infrastructure specialists, data scientists, microbiologists, system administrators, project managers, as well as other technical and public health experts. At the same time, CMLs participated in the pilot without financial compensation. Since there was no formal commitment for CMLs, the project relied entirely on their input and voluntary active participation to execute this joint vision. Thus, it was important to ensure that implementation allowed flexibility. It also proved critical to align expectations in the early stages of the project and invest time in developing a common understanding, i.e. "translating" between disciplines. 1.6 Core messages Interdisciplinary collaboration is essential Complex projects like this require strong collaboration between IT specialists and scientific experts. Bridging different professional "languages" can be difficult. Therefore, having so-called “champions” in each relevant discipline can be beneficial for the successful implementation of such projects. It's crucial to involve all relevant representatives from the beginning, ranging from the strategic level to those that are practically implementing and working with the pilot product. Clear communication with all stakeholders within CMLs, from leadership to end-users, ensures common understanding and engagement. Risk management and expectation alignment are critical Aligning timelines and expectations early on helps to prevent delays and misunderstandings. A good understanding of how different stakeholders operate (e.g. taking release windows of certain stakeholders into account) allows better planning and risk mitigation throughout the project. Strong partnerships require flexibility Since participation in the pilot was voluntary and non-funded for CMLs, the execution of this pilot relied heavily on believing in and executing a common vision. Motivating stakeholders with competing interests required flexibility. The SSI project group showed flexibility by regularly adjusting internal plans and priorities to accommodate priorities of external stakeholders. Plan for sustainability To ensure the long-term impact of the pilot, follow-up funding has been secured through the EU-co-funded direct grant project UpSurvDK, which will keep building on the foundation laid by this pilot. Alignment with international initiatives With the approaching implementation of the European Health Data Space (EHDS) 9 – aimed at sharing electronic health data across the EU – close collaboration among stakeholders and a deeper reflection on the lessons learned from this project will be required. One of the next steps will be to focus on ensuring interoperability between the new national data transfer standard and the emerging European standards, as addressed by the Joint Action Extended EHR@EU Data Space for Primary Use (Xt-EHR) 10 , among other initiatives. 9 European Health Data Space Regulation (EHDS) - European Commission 10 Joint Action Extended EHR@EU Data Space for Primary Use (Xt-EHR)