No 44b - 2023

Amended Executive order on notification of infectious diseases

On 1 November 2023, an amended Executive Order on Notification of Infectious Diseases (Stat. Ord. no. 1260 of 27/10/2023) became effective.

Monitoring of infectious diseases is essential during crises, which became evident during the COVID-19 pandemic. However, monitoring of infectious diseases is also important for our normal everyday lives; among others to identify and fight, e.g., foodborne outbreaks, prevent spreading of serious diseases among children and curb antimicrobial resistance.

With the Danish Health Authority’s amended Executive order on Notification of Infectious Diseases, we gain a more comprehensive, current and effective monitoring of infectious diseases in Denmark, which paves the way for strengthened prophylactic efforts and enhanced control of disease outbreaks.

The order stipulates which diseases should be reported in writing to Statens Serum Institut (SSI) and the Danish Patient Safety Authority (STPS), which microorganisms are included in the laboratory monitoring and for which microorganisms it is mandatory to submit isolates or other biological material to SSI. Furthermore, the order defines the tasks of physicians and laboratories in relation to disease monitoring and notification in connection with the pregnancy screening and donor screening.

The novel elements are as follows:

• Laboratory data plays an increasingly significant role in surveillance of infectious diseases (this does not mean that the laboratories need to change their normal practice).
• Laboratory-based surveillance includes more than 25 micro-organisms that were not previously monitored. This includes several parasites and fungi and an expansion of the antibiotic resistance area.
• The departments of clinical microbiology’s submission of lists to the SSI stating the number of disease cases is now discontinued for the majority of diseases and will, in the longer term, be discontinued for all diseases.
• A range of agreement-based schemes to submit isolates to the SSI are now made mandatory to ensure sufficient monitoring in the future.
• Various conditions shift from being notifiable in writing to being laboratory-monitored only:
  o Cases of bacterial meningitis, barring meningococcal meningitis (i.e. meningitis cases caused by Haemophilus influenzae type B, listeria and pneumococci, among others)
  o Neuroborreliosis
  o Mumps (parotitis)
  o Typhus
  o Shiga-toxin-producing E. coli (STEC), NOT associated with HUS (HUSEC)
• Measles cases (including cases of enhanced clinical suspicion) must be notified by phone to ensure prophylactic treatment for any non-immune contacts and to contribute to the measles eradication scheme.
• For whooping cough, the written duty of notification is extended to include cases in children < 6 years (previously only cases in children < 2 years).
• As from now, only variant Creutzfeld-Jakob disease (vCJD) is notifiable. Other types of CJD are no longer notifiable.
• The wording concerning notification of food- and water-borne infections has been clarified, specifying that notification is required only in disease cases with information about several associated cases. The agent in question does not necessarily need to have been detected.
• Suspicion of clusters of disease cases of a serious or unusual character is notifiable regardless of whether the cause is known (this applies to notifiable and non-notifiable diseases alike).
• The order introduces various changes to the previous order and other subsequent Executive orders on infectious diseases, e.g., the Order on Notification of COVID-19.
• Reporting of treatment information, including treatment outcome, for patients with tuberculosis is now mandatory.

The laboratory-based surveillance is based on laboratory data reported by the departments of clinical microbiology to the MiBa, supplemented by other laboratory data of relevance to infections reported by clinical biochemistry departments and clinical biochemistry departments to the laboratory data bank (LABA).

As part of the modernisation of the notification system, an electronic notification system has already been introduced for written notifications under the Health Data Authority’s Electronic Notification System (SEI2), and the automatised laboratory reporting is being extended and prepared for use in the surveillance.

The structure of the Executive order

The Executive order places infectious diseases and microorganisms on various lists. The handling of cases pertaining to each list is different. To see which lists comprise the individual diseases/microorganisms, please refer to the order.

List 1a: Notification by phone to the STPS and in writing to both the STPS and the SSI, cf. § 3 and § 5 of the order, and laboratory notification to the SSI, cf. § 6.

List 1b: Notification in writing to the STPS and the SSI, cf. § 5, and laboratory notification to the SSI, cf. § 6.

Furthermore, notification by phone to the STPS on the next working day if the patient is a child attending early childhood education services (day-care institutions, day-care centres, etc.) or an employee in these services with close contact to children, cf. § 4 of the Order.

Liste 1c: Notification in writing to the SSI, cf. § 5 of the order, and laboratory notification to the SSI, cf. § 6 of the order.

List 2: Laboratory notification to the SSI only, cf. § 6 of the order.

The “Guideline on notification of infectious diseases” was prepared along with the order. The guideline elaborates the contents of the order, including its aim, tasks, procedures and which items of information need to be passed on. Furthermore, the guideline provides a set of criteria for written notification, which are described for each individual notifiable disease. Additionally, the guideline contains an overview of the purpose and scope of submitting isolates or other biological material, for the microorganisms for which submission to SSI is mandatory.

Furthermore, the “Handbook on submission of isolates etc. for monitoring and referencing” (Danish language: Håndbog om indsendelse af isolater m.v. til overvågning og reference), which targets departments of clinical microbiology and other laboratories in Denmark, provides in-depth information on the objective of submitting isolates, states what needs to be submitted and when, and contains information about sampling material, packaging, storage, shipment, notification and ordering. The manual also details which special analyses are made at the SSI as part of the monitoring efforts, provides response times and explains the elements of the results provided. The manual comprises both microorganisms for which submission is mandatory and microorganisms submitted as part of a voluntary scheme.

The requirement that laboratories send a list of the positive test results of various microorganisms on a weekly, monthly or quarterly basis to the SSI was revoked as per 1 November 2023, barring shiga toxin-producing E. coli (STEC) and Shigella spp. / enteroinvasive E. coli (EIEC) (ipaH positive), for which the lists must still be submitted. Furthermore, the monthly lists detailing the number of HIV tests performed must also still be submitted. In the longer term, once the development of automatised algorithm-based interpretation of results has been completed, the requirement to submit the above lists will also be revoked.

Read more about disease monitoring and notification of infectious diseases (In Danish language).

(S. Voss, S. Cowan, Department of Infectious Disease Epidemiology and Prevention)

3 November 2023