The Public Health Center’s laboratory received reference laboratory status under the new public health regulation
This laboratory is the fourth in Ukraine to have been granted reference laboratory status recently under the new rules and requirements. Previously, the Ternopil Regional Center for Disease Control and Prevention (CDC) laboratory received the status of a reference laboratory in the public health system under the new procedure approved by the Ministry of Health of Ukraine dated August 9, 2024, No. 1404, “On some matters of the activities of reference laboratories in the public health system.” The first to receive this status was the laboratory of the Kyiv Regional Center for Disease Control and Prevention, followed by the laboratory of the Rivne Regional Center for Disease Control and Prevention.
The new procedure allows for the creation of an extensive network of reference laboratories throughout the country. Such a network allows for rapid case confirmation and DNA typing. At the same time, it ensures a unified approach to diagnostics, quality control, storage of biomaterial, and information exchange. The modern European model of public health and laboratory control is also based on such a system.
“The basis for an effective public health and response system remains the laboratory network and the development of this infrastructure throughout the country. Historically, Ukraine followed a centralized approach, where only a limited number of institutions held reference laboratory status—often just one per field for the entire country. The new procedure takes into account modern European and international approaches to the formation of reference laboratory networks. It develops a network approach, designating laboratories across different regions according to their specializations, all operating under unified standards.”
A laboratory may apply for reference laboratory status within the public health system if it holds a valid accreditation certificate, complies with the required standards for equipment, personnel, and safety, and conducts public health laboratory testing. Eligible institutions include regional Centers for Disease Control and Prevention, independent public or private laboratories, and laboratories within healthcare facilities that meet the specified criteria.
An open application system has been established for laboratories seeking reference laboratory status. Applications and subsequent decisions to approve or deny status are reviewed by the Commission on Reference Laboratory Status. Laboratories may receive the status for a period of 1 to 4 years, limited to the duration of their accreditation certificate.
Official reference laboratory status enables a laboratory to:
- Conduct confirmatory testing of particularly dangerous and other infectious agents;
- Provide methodological guidance to the network of laboratories;
- Ensure laboratory oversight during emergencies, such as outbreaks or biological threats;
- Represent Ukraine in international projects;
- Maintain consistent laboratory diagnostic standards nationwide—from frontline regions to Kyiv;
- Enhance international confidence in Ukrainian laboratories, facilitating access to support programs, technical assistance, exchanges, and training.
The Order of the Ministry of Health defined criteria for granting reference laboratory status, based on equipment, staff qualifications, research areas, and biosafety standards. Reference laboratories are assigned specific functions: conducting confirmatory testing, providing methodological support, performing epidemiological monitoring, ensuring quality control, and responding to public health emergencies.
As the reminder, the new procedure allows for the creation of an extensive network of reference laboratories throughout the country. Such a network allows for rapid case confirmation and DNA typing. At the same time, it ensures a unified approach to diagnostics, quality control, storage of biomaterial, and information exchange. The modern European model of public health and laboratory control is also based on such a system.