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Saatja: "WHO Europe Lab Accreditation" <[email protected]> Saaja: "Karmen Joller - SOM" <[email protected]>, "Agne Nettan-Sepp - SOM" <[email protected]>, "Helen Sõber - SOM" <[email protected]> Teema: 2026 Accreditation of WHO Reference Measles and Rubella Laboratories Kuupäev: 2025-10-09 07:50 Please see the attached correspondence sent from the World Health Organization, Regional Office for Europe. One or more attachments may be included. Veuillez vous référer à la correspondance ci-jointe du Bureau régional de l'Europe de l'Organisation mondiale de la santé. Une ou plusieurs annexes peuvent être jointes. Mit der Bitte um Kenntnisnahme der beiliegenden Korrespondenz (eine oder mehrere Anlagen), Weltgesundheitsorganisation, Regionalbüro für Europa. См. прикрепленные письма от Европейского регионального бюро Всемирной организации здравоохранения (один или несколько прикрепленных файлов) WORLD HEALTH ORGANIZATION Date: 9 October 2025 ORGANISATION MONDIALE DE LA SANTÉ WELTGESUNDHEITSORGANISATION ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ Dr Karmen Joller Minister of Social Affairs REGIONAL OFFICE FOR EUROPE BUREAU RÉGIONAL DE L’EUROPE Ministry of Social Affairs REGIONALBÜRO FÜR EUROPA Suur-Ameerika 1 ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО 10129 Tallinn Head office: Estonia UN City, Marmorvej 51, DK-2100 Copenhagen Ø, Denmark Tel.: +45 45 33 70 00; Fax: +45 45 33 70 01 Email: [email protected] Website: https://www.who.int/europe Dear Madam, WHO European Regional Measles and Rubella Laboratory Network Laboratory accreditation for 2026 As part of the annual accreditation procedure, the national measles and rubella laboratory of your country, as a member of the WHO Global Measles and Rubella Laboratory Network (GMRLN), was reviewed by the WHO Regional Office for Europe. Based on the results of this review, I am pleased to inform you that the laboratory is fully accredited as a WHO national measles/rubella laboratory for 2026. Enclosed is the accreditation review summary, including the scope of the accreditation and the recommendations of the review, for your information. To implement the laboratory-supported elimination-standard surveillance of measles and rubella and to optimize laboratory contribution to the verification of disease elimination, it is of the utmost importance that WHO-accredited national laboratories: • comply with the requirements of the WHO Manual for Measles Rubella Laboratories and the guidance Eliminating measles and rubella in the WHO European Region; • report their laboratory data monthly to the newly established WIISE MR Lab System; and • are empowered to oversee laboratories outside the GMRLN performing measles and rubella testing, to coordinate national measles and rubella laboratory networks, and/or to establish periodic measles and rubella serology and molecular external quality assessment schemes. Technical advice is available from the WHO Regional Office for Europe to assist in these processes. In the current context of reduced funding and a rapidly evolving public health landscape, I urge national health authorities to reaffirm their commitment to supporting the sustainability and the expertise of WHO measles and rubella laboratories. These laboratories are integral to our collective efforts to eliminate measles and rubella, diseases that continue to pose significant health threats across the WHO European Region. I appreciate your continued support to the measles and rubella elimination programme and would like to congratulate the staff of the laboratory on the successful accreditation. Yours very truly, Dr Ihor Perehinets Health Security and Regional Emergency Director Division of Health Security UN City, Marmorvej 51 Tel.: +45 45 33 70 00 Email: [email protected] DK-2100 Copenhagen Ø Fax: +45 45 33 70 01 Website: https://www.who.int/europe Denmark Encls: Accreditation review summary Copy for information to: Ms Helen Sõber, Adviser, European Union Affairs and International Co-operation Department, Ministry of Social Affairs, Suur-Ameerika 1, 10122 Tallinn, Estonia Ms Agne Nettan-Sepp, Head, European Union Affairs and International Co-operation Department, Ministry of Social Affairs, Suur-Ameerika 1, 10129 Tallinn, Estonia H.E. Ms Riia Salsa-Audiffren, Ambassador Representative of the Republic of Estonia, Permanent Mission of the Republic of Estonia to the United Nations Office and other international organizations in Geneva, Chemin du Petit-Saconnex 28A, CH-1209 Genève, Switzerland H.E. Mr Andre Pung, Ambassador Extraordinary and Plenipotentiary, Embassy of the Republic of Estonia, Frederiksgade 19, 4th floor, 1265 Copenhagen K, Denmark Ms Kristina Köhler, Liaison Officer, WHO Country Office, Estonia, Paldiski Road 81, 10617 Tallinn, Estonia –2– Measles and Rubella National Laboratory or sub-National Laboratory Check- list for WHO Accreditation Section 1: General Review & Overall Findings Dates of 01/01/2024 – On-site / Desk Review Accreditation for Review: 31/12/2024 calendar year: 2026 Name of Laboratory of Communicable Diseases Laboratory: Health Board / Terviseamet Address: Paldiski mnt 81, 10614 Tallinn Country ESTONIA Phone: 3727943500 Email: [email protected] Website: www.terviseamet.ee [email protected] Head of Institute: Brigit Lao Head of Department: Liisi Kink Head of Measles and Rubella Laboratory: Oksana Joamets Technical Supervisor: Oksana Joamets Number of laboratories under supervision: 1 Name of Reviewer(s): Dr. Myriam Ben Mamou & Dovile Videbaek, WHO/Europe Name of National Accreditation Authority (if appropriate) and current accreditation status from this authority (e.g. ISO15189 or other, provide documentation): Estonian Accreditation Centre, EVS-EN ISO 15189:2022. Accreditation Certificate No M004. Accreditation is valid until 29.06.2029 (http://eak.ee/dokumendid/pdf/kasitlusala/M004.pdf) 1  Summary of Accreditation Review Recommendations (check one): Accredit: Laboratory meets all criteria Measles: Rubella: Serology Serology Detection RT-PCR/RT-qPCR Detection RT-PCR/RT-qPCR Sequencing Sequencing Cell Culture Cell Culture Measles testing not done Rubella testing not done Provisionally accredit: Laboratory passed the most recent proficiency test, but needs to strengthen one or more of the remaining criteria (check off relevant criteria): Measles: Rubella: Serology Serology Detection RT-PCR/RT-qPCR Detection RT-PCR/RT-qPCR Sequencing Sequencing Cell Culture Cell Culture Measles testing not done Rubella testing not done Do not accredit: Laboratory did not pass the most recent proficiency test and/or did not meet other performance indicators. Measles: Rubella: Serology Serology Detection RT-PCR/RT-qPCR Detection RT-PCR/RT-qPCR Sequencing Sequencing Cell Culture Cell Culture Measles testing not done Rubella testing not done 2  Main General Findings: Findings: Confirmatory test results of Sub-national Laboratories’ referred specimens are reported 1. 100% within 14 days for ≥ 80% of specimens received: Completeness: 2. The laboratory reports monthly to WHO (≥ 80%): 100% Timeliness: 3. IgM tests are performed on at least 50 specimens annually: Measles: 59 Rubella: 248 Measles and Rubella IgM test results conducted for primary 4a. diagnostics are reported by the laboratory within 4 days of Measles: 95% receipt, for ≥ 80% of specimens Rubella: 100% If molecular virus detection by real-time RT-PCR is performed Measles: 100% 4b. in addition to serology, positive test results are reported by the Rubella: NA laboratory within 4 days of receipt, for ≥80% of specimens The accuracy of IgM detection is ≥ 90% (NLs sending sera to Measles: 98% 5. RRL and SNLs to NLs for confirmatory testing) - Rubella: 100% 50 measles and 4 rubella samples At least one run per month is performed for measles and rubella Measles: Yes 6a. detection Realtime RT-PCR Rubella: NA At least one run per quarter is performed for measles and rubella Measles: Yes 6b. GT RT-PCR & sequencing Rubella: NA Score on most recent WHO Serology proficiency test is ≥ 90%: Measles: Second test 100% 7. PT panel number: 02401 Date reported: 20/03/2025 Rubella: Second test 100% Performance on most recent WHO Molecular EQA Measles Mol detection: Passed is passed (P) /re-test (R) (provisionally passed)/fail (F) Measles Sequencing: Passed 8. Panel number for measles: 24-1 Date reported: 29/11/2024 Rubella Mol detection: NA Panel number for rubella: Date reported: dd/mm/yyyy Rubella Sequencing: NA For labs that conduct virus sequencing: Virus sequencing is completed AND reported to WHO through MeaNS or RubeNS within 2 months of MeaNS; 100% (2/2) 9. receipt of specimens, for ≥80% of the specimens appropriate for genetic RubeNS: NA analysis 10. Score from on-site review of laboratory operating procedures and practices is ≥ 80%: Conclusion • Good performance for serology; excellent for measles rRT-PCR and sequencing • Excellent monthly data reporting to WHO. 3