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Saatja: ABDUSALYAMOVA, Malika <[email protected]> Saadetud: 13.12.2022 18:32 Adressaat: Peep Peterson <[email protected]>; Triin Uusberg <[email protected]>; Elen Ohov <[email protected]> Koopia: Elen Ohov <[email protected]>; Triin Uusberg <[email protected]>; SM Info <[email protected]>; Ms K. Saarsalu-Layachi <[email protected]>; <[email protected]>; Kaisa.Mitt-Alvarez <[email protected]>; <[email protected]>; <[email protected]>; KÖHLER, Kristina <[email protected]>; BEN MAMOU, Myriam Corinne <[email protected]>; VIDEBAEK, Dovile <[email protected]> Teema: 2023 Accreditation of WHO Reference Measles and Rubella Laboratories Please see the attached correspondence sent from the World Health Organization, Regional Office for Europe. One or more attachments may be included.Veuillez vous r¨¦f¨¦rer ¨¤ la correspondance ci-jointe du Bureau r¨¦gional de l'Europe de l'Organisation mondiale de la sant¨¦. Une ou plusieurs annexes peuvent ¨ºtre jointes.Mit der Bitte um Kenntnisnahme der beiliegenden Korrespondenz (eine oder mehrere Anlagen), Weltgesundheitsorganisation, Regionalb¨¹ro f¨¹r Europa§³§Þ. §á§â§Ú§Ü§â§Ö§á§Ý§Ö§ß§ß§í§Ö §á§Ú§ã§î§Þ§Ñ §à§ä §¦§Ó§â§à§á§Ö§Û§ã§Ü§à§Ô§à §â§Ö§Ô§Ú§à§ß§Ñ§Ý§î§ß§à§Ô§à §Ò§ð§â§à §£§ã§Ö§Þ§Ú§â§ß§à§Û §à§â§Ô§Ñ§ß§Ú§Ù§Ñ§è§Ú§Ú §Ù§Õ§â§Ñ§Ó§à§à§ç§â§Ñ§ß§Ö§ß§Ú§ñ (§à§Õ§Ú§ß §Ú§Ý§Ú §ß§Ö§ã§Ü§à§Ý§î§Ü§à §á§â§Ú§Ü§â§Ö§á§Ý§Ö§ß§ß§í§ç §æ§Ñ§Û§Ý§à§Ó). Measles and Rubella National Laboratory or sub-National Laboratory Check- list for WHO Accreditation Section 1: General Review & Overall Findings Dates of 01/01/2021 – On-site / Desk Review Accreditation for Review: 31/12/2021 calendar year: 2023 Name of Health Board Laboratory of Communicable Diseases Laboratory: Address: Paldiski mnt 81, 10614 Tallinn Country ESTONIA Phone: +372 794 Email: [email protected] Website: www.terviseamet.ee 3638 Head of Institute: Birgit Lao Head of Department: Janne Pullat 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 15189:2012. Accreditation Certificate No M004. Accreditation is valid until 29.06.2024 (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. NA within 14 days for ≥ 80% of specimens received: Completeness: 92% 2. The laboratory reports monthly to WHO (≥ 80%): Timeliness: 67% 3. IgM tests are performed on at least 50 specimens annually: Measles: 168 Rubella: 173 Measles and Rubella IgM test results conducted for primary 4. diagnostics are reported by the laboratory within 4 days of Measles: 96.4% receipt, for ≥ 80% of specimens Rubella: 96.5% The accuracy of IgM detection is ≥ 90% (NLs sending sera to Measles: 100% 5. RRL and SNLs to NLs for confirmatory testing) - Rubella: 100% 13 measles and 6 rubella samples Measles Mol detection: No Molecular tests are performed on at least 2 specimens per Measles Sequencing: No 6. quarter, for measles and rubella (RT-PCR, GT) Rubella Mol detection: NA Rubella Sequencing: NA Score on most recent WHO Serology proficiency test is ≥ 90%: 7. Measles: 100% PT panel number: 02105 Date reported: 03/03/2022 Rubella: 97.5%* 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: 21-1 Date reported: 18/04/2022 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; NA 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%: *Rubella in-house control not available Key accreditation criteria 2- The laboratory should send monthly data reports to WHO in a timely manner (80% at least) including zero reporting (no specimens from suspected cases). Conclusion • Good performance for serology and measles RT-PCR & sequencing 3 WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTÉ WELTGESUNDHEITSORGANISATION ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ Date: 13 December 2022 REGIONAL OFFICE FOR EUROPE BUREAU RÉGIONAL DE L’EUROPE Mr Peep Peterson REGIONALBÜRO FÜR EUROPA Minister of Health and Labour ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО Ministry of Social Affairs Head office: Suur-Ameerika 1 UN City, Marmorvej 51, DK-2100 Copenhagen Ø, Denmark 10129 Tallinn Tel.: +45 45 33 70 00; Fax: +45 45 33 70 01 Estonia Email: [email protected] Website: http://www.euro.who.int Our reference: Your reference: Notre référence: Votre référence: Unser Zeichen: Ihr Zeichen: См. наш номер: На Ваш номер: Dear Sir, As part of the annual accreditation procedure, the National Measles/Rubella Laboratory of your country, as a member of the WHO Global Measles and Rubella Laboratory Network, 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 2023. Please find enclosed the scope of the accreditation and the recommendations of the review for your information. After COVID-19 pandemic-related disruptions, the risk for large measles outbreaks has increased while measles and rubella surveillance performance has declined in many countries. WHO’s Measles Outbreak Guide (2022) reiterates the importance of early detection and confirmation of cases to ensure proper case management and enable implementation of appropriate public health intervention to control further transmission. Measles and rubella laboratory investigations including molecular characterization of sporadic cases and chains of transmission are a key pillar of disease surveillance and data originating from proficient laboratories are an essential contribution to verify disease elimination. In this regard, I would appreciate your support of the National Measles/Rubella Laboratory of your country to fully conduct its role, including the oversight of other laboratories in charge of measles and rubella testing, and its meaningful involvement in preparing the annual status update for the European Regional Verification Commission for Measles and Rubella Elimination. I take this opportunity to thank you personally for your ongoing contribution to measles and rubella elimination and congratulate the staff of the laboratory on the successful accreditation. Yours very truly, Dr Hans Henri P. Kluge Regional Director UN City, Marmorvej 51 Tel.: +45 45 33 70 00 Email: [email protected] DK-2100 Copenhagen Ø Fax: +45 45 33 70 01 Website: http://www.euro.who.int Denmark Copy for information to: Ms Elen Ohov, Adviser, European Union Affairs and International Co-operation Department, Ministry of Social Affairs, Suur-Ameerika 1, 10122 Tallinn, Estonia Ms Triin Uusberg, Head, European Union Affairs and International Co-operation Department, Ministry of Social Affairs, Suur-Ameerika 1, 10129 Tallinn, Estonia H.E. Ms Katrin Saarsalu-Layachi, Ambassador Extraordinary and Plenipotentiary, Permanent Representative, 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 William Mart Laanemäe, 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–