We would like to inform accredited medical laboratories and potential applicants for accreditation of significant changes in assessment:
- It was released on December 6, 2022. new version of ISO 15189. From this date, the ILAC resolution establishes a three-year transitional period of validity of the accreditation certificate according to the current version of the standard. CAI is intensively preparing the introduction of the standard into the accreditation system of the Czech Republic, because after the publication of the Czech version of the standard, it will no longer be possible to accept applications for the granting or extension of the validity of accreditation according to ČSN EN ISO 15189:2013.
- Effective January 1, 2023, CAI will only consider the personnel requirements listed in Decree of the Ministry of Health of the Czech Republic No. 99/2012 Coll.. on the requirements for minimum staffing of health services, as a relevant sectoral regulation. When assessing the adequacy of staffing of a specific Medical Laboratory, the group of assessors will take into account the type and volume of healthcare provided and the range of services and activities performed. The recommendations of professional medical societies of the Czech Medical Laboratory Association have the character of professional recommendations and will be taken into account as such during the assessment.
- The revised law will enter into force on 1 January 2023. MPA 00-09-22 Flexible scope of accreditation, which incorporates the requirements of the mandatory document EA-4/17M:2022 Description of scopes of accreditation for medical laboratories. These requirements fundamentally change the way in which the scope of accreditation is described in the annexes to the accreditation certificate. The transitional period for the application of the requirements for accredited medical laboratories is set until 17 February 2024. Further information on the description of the scope of accredited examinations and sampling in the annexes to the accreditation certificate will be provided in the revised Instructions for the preparation of Annex No. 3 at https://www.cai.cz/?page_id=2969.
More detailed information about all the above changes will be provided at the seminar for Medical laboratories , which will be held on March 22, 2023 (Brno) and March 3, 28.3.2023 (Prague).