On June 13, 2022, the Institute of Public Health issued Exempt Resolution No. 1297 of 2022, which approves the “Instructions for the verification of the manual of the general standard of accreditation of clinical laboratories”.
This instruction has as background the provisions of Supreme Decree No. 15 of 2007, Regulation of the accreditation system for institutional health providers and the Exempt Resolution No. 1538 dated June 10, 2020, which approved the instruction of verification of the Manual of the General Accreditation Standard for Clinical Laboratories, which needed to be updated in terms of its normative references and incorporate new instructions.
The objective of this new version is to guide Accreditation Bodies (AE) in the verification and use of the accreditation report format, in cases where it is necessary to evaluate compliance with the Manual of the General Accreditation Standard for Clinical Laboratories.
In general, the new instructions include specifications regarding:
I. Data of the accreditation or reaccreditation process.
II. Procedures established for the evaluation, referring to the measures adopted by the entities to be accredited, its objectives and essential aspects.
III. Considerations for filling out the accreditation report format, both in terms of laboratories and sampling of the provider, characteristics that do not apply to laboratories, clinical laboratories without sampling and description of the documents required by the standard.
IV. Verification of indicators and periodic evaluation of the same, in addition to the record of the results delivered by the provider for the periodic evaluation.
V. Description of the evaluated attributes that have a large number of documents associated with them.
VI. Other characteristics of the measured standard.
This resolution leaves without effect the Exempt Resolution No. 1538 dated June 10, 2020.
It is hereby noted that this resolution and its effects will become effective upon its publication in the Official Gazette, which is still pending.