📋 Tender Overview
As part of the work it has been developing since February 2020, the National Mycobacteria Reference Laboratory (LRNM), maintains the accreditation of the test "Online probe assay for the identification and detection of resistance to rifampicin and isoniazid of the Mycobacterium tuberculosis complex" with the NTP-ISO 15189: 2014.
For this year, the LRNM renews its commitment to the quality management system in attention to the well-being and care of patients, ensuring the quality and competence of the laboratory in the generation of technically valid results, managing to expand its scope of accreditation with the NTP-ISO 15189: 2014 standard. Clinical Laboratories. Particular requirements for quality and competence.
The scope of accreditation is extended to 02 test methods: "In-line probe assay for the identification and detection of resistance to fluoroquinolones and aminoglycosides/cyclic peptides of the Mycobacterium tuberculosis complex" and "Antituberculosis drug sensitivity panel in liquid culture medium with mycobacterial growth indicator".
The extension of the accreditation has been possible thanks to the effort, dedication and competence of all the personnel involved in the LRNM, as well as the support of the Directorate and the areas and / or units that make up the National Center for Public Health such as: Sample Reception and Collection Area, Disinfection and Sterilization Area, Quality Management Team, Biomedicine Coordination, Biosafety Area, Maintenance and Calibration Area, and Public Health Information System Team.
Additionally, PAHO/WHO and the Andean Health Agency-Hipólito Unanue Agreement (ORAS-CONHU) have collaborated through the program "Strengthening TB laboratory diagnosis in the Region of the Americas", through the execution of the consultancy called "Accompaniment to the accreditation process of the Tuberculosis laboratory", during the years 2022 and 2023.
This allows to provide a support of reliability and assurance of the validity of the results, with technically valid, reliable, and interpretable analyses from the technical point of view for clinical decision-making based on evidence, for the benefit and care of the patient, whose methodologies that are carried out in the LRNM are part of the treatment scheme of patients living with tuberculosis in Peru with MDR-TB and XDR-TB diagnosis; thus contributing to provide an effective diagnosis for the health of patients.
This extension of the accreditation granted on August 31, by the National Accreditation System of Peru – National Institute of Quality (INACAL) to the LRNM, makes it the first national laboratory that has all its specialized diagnostic methodologies accredited under the highest standards of quality and competence, evaluated and recognized by INACAL, in order to contribute to the strengthening of tuberculosis diagnosis by generating timely, reliable and traceable results; giving reliable support to patients, users and stakeholders.
In this way, the INS through the National Mycobacteria Reference Laboratory (LRNM), belonging to the Executive Subdirectorate of Communicable Diseases of the National Center for Public Health of the National Institute of Health, strengthens the development of specialized diagnostics, the supervision and research of new technologies for the control and prevention of diseases caused by mycobacteria in addition to the conduction of the Network of tuberculosis laboratories in the Network National Public Health Laboratory.
