TABLE 2.

Main challenges experienced and actions taken to accomplish ISO 15189:2012 requirements for accreditation of the National Tuberculosis Reference Laboratory, Mozambique, 2011–2013.

Requirements for quality and competence: ISO 15189:2012 international standards†	Critical points	Actions taken
4.6 External services and suppliers	In case of an emergency situation, difficulty in referring samples to an accredited laboratory located in Mozambique, since NTRL was the first to be accredited. Difficulty in defining other criteria that could be accepted by the accreditation board.	Select a laboratory with good performance on EQA results, have a written agreement, to be renewed annually, according to their EQA results.
5.3 Laboratory equipment, reagents, and consumables	Difficulties in selecting and hiring a local company to provide equipment service, which follows all ISO requirements for calibration (companies should be ISO 17025 accredited to perform relevant calibration of equipment, e.g., specific temperature ranges for incubators).	Select services from abroad that accomplish all requirements.
5.6 Ensuring quality of examination results	Difficulties in maintaining an EQA for culture for four consecutive years (accreditation cycle), including customs clearance of imported EQA schemes.	EQA for culture was purchased. An agreement with an EQA provider in South Africa and with a transportation company was signed, including transport and customs clearance.
5.7 Post-examination processes	The report of test results did not include all ISO 15189 requirements, due to constraints in adapting the LIS format.	Testing reports were redesigned according to ISO 15189 requirements.

Abbreviations: EQA, external quality assurance; ISO, International Standards Organization; LIS, laboratory information system; NTRL, National Tuberculosis Reference Laboratory.

^†Other ISO 15189 requirements are not listed in the table, since they were not linked to the major critical points.