1. External Quality Assessment, EQA 2. Objectives and Scope

Institution Code: Laboratory name Standard Operating Procedure (SOP) Version: no. Location Date: of release Head/Responsible person External Quality Assessment Page: 1 of 2

1. External Quality Assessment, EQA

2. Objectives and scope This procedure describes the general procedure for external quality assessment (EQA). This concerns objective assessment of all tests done within the laboratory to investigate the proficiency of the laboratory and see if this is within acceptable limits.

3. Abbreviations, definitions and terms

NTRL National Tuberculosis Reference Laboratory

4. Tasks, responsibilities and accountabilities

See for general authorizations the Authorization matrix included in the quality manual. Task Authorized Responsible Carrying out examinations of EQA (blinded) Lab technician Lab manager Reporting result to the organization of the EQA Lab technician/Data Lab manager scheme manager Determining corrective actions upon results of Section head of the Lab manager the EQA section concerned

5. Safety and environment Safety and environments for the specific tests concerned shall be respected.

6. Procedure

6.1 EQA: 1. The laboratory can measure and compare its performance to the acceptable range by participating in an EQA scheme for every examination/test done in the laboratory. These tests shall be carried out blinded by a laboratory technician. 2. The samples of the EQA will be treated according to the manual attached to the delivery of the samples. 3. The test-values will be given to the lab manager who will send the result report to the organizer of the EQA. 4. The organizer of the EQA will process the results anonymously and will send a report to the laboratory with the EQA results. 5. The laboratory manager will formulate any corrective actions if necessary, based on rigorous root-cause analysis (see SOP “Notifications, complaints, and improvement suggestions”). The EQA results will also be included in the quarterly report of the laboratory, together with any corrective actions and the results of those. 6. EQA report will be archived for a duration indicated in the quality manual, appendix x, Duration of archiving laboratory documents.

7. Related documents

Source: GLI Stepwise Process towards TB Laboratory Accreditation SOP “Notifications, complaints and improvement suggestions” Quality manual

8. Related forms

SOP “Reporting”, appendix 1, Request and reporting form

9. References

APHL, CDC, IUATLD, KNCV, RIT, WHO. Externa Quality Assessment for AFB Microscopy. 2002

10. Attachments / Annexes

Source: GLI Stepwise Process towards TB Laboratory Accreditation