The US Centers for Disease Control and Prevention (US CDC) under the Global Health Security Agenda (GHSA) tasked Integrated Quality Laboratory Services (IQLS) with provision of laboratory support to the Ghana public health laboratory system. Improving Quality Management Systems (QMS) was deemed key to improving quality of testing services in zonal public health laboratories (ZPHLs). The ZPHLs (Located in Tamale, Sekondi and Kumasi) are strategically located in Ghana and are responsible for providing microbiology referral testing and other testing services relevant to diseases of public health concern.
Since 2013 the ZPHLs have been implementing QMS with limited success. Considering the ground reality, CDC and IQLS decided to implement ISO 9001:2015 as standards for the ZPHLs. In March 2020, IQLS began supporting implementation of ISO 9001:2015 standards in the Sekondi and Tamale ZPHLs . The support started with a baseline audit using a modified WHO Facility Laboratory assessment tool (F-LAT) to build on previous accomplishments. Based on the findings of the F-LAT baseline audit, a list of corrective actions was generated to address the identified gaps. The following activities were undertaken by IQLS, with support of US CDC and AFENET:
- ISO 9001 level 1 training
- ISO 9001 level 2 training
- Internal audit training
- Enrolling into EQA programs
- Establishing equipment maintenance and calibration
- Acquiring reference materials and standards
- Providing remote and onsite technical support
- Supporting internal and external audits
Ghana Standards Authority (GSA), an ISO 9001 certification body in the country, conducted external audits to assess the laboratories for their respective readiness for certifications. The GSA conducted audits in three stages: pre-assessment, stage one, and stage two in the areas of ‘methods in bacteriology’, ‘serology’, and ‘molecular biology’. During the audits, minor non-conformities were identified and addressed accordingly under the mentorship of IQLS. As a result, on 14 December 2021, Tamale ZPHL and Sekondi ZPHL were ISO 9001:2015 certified for an initial period of 3 years.
This is a major achievement to ensure quality of laboratory test results for patient care and public health purposes in Ghana. This has also boosted the morale of the laboratorians, and a culture of quality is taking shape in Ghana. To ensure sustainability of the established QMS, CDC and IQLS will continue to engage with all relevant stakeholders at the regional and national levels of the Public Health Division and Ghana Health Service.