Implementation of the COVID-19 laboratory testing certification program (CoLTeP), Zimbabwe, 2021.

The Africa Union (AU) Trusted Travel Initiative was introduced in 2021 to support Africa Union member states enhance their current health screening systems. Trusted Travel offers an online digital platform for the verification and authentication of COVID-19 results based on a collaborative effort across a network of participating COVID-19 testing laboratories. In this paper, we describe the certification process of laboratories to qualify for listing on the AU Trusted Travel platform as approved and recognized COVID-19 testing facilities. A checklist prepared from the ISO15189: 2012, ISO15190: 2020 and World Health Organization Laboratory Safety Manual, 4th edition was used to audit laboratories. Approved auditors completed the audit checklist through reviewing laboratory documents and records, observing laboratory operations whilst asking open-ended questions to clarify documentation seen and observations made. A laboratory was recommended for certification after scoring at least 90%. Between May and September 2021, a total of 26 (19%) of the 134 medical laboratories authorized for SARS-CoV-2 testing had been audited for CoLTeP certification in Zimbabwe. The majority 16 (62%) attained 5 stars rating with 10 (38%) attaining 0-4 stars. Performance was highest in the area of test result and data management (mean score 93%, SD 9.1). The least performance of the laboratories was on the laboratory biosafety and biosecurity (mean score 73%, SD 17.0) and Quality Control and Assurance (mean score 71%, SD 15.0). There is need for laboratories to commit their resources to quality assurance programs and training of laboratory personnel in biosafety and biosecurity as part of continuous quality improvement.

Implementation of COVID-19 Laboratory Testing Certification Program (CoLTeP) in African Region.

Objectives: Coronavirus disease 2019 was declared a global pandemic in March 2020 with correct and early detection of cases using laboratory testing central to the response. Hence, the establishment of quality management systems and monitoring their implementation are critical. This study describes the experience of implementing the COVID-19 Laboratory Testing and Certification Program (CoLTeP) in Africa. Methods: Private and public laboratories conducting SARS-CoV-2 testing using polymerase chain reaction were enrolled and assessed for quality and safety using the CoLTeP checklists. Results: A total of 84 laboratories from 7 countries were assessed between April 2021 to December 2021 with 52% of these from the private sector. Among them, 64% attained 5 stars and were certified. Section 4 had the highest average score of 92% and the lowest of 78% in Section 3. Also, 82% of non-conformities (NCs) were related to sample collection, transportation, and risk assessments. Non-availability, inconsistency in performing, recording, instituting corrective actions for failed internal and external quality controls were among major NCs reported. Conclusions: Laboratories identified for SARS-CoV-2 testing by public and private institutions mostly met the requirements for quality and safe testing as measured by the CoLTeP checklist.