Strategic Framework for Strengthening Health Laboratory Services in the COVID-19 Pandemic in Iran.

Background & Objective: Providing equitable access to good quality, timely, and affordable laboratory testing has always been a top priority for the Ministry of Health and Medical Education (MoH-ME) and the Reference Health Laboratory (RHL). Considering the significant role of medical laboratories in disease surveillance, RHL developed a strategic plan to manage laboratory services during the COVID-19 pandemic based on the "Strategic Framework for strengthening health laboratory services, 2016-2020" proposed by the World Health Organization (WHO). This article describes the steps taken to establish the strategic framework in Iran. Methods: Firstly, a National Laboratory Committee was formed in MoH-ME and a situation analysis was conducted to explore the strengths, weaknesses, opportunities, and threats in different components of our laboratory system. Gaps and resources needed to address those gaps were determined; then, RHL outlined operational processes and mechanisms for monitoring the activities. Results: The WHO strategic roadmap and its six strategic goals concerning leadership, quality, human resources, safety and security, laboratory networking, and rational use of laboratory testing, helped us to promote national laboratory services in accordance with health system requirements in the COVID-19 pandemic. Conclusion: The establishment of a national molecular laboratory network with more than 500 laboratories from different sectors may result in timely access to countrywide laboratory services and would be beneficial for future COVID-19 and/or other viral outbreaks. Continual evaluation of the COVID-19 laboratories' performance, production of PCR test kits by the local manufacturers, and development of a platform for virtual training would be other accomplishments that Iran achieved in coping with the recent pandemic.

Establishment of national laboratory standards in public and private hospital laboratories.

In September 2007 national standard manual was finalized and officially announced as the minimal quality requirements for all medical laboratories in the country. Apart from auditing laboratories, Reference Health Laboratory has performed benchmarking auditing of medical laboratory network (surveys) in provinces. 12(th) benchmarks performed in Tehran and Alborz provinces, Iran in 2010 in three stages. We tried to compare different processes, their quality and accordance with national standard measures between public and private hospital laboratories. The assessment tool was a standardized checklist consists of 164 questions. Analyzing process show although in most cases implementing the standard requirements are more prominent in private laboratories, there is still a long way to complete fulfillment of requirements, and it takes a lot of effort. Differences between laboratories in public and private sectors especially in laboratory personnel and management process are significant. Probably lack of motivation, plays a key role in obtaining less desirable results in laboratories in public sectors.