ADLM workshops in Mongolia expand from quality control to regulatory guidance

ADLM began working in Mongolia in 2023 to expand the reach of the Global Lab Quality Initiative, funded by the Wallace H. Coulter Foundation. The workshop covered the selection of quality-control procedures and the recognition and mitigation of risks throughout the total testing process.

ADLM Asia-Pacific Subcommittee members Anu Maharjan, PhD, MD, Qing Meng, PhD, MD, Robert Rej, PhD, and Victoria Zhang, MBA, PhD, focused their presentations on using quality control to add value to patient care. The speakers also asked participants about quality-control practices in Mongolia, prompting an extended discussion. All presentations focused on statistical concepts as requested by the Mongolian Association of Health Laboratorians (MAHL). 

The workshop was originally scheduled for 2020 but was postponed because of the COVID-19 pandemic. During the postponement, ADLM and the Mongolian Association of Health Laboratorians (MAHL) refined the workshop topics. Zhang presented the basic principles and concepts of quality control and quality assurance, which provided a foundation for subsequent presentations on quality monitoring, including practical exercises in statistical quality control applications. Meng further discussed the selection of quality control procedures and the laboratory accreditation system in the United States. Rej presented on establishing quality control and external quality assurance programs, along with the associated statistical concepts. Dr. Maharjan presented troubleshooting and corrective actions for quality failures, as well as a risk-based approach for quality control. 

In 2026, three speakers from the earlier workshop returned with Barbara Goldsmith, PhD. The Mongolian Ministry of Health had broadened the scope of the discussion to national laboratory governance and public health infrastructure, including elements modeled on the U.S. Centers for Disease Control and Prevention. In April, the Mongolian Ministry of Health invited ADLM to conduct a workshop on approaches to establishing a national laboratory regulatory body.

Ministry representatives identified the topics on which they wanted perspectives from ADLM speakers, including national laboratory functions, standardization, and harmonization. Speakers from the MoH presented their current laboratory system and shared their vision of nationwide standardization and harmonization. One of the major topics of discussion was the role of the national laboratory as a reference laboratory for testing samples from different provinces and territories. Additional discussions addressed resource availability and the challenges of achieving standardization, including the harmonization of reference intervals across different instruments and diverse population groups. 

ADLM speakers presented approaches to establishing and implementing laboratory systems and practices. Zhang discussed clinical laboratory regulations and governance structures in the United States, which connected to her additional presentations on laboratory information systems, digital integration, and the regulation of medical devices and in vitro diagnostics (IVDs). Rej discussed how national laboratory services can organize the relationship between public health and hospital laboratories, a priority as the ministry considered elements of the CDC model. Goldsmith discussed quality systems and the harmonization of laboratory testing. Maharjan further discussed the “how” of validation, verification, and addressed how to structure and organize a point of care testing program. 

The ADLM workshops of 2023 and 2026 in Mongolia reflect a growing partnership dedicated to patient care through stronger laboratory quality, standardization, and public health infrastructure. What began as a workshop in laboratory quality control and risk management evolved into broader conversations on laboratory governance, harmonization, and the development of a centralized laboratory system across Mongolia. Through knowledge sharing, ADLM members provided practical approaches on quality systems, regulation, validation, accreditation, and laboratory infrastructure builds. As Mongolia advances its journey toward national laboratory guidance, continued collaboration and exchange of expertise will be a key to building a high-quality and sustainable laboratory system in Mongolia that supports both patient care and public health.