CAP Standards and Experience in Building a Laboratory

Quality Management - The Foundation for Accurate Testing
Quality management in medical testing plays an essential role in ensuring accurate results for patients. This process not only guarantees the output quality but also includes a strict control and processing system from sample collection, preservation, analysis, to result reporting and consultation. In genetic testing, the importance of quality management becomes even more vital. Prof. Dr. Tran Duc Phan - Chairman of the Vietnam Society of Medical Genetics shared: “This is a field where even a small mistake in the process can lead to serious consequences, not just for the individual patient but also for their family. Unlike other tests that can vary depending on physical condition or timing, genetic information is immutable—meaning a wrong result can lead to a cascade of errors in consultation, diagnosis, or future treatment directions. Therefore, building a comprehensive quality management system not only helps minimize errors but also lays the foundation to build trust between the laboratory, treating doctors, and patients. A laboratory system controlled from input to output ensures accuracy, consistency, and traceability. These are core factors to support effective treatment and ensure patient safety.”

The Role and Benefits of CAP Standards
Among the quality management systems currently applied, CAP standards stand out due to their level of detail and depth, especially in genetics and molecular biology. Established and managed by the College of American Pathologists (USA), CAP is recognized as one of the strictest standards today, requiring synchronized control of equipment, operational processes, personnel capacity, and result quality. Dr. Pham Dinh Minh (Director of R&D at GENTIS - one of the genetic testing units certified by CAP) shared: “CAP standards not only focus on technical criteria but also require laboratories to build an effective internal quality control system (IQCP) and regularly participate in external quality control with international organizations. For genetic tests, this standard covers every stage: from sample collection and quality control to analysis, interpretation, and clinical reporting. These are essential requirements for genetic testing, where accuracy must be maintained absolutely and results need to reach the highest reliability. Achieving CAP certification means the laboratory can provide internationally recognized results, accepted in countries that apply equivalent standards. This not only enhances professional credibility but also expands the opportunities for international collaboration, sample exchange, and data sharing with foreign healthcare entities.”

The Journey of Building and Achieving CAP Certification
Sharing about the process of achieving CAP certification, Dr. Minh mentioned that it was not an easy journey. In Vietnam, several units have pioneered pursuing this standard and achieved impressive results after a preparation period of more than 18 months. During this period, laboratories had to re-establish their entire internal control process according to the IQCP model and participate in regular external quality control as per CAP’s prescribed frequency. All operational processes, technical documentation, and test data had to be standardized according to CAP requirements. It wasn’t just about investing in equipment and infrastructure; the key factor in this journey was the people. CAP requires laboratories to have a highly skilled workforce, especially genetic counselors and genetic doctors who can analyze data and provide accurate advice to treating doctors. Additionally, since the entire system works and communicates with CAP using specialized English, language proficiency became a significant obstacle, requiring key personnel to receive proper training and continuously update their knowledge - Dr. Pham Dinh Minh shared his practical experiences in GENTIS’s journey to CAP certification. The final result was an internationally certified testing system with tight risk control, efficient operation, transparency, and readiness to integrate into the global healthcare ecosystem. “After achieving CAP certification, GENTIS has had the opportunity to work with other CAP-certified laboratories from Japan, Singapore, and Malaysia. This expands collaboration opportunities and enhances Vietnam’s position on the regional and global map,” Dr. Minh shared.

What Benefits Do Partners and Clients Gain?
CAP standards create practical and direct value for stakeholders, especially clinical doctors, patients, and domestic and international medical partners. Prof. Dr. Tran Duc Phan shared: “For doctors, CAP provides trust in the test results—a crucial foundation for making accurate treatment decisions, personalizing protocols, and shortening the diagnosis time. When the results are highly reliable, doctors will reduce the need for retesting, saving time and costs for patients. For service users, being tested in a CAP-certified laboratory means they are accessing a standardized, reliable testing system with international compatibility. This is particularly meaningful for patients planning treatment abroad, as results from CAP-certified laboratories are often accepted in many countries without the need to retest. Furthermore, high quality also means a reduced risk of treatment errors, minimized additional costs, and enhanced peace of mind throughout the healthcare process.” In addition to doctors and patients, partners collaborating with CAP-certified laboratories also benefit: “For partners, collaborating with a CAP-certified laboratory like GENTIS opens up the possibility of data exchange, sample sharing, conducting clinical research, or providing testing services according to international standards,” Dr. Pham Dinh Minh added.

CAP standards are not only a quality evaluation system but also a strategic tool that enhances professional reputation, expands international collaboration opportunities, and—most importantly—creates real value for patients, doctors, and the entire healthcare system. In the current trend of integration and precision medicine, building a CAP-certified laboratory is a significant step forward, affirming the position of Vietnamese healthcare on the international stage.