Nine more Test types ISO 15189 accredited at FV Hospital

The Bureau of Accreditation (BoA) under the Ministry of Science and Technology Viet Nam (MOST) have conducted a quality assessment of the Laboratory and Blood Bank over two days, 26 – 27 November 2021. The focused assessment was mainly concerning biochemical and haematological tests, based on ISO 15189:2012 and ARLM 03:2020 standards.

Of the nine newly certified tests, there were five biochemical tests (including Cholesterol, HDL, LDL, Triglyceride) and four haematological tests (including WBC, RBC, HGB, PLT). Up to now, there are 16 tests accredited ISO 15189:2012 standard.

Although ISO 15189 has been adjusted to be appropriate with different countries, it is the official international standard for quality, competence, and professionalism for medical laboratories. In many countries, medical laboratories are only allowed to provide testing services after their services accredited with ISO 15189. Although it is not mandatory in Vietnam, FV wants that our doctors and patients will have a more solid foundation to confirm in the quality and capacity of our Laboratory & Blood Bank. The accuracy of test results has a great influence on the decisions made by doctors, and on the treatment delivered to our patients.

Accordingly, the Assessment Specialist Team of BoA confirmed that the Laboratory & Blood Bank Department at FV continues to maintain and follow the quality management system, in line with the requirements of the two accreditation standards ISO 15189:2012 and ARLM 03:2020. Staff at the Faculty are also professionally trained in their field. In addition, the equipment also meets the quality and requirements specified by the standard.

Mr Friend Maviza (Head of FV Laboratory & Blood Bank) said: “The assessment helps us confirm the commitments that the Laboratory & Blood Bank meet the quality and standards in medical tests. The review also highlights the value of teamwork in improving test quality. I am proud to be part of my team.” In addition, he believes that the support from other departments in the hospital is also a factor that brings success in the ISO standards assessment.

During the pandemic in recent years, the Ministry of Health has paid great attention to inspecting, supervising, and encouraging domestic medical laboratories to pursue quality standards, especially ISO 15189. This effort helps to improve the efficiency of medical examination and treatment. It is also the key to the prevention of the COVID-19 pandemic. Therefore, the Laboratory & Blood Bank strives to learn and maintain these quality criteria although it is not a mandatory requirement in Vietnam.

To maintain the quality, from the first ISO 15189 assessment, the Laboratory & Blood Bank put these criteria into daily practice. As a result, every employee is familiar with the practices of these standards in their daily tasks. Everyone is ready for the assessment. When the assessment team arrives, they simply demonstrate and explain their usual day-to-day work.

“Currently, we are the only laboratory in Vietnam operating at a JCI-certified hospital, and also accredited to ISO 15189 and Westgard Sigma VP certification. I am very glad that we are the first private laboratory to be allowed to confirm the results of COVID-19 by real-time PCR,” emphasised Mr Friend Maviza.

In addition to the strengths, the assessment specialists also made some recommendations for FV to further improve the testing stages. It is expected that in early 2022, these small notes will be implemented, bringing even better test quality to patients. The FV Laboratory & Blood Bank aims to maintain and promote the criteria of the accreditation they are recognised. Besides, the Laboratory hopes to expand to other tests and build a laboratory system at FV Saigon Clinic.