Laboratory mentoring for quality systems implementation under the Better Labs for Better Health initiative: activities from January–April 2017

A key method for effective and efficient strengthening of medical laboratories is the implementation of a laboratory quality management system (LQMS) based on the international quality standard ISO 15189:2012. In 2014, WHO launched a web-based tool that guides laboratories through the practical day-to-day implementation of an LQMS: the Laboratory Quality Stepwise Implementation (LQSI) tool.

Even though the use of the LQSI tool minimizes the need for external assistance in the implementation process, regular mentoring remains crucial. During these mentoring visits the mentors can answer questions, help to develop action plans to overcome obstacles, perform external audits and provide training.

WHO expanded LQMS mentoring activities in 2017 to include 2 new laboratories, bringing the total number being mentored to 9. Below is a summary of activities that took place in January–April 2017.

January

• A second visit was conducted to the Virology Laboratory of Mater Dei Hospital in Msida, Malta. The laboratory staff and external staff were trained on several topics, including nonconformities, root cause analysis and the basics of internal auditing. They identified and discussed challenges, many of which related to the fact that some changes have to be discussed with the unions before they can be officially implemented, and to the lack of a quality manager for coordination.
• A visit was also conducted the Department of Zoonoses and Influenza at the State Research Centre of Virology and Biotechnology VECTOR in Koltsovo, Novosibirsk Region, Russian Federation, for the third time. Since the previous visit, department staff had successfully completed WHO training in LQMS, conducted a course in English for personnel and trained a representative in biomaterials shipment.
• A first visit was conducted to the National Public Health Surveillance Laboratory Clinical Testing Department in Vilnius, Lithuania. The overall mentoring programme, including goals and expectations, was explained and discussed with the staff and directors. The virology, microbiology, serology and molecular biology sections of the laboratory were also assessed, and training in quality management systems was provided to the staff.

February

• A first full visit was conducted to the Virology Reference Laboratory at the Centre of Public Health and Nutrition in Ashgabat, Turkmenistan. The laboratory was assessed in detail, existing standard operating procedure documents were evaluated, and staff were trained in LQMS. A mentoring plan was also developed.
• A fifth visit was also made to the National Influenza Centre in St Petersburg, Russian Federation. Mentoring activities included reviewing prepared documents, drafting new documents, providing training in internal auditing and discussing future activities.

March

• A fourth visit was conducted to the Bacteriology Laboratory at the Republican Center of Quarantine and Especially Dangerous Infections in Bishkek, Kyrgyzstan. Among other activities, participants continued the training programme on internal auditing, corrective and preventive actions, and method validation. With the assistance of trainee internal auditors, 2 internal audits were conducted for methods at all stages: pre-examination, analytical, and post-examination. The specialists received training in how to plan an audit, formulate nonconformities, and draw up an audit report.
• Second visits were made to both the Virology Laboratory of the Tajik Research Institute of Preventive Medicine and the National Public Health Laboratory in Dushanbe, Tajikistan. Staff confirmed their commitment to the implementation of LQMS, and showed that they had completed the majority of action points defined during the initial mentoring visit. The second visit involved further work to expand the understanding, adoption and implementation of the principles of LQMS in the laboratory.

April

• During the fourth mentoring visit to the Clinical Diagnostic Laboratory at the Republican Diagnostic Centre in Bishkek, Kyrgyzstan, staff demonstrated that the laboratory facilities were gradually being renovated and computerization was being implemented. They also organized training in computer skills and began their training as internal auditors.

Funding for visits to the WHO-recognized national influenza centres in Malta and the Russian Federation, and to the WHO H5 reference laboratory at VECTOR, was provided by the Pandemic Influenza Preparedness Framework Partnership Contribution. Visits to the laboratories in Kyrgyzstan, Tajikistan and Turkmenistan were supported by the European Union (European Commission’s Directorate-General for International Cooperation and Development) as part of the project on strengthening health laboratories to minimize potential biological risks (contract IFS/2013/332312).