Setting the foundations for quality diagnostics in Cambodian laboratories
Quality management systems are the invisible backbone of high-performing laboratories and a prerequisite for international accreditation. In Cambodia, national mentors are supporting laboratory teams to implement such systems, with encouraging results.
The radar for an effective health system
Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization, once said that access to quality tests and laboratory services ‘is like having a good radar system that gets you where you need to go. Without it, you’re flying blind.’ At the Kratié Provincial Referral Hospital, in northeastern Cambodia, the person in charge of this ‘radar system’ is Mr Hay Lor, the manager of the hospital’s clinical laboratory.
In a typical week, his 14-person team performs more than 1600 diagnostic tests – ranging from full blood counts to urine analyses and tests for tuberculosis and hepatitis – to support doctors in making treatment decisions for the patients in their care. It is Hay Lor’s job to ensure that the laboratory provides accurate, reliable and timely results – and for this, he needs a strong Laboratory Quality Management System (LQMS). An LQMS can be understood as a set of coordinated, routine activities for checking that every step of complex laboratory processes, from sample collection to documentation of test results, is carried out correctly.
Since early 2022 the Kratié Provincial Referral Hospital has been participating in a project, supported by the German Federal Ministry for Economic Cooperation and Development (BMZ), which aims to develop the capacity of clinical laboratories to implement elements of LQMS in line with ISO 15189:2022, the international standard for quality and competence in medical laboratories. Hay Lor already sees clear benefits from the training and mentoring he and his colleagues have received – the laboratory’s performance, as measured by external assessors, has improved significantly – and he is committed to further institutionalising quality management as his lab works toward compliance with ISO standards. ‘LQMS helps me to answer the questions I am always asking: “Where does my laboratory stand? And what else can be improved?”’
Significant advances in Cambodia’s labs, but quality management systems remain underdeveloped
Cambodia’s network of medical laboratories, which is overseen by the Ministry of Health’s Bureau of Medical Laboratory Services (BMLS), has seen significant progress in recent decades as part of reforms to the country’s public health system. The Government of Cambodia and its partners have upgraded provincial laboratories, such as the one in Kratié, with the equipment needed to perform many essential diagnostic tests. Laboratory technicians have had opportunities to hone their diagnostic skills through on-the-job training and coaching.
Despite these advances, external assessments of the laboratory system have revealed gaps in laboratory quality management systems and in the reliability of diagnostics. This has worrisome implications for the quality of care being provided to patients, as well as for the capacity of laboratories to detect and respond to disease outbreaks. Thus far, only three laboratories in Cambodia – the Angkor Hospital for Children, the Institut Pasteur du Cambodge and the National Institute for Public Health – have attained accreditation under ISO 15189, i.e. have been found via a process of external assessment to adhere to internationally recognised standards. In neighbouring Viet Nam, by contrast, more than 100 laboratories have already achieved this designation.
After investing €2 million in equipment and technology for Cambodian public laboratories during the COVID-19 pandemic, German development cooperation is now supporting the Bureau of Medical Laboratory Services to continue strengthening the routine work of laboratory teams both technically and organisationally. ‘What goes on behind the scenes in laboratories is incredibly important,’ says Franziska Fürst, a team leader with the Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ), which works in Cambodia on behalf of BMZ. ‘Without strong internal management systems, it is difficult to ensure laboratory results which patients and doctors can trust.’
Twelve laboratories, twelve LQMS building blocks
The current project is far from the first to focus on quality management systems in Cambodia, but it is distinctive for its emphasis on collaborative learning. The strategy is to bring teams from 12 laboratories with different levels of LQMS capacity together so that they can learn from one another’s experiences, as well as from quality management experts.
Over the course of 2,5 years, representatives of the participating laboratories attend regional training workshops, host groups of mentors in their own laboratories, and visit other labs to see how they organise their work. These three learning ‘touch points’ are repeated multiple times, with each cycle focusing on one or more of the 12 building blocks of LQMS (see Figure 1).
As part of the project, the participating laboratories develop and implement action plans to improve those quality building blocks which were identified as weak during the baseline assessment. During mentoring visits, three- to four-person mentoring teams – including an observer from another participating laboratory – review their progress, provide feedback and guide them on next steps.
‘Quality management systems cannot be a “cut and paste” from one setting to another,’ says Vivian Fensham, a microbiologist and quality expert with m4h/IQLS who is leading the project activities on behalf of GIZ. Each of the 12 quality elements needs to be ‘unpacked’, understood and adapted to the specific situation of the individual laboratory. ‘By creating space for mentoring and emphasising teamwork, we are trying to build a sense ownership around LQMS that will continue long after this project is over,’ she says
A dynamic combination of learning formats
Hay Lor, the laboratory manager from Kratié Provincial Referral Hospital, has appreciated the combination of expert input, team-based practical work and individualised support from mentors. ‘We have gotten a lot of knowledge from experienced trainers at the regional meetings, and the chance to share experiences and advice with other labs has also been positive,’ he explains. ‘I am also very satisfied with the mentoring, because this allows our laboratory staff to see where there are actual gaps in real-life scenarios, and to fix the problem or take corrective action,’ Hay Lor adds.
‘We see that people enjoy this type of learning and find it more attractive than standard training approaches,’ says Sophat Sek, a technical advisor with the GIZ-implemented Improving Social Protection and Health project. Working in this way not only strengthens horizontal connections between public laboratories, he points out, but also helps to create national pools of experienced mentors and laboratory assessors which the laboratory system can draw upon in the future.
For the mentors, too, the experience brings many benefits. Seng Somanich, an assistant quality officer at the Takeo Provincial Referral Hospital, is one of a handful of laboratory experts who have been selected and trained as mentors under the auspices of the project. She finds the role personally and professionally rewarding: ‘I think if one has learned to do something, it’s important to share it with others so that they benefit, as well,’ she says. ‘If I visit a lab and see that their document management has improved a lot since my previous visit, I feel that I’ve done something positive.’
Mentoring is also exposing her to new ideas and ways of working which she is able to apply in her own laboratory. ‘I’ve begun introducing LQMS concepts into the internal training sessions I lead every Friday for my colleagues,’ Seng Somanich explains.
External assessments show progress – with significant improvements in some labs
‘The activities supported by this project have brought substantial value to the routine work of the participating laboratories,’ says Dr Sau Sokunna, the Deputy Director of Hospital Services at the Ministry of Health, responsible for the Bureau of Medical and Laboratory Services. ‘The focus on quality management systems is enhancing the overall credibility and trust in laboratory services among both healthcare providers and patients.’
That progress is being made is evident in the results of a midline assessment which the project team undertook in early 2024 to monitor the implementation of six of the twelve quality building blocks. A group of international laboratory assessors led the review, joined by a select group of national assessors who had been newly trained by the project in auditing methods. While the results varied from lab to lab, there was an overall improvement in the scores of the 12 labs, compared to a similar assessment undertaken at the start of the project.
The lab at Kratié Provincial Referral Hospital was one of the strongest performers, with significant improvements in scores in areas such as documents and records (from 61% to 93%), management reviews (29% to 93%), and identification of non-conformities (26% to 79%). ‘We see now that some aspects of our quality management systems in the past were not clear,’ says Hay Lor, the laboratory manager. ‘Our laboratory has changed a lot. We’ve introduced risk assessment, our documentation is better, and the Standard Operating Procedures we’ve developed are easier to use and of better quality.’
These improvements are not going unnoticed. Hay Lor is proud to see that satisfaction with the work of the laboratory has been increasing year on year, as shown in the results of an annual satisfaction survey the laboratory conducts with doctors at the hospital.
Quality management systems are key for pandemic preparedness
The COVID-19 pandemic demonstrated the importance of having reliable and efficient laboratory services in place when a health crisis emerges. Investments in laboratory quality management systems not only improve the accuracy and timeliness of routine diagnostic testing, but also strengthen defenses against future disease outbreaks or pandemics. With its focus on continuous quality improvement, the current project is contributing to a resilient laboratory network in Cambodia that will be better equipped to respond swiftly and effectively to future health threats.
When the project ends later this year, it will leave behind a core group of laboratories which have been introduced to the LQMS ‘scaffolding’ and sensitised to the importance of teamwork in implementing each of its building blocks. ‘The laboratory managers and teams involved with the project have understood the importance of LQMS and are committed to its implementation,’ says Sophat Sek of GIZ. The pools of experienced mentors and laboratory assessors which have been created as part of this project can serve as important resources as Cambodian labs continue their quality management journeys. ‘We will use their expertise to support laboratories to achieve and maintain national and international standards,’ says Dr Sau Sokunna.
Karen Birdsall
July 2024