Kenya’s National Public Health Laboratory (NPHL) has launched new guidelines to enhance the provision of accurate and reliable laboratory diagnosis to enhance effective patient treatment, management, and disease surveillance. Kenya’s Medical Laboratory Continuous Quality Improvement (LCQI) Guidelines (2022) aim to ensure standardized processes for implementing laboratory-level quality systems improvement while using CQI tools to implement monitoring and corrective action. This underscores the need for laboratory accreditation to ensure quality, patient safety, compliance with regulations, international recognition in advancing healthcare standards and delivering reliable diagnostic services.
Speaking during the launch, Dr Kamene Kimenye, Head of, the Directorate of Public Health and Sanitation and the Director of the National Public Health Institute, highlighted that “Accredited laboratories not only provide enhanced competency for laboratory staff but also deliver timely testing services to address current and emerging health threats. While Kenya has made significant strides in implementing Laboratory Quality Management Systems (QMS), leading to ISO 15189 accreditation for over 100 laboratories, accreditation is an ongoing process that requires continuous quality improvement (CQI) strategies at the laboratory level,” she said.
The LCQI Guidelines will offer a framework to guide laboratories in implementing CQI across the quality system essentials (QSEs) to achieve and maintain international accreditation, such as ISO 15189. By employing LCQI guidelines, laboratories will ensure adherence to accreditation requirements and consistently deliver timely, accurate, reliable, and reproducible results for patient care.
“To support the monitoring and evaluation of QMS improvements, standardized CQI tools play a vital role in enabling laboratories to assess their progress and identify areas for further improvement. Recognizing that not all laboratories may achieve ISO 15189 accreditation due to cost constraints, the LCQI Guidelines will offer a practical solution. Laboratories, both accredited and non-accredited, can routinely implement LCQI across the testing cycle to ensure the delivery of timely, accurate, reliable, and reproducible results for patient care” Noel Odhiambo – Senior Technical Advisor – SLQS Project
During the event, the Post-Market Surveillance for In-Vitro Diagnostics was also launched. According to WHO, Post-market surveillance aims to safeguard individual and public health by continually monitoring in-vitro diagnostic devices (IVDs) after they are released to the market, ensuring manufacturers fulfil their obligations, assess and mitigate risks, and maintain compliance with safety, quality, and performance requirements. “Post-market surveillance is a critical aspect of ensuring the ongoing safety and efficacy of in-vitro diagnostic devices and medical devices. To achieve patient-centred approaches to services, the laboratory and the clinical teams will need to reference these documents,” Dr Kamene said.
“By actively monitoring the performance of in-vitro diagnostic devices, post-market surveillance will enable the early detection of adverse events or safety concerns allowing for timely interventions and mitigating potential risks to patients and healthcare providers. It is important that health facilities have a roadmap towards accreditation to achieve all this.” reiterated Dr Kamene.
According to Noel Odhiambo, the successful implementation of the LCQI Guidelines and post-market surveillance will heavily rely on collaboration among laboratories, regulatory bodies, manufacturers, and healthcare professionals to create a comprehensive ecosystem that fosters continuous improvement and upholds the highest standards of quality and safety in laboratory services.
In closing, Dr Ernest P Makokha from CDC Kenya encouraged Counties and Implementing Partners to adopt the new PEPFAR strategy, which is anchored on health systems strengthening and sustainability to overcome the challenges they face in achieving quality management systems in laboratory services.
This milestone has been made possible through collaborative efforts of the Ministry of Health Kenya, CDC Kenya, the Sustainable Laboratory Quality Systems (SLQS) project and other stakeholders. SLQS project support is coordinated at the national level in conjunction with the National Public Health Laboratories (NPHL) and cascaded to the health facility level by the County Health Management Teams and the lead Clinical Partners to ensure timely, efficient and reliable services for HIV/TB patients.
Article authored by Edna Musa, Communications Officer, Amref Health in Kenya