The unsung heroes of healthcare: Ensuring quality in diagnostic laboratories
As part of Lab Week, Eslam Darwish shares how teamwork, innovation, and rigorous quality control drive excellence in laboratory diagnostics and patient care
22 Apr 2025
Eslam Darwish, QA Quality Assurance Supervisor at Haven Scientific
As part of Lab Week, our Lab4Life feature hosts a special series highlighting the inspiring journeys of scientists dedicated to clinical science and global health. In this guest blog, Eslam Darwish, Quality Assurance and Quality Control Manager at Haven Scientific, a company located at King Abdullah University of Science and Technology (KAUST) in Jeddah, discusses the importance of quality management in diagnostic labs, and how teamwork and collaboration drive advancements in healthcare.
Introduction
Medical laboratories are the backbone of modern healthcare, providing critical data that influences patient treatment and public health decisions. As a Quality Assurance Supervisor at Haven Scientific, I have witnessed firsthand how rigorous quality management in diagnostic labs ensures accurate, reliable, and timely test results. I am responsible for quality control and implementing the quality system for the production of PCR diagnostic tests.
In an era where precision in medical diagnostics can mean the difference between early disease detection and delayed treatment, laboratory professionals play a vital yet often unseen role. Our work extends beyond running tests — it involves meticulous adherence to regulatory standards, process optimization, and continuous innovation to uphold the highest levels of accuracy and patient safety.
Teamwork and collaboration: The key to laboratory excellence
Ensuring quality in a diagnostic laboratory is not a one-person job; it requires seamless collaboration among quality assurance, quality control, R&D, and regulatory teams. At Haven Scientific, we manufacture IVD PCR detection kits, which undergo extensive testing and validation before they reach healthcare providers.
One example of teamwork in action was during the validation of our SARS-CoV-2 qPCR Detection Assay. Our team worked closely with National Guard Health Affairs laboratories to conduct clinical evaluations, ensuring our kits met both SFDA and ISO 13485 standards. Through continuous feedback loops and rigorous quality assessments, we refined our processes to enhance sensitivity, specificity, and reproducibility — ultimately delivering a diagnostic tool that clinicians could trust.
Challenges and triumphs in the lab
One of the biggest challenges in laboratory diagnostics is balancing regulatory compliance with innovation. As we develop new reagents and testing methods, we must ensure they align with SFDA, ISO, and GMP standards. Additionally, supply chain disruptions pose significant hurdles in maintaining a steady flow of high-quality raw materials for reagent production.
A major achievement in our lab was implementing a quality risk management system that proactively identifies potential failure points in testing workflows. By integrating AI-driven data analysis, we improved our quality control processes, reducing variability and enhancing overall lab efficiency.
Spotlight on a mentor
Throughout my career, I have been fortunate to work alongside professionals who have shaped my approach to quality management. One mentor who stands out is Dr. Mazin Zamzami, whose expertise in regulatory affairs and laboratory accreditation reinforced the importance of documentation, traceability, and continuous improvement. Their guidance has been instrumental in helping me navigate complex compliance landscapes and drive quality excellence in diagnostic manufacturing.
Impact on healthcare
Every quality control measure we implement has a direct impact on patient care. Reliable diagnostic tests lead to accurate diagnoses, appropriate treatments, and better patient outcomes. In the case of infectious diseases like COVID-19, high-quality PCR testing has been essential in controlling outbreaks and guiding public health responses.
At Haven Scientific, our commitment to rigorous quality assurance, precision testing, and regulatory compliance ensures that every diagnostic product we manufacture meets the highest standards. This dedication contributes to enhanced patient safety and greater confidence in medical testing worldwide.
Future outlook
Looking ahead, the future of laboratory diagnostics will be shaped by AI, automation, and digital quality management systems. The integration of machine learning in quality control will allow for predictive analytics, reducing errors and improving overall lab efficiency. Additionally, advancements in IoT-enabled lab equipment will revolutionize real-time monitoring and compliance tracking.
As we celebrate Medical Laboratory Professionals Week, I want to recognize the dedication of laboratory scientists and quality professionals worldwide. Our work may often be behind the scenes, but its impact is undeniable—we are the silent guardians of healthcare, ensuring every test result is one that clinicians and patients can trust.