Everything we do is driven by quality. Our teams at Thermo Fisher Scientific™ Microbiology strive to deliver accurate and dependable results for our customers on a daily basis. By maintaining uncompromised reliability of our product performance, we hope to protect the level of support you offer to your patients as laboratory personnel and health care professionals.
World Quality Day on November 12th, 2020 is designed to recognise the contributions of professionals worldwide and celebrate excellence in the quality sector, it’s a reminder for us all to keep on pushing to deliver the best possible standard of products.
Thermo Scientific™ Sensititre™ Systems for AST solutions are designed and developed for optimum efficiency. Their performance is maintained by our overall Quality Control Plan (QCP) to ensure AST products support delivering reliable results from patient samples. Adherence to the QCP maintains the required focus on good manufacturing practices and ensures the utmost integrity of products.
Sensititre™ System and Thermo Scientific™ Oxoid™ Antimicrobial Susceptibility Discs manufacturing sites both operate under stringent quality standards such as ISO 13485:2016 & MDSAP and ISO9001 (manufacturing site for discs products) & FDA 21 CFR Part 820 (manufacturing site for Sensititre products) fulfilling the quality requirements for development, manufacture and distribution of IVD testing systems.
As an example, at our Sensititre plate manufacturing facility a new antimicrobial compound is tested for both potency and solubility upon receipt. Following this, on every subsequent day that this antimicrobial is used in a manufacturing process, antimicrobial stock suspensions are freshly prepared and further diluted into working solutions. To avoid human error impacting the final product, each step is checked by two lab technicians, and as an additional auditing mechanism, part of the process is tracked via camera. Captured video footage offers the option for relevant individuals in the manufacturing team to confirm that any given procedure was followed correctly. Video footage has an additional benefit of offering excellent options to train and re-train new or existing staff, respectively. Each and every broth microdilution plate aliquoted with antibiotics also receives a visual check after dosing, in order to ensure liquid is being dispensed correctly into each well.
Finished products are inspected for accurate packaging & labelling and of course, for product performance. Performance testing for broth microdilution plates and antibiotic disks is completed by utilising a wide range of well characterised, known QC organisms approved by CLSI1 and EUCAST2 in addition to some in-house strains. Each individual Sensititre plate format can have up to 14 QC organisms tested, with up to as many as five replicates per plate, and all results must show an MIC within the defined QC range before product can be released. Additional QC testing methodology such as Radial Diffusion Assays can also be used to assess the potency of the antimicrobic within a given well. All plates undergo the same intensity of testing regardless of whether they will be used as Research Use Only, Veterinary Use or In-vitro Diagnostic Use, ensuring our commitment to product integrity and performance. With Oxoid disc quality testing the antimicrobial concentration is checked by plate assay or HPLC as well as for antibiotic and microbial contamination.
We understand the complexities when seeking exact answers. Regardless of the AST system used each lab requires quality control organisms to ensure patient sample results can be trusted. At Thermo Fisher Scientific we rely on our Thermo Scientific™ Culti-Loops™ quality control products:
Strictly adhering to medical and scientific guidelines ensures AST processes are accurate, reliable and timely.
QC is a critical component of a Quality Control Plan to ensure reliable patient results. When AST is not performed correctly, test results may lead to incorrect patient treatment, invalid surveillance data or inaccurate research data
QC is part of the bigger picture – the overall Quality Control Plan is made up of several elements including monitoring, corrective action, calibration, record-keeping and competency assessment. They all work together to strengthen efficiency, but QC is the backbone of the QCP.
Man and machine
QC assess people as well as processes, meaning lab personnel are reviewed to ensure their jobs are being carried out to optimum efficiency, as well as the processes they are using.
Quality Control = Quality of life
Putting aside the scientific elements of QC and doing a good job simply demonstrates that an individual cares. Our industry is geared towards improving people’s quality of life, so it’s natural that we’d put every effort into ensuring maximum quality and settling for nothing less.
We welcome the next incoming World Quality Day, and look forward to learning more from those that drive the event. Coronavirus has presented so many obstacles this year, so reading about progress and forward-thinking ideas will be a great source of hope and inspiration. In terms of our commitment, every day at Thermo Fisher Scientific is a Quality Day as we strive for accuracy, reliability and precision in all that we do.
1. CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 30th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2020
2. The European Committee on Antimicrobial Susceptibility Testing. Routine and extended internal quality control for MIC determination and disk diffusion as recommended by EUCAST. Version 10.0, 2020. http://www.eucast.org.
3. Karatuna, O. 2012. Quality Assurance in Antimicrobial Susceptibility Testing https://www.intechopen.com/books/latest-research-into-quality-control/quality-assurance-in-antimicrobial-susceptibility-testing
4. Antimicrobial Susceptibility Test (AST) Systems - Class II Special Controls Guidance for Industry and FDA, 2007 https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/antimicrobial-susceptibility-test-ast-systems-class-ii-special-controls-guidance-industry-and-fda