Establishing Excellence in Quality with KFI’s Clinical Pathology Lab

kfi labMy Study Directors love me. Why? Because I am the source of much of their laboratory study data. At any time they can simply walk down the hall, watch their samples being analyzed, and talk to me directly. At Kingfisher International Inc. we live by a single point of control philosophy. Our Study Directors are the control point – among other things, they are responsible for overseeing the collection of data and relaying it to the study Sponsors. Since keeping the Sponsors informed is essential for the smooth progression of a study, we strive to provide them with clinical pathology data that is as accurate as it is efficient. That’s where I come in!

The clinical pathology lab at KFI is pivotal in producing quality data. It is equipped with analyzers for hematology, clinical chemistry, coagulation, and urinalysis; everything we need to carry out most of the analyses required during a study. We also validate our analyzers to GLP standards in-house, which gives us complete control over the quality of data we produce.One of the greatest benefits of our in-house laboratory is the ability to generate our own reference ranges based on historical data. Since our reference ranges are generated from animals that are sourced from the same suppliers and housed and fed under our standard conditions, they are directly applicable to our studies. These normal ranges are specific to the species, breed, and age of the animals we house. What is considered normal for an 11 month-old Beagle may not be considered normal to a commercial laboratory that may generate their ranges from dogs of all breeds, ages, and lifestyles. Our tighter, specialized frame of reference gives us the confidence to clearly identify abnormalities without questioning the quality of our data.
Maintaining consistent sample temperature and minimizing time between collection and analysis is paramount for the quality of clinical pathology data. Externally shipping samples typically requires at least 24 hours, tight temperature controls, and may result in samples being subjected to storage fluctuations outside of our control. Not only does shipping take valuable time, but it also creates concern for sample stability. We have found that some analytes show degradation in as little as 6 hours.  By the time the samples are received and processed the results could be questionable and could therefore impede upon the final outcome of a study. KFI maintains a controlled environment which ensures that samples remain at a consistent temperature and are analyzed efficiently within their stability timeframe.While KFI takes every measure to ensure each study starts and completes on time without compromise, things don’t always go as planned. In the event of an individual showing clinical signs of illness, we can immediately produce clinical pathology data and concurrently communicate with the Study Director and Sponsor. We can keep everyone informed in real-time while the study moves forward, reducing the risk of losing statistical power, minimizing deviations and maintaining data integrity.
Above all though, KFI strives to maintain the integrity and quality of our Sponsors’ studies and all data produced. Our clinical pathology laboratory is central to achieving our goal by allowing for the immediate, validated analysis of all samples. Our Sponsors can feel assured that we will produce consistent, high quality results in all aspects of their studies each and every time.

Robyn Nicholls, BSc is a Laboratory Technician at Kingfisher International Inc.