Managing quality control in point-of-care testing
16 Apr 2015
As breakthroughs in medical diagnostics bring earlier and more accurate diagnosis, we’re seeing patients benefiting from faster access to treatment, says Randox quality control manager David Hunter.
There can be but a few industries that are evolving just as quickly as the clinical diagnostics market.
Traditionally, the majority of medical diagnostic tests were conducted in the clinical laboratory where procedures and protocols were under the watchful eye of the laboratory manager.
However, as technology progresses and scientific advancements are made, we are now seeing an increasing amount of patient testing being carried out at the bedside or at the point of care (POC).
“Review the marketplace to ensure you find a platform to suit your laboratory’s needs
Randox QC manager David Hunter
The benefits of POC testing are clear: convenience, ease of use and rapid results clearly enable faster medical diagnosis, meaning patients can potentially start receiving treatment sooner.
However, POC testing is only beneficial if the results being produced are accurate and reliable.
Internal quality control (IQC) exists to monitor precision during the analytical process. However, IQC in POC testing can be difficult to manage.
In the laboratory we would expect good quality control procedures to be well established.
Unfortunately, for most non-laboratorians conducting POC testing, quality control is unknown territory.
Ultimately, laboratory managers are responsible for managing IQC in the point of care setting.
However, many struggle to find effective IQC solutions that are suitable for multiple locations and operators unfamiliar with quality control.
Laboratory managers may find it difficult to monitor results in remote sites and across a variety of POC devices and users.
They may also struggle to ensure the process is both cost effective and efficient.
How, therefore, can laboratory managers ensure adequate quality control is being carried out in POC settings and how can they monitor results and assess the effectiveness of the analytical process?
Online data management software can provide a good solution, helping overcome all of the above issues by facilitating the monitoring of POC results anywhere that internet access is available, at any time.
Every POC device throughout the clinical setting should be registered on the data management platform.
Results can be entered in a variety of ways: on PCs, laptops, tablets or smartphones, and once this is done, the software will automatically accept or reject the results based on the performance of the control.
This offers POC users a simple and effective way to ensure that their POC device is ’in control’ and that the results produced are reliable.
Furthermore, results from multiple analysers are stored together in the software making it convenient for lab managers to review results.
Just by logging onto the software, the laboratory manager can review and compare results from all POC devices around the hospital or even across multiple sites.
This provides a lab manager with a comprehensive overview of test performance across the entire clinical setting, without even having to leave their desk.
This gives a long term view of how each device is performing, helping lab managers to identify any maintenance issues or training needs of the operators.
Some of the available online data management platforms offer different levels of user access.
This means that POC device operators will have their own unique log-in ID and can have restricted access to the software’s functionality.
For example, users can only enter results, not edit or delete them. This enables lab managers to track individual users, helping to identify operators who perhaps need more training or support in carrying out POC medical tests.
Many of the software packages available will calculate internal statistics such as the mean and CV, displaying graphs showing trends in IQC data.
In addition, a peer-group functionality gives the laboratory visibility of results produced by other users globally using the same POC devices.
The cost effectiveness and efficiency of monitoring POC devices using online software is perhaps the most important benefit as some software providers offer unlimited multiple instrument registrations free of charge.
This means that a laboratory can register all of their POC devices on one licence.
With the right online data-management system in place ensuring effective monitoring of internal quality control, both in and out of the laboratory, could get a whole lot easier.
Review the marketplace to ensure you find a platform to suit your laboratory’s needs.
David Hunter is a quality control global business manager at clinical diagnostics firm Randox.