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The role of quality management

What is quality management and why it is important
How do you control the quality of the test at this scale, and how do you manage the lab information? And is this somehow standardised across all the national labs? Yeah. That’s a great question. It’s really important. We have a couple of advantages. One thing is that we do the same thing, one thing, all day. Every day. And so there’s very little diversity. This can creep in as maybe sort of boring at times, so you have to manage that and make sure that operators stay engaged so they don’t make mistakes. But what it means is training is simplified. All the SOPs are much easier to follow because there’s really only one path for anything to– any sample to go down.
But it is a very large organisation. There are lots of samples going through, and we have very little capability of planning what our day looks like. We get samples when we get samples because people put swabs in their nose. And so we had to build that in. That’s where the diversity comes rather than diversity of different sample types, for instance. So we have a very rigorous training programme. Everyone has to be qualified on the workstation that they belong.
People can get qualified on multiple workstations to add some diversity to their day-to-day work, as well as opportunities for advancement so people can become team leaders or work more on the Quality team or in the Data team, any sorts of things to advance their careers, as well as get a little extra stimulation and diversity. And then the quality system itself has to be as world-leading as the rest of our organisation. So when we set up the lab, we had to move very quickly. Fortunately, my business also has an ISO quality system, and we were able to just copy that over and then build from there so that we had the necessary tools to have the accreditation required for this.
But it’s a massive undertaking to make sure that these things are in place. And then we have to constantly monitor it to make sure that no problems sneak in and get out to patients. And so we have an entire team dedicated to a whole number of checks on a day-to-day, hour-to-hour basis, as well as management reviews over time, and make sure that there’s no changes in performance that would indicate a problem, even a very small problem. When you’re running at our scale, you can see very quickly. You can react and make sure that it gets fixed before it creeps into any impact to patients.

In this video Ana and Dr Harper VanSteenhouse talk about the quality control and standards that can be used across a national laboratory network.

To ensure that laboratories provide accurate and reliable results and reduce the risk of errors, implementing a Quality management system (QMS) is important. However, in resource-constrained settings, most laboratories are not accredited and may only be partially implementing elements of a QMS. Introducing a new test, particularly under outbreak conditions, may therefore come with a high risk of errors. This step describes the key critical elements that laboratories should put in place to ensure quality results, particularly during COVID-19.

Quality control (QC) is a mechanism that monitors the analytical performance of the test when used with or as part of a test system. It may monitor the entire test system or only one aspect of the test. QC validates the competency of testing laboratories by assessing sample quality and monitoring test procedures, test kits, and instruments against established criteria. It also includes the review of PCR results and documentation of the validity of testing methods. Hence, QC is a multi-step process with certain checkpoints throughout the testing process: pre-analytical, analytical, and post-analytical stages. In general, “QC should be performed regularly to detect, evaluate, and correct errors due to test system failure, environmental conditions, or operator performance before reporting test results.”

QCs that are commonly employed for PCR testing include extraction negative control (checks contamination at extraction phase), extraction positive control (checks extraction process-reagents and equipment functionality), non-template control (checks contamination at PCR phase), positive template control(s) (check (s) limit of detection and robustness of the assay). Commercial QCs for positive controls are preferred; however, laboratories can use patient samples with known viral RNA concentration, preferably samples with low cycling threshold (Ct) values (25–30) for the target sequences of SARS-CoV-2. Nuclease-free water or viral transport medium can be used as the negative control. QC failures, for example, when a positive control turns out negative or a negative control turns out positive, invalidates the test results. The test must be repeated either from stored or newly collected samples after investigating and fixing the cause of the QC failure, such as contamination or degradation of samples, or expired reagents.

External Quality Assessment (EQA) is a process that allows laboratories to assess their performance by comparing their results with results from other laboratories within the network (testing and reference laboratories) via panel testing and retesting. EQA also includes the onsite evaluation to review the quality of the laboratory performance. EQA usually evaluates testing competency, the performance of the laboratories, reliability of the testing methods, and accuracy of the results reports, including follow-up for unacceptable EQA results with corrective action. One or more of the following three EQA methods can be applied to COVID-19 molecular testing laboratories.

Proficiency testing (PT) is when an external provider sends a set of SARS-CoV-2 positive and negative simulated clinical samples for testing in different laboratories and the results of all laboratories are analyzed, compared, and reported back to the participating laboratories. Laboratories should select PT providers with a track record in delivering PT panels within their region.

Retesting are samples that have been tested at one laboratory and are retested at another laboratory, allowing for inter-laboratory comparison. A laboratory’s first positive COVID-19 sample should be sent to another testing laboratory, preferably a national or a WHO reference laboratory. In the absence of PT, national COVID-19 laboratories should send five positive and ten negative samples, systematically selected, to WHO reference laboratories for retesting. Similarly, sub-national COVID-19 testing laboratories should send retesting samples to their national COVID-19 reference laboratory.

Onsite evaluation should be performed by experienced subject matter experts, who observe and assess the quality management systems of the COVID-19 testing laboratories across the three testing phases. Onsite evaluation includes Patient Management, Biosafety adherence, Quality control procedures, Staff competency, Sample collection procedures, Standardized testing policies, Documentation and maintenance of records. Onsite evaluation should be conducted at least annually, but preferably every three to six months.

For further information about quality management have a look at the material developed by the Africa Society for Laboratory Medicine and Africa Centres for Disease Control and Prevention available for download below.

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From Swab to Server: Testing, Sequencing, and Sharing During a Pandemic

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