Implementing Individualized quality control plans and managing risk at the point-of-care for molecular diagnostics

ABSTRACT

Introduction

Faster turnaround times can lead to rapid patient treatment. Implementing a point-of-care (POC) molecular COVID-19 test requires careful planning. In the POC setting, there are numerous operators and regular monitoring of their activities is key to the successful implementation of a POC molecular test. Test errors can arise from samples, operators, reagents, the testing system, and even from the environment. These sources of error should be considered when implementing a new test.

Areas covered

We outline the importance of establishing well-defined policies for staff to follow at the preanalytic, analytic and postanalytic phases of SARS-CoV-2 testing. As these factors are crucial for the accuracy and reliability of the test results. The key discussion points are from the CLSI EP23-Ed2 document on developing individualized quality control plans and medical literature search engines such as EMBASE, MEDLINE and MedlinePlus.

Expert opinion

The risk management principles applied when implementing nucleic acid POC tests can identify specific control processes to help mitigate common sources of error when conducting molecular testing at the POC.

KEYWORDS:

• Quality control
• risk management
• pandemic
• nucleic acid test
• point-of-care test
• COVID-19

Article highlights

• Onsite POC tests are faster than laboratory analysis and can allow rapid patient treatment decisions.

• Risk management assesses workflow for weaknesses and allows laboratories to develop control processes to mitigate errors before they occur.

• Errors in POCT can occur in the preanalytical, analytical, and post-analytical phases of testing.

• Individual Quality Control Plans (IQCP) justify our actions, giving meaning to why we needed to perform certain activities to ensure quality.

• IQCPs provide opportunities for laboratories to interact with clinical departments on a shared quality improvement project that can ensure result reliability while improving workflow and operational efficiency.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants, or patents received or pending, or royalties.

Acknowledgments

The authors thank all members of the Point-of-care team for technical and material support.

Author contributions

All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper is not funded.