1 The importance of data integrity and data quality

It is essential that microbiology laboratories generate data that are fit for purpose (that is, are of high quality) and are trustworthy (have integrity). High-quality data are accurate, consistent, reliable and timely, while data have integrity if they are accurate, validated and complete. You will learn more about these terms in the Fundamentals of data for AMR module.

The principles and practices described in this module minimise the likelihood of an error occurring at each step of the testing process. Doctors and veterinarians must be confident about laboratory reports of test results to inform clinical decisions for a sick person or animal, such as deciding which treatment to give or what additional tests are needed.

For AMR surveillance, pathogen identification and an antibiotic susceptibility test (AST) must be robust and reliable. This is because the data are used to make important healthcare decisions, for example on the procurement of drugs and drug budgets, producing empirical treatment guidelines or developing vaccination programmes at local, national and international levels. Having high-quality, accurate data ensures that meaningful comparisons can be made between different sites, regions and countries, which inform the generation of policies to reduce infection rates and improve patient care. The AMR data collected over time are key to determining trends in resistance patterns and informing public health interventions.

Activity 2: Potential harmful consequences arising from data issues

Timing: Allow about 10 minutes

Data quality and integrity are important at each step of the AMR surveillance process. In particular, data issues that arise at a local level can have far-reaching effects. For each of the following situations in this activity we would like you to suggest possible negative outcomes for patient care and/or AMR surveillance.

  1. The pathogen isolated from an individual specimen is wrongly identified.

Answer

The antibiotic chosen to treat the patient may be inappropriate and the patient’s clinical condition could worsen, possibly leading to death.

  1. The AST result for an isolate is not interpreted correctly; for example, the inhibition zone diameter is not compared to international standards.

Answer

The patient may receive an ineffective or a sub-optimal dose of antibiotic. Patient care may be compromised.

  1. The AST methodology is not strictly followed, and different operators use different methods or processes; for example, the McFarland standard is not used.

Answer

Multiple AST results may be inaccurate with the following potential outcomes:

  • Individual results are wrongly reported as susceptible/resistant to the chosen antibiotic and patients may receive an ineffective antibiotic or sub-optimal dose.
  • The integrity of AST data collected for AMR surveillance is compromised. Policy decision-making by those involved in environmental, public and veterinary health may be affected.

High-quality data generated by microbiology laboratories are the foundation for good patient care and effective AMR surveillance. Incorrect data can negatively impact decision- making at all levels. It is vital that all those employed in a laboratory recognise the need to work to agreed standards of practice and follow measures to ensure that data are reliable.

Introduction

2 Ensuring quality in the laboratory