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Four perspectives on preanalytics and patient safety

Up to 70% of all medical decisions are based on the results of laboratory tests
Up to 66% of laboratory errors occur during the preanalytical phase
Up to 65% of emergency department sample rejection is due to haemolysis

BD participated in the 5th European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) conference on preanalytical phase in Zagreb, Croatia 22–23 March 2019.  At the conference, we met Mr Steve McManus, Prof Ana-Maria Simundic, EFLM conference chair, Prof Mario Plebani and Dr Alexander von Meyer, member of the EFLM conference scientific committee. Prof Simundic and Dr von Meyer belong to the EFLM Working Group for Preanalytical Phase (WG-PRE). They gave us their views on patient safety, the preanalytical phase and its impact on the emergency department (ED).

Healthcare’s purpose is to maintain or improve patients’ health. With the introduction of new technologies, medicines and treatments, healthcare is getting more complex. There is growing awareness that human and systemic factors can harm patients through preventable adverse events. Medical errors that lead to these adverse events are a major burden on healthcare systems across Europe. Up to 70% of all medical decisions are based on the results of laboratory tests and up to 66% of diagnostic errors occur during the preanalytical phase. This is why these errors have the potential to cause great harm to patients according to Prof Plebani.

The challenge of haemolysis and other preanalytical errors

For Prof Simundic, there is a lot to be done to prevent preanalytical errors in the ED. Haemolysis is by far the most frequent preanalytical error and the main reason for rejected samples. It occurs when red blood cells rupture and release haemoglobin and other intra- cellular components into the plasma or serum. Causes include drawing blood incorrectly, underfilling tubes, shaking of samples and using intravenous catheters to collect blood samples. Haemolysis may lead to unreliable results, delayed diagnosis and avoidable harm to patients. But as Prof Simundic pointed out during her presentation at the EFLM conference, not all clinical laboratories in Europe use the same haemolysis index cut-offs or the same detection techniques. She pointed out that the visual detection of haemolysis has been found to be highly unreliable and extremely inconsistent.

According to Prof Simundic and Prof Plebani, the highest rates of haemolysis are in the ED, with 65% of samples rejected for this reason. Prof Simundic said the ED is the hospital department where most preanalytical errors (e.g., patient misidentification) occur. Prof Plebani found that it is more difficult to identify haemolysis with point of care testing (POCT) than testing performed in central laboratories. With the rapid growth of POCT in clinical settings such as the ED, the role of the preanalytical phase in POCT may therefore pose an increasing challenge. It is also common in the ED.

Measuring preanalytical quality

Preanalytical quality indicators are used to measure performance in the ED and other hospital wards. Dr von Meyer identified the most important quality indicator for healthcare systems as being turnaround time (TAT). Though definitions vary, we define it here as the time from test request to reporting of results. Dr von Meyer mentioned that we do not always know the exact sampling time, and this is important for calculating TAT. Some reference values are correlated to the time of day and sampling time is needed to calculate drug doses. However, clinical laboratories do not agree on a standardised way to use quality indicators to measure laboratory performance during the total testing process (TTP).

Preventing errors and improving preanalytical quality

Solutions exist to reduce preanalytical errors and positively impact patient safety. Better haemolysis management requires using automatic detection systems instead of visual identification, defining haemolysis index cut-offs based on biologically variable data instead of using one cut-off for all tests and all patients and informing clinicians when results are from haemolysed samples. If automatic detection systems are not available, the laboratory should use a colour chart for visual identification.

Dr von Meyer stressed the importance of knowing sampling time to improve TAT and ensure sample stability. The exact sampling time should be documented and included with each sample. Faster TATs may lead to more timely treatment and improved clinical outcomes. Techniques used to reduce centrifugation time may also have an impact on TAT.

Since 2008, Prof Plebani’s team has been working on the harmonisation of quality indicator management. Over the past five years, laboratories have uploaded data on the model of quality indicators (MQI) website. This is a free service. Prof Plebani’s team has been collecting and analysing this data, from which they have identified 26 quality indicators and 53 measurements, with defined benchmarks. Their final goal is to create an MQI that could be used by clinical laboratories all over the world to help increase sample quality while reducing laboratory errors.

Future perspectives: point of care testing and a culture of safety

For Dr von Meyer and Prof Simundic, the future of preanalytics will be in POCT. POCT has been shown to reduce TAT, while providing rapid answers for decision making in the intensive care unit. However, it presents specific challenges because POCT sample collection is usually performed by clinical staff who have varying levels of experience with sample analysers. Care settings where POCT is used tend to have heavy workloads and the preanalytical phase varies from patient to patient based on level of urgency, which makes minimising human error an added challenge. Effectively training clinical staff in quality control and ensuring close collaboration with laboratory staff are important for maintaining the reliability of results from POCT.

According to Mr McManus, learning is at the heart of a culture of safety. By learning from mistakes and applying that knowledge to workflows, we can improve patient safety. Mr McManus and Prof Simundic also said that it is important to create the right conditions for this kind of organisational culture.

Healthcare workers and laboratory staff should feel comfortable reporting errors and suggesting ways to improve these workflows. Another way to improve patient safety during the preanalytical phase is through clinician-lab cooperation. A recent study by McKeeman et al showed that having a laboratory technician processing samples in the ED can reduce TAT and improve communication with the laboratory. Clinicians should feel free to come to the laboratory and laboratory workers to meet with their colleagues in care settings to improve communication between these import- ant stakeholders along the care continuum and enhance patient safety.

Preventing haemolysis, keeping TAT as short as possible, reducing preanalytical errors, harmonising quality indicators, maintaining the reliability of POCT results and building a culture of safety are all ways to ensure patient safety throughout the preanalytical phase in the ED and beyond.

*References may be requested from the author

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