The top 4 challenges facing clinical and diagnostic laboratories

Save time, minimize risk and improve productivity with environmental monitoring

Managing or working in a clinical or diagnostic laboratory can be a rewarding yet hugely demanding role. There are commercial and technical challenges at the best of times. But when economic, staffing and regulatory pressures combine, these challenges can increase dramatically.

Right now, laboratory managers, technicians, analysts and scientist are under greater pressure than ever before. Operating budgets are stretched, workloads are increasing, recruitment is difficult and regulators are becoming ever-more vigilant.

So, what are the top four challenges that we feel clinical and diagnostic laboratories are facing today?

1. Compliance and risk management

The costs to the healthcare and medical sectors of using clinical and diagnostic laboratories may be relatively low as a percentage of overall healthcare budgets, but the impact of their work in terms of research, clinical trials and patient health are considerable – certainly out of all proportion to the costs involved.

The importance of laboratory work is one of the key reasons why they are heavily regulated. For example, GLP (Good Laboratory Practice), ISO 17025 and 15189 and FDA 21 CFR Part 11 all mandate clearly defined practices for various aspects of laboratory operation. The key objectives being to ensure compliance, traceability and mitigation of risk.

Risk management, in terms of equipment and systems, staff safety and the integrity of tests, analyses or research being carried out, is therefore crucial. The challenge is that developing, implementing and monitoring risk procedures can be time consuming, potentially costly and, if monitoring processes fail or produce inaccurate results, then the damage commercially and reputationally can be significant.

2. Audit failure

A failure in risk management procedures can also lead to the failure of an independent laboratory audit, carried out for example under the remit of GLP.

Failing an audit can also have serious consequences. It can result in loss of work and revenue, undermine reputation, waste time and divert staff resources and, in the worst-case scenario result in fines or prosecution.

The challenge today is to ensure that each laboratory complies with its regulatory requirements, during a period when staff shortages and funding cuts are reducing the time and resources available to maintain regular and appropriate environmental monitoring and control procedures.

Laboratory staff time and utilization

This leads us neatly to the final two challenges:

3. Time pressures

4. Recruitment and staff utilization.

In many clinical and diagnostic laboratories a considerable amount of time is wasted in maintaining manual monitoring processes; for example, the weekly recording of fridge temperatures. This is time that staff could better spend on more productive tasks that add value to laboratory operations and the services provided to customers.

This situation is exacerbated by the difficulties that many laboratories have in recruiting and retaining skilled staff. Forbes magazine recently reported that in the United States and Canada there are as many as 25,000 vacancies for medical laboratory professionals. A similar situation can be found in other countries around the world.

A simple solution

Ok, perhaps there’s no single solution, but there are simple options. Clearly, greater laboratory automation is one way of reducing the dependence on staff while minimizing the risk of potentially audit-failing human errors. One aspect of this is to consider intelligent environmental monitoring systems, which eliminate the need for manual or semi-automated data logging and analysis. Our PST Real-Time Monitoring Solutions, for example, are simple to install and use, and provide precise, real-time data management for critical laboratory equipment such as fridges, incubators, autoclaves, cryogenic storage and so on. This ensures full traceability, which is ideal for quality and audit purposes, improves productivity and frees-up staff resources for activities that add real value to the laboratory.

Related Blog Post: Advantages of Digital Sensors in an Environmental Monitoring System

Author:
James Pickering, Director of Environmental Monitoring Systems
Sources: Forbes