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Temperature monitoring systems and meeting the needs of the Health and Social Care Act 2014: Regulation 12 (2)(b)

When considering a temperature and data monitoring system in a regulated healthcare facility, it’s critical that Safety and Risk are the drivers when considering systems to manage and comply with the above.

How do you need to treat risk according to the ACT?

To do this let’s look simply at section 12(2)(b). To summarise this clause, this means doing all that is “reasonably practicable” to mitigate any such risks.

In legal terms, “all that is reasonably practicable” means that the degree of risk in a particular situation can be balanced against what would be deemed acceptable in terms of the time, trouble, cost and physical difficulty of taking measures to avoid the risk.

How does this translate within the Healthcare Sector?

Incidents that affect the health, safety and welfare of people using services must be reported internally and to relevant external authorities/bodies. Such incidents must be reviewed and thoroughly investigated by competent staff and monitored to make sure that action is taken to remedy the situation.

What we should reasonably expect thereafter is a process implemented that prevents further occurrences and make sure that improvements are made as a result. Staff who were involved in incidents should receive information about them, and this should also be shared with others to promote learning. Incidents include those that have potential for harm.

How does this specifically impact the Temperature Monitoring of medicines and other regulated products?

In our experience, we find two typical approaches to monitoring solutions which totally fail to mitigate risk:

  • A manual temperature data recording system. These “quill-pen” processes are reliant on often highly qualified front line staff busy with their day job. This implies competing priorities and risks recording errors and/or gaps in data,
  • Budget automated systems. These being cheap are fully automated and reliant on digital communication methods such as text or email communication. Being machine driven, these systems rely on busy staff to read and respond to automatically generated messages. There are no checks and balances.

Have you genuinely taken “all reasonable practicable steps” to reduce risk if it can be shown that reporting excursions are not in real time, relying on error-prone manual recording; or automated systems that use purely texts or emails which do not report excursions directly to staff on site?

Mitigating Risk and Compliance with the Act

Incidents like excursion events must be reviewed and thoroughly investigated by competent staff and monitored to make sure that action is taken to remedy the situation, prevent further occurrences and make sure that improvements are made as a result.

To meet these requirements: –

  • Do you have an incident report which is raised independently?
  • Are they recorded, investigated and record the corrective action?
  • Who signed if off to demonstrate learning for corrective action?

Staff who were involved in incidents should receive information about them and this should be shared with others to promote learning. Incidents include those that reasonably be expected to have potential for harm.

Therefore, against the “all that is reasonably practicable” test, generic communication may not be considered as “mitigating risk”, but a system that responds to named specific staff, which are nominated to receive direct communication to take responsibility most definitely does.

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