Health and Social Care Act 2008 published guidance for healthcare providers. This guidance describes how providers and managers can meet the regulations. These include the fundamental standards – the standards below which care must never fall.
Once this is clearly understood – why the regulation is required, then meeting it becomes far easier to grasp. Here is Tutela’s take on how best to meet the CQC regulation as it relates to the safe storage of medicines.
Our focus is on Regulation 12 and is the most relevant to those involved in medicine management, for example the temperature controlled storage of drugs. The intention of this regulation is to prevent people from receiving unsafe care and treatment and prevent avoidable harm or risk of harm. This is covered in detail in Part G “the proper and safe management of medicines”.
From our perspective as leading temperature monitoring providers to the NHS, we see 5 simple steps to ensure that your facility can meet CQC requirements.
CQC can and will prosecute for a breach of this regulation or a breach of part of the regulation. This is triggered if a CQC audit identifies that a failure to meet the regulation has resulted in ‘avoidable harm’ to a person using the service or if a person using the service is exposed to significant risk of harm.
They do not have to serve a warning notice before prosecution, so prosecution can come out of the blue. Additionally, CQC may also take other regulatory action.
That’s pretty serious because they monitor, inspect and regulate services to make sure they meet fundamental standards of quality and safety. A failed audit will end up in the public domain. CQC will publish what they find, including performance ratings. The sole reason for this is to help people choose the right place to have their care.
When they identify poor practice, they record and highlight the area for improvement and if it is serious will down grade the area of care for improvement.
So, in these digitally enlightened times, negative findings will always be visible on the internet and social media – even in general searches.
The regulation states that care and treatment must be provided in a safe way for service users and, in section G the proper and safe management of medicines and covered in specific detail. Have a written policy for each section and stick to it.
Section G covers:
In order to ensure that medicines perform as required by then they must be stored and handled in accordance with the manufacturer’s instructions. This requires many medicines to be stored at specific temperatures in fridges or freezers until required.
Highly qualified front line staff are busy doing their day job, and manually checking fridge temperatures by hand is a poor use of skilled resource, and a bad return on investment. As such, a manual monitoring process often has data gaps because log sheets are not filled in.
This ensures that the facility has failed to meet the CQC standard of care expected. And it is totally avoidable.
Temperature monitoring systems exist to remove this particular CQC threat. To have complete peace of mind, simple automated monitoring is not sufficient.
An integrated system of digital technology, allied to a 24/7 alarm bureau of trained independent staff that actively contacts the point of care provider in person and bring to their attention a failing fridge or freezer, will meet the CQC needs 100%.
Stored poorly and not monitored correctly, vaccines, bloods, insulin and a range of medicines don’t just become inactive, they can become outright dangerous if used, putting lives at risk.
It’s therefore important that an alert or alarm is raised to trigger a corrective action report, which requires manual intervention to correct. This is unavoidable and investigating the cause is mandatory as well as detailing the corrective action. In a good temperature monitoring system, all these processes are track-able and auditable for quality control processes to maintain patient safety and provide healthy outcomes.
Tutela’s technology can remotely monitor every fridge or freezer door, temperature, ambient and humidity. In every room, ward, department, hospital or remote clinic all under one account. Protected, secure with full reporting and action audit trail.
Our goals are simple, with independent monitoring of the healthcare and drug development activity, we aim to Improve health outcomes, protect reputations and support your team because as healthcare specialists, Tutela understand the need to deliver on the proper and safe management of medicines.