A Service Level Agreement (SLA) is a contract, of sorts, between the lab providing oversight and the area in which the Point of Care (POC) device resides and the users of that area. It ensures that both parties are aware of their responsibilities and the governance framework which surrounds the device. The SLA format I use is similar to the one utilised by main laboratory, which is used for sending tests between hospital/boards. The SLA’s do contain some legal language in there which can be intimidating, but it is so important that we have the clinical area on board with clear guidance of what is expected of them. To provide a safe and effective service all POC schemes require good communication, open and honest relationships between the lab and the area of placement. The new ISO 15189(2022) standard places much more emphasis on risk and the provision of an SLA reduces risk of non-compliance, encourages collaboration between the lab and the clinical area to ensure that POC devices are used correctly with positive patient benefit. 

Since coming into post in July 2020, all new devices and new schemes have been implemented within an SLA. For the most part this has gone well; it has encouraged active engagement and understanding from the clinical side, and ensures the POC team always have a point of contact to address any issues with. Those new schemes have been able to be implemented with an SLA due to the fact that we also have a full POC team. This resource ensures that we, from the lab, are able to audit, educate and review the use of the device as well as building a lasting and mutually beneficial relationship with the clinical area.

The main problem lies with historical devices and services that have been inherited by our team. These have tended to be smaller devices such as handheld glucose and ketone meters. Smaller device carry equal or perhaps larger risk because these are the devices that possibly cause the biggest headache to POC coordinators with users sharing barcodes, recertification and competency requirements. These are the devices that are everywhere and are easy to use so why do I need this document, and how can I persuade the clinical areas that they now need to adopt such a formal agreement?

To address some of these issues we have asked the areas that have several POC schemes have one SLA governing everything. We don’t know if this is right or wrong, and the new ISO15189 (2022) isn’t that prescriptive. However, given that it is the same staff group if you get them to understand the whys behind an SLA then it can be bit more palatable to have one agreement for a group of devices. 

I’d be happy to hear other’s experience and why they have chosen to go down a particular route, this is a learning curve and by sharing what we do we may achieve better practices.

On the downside, it has been a struggle to engage the areas with the SLA’s – and I do try..... We have areas where POC devices are not seen as vital, and therefore the users have no engagement with us until they no longer work!

Then of course it becomes a medical physics issue ....... you see they have lost sight of who has oversight ... the lab and all POC devices should come via the lab for troubleshooting. If we had a SLA we would have had a named person and deputy who is responsible in the placement area, and by signing the SLA they also know the responsibilities of the lab. Ensuring that they know how to direct issues to ensure clinical practice is undisturbed, thereby illustrating the need for SLA’s as a way of mitigating risk.

So.... tells us about your SLA.....