Advice for the Assessment of Remote Blood Fridges

Background

For sometime it has been CPA policy that during an assessment visit, all remote blood fridges must be visited and assessed against standards. Many fridges are off site and take a considerable time out of the assessor’s already busy schedule. On some occasions visit times have been extended just to visit these fridges.

In an attempt to maximise the time of assessors involved in such visits the following advice has been produced.

Assessment of remote blood fridges

Where a site has a number of remote fridges, and in the assessors view visiting them is not practicable, the following process should be followed:-

Chose one of the fridges at random and visit making all assessments as normal. These should include security of the fridge, its location, fridge type, temperature control, general condition, statement of need etc

Then evaluate the laboratories quality documentation for all other fridges. Without being prescriptive such documentation should include evidence around the following:-

· evidence of regular service records (D1.2e, D1.3d, D1.4)

· evidence that alarms sound at a remote location as well as at the fridge (C4.1c, D1.1)

· temperature chart records (D1.2g)

· evidence of daily/weekly maintenance (checking alarms, batteries new temperature chart, cleanliness etc) (D1.2e, D1.4)

· If appropriate evidence that temperature chart discs, are checked for completeness on a regular basis (C4.1c, D1.2g)

· Adherence to the working instruction on the safe handling and transportation of blood units.(A2.4a, C5.3j, F2.1)

· statement of need (A2.2, D1.2a)

· associated incidents (if any) (D1.2f, D1.3e)

If both the spot check and paper work are acceptable then complete assessment as compliant. If the spot check or paperwork is non-compliant, then simply raise non compliance against these findings. If systems are shown to be inadequate and the assessor has time they may consider spot checking a second fridge.

It is hoped that subsequent assessments will spot check different fridges.

Where a number of fridges exist on the main hospital site, especially when numbers are low, assessors may chose to visit these under one of their Horizontal assessments, thus saving time.