Hello

Speaking from a contracting perspective, we are reviewing our current EBME provider and were wondering what would be the best approach for assessing their competence in servicing the hundreds of items they service for us each year. I have read some of the threads on here and it seems different EBME departments operate in different ways. We are playing catch up, I would assume normally that when purchasing new equipment we would check then (thrashing out those details internally). Should we just ask for a declaration from EBME departments for each item, or see some kind of credentials?

Thanks

Russ

"Reviewing your current EBME provider". NHS, or private? When you say "EBME" provider, are we to assume that you're referring to repair and maintenance services in-house and/or on-site? Are you using a third-party company to do this?

Are these people carrying out PM, or just a "repair as necessary" function?

If PM? On they on top of the schedule (most important, in my view)?

How to assess? How about calling in an independent outsider to do that for you?

Or are you talking about going out to tender for biomed engineering services?

If so, the key is in the amount of effort (thought, as well) put into the Request for Proposal.

That is, you decide what you want, and get it clearly drafted into the RFP.

If you want kit PM'd twice a year, then that's what you put in. If you want to reserve the right to impose financial penalties for poor performance (all of which must be clearly defined), then in that goes as well ... etc., etc.

The bottom line is:- you are (or should be) in the driver's seat! That is, you tell them what you want, rather than having to put up with them saying "this is what you're getting".

Hi Geoff - sorry for delay in replying!

It is an NHS EBME dept servicing equipment for us, another smaller NHS body. We need to have stuff serviced to the correct frequency, and working on establishing a complete inventory with these on. But in the meanwhile, I was wondering how we assure ourselves that the engineer they use currently is competent to service all equipment he's asked to. We do have the contract up towards the end of this year - currently its a single sheet of paper so totally inadequate - so will be devising a specification for services we expect any future provider to meet. It's more in the meanwhile, how we can assure CQC for example that the current lot are competent (and I am sure they are 95% of the time).

Unless something has cropped up to throw some doubt on things, why worry?

You'll only end up with a file full of bits of paper "proving" this or that (or nothing at all, more like).

What matters (as always) is the state (the condition) of the kit itself. If it's all fully serviceable, and any faults etc. get dealt with efficiently ... what's the problem?

But "a single sheet of paper"? Can I bung in a bid next time?

Things have changed - we are assessed under CQC judgement framework towards the end of the year. We need to evidence its all maintained correctly (erm, outcome 11?) (ie to manufacturers recommendations) and by technically competent individuals. I am sure they are competent, but the point is how we evidence it. It may mean a file with bits of paper, but needs to be done. It may even be an outline on how they monitor their engineers abilities ie rate of failures, revisits etc, but at the moment we could not show them anything..

We have had a few incidences eg phoning for a new piece of equipment and engineer saying he needs to find out more about it, which hasnt been that reassuring.

We will be asking how they can provide evidence, but was wondering what would be the generally accepted approach. I am sure anyone who runs an EBME department at an acute has had to consider this already under CQC assessments, let alone their own QA processes.

And apologies but wasnt too clear in first post, but we need to consider ongoing checks if/when we award contract elsewhere and what we should be looking for.

It is usually difficult (not to mention unfair) to apply new conditions to a contract retrospectively.

I would have thought that the best way forward is to simply write any new requirements into the next contract.

All that extra stuff will end up costing you more, of course, especially if the contractor needs to be worrying about protecting himself the whole time.

As I say, what matters is the condition of the kit. If you can't judge that for yourself, then you may need to consider calling in a third party to examine it (spot checks, whatever) on your behalf. More expense!

What sort of equipment are we talking about here, by the way?

Meanwhile, the fact that a tech had to check up on something or other sounds to me like a good sign. Honesty, due diligence etc. ... rather than simply bluffing his way through!


Show them the kit itself! And if they know what it is they are are looking at, and it's in good shape, then it's Game, Set, and Match!

Showing them the kit wont be sufficient, I am 99.99% confident on that, but thank you. I think we will ask them to prove competence to us if there's no standard approach, and then think about a third party inspection to ensure stuff has been done adequately, that's a good idea and helps to ensure we don't just rely on the trust we currently work on.

Quis custodiet ipsos custodes?

There's no need to check it all. Random checks are usually sufficient to keep the workers on their toes!

Who was it who said that "policy without inspection is just an exercise in wishful thinking"? Oh well, perhaps it was me.

It's (yet) another area where I feel the NHS is a bit lacking. If folk want QA (and why not?), then why not just have the blokes come across from Hospital A to check out the kit at Hospital J (Hospital B being too close to A, if you see what I'm saying). A nice week out for the inspectors ... who had better watch out when the situation is reversed.

By the way, the army was using that approach to my certain knowledge forty years ago! As usual, the simple solutions are the best.

Hi Russ

Who's to say that the inspectors are qualified and up to play with all current legislation?
Proves to be quite an interesting point in the land of the white cloud.

Regards

An inspector does not need to "up on current legislation".

He just needs to be able to inspect kit!

That is, for serviceability, safety, completeness and general condition.

He is a practical, hands-on guy ... not a lawyer, accountant, or worse!

I think in reality here Geoff, the person needs both skills as it is necessary to not only assess the status of the "kit" but also the record keeping, performance against current standards, performance against contract KPIs, etc, etc.

Although a lot can be told from the "kit" in reality, this is only a part (all be it a large part) of the picture.

What you say is fair enough ... but who's going to pay for all that? If you're not careful you could end up paying more for the "consultancy" than you do for the "maintenance" (or the real work, if you like)!

When it comes to checking the paperwork (and that all the boxes have been ticked) ... well, the Contracts Manager (client?) can do that. But if he (she) isn't a "technical person", then he (she) will need to call upon someone who can actually check-out the kit.

OK ... it was all "once upon a time" ... in a "place far, far away" ... but no-one ever said to me:- "can you please come and check our paperwork"? It was only ever "can you take a look at our equipment, and give us your 'opinion' (proposal, whatever)"?

They could prove compitance with cetificates from couses and or records of previous jobs done on certain equipment going back so many years to show that they are well versed on the equipment in question.

If they inspect a piece of equipment and it is not serviced correctly (and CQC inspections are hands on like you say, in some respects), they need to look at what we do to ensure that these are not recurring incidences. So you need to have the paper trails in place that give you assurance its all being done correctly and items arent being missed etc, and that service personnel are competent..

I would imagine that if you had random sampling that this would go a long way to checking technical personnel are doing it correctly. However I also read on here people keeping stats as to breakdowns and other stats for engineers, against national averages, and where its higher, it can be used to identify training requirements. Not sure how often such a system is used. Training certs seem to be inappropriate because engineers I guess build up general competencies that can cover a range of items which wouldn't be covered by certificates all the time?

Russ can you direct us to the appropriate legislation? I've had a look at the CQC website but it's quite hard to find the salient points.

BTW, we had a CQC visit earler this year, all the were interested in was whether we washed our hands or not!

Sounds like they're getting a handle on this "hands-on" thing, then!

It's outcome 11 on the judgement framework

http://www.cqc.org.uk/_db/_documents/Sum...INAL_081209.pdf

biomedbill - I wish they only asked about hand washing, I might be able to get some other work done!

Hi Russ,

Thanks for the link.

I'm sure the CQC looked at more than handwashing, but it was widely put round our organisation that any inspection would concentrate on cleanliness and infection control. I suspect that any inspection by the CQC would cover a fairly specific area depending on which way the political/ media wind is blowing. They wouldn't have the resources to inspect all aspects.

Back to medical equipment, the CQC document does not mention the most appropriate document, DB2006(05) . Have a look through this document, it should put you on the right track.

p.s. I'm not sure if this is the most up to date version, I'm sure someone out there will put us right.

You could start with what CQC want & NHSLA want for you to attain level 3. At least then you will know that they are doing something right as L3 is a shall we say bit of a pain to get and keep.

It would appear that this discussion has two key questions:

1. What evidence do we keep for ensuring that our staff are competent?
For me registered staff should be on the VRCT (IPEM)and have records of training esternal and internal. Records of teaching back to a more experienced engineer how the equipment is serviced is a very good method.

2. CQC/NHSLA compliance
I too had a CQC interview recently. I started by asking them for a definition of safety. In the end they agreed that the IEC Guide 51 definition I gave them was right. Safety is 'freedom from unacceptable risk'.

All medical engineering teams either in a structured was or simply intuitively manage down risk. We have a structured approach in that equipment models are classified into 5 risk bands based on the 'immediacy of the impact on the patient'.
And we have a system of monitoring how well we are doing.
That's our model - it's the best we've come up with so far, but it's not the only model. there are things where we declare that we don't routinely service, but have a rationale why we don't.

The impression I get is that the CQC want to hear that medical engineering teams understand the challenges and risks, have a structure/model that addresses these to the best of our ability and resources.

Good records and a monitoring system are these days essential.

And is there a mechanism for passing up difficult problems (e.g. major risks) up the ladder, rather than hiding them within the local medical engineering team.

"Immediacy" only?

Not "consequence"?

Care to list your five levels of Risk, there, Chris?

Chris

You are right on the record keeping especially if there is a chance of standing in front of the judge.

We have the problem here that a ward says There was a problem with a piece of equipment while it was on a patient. They raise an incident report and send it off to risk. Now they get around to telling us we test it and find it good/bad but there is no link to the incident. The powers that be have been told and have done sod all about it.

As for the training records we maintain them as education was tasked and has so far lost everyones record in the trust. Lucky for our backups. (certs in a folder). They are now asking everyone if they have done their health and safety, so far it looks like everyones up to date

I dont agree with the VRCT in that the name gives it away (Voluntary). How are you going to defend yourself in court if you dont employ someone not in the voluntary register. If your driving licence was voluntary would you pay for one?

Keep your records up to date as there is no support when the proverbial hits the fan. That includes all the emails highlighting the problem.

Sounds like you're besieged by incompetence there, Billy.

But, don't worry Mate ... "lessons are being learned" the whole time.

Yes but they are only learnt when it hits the fan. They are talking about using bore hole water here now even though the renal national guidelines say this is a no no. Why does it have to end up in court with someone dead before they get there act together. It is all down to cost by the way.

If we had less management we may have the money to pay for people who can do the job and for the equipment needed.

I used to work for a company installing bore holeds and water systems. One client a farmer was told that he could not use the water from the mains for food production as it did not meet the standards, but the water he got from his own well / bore hole did pass the standards. He was unable to get recompense from the water company as they said that it was fit for human consumption. Enough said!

It could be something to do with the big radioactive place down the road here

Getting back to Russ.

If you are going to use an outside agency for the calibration/service of your equipment then things to check.

1. A list of the test equipment used on the returned item (for audit purposes).
2. Sevice engineer (print and signature) again for when it all goes wrong (Are they in possession of certification from the manufacturer or are they covered under the companies insurance)
3. Is the company you are using insured to carry out the task.
4. Do you operate a full trust procedure or do you carry out a batch test of equipment returned.
5. Full data access to the tests carried out (Flow/occlusion graphs with time/date of test).
6. If a repair has been carried out, have they used oem parts or third party. Also whats the warranty on the repair.

Its a minefield, good luck.

All good stuff, Billy.

But I think you may find that Russ could be thinking in terms of an NHS EBME department at a nearby hospital.

Remember also that you get what you pay for. So all that stuff you mention should be listed up front in the original contract tender, and not sprung on the "contractor" later on.

No-one likes surprises (well, not in this context, anyway). And neither do clients usually enjoy receiving change orders, either!

Meanwhile, in situations like this, I would advise that it may be better to bring in temporary staff to carry out the work you need doing. That way, you remain in control.

Interesting topic...

Russ, ask the provider for their own PCA form for outcome 11 and use this as evidence and use this for your own evidence of 'external assurance'. If they are ISO then you could also seek a copy of their certificate or audit report as further verified checks of their competence.

After all, both CQC and ISO will be monitoring competence under various clauses and this will be a good source of evidence with very little work for you to do.

OK, let's play "tick the boxes", shall we? For convenience and clarity, I'll use the terminology "client" and "contractor":-

Contractor must have:-

1 [ ] Competent technicians able to carry out the work
2 [ ] Public liability insurance
3 [ ] "Quality System" certification (eg, ISO whatever)
4 [ ] Appropriate tools and test equipment
5 [ ] All test equipment calibrated and within date
6 [ ] Recent training certs for all equipment on "the list"

1 - tick
2 - tick
3 - why? It's the client who should have a QA system in place (and the contractor should be obliged to follow that)
4 - tick
5 - tick
6 - may not be possible for all equipment (some of which may be basic anyway)

Perhaps we're talking about a list of kit that any biomed worth his salt should be competent to work through. That's why I asked earlier:- "What sort of equipment are we talking about here"?

However, as I've mentioned before, the client can add as many requirements and conditions as he sees fit. But each one will end up costing him more.

And (at the famous "end of the day") he will probably end up with the same blokes doing the work, anyway.

Generally speaking, I don't think it's any great secret that contractors will agree to "anything" as long as the price is right. They carry the risk.

Also, if there is still lingering doubt about capability etc. ... why not simply follow that age-old method of seeking references from previous happy clients?

But to my mind all that is just so much guff. As I said before, what really matters is the condition of the kit!

Where's Russ? He's not been back since the 3rd.

sorry, I took a break! Thanks for the many replies, I didn't expect the thread still to be going. I did bookmark but only just had a chance to have a look.

You are right in that, any spec should be agreed prior to going to market and with contractor input (with contractor generally being external EBME departments). We will be doing so, although some useful points on here about auditing and 'proving competence'. We will ask for the PCA as a good starting point. I think we would leave a spec broadly based for technical competence, as like has been pointed out, there are a variety of ways competence could be proven - can then assess the EBME provider's response on how they will evidence it, and then build this into any final contract.

On the original CQC requirements we have records of engineer training and have spent the last month collating manufacturer recommendations on servicing frequencies, to monitor more closely going forwards, and with PCA we should be covered.

As for equipment range - we run community health services, with a few bedded units in some hospitals. Most of the equipment is fairly low risk when compared to acute trusts etc, although it ranges from audiology testing equipment to bed frames, sphygometers, glucometers, treadmills, etc..

This is a logical way of going about things, especially for a small dependency (inventory). But it assumes that you have access to relevant service manuals (so you may need to get hold of them):-

1) Get someone to go through each manual to establish the PVP* for every type of equipment (that is, the manufacturers' recommendations)

2) Make up a binder containing those procedures and make a note of the quantity of each equipment type

3) Issue this information as an Addendum to the contract bid document

4) Have the Contractor confirm that he is able to carry out those procedures (and that, ultimately, he actually does)

That way you have something tangible to base your requirements (and subsequent monitoring) on, and the Contractor will know what's expected of him right from the onset.

Note as well that those procedures may also indicate what test equipment is needed to carry them out.

If your requirement is for real PM (that is, actual servicing rather than just "checking") ... then follow a similar process but ascertain the PM procedures instead. But be aware that this will probably involve the fitting of parts, and that will be an extra expense for you. So, using your binder of procedures, you will need to decide whether you will purchase the parts (and have the Contractor fit them), or leave it to the Contractor to do so (and then bill you ... unless both parties agree to a "including parts" deal).

For the Contractor, it will all be down to the time that he is committing to. And, as we all know, Time is Money!

* Performance Verification Procedure (rather than PM Procedure - as the later should include calibration and adjustment, and replacement of "lifed" parts as well as performance checks).

We managed to get user manuals (some details servicing requirements) but haven't got the service manuals. Oh well.. will have to stipulate service provider to source those, they will no doubt have a headstart on us in that regards.

Time is money, but I think we have enough to cover what we would be demanding

When we purchase anything now, it is our first words 'do you supply technical training and service manuals'. 'We want them added into the deal if you do, as well as all specialist test equipment'. Failure to comply means they get binned from the suppliers unless the ward want to take on the service contract and we have nothing to do with the equipment.

Don't all departments follow such a policy, then?