Let me start with a quotation from easily the most useful medical textbook I have ever read - one that has actually helped me save lives,
(Speaking of operating in a developing country) 'In an emergency you may even have to operate by the light of a hurricane lantern. The light will attract insects, and these will fall into the wound, but even so they are unlikely to influence the patients' recovery'
The point being made here depends upon the concept of marginal risk reduction. Using surgery as the example there are a number of ways you progressively reduce the risk to the patient.
Firstly, choose your cases carefully.
Not opening an abdomen that doesn't need opening is always going to be safer. Of all the potential cases for laparotomy, 40% may not need surgery.
Pre-op: have a check-list - 15% risk further reduction
Good anaesthetic technique - 15% more, say
When you operate use sterile equipment - that's another 15% risk reduction
Use good surgical techniques - handle tissues gently and you have another 10%
Sterile gloves 2%, experienced assistant 2% and so on.
Each addition gives a marginal risk reduction which is subject to the law of diminishing returns.
So what if a moth falls in the wound (desirable if it doesn't of course and believe me fly screens are much more useful in Africa than here) but it only has a minor impact on outcome when all the rest is in place.
Using single use instruments will reduce risk further, but by nothing like as much as sterility. Similarly different scrub techniques of longer duration and newer antiseptics and laminar air flow and hotter water and plastic floors and de-cluttering and no touch taps all will help but, in ordinary primary care minor procedures, not detectably so when the rest is in place.
It is at these margins when already high levels of safety are in operation that I start to question the regulatory regimes. For new builds or major renovation, no problem; but when the margin of potential further benefit is small the risk of generating harm by perturbing an existing system becomes significant. If the process of implementing a regulation carries a greater risk than the potential marginal risk reduction it could bring, it is stupid to implement the regulation.
Let me relate the story of my tap.
At 5am on 28/4/2014 I was called to the surgery by our cleaners as one of 4 new automated taps, only changed to meet CQC regulations and done 3 days earlier, had flooded my consulting room, the corridor and part of a neighbouring room with over 30l of water, rendering it smelly and unusable for over a week. We had to employ a specialist cleaning company to make my room habitable again. Prior to this my single lever mono basin mixer tap had functioned for over 20 years (actually 7,390 days) without flooding, Legionnaires Disease or any attributable infection in well over 1000 minor procedures carried out in my office. The introduction of a new tap would appear to be at least 615 times (7,390 / [3x4]) more likely to cause an incident that damages patient care than the old tap in usual operation! As one of our lovely-wiser-than-CQC cleaners put it, 'If it ain't broke...'
In order to be sure of overall patient benefit from changing a system, the ongoing risk to patients from the old system must be greater than the risk to patients from the new system plus the risk to patients from the process of change-over. However, from our experience, it would seem that the maximum absolute risk reduction achievable by changing taps (which equals the absolute risk to patient care from the old taps) is likely well over 600 times smaller than the risk attributable to the process of changing the taps.
Should CQC have required that we only change taps at the end of their operational lives (ie when we have to incur the risk of change)? I wondered if CQC risk-assessed the implementation of their regulations by balancing achievable marginal risk reduction against the risk of system change. I asked Prof Steve Field at the RCGP Conference 2014 but I don't think he really 'got' the question and possibly I didn't ask it very clearly, so I still don't know. I didn't find anything on the CQC website on this.
Now maybe we were just exceptionally unlucky in having the only incident in the installation of at least 2,400 (4 x 600) taps or maybe my old tap was actually far more dangerous than direct observation suggests but it seems very unlikely.
This may seem a trivial example, but if it is generalisable there is a real chance that systematic damage is being done up and down the country in CQC's name. Tick box regulation: 'Have you got this new super tap Y/N?' is simple but at best simplistically naive and if it has not accounted for marginal risk properly, at worst it is negligent.
However, the risks are not confined to direct service delivery; there are opportunity costs and unquantifiable risks (but increasingly real as the GP recruitment crisis unfolds) such as the negative effect over-regulation might have on morale. We had to spend practice resource on these changes and as the marginal risk reduction is tiny then the benefit/cost ratio is also and may have been a lot smaller than say spending the money on increased staff. To spend on improperly assessed regulatory requirements is to waste NHS resource.
I would be grateful if CQC could reassure us that it routinely assesses the risk to patient care resulting from the process of implementation of its regulatory requirements and only insists on implementation where the overall risk is shown to be lower.