21 June 2011

A focus on Patient Safety: Stafford Hospital Inquiry. NPSA

MidStaffs Public inquiry Day 102.
Suzette Woodward  is Director of the National Patient Safety Agency. http://www.npsa.nhs.uk/
The NPSA is a small organisation working quietly in the background to try and understand issues which affect patient safety and to try and see what lessons can be learnt, and ways of changing practice for the better.  The existence of this organisation and the amazingly detailed work that it does goes some way to disprove the allegation that the Health service has not had sufficient emphasis on Quality and Safety. The output on their website is impressive. I would advise taking a look. Many safety issues have been identified and directed back the health service for action to be taken. A lot of progress has been made. One could perhaps argue that greater resources would have brought greater results, but funding is always an issue. The organisation is now set to close as a result of the “health reforms”, though some of its functions may be retained.
Dr Woodward worked with the agency since 2003 and became director in 2010.
The perception that people in Stafford may well have formed over the last few years is that adverse incidents quite rare and we have had an unusually high level of them in our hospital. I was of course interested to see if the evidence of Dr Woodward would support this perception.
She tells us that the NPSA now has data on over 7 million incidents.  These incidents are reported to the NPSA at the rate of around 3000 a day; Over 1 million every year.  Dr Woodward says this was initially a surprise to the organisation. They of course knew that “adverse incidents” do occur to around 1 in every 10 people who are treated in hospital, but they had initially been told that the culture of the NHS would be too defensive, and that people would not come forward on a voluntary basis to report things that go wrong.  They expected very small numbers of reports, and Dr Woodward thinks it is a measure of success that people came forward with reports from the beginning and the level of reporting has become steadily higher and more open.
It is probably worth saying that these incidents are graded. They vary from an incident in which there is no harm done, through to actual harm, severe harm and death.  We saw charts of how the pattern of reporting has changed over the 7 years.

As part of the task of bringing about an open and learning culture and moving away from an environment where staff are afraid to own up to mistakes  staff have been asked to get in the habit of reporting very minor incidents, as well as more worrying severe events.   In the open culture that Dr Woodward would like hospitals to foster there tends to be an increasing reporting of No harm and Low harm events, and a very much smaller number incidence of severe harm and deaths. This is where Stafford now is, though it is clear from Dr Woodward’s evidence that they did take time and training to get to this level.

One of the minor issues she picked up on was a matter of Coding. (The legal team are now correctly interested in how the hospital copes with coding whenever we see it, because we know that this was such a major contributor to the concerns about the mortality rates.)  We heard that the hospital initially was misunderstanding the coding requirement. They were coding a number of incidents where there was the potential of severe harm, as severe harm, when in no actual  harm or low harm had resulted. This is of particular importance with issues like falls which are one of the most common kinds of adverse incident.  

Dr Woodward indicated that coding anomalies are quite common with many smaller hospitals, and it did cross my mind that bigger hospitals may be able to support more specialist staff who can handle more of the paperwork and reporting systems. – this is just a thought – I do not know if it is accurate, or if anyone has done any research on this.  What do we know about the way in which different hospitals handle reporting and coding?

At the coffee break in the inquiry a number of people indicated their surprise about the numbers of severe harm and death related incidents for this hospital.

If there really had been unusually high numbers of people dying in Stafford Hospital it might be expected that we should see significantly high numbers in these categories.

Deaths related to an adverse incidents in 6 month swathes from April 2006 – to Sept 2009 came up as 0, 1, 0, 0, 4, 4, 5

Severe Harm incidents for the same period came up as 9, 23, 23, 28, 51, 68, 11

The System does rely on voluntary reporting so it may not give us a full picture, but with the more severe incidents and death it is reasonable to assume that reports would have generally been filed.

What we are seeing here is of course only those deaths and severe harm related to something identifiable that went wrong. Every one of these cases is clearly awful for the families involved. A real tragedy, and it is the job of the NPSA to try to find ways of learning as much as possible from every tragedy like this and to help the NHS to avoid such tragedies in the future.  But the pattern of reporting of adverse incidents for Stafford is something that does not stand out within the NHS.

If there have been unusually high numbers of deaths in Stafford, (which is of course an open and hotly disputed question) it does not look – at least on the evidence we saw- as if the explanation lies in terms of an unusually high level of adverse incidents.

Dr Woodward pointed out that there is a pattern across the NHS that nurses are far more likely to file adverse incident reports than doctors.

Dr Woodward explains that they had different levels of success with different kinds of problems, and there was a tendency to pick the low hanging fruit. If you have a tiny organisation it makes sense to do things that actually make a difference.   If you have a procedure that people were doing wrongly, then it was a simple matter to put out an analysis with this and advice, and work with the locally based advisors to change the procedure. If is something bigger, and she cited the matter of being more open with patients – something we all see as desirable – then this actually entails a massive cultural change, and Dr Woodward felt that you were looking at a minimum of 7 to 10 years to bring this kind of change about.

They had three and a half staff members to cover the 1 million reports they received each year. They had to prioritise, and they concentrated on the Deaths and Serious harm cases. These key cases picked on important things that had gone wrong with serious effect. They then drilled down into the huge data base to bring out evidence of how widespread the problem behaviour actually was within the NHS and to research ways of remedying the problem.

The Big issue of Staffing Levels
We saw some of the reports that had been sent in from Stafford internal Safeguarding system. Most  related most strongly to staffing levels. Some were clearly being written by nurses who were at the end of their tether, had just been doing a really difficult shift, and felt that the staffing levels had made it impossible for them to do their job properly. They read as if the nurses involved were “letting off steam”. They were using this avenue to emphasis the simple point that they did not have enough staff, and using it (as we know from previous evidence) with the clear knowledge that the reporting would increase the evidence in the ongoing staffing level review to argue for an increase in resources.

What we have heard from many witnesses to the inquiry is that during the period 2006 to 2007 staffing shortages were present throughout the NHS. More money had been spent on the NHS than was politically acceptable to the electorate. Money was tight everywhere, and there was no simple formula which would allow a hospital to demonstrate that it did not have the level of staffing it needed to cope with the kind of case load it was carrying.

With no formula to prove need and financial cut backs hospitals all over the country were struggling. For those nurses who were suffering and felt their patients were suffering because of this the reports which reached the NPSA leave us a powerful record of what it felt like to be there at that time.

There is a lengthy section on staffing starting at page 40 of the transcript.  This is worth reading in full. Here are some of the points I picked up on.

·         Staffing levels would not be seen as an issue that NPSA could focus on.
·         It would be seen as a local issue.
·         Royal colleges should be the lead bodies in ruling on staffing level needs.
·         THE CHAIRMAN: So if all trusts happen to be suffering the same sort of staffing shortage/safety issue, they're not  going to stand out? A: Correct.
·         940 incident reports relating to staffing levels at Stafford  between 2005 and 2010

Three reports from nurses given verbatim.

A report from a nurse: "For 18 bedded acute ward only one trained nurse and
6 one untrained on duty. Most of the night shift I start
7 with lots of outstanding jobs from previous shift.
8 Two/three confused patients who climbs out of bed. Some
9 patients who needed one to one care. 2200 hours
10 medications patients are getting at midnight or after.
11 Leaving the ward an going around to ACU/ward 2 to ask
12 for help. Checking IV antibiotics. This staffing level
13 at night shift particularly in ward 2 seriously
14 dangerous and this incident form I have done many times.
15 No action no feedback. I am very unhappy about patient
16 care."

"During the late shift there was no allocation of
21 staff to the four bedded CDU. Upon transferring
22 a patient from minor injuries to the CDU I found one
23 elderly a very distressed patient shouting for help.
24 Another patient said she had been shouting for hours.
25 When I assisted the patient on to the commode her bed
1 was soaked in urine which had started to dry. None of
2 the patients had nurse call buzzers. None of the
3 patients had been given any food or drink."

Yet again the experience and quantity of the
8 trained staff is not adequate to cover the floor safely.
9 There were only two trained staff who have experience to
10 do three jobs ..."

There is a lengthy exchange detween the Chairman and Dr Woodward on P49 of which this is part

THE CHAIRMAN: But if we look at the period during which
11 this was happening, what look on occasions to be quite
12 distressed members of staff are reporting distressing
13 incidents saying nothing has been done about it. If we
14 assume for the moment that the trust management was not
15 listening or capable or for whatever reason doing
16 anything about it, who else was?
17 A. Those types of incidents would not, unless the patient
18 had died, been generally reported as serious untoward
19 incidents. So it's unlikely that the PCT or the SHAs
20 would have been looking at those incidents. So it is
21 highly reliant on a good local risk management system.

This all raises some very difficult issues. It raises a stream of questions in my mind.
If it is something as fundamental as the level of staffing required to run the service well, then this is essentially like the elephant in the room.  You cannot see it in comparative data, because it is something that is happening across the board.  You cannot resolve it because there is neither the money nor the political will to do so. People will vote to protect the NHS, they will not vote for the taxes necessary to carry this through!
It is virtually impossible to agree a formula for staffing levels, because there are so many different vested interests. It becomes increasingly difficult as we shift to Foundation Trusts where staffing levels becomes commercially sensitive.
If the staffing levels are too low either in some or in all hospitals, then I think it is reasonable to assume this will increase the likelihood of adverse incidents.  As we heard in the evidence from the HPA a hospital operating under great stress is much more likely to suffer problems with infection.
People are not superhuman. If you put them under too much pressure individual staff will either work themselves to a standstill or standards will slip.

Mortality Rates
Dr Woodwards statement makes mention of the HSMR mortality rates, she has been asked to comment on why the NPSA did not pick up on the increased mortality rate identified by the Dr Foster Figures. Perhaps the underlying assumption behind this question is that if there were to be unusually high levels of mortality in a hospital then one might reasonably expect that some of these additional deaths would have to be accounted for by adverse incidents.
Dr Woodward points out that the NPSA does not rely on HSMR. The NPSA is looking at actual incidents and will only be notified of those  deaths which have been caused by an incident.
Dr Woodward does make reference to the need for a hospital to understand the systems for coding mortality, and especially co-morbidities well, in order to be able to gain reliable data from their mortality rate systems. 
The Seven Steps to Patient Safety
This is a simple way in which the NPSA has tried to bring about a safer culture within the NHS. You will find all the documentation related to this on their website.
The steps provide a simple checklist to help NHS organisations plan their activity and measure performance in patient safety. Following them will help ensure that the care they  provide is as safe as possible, and that when things go wrong the right action is taken. They will also help NHS organisations meet their current clinical governance, risk management and controls assurance targets.
The steps are:
1. Build a safety culture.
2. Lead and support your staff.
3. Integrate your risk management activity.
4. Promote reporting.
5. Involve and communicate with patients and the public.
6. Learn and share safety lessons.
7. Implement solutions to prevent harm.
 Looking to the Future.
Like many organisations in or close to the NHS, the future is uncertain. The NPSA will cease to exist, some of its functions will be taken up by the Commissioning body.  It remains to be seen what effect this will have on peoples willingness to report adverse incidents. Will this improve or threaten the desire to create an open culture.
There are many things that Susan Woodward would like to be doing now, but the re-organisation is taking its toll. Many new projects cannot now begin until after 2012. At the moment the priority is to  write legacy documents. I suspect these will be the matter of many future academic studies where we look back to see what we have lost.

Here are a few items off the NPSA website. Take a look! Nil by mouth study and recommendations http://www.nrls.npsa.nhs.uk/resources/?EntryId45=94854 http://www.nrls.npsa.nhs.uk/resources/collections/never-events/ never events