Care Bill [Lords]

Written evidence submitted by Ken Lownds (CB 34)

1. This is evidence about certain aspects of the Care Bill and particular Part 2 Clause 80 Duty of Candour and Clause 90 Offence and 91 Penalties.

2. From October 2008 until February 2013 I was a member of Julie Bailey’s campaign group Cure the NHS. Along with the other members of the group I was, therefore, a determined campaigner for the Public Inquiry which reported a year ago and for a radical improvement in the levels of patient safety afforded to NHS patients.

3. The Public Inquiry laid bare the lack of an appropriate regulatory system for the NHS. Healthcare worldwide is probably the only safety-critical sector lacking in appropriate regulatory structures; sadly the NHS is no exception.

4. The NHS and the UK care and healthcare sectors have many regulators but they each cover small parts of the whole. Robert Francis demonstrated how unsatisfactory this is; other safety-critical sectors tend to have a single regulator covering all aspects of the licensing of personnel and provider organisations.

5. UK civil aviation is regulated in an all-encompassing legislative structure which enables one body, "Civil Aviation Authoprity UK", to cover all elements of ensuring safety for UK air passengers.

6. One CAA UK "directorate" covers all elements of personnel, airline, and aircraft manufacturer regulation and licensing.

7. An entirely separate investigatory body, "The Aircraft Accident Investigation Branch , " reports to the Transport Secretary , and carries out all investigations of accidents and incidents .

8. The UK rail, maritime, nuclear, and offshore drilling sectors have similar structures regulating the safety of their operations.

9. The key suggestions set out in this document were conceived by me as a member of Cure the NHS after the publication of the Healthcare Commission’s report into Mid Staffs in March 2009. I drew on my own twenty years of experience working for a number of major airlines in ground operations roles, including in safety training roles, and believe strongly that a "single regulator" structure is essential for proper regulation, inspection and audit.

10. The suggestions were sent to Richmond House in a document called "Turning the NHS the Right Way Up" in Summer 2009 and then incorporated in extended form in the group’s submission to Steve Field’s "Future Forum" in October 2010. In December 2010 I set out a detailed account of the ideas in my written and oral evidence to the Public Inquiry. In December 2011 I incorporated the key suggestions as "A Blueprint for a New NHS" in the appendix to the group’s closing submission to the Public Inquiry. Viz:-

10a. Implementing Two Essential Systems

Develops an NHS "patient safety management system" which will set out the underlying patient safety principles and activities to enable zero harm to be delivered.

Charges each provider with developing a complementary "Patient Safety Management System" to turn the NHS system into a way of working for its own particular circumstances.

Develops NHS "Patient Care Quality Management System" to provide one authoritative source for all standards, procedures, policies, processes, protocols, and policies used in treating patients.

Charges each provider with developing a complementary "Patient Care Quality Management System" to turn the NHS system into a way of working for its own particular circumstances.

10b. Establishing a Single Regulatory Body

Establishes a "virtual single regulator" by immediately instigating a daily safety and quality review of NHS operations at chief executive level, instigated by the Care Quality Commission, with the participation of the chief executives of all of the current "regulatory" bodies.

Moves as quickly as possible, acknowledging the many organisational changes required, to turn the "virtual single regulator" into a "real single regulator", drawing under one umbrella all of the current bodies which carry out this task but in a way that is far too disjointed.

Safety and quality cannot be inspected or regulated into the NHS; it is the primary responsibility of frontline carers to deliver only safe, high quality care, and in effect to "regulate" themselves and their colleagues.

10c. "Stop and Make Safe" – Assuring Patients and Communities

Commands every provider to deliver regular "stop and make safe" sessions to its community, comprising standardised mortality ratios, anonymised serious incident reports, summarised and anonymised serious complaints, and other key safety and quality information.

10d. Drawing Coroners into the Assurance of Patient Safety and Quality of Care

Ensures that all medical examiners are appointed.

Ensures that inquests are held in all appropriate cases and that the verdicts become patient safety information at local and national level.

10e. Investigation of Healthcare Failures

Establishes a small team of healthcare investigators to move in when evidence of failure comes to light. This team would report directly to the Minister of State.

11. Other recommendations covered the transformations of culture essential to meet Cure the NHS’s goal that no other patient should ever again have to endure the appalling treatment and care which the patients of Mid Staffs Hospital endured.

12. Sadly these system and regulatory aspects of patient safety did not feature in the report of the public inquiry as an entity in spite of my presenting them in my own written and oral evidence and in spite of their featuring significantly in the closing submission of Cure the NHS. Robert Francis did of course addresses them widely in his 290 recommendations but I believe they should have been gathered together as elements of an identifiable system to be imposed wholesale on the NHS and other providers of both health care and social care. This should have been the framework for an entirely new legislative framework for patient safety.

13. I have now published in the iPad app Zero Harm Healthcare name available from the Apple "App Store" how the systems can be implemented at hospital level.

14. However the essence of Cure the NHS’s submission "Zero Harm, Right First Time", or at least the "Zero Harm" part, did feature in the Prime Minister’s presentation of Robert Francis’s report of the Public Inquiry in the House of Commons on 6 February 2013 in the House of Commons –

"….Quality of care means not accepting that bed sores and hospital infections are somehow occupational hazards-that a little bit of these things is somehow okay.

It is not okay; they are unacceptable-full stop, end of story. That is what Zero Harm means.

I have therefore asked Don Berwick, who has advised President Obama on this issue, to make zero harm a reality in our NHS."

15. So I believe that given the epoch-making impact which the Mid Staffs Hospital disaster has had on the NHS and the wider healthcare world that t here should be a comprehensive Bill to consolidate and cover all aspects of "patient safety and quality of treatment and care" . This vital subject which is as yet too-little discussed in any quarter but which lies at the heart of delivering the age-old maxim " do no harm " deserves its own Bill which is not only legislation but which forms the a uthoritative source for patient s and public to read how the law is framed to keep their loved ones and themselves safe and how health providers will be held accountable for their actions.

16. As a member of Cure the NHS I developed a substantial part of a layperson’s draft of such a Bill.

17. Until such a comprehensive piece of legislation is brought forward Part 2 Clause 80 Duty of Candour does seem a little bit of an orphan and a little brief. My belief is that a duty of candour anyway exists in the codes of conduct of doctors and nurses. Rather than have a general Duty of Candour as envisaged here I believe any duty additional to what already exists in the codes of conduct should be built into a "mandatory incident reporting system".

18. Indeed only recently NHS England have announced a strengthening of the system for patient safety alerts and it is as part of this system and the rapid generation of incident reports which are themselves the first element in the alerts loop that such a duty belongs.

19. That incident – alert system itself belongs within the Patient Safety Management System which I advocate above.

20. A mature an highly-successful system of this nature has been managed by UK CAA from many years and is well-worth some study.

21. I do not understand if Part 2 Clause 90 Offence and clause 91 Penalties are meant to apply to Clause 80 Duty of Candour admissions. If they are I urge the members of the Bill Committee to weigh very carefully to what extent investigations and legal processes should further to be brought into the healthcare environment beyond those which are already there and at the disposal of the Police and the Health and Safety Executive.

22. I am in no doubt that the disaster at Mid Staffs Hospital was first and foremost a failure of professional discipline and commitment which spread widely across the hospital staff. One could cite very many examples of similar failures. The Patient Safety Management System I advocate would provide the legislative structure to help prevent such failures, the cultural transformation set out in Blueprint for a New NHS would provide the behavioural change.

February 2014

Prepared 5th February 2014