1. The NHS (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011 Rachael Powell Investigations & Redress Manager

2. Redress Regulations Came into effect on 1st April 2011.
Defines “concerns” broadly to include expressions of dissatisfaction or complaints from patients and incidents reported by staff.
Removes Independent Review Panel Secretariat.
Introduces need to consider appropriateness of offering redress, up to £25k, where negligence accepted.

3. Redress Scope
Redress does NOT apply to Primary Care Providers or Independent Providers of care to the NHS.
Part 7 of the regulations relating to NHS organisations outside of NHS Wales comes into effect on 1st April 2012.
Regulations apply to Health Boards, Trusts and Primary Care providers (Independent providers of treatment are covered but excluded from redress).

4. Redress Stages 2 stages Local Resolution Public Service Ombudsman
Concerns may be raised by anyone who has used the service/facilities, or a relative/carer on behalf of a patient.
There is a 12 month time limit for raising concerns, although flexibility up to 3 years is expected.

5. Local Resolution Responsible Officer Senior Investigations Manager
Involve the Patient, even if concern raised through incident reporting
Learning lessons
Acknowledge within 2 days. Offer to discuss:
How the investigation will be conducted.
What advocacy services are available.
Likely timescale for completion.

6. Local Resolution
Investigation must be appropriate to severity and may include:
Invitation to meet with staff
Arranging independent opinion if necessary
Offering alternative dispute resolution
Once complete:
Response in 30 days, or inform complainant of reason for delay and confirm new timescales.

7. Redress
Part 6 requires Health Boards, but not primary care providers or independent providers of care, to consider if redress should be made.
If we believe there may have been negligence, we must:
Inform complainant
Provide copies of reports and evidence
Offer free legal advice
Offer financial redress up to £25k
Offer to provide care or treatment

8. Part 6: Redress Process Establish: if there is a duty of care?
has duty of care been breached?
has damage been caused?
Seek advice from WHLS regarding the amount of damages to be offered.
Send a memo to the Medical Director seeking authorisation to offer amount advised by WHLS.
A legal duty of care arises when the healthcare system accepts the patient.
Has the duty of care been breached? The patient must demonstrate that the standard of treatment provided fell below the expected standard.
Causation of damage. Did the healthcare provider’s acts or omissions
cause harm to the patient?
The claimant must prove all three elements to establish liability.

9. Redress (cont)
Redress cases soon to be reviewed by panel at Claims Sub Committee meetings.
Panel comprises of:
Non Executive Directors x 2
Medical Director
Nurse Director
Assistant Director of Governance.
They meet quarterly, and will effectively “approve” all Redress cases.(Each case will have been investigated, had qualifying liability established and been discussed with Solicitors at WHLS, both for advice on content of response letter and amount of money to be offered for damages).

10. Public Service Ombudsman for Wales
Those who are dissatisfied may write to the PSOW to ask for a further investigation.
PSOW won’t accept cases over 12 months old, unless good reason why not referred sooner.
PSOW has no power to enforce recommendations or order sanctions.
PSOW will report findings to WG.

11. Key Implications for NHS Wales Staff
Clinical engagement and culture of openness
Greater involvement of patients and families
Identifying themes and ensuring lessons are learned
Availability of free legal advice and advocacy
Assessment of qualifying liability
Investigative capacity and capability
Documenting concerns resolves at the point of delivery

12. Department of Investigation and Redress
Governance assurance is provided by an integrated, central DIR, whose role, as part of the overall risk management system is to:
Ensure concerns are managed in accordance with the Regulations
Identify corporately, through analysis of complaints, claims and incidents areas for concern where failures have/will occur
Centrally coordinate inquests concerning the Health Board
Ensure appropriate investigation of issues raised
Ensure that where failures are found, changes are made to either system design and/or personal approach such that the risk of the event happening again is eliminated or reduced to an acceptable level

13. Root Cause Analysis (RCA) Investigations
There are three levels of RCA investigation:
- Concise investigation
- Comprehensive investigation
- Independent investigation
Investigations should be conducted at a level that is appropriate and proportionate to the incident, claim, complaint or concern under review (please refer to NPSA guidance on Triggers for RCA investigation).

14. Root Cause Analysis (RCA) Investigations
There are three levels of RCA investigation:
- Concise investigation
- Comprehensive investigation
- Independent investigation
Investigations should be conducted at a level that is appropriate and proportionate to the incident, claim, complaint or concern under review (please refer to NPSA guidance on Triggers for RCA investigation).

15. Red/Amber Complaints and Incidents Process
Directorate or Locality to deal with
Datix Record opened and Complaint Acknowledged. Copy sent to relevant Executive/locality director
DIR
Concern Graded
DIR
Complaint Received
Green/ Yellow
Datix triggers sent to designated staff. Anything red or amber triggered to DIR Staff to establish necessary reporting.
Incident Reported via Datix
Red/Amber
Issue Final Terms of Reference
DIR Lead
Contact Complainant
DIR Lead with LI
Agree Lead Investigator (LI)
DIR Lead with Directorate/Locality
Draft Terms of Reference
DIR Lead
Undertake Investigation
Lead Investigator
Produce Investigation Report
Lead Investigator
Quality Assure Investigation Report
DIR Lead
Request Action Plan if appropriate
DIR Lead
Draft Response Letter
DIR Lead
Draft Action Plan
Directorate/Locality
Executive Director signature, Letter, Report and Action Plan Dispatch
DIR
Review and approval of Draft Response/cover Letter, Report and Action Plans
Clinical/Locality Director
Close off with Complainant/incident and close Datix Record
DIR Lead

16. Root Cause Analysis
National Patient Safety Agency – National Reporting and Learning Service resources available from:

17. Putting Things Right Information and leaflets are available from:
An e-learning package is available from:

18. Awareness Raising
In an effort to increase awareness, an information package has been developed which has been posted on the homepage of the intranet. It’s a tab on the left hand side entitled, “Putting Things Right.”

19. Thank you for listening Any questions?
My address is:
Tel: