being open policy

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Being Open Policy(including requirements under Duty of Candour)

EQUALITY IMPACT

The Trust strives to ensure equality of opportunity for all both as a major employer and asa provider of health care. This Controlled Document Policy has therefore been equalityimpact assessed to ensure fairness and consistency for all those covered by it regardlessof their individual differences, and the results are shown in Appendix 4.

Version: 5Authorised by: Executive ApprovalDate authorised: February 2015Next review date: February 2017Document author: Director of Quality and Governance


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TAMESIDE HOSPITAL NHS FOUNDATION TRUST BEING OPEN POLICY

FINAL v5February 2015 Page 2 of 28CHECK THE INTRANET FOR THE LATEST VERSION

VERSION CONTROL SCHEDULE

Being Open Policy

Version Number Issue Date Revision comment

1 August 2007 First Issue

1.1 April 2008 Change to Trust logo and nameAmended training sectionAmended monitoring sectionEIA review & new appendix 4Typing errors and formatting

2.0 October 2009 Reviewed and significantly revised.Monitoring section reviewed andamended.

2.1 February 2010 Minor amendments requested forclarification by the Medical Director.Approved by Medical Director

3.0 October 2011 2011 Minor amendments to committeenames and references toappendices 1 and 3 inserted onpage 7.Updating of learning lessons sectionChanges to Training section

4 April 2014 Reviewed and significantly revised to reflectchanges in organisation.

5 February 2015 Revised and changes incorporated to includeDuty of Candour Requirements


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Contents

1. Introduction: ............................................................................................................ 4

2. Procedure Scope:.................................................................................................... 4

4. Fair Blame Culture .................................................................................................. 5

5.

Responsibilities:...................................................................................................... 5

6. Recognising when the Being Open Procedure needs to be Implemented:........ 6

7. Implementing the Being Open Procedure:*.......................................................... 8

Step 1: Healthcare Professional Pre-Meeting/Preparation e.g............................... 8Step 2: Planning the Preliminary Meeting with the Patient and/or their Carers. 8Step 3: Discussion with the Patient and/or their Carers:..................................... 9Out of Hours .............................................................................................................. 11Step 4: Documentation:........................................................................................... 11Documentation of the Being Open Discussion:..................................................... 12

Principle of Confidentiality: ..................................................................................... 12Step 5: Follow Up:.................................................................................................. 13

Step 6: Completing the process:.......................................................................... 13Communication with the Patient and/or their Carers:........................................... 13Continuity of Care:.................................................................................................... 14

8. Special Circumstances:........................................................................................ 14

(a) When a patient has died:................................................................................. 14(b) Being Open with Children:.............................................................................. 14(c) Patients with Mental Health Issues:............................................................... 15(d) Patients with Cognitive Impairment:.............................................................. 15

(e)

Patients with Learning Disabilities:............................................................... 15

(f) Patients who do not agree with the information provided:.......................... 16(g) Patients with different language or cultural considerations........................ 16(h) Patients with Different Communication Needs:............................................ 16

9. Patient Information and Support: ........................................................................ 16

10. Linking with External Stakeholders:.................................................................... 17

(a) Strategic Health Authority: ............................................................................. 17(b) Coroner:............................................................................................................ 17(c) General Practitioner: ....................................................................................... 17(d) Other Healthcare Organisations..................................................................... 18

11.

Being Open Training:............................................................................................ 18

12. Promotion of the Being Open Procedure:........................................................... 18

13. Other Relevant Policies and Procedures............................................................ 18

14. Monitoring compliance with this procedure:...................................................... 18

Appendix 1 - BEING OPEN PATIENT BRIEFING........................................................ 20

Appendix 2 - NPSA Terms and Definitions for Grading Patient Safety Incidents... 23

Appendix 3Saying Sorry .......................................................................................... 24

Appendix 4 - Equality Impact assessment.28


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1. Introduction:

Promoting a culture of openness is essential to improving patient safety and the qualityof services provided. It involves apologising and explaining what happened to patientswho have been harmed as a result of errors or problems with their healthcare

treatment. Tameside Hospital NHS Foundation Trusts Being Open procedure providesguidance on creating an environment where patients, their carers, healthcareprofessionals and managers all feel supported when things go wrong, and therefore,have the confidence to act appropriately.

The Trust is committed to the key principles of communicating patient safety incidentsas cited by the former National Patient Safety Agency, The National Health serviceLitigation Authority and NHS England. These are shown in Appendices 1, 2 and 3.

Procedure Aims:

The aim of the Being Open Procedure is to ensure systems are in place to:

(a) acknowledge, apologise and explain to patients and/or carers when things gowrong;

(b) conduct a thorough investigation into the incident (whether identified from Incidentreporting , complaint or claim) and reassure patients and/or their carers,healthcare teams and other healthcare organisations that lessons learned willhelp prevent the incident recurring;

(c) provide support to those involved, to cope with the physical and psychologicalconsequences of what happened

This procedure also aims to ensure that:

(d) communication with patients and/or their carers, following a patient safety incidenthas been handled in the most appropriate way, ensuring incidents are discussedfully in a timely and thoughtful manner

(e) there is improved understanding of incidents from the perspective of the patientand/or their carers

(f) lessons are learned from incidents that will help prevent them from happeningagain

(g) The Trust complies with requirements for Duty of Candour under Regulation 20 ofthe Care Quality Commission (CQC) registration requirements.

2. Procedure Scope:

The Trust recommends that where an incident leads to moderate, major or catastrophicharm or death, or where it is likely to lead to future harm or death then they bediscussed with patients and or/their carers. This document should be read inconjunction with the Trust Incident Reporting Policy, Incident and Complaints PolicyInvestigation Policy which describes how healthcare teams and other healthcareorganisations are engaged in the processes. This policy should also be consideredalongside Duty of Candour Regulatory Requirements for more information

http://www.cqc.org.uk/content/fit-and-proper-persons-requirement-and-duty-candour-nhs-bodies
http://www.cqc.org.uk/content/fit-and-proper-persons-requirement-and-duty-candour-nhs-bodieshttp://www.cqc.org.uk/content/fit-and-proper-persons-requirement-and-duty-candour-nhs-bodieshttp://www.cqc.org.uk/content/fit-and-proper-persons-requirement-and-duty-candour-nhs-bodieshttp://www.cqc.org.uk/content/fit-and-proper-persons-requirement-and-duty-candour-nhs-bodies


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4. Fair Blame Culture

The Trust actively encourages the use of the National Patient Safety Agency (NPSAs)Incident Decision Tree as the required framework for managers in deciding upon acourse of action to take with a member of staff following a serious patient safetyincident. The Incident Decision Tree was developed through consultation with the

National Clinical Assessment Service (NCAS), the Royal Colleges, the Audit Office,staffside organisations and clinicians. It poses a series of structured questions aboutthe individuals actions, motives and behaviour at the time of the incident. The treehelps to support the Trusts open and fair culture and further details are available fromthe Trusts Serious Untoward Incident Procedure.

The Trust will also:

Ensure that formal and informal debriefing for those staff involved in a patient safetyincident, takes place when appropriate (see procedure for supporting staff involvedin incidents, complaints and claims).

Provide opportunities for healthcare staff involved in the being open process todiscuss their involvement and/or the circumstances leading up to the patient safetyincident and what they are going to say

Ensure that information is provided through the Trusts Occupational Health Service(see procedure for supporting staff involved in incident complaints and claims).

5. Responsibilities:

(a) Trust Board - is collectively responsible for ensuring that mechanisms are in placefor proper reporting, recording, investigation and treating of all incidents. TheExecutive and Non-Executive leads responsible for Quality and Governance in the

Trust are the Leads responsible for leading the Being Open Policy and Duty ofCandour requirements. All serious untoward incidents that result in catastrophicharm, where patients and/or their carers have been consulted, must be reported tothe Board. This will occur in part II of the Trust Board. (The Quality andGovernance Committee, reviews data on a systematic basis with regard to the typesand numbers of incidents and the lessons that have been learned).

(b) Chief Executive must be informed of all incidents that result in major orcatastrophic harm, where patients and/or their carers have been consulted andensure that appropriate action is being taken. Action has been delegated to theTrusts Quality and Governance Unit.

(c) Non-Executive Directors The Non-Executive Lead for Quality and GovernanceCommittee is the nominated lead for this policy from a Non-Executive Directorperspective

(d) Medical Director - Lead Executive Director for Being Open - Must be informed, inadvance of the patient/and or their relative being notified, of all incidents leading tomajor or catastrophic harm or death (or where it is likely to lead to future harm ordeath). The Medical Director and Director of Quality and Governance willencourage staff to feel safe in reporting all incidents, through an established positiveand fair blame approach to handling all incidents.

(e) Director of Nursing - Supports the Chief Executive, Medical Director and Directorof Quality and Governance in discovering the circumstances of the incident, and

ensures that appropriate communications/discussions with patient/carers havetaken or will take place. Through the Divisions/Directorates promote the BeingOpen procedure and Duty of Candour requirements with medical staff.


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(f) Director of Quality and Governance - Must ensure that the Risk ManagementStrategy and Plan and underpinning policies support a culture where Being Openand Duty of Candour can be embedded into every day practice and service deliveryand supports the Director of Nursing and Medical Director.

(g) Complaints and PALs Officers- Must ensure the Trust policy and procedure forcomplaints and claims handling supports a culture of being open and that

complainants are actively encouraged to attend a meeting with senior members ofTrust staff to discuss their complaint in the spirit of Being Open and Duty ofCandour and ensure complaints meetings are documented to the Being Openminimum standard. The Patient Advice and Liaison Service - Can be accessedby patients and carers if they feel they would benefit from additional support inliaising with the relevant staff to find out why an incident has occurred.

(h) Divisional General Managers / Clinical Directors / Divisional GovernanceLeads - Should be informed, in advance of the patient/and or their relative beingnotified, of all incidents leading to moderate, major or catastrophic harm or death (orwhere it is likely to lead to future harm or death). The Divisional Management teamwill confirm the way forward for liaising with the patient/carer in line with Duty of

Candour requirements and the Being Open Procedure.(i) Healthcare Professionals/Clinicians/Nurse Leads -All Clinicians must be aware

of the procedure of Being Open, and Duty of Candour requirements and the needto inform and discuss adverse events with the patient/carers, in line with thisProcedure. Any member of staff, who believes that a colleague is not following thisprocedure after an incident, should discuss with their line-manager.

(j) All Staff - To take action in line with the Being Open Procedure and Duty ofCandour requirements and ensure that incidents leading to moderate, major orcatastrophic harm or death (or where it is likely to lead to future harm or death) arereported to the key officers described in this procedure in order for the Duty ofCandour requirements and Being Open procedure to be implemented.

6. Recognising when the Duty of Candour requirement is applicable and when theBeing Open Procedure needs to be Implemented:

As soon as a patient safety incident is identified, the top priority is prompt andappropriate clinical care and prevention of further harm. The Trusts Policy andProcedure for Incident Reporting and Management must be followed. If an incident isretrospectively identified from a complaint or claim then these respective processesmust be followed. Depending on the seriousness of the incident, the Trusts SeriousUntoward Incident Procedure and the investigation / Root Cause Analysis proceduremust be followed.

All incidents must be assessed initially by the healthcare team to determine the level ofresponse required and then discussed with the Quality & Governance Team via theHead of Patient Safety and Risk Management and Director of Quality and Governanceif it is considered that a high level of response is required. However, it is recognisedthat such incidents may also come to light via Complaints, PALS contacts or Inquests.


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The level of response to patient safety incidents depends on the nature of the incidentas follows:

Acknowledging/apologising and explaining

Level of

harm causedby Incident

Action Required

Prevented ornear misspatient safetyincidents)

Patients will not normally be contacted or involved in investigationsand these types of incidents are outside the scope of the TrustsBeing Open and Duty of Candour procedures however complaintsinvolving such circumstances may require the Being Open principlesto be adopted these circumstances will come to light during aninvestigation and any complaints meetings

Insignificant /Minor Harm

Unless there are specific indications or the patient requests it, thecommunication, investigation and analysis and the implementation ofchanges will occur at local service delivery level, with the

participation of those directly involved in the incident, howevercomplaints involving such circumstances may require the BeingOpen principles to be adopted these circumstances will come tolight during an investigation and any complaints meetings.

How will this be done?

Acknowledgment, apology and explanation will be communicated inthe form of an open discussion between the staff providing thepatients careand the patient and/or their carers. Documentation willbe in the form of either patients records, letters to patients or notes ofmeetings with patients. Reporting to the Quality and Governance Unit

will occur through standard incident reporting mechanisms orcomplaints & claims process and be analysed centrally to detect highfrequency events. Review will occur through aggregated trend dataand local investigation. Where the trend data indicates a pattern ofrelated events, further investigation and analysis may be needed.

Moderate,Major,CatastrophicHarm, ordeath (orwhere it islikely to leadto futureharm ordeath)

A higher level of response is required in these circumstances. TheDirector of Quality & Governance should be notified immediately andbe available to provide advice on Duty of Candour and support andadvice during the Being Open process if required. Acknowledgment,apology and explanation will be communicated in the form of an opendiscussion between the staff providing the patients care and thepatient and/or their carers where possible. Documentation will be inthe form of either patientsrecords, letters/leaflets to patients or notesof meetings with patients. Duty of Candour requires that as soon asreasonably practicable after becoming aware that a notifiable safetyincident has occurred the Trust must notify the patient/relevantperson of the incident. The NHS Standards Contract requires thatthis be at most 10 working days of the incident being reported to localsystems. The Trusts Being Open Procedure and Duty ofCandour requirements are therefore implemented Complaintsand Litigation officers will initiate this process during the course

of Complaints/Claims investigations as cited in the respectivepolicy. Written letters will acknowledge, apologise and explainwhen things go wrong in such circumstances.


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7. Implementing the Being Open Procedure:*

Step 1: Healthcare Professional Pre-Meeting/Preparation e.g.

A pre-meeting / discussion amongst healthcare professionals should be held / had, inadvance of meeting with the patient and/or their carers, so that everyone knows the

facts and understands the aims of the meeting with the patient/and or their carer.

Step 2: Planning the Preliminary Meeting with the Patient and/or their Carers

Any meeting with the Patient and/or their Carers should be held as soon after theincident as possible, taking the following into consideration:

(a) The patients and/or their carers home and social circumstances(b) Ask the patient and/or their carers who they would like to be present(c) Check that the patient and/or carer is happy with the timing and venue of

the meeting

(d) Offer them a choice of times and confirm the chosen date in writing(e) Do not cancel the meeting unless absolutely necessary

It is acknowledged that incidents may be identified retrospectively. In the case ofclaims, management of meetings with patients will be at the discretion of legal teamsand in the case of complaints the complaints meeting team will need to consider theserequirements.

In addition, consider the following when deciding who should attend the meeting:

There must be a lead staff member present who is normally the most senior person

responsible for the patients care and/or someone with experience and expertise in thetype of incident that has occurred. This could either be the patients Consultant, NurseConsultant or any other Healthcare Professional who has a designated caseload ofpatients. They should have received training or have relevant experience, incommunication of patient safety incidents and ideally, have the followingcharacteristics:

(a) Be known to, and trusted by the patient and/or their carers;(b) Have a good grasp of the facts relevant to the incident;(c) Be senior enough or have sufficient experience and expertise in relation to

the type of patient safety incident to be credible to patients, carers andcolleagues;

(d) Have excellent interpersonal skills, including being able to communicatewith patients and/or their carers in a way they can understand and avoidexcessive use of medical jargon;

(e) Be willing and able to offer an apology, reassurance and feedback topatients and/or their carers;

(f) Be able to maintain a medium to long term relationship with the patientand/or their carers, where possible, and to provide continued support andinformation; and

(g) Be culturally aware and informed about the specific needs of the patient

and/or their carers


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The person taking the lead should be supported by at least one other member of staff,for example, a member of the healthcare team treating the patient, Head of Nursing /Midwifery/ Divisional General Managers, Head of Patient Safety, Head of Complaintsand PALs, the Director of Nursing, the Medical Director, the Clinical Director, DivisionalGovernance Lead, the Service Manager and/or Complaints Officers.

Where a junior healthcare professional has been involved in a patient safety incidentand asks to be involved in the Being Open discussion they must be accompanied andsupported by a senor team member. It is unacceptable for junior staff to communicatepatient safety information alone or to be delegated the responsibility to lead a BeingOpen discussion unless they volunteer and have received appropriate training andmentorship for this role.

Ensure that those members of staff who do attend the meetings can continue to do so;continuity is very important in building relationships. In exceptional circumstances, ifthe healthcare professional who usually leads the Being Open discussion cannotattend, they may delegate to an appropriately trained substitute. The substitute may be

the clinician responsible for risk, or someone of similar experience.

Consider each team members communication skills; they need to be able tocommunicate clearly, sympathetically and effectively.

The meeting must be held in a quiet room / area where team members will not bedistracted by work or be interrupted wherever possible. Do not host the meeting nearto the place where the incident occurred as this may be difficult for the patient and/ortheir carers. It may be appropriate to visit the patient/carer in their own home, or othervenue of their choice or in an office without a desk as a barrier.

Step 3: Discussion with the Patient and/or their Carers:

When approaching the patient and/or their carers, speak to them as you would wantsomeone in the same situation to communicate with a member of your own family. Donot use jargon or acronyms. Use clear, straightforward language. Consider the needsof patients with special circumstances, for example, linguistic or cultural needs andthose with learning disabilities or children and young persons.

Discussions with the patient and/or their carer should be based on the followingguidance:

(a) The patient and/or their carers should be advised of the identity by theperson leading the discussion and role of all people attending the BeingOpen discussion before it takes place. This allows them to state their ownpreferences about which healthcare staff should be present.

(b) There must be an expression of genuine sympathy, regret and an apologyfor the harm that has occurred, see Saying Sorry, appendix 3.

(c) The facts that are known are agreed by the multidisciplinary team. Wherethere is disagreement, communication about these events should bedeferred until after the investigation has been completed. The patientand/or their carers should be informed that an incident investigation is

being carried out and more information will become available as itprogresses.


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(d) It must be made clear to the patients and/or their carers that new facts mayemerge as the incident investigation proceeds.

(e) The patients and/or carers understanding of what happened should betaken into consideration, as well as any questions they may have.

(f) There must be consideration and formal noting of the patients and/orcarers views and concerns, and demonstration that these are being heard

and taken seriously(g) Appropriate language and terminology should be used when speaking topatients and/or their carers. For example, using the terms patient safetyincident or adverse event may be meaningless and at worst insulting to apatient and/or their carers. It is also important to consider language needsi.e. if they would like the discussion conducted in another language, thenthis should be arranged.

(h) An explanation must be given about what will happen next in terms of thelong term treatment plan and incident analysis findings

(i) Information on likely short and long term effects of the incident (if known)should be shared. The latter may have to be delayed to a subsequent

meeting when the situation becomes clearer.(j) An offer of practical and emotional support should be made to the patient

and/or their carers. This may involve getting help from third parties suchas charities and voluntary organisations as well as offering more directassistance. Information about the patient and the incident should notnormally be disclosed to third parties without consent.

(k) Patients and or their carers may be anxious, angry and frustrated, evenwhen the Being Open discussion is conducted appropriately. It is essentialthat speculation, attribution of blame, denial of responsibility and providingconflicting information from different individuals does notoccur.

(l) Introduce and explain the role of everyone present to the patient and/or

their carer and ask them if they are happy with those present.(m) Acknowledge what happened and apologise on behalf of the team and the

organisation. Saying sorry is not an admission of liability.(n) Stick to the facts that are known at the time and assure them that if more

information becomes available, it will be shared with them.(o) Suggest sources of support and counselling as appropriate(p) Check they have understood what you have told them and offer to answer

any questions(q) Provide a named contact who they can speak to again

Principle of Apology:

The Trust requires patients and /or their carers to receive a sincere expression ofsorrow or regret for the harm that has resulted from a patient safety incident. Thisshould be in the form of an appropriately worded and agreed manner of apology asearly as possible. Both verbal and written apologies should be given. The appropriatemember of staff to issue these apologies to patients and/or their carers will bedependent upon local circumstances. The decision should consider seniority,relationship to the patient, and experience and expertise in the type of patient safetyincident that has occurred.

Verbal apologies are essential because they allow face-to-face contact between thepatient and/or their carers and the healthcare team. This should be given as soon asstaff are aware an incident has occurred. It is important not to delay for any reason,


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including: setting up a more formal multi-disciplinary being open discussion with thepatient and/or their carers; fear and apprehension; or lack of staff availability. Delaysare likely to increase the patients and/or their carers sense of anxiety, anger orfrustration. It is reported that patients are more likely to seek medico-legal advice ifverbal and written apologies are not delivered promptly. A record of the apologyshould be made in the patients health record.

A written apology, which clearly states the Trust, is sorry for the suffering and distressresulting from the incident must also be given.

The National Health Service Litigation Authority have identified that such an expressionof regret would not normally constitute an admission of liability, either in part or in full.Staff wishing to clarify this position should contact the Director of Quality & Governanceor if unavailable another member of the Quality and Governance Unit, in the case of aprima facia claim of negligence legal advice will be sought in relation to the nature ofthe apology.

Principle of Truthfulness, Timeliness and Clarity of Communication:

The Trust requires information about a patient safety incident to be given to patientsand/or their carers in a truthful and open manner by an appropriately nominated person.Patients want a step-by-step explanation of what happened that considers theirindividual needs and is delivered openly.

Communication must also be timely, patients and/or carers should be provided withinformation about what happened as soon as practicable. It is also essential that anyinformation given is based solely on the facts known at the time. Healthcare staffshould explain that new information may emerge as an incident investigation is

undertaken, and patients and/or their carers will be kept up-to-date with the progress ofan investigation. The Duty of Candour Regulations require that information be given assoon as is reasonably practicable and be given in writing so later than 10 days after theincident was reported through the local systems

Patients and/or their carers must receive clear, unambiguous information and be givena single point of contact for any questions or requests they may have. They should notreceive conflicting information from different members of staff, and using medical jargonwhich they may not understand should be avoided.

Out of Hours

Depending on the severity of the incident, if an incident occurs out of hours, theinformation must be escalated to the appropriate people i.e. Senior Manager on-callwho will escalate to the Director on-call if appropriate.

Step 4: Documentation:

Documentation of Records:

The communication of patient safety incidents must be recorded. Required documentation

during a discussion includes the following:


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(a) A copy of the relevant medical information, which must be filed in thepatients medical records

(b) Incident Report (original complaint or claim) and record of the investigationand analysis process. This must be stored separately to the patientsmedical records as a patient safety incident record/ claims/ complaint andkept as part of the Trusts governance reports.

Documentation of the Being Open Discussion:

There should be a written record of:

(a) The time, place, *date (as minimum) as well as the name and relationshipsof all attendees;

(b) The plan for providing further information to the patient and/or their carers;(c) Offers of assistance and the patients and/or carers response(d) Questions raised by the family and/or carers or their representatives and

the answers given *;

(e) Plans for follow up as discussed;(f) Progress notes relating to the clinical situation and an accurate summary of

all the points explained to the patient and/or their carers;(g) Copies of letters sent to patients, carers and the GP for patient safety

incidents not occurring within primary care(h) Copies of any statements taken in relation to the patient safety incident(i) A copy of the incident report(j) A summary of the being open discussion*

*The Trust minimum expectation in any discussion the other areas are providedas guidance and are best practice

This written record must be retained with the incident report/complaint/claim file,documentation in the form of notes of meetings with Patients, Families, Carerswill be acceptable

Principle of Confidentiality:

The Trust requires the procedure for Being Open to give full consideration of, andrespect for, the patients and/or their carers and staff privacy and confidentiality.Details of a patient safety incident should at all times be considered confidential. Theconsent of the individual concerned should be sought prior to disclosing informationbeyond the clinicians involved in treating the patients. Where this is not practicable oran individual refuses to consent to the disclosure, disclosure may still be lawful ifjustified in the public interest or where those investigating the incident have statutorypowers for obtaining information. Communications with parties outside of the clinicalteam should also be on a strictly need-to-know basis and, where practicable, recordsshould be anonymous. In addition, it is good practice to inform the patient and/orcarers about who will be involved in the investigation before it takes place, and givethem the opportunity to raise any objections.


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Step 5: Follow Up:

Following discussion with the team, a preliminary follow up discussion with the patientand/or their carers is an important step in the Being Open process. The followingguidelines should assist in making the communication effective:

(a) The discussion should occur at the earliest practical opportunity(b) Consideration should be given to the timing of the meeting, based on boththe patients health and personal circumstances

(c) Consideration should be given to the location of the meeting e.g. thepatients home

(d) Feedback should be given on progress to date and information provided onthe investigation process

(e) There should be no speculation or attribution of blame. Similarly, thehealthcare professional communicating the incident must not criticise orcomment on matters outside of their own experience

(f) The patient and/or their carers should be offered an opportunity to discuss

the situation with another relevant professional where appropriate(g) A written record of the discussion should be kept and shared with the

patient and/or their carers(h) All queries should be responded to appropriately(i) If completing the process at this point, the patient and/or their carers

should be asked if they are satisfied with the investigation and a note ofthis made in the patients records

(j) The patient should be provided with contact details so that if further issuesarise later, there is a conduit back to the relevant healthcare professionalsor an agreed substitute.

Step 6: Completing the process:

Communication with the Patient and/or their Carers:

After completion of the incident investigation, feedback should be in writing unless thisis not acceptable to the patient or relevant person. Whatever method is used, thecommunication should include:

(a) The chronology of clinical and other relevant facts(b) Details of the patients and/or their carers concerns and complaints(c) A repeated apology for the harm suffered and any shortcomings in the

delivery of care that led to the patient safety incident(d) A summary of the factors that contributed to the incident(e) Information on what has been and will be done to avoid recurrence of the

incident and how these improvements will be monitored

It is expected that in most cases there will be a complete discussion of the findings ofthe investigation and analysis. In some cases, information may be withheld orrestricted, for example, where investigations are pending a coroners inquest, or wherespecific legal requirements preclude disclosure for specific purposes. In these casesthe patient will be informed of the reasons for the restrictions.


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Continuity of Care:

When a patient has been harmed during the course of treatment and requires furthertherapeutic management or rehabilitation, they must be informed, in an appropriate way, ofthe ongoing clinical management plan. This may be encompassed in discharge planningpolicies addressed to designated individuals such as the referring GP when the patient

safety incident had not occurred in primary care.

Patients and/or their carers must be reassured that they will continue to be treatedaccording to their clinical needs, even in circumstances where there is a dispute betweenthem and the healthcare team. They should also be informed that they have the right tocontinue their treatment elsewhere if they have lost confidence in the healthcare teaminvolved in the patient safety incident.

8. Special Circumstances:

The following gives guidance on how to manage different categories of patient

circumstances:

(a) When a patient has died:

When a patient safety incident has resulted in a patients death, it is crucial thatcommunication is sensitive, empathic and open. It is important to consider the emotionalstate of the bereaved relatives or carer and to involve them in deciding when it isappropriate to discuss what has happened. The patients family and/or carers will needinformation on the processes that will be followed to identify the causes(s) of death.Establishing open channels of communication may also allow the family and/or carers toindicate if they need bereavement counselling or assistance at any stage. Duty of Candour

requirements are that the family are informed of the incident and investigation within 10days of the incident being reported.

In certain circumstances, the Trust may consider it appropriate to wait for the coronersinquest before holding the Being Open discussion with the patients family and/or carers(refer to section 10b, page 16). The coroners report on post mortem findings is a keysource of information that will help to complete the picture of events leading up to thepatientsdeath. In any event, an apology should be issued as soon as possible after thepatients death, in line with Duty of Candour requirements together with an explanation thatthe coroners process have been initiated and a realistic timeframe of when the familyand/or carers will be provided with more information.

The Governance Unit will offer support and advice on this process.

(b) Being Open with Children:

The legal age of maturity for giving consent to treatment is 16. It is the age at which ayoung person acquires the full rights to make decisions about their own treatment and theirright to confidentiality becomes vested in them rather than their parents or guardians.However, it is still considered good practice to encourage competent children to involvetheir families in decision making.

The courts have stated that younger children who understand fully what is involved in theproposed procedure can also give consent. This is sometimes known as Gillick


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competence or the Fraser guidelines. Where a child is judged to have the cognitive abilityand the emotional maturity to understand the information provided, he/she should beinvolved directly in the Being open process after a patient safety incident.

The opportunity for parents to be involved should still be provided unless the childexpresses a wish for them not to be present. Where children are deemed not to have

sufficient maturity or ability to understand, consideration needs to be given to whetherinformation is provided to the parents alone or in the presence of the child. In theseinstances the parents views on the issue should be sought. More information can befound on the Department of Healths website:www.doh.gov.uk

(c) Patients with Mental Health Issues:

Being open for patients with mental health issues should follow normal procedures, unlessthe patient also has cognitive impairment (see below). The only circumstances in which it isappropriate to withhold patient safety incident information from a mentally ill patient is whenadvised to do so by a consultant psychiatrist who feels it would cause adverse

psychological harm to the patient. However, such circumstances are rare and a secondopinion (by another consultant psychiatrist) would be needed to justify withholdinginformation from the patient. Apart from in exceptional circumstances, it is neverappropriate to discuss patient safety incident information with a carer or relative without theexpress permission of the patient. To do so is an infringement of the patients humanrights.

(d) Patients with Cognitive Impairment:

Some individuals have conditions that limit their ability to understand what is happening tothem. They may have authorised a person to act on their behalf by an enduring power of

attorney. In these cases steps must be taken to ensure this extends to decision makingand to the medical care and treatment of the patient. The Duty of Candour requirementsand Being open discussion would be held with the holder of the power of attorney. Wherethere is no such person the clinicians may act in the patients best interest in deciding whothe appropriate person is to discuss incident information with, regarding the welfare of thepatient as a whole and not simply their medical interests. However, the patient with acognitive impairment should be involved directly in communications about what hashappened. An advocate with appropriate skills should be available to the patient to assist inthe communication process.

This should be read in conjunction with Trust Policies and the Mental Health Capacity Act

(e) Patients with Learning Disabilities:

Where a patient has difficulties in expressing their opinion verbally, an assessment shouldbe made about whether they are also cognitively impaired (see above). If the patient is notcognitively impaired they should be supported in the Being open process by alternativecommunication methods (i.e., given the opportunity to write questions down). An advocate,agreed on in consultation with the patient, should be appointed. Appropriate advocatesmay include carers, family or friends of the patient. The advocate should assist the patientduring the Being open process, focusing on ensuring that the patients views are

considered and discussed.

This should be read in conjunction with Trust Policies and Mental Health Capacity Act
http://www.doh.gov.uk/http://www.doh.gov.uk/http://www.doh.gov.uk/


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(f) Patients who do not agree with the information provided:

Sometimes, despite the best efforts of healthcare staff or others, the relationship betweenthe patient and/or their carers and the healthcare professional breaks down. They may notaccept the information provided or may not wish to participate in the Being open process.In this case the following strategies may assist:

deal with the issue as soon as it emerges where the patient agrees, ensure their carers are involved in discussions from

the beginning ensure the patient has access to support services where the senior health professional is not aware of the relationship difficulties,

provide mechanisms for communicating information, such as the patientexpressing their concerns to other members of the clinical team

offer the patient and/or their carers another contact person with whom they mayfeel more comfortable. This could be another member of the team or theindividual with overall responsibility for risk management

use a mutually acceptable mediator to help identify the issues between thehealthcare organisation and the patient, and to look for a mutually agreeablesolution

ensure the patient and/or their carers are fully aware of the formal complaintsprocedures

write a comprehensive list of the points that the patient and/or their carerdisagree with and reassure them you will follow up these issues and respond tothem within an agreed timescale.

(g) Patients with different language or cultural considerations

The need for translation and advocacy services, and consideration of special culturalneeds (such as for patients from cultures that make it difficult for a woman to talk to a maleabout intimate issues), must be taken into account when planning to discuss patient safetyincident information. It would be worthwhile to obtain advice from an advocate or translatorbefore the meeting on the most sensitive way to discuss the information. Avoid usingunofficial translators and/or the patients family or friends as they may distort informationby editing what is communicated. The Trust has access to translation services, and furtherinformation can be provided through the Patient Advice and Liaison Service or the Equalityand Diversity Officer

(h) Patients with Different Communication Needs:

A number of patients will have particular communication difficulties, such as a hearingimpairment. Plans for the meeting should fully consider these needs. Knowing how toenable or enhance communications with a patient is essential to facilitating an effectiveBeing open process, focusing on the needs of individuals and their families and beingpersonally thoughtful and respectful.

9. Patient Information and Support:

Patients and/or their carers may need considerable practical and emotional help and

support after experiencing a patient safety incident. It is therefore important to discusstheir individual needs with the patient and/or their carers.


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Support may also be provided by the following:

The patients family Social Workers Religious Representatives Independent Complaints Advocacy Service (ICAS)

Where the patient needs more detailed long term emotional support, advice should beprovided on how to gain access to appropriate counselling services.

The Trust will provide information on services offered by all the support agencies, includingcontact details that can give emotional support, help the patient identify the issues ofconcern, support them at meetings with staff and provide information about appropriatecommunity services.

The Trust will also provide information on the Being openprocess, in the form of a shortinformation briefing, explaining what to expect (Appendix 1). Information on how to make a

formal complaint/and or any other available means of giving positive or negative feedbackto healthcare staff involved in their care should also be provided in line with the TrustsComplaints Management Procedure.

10. Linking with External Stakeholders:

(a) Commissioners / NHS England:

In line with the Trusts Serious Untoward Incident procedure, the Trust is required to reportall serious untoward clinical incidents meeting StEIS criteria to the, Commissioners andRegional Director of Public Health on relevant cases, via the Strategic Executive

Information System (StEIS). The Director of Quality and Governance will facilitatereporting via the StEIS in line with current guidelines. Please refer to the Trusts IncidentReporting Policy for further guidance.

(b) Coroner:

All cases of untimely, unexpected or unexplained death and suspected unnatural deathsneed to be reported to the coroner. A coroner may request that the case not be discussedwith other parties until the facts have been considered. If necessary, the coroner willadvise on whether an apology should proceed. However this should not precludefulfillment of Duty of Candour requirements a verbal and written apology or expression ofregret where appropriate. In this situation it should be made clear to the family that a fulldiscussion of the circumstances and any residual concerns will be arranged at a date tosuit both parties after the coroners assessment is finished. It should also be recognisedthat coroners investigations are stressful for patients family, their carers and healthcareprofessionals. Bereavement counseling and advice on professional support groups shouldbe offered at the outset of a coroners investigation.

(c) General Practitioner:

Consideration should be given to contacting the referring GP at an early time for incidents

that have not occurred within primary care, but have implications for continuity of care. Byinforming them, they can offer their support to the patient and/or their carers.


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(d) Other Healthcare Organisations

The Trust Policies on Incident Reporting, Claims Management and ComplaintManagement, identifies how Healthcare teams and partner Healthcare organisations will

be communicated with, the principle outlined in this document apply to those partners.

11. Being Open Training:

Being Open training will be provided to key healthcare professionals and clinicians as partof the Trust investigation training programme and complaints training programme, andthose staff who may be involved in communicating a patient safety incident either to thepatient and/or their carer.

12. Promotion of the Being Open Procedure:

The Trusts Being Open Procedure will be promoted as follows:

(a) A statement will be made promoting the procedure to the public, to demonstrate theTrusts commitment to being open.

(b) A Patient Information Briefing will be available for all patients and/or their carers.(Appendix 1). Reference to the Being Open process will be included in theinformation leaflet provided to patients/relatives/carers who wish to raise concernsor make a complaint

(c) In order to be able to conduct the Being Open Procedure, training will be provided tokey clinicians and those staff who may be involved in the Being Open process, asdescribed in section 11 of this procedure

13. Other Relevant Policies and Procedures

This procedure document is to be adhered to, in conjunction with following Trust Policies:

Procedure for Incident Reporting and Management Serious Untoward Incident Procedure Investigation and Root Cause Analysis Procedure Complaints Policy and Procedure Claims Management Procedure

14. Monitoring compliance with this procedure:

From April 2014 the Quality and Governance Unit will monitor the application andeffectiveness of this policy. This will be undertaken by, as a minimum, each calendaryear carrying out an audit in respect of applying the Being Open Policy. The audit willspecifically, as a minimum, monitor the process of open communication anddocumentation requirement by undertaking a retrospective review of incident reportsrated moderate or above, complaints and claims.

As a minimum 15 incidents, 20 complaints, 10 claims and 10 serious untoward

incidents (or less if less than 10 SUIs have occurred, red graded), will be used as thesource of the audit.


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This audit will be reported to the Learn from Experience Group on behalf of ServiceQuality and Operational Governance Group and action plans put in place will bemonitored by the Patient Safety Group.

When the monitoring has identified deficiencies, recommendations and action plans willbe developed and changes implemented accordingly.

The process for communication between healthcare organisations is outlined in theIncident, Complaints and Claims Policies. This aspect of communication will bemonitored and reported up in the audit of these respective processes.


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Appendix 1 - BEING OPEN PATIENT BRIEFING

THE TEN PRINCIPLES OF BEING OPEN

1. Principle of Acknowledgement

All patient safety incidents must be acknowledged and reported as soon as they areidentified. When patients and/or carers inform healthcare staff when somethinguntoward has happened, it must be taken seriously and the patients and/or carerstreated with compassion and understanding by all healthcare staff. Where it is indicatedthat moderate, severe or catastrophic harm has occurred Duty of Candour applies andpatients/relevant persons should be notified of the incident in writing as soon aspossible and within 10 days of the reporting of the incident to the local systems.

2. Principle of Truthfulness, timeliness and clarity of communication

Information about a patient incident must be given to patients and/or carers in a truthful

and open manner and be based solely on the facts knows as the time. New informationmay emerge as the incident investigation develops and patients and/or carers must bekept up to date as the investigation progresses. The information given must be clearand unambiguous and patients and/or carers must be given a single point of contact forany questions or requests they may have at a later date.

3. Principle of Apology

Patients and/or their carers must receive a sincere expression of sorrow or regret forthe harm/error/near miss that has resulted from a patient safety incident. This must bein the form of an appropriately worded and agreed manner of apology, as early as

possible. Both verbal and written apologies must be given by the most appropriatehealthcare member of staff.

4. Principle of recognising patient and care expectations

Patients and/or carers can reasonably expect to be fully informed of the issuessurrounding a patient safety incident, and its consequences, in a face-to-face meetingwith representatives from the healthcare organisation. They must be treatedsympathetically, with respect and consideration. Confidentiality must be maintained atall times. Patients and/or their carers must also be provided with support in a mannerappropriate to their needs.

5. Principle of professional support

Healthcare organisations must create an environment in which all staff, whether directlyemployed or independent contractors, are encouraged to report patient safety incidents.Staff must feel supported throughout the incident investigation process because theytoo may have been traumatised by being involved. They must not be unfairly exposedto punitive disciplinary action, increased medico-legal risk or any threat to theirregistration.

To ensure a robust and consistent approach to incident investigations, the Trust will usethe NPSAs incident decision tree. Where there is a reason for the Trust to believe amember of staff has committed a punitive or criminal act, the Trust will take steps to


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preserve its position and advise the member(s) of staff at an early stage to enable themto obtain separate legal advice and/or representation.

The Trust must encourage staff to seek support from relevant professional bodies suchas the General Medical Council, Royal College, the Medical Protection Society, theMedical Defence Union and the Nursing and Midwifery Council.

6. Principles of risk management and systems improvement

Root cause analysis (RCA), significant event audit (SEA) or similar techniques must beused to uncover the underlying causes of a patient safety incident. Investigations mustfocus on improving systems of care, which will then be reviewed for their effectiveness.

The Trusts Being Open policy will be integrated into local incident reporting and riskmanagement policies and processes. Being open is one part of an integrated approachto improving patient safety following a patient safety incident.

7. Principle of multidisciplinary responsibility

Any local policy on openness must apply to all staff that have key roles in the patientscare. Most healthcare provision involves multidisciplinary teams and communicationwith patients and/or their carers following an incident that led to harm, must reflect this.This will ensure that the Being open process is consistent with the philosophy thatincidents usually result from systems failures and rarely from the actions of anindividual. To ensure multidisciplinary involvement in the Being open process, it isimportant to identify clinical, nursing and managerial opinion leaders who will championit. Both senior managers and senior clinicians who are local opinion leaders mustparticipate in incident investigation and clinical risk management.

8. Principle of governance

Being open requires the support of patient safety and quality improvement processesthrough clinical governance frameworks, in which patient safety incidents areinvestigated and analysed, to find out what can be done to prevent their recurrence. Italso involves a system of accountability through the Chief Executive to the Board toensure these changes are implemented and their effectiveness reviewed. Thesefindings must be disseminated to healthcare workers so that they can learn from patientsafety incidents. Practice based risk systems must be established within primary care.Continuous learning programmes and audits must be developed that allow healthcareorganisations to learn from the patients experience of Being openand that monitor theimplementation and effects of changes in practice following a patient safety incident.

9. Principle of confidentiality

Policies and procedures for Duty of Candour and Being open must give fullconsideration of, and respect for, the patients and/or their carers and staff privacy andconfidentiality. Details of a patient safety incident must at all times be consideredconfidential. The consent of the individual concerned must be sought prior to disclosinginformation beyond the clinicians involved in treating the patient. Where this is not

practicable or an individual refuses to consent to the disclosure, disclosure may still belawful if justified in the public interest or where those investigating the incident havestatutory powers for obtaining information. Communications with parties outside of the


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clinical team must also be on a strictly need-to-know basis and, where practicable,records should be anonymous. In addition, it is good practice to inform the patientand/or their carers about who will be involved in the investigation before it takes place,and give them the opportunity to raise any objections.

10. Principle of continuity of care

Patients are entitled to expect they will continue to receive all usual treatment andcontinue to be treated with respect and compassion. If a patient expresses apreference for their healthcare needs to be taken over by another team, the appropriatearrangements must be made for them to receive treatment elsewhere.


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Appendix 2 - NPSA Terms and Definitions for Grading Patient Safety Incidents

Grade of PatientSafety Incident

Definition

No harm Incident prevented - any patient safety incident that hadthe potential to cause harm but was prevented, and noharm was caused to patients receiving NHS-funded care.

Incident not preventedany patient safety incident thatoccurred but no harm was caused to patients receivingNHS-funded care.

Minor harm Any patient safety incident that required extra observation orminor treatment* and caused minimal harm to one or morepatients receiving NHS-funded care.

* Minor treatment is defined as first aid, additional therapy, or additional medication. Itdoes not include any extra stay in hospital or any extra time as an outpatient, orcontinued treatment over and above the treatment already planned nor does it include areturn to surgery or readmission.

Moderate harm Any patient safety incident that resulted in a moderate increase intreatment* and that caused significant but not permanent harm toone or more patients receiving NHS-funded care.

* Moderate increase in treatment is defined as a return to surgery, an unplannedreadmission a prolonged episode of care, extra time in hospital or as an outpatient,cancelling of treatment, or transfer to another area such as intensive care as a result ofthe incident.

Severe harm Any patient safety incident that appears to have resulted inpermanent harm* to one or more patients receiving NHS-funded

care.

* Permanent harm directly related to the incident and not related to the natural course ofthe patients illness or underlying condition is defined as permanent lessening of bodilyfunctions, sensory, motor, physiological or intellectual, including removal of the wronglimb or organ, or brain damage.

Death Any patient safety incident that directly resulted in the death* ofone or more patients receiving NHS-funded care.

*The death must be related to the incident rather than to the natural course of thepatients illness or underlying condition.


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Appendix 3Saying Sorry


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Appendix 4 EQUALITY IMPACT ASSESSMENT

Yes/No Comments

1. Does the policy/guidance affect onegroup less or more favourably thananother on the basis of:

Race No

Ethnic origins (including gypsies andtravellers)

No

Nationality No

Gender No

Culture No

Religion or belief No

Sexual orientation including lesbian,gay and bisexual people

No

Age No

Disability - learning disabilities, physicaldisability, sensory impairment andmental health problems

No

2. Is there any evidence that somegroups are affected differently?

No

3. If you have identified potentialdiscrimination, are any exceptionsvalid, legal and/or justifiable?

n/a

4. Is the impact of the policy/guidancelikely to be negative?

No

5. If so can the impact be avoided? n/a

6. What alternatives are there toachieving the policy/guidance

without the impact?

n/a

7. Can we reduce the impact by takingdifferent action?

n/a

being open policy

Documents