Policy for Being Open and the Duty of Candour

Transcription

1 Plicy fr Being Open and the Duty f Candur Dcument ref. n: PP(16)394 Fr use in: Trustwide Fr use by: All Staff Fr use fr: Being Open and the Duty f Candur Dcument wner: Giles Thrpe Apprval Cmmittee Executive Team Status: (date apprved) 27th January 2016 The full dcument can be accessed thrugh the Dcument Management System

2 Being Open Plicy Reference: CO/PO/00107 Status: Versin 3.0 Dcument Title: Dcument Purpse: Dcument Statement: Plicy fr Being Open and the Duty f Candur This plicy aims t imprve the quality and cnsistency f cmmunicatin when incidents invlving patients, staff r visitrs ccur and/r in situatins which give rise t cmplaints. The plicy will make sure that if mistakes are made the patient and/r their carer, relative, staff member r visitr will be given an pprtunity t discuss what went wrng, that they will receive an aplgy and be infrmed f the actin the Trust will take t prevent it happening again. This dcument als utlines the prcess by which staff must cmply with the prfessinal, cntractual and statutry Duty f Candur t ensure that when harm events ccur, patients and relatives are fully infrmed and are invlved in the investigatin prcess. The Bard f Directrs is cmmitted t an pen and hnest apprach in all matters. It fully endrses the principles f Being pen and the Duty f Candur and it is the duty f all staff t fllw this apprach. The Trust is cmmitted t an pen, hnest and fair culture and the verall apprach expected within the rganisatin is ne f help and supprt. Main imperatives f this dcument are: If ptential harm has ccurred as a result f a mistake r errr in their care we as an rganisatin must: aplgise fr the harm caused; explain, penly and hnestly, what has gne wrng; describe what we are ding in respnse t the incident; ffer any supprt that might be f help; prvide the name f a persn t speak t; give updates n the results f any investigatin/develpments. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 2 f 29

3 CONTENTS PAGE WHAT YOU NEED TO KNOW WHEN COMPLETING THE DUTY OF CANDOUR.4 1. INTRODUCTION SCOPE 6 3. DEFINITIONS ROLES AND RESPONSIBILITIES.8 5. THE BEING OPEN PROCESS THE DUTY OF CANDOUR PATIENT ISSUES MONITORING TRAINING IMPLEMENTATION..14 APPENDIX A PRINCIPLES OF BEING OPEN...15 APPENDIX B FLOWCHART FOR UNDERTAKING THE DUTY OF CANDOUR PROCESS.18 APPENDIX C DETAILED GUIDANCE FOR UNDERTAKING ACTIONS RELATED TO BEING OPEN OR DUTY OF CANDOUR.19 APPENDIX D ILLUSTRATED EXAMPLES OF MODERATE HARM, SEVERE HARM AND DEATH REQUIRING DUTY OF CANDOUR...24 Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 3 f 29

4 Key Message Review Incident Verbal Duty f Candur OR Being Open Detail Yu are made aware/invlved in an incident has ccurred invlving a patient? D yu suspect there is a pssibility that the patient has suffered frm harm? YES NO Prvide an aplgy t patient (r relatives) and explain and that an initial investigatin will be undertaken t find ut what has ccurred and that can be shared with the patient/relative. Prvide an aplgy t patient (r relatives) fr any aspect f pr patient experience, and prvide cntact details fr PALS team if required Dcument Dcument clearly in the ntes the fllwing: Reference incident number fr tracking purpses Identify wh was present Detail f aplgy made t patient/relative(s) Explanatin f investigatin prcess (if ptential f harm) Explanatin written fllw up (if ptential f harm) Evidence f prvisin f cntact details Any questins raised and answers prvided Cnfirmatin f mderate harm/si/ Frmal Duty f Candur Written Duty f Candur Incident investigatin Duty f Candur sharing the reprt Meeting Dcument Evidence f Cmpliance 24 Hur review will be reviewed at Executive SI Review Grup Within 10 wrking days f SI being declared - written aplgy and utline f prcess f Serius Incident investigatin t be sent t patient/relative, with cnfirmed ffer f sharing the investigatin nce it has been cmpleted and apprved by the Clinical Cmmissining Grup. (Template prvided by Clinical Gvernance and Risk Department) Prcess f investigatin f Serius Incident fllws accrding t timeline as set within prcedure. Within 10 wrking days f the Trust apprving the reprt as clsed written letter ffering the pprtunity t review the reprt, prviding the pprtunity t meet t discuss the reprt, and t prvide any additinal assistance required. Facilitate meeting with family t review the reprt, where this has been accepted, t ensure a clear understanding f the utput and ffer the pprtunity t cme back t evidence practice changes. Ensure that utput frm the meeting is dcumented and upladed nt the Datix system, with an entry int the medical recrds. The Divisinal Management Team must ensure that all aspects f Duty f Candur have been evidenced and upladed n the Datix system t meet cntractual and legal respnsibilities. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 4 f 29

5 1. Intrductin Clchester Hspital University NHS Fundatin Trust is cmmitted t the prvisin f high quality health care in all aspects f its services t patients, relatives, visitrs, lcal cmmunity and staff. As part f this bjective, the Trust has a duty t limit the ptential impact f a wide variety f clinical and nn-clinical risks and put in place rbust and transparent systems t make sure that all incidents which might cause actual r ptential harm t patients, visitrs and staff are identified, investigated and rectified. Prmting a culture f penness and truthfulness is a prerequisite t imprving the safety f patients, staff and visitrs as well as the quality f healthcare systems. It invlves aplgising and explaining what happened t patients wh have been harmed as a result f their healthcare treatment as in-patients r utpatients f the Trust. It als invlves aplgising and explaining what happened t staff r visitrs wh have suffered harm. It encmpasses cmmunicatin between healthcare rganisatins, healthcare teams and patients and/r their relatives/carers, staff and visitrs and makes sure that penness, hnesty and timeliness underpins respnses t such incidents Being Open The culture f being pen shuld be intrinsic thrughut the Trust in relatinships with and between patients, the public, staff and ther healthcare rganisatins. This plicy is based n guidance frm the Natinal Patient Safety Agency (NPSA), Being pen: Saying srry when things g wrng (2009) and the Natinal Health Service Litigatin Authrity (NHSLA) cmmunicatin f 1 May 2009 Aplgies and explanatins. The NPSA states that Being Open ; is what patients want; is ethically and mrally the right thing t d; it reduces litigatin csts; and is a vehicle fr winning back patient cnfidence. Elements f the Being Open plicy reflect ther gvernment initiatives and recmmendatins frm majr inquiry reprts such as the 5th Shipman Inquiry Reprt (2004) and the NHS Litigatin Authrity s Striking the Balance (NHSLA initiative 2003). These identify the need fr clear and accurate dcumentatin and the imprtance f prviding supprt fr healthcare prfessinals invlved in a cmplaint, incident r claim The Duty f Candur The Chief Medical Officer s cnsultatin dcument, Making Amends (2003), utlines prcesses t encurage penness in the reprting f adverse events, stating that there exists a Duty f Candur which requires clinicians and health services managers t infrm patients abut actins which have resulted in harm. In additin, penness and hnesty twards patients is actively encuraged by such prfessinal bdies as the Medical Prtectin Sciety, the Medical Defence Unin and the General Medical Cuncil. Since 2013 there has been a cntractual requirement by NHS Trusts t ensure cmpliance with the Duty f Candur within the NHS Standard Cntract fr thse incidents that result in mderate r severe harm, r death (utilising the Natinal Patient Safety Agency (NPSA) definitins). Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 5 f 29

6 Regulatin 20 f the Health and Scial Care Act 2008 (Regulated Activities) Regulatins 2014 (lcated at is a direct respnse t recmmendatin 181 f the Francis Inquiry reprt int Mid Staffrdshire NHS Fundatin Trust. This recmmendatin states that a statutry duty f candur shuld be impsed n healthcare prviders. In interpreting the regulatin n the duty f candur, the Care Quality Cmmissin has published guidance n hw this will be regulated and inspected. This guidance can be lcated at: The CQC have used the definitins f penness, transparency and candur used by Rbert Francis in his reprt: Openness enabling cncerns and cmplaints t be raised freely withut fear and questins asked t be answered. Transparency allwing infrmatin abut the truth abut perfrmance and utcmes t be shared with staff, patients, the public and regulatrs. Candur any patient harmed by the prvisin f a healthcare service is infrmed f the fact and an apprpriate remedy ffered, regardless f whether a cmplaint has been made r a questin asked abut it. The regulatin and its implementatin reflect the apprach prpsed by the Daltn/Williams review (lcated at including defining a ntifiable safety incident t include mderate harm, severe harm, death, and prlnged psychlgical harm. These definitins are cntained within Regulatin 20 itself. NHS bdies have been encuraged fr sme time t vluntarily reprt mderate incidents. 2. Scpe This plicy relates t incidents, cmplaints and claims and details arrangements fr cmmunicatin with patients, relatives and/r their relatives/carers wh have suffered harm within the Trust. The same principles and prcess shuld be applied if a member f staff r visitr suffers harm as a result f an incident within the Trust s prperty. It is aimed at any healthcare staff member, clinical r nn-clinical, respnsible fr making sure that the infrastructure is in place t supprt penness between healthcare prfessinals and patients and/r their relatives/carers fllwing an incident, cmplaint r claim. It describes the prcesses f being pen with patients and gives advice n the ds and dn ts f cmmunicating with patients and/r their relatives/carers fllwing harm. Whilst this Trust encurages staff t reprt all patient safety incidents, including n harm and near misses, this plicy nly relates t thse incidents that cause mderate harm, severe harm r death n the actual impact grading scale belw. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 6 f 29

7 Patient Safety Incident Severity Level N harm/near miss/n injury Minr/Lw harm Mderate harm, Severe harm r death Respnse Patients are nt usually invlved in investigatins and these types f incidents are utside the scpe f the Being Open and Duty f Candur plicy. Hwever, it is within the scpe f the healthcare prfessinal s accuntability and respnsibility t hld a discussin with the patient and/r relative, shuld this prve apprpriate. Unless there are specific indicatins r the patient requests it, the cmmunicatin, investigatin, analysis and the implementatin f changes will happen at service delivery level with the participatin f thse directly invlved in the incident. Again it is within the scpe f healthcare prfessinal s accuntability and respnsibility t hld a discussin with the patient and/r relative, in the spirit f Being Open and transparent, including them in all aspects f care delivery and gvernance. A higher respnse is required in these circumstances. Ntificatin shuld be in accrdance with the Incident Reprting prcedure. A member f the Clinical Gvernance and Risk Department r Cmplaints Team will be available t prvide supprt and advice during the Duty f Candur prcess. The patient (if pssible) and their family/relatives/carers must be kept infrmed f investigative prcedures, utcmes and actin planning. 3. Definitins Being Open: the prcess fr cmmunicating adverse events with patients, relatives, carers, staff and visitrs. Harm: injury (physical r psychlgical), disease, suffering, disability r death. Patient safety incident: Any unintended r unexpected incident that culd have r did lead t harm fr ne r mre patients receiving NHS healthcare. Risk: the chance f smething happening that will have an impact n individuals and/r rganisatins. Rt Cause Analysis: a systematic prcess whereby the factrs that cntributes t an incident are identified. Mderate harm: Mderate harm means harm that requires a mderate increase in treatment, and significant, but nt permanent, harm, fr example a mderate increase in treatment means an unplanned return t surgery, an unplanned re-admissin, a prlnged episde f care, extra time in hspital r as an utpatient, cancelling f treatment, r transfer t anther treatment area (such as intensive care). Prlnged pain : Prlnged pain means pain which a service user has experienced, r is likely t experience, fr a cntinuus perid f at least 28 days; Prlnged psychlgical harm: Prlnged psychlgical harm means psychlgical harm which a service user has experienced, r is likely t experience, fr a cntinuus perid f at least 28 days. Severe harm: Severe harm means a permanent lessening f bdily, sensry, mtr, physilgic r intellectual functins, including remval f the wrng limb r rgan r brain damage, that is related directly t the incident and nt related t the natural curse f the service user s illness r underlying cnditin. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 7 f 29

8 4. Rles and Respnsibilities Chief Executive The Chief Executive as the Accunting Officer has verall respnsibility fr the quality and safety f services prvided by the Trust. In this respect, he/she is respnsible fr ensuring that the infrastructure required supprting the delivery and implementatin f this dcument is available. He/she will delegate the full implementatin f this dcument t a relevant Executive Directr. Medical Directr The Medical Directr is respnsible fr ensuring that the necessary systems, prcesses, training and cmpetency assessment (where apprpriate) are available t ensure that all medical and dental staff are able t cmply with the cntents f this dcument. In additin, he/she is respnsible fr ensuring that the mnitring and audit f this dcument is undertaken and reprted in the apprpriate frum as indicated in the dcument. Directr f Nursing The Directr f Nursing is respnsible fr ensuring that the necessary systems, prcesses, training and cmpetency assessment (where apprpriate) are available t ensure that all nn-medical staff (nurses, midwives and allied health prfessinals) are able t cmply with the cntents f this dcument. Deputy Directr f Nursing The Deputy Directr f Nursing is respnsible fr ensuring that there are systems and prcesses in place t cmmunicate and implement this dcument in the clinical areas. He/she is als respnsible fr ensuring that infrmatin relating t cmpliance with the cntractual and statutry Duty f Candur is analysed, t help identify requirements fr further supprt and guidance, and prvide relevant infrmatin t internal and external stakehlders, including cmmissiners and regulatrs. Divisinal Directrs The Divisinal Directrs are respnsible fr ensuring that systems and prcesses are in place thrughut the Divisins t ensure that this dcument is disseminated apprpriately and that mnitring f cmpliance is undertaken, with remedial actin implemented as apprpriate. In additin, the Divisinal Directrs are respnsible fr ensuring that all medical and dental staff cmplies with the cntents f the dcument. Assciate Directrs f Operatins: The Divisinal Assciate Directrs f Operatins are respnsible fr implementing the systems and prcesses required thrughut the Divisins t ensure that this dcument is disseminated apprpriately and that mnitring f cmpliance is undertaken, with remedial actin implemented as apprpriate. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 8 f 29

9 Assciate Directrs f Nursing/Head f Midwifery: The ADNs/HM are respnsible fr ensuring that the plicy is disseminated thrughut the Divisin and that the required mnitring and audit are undertaken, with the resurces prvided t supprt this. Clinical Service Unit Leads/Managers: Clinical Service Unit Clinical Leads and Unit Managers are respnsible fr implementing this dcument in the Clinical Service Unit and fr mnitring the impact n the service and reprting cmpliance with the dcument. They are accuntable t the Divisinal Clinical Directr and General Manager in this respect. Matrns/Lead Nurses Lead Nurses are respnsible fr ensuring that all nursing staff (including Nurse Specialists, Practitiners/Advisrs) within the Clinical Service Unit cmplies with the cntents f this dcument and fr taking actin when this is nt the case. The Lead Nurse will make sure that all necessary training is prvided. Medical Staff The Cnsultant hlds ultimate respnsibility fr ensuring that all members f the medical team fllw the dcument cntained within this dcument. Senir Sisters/Charge Nurses The Senir Sister/Charge Nurse is accuntable fr the safe care and management f patient n the ward. They are therefre respnsible fr ensuring that all staff within the ward cmplies with this dcument and fr implementing a system t prvide assurance that this is the case. 5. The Being Open Prcess The Trust s prcess fr encuraging pen cmmunicatin is reflected in the Ten Principles f Being Open as identified in the Natinal Patient Safety Agency s dcument Being Open: cmmunicating patient safety incidents with patients and their relatives/carers (NPSA, 2009). These can be fund at Appendix A Detecting and recgnising an incident The Being Open prcess begins with the acknwledgement that a patient has suffered harm as a result f a patient safety incident. Please refer t the Trust s Incident Reprting Prcedure fr detail n the prcess f cmpleting an incident frm via the Datix system. A patient safety incident may be recgnised by a member f staff, patient and/r carer, as a result f a cmplaint r legal claim r ther surces. In all cases the Trust s Incident Reprting Prcedure must be implemented including identifying why there has been a delay in reprting an incident. As sn as a patient safety incident is identified, the tp pririty is prmpt and apprpriate clinical care and the preventin f further harm. Where additinal treatment is required, this shuld happen as sn as reasnably practicable after a discussin with the patient (r relative/carer if the patient is unable t participate in the discussin) and with apprpriate cnsent. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 9 f 29

10 A recrd f discussins must be made in the patient s health recrd which must be descriptive but it des nt need t be a verbatim recrd. The patient and/r carer respnse/reactin shuld als be recrded. It may nt be immediately evident t the patient and/r carer that an adverse event has taken place. Hwever the adverse event must be advised t the patient as sn as pssible after the event but certainly within a week f the incident ccurring. At that time, an initial aplgy and explanatin must be given. It is imprtant that patients and/r their relatives/carer receive a meaningful aplgy. An aplgy des nt cnstitute an admissin f liability. Explanatins shuld nt cntain admissins f liability. 6. The Duty f Candur This cntractual and statutry duty means that patients r their family/carer must be infrmed f a suspected r actual patient safety incident that has resulted in mderate r severe harm, r death, within 10 wrking days f the incident being reprted n the incident reprting system. This ntificatin must ccur: 6.1. Hw t undertake Duty f Candur When undertaken the Duty f Candur, the fllwing steps must be taken ensuring that: Duty f Candur is initially undertaken verbally (face t face where pssible) unless the patient (r relative) declines. This verbal ntificatin (r decline) must be dcumented in the patient s medical recrd, including any respnses by the patient (r relative if the patient is unable t be invlved in the prcess themselves), ensuring that the assciated incident number is dcumented. An aplgy must be prvided A step by step explanatin f what happened, in plain English, must be ffered as sn as is practicable. Lack f clarity whether a patient safety incident, r the degree f harm, has ccurred, is nt a reasn t avid disclsure. Fllw up f the verbal ntificatin must be in writing, utlining the prcess f the investigatin, ptential timescales and relevant cntact details must be prvided. Sharing the investigatin reprt must be ffered t the patient r relative/carer within 10 wrking days f the investigatin being signed ff as cmplete by the Trust. A table utlining the prcess f Duty f Candur can be fund at Appendix B. Detailed guidance n undertaking the varius aspects f Being Open and Duty f Candur can be fund at Appendix C Illustrative Examples f thse ntifiable incidents that wuld require the Duty f Candur (as prvided by the Care Quality Cmmissin) can be fund at Appendix D. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 10 f 29

11 7. Patient issues The apprach t Being pen may need t be mdified accrding t the patient s persnal circumstances When a patient dies When a patient safety incident has resulted in a patient s death, it is even mre crucial that cmmunicatin is sensitive, empathic and pen. It is imprtant t cnsider the emtinal state f bereaved relatives r carers and t invlve them in deciding when it is apprpriate t discuss what has happened. The patient s family and carers will prbably need infrmatin n the prcesses that will be fllwed t identify the cause(s) f death. They will als need emtinal supprt. Establishing pen channels f cmmunicatin may als allw the family and/r carers t indicate if they need bereavement cunseling r assistance at any stage. Usually the initial discussin and any investigatin will ccur befre the crner s inquest. Hwever it might be cnsidered apprpriate t wait fr the crner s inquest befre hlding the Duty f Candur discussin. The crner s reprt n pst-mrtem findings is a key surce f infrmatin that will help cmplete the picture f events leading up t the patient s death. In any event an aplgy shuld be issued as sn after the patient s death alng with an explanatin f the prcesses that have been initiated Children The legal age f maturity fr giving cnsent t treatment is 16 years ld. It is the age at which a yung persn acquired the full rights t make decisins abut their treatment and their right t cnfidentiality becmes vested in them rather than their parents r guardians. Hwever it is cnsidered gd practice t encurage cmpetent children t invlve their families in decisin making. The pprtunity fr parents t be invlved shuld still be prvided unless the child expresses a wish fr them nt t be present. Where children are deemed nt t have sufficient maturity r ability t understand, cnsideratin needs t be given t whether infrmatin is prvided t the parents alne r in the presence f the child. In these instances the parents views n the issue shuld be sught Patients with mental health issues Being pen fr patients with mental health issues shuld fllw nrmal prcedures unless the patient als has cgnitive impairment (see Patients with cgnitive impairments). The nly circumstances in which it is apprpriate t withhld patient safety incident infrmatin frm a patient with mental health issues is when advised t d s by a cnsultant psychiatrist wh feels it wuld cause adverse psychlgical harm t the patient. Hwever, such circumstances are rare and a secnd pinin (by anther cnsultant psychiatrist) wuld be needed t justify withhlding infrmatin frm the patient. Apart frm in exceptinal circumstances, it is never apprpriate t discuss patient safety incident infrmatin with a carer r relative withut the express permissin f the patient. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 11 f 29

12 7.4. Patients with cgnitive impairment Sme individuals have cnditins that limit their ability t understand what is happening t them. They may have authrised a persn t act n their behalf by an enduring Pwer f Attrney. In these cases, steps must be taken t ensure that this extends t decisin making and t the medical care and treatment f the patient. The Being pen r Duty f Candur discussin wuld be cnducted with the hlder f the pwer f attrney. Where there is n such persn, the clinicians may act in the patient s best interest in deciding wh the apprpriate persn is t discuss incident infrmatin with, regarding the welfare f the patient as a whle and nt simply their medical interests. Hwever, patients with cgnitive impairment shuld, where pssible, be invlved directly in cmmunicatins abut what has happened. An advcate with apprpriate skills shuld be available t the patient t assist in the cmmunicatin prcess. See Patients with learning disabilities fr details f apprpriate advcates Patients with learning disabilities Where a patient has difficulties in expressing their pinin verbally, an assessment shuld be made abut whether they are als cgnitively impaired (see Patients with cgnitive impairment ). If the patient is nt cgnitively impaired they shuld be supprted in the Being pen r Duty f Candur prcess by alternative cmmunicatin methds (e.g. given the pprtunity t write questins dwn). An advcate, agreed n in cnsultatin with the patient, shuld be appinted. Apprpriate advcates may include carers, family r friends f the patient. The advcate shuld assist the patient during the Being pen r Duty f Candur prcess, fcusing n ensuring that the patient s views are cnsidered and discussed Patients with different language r cultural cnsideratins The need fr translatin and advcacy services, and cnsideratin f special cultural needs (such as fr patients frm cultures that make it difficult fr a wman t talk t a male abut intimate issues), must be taken int accunt when planning t discuss patient safety incident infrmatin. It wuld be wrthwhile t btain advice frm an advcate r translatr befre the meeting n the mst sensitive way t discuss the infrmatin. Avid using unfficial translatrs and/r the patient s family r friends as they may distrt infrmatin by editing what is cmmunicated Patients with different cmmunicatin needs A number f patients will have particular cmmunicatin difficulties, such as a hearing impairment. Plans fr the meeting shuld fully cnsider these needs. Knwing hw t enable r enhance cmmunicatins with a patient is essential t facilitating an effective Being pen prcess. This invlves fcusing n the needs f the patient, their family and carers, and being persnally thughtful and respectful. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 12 f 29

13 7.8. Patients wh d nt agree with the infrmatin prvided Smetimes, despite the best effrts f healthcare staff r thers, the relatinship between the patient, their family and carers and the healthcare prfessinal breaks dwn. They may nt accept the infrmatin prvided r may nt wish t participate in the Being pen r Duty f Candur prcess. In this case, the fllwing strategies may assist: deal with the issue as sn as it emerges; where the patient agrees, ensure their family and carers are invlved in discussins frm the beginning; ensure the patient has access t supprt services; where the senir health prfessinal is nt aware f the relatinship difficulties, prvide mechanisms fr cmmunicating infrmatin, such as the patient expressing their cncerns t ther members f the clinical team; ffer the patient, their family and carers anther cntact persn with whm they may feel mre cmfrtable. This culd be anther member f the team r the individual with verall respnsibility fr clinical risk management; use a mutually acceptable mediatr t help identify the issues between the healthcare rganisatin and the patient, and t lk fr a mutually agreeable slutin; ensure the patient, their family and carers are fully aware f the frmal cmplaints prcedures; write a cmprehensive list f the pints that the patient, their family and carers disagree with and reassure them yu will fllw up these issues. 8. Prcess fr mnitring cmpliance with this plicy Please see Appendix 1 fr mnitring details. This will be led by the Divisins respnsible fr the delivery f Being Open and Duty f Candur within their mnthly Gvernance meetings and with a synpsis f cmpliance against the agreed standards being reprted thrugh t Risk and Cmpliance Grup. Further mnitring will be undertaken in line with the Trust s Perfrmance Management Framewrk. 9. Training In line with the Being Open Patient Safety Alert frm the NPSA and in line with the requirements fr statutry Duty f Candur the Trust has nminated 4 senir peple t act as champins t give supprt and guidance t fellw staff members n matters relating t Being Open r the Duty f Candur. These are the Medical Directr, the Directr f Nursing, the Assciate Medical Directr fr Patient Safety and the Deputy Directr f Clinical Gvernance. In additin an awareness f the Being Open principles will be given at Crprate Inductin. Further guidance will als be incrprated in Incident Investigatin training fr Managers Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 13 f 29

14 10. Implementatin The Being Open and Duty f Candur Plicy will be disseminated and made available by the Deputy Directr f Clinical Gvernance. Clinical Directrs, Assciate Directrs f Nursing and Quality and Assciate Directrs f Operatins are expected t cmmunicate the plicy as part f lcal inductin prcedures. All staff are intrduced t the principles during their incident reprting and risk management training. The plicy will be available n the Hub (Trust Intranet) and in the hard cpy dcument libraries. The plicy will be reviewed in line with any guidance/ntices published by the NPSA pertinent t Being Open r Duty f Candur. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 14 f 29

15 Principle f acknwledgement Appendix A - Principles f Being Open All patient safety incidents shuld be acknwledged and reprted as sn as they are identified. In cases where the patient and/r their carers infrm healthcare staff when smething untward has happened, it must be taken seriusly frm the utset. Any cncerns shuld be treated with cmpassin and understanding by all healthcare staff. Principle f truthfulness, timeliness and clarity f cmmunicatin Infrmatin abut a patient safety incident must be given t patients, family and/r carers in a truthful and pen manner by an apprpriately nminated persn. Patients shuld be prvided with a step-by-step explanatin f what happened, that cnsiders their individual needs and is delivered penly. Cmmunicatin shuld als be timely; Patients, family and/r carers shuld be prvided with infrmatin abut what happened as sn as practicable. It is als essential that any infrmatin given is based slely n the facts knwn at the time. Healthcare staff shuld explain that new infrmatin may emerge as an incident investigatin is undertaken, and patients, family and/r carers will be kept up-t-date with the prgress f an investigatin. Patients, family and/r carers shuld receive clear, unambiguus infrmatin and be given a single pint f cntact fr any questins r requests they may have. They shuld nt receive cnflicting infrmatin frm different members f staff. Medical jargn, which they may nt understand, shuld be avided. Principle f aplgy Patients, family and/r carers shuld receive a meaningful aplgy ne that is a sincere expressin f srrw r regret fr the harm that has resulted frm a patient safety incident. This shuld be in the frm f an apprpriately wrded aplgy, as early as pssible. Bth verbal and written aplgies shuld be given. The decisin n which staff member shuld give the aplgy shuld cnsider senirity, relatinship t the patient, and experience and expertise in the type f patient safety incident that has ccurred. Verbal aplgies are essential because they allw face-t-face cntact between the patient and/r their carers and the healthcare team. This shuld be given as sn as staff are aware an incident has ccurred. A written aplgy, which clearly states the healthcare rganisatin is srry fr the suffering and distress resulting frm the incident, must als be given. It is imprtant nt t delay fr any reasn, including; setting up a mre frmal multidisciplinary Being pen discussin with the patient and/r their carers; fear and apprehensin; r lack f staff availability. Delays are likely t increase the patient s, family s and/r their carer s sense f anxiety, anger r frustratin. Patient and public fcus grups reprted that patients were mre likely t seek medic-legal advice if verbal and written aplgies were nt delivered prmptly. Principle f recgnising patient and carer expectatins Patients, family and/r carers can reasnably expect t be fully infrmed f the issues surrunding a patient safety incident and its cnsequences, in a face-t-face meeting. They shuld be treated sympathetically, with respect and cnsideratin. Patients, family and/r carers shuld als be prvided with supprt in a manner apprpriate t their needs. This invlves cnsideratin f special circumstances that can include a patient requiring additinal supprt, such as an independent patient advcate r a translatr. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 15 f 29

16 When apprpriate, infrmatin n accessing the Patient Advisry and Liaisn Service (PALS) and ther relevant supprt grups like Cruse Bereavement Care and Actin against Medical Accidents (AvMA) shuld be given t the patient as sn as it is pssible. Principle f prfessinal supprt Organisatins must create an envirnment in which all staff, whether directly emplyed r independent cntractrs, are encuraged t reprt patient safety incidents. Staff shuld feel supprted thrughut the incident investigatin prcess as they t may have been traumatised by being invlved. They shuld nt be unfairly expsed t punitive disciplinary actin, increased medic-legal risk r any threat t their registratin. T ensure a rbust and cnsistent apprach t incident investigatin, healthcare rganisatins are advised t use the Natinal Reprting and Learning Service (NRLS) Incident Decisin Tree. Where there is reasn fr the rganisatin t believe a member f staff has cmmitted a punitive r criminal act, the rganisatin shuld take steps t preserve its psitin, and advise the member(s) f staff at an early stage t enable them t btain separate legal advice and r representatin. Principle f risk management and systems imprvement Rt cause analysis (RCA) shuld be used t uncver the underlying causes f a patient safety incident. Investigatins shuld fcus n imprving systems f care, which will then be reviewed and audited fr their effectiveness. Every rganisatin s Being pen plicy shuld be integrated int lcal incident reprting and risk management plicies and prcesses. Being pen is ne part f an integrated apprach t imprving patient safety fllwing a patient safety incident. It shuld be embedded in an verarching apprach t risk management that includes lcal and natinal incident reprting, analysis f incidents using Rt cause Analysis r Significant Event Audit, decisin-making abut staff accuntability using the Incident Decisin Tree and an rganisatinal apprach that fllws the NPSA s Seven steps t patient safety (2009). Principle f multidisciplinary respnsibility Any plicy n penness applies t all staff that have key rles in the patient s care. Mst healthcare prvisin invlves multidisciplinary teams and cmmunicatin with patients and/r their carers fllwing an incident that led t harm, shuld reflect this. This will ensure that the Being pen prcess is cnsistent with the philsphy that incidents usually result frm systems failures and rarely frm the actins f an individual. T ensure multidisciplinary invlvement in the Being pen prcess, it is imprtant t identify clinical, nursing and managerial leaders that will supprt it. Bth senir managers and senir clinicians wh are pinin leaders must participate in incident investigatin and clinical risk management. Principle f clinical gvernance Being pen has the supprt f patient safety and quality imprvement prcesses thrugh the clinical gvernance framewrk, in which patient safety incidents are investigated and analysed, t find ut what can be dne t prevent their recurrence. It als invlves a system f accuntability thrugh the Chief Executive t the Bard t ensure these changes are implemented and their effectiveness reviewed. These findings shuld be disseminated t staff s that they can learn frm patient safety incidents. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 16 f 29

17 These actins are mnitred t ensure that the implementatin and effects f changes in practice fllwing a patient safety incident. Cntinuus learning prgrammes and audits shuld be develped that allw healthcare rganisatins t learn frm the patients experience and that mnitr the implementatin and effects f changes in practice fllwing a patient safety incident. Principle f cnfidentiality Full cnsideratin f, and respect fr, shuld be given t the patient s and/r their carer s and staff s privacy and cnfidentiality. Details f a patient safety incident shuld at all times be cnsidered cnfidential. The cnsent f the individual cncerned shuld be sught prir t disclsing infrmatin beynd the clinicians invlved in treating the patient. Where this is nt practicable r an individual refuses t cnsent t the disclsure, disclsure may still be lawful if justified in the public interest r where thse investigating the incident have statutry pwers fr btaining infrmatin. Cmmunicatins with parties utside f the clinical team shuld als be n a strictly need-tknw basis and, where practicable, recrds shuld be annymus. In additin, it is gd practice t infrm the patient and/r their carers abut wh will be invlved in the investigatin befre it takes place and give them the pprtunity t raise any bjectins. Principle f cntinuity f care Patients are entitled t expect they will cntinue t receive all usual treatment and cntinue t be treated with respect and cmpassin. If a patient expresses a preference fr their healthcare needs t be taken ver by anther team, the apprpriate arrangements shuld be made fr them t receive treatment elsewhere. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 17 f 29

18 Appendix B Flwchart fr cmpleting the Duty f Candur Key Message Detail Review Incident Verbal Duty f Candur OR Being Open Yu are made aware/invlved in an incident has ccurred invlving a patient? D yu suspect there is a pssibility that the patient has suffered frm harm? YES NO Prvide an aplgy t patient (r relatives) and explain and that an initial investigatin will be undertaken t find ut what has ccurred and that can be shared with the patient/relative. Prvide an aplgy t patient (r relatives) fr any aspect f pr patient experience, and prvide cntact details fr PALS team if required Dcument Dcument clearly in the ntes the fllwing: Reference incident number fr tracking purpses Identify wh was present Detail f aplgy made t patient/relative(s) Explanatin f investigatin prcess (if ptential f harm) Explanatin written fllw up (if ptential f harm) Evidence f prvisin f cntact details Any questins raised and answers prvided Cnfirmatin f mderate harm/si/ Frmal Duty f Candur Written Duty f Candur Incident investigatin Duty f Candur sharing the reprt Meeting Dcument Evidence f Cmpliance 24 Hur review will be reviewed at Executive SI Review Grup Within 10 wrking days f SI being declared - written aplgy and utline f prcess f Serius Incident investigatin t be sent t patient/relative, with cnfirmed ffer f sharing the investigatin nce it has been cmpleted and apprved by the Clinical Cmmissining Grup. (Template prvided by Clinical Gvernance and Risk Department) Prcess f investigatin f Serius Incident fllws accrding t timeline as set within prcedure. Within 10 wrking days f the Trust apprving the reprt as clsed written letter ffering the pprtunity t review the reprt, prviding the pprtunity t meet t discuss the reprt, and t prvide any additinal assistance required. Facilitate meeting with family t review the reprt, where this has been accepted, t ensure a clear understanding f the utput and ffer the pprtunity t cme back t evidence practice changes. Ensure that utput frm the meeting is dcumented and upladed nt the Datix system, with an entry int the medical recrds. The Divisinal Management Team must ensure that all aspects f Duty f Candur have been evidenced and upladed n the Datix system t meet cntractual and legal respnsibilities. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 18 f 29

19 Appendix C Detailed guidance fr undertaking actins related t Being Open r Duty f Candur Organising a preliminary meeting fr Being Open r Duty f Candur The fllwing factrs shuld be taken int accunt when rganising a preliminary meeting with a patient and their relative/carer. clinical cnditin f the patient; availability f key staff invlved in the incident; availability f the patient s family and/r carers; availability f supprt staff, e.g. translatr/independent advcate, if required; patient preference (in terms f when and where the meeting takes place and which healthcare prfessinal leads the discussin); privacy and cmfrt f the patient; arranging the meeting in a sensitive lcatin. Chsing the individual t cmmunicate with patients/carers This shuld be the mst senir persn respnsible fr the patient s care and/r smene with experience and expertise in the type f incident that has ccurred. This culd either be the patient s cnsultant, nurse cnsultant, r any ther healthcare prfessinal, wh has a designated caselad f patients. If pssible, the persn shuld: be knwn t, and trusted by, the patient, relative/carer; have a gd grasp f the facts relevant t the incident; be senir enugh r have sufficient experience and expertise in relatin t the type f incident t be credible t patients/carers; have excellent interpersnal skills, aviding excessive use f medical jargn; be willing and able t ffer an aplgy, reassurance and feedback; In exceptinal circumstances, if the relevant healthcare prfessinal cannt attend, they may delegate t an apprpriately trained substitute. The qualificatins, training and scpe f respnsibility f this persn shuld be clearly delineated. The substitute may be the clinician respnsible fr clinical risk (fr example, the Clinical Lead fr patient safety) r smene f similar experience. The healthcare prfessinal cmmunicating infrmatin abut an incident shuld be able t nminate a clleague t assist them with the meeting. Ideally this shuld be smene with experience r training in cmmunicatin and Being Open prcedures. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 19 f 29

20 Respnsibilities f junir healthcare prfessinals Junir staff r thse in training shuld nt lead the prcess except when all f the fllwing criteria have been cnsidered: the incident resulted in lw harm (and therefre des nt fall within the Duty f Candur prcess); they have expressed a wish t be invlved in the discussin; the senir healthcare prfessinal respnsible fr the care is present fr supprt; the patient, relative/carer agree. Cntent f the initial discussin with the patient, relative/carer The patient r relatives/carers shuld be advised f the identity and rle f all peple attending the discussin befre it takes place. This allws them the pprtunity t state their wn preferences abut which healthcare staff shuld be present. There shuld be an expressin f genuine sympathy, regret and an aplgy fr the harm that has ccurred. The facts that are knwn are agreed by the multidisciplinary team. The patient, relative/carer shuld be infrmed that an incident investigatin is being carried ut and mre infrmatin will becme available as it prgresses. It shuld be made clear t the patient, relatives/carers that new facts may emerge as the incident investigatin prceeds. The patient s/relative s/carer s understanding f what happened shuld be taken int cnsideratin, as well as any questins they may have. There shuld be cnsideratin and frmal nting f the patient s/relative s/carer s views and cncerns. Apprpriate language and terminlgy shuld be used when speaking t patients and relatives/carers. An explanatin shuld be given abut what will happen next in terms f the lng term treatment plan and incident analysis findings. Infrmatin n likely shrt/lng term effects f the incident (if knwn) shuld be shared. This may have t be delayed t a subsequent meeting when the situatin becmes clearer. An ffer f practical and emtinal supprt shuld be made t the patient, relative/carer. Infrmatin abut the patient and the incident shuld nt nrmally be disclsed t third parties withut cnsent. It shuld be recgnised that patients and/r relatives/carers may be anxius, angry and frustrated even when the discussin is cnducted apprpriately. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 20 f 29

21 It is essential that the fllwing des nt ccur: speculatin; attributin f blame; denial f respnsibility; prvisin f cnflicting infrmatin frm different individuals. The initial discussin is the first part f an nging cmmunicatin prcess. Many f the pints raised here shuld be expanded n in subsequent meetings with the patient, relative/carer. Written recrds f discussins with patients/carers There shuld be dcumentatin f: the time, place, date, as well as the name and relatinships f all attendees; the plan fr prviding further infrmatin t the patient/carers; ffers f assistance and the patient s/carer s respnse; questins raised by the carers r their representatives, and the answers given; plans fr fllw-up as discussed; prgress ntes relating t the clinical situatin and an accurate summary f all the pints explained t the patient and/r relatives/carers; cpies f letters sent t patients, carers and the GP; cpies f any statements taken in relatin t the incident; A cpy f the incident reprt. A summary f the discussin shuld be shared with the patient, family/carer. Fllw up meetings and cmpleting the prcess Fllw-up discussins with the patient/carers are an imprtant step in the Being pen r Duty f Candur prcess nce any investigatin has been cmpleted. The fllwing guidelines shuld assist in making the cmmunicatin effective: The discussin shuld ccur at the earliest practical pprtunity. Cnsideratin shuld be given t the timing f meeting, based n bth the patient s health and persnal circumstances. Cnsideratin shuld be given t the lcatin f the meeting e.g. the patient s hme. Feedback shuld be given n prgress t date and infrmatin prvided n the investigatin prcess. If the investigatin is cmplete, the cmmunicatin shuld include: the chrnlgy f clinical and ther relevant facts; details f the patient s/carer s cncerns and cmplaints; a repeated aplgy fr the harm suffered and any shrtcmings in the delivery f care that led t the incident; a summary f the factrs that cntributed t the incident; infrmatin n what has been and will be dne t avid recurrence f the incident and hw these imprvements will be mnitred. There shuld be n speculatin r attributin f blame. Similarly, the healthcare prfessinal cmmunicating the incident must nt criticise r cmment n matters utside their wn experience. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 21 f 29

22 The patient, relatives/carers shuld be ffered an pprtunity t discuss the situatin with anther relevant prfessinal where apprpriate. A written recrd f the discussin shuld be kept and shared with the patient/ carers. If cmpleting the prcess at this pint, the patient/carers shuld be asked if they are satisfied with the investigatin and a nte f this made in the patient s recrds. The patient shuld be prvided with cntact details s that if further issues arise later there is a cnduit back t the relevant healthcare prfessinals r an agreed substitute. It is expected that in mst cases there will be a cmplete discussin f the findings f the investigatin and analysis. In sme cases infrmatin may be withheld r restricted, fr example, where cmmunicating infrmatin will adversely affect the health f the patient; where investigatins are pending crnial prcesses; r where specific legal requirements preclude disclsure fr specific purpses. In these cases the patient will be infrmed f the reasns fr the restrictins. Cntinuity f care When a patient requires further management r rehabilitatin they shuld be infrmed f the nging plan f care. Patients/carers shuld be reassured that they will cntinue t be treated accrding t their clinical needs. They shuld als be infrmed that they have the right t cntinue their treatment elsewhere if they have lst cnfidence in the healthcare team invlved in the incident. Cmmunicatin with the GP and ther cmmunity care services Wherever pssible, it is advisable t send a brief cmmunicatin t the patient s GP, befre discharge, describing what happened. When the patient leaves the care f the Trust, a discharge letter shuld als be frwarded t the GP r apprpriate cmmunity care service. It shuld cntain summary details f: the nature f the incident and the cntinuing care and treatment; the current cnditin f the patient; key investigatins that have been carried ut; recent results; prgnsis It may be valuable t cnsider including the GP in ne f the fllw-up discussins either at discharge r at a later stage. Incidents related t the envirnment f care In such cases a senir manager f the relevant service will be respnsible fr cmmunicating with the patient, relative/carer. A senir member f the multidisciplinary team shuld be present t assist at the discussin. The healthcare prfessinal respnsible fr treating the injury shuld als be present t assist in prviding infrmatin n what will happen next and the likely effects f the injury. Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 22 f 29

23 Invlving healthcare staff wh made mistakes Sme incidents will result frm errrs made by staff while caring fr the patient. In these circumstances the member(s) f staff invlved may r may nt wish t participate in the discussin with the patient, relative/carer. Every case where an errr has ccurred needs t be cnsidered individually, balancing the needs f the patient, relative/carer with thse f the healthcare prfessinal cncerned. In cases where the healthcare prfessinal wishes t attend the discussin t aplgize persnally, they shuld feel supprted by their clleagues thrughut the meeting. In cases where the patient, relative/carer express a preference fr the healthcare prfessinal nt t be present, it is advised that a persnal written aplgy is handed t the patient, relative/carer during the first discussin Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 23 f 29

24 Appendix D Illustrative examples and f Mderate Harm, Severe Harm r Death Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 24 f 29

25 Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 25 f 29

26 Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 26 f 29

27 Surce: Deputy Directr f Nursing Status: Apprved January 2016 Page 27 f 29