SERIOUS INCIDENT MANAGEMENT POLICY

Transcription

1 SERIOUS INCIDENT MANAGEMENT POLICY DOCUMENT CONTROL Versin: 14.1 Ratified by: Quality Cmmittee Date ratified: 14 April 2016 Name f riginatr/authr: Head f Allied Health Prfessins & Patient Safety Name f respnsible cmmittee/individual: Quality Cmmittee/Head f Allied Health Prfessins & Patient Safety Date issued: 20 May 2016 Review date: April 2019 Target Audience All staff

2 CONTENTS SECTION PAGE 1. INTRODUCTION 3 2. PURPOSE 3 3. SCOPE 3 4. RESPONSIBILITIES, ACCOUNTABILITIES AND DUTIES 3 5. PROCEDURE/IMPLEMENTATION Duty f Candur and Being Open What is a Serius Incident? Purpse f the investigatin Stage One - Ntificatin Stage Tw Data Gathering/Investigatin Stage Three Finalising the Investigatin Stage Fur Fllw up TRAINING IMPLICATIONS MONITORING ARRANGEMENTS EQUALITY IMPACT ASSESSMENT SCREENING Privacy, Dignity and Respect Mental Capacity Act LINKS TO ASSOCIATED DOCUMENTS REFERENCES APPENDICES Appendix A SI Prcess Flw Chart 19 Page 2 f 19

3 1. INTRODUCTION Serius Incidents in health care are adverse events, where the cnsequences t patients, families and carers, staff r rganisatins are s significant r the ptential fr learning is s great, that a heightened level f respnse is justified. Trusts are respnsible fr the safety f their patients, visitrs and thers using their services, and must ensure rbust systems are in place fr recgnising, reprting, investigating and respnding t Serius Incidents and fr arranging and resurcing investigatins. 2. PURPOSE The purpse f this plicy is t utline the prcedure by which all Serius Incidents (SIs) will be managed (irrespective f the cmmissiner fr the service(s) invlved in the patient s care), supprt staff in reprting a SI and t give assurance t the Bard f Directrs that apprpriate actins are being taken, that lessns are being learnt, shared and imprvements made t bth care and service delivery fllwing the ccurrence f a serius incident. An verview f the pathway f managing the serius incident is prvided in the flw chart in Appendix A. 3. SCOPE The plicy applies t all staff emplyed within the Trust (permanent r temprary r hnrary), students and vlunteers, cntractrs and emplyees f ther rganisatins wrking n the Trust s estate. Fr multiagency investigatins please refer t sectin RESPONSIBILITIES, ACCOUNTABILITIES AND DUTIES 4.1. Chief Executive Officer and Bard f Directrs The Chief Executive Officer, thrugh the Bard f Directrs, has verall respnsibility fr the prvisin f adequate systems fr the management f Serius Incidents Executive Directr f Nursing and Quality As the lead directr fr clinical quality assurance they are respnsible fr ensuring that there is a framewrk fr SIs t effectively manage, investigate and that rganisatinal learning is taking place. In additin the Executive Directr f Nursing and Quality is respnsible fr the frmal sign ff f all SI investigatin reprts prir t submissin t the relevant Clinical Cmmissining Grup (CCG) Head f Allied Health Prfessins and Patient Safety The Head f Allied Health Prfessins and Patient Safety is respnsible fr the peratinal management f the SI prcess including: Ensuring all SI s are managed and investigated apprpriately ensuring rbust and timely actin plans are prduced. Mnitring SI themes acrss the Trust and the implementatin f actin plans and reprting t the Bard f Directrs and executive Management Team. Chairing the Organisatinal Learning Frum (OLF) t ensure learning frm the incidents and SIs are shared acrss the Trust. Attend the CCG s SI Cmmittees n behalf f the Trust and respnd t Cmmissining requests. Page 3 f 19

4 4.4. Crprate Patient Safety Team The Crprate Patient Safety Team is respnsible fr supprting the Head f Allied Health Prfessins and Patient Safety in the day t day peratin f SI management including: Ensuring CEO and Senir Directrs are aware f any SI. Liaising with cmmissiners. Lgging SI s nt Strategic Executive Infrmatin System (STEIS). Infrming the relevant Cmmissiner f any new Serius Incidents. Alerting the Medical Directrate f all incidents invlving trainee dctrs fr them t infrm the Yrkshire and Humber Deanery. Infrming the Mental Health Act Manager f any deaths f detained r liable t be detained patients lgged as an SI s that ntificatin t the CQC can be made. Facilitating the Crprate Review and prviding feedback t the investigatr. Submitting reprts t the nminated Cmmissiner within the 12 week timeframe. Prductin f reprts t relevant grups including an Annual Reprt. Reprting all SIs t the Bard f Directrs. Cmpleting the rt causes and lessns learned bxes n the STEIS system fllwing investigatin, even if it is t indicate that learning was nt identified in a particular case. Undertake the training f Lead Investigatrs n Rt Cause Analysis Service Directrs The Service Directrs fr Mental Health Services and Children s and Cmmunity Services are respnsible fr: Reviewing STEIS lg frms n receipt frm the Crprate Patient Safety Team. Reviewing and cmmenting n the draft investigatin reprts. Ensuring Assistant Directr s effectively respnd t SI s, carry ut all their actins and review themes t ensure peratinal services are safe. Where required, ensure that the Duty f Candur requirements are fulfilled Assistant Directrs The Assistant Directrs are respnsible fr ensuring that all SI s are reprted t the Crprate Patient Safety Team and that a full investigatin is undertaken including: Ensuring that the incident is reprted via: Safeguard Incident Reprting System. STEIS address STEIS@RDASH.nhs.uk, using the STEIS Infrmatin lg frm (see SI frms and templates n the intranet). Appinting a Lead Investigatr, utside the Business Divisin where apprpriate. Ensuring that the Being Open and Duty f Candur Plicy is implemented. Ensuring that a 72 hur reprt is prvided and that the investigatin reprt is submitted within the 12 week timescale. Ensuring that the quality check f the SI reprt is cmpleted within the Business Divisin befre it is prvided t the SI review panel fr review. Frmally signing ff the final investigatin reprt and sending t the Crprate Patient Safety Team fr submissin t the relevant Cmmissiner within the 11 week timescale. Page 4 f 19

5 Ensuring that relevant staff receive a debrief n investigatin findings and lessns learned and cmmunicating lessns learned t Organisatinal Learning Frum (OLF). Ensuring the cmpletin and implementatin f any actin plans arising frm the investigatin Lead Investigatrs The Lead Investigatrs are respnsible fr undertaking a full investigatin as set ut in this plicy and using the tls and techniques utlined in the RCA training prvided: Wrking with staff with apprpriate expertise e.g. Accuntable Officer fr Cntrlled Drugs (Chief Pharmacist), Infrmatin Gvernance Manager etc. Thrughut the prcess cmply with the: Being Open and Duty f Candur Plicy Supprting Staff Invlved in a Traumatic/Stressful Incident, Cmplaint r Claim Plicy Use the Trust NPSA apprved Rt Cause Analysis methdlgy in their investigatin prcess. Supprt families and carers during the curse f the investigatin and keep them infrmed if requested t d s. Use the apprved Trust reprting template (see SI frms and templates n the intranet). Develping a SMART actin plan wrking with the Service Managers, Assistant Directrs and any ther staff wh will be respnsible fr the implementatin f the actins. Timely submissin f the investigatin reprt t the Assistant Directr. Debrief staff teams n the utcme/s f their investigatin fcussing n identified gd practice and areas fr imprvement. Benchmark findings against Trust plicies and prcedures, natinal guidelines and standards and current evidence base t determine gd practices and areas fr imprvement Line Managers/Designated Incident Managers Line Managers/Designated Incident Managers are respnsible fr; ensuring staff reprt Serius Incidents n the incident reprting system, mderating the incident reprt t ensure that it reflects the incident and its utcme apprpriately, ensuring that all immediate actins required as a result f the incident are implemented including, as apprpriate, the initial stages f Duty f Candur ensuring that suitable and sufficient supprt t families, carers and staff affected by the incident is in place All Staff All staff are respnsible fr reprting all ptential and actual Serius Incidents n the Trust Electrnic IR1 frm via the Safeguard electrnic incident reprting system e.g. Cmplaints, accidents, incidents, health and safety issues, security issues, alleged clinical negligence r malpractice and alleged abuse f patients, staff and prperty. See Incident Reprting Plicy. Where ptential and actual serius incidents invlve fraud, bribery, r crruptin staff shuld als refer t the Cunter Fraud, Bribery and Crruptin Plicy Page 5 f 19

6 4.10. Trust Cmmittees/Grups with Respnsibility fr Serius Incidents The Quality Cmmittee is respnsible fr prviding assurance t the Bard f Directr that the framewrk fr SIs is being managed effectively and that rganisatinal learning is taking place. The Quality and Safety Sub Cmmittee which reprts t the Quality Cmmittee is respnsible fr: Prvide scrutiny f the incident management prcess by receiving mnthly updates n Incidents, Duty f Candur, Serius Incidents, Cmplaints, and ther incident related data. Prvide scrutiny f the Patient Safety prcess by reviewing incidents, cmplaints and claims n a quarterly basis, this includes examining themes, trends, causal factrs, utcmes f investigatins including gaps in service and perfrmance against actin plans. Receiving and acting upn as apprpriate n Patient Safety Benchmarking/Incident Analysis Reprts. Review f the SI Actin Plan Exceptin Reprt prir t submissin t the Quality Cmmittee and Cmmissiners Review the Serius Incident Annual Reprt prir t submissin t the Quality Cmmittee and Cmmissiners The Organisatinal Learning Frum (OLF) is respnsible fr develping and managing a structured apprach t learning and sharing lessns fr imprvement in practice, where lessns learned are embedded in the Trust s culture and practice frm Serius Incidents, Cmplaints and Claims as a result f investigatins. The Organisatinal Learning Frum (OLF) reprts t the Quality and Safety Sub Grup. The Crprate SI Review Panel is respnsible fr the review all SI investigatin reprts t assess the quality against its Cmmissiner s reprt criteria and advising Authrs and their Assistant Directrs f changes/clarificatins required prir t submissin. 5. PROCEDURE/IMPLEMENTATION 5.1. Duty f Candur and Being Open Full details f the requirements t cmply with the Duty f Candur are detailed in the Being Open and Duty f Candur Plicy. The Duty f Candur applies t all patient safety incidents with an actual, r ptential, significant (Mderate r higher) harm t the patient whether the incident is t be investigated as a serius incident r nt. Every incident has a Designated Incident Manager (in line with the Incident Reprting Plicy) wh is respnsible fr starting the Duty f Candur prcess. This persn will arrange t meet the patient r relevant persn t infrm them that the incident ccurred, aplgise and explain what is t happen next. They will then fllw that up by sending a letter summarising that cnversatin. This shuld be cmpleted within 10 wrking days f the incident ccurring. Fr Serius Incidents, the investigatin is allcated t a Lead Investigatr, wh is als respnsible fr the Duty f Candur after the initial 10 wrking day perid. The investigatin timescales can fllw the SI prcess rather than the Duty f Candur Page 6 f 19

7 timescales if it is suitable t d s. Once the investigatin is cmplete, the Lead Investigatr is t prduce a suitable, easy t understand, shrt reprt fr the patient r relevant persn. It is unlikely that the Serius Incident reprt wuld be suitable fr cmpliance with the Duty f Candur and therefre the investigatr may be required t prepare tw reprts, ne full Serius Incident reprt fr the Trust and Cmmissiner s, and a shrter, easy read reprt fr the patient r relevant persn. The Lead Investigatr is t ensure that the Duty f Candur sectin f the IR1 is kept up t date and crrectly clsed nce the investigatin is cmpleted and the requirements f the Duty f Candur cmplied with. Shuld a Serius Incident be de-lgged the respnsibility fr cmplying with Duty f Candur reverts back t the Delegated Incident Manager. The Lead Investigatr must cntact the Delegated Incident Manager t advise that the incident has been de-lgged and discuss the findings t date What is a Serius Incident? The 2015 SI Framewrk states that there is n definitive list f events/incidents that cnstitutes a serius incident as this can lead t incnsistent r inapprpriate management f incidents. Where lists are created there is a tendency t nt apprpriately investigate things that are nt n the list even when they shuld be investigated. The SI framewrk encurages prviders t review each pssible SI n a case by case basis and engage in discussin with cmmissiners. An SI that requires investigatin culd be defined as acts and/r missins that have resulted in: unexpected r avidable death, unexpected r avidable injury that has resulted in serius harm r requires further treatment t prevent death r serius harm, actual r alleged abuse, an incident that prevents r threatens t prevent the Trust s ability t cntinue t deliver an acceptable quality f healthcare majr lss f cnfidence in the service never event (please refer t the Never Events Framewrk n the intranet), screening incident (please refer t the Screening Framewrk n the intranet) This is by n means an exhaustive list and if there is any dubt as t whether an incident is a serius incident then the Crprate Patient Safety Team shuld be cntacted fr a discussin and if necessary this can be clarified with the cmmissiners by the Crprate Patient Safety Team Purpse f the Investigatin The purpse f the investigatin is t identify: the prblems that led t the incident ccurring Any cntributry factrs that led t the incident ccurring Any missins and inactins which led t the incident ccurring the fundamental issues/rt causes that need t be addressed any necessary recmmendatins t prevent the incident re-ccurring lessns learnt and disseminate the learning acrss the Trust The scale and scpe f the investigatin (as agreed with the Assistant Directr / Page 7 f 19

8 Service Directr see 5.5) shuld be prprtinate t the cause, impact r cnsequence f the incident t ensure resurces are effectively utilised Stage One Ntificatin Once an SI has been identified the Manager is required t ensure that: any necessary actin t make the situatin safe including retaining and islating any equipment, medicatin r dcumentatin is taken, ffer/arrange supprt t staff /service users/any ther persn invlved in the incident an IR1 is cmpleted (within 12 hurs f the incident being identified), a STEIS infrmatin lg frm is cmpleted and sent t the Assistant Directr/Service Directr (as sn as practicable but within 6 hurs f the serius incident being identified) where applicable initial stages f Duty f Candur is cmpleted (verbal and written aplgy within 10 days fr further infrmatin please refer t the Being Open and Duty f Candur Plicy) Where ptential media interest exists, the Head f Cmmunicatins shuld be ntified. On receipt f the cmpleted STEIS Infrmatin Lg the Assistant Directr/Service Directr shuld check the frm t ensure that it is apprpriately cmpleted and meets the criteria f an SI. Fr SIs invlving medicatin/medicatin errrs, the type r name f the drug(s) shuld be included alng with details f the errr. Fr SIs invlving junir dctrs, the grade and specialty f the dctr shuld be included. Fr SIs reprted invlving patient(s) in receipt f mental health services, cnfirmatin if the patient is a frmal r infrmal patient shuld be given and if frmal, details f the sectin f the Mental Health Act the patient is detained under (if applicable) shuld be included. If there is any dubt as t whether r nt an incident meets the SI reprting criteria, the Serius Incident Officer shuld be cntacted fr advice. Sketchy infrmatin given early is better than full infrmatin given late. In certain circumstances, a watching brief may be maintained by cmmissiners, pending further details f the incident. If the incident meets the criteria f a SI the cmpleted STEIS infrmatin Lg frm shuld be frwarded t STEIS@RDASH.nhs.uk (within 1 wrking day f the incident being identified) On receipt f the STEIS Infrmatin Lg frm in the STEIS accunt the Crprate Patient Safety Team will: Reprt nt STEIS within 2 wrking days f the incident being identified, Ntify the Chief Executive, Medical Directr, Directr f Nursing & Quality Services Directrs, Medical Directrate Manager, Safeguarding Team and the Head f Health Safety and Security that the SI has been lgged. Ntify the relevant Assistant Directr that the SI has been lgged and prviding the reprting deadlines applied t the investigatin and a reminder that Duty f Candur must be implemented. In additin the fllwing external agencies require ntificatin: The Infrmatin Cmmissiner s Office will be ntified by the Infrmatin Page 8 f 19

9 Gvernance Manager f any incidents categrised as an Infrmatin Gvernance Serius Incident Requiring Investigatin (data lss incidents which are level 2 and abve) in accrdance t the Checklist fr Reprting, Managing and Investigating Infrmatin Gvernance Serius Untward Incidents. Any death f a detained patient r patient liable t be detained under the MHA 1983 will be reprted t the CQC by the Mental Health Act Manager. Any abscnsin (frm Amber Ldge, Jubilee Clse r Cral Ldge nly) f a detained patient r patient liable t be detained under the MHA 1983 will be reprted t the CQC by the Mental Health Act Manager. Any admissin f a child r yung persn t an adult psychiatric ward r unit will be reprted t the CQC by the Mental Health Act Manager. Any death f a patient subject t the Deprivatin f Liberty Safeguards under the Mental Capacity Act 2005 will be reprted t the Crner by the persn respnsible fr verificatin f the death. The Supervisry Bdy will be ntified by the Mental Capacity Lead r the Registered Manager (LD Cmmunity Hmes). The CQC will be infrmed by the Assistant Directr f Learning Disabilities f any f the fllwing incidents in Learning Disability Cmmunity Hmes death, abuse r allegatin f abuse, events which stp r may stp the services frm running safely and prperly, serius injuries t peple wh use the service. The Frensic Business Divisin is a specialist service that has additinal cmmissining criteria fr SIs (please refer t Prcedure fr Managing Incidents and Serius Incidents within Specialised Mental Health Services directly cmmissined by NHS England). All such SI s are reprted t NHS England by the Crprate Patient Safety Team. The Yrkshire and Humber Deanery will be infrmed f all SIs directly invlving trainee dctrs by the Medical Staffing department. The relevant cmmissiner will be infrmed f all safeguarding children s SIs by Head f Nursing & Quality (Safeguarding). This includes advising the cmmissining CCG where the child is registered. Where a fatality ccurs n hspital premises apparently r ptentially as a cnsequence f alleged service user actin, self-harm r cntributry actin by staff then the Assistant Directr will reprt the incident t fllwing agencies: Crner s Office/Plice Natinal Cnfidential Inquiry - Hmicide r Suicide incidents CQC if detained patient is invlved in the incident The Lcal Cunter Fraud Specialist is respnsible fr undertaking all cunter fraud, bribery and crruptin wrk within the Trust and will infrm NHS Prtect f all incidents f fraud, bribery and crruptin in accrdance with NHS Prtect Standards fr Prviders. Mnitr (NHS Imprvement) Mnitr has a statutry duty t assess, authrise and regulate NHS Fundatin Trusts and expect them t ntify them in writing f any incidents, events r reprts that may reasnably be regarded as raising ptential cncerns ver cmpliance with ur licence. Any such cncerns are highlighted t Mnitr by the Chief Executive Officer r Deputy Chief Executive as they ccur. Pressure Ulcer RCA Prcess All pressure ulcer SIs are reviewed by the Pressure Ulcer RCA Panel t Page 9 f 19

10 determine whether they are inherited, avidable r unavidable. Inherited and/r unavidable pressure ulcer / wund SIs are de-lgged frm the system and avidable pressure ulcer / wund SI s cntinue thrugh the SI investigatin prcess Stage Tw Data Gathering/Investigatin On request by the Crprate Patient Safety Team the Assistant Directr/Service Directr must ensure that a 72 hur reprt (see SI frms and templates available n the intranet) is submitted t the Serius Incident Officer fr submissin t the relevant cmmissiner. A Lead Investigatr shuld be identified within 7 days. Cnsideratin shuld be given t: identifying an investigatr frm utside the Business Divisin fr clinical serius incidents that a registered healthcare prfessinal is the investigatr. fr incidents subject t a crner s investigatin that an experienced investigatr is identified as they may be required t testify at the inquest the investigatr must nt be invlved in the direct care f thse patients affected nr shuld they wrk directly with thse invlved in the delivery f that care in rder t maintain bjectivity. the investigatr must have undertaken Rt Cause Analysis Training prir t cnducting an investigatin. The Assistant Directr / Service Directr and Lead Investigatr shuld set ut the Terms f Reference f the investigatin that will cver: Specific prblems r issues t be addressed Wh cmmissined the investigatin (and at what level in the Trust) Investigatin Lead (and the team where relevant) Aims and Objectives f the investigatin and desired utputs. Scpe and bundaries beynd which the investigatr shuld nt g e.g. disciplinary prcess. Timescales fr the reprt and fr reviewing prgress n the actin plan Administratin arrangements (including accuntability, meetings, resurces, reprting and mnitring arrangements) Actual r ptential fr invlvement with the plice, crner etc and plans fr this t be addressed and managed effectively at the earliest pint. Wh the audience is fr the final reprt. This will include where services are cmmissined by nn NHS Cmmissiners and clarity abut the reprting and disseminatin f the SI Investigatin Reprt. The 3 key cmpnents f investigatin at this stage are: What happened? Establish the chrnlgy (the timeframe varies dependant n the type f incident being investigated e.g. Cnfidentially leak wuld cver the time when the incident ccurred t date it was discvered and immediate actins taken whereas self-harm/suicide wuld require an verview f the patients life t understand and cver the key pints that have ccurred t lead them t the pint f the incident) f event and state the immediate actin taken. Identify wh was invlved in the event, when the event tk place and where the event ccurred. Identify peple fr interview (patients/carers/staff/visitrs as apprpriate) thse directly invlved r wh have an expert knwledge. Page 10 f 19

11 Obtain written statements frm thse invlved and btain, preserve and examine any evidence (e.g. equipment). Cnduct interviews in private ensuring adequate staff supprt. Hw did it happen? Identify the prblems r events that led t the ccurrence. Identify any cntributry factrs that led t the incident ccurring Identify any and inactins which led t the incident ccurring Identify gd practice. Establish a chrnlgy r sequence f events fr these details and facts. Why did it happen? Cmpare the evidence with relevant standards, plicies, prtcls, guidelines r prfessinal practice (lcal r natinal) t identify care management prblems r system weaknesses. Cnsider pssible and knwn causal and risk factrs. Identify the cntributing factrs and rt cause(s) that led t the incident ccurring. Remember it is unusual fr an incident t ccur as a direct result f any ne factr but mre usually due t a cmbinatin f several factrs. It is imprtant that the Trust is pen and transparent during any investigatin and the invlvement f the patient, family and carers is central t this prcess. The views and pinins f the patient and/r the family shuld be sught at an early stage, and they shuld be kept up t date with prgress thrughut the investigatin prcess. It is vital that an investigatin in nt undertaken withut the invlvement f key staff fr advice and cnsultatin, such as: - Clinical Directr fr all patient related incidents - Infrmatin Gvernance Manager if infrmatin gvernance issues are raised - Mental Health Act Manager if detained r liable t be detained patient invlved - Accuntable Officer fr Cntrlled Drugs (Chief Pharmacist) if medicatin including cntrlled drugs is a factr in the incident - Lcal Cunter Fraud Specialist fr all incidents and allegatins that invlve fraud, bribery r crruptin. - Lcal Security Management Specialist fr all incidents and allegatins that invlve security, crime, vilence and assault. Reprting Deadlines If the reprting deadlines are nt being adhered t the Crprate Patient Safety Team will liaise with the Business Divisin C-rdinatr/Investigating Officer in the first instance and if there is n respnse then the issue will be escalated t the Assistant Directr and Service Directr. De-lgging an SI If during the curse f the investigatin it is believed the incident des nt meet the SI criteria then the Lead Investigatr shuld the Crprate Patient Safety Team t discuss the ptential fr de-lgging the incident. If de-lg is agreed the Crprate Patient Safety Team will make a request t the relevant CCG. Page 11 f 19

12 When a Serius Incident is de-lgged the respnsibility fr cmplying with Duty f Candur reverts back t the Delegated Incident Manager. The Lead Investigatr must cntact the Delegated Incident Manager t advise that the incident has been de-lgged and discuss the findings t date. Extensins Requests If during the curse f the investigatin it becme apparent that the 12 week timeframe cannt be achieved then the Lead Investigatr shuld the Crprate Patient Safety Team t discuss the ptential fr an extensin. If the ratinale fr the extensin is deemed reasnable the Crprate Patient Safety Team will make a request t the relevant CCG. If an extensin is granted the Lead Investigatr must keep the Crprate Patient Safety Team infrmed f prgress. Plice invlvement - In sme situatins, a serius incident may give rise t plice investigatin. In such instances the investigatr shuld: - Cntact the plice t ntify them f the plans fr the Trust investigatin and request permissin t prceed. - If the Plice make a specific request that the Trust des nt undertake any investigatin due t the pssibility f it hindering / cmprmising a criminal investigatin a nminated persn is t maintain regular cntact with the plice t ensure the psitin is kept under review t prevent any undue delay t the Trust cmmencing its wn investigatin. NB: Fllwing ntificatin frm the plice that the Trust investigatin can prceed the Lead Investigatr must cntact the Crprate Patient Safety Team t discuss the timescale that will be applied. - If the Plice make a request nt t cntact a specific persn(s) then the investigatin shuld cntinue within the plice bundaries and an interim reprt cmpleted. - If the plice make n requests fr restrictins the investigatin shuld prceed as planned. - Ntify the Crprate Patent Safety Team f plice invlvement and keep them infrmed f plice prgress. HR invlvement - If, in the curse f an investigatin, it appears that the incident may have ccurred r have been aggravated as result f failings n behalf f a member f staff, the individual(s) cncerned shuld be infrmed at the earliest pprtunity that actin under the Trust s Disciplinary Prcedure may be instigated, and cnsequently advised f their rights f representatin within that prcedure. Safeguarding Where an incident is being investigated as an SI and as a Safeguarding Cncern the lead investigatrs must keep each ther up t date with their findings. Internal investigatins with External Input - This will be apprpriate in the fllwing circumstances: - Where the level f expertise t critically review the incident is either nt available within the Trust, r the invlvement f persn(s) utside the Trust wuld ffer additinal expertise t the prcess - External input wuld be apprpriate t lend further bjectivity t the Page 12 f 19

13 prcess - External input wuld be apprpriate as the riginal incident either invlves r has impact upn ther agencies wh may need t be invlved - The requirements f public accuntability mitigate in favur f external invlvement. The cmpsitin f the investigatin panel is t be determined, as apprpriate, by the Assistant Directr/ Service Directr / Chief Executive, wh will, as necessary, take apprpriate advice n the appintment f the external participant(s). SI s cvering Mre than One Organisatin - Where a SI relates t an incident where the patient receives care frm mre than ne rganisatin (e.g. a patient affected by system failures bth in an acute hspital and in primary care), a decisin shuld be made jintly by the rganisatins cncerned abut where the frequency/ severity f the prblem(s) appears t have been greatest, if necessary referring t relevant Cmmissiner fr advice. The lead rganisatin shuld reprt the SI t the Cmmissiner and take respnsibility fr the investigatin, invlving the ther rganisatin(s) cncerned. In practice, separate meetings in different rganisatins may take place, but the Cmmissiner wuld expect t see a single investigatin reprt and actin plan submitted by the reprting rganisatin. Independent investigatins - The Trust wuld be respnsible fr btaining service users cnsent fr release f their ntes t the investigatin team. The CCG, CSU, the Trust and ther rganisatins shuld cme t lcal agreement with respect t arrangements fr funding and supprting independent investigatins. An early meeting with all the stakehlders invlving the senir manager shuld take place t agree a cmmn apprach t: - The timing f investigatin - Sharing f infrmatin, including issues f cnfidentiality - Cmmunicatin with families, carers, staff and media Stage Three Finalising the investigatin The final key cmpnent f the investigatin is: What des all this tell us and what next? Review all the infrmatin gathered and draw cnclusins. Frm the results f the rt cause analysis it shuld be clear where the prblems lie. Develp recmmendatins t address the rt causes. Any changes recmmended need t be incrprated int the way staff wrk at all levels f the Trust. Investigatins leads will prpse risk reductin measures which are: - Realistic - Sustainable - Cst effective These measures shuld be reviewed by service managers t make sure that they will be achievable in practice, as part f the investigatin and befre the investigatin reprt is finalised. Page 13 f 19

14 RCA cncludes with an investigatin reprt dealing with all aspects f the investigatin, the recmmendatins made as a result f the investigatin, lessns learnt and actins required t reduce any highlighted risks and t avid recurrence. Once the investigatin has been finalised the draft reprt shuld be reviewed by the Business Divisin/Directrate as part f the quality assurance prcess. Part f this prcess will be t: - Feedback the findings t the service managers and staff. - Assess the recmmendatins and actins with the Service Manager/Assistant Directr t check they imprve/mitigate the issues fund during the investigatin. The draft reprt must be apprved by the Assistant Directr / Service Directr prir t first submissin t the Crprate Patient Safety Team at week 8 f the investigatin timeframe. This first submissin is a cntinuatin f the review prcess by the Crprate SI Review Panel and review by the Directr f Nursing & Quality and Service Directr s. Feedback frm this review is prvided at week 9 giving the Lead Investigatr 2 weeks fr any further wrk required t finalise the secnd draft. At week 11 the secnd draft must be submitted t the Crprate Patient Safety Team wh will: Check the Rt cause Frward t the Directr f Nursing & Quality fr frmal Sign ff by the Trust Submit t the relevant Clinical Cmmissining Grup by week Stage Fur Fllw up External - Cmmissiner agreement/feedback Fllwing submissin t the cmmissiner the investigatin reprts are reviewed with Trust representatin in attendance t answer any queries raised. The utcmes frm the review are frmally fed back t the Crprate Patient Safety Team. The ptins being: Accepted - clsed n STEIS* Accepted - clsed n STEIS* hwever further clarificatin required Nt accepted - further infrmatin/wrk required * Excluding Nrth Linclnshire where all SI s are nt clsed n STEIS until all actins n the actin plan have been implemented and/r the crner s cnclusin is knwn. Where further clarificatin, infrmatin r wrk is required this must be frwarded t the Crprate Patient Safety Team within 3 weeks fr checking prir t submissin within the 4 week timeframe. Internal - Sharing learning One f the key aims f the serius incident reprting and learning prcess is t reduce the risk f recurrence. The timely and apprpriate disseminatin f lessns learned fllwing a serius incident is cre t achieving this and t ensure that these lessns are embedded in practice. Using a frmat suitable fr the relevant grup/methd, learning frm SIs is disseminated via: Ward/Team meetings Business Divisin Clinical Gvernance Grups Organisatinal Learning Frum discussin grup where members bring Page 14 f 19

15 learning t share What have we learnt intranet psting f utcmes frm cmpleted SI s #Learning Matters Biannual newsletter prviding tp themes f the utcmes and examples f gd practice Actin Plan Implementatin The Crprate Patient Safety Team will mnitr the implementatin f all actin plans resulting frm SI investigatins by requesting mnthly updates and reprting exceptins t the Quality and Safety Sub Cmmittee and relevant CCG s. In additin mnthly sampling f implementatin will be undertaken by asking fr evidence fr each actin n the randmly selected cmpleted actin plan. Media Relatins The Head f Cmmunicatins will be briefed by the Head f Allied Health Prfessins and Patient Safety r the relevant Directr/Assistant Directr cncerning incidents which may attract media interest. The Head f Cmmunicatins r a team member will be respnsible fr the preparatin f a press statement which will be apprved by the relevant Directr/s. A cmmunicatins plan will be develped which cvers all aspects f the cmmunicatin including the media, MPs, Clinical Cmmissining Grups, Legal Representatives, staff, and ther stakehlders where this is apprpriate. Fr incidents invlving staff wrking in a multi-agency service, the respective cmmunicatin teams will cnfirm which rganisatin is leading the respnse t ensure clear and timely cmmunicatin between rganisatins, i.e. media, internal cmmunicatins with staff and any partner agencies. The Cmmunicatin Team will wrk clsely with rganisatinal; staff t determine the precise nature, frequency and cntent f such cmmunicatins. 6. TRAINING IMPLICATIONS It is imprtant that all staff invlved in the SI prcess are familiar with this plicy and that its purpse and principles are well understd and the assciated prcedures are rigrusly applied. All investigatrs are required t have attended the Rt Cause Analysis Training prir t undertaking an investigatin. The Rt Cause Analysis prgramme is a structured team based apprach, which when used crrectly, can benefit all stakehlders invlved in prviding care and treatment t patients. The bjective f the prgramme is t develp learning and pen culture where staff are practive and cmmitted t cntinuusly imprving bth patients/service users and their wn safety. The Trust prvides a full day RCA training t equip staff with the right tls t: Gather and rganise infrmatin Establish gd clinical practice Analyse and define the prblem Understand and lcate the rt cause f the prblem Put crrective actin int place Mnitr prgress Learn and share experiences The key tls (see RCA Tls available n the Intranet) intrduced are: Page 15 f 19

16 The Time and Tabular Timeline The 5 Why s The Incident Decisin Tree Change analysis The Nminal Grup Technique and Ranking The Fishbne The Patient Safety Lead delivers the Rt Cause Analysis training and will prvide bespke training t grups and individuals n request. 7. MONITORING ARRANGEMENTS Area fr Hw Wh By Reprted t Frequency Mnitring/ Type f reprt New Serius Incidents Reprt Head f Allied Health Prfessins and Bard f Directrs Mnthly Perfrmance Management Actin Plans Quarterly status update reprt Thematic review Reprt Reprt Reprt Patient Safety Head f Allied Health Prfessins and Patient Safety Head f Allied Health Prfessins and Patient Safety Head f Allied Health Prfessins and Patient Safety Annual Reprt Reprt Head f Allied Health Prfessins and Patient Safety Quality and Safety Sub Cmmittee Cmmissiners Bard f Directrs Quality and Safety Sub Cmmittee Mnthly Quarterly Quarterly Annually 8. EQUALITY IMPACT ASSESSMENT SCREENING The cmpleted Equality Impact Assessment fr the Plicy fr the Management f Serius Incidents will be published n the Equality and Diversity webpage f the RDaSH Website as fllws: Equality and Diversity Impact Assessment 8.1. Privacy, Dignity and Respect The NHS Cnstitutin states that all patients shuld feel that their privacy and dignity are respected while they are in hspital. High Quality Care fr All (2008), Lrd Darzi s review f the NHS, identifies the need t rganise care arund the individual, nt just clinically but in terms f dignity and respect. As a cnsequence the Trust is required t articulate its intent t deliver care with privacy and dignity that treats all service users with respect. Therefre, all prcedural dcuments will be cnsidered, if relevant, t reflect the Indicate hw this will be met N issues have been identified in relatin t this plicy. Page 16 f 19

17 requirement t treat everyne with privacy, dignity and respect, (when apprpriate this shuld als include hw same sex accmmdatin is prvided) Mental Capacity Act Central t any aspect f care delivered t adults and yung peple aged 16 years r ver will be the cnsideratin f the individuals capacity t participate in the decisin making prcess. Cnsequently, n interventin shuld be carried ut withut either the individuals infrmed cnsent, r the pwers included in a legal framewrk, r by rder f the Curt Therefre, the Trust is required t make sure that all staff wrking with individuals wh use ur service is familiar with the prvisins within the Mental Capacity Act. Fr this reasn all prcedural dcuments will be cnsidered, if relevant t reflect the prvisins f the Mental Capacity Act 2005 t ensure that the interests f an individual whse capacity is in questin can cntinue t make as many decisins fr themselves as pssible. Indicate Hw This Will Be Achieved. All individuals invlved in the implementatin f this plicy shuld d s in accrdance with the Guiding Principles f the Mental Capacity Act (Sectin 1) 9. LINKS TO ANY ASSOCIATED DOCUMENTS It is imprtant t recgnise that ther Trust plicies exist which may be cmplementary r even verlap this plicy. In such situatins, due cnsideratin shuld be given t thse plicies either thrughut the prcess r fr nward referral nce the findings f an investigatin have cme t light. Incident Reprting Plicy Absent Withut Leave Plicy Standard Operating Prcedure fr the Management f Infrmatin Gvernance Serius Incidents Requiring Investigatin (IG SIRI) Plicy and Prcedure fr the Handling f Frmal Cmplaints - General Plicies Claims Handling Plicy Being Open and Duty f Candur Plicy: Cmmunicating service user safety incidents with service users and their carers Plicy and Prcedure fr cmpliance with the management f Health and Safety at Wrk Regulatins 1999 and Health and Safety at Wrk actin 1974 Clinical Risk Assessment and Management Plicy Plicy fr the Safe and Secure Handling f Medicines Risk Management Strategy Plicy in Relatin t the Trust Disciplinary Prcedure Plicy n Supprting staff invlved in a Traumatic/Stressful Incident, Cmplaint, r Claim Disclsure f Cncerns Safeguarding Children Plicy Safeguarding Adults Plicy Cunter Fraud, Bribery and Crruptin Plicy Page 17 f 19

18 10. REFERENCES Care Quality Cmmissin (2015) Guidance fr prviders n meeting the regulatins Serius Incident Framewrk March 2015 Never Events Plicy 2015 NPSA (2009) Being pen Cmmunicating patient safety incidents with patients and their carers NPSA (2010) Infrmatin Resurce t Supprt the Reprting f Serius Incidents NPSA (2010) Natinal Framewrk fr Reprting and Learning frm Serius Incidents Requiring Investigatin NPSA (2008) Independent Investigatin f Serius Patient Safety Incidents in Mental Health Services; Gd Practice Guidance NHS Yrkshire and the Humber Prcedure fr the management f Serius Incidents (SIs)-Versin 6 Octber 2010 NHS Yrkshire and the Humber Cmmissining f Independent Investigatins Plicy Statement NHS Yrkshire and the Humber learning the lessns frm extreme SUIs: Hw d we ensure that it culdn t happen here? December 2009 Institute fr Healthcare Imprvement (2006) Leadership Guide t Patient Safety Department f Health (2007) Safer Management f Cntrlled Drugs A Guide t Gd Practice in Secndary Care Dangerus Drugs, England and Sctland - Instrument N The Cntrlled Drugs (Supervisin f Management and Use) Regulatins 2006 Department f Health (2010) Checklist fr Reprting, Managing and Investigating Infrmatin Gvernance Serius Incidents, Gateway Ref: 13177, Infrmatin Gvernance Plicy Page 18 f 19

19 WEEK 12 WEEK 9-11 WEEK WEEK 2 WORKING DAYS Appendix A SERIOUS INCIDENT (SI) MANAGEMENT PROCESS FLOWCHART Ptential SI Occurs IR1 cmpleted STEIS Infrmatin Lg cmpleted and submitted t AD YES Discuss with CPST t check if an SI NO n further actin required STEIS Infrmatin Lg submitted t STEIS@rdash.nhs.uk accunt [AD] External agencies ntificatins [speciality team] CPST t ntify CEO, DN, SD s, MD SI reprted n the STEIS [CPST r deputy] Staff Debriefing [AD] 72 Hurs reprted t be cmpleted [AD] and sent t CPST CPST submits t CCG 10 wrking days Duty f Candur, if apprpriate [DIM] t be implemented & Safeguard updated AD t appint LI and infrm CPST, DIM t hand ver t LI t ensure cntinuity LI t undertake investigatin and will include: Liaise with expert advice e.g. Accuntable Officer cntrlled drugs (Chief Pharmacist), Infrmatin Gvernance manager etc Interview staff (witnesses & line management, patient, family Use RCA tls, 5 Why s, fishbne etc Liaise with Clinical Directr Liaise with team/service manager t agree recmmendatin(s) and actin(s) Investigatin Reprt t be review in Business Divisin/ Directrate internal panel AD t review reprt, sign ff and submit t CPST CPST t send t DN, and SD s fr review Quality check by SI Review Panel [CPST] AD t review reprt, sign ff and submit t CPST Feedback t LI [CPST] Final Versin f reprt t AD [LI] Staff Debriefing [AD] CPST t check Rt Cause then frward t DN fr sign ff CPST submit final reprt t CCG Discussin and agreement f changes with LI [CPST] AD - Assistant Directr CPST - Crprate Patient Safety Team DN - Directr f Nursing & Quality MD - Medical Directr DIM - Designated Incident Manager LI - Lead Investigatr SD s - Service Directr s CEO - Chief Executive Officer CCG - Clinical Cmmissining Grup