Regulation 5: Fit and proper persons: directors. and. Regulation 20: Duty of candour

Transcription

1 Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies Nvember 2014

2 The Care Quality Cmmissin is the independent regulatr f health and adult scial care in England Our purpse We make sure health and scial care services prvide peple with safe, effective, cmpassinate, high-quality care and we encurage care services t imprve. Our rle We mnitr, inspect and regulate services t make sure they meet fundamental standards f quality and safety and we publish what we find, including perfrmance ratings t help peple chse care. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 2

3 Cntents Frewrd 4 Intrductin 6 CQC s perating mdel 6 Overview f the new regulatins 9 Regulatin 5: Fit and prper persns: directrs 9 Regulatin 20: Duty f candur 14 Our apprach t guidance n regulatins 17 Guidance fr prviders 18 Regulatin 5: Fit and prper persns: directrs 19 Regulatin 20: Duty f candur 28 Appendix A: Descriptin f terms used in ur guidance abut the fit and prper requirement fr directrs 36 Appendix B: Descriptin f terms used in ur guidance abut duty f candur 38 Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 3

4 Frewrd We set ut a new visin and directin fr the Care Quality Cmmissin (CQC) in ur strategy fr , Raising standards, putting peple first, and in ur cnsultatin, A new start, which prpsed radical changes t the way we regulate health and adult scial care services. We develped these changes with extensive engagement with the public, ur staff, prviders and key rganisatins. A new start set ut the new verarching framewrk, principles and perating mdel that we will use. This includes the five key questins that we will ask f all services: Are they safe? Are they effective? Are they caring? Are they respnsive? Are they well-led? Stakehlders and the public acrss the care sectrs welcmed ur prpsals, which include a mre rbust apprach t registratin; the intrductin f chief inspectrs; expert inspectin teams; ratings t help peple chse care; a fcus n highlighting gd practice; and a cmmitment t listen better t the views and experiences f peple wh use services. We have published handbks fr prviders in each sectr, which prvide detailed guidance n ur new apprach t regulating and inspecting services. Within this new apprach, we must cntinue t ensure that prviders meet Gvernment regulatins abut the quality and safety f care. As part f this, we are required t publish guidance fr prviders t help them meet the requirements f the regulatins. New regulatins setting ut fundamental standards f care will cme int frce fr all care prviders n 1 April Hwever, tw f the new requirements the fit and prper persns requirement fr directrs and the duty f candur will cme int frce fr NHS bdies n 27 Nvember The term NHS bdies means NHS trusts, NHS fundatin trusts and special health authrities. The intrductin f a statutry duty f candur is an imprtant step twards ensuring the pen, hnest and transparent culture that was lacking at Mid Staffrdshire NHS Fundatin Trust. The failures at Winterburne View Hspital revealed that there were n levers in the system t hld the cntrlling mind f rganisatins t accunt. The fit and prper persns requirement fr directrs plays a majr part in ensuring the accuntability f directrs f NHS bdies. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 4

5 It is essential that CQC uses these new pwers well t encurage a culture f penness and t hld prviders and directrs t accunt. This guidance n the tw new regulatins is interim guidance. CQC s new guidance n implementing all the fundamental standards, which will be implemented in April 2015, will replace, in its entirety, the Guidance abut cmpliance: Essential standards f quality and safety. It will include guidance fr all sectrs n the fit and prper persns requirement fr directrs and the duty f candur fr all prviders. Our current enfrcement plicy will als be replaced. David Behan Chief Executive Care Quality Cmmissin Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 5

6 Intrductin CQC s perating mdel Our prvider handbks set ut the details f ur new apprach fr each sectr. They describe hw we will carry ut inspectins, make judgements and award ratings t prviders. Our apprach in each sectr reflects cmmn principles that are intended t ensure that health and adult scial care services prvide peple with safe, effective, cmpassinate, high-quality care, and t encurage care services t imprve. Our new perating mdel describes hw we will register, mnitr, inspect and award ratings t prviders. It is illustrated by the fllwing diagram: Figure 1: CQC s verall perating mdel Within this new apprach, we must cntinue t ensure that prviders meet Gvernment regulatins abut the quality and safety f care. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 6

7 Hw ur guidance n meeting regulatins fits int ur perating mdel All registered prviders must demnstrate that they are meeting regulatry requirements in rder t register with CQC and then cntinue t deliver regulated services. The law states that ur guidance n meeting the regulatins must be taken int accunt in relatin t all regulatry decisins that CQC makes. Frm 27 Nvember 2014, in additin t the existing regulatins, NHS bdies, defined as NHS trusts, NHS fundatin trusts and any special health authrities carrying n a regulated activity, must meet the new Regulatin 5: fit and prper persns: directrs and the new Regulatin 20: duty f candur. Thrughut the text f this guidance, fr ease f language, we refer t Regulatin 5 as the fit and prper persns requirement fr directrs (FPPR). Where we use the term prvider in this dcument it refers t NHS bdies. Our guidance n meeting the fit and prper persn requirement fr directrs regulatin and the duty f candur regulatin will be central t bth registratin and inspectin. 1. Registratin As set ut in ur strategy, we will cntinue t strengthen ur apprach t assessing applicatins fr registratin with CQC. Frm 27 Nvember 2014, when cnsidering new NHS applicatins fr registratin, and variatin applicatins made by existing NHS bdies, we will take int accunt the FPPR and duty f candur. We will use this guidance t d this. We d nt require NHS bdies t ntify us when there is a change t the bard membership r where there is a merger r acquisitin. Hwever, if the newly frmed trust is a new legal entity, then the prcesses described will apply. We will keep this under review. 2. Inspectin In cmprehensive inspectins (leading t ratings f individual services and the prvider verall), we primarily lk fr gd care, rather than checking cmpliance with regulatins. We have develped characteristics f what gd care lks like in partnership with patients, peple wh use services and subject matter experts, and therefre what wuld cnstitute a gd rating. We will use key lines f enquiry (KLOEs) t assess this, checking whether a prvider is delivering services that are safe, effective, caring, respnsive and well-led. The characteristics f gd care and the KLOEs are set ut in ur prvider handbks. If we find gd care, we will als assess whether it meets the characteristics f an utstanding rating. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 7

8 Hwever, if we find care that des nt reflect the characteristics f gd, we will assess whether it requires imprvement r is inadequate. We will als cnsider whether a regulatin has been breached. We will take this guidance int accunt t determine whether r nt a prvider has cmplied with the tw new regulatins. In fcused inspectins, we either fllw up specific cncerns frm earlier inspectins r respnd t new, specific, cncerning infrmatin that has cme t ur attentin. In these circumstances, we assess whether the prvider has imprved s that it is n lnger in breach f regulatins r whether the new cncern amunts t a breach f regulatins. We will take this guidance int accunt in making these judgements. We will use ur enfrcement pwers as utlined in ur Judgement Framewrk and Enfrcement Plicy bth t prtect patients and t hld prviders and, in sme cases, individuals t accunt. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 8

9 Overview f the new regulatins Regulatin 5: Fit and prper persns: directrs The aim f this regulatin is t ensure that all bard level appintments f NHS fundatin trusts, NHS trusts and special health authrities 1 carrying n a regulated activity are respnsible fr the verall quality and safety f that care, and fr making sure that care meets the existing regulatins and effective requirements f the Health and Scial Care Act 2008 (Regulated Activities) Regulatins This regulatin is abut ensuring that thse individuals are fit and prper t carry ut this imprtant rle. It will apply t directrs by which, we mean executive and nn-executive, permanent, interim and assciate psitins, irrespective f their vting rights. This regulatin will nt apply t the bard f gvernrs f a fundatin trust, but will apply t a gvernr if they are a member f the trust bard. Regulatin 5 has been intrduced as a direct respnse t the failings at Winterburne View Hspital and the Francis Inquiry reprt int Mid Staffrdshire NHS Fundatin Trust 3, which recmmended that a statutry fit and prper persns requirement be impsed n health service bdies. Health service prviders currently have a general bligatin t ensure that they nly emply individuals wh are fit fr their rle. CQC assesses the fitness f 'crprate' service prviders (that is, all prviders ther than individuals and partnerships) by fcusing n the fitness f their nminated individuals. When assessing the fitness f the nminated individual, we cnsider whether the prvider has taken apprpriate steps t ensure that they are f gd character, are physically and mentally fit, have the necessary qualificatins, skills and experience fr the rle, and can supply certain infrmatin (including a Disclsure and Barring Service (DBS) check and a full emplyment histry). The intrductin f the fit and prper persns requirement fr directrs (FPPR) impses an additinal requirement n directrs. It will be the ultimate respnsibility f the chair f the NHS bdy t discharge the requirement placed n the prvider, t ensure that all directrs meet the fitness test and d nt meet any f the unfit criteria. 1. NHS fundatin trusts, NHS trusts and special health authrities are defined as health service bdies in the regulatins. 2. The Health and Scial Care Act 2008 (Regulated Activities (Regulatins 2014) will cme fully int frce n 1 April Reprt f the Mid Staffrdshire NHS Fundatin Trust Public Inquiry, chaired by Rbert Francis QC, Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 9

10 In additin t the usual requirements f gd character, health, qualificatins, skills and experience, the regulatin ges further by barring individuals wh are prevented frm hlding the ffice (fr example, under a directr s disqualificatin rder) and significantly, excluding peple wh: "have been respnsible fr, been privy t, cntributed t r facilitated any serius miscnduct r mismanagement (whether unlawful r nt) in the curse f carrying n a regulated activity, r prviding a service elsewhere which, if prvided in England, wuld be a regulated activity. We will wrk cllabratively with the NHS Trust Develpment Authrity, Mnitr and cuncils f gvernrs n hw these prpsals fit with the appintments f trust chairs. This will enable valuable infrmatin t be shared and will help t avid impsing additinal burden n prviders. T meet the requirements f Regulatin 5, a prvider has t: Prvide evidence that apprpriate systems and prcesses are in place t ensure that all new directrs and existing directrs are, and cntinue t be, fit, and that n appintments meet any f the unfitness criteria set ut in Schedule 4 f the regulatin. This means that bard directrs shuld be f gd character, have the required skills, experience and knwledge and that their health enables them t fulfil the management functin. Nne f the criteria f unfitness shuld apply, which include bankruptcy, sequestratin and inslvency, appearing n barred lists and being prhibited frm hlding directrships under ther laws. Directrs shuld nt have been invlved r cmplicit in any serius miscnduct, mismanagement r failure f care in carrying n a regulated activity. Make every reasnable effrt t assure itself abut an individual by all means available. Make specified infrmatin abut bard directrs available t CQC. Be aware f the varius guidelines available and t have implemented prcedures in line with this best practice. Where a bard member n lnger meets the fit and prper persns requirement, infrm the regulatr in questin where the individual is registered with a health care r scial care regulatr, and take actin t ensure the psitin is held by a persn meeting the requirements. Directrs may persnally be accused and fund guilty by a curt f serius miscnduct in respect f a range f already prescribed behaviurs set ut in legislatin. Prfessinal regulatrs may remve an individual frm a register fr breaches f cdes f cnduct. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 10

11 CQC recgnises that individuals may be fit fr their rles while, cllectively, the bard demnstrates a lack f fitness. We will address this in the mst apprpriate, relevant and prprtinate apprach n a case by case basis. The prvider is respnsible fr the appintment, management and dismissal f its directrs. The prvider is respnsible, as part f the recruitment and perfrmance management prcesses, t ensure that FPPR is met. CQC will nt undertake a fit and prper persns test f a directr r determine what is serius mismanagement r miscnduct, but we will examine hw the prvider has discharged its respnsibility under the new regulatin. It is a breach f the regulatin t have in place smene wh des nt satisfy the FPPR. Evidence f this culd be if: A directr is unfit n a mandatry grund, such as a relevant cnvictin r bankruptcy. The prvider will determine this. A prvider des nt have a prper prcess in place t enable it t make the assessments required by the FPPR. On receipt f infrmatin abut a directr s fitness, a decisin is reached n the fitness f the directr that is nt in the range f decisins that a reasnable persn wuld make. CQC will nw be able t take enfrcement actin fr breaches f the fit and prper persn requirement, in accrdance with ur Judgement Framewrk and Enfrcement Plicy. Where a breach is identified, we will use ur existing regulatry pwers. Breaches f ther regulatins may give CQC cause t questin whether they have resulted frm a breach f this regulatin. In respnse t ur cnsultatin n this guidance, peple asked fr a clearer descriptin f the key terms that are used, and these are given in appendix A. Our apprach t the fit and prper persns requirement fr directrs Our apprach t FPPR is part f ur new inspectin apprach. CQC will check and mnitr the extent t which the prvider meets the regulatin at the pint f registratin, during the inspectin, n receipt f cncerning infrmatin and where there is serius a systemic failure f a prvider. During ur registratin prcess, we will test ut with the prvider that they understand the requirements f the regulatin and ask them what systems they have in place t ensure that they will be able t meet these requirements. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 11

12 We will require the chair f the NHS prvider t declare that apprpriate checks have been undertaken in reaching a judgement that all directrs are deemed t be fit and nne meet any f the unfit criteria. This will be a self-declaratin and we will nly fllw this up if we have cncerns abut the recruitment prcess. This new requirement will nt delay prviders prcesses fr appinting directrs, r increase their administrative wrklad significantly. If we receive cncerns abut an individual directr, we may als ask the prvider t check their fitness and prvide the same assurance t us. If a prvider that aspires t register with CQC cannt demnstrate that it will meet the requirements f the regulatin frm its first day f business, we may refuse its applicatin. During the inspectin prcess, we will assess whether the prvider is delivering gd quality care. The specific key line f enquiry (KLOE) and prmpts that are relevant fr the FPPR are under the well-led key questin, as fllws: W3: Hw des the leadership and culture reflect the visin and values, encurage penness and transparency and prmte gd quality care? Prmpt: D leaders have the skills, knwledge, experience and integrity that they need bth when they are appinted and n an nging basis? Prmpt: D leaders have the capacity, capability and experience t lead effectively? Using the well-led key questin, CQC will cnfirm that the prvider has undertaken apprpriate checks and is satisfied that, n appintment and subsequently, all new and existing directrs are f gd character and are nt unfit. This may invlve checking persnnel files and recrds abut appraisal rates fr directrs. The inspectin team will want t check prviders awareness f the varius guidelines and that they have implemented appraches in line with best practice. We will reprt n the FPPR under well-led in ur inspectin reprts at prvider level. If we find that prviders d nt reflect the characteristics f gd as described in ur handbks, we will assess whether they require imprvement r are inadequate. We will als cnsider whether a regulatin has been breached, including Regulatin 5. Where there is a serius systemic failure f a prvider we will carry ut a fcused inspectin, including the FPPR aspects f crprate failure, and will use the evidence f such an inspectin t infrm ur judgements abut Regulatin 5 and any breaches that may have taken place. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 12

13 We will nt use the fact that a prvider is in special measures as evidence r an indicatin that a directr is unfit. Hwever we wuld, if necessary because f special measures, assess the effectiveness and rbustness f the prcesses fr the appintment f directrs. We will have regard t any ther infrmatin that we hld r btain abut directrs in line with current legislatin n when cnvictins, bankruptcies r similar matters are t be cnsidered spent. Where a directr is assciated with serius miscnduct r respnsibility fr failure in a previus rle, we will have regard t the seriusness f the failure, hw it was managed, and the individual s rle within that. Infrmatin received frm a member f the public r the prvider s staff abut an existing bard member will be dealt with in line with CQC s safeguarding and whistleblwing prtcls where relevant. When a cncern arises abut the fitness f a directr, we will fllw a clear prcess explaining t bth the individual and the prvider what we intend t d. We will manage this in line with infrmatin gvernance requirements. CQC will cnvene a panel, led by the Chief Inspectr f Hspitals r a persn designated by them, t determine whether the infrmatin is significant and shuld be cnsidered by the prvider. We will request cnsent frm the directr cncerned t pass this infrmatin t the prvider. If we d nt gain this cnsent frm the directr cncerned, CQC will cnsider whether t share the infrmatin, acting in accrdance with the Data Prtectin Act. The respnse received will either satisfy the Chief Inspectr f Hspitals that due prcess has been fllwed r lead t a request fr further dialgue with the prvider, a fllw-up inspectin, r regulatry actin using CQC s current enfrcement plicy. CQC will take all circumstances int accunt when making a decisin and wuld nt take actin against a prvider if we cnsider it is reasnable fr a prvider t wait fr the decisin f a tribunal (such as an emplyment tribunal) befre determining whether a directr is unfit. Fllwing this, CQC wuld then assess whether the prvider s judgement is reasnable, taking accunt f the tribunal s decisin. There are sme cre public infrmatin surces abut prviders that we believe are relevant fr prviders t use as part f their FPPR due diligence. We intend t prvide sme f these n ur website, r indicate where they can be fund. Fr example, this includes, but is nt limited t, infrmatin frm public inquiry reprts, serius case reviews and Ombudsmen reprts as utlined in ur guidance. In all situatins, CQC will determine the mst apprpriate, relevant and prprtinate apprach t take t meeting this regulatin n a case by case basis. These new arrangements will be used t prtect peple frm harm and the risk f Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 13

14 harm. Actin taken will be prprtinate t the cncerns identified and the impact n peple wh use services. Where a prvider is unable t demnstrate that it has undertaken the apprpriate checks in the appintment f its bard members, CQC will decide whether r nt t take regulatry actin, and what actin t take. CQC will wrk alngside the NHS Trust Develpment Authrity and Mnitr t ensure that the crrect prcesses are adhered t, that infrmatin is shared where apprpriate and that enfrcement activity is used prprtinately. Prviders may appeal t the First-tier Tribunal against a decisin by CQC t take enfrcement actin. The tribunal hears appeals against decisins f the Secretary f State t restrict r bar an individual frm wrking with children r vulnerable adults and decisins t cancel, vary r refuse registratin f certain health care, child care and scial care prvisin. Prviders may als challenge by way f judicial review if they cnsider that a decisin breaches public law principles such as being unreasnable, irratinal and unfair. Judicial review is a prcedure in English administrative law by which the curts in England and Wales may be asked t set aside (quash) allegedly unlawful decisins made by a public bdy, such as gvernment minister, the lcal cuncil r a statutry tribunal. As the statutry fit and prper persns requirement fr directrs is a new regulatin, we expect t learn frm what we find. We will share ur learning frm the early stages f implementatin and aim t publish this when there is a sufficient bdy f infrmatin available. This learning will als infrm the develpment f ur guidance n meeting the new fundamental standards in all sectrs. This guidance n Regulatin 5 will be updated and incrprated int ur guidance, t be issued befre 1 April 2015, n meeting all the fundamental standards. Regulatin 20: Duty f candur The aim f this regulatin is t ensure that health service bdies 4 are pen and transparent with the relevant persn (as defined in the regulatin) when certain incidents ccur in relatin t the care and treatment prvided t peple wh use services in the carrying n f a regulated activity. The regulatin defines the relevant persn as the persn using the service and, in certain situatins, extend t peple acting lawfully n their behalf, fr example a persn under 16 wh is nt cmpetent t make decisins abut their care and 4 Health services bdies are defined in the regulatins as NHS trusts, NHS fundatin trusts and special health authrities. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 14

15 treatment, r a persn aged 16 r ver wh lacks the capacity t make decisins abut their care and treatment. If the relevant persn cannt be cntacted r declines t speak t the representative f the health service bdy, then the health service bdy must keep a written recrd f its attempts t cntact r speak t the relevant persn. The intrductin f Regulatin 20 is a direct respnse t recmmendatin 181 f the Francis Inquiry reprt int Mid Staffrdshire NHS Fundatin Trust 5, which recmmended that a statutry duty f candur be impsed n healthcare prviders. In interpreting the regulatin n the duty f candur, we use 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 6, 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. Mst NHS bdies are already subject t a cntractual duty f candur under the NHS Standard Cntract. Cntractual requirements are clearly set ut in Standard Cnditin 35 f the cntract. CQC already expects registered prviders t meet these requirements, and we include this in ur inspectin apprach as part f the key questin Are services safe? Regulatin 20 applies t NHS bdies when they are prviding care and treatment t peple wh use services in the carrying n f a regulated activity nly. T meet the requirements f Regulatin 20, an NHS bdy has t: Make sure it acts in an pen and transparent way with relevant persns in relatin t care and treatment prvided t peple wh use services in carrying n a regulated activity. 5. Reprt f the Mid Staffrdshire NHS Fundatin Trust Public Inquiry, chaired by Rbert Francis QC, 6. Sir David Daltn and Prf. Nrman Williams, Building a culture f candur: a review f the threshld fr the duty f candur and f the incentives fr care rganisatins t be candid, Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 15

16 Tell the relevant persn in persn as sn as reasnably practicable after becming aware that a ntifiable safety incident has ccurred, and prvide supprt t them in relatin t the incident, including when giving the ntificatin. Prvide an accunt f the incident which, t the best f the health service bdy s knwledge, is true f all the facts the bdy knws abut the incident as at the date f the ntificatin. Advise the relevant persn what further enquiries the health service bdy believes are apprpriate. Offer an aplgy. Fllw this up by giving the same infrmatin in writing, and prviding an update n the enquiries. Keep a written recrd f all cmmunicatin with the relevant persn. In respnse t ur cnsultatin n this guidance, peple asked fr a clearer descriptin f key terms that are used. Where these are nt already defined in Regulatin 20, these are given in appendix B. Our apprach t the duty f candur Our apprach t the duty f candur is part f ur new inspectin apprach. During ur registratin prcess we will test ut with a prvider that they understand the requirements f the regulatin and ask them what systems they have in place t ensure that they will be able t meet these requirements. During the inspectin prcess, we will assess whether the prvider is delivering gd quality care. Tw specific key lines f enquiry (KLOEs) under the safe and well-led questins are relevant t the duty f candur: S2: Are lessns learned and imprvements made when things g wrng? Prmpt: Are peple wh use services tld when they are affected by smething that ges wrng, given an aplgy and infrmed f any actins taken as a result? W3: Hw des the leadership and culture reflect the visin and values, encurage penness and transparency and prmte gd quality care? Prmpt: Des the culture encurage candur, penness and hnesty? Our handbks describe what gd care lks like in relatin t each f the five key questins. Services that are safe ensure that when smething ges wrng, peple receive a sincere aplgy and are tld abut any actins taken t imprve Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 16

17 prcesses t prevent the same thing happening again. In services that are wellled, candur, penness, hnesty and transparency and challenges t pr practice are the nrm. Leadership at all levels in the rganisatin is central t ensuring a culture that supprts this. We will reprt n the duty f candur under the safety key questin in ur inspectin reprts at prvider level. If we find care that des nt reflect the characteristics f gd as they are described in ur prvider handbk, we will assess whether the service requires imprvement r is inadequate. We will als cnsider whether a regulatin has been breached. We will take this guidance int accunt t determine whether a prvider is meeting Regulatin 20. An internal CQC advisry panel will be set up t supprt cnsistency in decisin-making and t capture and share learning. Infrmatin received frm a member f the public r the prvider s staff relating t the statutry duty f candur will be dealt with in line with CQC s safeguarding and whistleblwing prtcls where relevant. When we identify a breach f Regulatin 20, we will assess the impact n peple and decide whether r nt t take regulatry actin, and what actin t take, in accrdance with ur Judgement Framewrk and Enfrcement Plicy. As the statutry duty f candur is a new regulatin, we expect t learn frm what we find. This learning will als infrm the develpment f ur guidance n meeting the new fundamental standards in all sectrs. This guidance n Regulatin 20 will be updated and incrprated int ur guidance, t be issued befre 1 April 2015, n meeting all the fundamental standards. Our apprach t guidance n regulatins We develped this guidance with the help f patients and peple wh use services, rganisatins that represent them, prviders, ther regulatrs and prfessinal bdies. We are grateful fr their many suggestins. In the guidance, we explain the intentin f each regulatin. We then cnsider each element f the regulatin in turn, setting ut ur guidance that prviders must have regard t. Fr each regulatin, we prvide links t key legislatin and guidance that we will cnsider when making judgements. The listed legislatin and guidance is nt exhaustive. We expect prviders t take accunt f ther relevant guidance that is specific t the services they deliver. We intend ur guidance t be as helpful as pssible t prviders. Hwever, it is nt CQC s rle t tell prviders what they must d t deliver their services. It is the prvider s respnsibility t meet the regulatins and t decide hw t d this. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 17

18 Guidance fr prviders Hw t meet Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Yu can see the Health and Scial Care Act 2008 (Regulated Activities) Regulatins 2014 n this link: Regulatins 5 and 20 cme int frce fr NHS bdies n 27 Nvember Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 18

19 Regulatin 5: Fit and prper persns: directrs 5 (1) This regulatin applies where a service prvider is a health service bdy. (2) Unless the individual satisfies all the requirements set ut in paragraph (3), the service prvider must nt appint r have in place an individual (a) as a directr f the service prvider, r (b) perfrming the functins f, r functins equivalent r similar t the functins f, such a directr. (3) The requirements referred t in paragraph (2) are that (a) the individual is f gd character, (b) the individual has the qualificatins, cmpetence, skills and experience which are necessary fr the relevant ffice r psitin r the wrk fr which they are emplyed, (c) the individual is able by reasn f their health, after reasnable adjustments are made, f prperly perfrming tasks which are intrinsic t the ffice r psitin fr which they are appinted r t the wrk fr which they are emplyed, (d) the individual has nt been respnsible fr, been privy t, cntributed t r facilitated any serius miscnduct r mismanagement (whether unlawful r nt) in the curse f carrying n a regulated activity r prviding a service elsewhere which, if prvided in England, wuld be a regulated activity, and (e) nne f the grunds f unfitness specified in Part 1 f Schedule 4 apply t the individual. (4) In assessing an individual s character fr the purpses f paragraph (3)(a), the matters cnsidered must include thse listed in Part 2 f Schedule 4. (5) The fllwing infrmatin must be available t be supplied t the Cmmissin in relatin t each individual wh hlds an ffice r psitin referred t in paragraph (2)(a) r (b) (a) the infrmatin specified in Schedule 3, and (b) such ther infrmatin as is required t be kept by the service prvider under any enactment which is relevant t that individual. (6) Where an individual wh hlds an ffice r psitin referred t in paragraph (2)(a) r (b) n lnger meets the requirements in paragraph (3), the service prvider must (a) take such actin as is necessary and prprtinate t ensure that the ffice r psitin in questin is held by an individual wh meets such requirements, and (b) if the individual is a health care prfessinal, scial wrker r ther prfessinal registered with a health care r scial care regulatr, infrm the regulatr in questin. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 19

20 SCHEDULE 4 Gd character and unfit persn tests PART 1 Unfit persn test 1. The persn is an undischarged bankrupt r a persn whse estate has had sequestratin awarded in respect f it and wh has nt been discharged. 2. The persn is the subject f a bankruptcy restrictins rder r an interim bankruptcy restrictins rder r an rder t like effect made in Sctland r Nrthern Ireland. 3. The persn is a persn t whm a mratrium perid under a debt relief rder applies under Part VIIA (debt relief rders) f the Inslvency Act The persn has made a cmpsitin r arrangement with, r granted a trust deed fr, creditrs and nt been discharged in respect f it. 5. The persn is included in the children s barred list r the adults barred list maintained under sectin 2 f the Safeguarding Vulnerable Grups Act 2006, r in any crrespnding list maintained under an equivalent enactment in frce in Sctland r Nrthern Ireland. 6. The persn is prhibited frm hlding the relevant ffice r psitin, r in the case f an individual frm carrying n the regulated activity, by r under any enactment. PART 2 Gd character 7. Whether the persn has been cnvicted in the United Kingdm f any ffence r been cnvicted elsewhere f any ffence which, if cmmitted in any part f the United Kingdm, wuld cnstitute an ffence. 8. Whether the persn has been erased, remved r struck-ff a register f prfessinals maintained by a regulatr f health care r scial wrk prfessinals. SCHEDULE 3: Infrmatin Required in Respect f Persns Emplyed r Appinted fr the Purpses f a Regulated Activity 1. Prf f identity including a recent phtgraph. 2. Where required fr the purpses f an exempted questin in accrdance with sectin 113A(2)(b) f the Plice Act 1997, a cpy f a criminal recrd certificate issued under sectin 113A f that Act tgether with, after the appinted day and where applicable, the infrmatin mentined in sectin 30A(3) f the Safeguarding Vulnerable Grups Act 2006 (prvisin f barring infrmatin n request). 3. Where required fr the purpses f an exempted questin asked fr a prescribed purpse under sectin 113B(2)(b) f the Plice Act 1997, a cpy f an enhanced criminal recrd certificate issued under sectin 113B f that Act tgether with, where applicable, suitability infrmatin relating t children r vulnerable adults. 4. Satisfactry evidence f cnduct in previus emplyment cncerned with the prvisin f services relating t (a) health r scial care, r (b) children r vulnerable adults. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 20

21 5. Where a persn (P) has been previusly emplyed in a psitin whse duties invlved wrk with children r vulnerable adults, satisfactry verificatin, s far as reasnably practicable, f the reasn why P s emplyment in that psitin ended. 6. In s far as it is reasnably practicable t btain, satisfactry dcumentary evidence f any qualificatin relevant t the duties fr which the persn is emplyed r appinted t perfrm. 7. A full emplyment histry, tgether with a satisfactry written explanatin f any gaps in emplyment. 8. Satisfactry infrmatin abut any physical r mental health cnditins which are relevant t the persn s capability, after reasnable adjustments are made, t prperly perfrm tasks which are intrinsic t their emplyment r appintment fr the purpses f the regulated activity. 9. Fr the purpses f this Schedule (a) the appinted day means the day n which sectin 30A f the Safeguarding Vulnerable Grups Act 2006 cmes int frce;. (b) satisfactry means satisfactry in the pinin f the Cmmissin;. (c) suitability infrmatin relating t children r vulnerable adults means the infrmatin specified in sectins 113BA and 113BB respectively f the Plice Act Summary f the regulatin This regulatin applies t health service bdies nly, frm 27 Nvember It will be extended t all ther prviders frm 1 April 2015, subject t Parliamentary prcess and apprval. This guidance will be updated and incrprated int ur guidance, t be issued befre 1 April 2015, n all the new fundamental standards. The intentin f this regulatin is t ensure that all bard level appintments f NHS fundatin trusts, NHS trusts and special health authrities carrying n a regulated activity are respnsible fr the verall quality and safety f that care, and fr making sure that care meets the requirements f the Health and Scial Care Act 2008 (Regulated Activities) Regulatins This regulatin is abut ensuring that thse individuals are fit and prper t carry ut this imprtant rle. It will apply t executive and nn-executive, permanent, interim and assciate psitins, irrespective f their vting rights. The regulatin applies t the gvernr(s) f a fundatin trust wh sit n the trust bard as representatives f the bard f gvernrs. Any further use f the wrd directr will encmpass the abve descriptin nly. Prvider will be used thrughut this dcument t refer t NHS trusts, NHS fundatin trusts and special health authrities prviding regulated activities. There is further guidance belw abut each cmpnent f the regulatin t which NHS bdies must have regard. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 21

22 Cmpnent f the regulatin 5(3)(a) the individual is f gd character Prviders must have regard t the fllwing guidance in relatin t this cmpnent: Prviders must make every effrt t ensure that all available infrmatin is sught t cnfirm that the individual is f gd character, and have regard t the matters utlined in Schedule 4, Part 2 f the regulatins when assessing whether an individual is f gd character. Rbust systems must be in place t ensure cntinuus assessment f the temperament, character and empathy f staff. It is nt pssible t utline every character trait an individual shuld have but amng them we wuld expect t see that the diligence prcesses take accunt f hnesty, trust and respect. If a prvider discvers infrmatin that suggests an individual is nt f gd character after they have been appinted t a rle, the prvider must take apprpriate and timely actin t investigate and rectify the matter. Where, fllwing the applicatin f a rbust prcess, a prvider deems the individual suitable despite the individual being cnvicted f an ffence and/r remved frm the register f a prfessinal health r scial care regulatr, the reasns shuld be recrded and infrmatin abut the decisin shuld be made available t thse that need t be aware. It is fr prviders and nt CQC t identify that particular directrs are fit and prper persns. Nte: By timely we mean as sn as can be achieved in rder t minimise harm r ptential harm t peple receiving services. We wuld assess actin taken n a case by case basis, but wuld expect prviders t take immediate actin t prtect peple frm harm and intrduce and cmplete investigatins quickly, evidencing reasns fr any delay that any reasnable trust wuld avid. 5(3)(b) the individual has the qualificatins, cmpetence, skills and experience which are necessary fr the relevant ffice r psitin r the wrk fr which they are emplyed Where specific qualificatins are deemed by the prvider as necessary fr a rle, the prvider must make this clear and shuld nly emply thse individuals wh meet the required specificatin, including any requirements t be registered with a prfessinal regulatr. The prvider must have apprpriate prcesses fr assessing and checking that the individual hlds the required qualificatins and has the cmpetence, skills and experience required, (which may include apprpriate cmmunicatin and leadership skills and a caring and cmpassinate nature) t undertake the rle. These must be fllwed in all cases and relevant recrds kept. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 22

23 Cmpnent f the regulatin Prviders must have regard t the fllwing guidance in relatin t this cmpnent: The prvider may cnsider that an individual can be appinted t a rle based n their qualificatins, skills and experience with the expectatin that they will develp specific cmpetence t undertake the rle within a specified timeframe. There is already a range f gd guidance dcuments fr prviders that cver value-based recruitment, appraisal and develpment, and disciplinary actins including dismissal fr chief executives, chairs and directrs. CQC, the NHS TDA and Mnitr will publish a jint dcument fr CEOs and chairs t direct prviders t these surces n r after 27 Nvember We expect all prviders t be aware f the varius guidelines and t have implemented prcedures in line with this best practice, as well as the seven principles f public life (the Nlan Principles) 7 and jint guidance frm CQC, Mnitr and NHS TDA n recruitment, perfrmance management and disciplinary arrangements fr CEOs and directrs (due t be published n 27 Nvember). 5(3)(c) the individual is able by reasn f their health, after such reasnable adjustments are made, f prperly perfrming tasks which are intrinsic t the ffice r psitin fr which they are appinted r t the wrk fr which they are emplyed Peple in psitin f cntrl within health service bdies must be physically and mentally fit. This des nt mean that peple wh have a lng-term cnditin, a disability r mental illness cannt be in such a psitin. This aspect f the regulatin relates t the ability t sustain the management functin. When appinting relevant individuals the prvider must have prcesses fr cnsidering a persn s physical and mental health in line with the requirements f the rle. Wherever pssible, the prvider must make reasnable adjustments t enable an individual t carry ut the rle. 7 The 7 principles f Public Life. (The basis f the ethical standards expected f public ffice hlders). Cmmittee n Standards in Public Life, Lrd Nlan, 31 May 1995 Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 23

24 Cmpnent f the regulatin 5(3)(d) the individual has nt been respnsible fr, been privy t, cntributed t r facilitated, any serius miscnduct r mismanagement (whether unlawful r nt) in the curse f carrying n a regulated activity r prviding a service elsewhere which, if prvided in England, wuld be a regulated activity, and Prviders must have regard t the fllwing guidance in relatin t this cmpnent: The prvider must have prcesses in place t assure itself that the individual has nt been respnsible fr, privy t, cntributed t, r facilitated any serius miscnduct r mismanagement in the carrying n f a regulated activity. This includes investigating any allegatin f such and making independent enquiries. The prvider must nt appint any individual wh has been respnsible fr, privy t, cntributed t, r facilitated any serius miscnduct r mismanagement (whether lawful r nt) in the carrying n f a regulated activity. In the case f a directr being cnvicted f breaching a health and safety requirement n the basis f the way the entire management team rganised and managed the activities f their rganisatin, prviders are expected t ascertain the rle f the individual s that they can make a judgement abut whether r nt it means they are unfit. Where the evidence demnstrates that the breach is attributable t the individual s cnduct, CQC wuld expect a prvider t find that the individual is unfit. While CQC will have regard t infrmatin n when cnvictins, bankruptcies r similar matters are t be cnsidered spent, there is n time limit fr cnsidering serius miscnduct r respnsibility fr failure in a previus rle. Nte: Serius miscnduct r mismanagement means behaviur that wuld cnstitute a breach f any legislatin/enactment that CQC deems relevant t meeting these regulatins r their cmpnent parts. Serius miscnduct might be expected t include assault, fraud and theft. Mismanagement might be expected t include mismanaging funds and/r nt adhering t recgnised practice, guidance r prcesses regarding care quality within which the individual is meant t wrk. These are nt exhaustive lists. Respnsible fr, cntributed t r facilitated means that there is evidence that a persn has intentinally, r thrugh neglect, behaved in a manner that wuld be cnsidered t be, r wuld have led t, serius miscnduct r mismanagement. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 24

25 Cmpnent f the regulatin Prviders must have regard t the fllwing guidance in relatin t this cmpnent: Privy t means that there is evidence that culd lead the prvider t reasnably cnclude that a persn was aware f serius miscnduct r mismanagement but did nt take the apprpriate actin t ensure it was addressed. 5(3)(e) nne f the grunds f unfitness specified in Part 1 f Schedule 4 apply t the individual. Only individuals wh will be acting in a rle that falls within the definitin f a regulated activity as defined by the Safeguarding Vulnerable Grups Act 2006 will be eligible fr a check by the Disclsure and Barring Service (DBS). Prviders must seek all available infrmatin t assure themselves that directrs are nt unfit, as defined in Schedule 4 Part 1. Rbust systems shuld be in place t assess directrs in relatin t bankruptcy, sequestratin, inslvency and arrangements with creditrs. In additin, prviders shuld establish whether the individual is n the children s and/r adults safeguarding barred list and whether they are prhibited frm hlding the ffice in questin under ther laws such as the Cmpanies Act r Charities Act. If a prvider discvers infrmatin that suggests an individual is unfit after they have been appinted t a rle, the prvider must take apprpriate and timely actin t investigate and rectify the matter. Where a prvider deems the individual is suitable despite nt meeting the characteristics utlined in Schedule 4, Part 1 f these regulatins, the reasns must be recrded and infrmatin abut the decisin shuld be made available t thse that need t be aware. Nte: Each persn will define apprpriate accrding t their wn particular circumstances. In essence it means suitable r prper fr the circumstances. CQC wuld take int cnsideratin all aspects surrunding decisin-making t determine apprpriateness. We wuld expect t see prcesses in place that include disciplining and dismissing directrs where relevant. By timely we mean as sn as can be achieved in rder t minimise harm r ptential harm t peple receiving the service. We wuld assess actin taken n a case by case basis, but wuld expect prviders t take immediate actin t prtect peple frm harm and intrduce and cmplete investigatins quickly, giving evidence f reasns fr any delay which any reasnable persn wuld avid. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 25

26 Cmpnent f the regulatin 5(6) Where an individual wh hlds an ffice r psitin referred t in paragraph (2)(a) r (b) n lnger meets the requirements in paragraph (3), the service prvider must (a) take such actin as is necessary and prprtinate t ensure that the ffice r psitin in questin is held by an individual wh meets such requirements, and (b) if the individual is a health care prfessinal, scial wrker r ther prfessinal registered with a health care r scial care regulatr, infrm the regulatr in questin Prviders must have regard t the fllwing guidance in relatin t this cmpnent: The prvider must regularly review the fitness f directrs t ensure that they remain fit fr the rle they are in. The prvider must determine hw ften t review fitness based n the assessed risk t business delivery and/r t the peple using the service psed by the individual and/r rle. The prvider must have arrangements in place t respnd t cncerns abut a persn s fitness after they are appinted t a rle, identified by itself r thers, and the prvider must adhere t these. The prvider must investigate, in a timely manner, any cncerns abut a persn s fitness r ability t carry ut their duties, and where cncerns are substantiated, then it must take prprtinate, timely actin. The prvider must demnstrate due diligence in all actins. Where a persn s fitness t carry ut their rle is being investigated, apprpriate interim measures may be required t minimise any risk t peple wh use the service. There are sme cre public infrmatin surces abut prviders that we believe are relevant fr prviders t use as part f their FPPR due diligence. We intend t prvide sme f these n ur website, r indicate where they can be fund. These include the fllwing (this list is nt exhaustive): Any prvider whse registratin had been suspended r cancelled due t failings in care in the last five years r lnger if the infrmatin is available because f previus registratin with CQC predecessr bdies. Public inquiry reprts abut the prvider. Infrmatin where we are ntified abut any relevant individuals wh have been disqualified frm a prfessinal regulatry bdy. This infrmatin wuld be shared with the individual and the prvider in accrdance with the Data Prtectin Act. Serius case reviews relevant t the prvider. Hmicide investigatins fr mental health trusts. Criminal prsecutins against prviders. Ombudsmen reprts relating t prviders. Regulatin 5: Fit and prper persns: directrs and Regulatin 20: Duty f candur Guidance fr NHS bdies 26