Docstoc

NHS Kensington and Chelsea

Document Sample
NHS Kensington and Chelsea Powered By Docstoc
					              NHS KENSINGTON AND CHELSEA TRUST BOARD MEETING
                           29 MARCH 2011

                                                                            AGENDA ITEM: 3.5
                                                                       AGENDA PAPER: 11/10.05

Title                    Primary Care Practitioner Performance
Presented by             Melanie Smith       Lead or Key           Dr Alison Hill
                                             Contact
                         To consider and agree the proposal to nominate the Medical
What is the decision
or action required?      Director (Performance) for NW London as the RO for Medical
                         Perfomers in Kensington and Chelsea and Accountable
                         Officer (AO) for Controlled Drugs.

Issues to be            The PCT is required by statute to appoint a Responsible
considered:             Officer for Medical Perfomers (RO). The paper contains
                        proposals to manage the risks to patient safety through the
   Revenue/resource
                        transition. The paper also includes a proposal for managing
    implications
                        the risks involved in the prescribing and use of controlled
   Evidence of best    drugs using the provisions of the Health Act 2006 to delegate
    practice            to NW London Medical Directorate, the role of Accountable
   Health Inequalities Officer (AO) for Controlled Drugs.

   Equality and        For both these roles the PCT has a responsibility to ensure
    Diversity           adequate resources are provided to the post holder to
                        discharge their functions. There will be no increased cost
   Views of users,     implications. Some economies of scale may be possible.
    patients and
    public              The RO is a new function. Annex A contains an overview of
                        current advice drawn from national sources.
                         DH Guidance “The role of the Responsible Officer: Closing the Gap in
                         Medical regulations- Responsible Officer Guidance.
                         Royal College of GPs “ A Guide to the Revalidation of General
                         Practitioners version 4”
                         Revalidation Support team : RO Job Description Template September
                         2010

Risk Assessment          Risk Register reference or Risk Assessment Matrix

                         Competency one: Recognised as a local leader for the NHS
World Class
Commissioning            Competency ten : Effectively manage systems and work in
Competencies             partnership with providers to ensure contract compliance and
                         continuous improvement in quality and outcomes and value
                         for money




Page 1 of 5
                                                                                             Chair Peter Molyneux
                                                                                    Chief Executive: Sarah Whiting
                                                             Chair Clinical Executive Committee: Andrew Steeden
                 Decision Making Process and Next Steps


    Committees            Date                       Decision




Page 2 of 5                                                               Chair Peter Molyneux
                                                                 Chief Executive: Sarah Whiting
                                          Chair Clinical Executive Committee: Andrew Steeden
                             NHS Kensington and Chelsea




                          Primary Care Practitioner Performance
          Introduction

1.         Managing the performance of individual primary care practitioners is an
           important component of ensuring patient safety through the transition to new
           management structures in the NHS following the White Paper. Currently
           each Primary Care Trust (PCT) has its own mechanism for managing its
           Performers Lists. As a result of the current management changes many of
           the post holders responsible for discharging this function and related
           activities are leaving and North West London Cluster has created a Medical
           Directorate (Practitioner Performance) to undertake this function for the eight
           PCTs in the cluster. Current staff undertaking these roles for Kensington
           and Chelsea will be leaving and the posts discontinued.
2.         During the transition it is also necessary to ensure the oversight of
           Controlled Drug (CD) prescribing. The Inner North West London Sub-cluster
           has the largest number of private prescribers of Controlled Drugs in the UK
           and a significant NHS service commitment to substance misusers. Each
           PCT must appoint an Accountable Officer for Controlled Drugs, who is
           advised by the Local Intelligence Network (LIN).
3.         The Inner North West London sub-cluster has appointed a senior pharmacist
           to manage the investigation of concerns and inspection of providers, working
           with appropriate national regulators and running the LIN. This post will serve
           the whole North West London Cluster and needs to report to an Accountable
           Officer.
4.         The purpose of this paper is to confirm the responsibilities of the Primary
           Care Trust to manage the risk of poor performance in independent
           contractors and in CD prescribers and to propose a solution for managing
           the risks during the transition.

           Background

5.         The Medical Profession (Responsible Officers) Regulations 2010. The
           Regulations came into force in January 2011. They are supported by
           detailed guidance, “The role of the Responsible Officer: Closing the Gap in
           Medical regulations- Responsible Officer Guidance” published in July 2010.
6.         The Regulations set out the role of the Responsible Officer (RO) for
           revalidation and the responsibilities of each PCT as a designated
           organisation responsible for the doctors on its Medical Performers List.
           Details are set out in the attached paper considered by the NHS
           Westminster Board in November 2010. (Annex A)


     Page 3 of 5                                                                     Chair Peter Molyneux
                                                                            Chief Executive: Sarah Whiting
                                                     Chair Clinical Executive Committee: Andrew Steeden
7.          Each PCT must appoint an RO as set out in the Regulations. Should that
            individual cease to hold that position, the PCT must nominate or appoint a
            replacement as soon as possible (Regulation 5(3) of the Medical Profession
            (Responsible Officers) Regulations 2010).
8.          The Responsible Officer must be a doctor with a license to practise and
            must have been registered with the General Medical Council for the past five
            years. They should be a senior doctor with management experience and be
            able to assure the Board that effective systems are in place to run an
            effective appraisal system for GPs on its Performers List, to investigate
            concerns and to manage performance, and to manage entry to its medical
            performers list.
9.          The role and competencies of the RO are set out in details in Annex A.
            These include

            to ensure that the PCT carries out regular appraisals on its medical
             performers
            to establish and implement procedures to investigate concerns about
             medical performers’ fitness to practise
            where appropriate to refer concerns to the General Medical Council
            monitor compliance with any conditions or undertakings imposed
            make recommendations to the GMC about a practitioners fitness to
             practise and
            maintain records of fitness to practise evaluations including appraisals and
             other investigations or assessments.
            assess applications for entry into the Performers List against national
             criteria
            regularly assess and review medical performers’ performance, taking any
             necessary steps to protect patients and put in place appropriate remedial
             measures where necessary.

10.         The Accountable Officer (AO) for Controlled Drugs is responsible under the
            Health Act 2006 for assuring the Board that appropriate steps are taken to
            ensure the safe management of Controlled Drug prescribing and use in
            organisations for which it is responsible under the Act. Details are set out in
            Annex B.
11.         The AO should be a senior manager, preferably a health professional, but
            must not be involved in any activity related to the management or use of
            Controlled Drugs. In other words should not prescribe, dispense or
            administer Controlled Drugs.
12.         For both these roles the PCT has a responsibility to ensure adequate
            resources are provided to the post holder to discharge their functions.

            Managing through the transition

13.         It has been assumed that Performers Lists management and RO function
            will move to the National Commissioning Board when the Health Bill is
            enacted. Therefore it is proposed these functions will be carried out by the

     Page 4 of 5                                                                      Chair Peter Molyneux
                                                                             Chief Executive: Sarah Whiting
                                                      Chair Clinical Executive Committee: Andrew Steeden
          cluster medical directorate on behalf of the North West London PCTs
          through the transition.
 14.      Regulations allow for PCTs as designated bodies to nominate or appoint as
          RO, a RO of another designated body.
 15.      The Health Act 2006 allows for PCTs to nominate as their AO for Controlled
          Drugs, the AO appointed by another designated body.
 16.     The North West London Cluster structure has identified two senior pharmacy
         posts to manage Controlled Drug provision and prescribing in support of the
         Medical Director (Practitioner Performance). The structure is therefore set up
         to support this post to take on the role of AO. The holder of that post meets
         the requirements set out above to fulfill the function of AO.
 17.      From April 1st 2011 the role of Medical Director (Practitioner Performance)
          for the North West London PCT cluster will be filled. It is therefore open to all
          PCTs in North West London to appoint the Medical Director (Practitioner
          Performance) as their RO for revalidation and as AO for Controlled Drugs.

         Recommendations

        1. The NHS Kensington and Chelsea Board nominate the Medical
           Director (Practitioner Performance) for North West London Cluster
           as the Responsible Officer for the medical performers of Kensington
           and Chelsea.

        2. The NHS Kensington and Chelsea Board nominate the Medical
           Director (Practitioner Performance) for North West London Cluster as
           the Accountable Officer for Controlled Drugs under the Health Act
           2006.



Alison Hill
Medical Director NHS Westminster
2nd March 2011




    Page 5 of 5                                                                      Chair Peter Molyneux
                                                                            Chief Executive: Sarah Whiting
                                                     Chair Clinical Executive Committee: Andrew Steeden
                                                                 ANNEX A


    Medical Revalidation and the Role of the Responsible Officer
                Update for the NHS Westminster Board
                            24 November 2010


Introduction

1. This document introduces the Medical Profession (Responsible
   Officers) Regulations 2010. The Regulations are due to come into force
   in January 2011.

2. They give senior doctors/medical directors in PCTs functions for
   specified doctors that will ensure doctors are appraised annually and
   where there are concerns about a doctor’s fitness to practice, they are
   investigated and referred to the GMC. Where the concerns are below
   the level for referral to the GMC to be considered necessary,
   Responsible Officers will investigate, identify the cause and take the
   appropriate action to bring the doctor back on track.

3. From January 2011 PCTs will be expected to be running an enhanced
   or strengthened system of annual appraisal for all doctors for whom it
   is responsible and to appoint, resource and support a senior doctor
   with a licence to practice as Responsible Officer (RO) for Medical
   Revalidation.

4. The Guidance accompanying the Regulations describes the role and
   key duties and relationships of the RO. The RO will be the conduit
   through which doctors will relate to the GMC by assuring the quality of
   their work individually and within teams

5. The paper also summarises the progress made by NHS Westminster
   to date.

6. This paper is presented as three components recognising the three
   potential audiences that will be affected by the change in Regulations. :

         The PCT ( Main Paper)

         The Responsible Officer (RO) (Appendix 1 and 2 )

         Doctors licensed with the General Medical Council (GMC) to
          practise medicine.

Background

7. The introduction of a system of regular Medical Revalidation has been
   government policy since the publication in 2007 of “Trust Assurance
   and Safety – the Regulation of the Medical Profession in the 21st
   century”.



                                                                             1
                                                                       ANNEX A


   8. It has recently been subject to consultations and pilot studies run by
      the General Medical Council (GMC), the Department of Health (DH)
      and the medical Royal Colleges, most notably the Royal College of
      General Practitioners (RCGP).

   9. NHS Westminster has been party to these consultations and is
      currently a pilot site for enhanced appraisal and revalidation run on
      behalf of DH by the Revalidation Support Team (RST).

   10. In July 2010 the government published the Medical Profession
       (Responsible Officers) Regulations 2010, supported by accompanying
       guidance. These regulations provide a legal framework for the
       Responsible Officer role and identify Primary Care Trusts (PCTs) as
       the designated organisations who will be responsible for running a
       system capable of recommending for Revalidation all doctors on the
       Performers List (PL), all doctors employed by the PCT and for any
       doctors in wholly private practice who reside within their area and who
       are not members of the Independent Doctors Forum or who do not
       have admitting rights to any other designated body.

   11. Following the national consultation on its proposals for revalidation last
      summer, the GMC is set to propose a simplified system. However the
      basic design is unlikely to change. This consists of a five year cyclical
      process based on five annual appraisals supported by a range of
      evidence that the doctor is up to date and fit to practice.(see figure in
      Appendix 3 ).

The Duty to nominate or appoint a Responsible Officer

   12. PCTs have been designated unconditionally to appoint a Responsible
       Officer. The legislation becomes effective from 1st January, 2011

Resourcing Responsible Officers

   13. The regulations require designated bodies to provide the RO with
      sufficient funds and other resources to discharge their duties. This
      applies to all ROs’ statutory functions, including clinical governance
      responsibilities under Regulations 14 and 19.

   14. It is crucial that ROs are supported at the appropriate level in order for
      them to fulfil their role of improving the quality of care across all its
      dimensions, including patient safety.

   15. It is also essential that the organisation provides sufficient time for the
      RO to perform their function effectively. The role is complex and
      demanding. It is likely to require a significant commitment. It is
      envisaged that some organisations may have to strengthen and re-
      arrange medical management infrastructures to enable ROs to delivery
      their responsibilities.




                                                                                 2
                                                                   ANNEX A


16. It is anticipated that PCTs will want to nominate an existing senior
   doctor, such as the Medical Director (MD). In such cases it is expected
   that this doctor will have been appointed to their post through an open
   competitive process.

17. Organisations will have to ensure that the RO is properly developed
   and supported by education, skills training and personal development
   opportunities. The organisation should ensure that the responsible
   officer takes part in a peer network to ensure sharing of learning,
   challenge and support in tackling new situations. Although much of the
   role of the RO is already undertaken by MDs, there will be a learning
   curve and employing organisations must ensure that they are as well
   supported and developed as possible.

18. The effectiveness of the RO will necessitate timely access to the
   appropriate information. This means that the employing organisation
   will have to ensure that information systems underpinning the clinical
   elements of corporate governance and any other relevant processes
   (for example multi-source feedback) are properly resourced and
   functioning. Much of the data will already be held on systems of clinical
   governance and the task will be mainly one of collation. It is essential
   that the staff charged with the performance are of high calibre, have
   credibility in the organisation, understand the absolute need for security
   of the information, are well trained and are regularly assessed.

NHS Westminster action taken

19. In preparation for Medical Revalidation NHS Westminster has created
    the separate post of Medical Director and has increased the number of
    sessions available for this post, in recognition of the need to support
    Revalidation.

20. The Medical Director was appointed in January 2010 and has attended
    learning sets and other events set up nationally and by NHS London to
    develop the role of RO.

21. The Medical Directorate has appointed an independent GP appraisal
    lead and has instituted a system of performance management of
    appraisers to complement the already well established system of
    support and training for appraisers. The Medical Directorate is
    responsible for managing the application process for independent
    contractors to be accepted on to our Performers Lists and provides the
    secretariat for the PPDMG.

22. NHS Westminster has reviewed the GP appraisal policy to bring it into
    line with current proposals for strengthened appraisal, in a way that is
    also capable of adjustment as required throughout the forthcoming
    transition period to post White paper arrangements for primary care.

23. The Medical Directorate has close links through the directorate
    structure of Integrated Governance with sources of clinical governance


                                                                               3
                                                                     ANNEX A


        information, which will complement the information obtained through
        the appraisal system for GPs.

  24. Participation by NHS Westminster in the national Revalidation Pilot
      should allow the Medical Director to advise the Board in due course of
      any additional resource implications for managing Revalidation locally.

  RECOMMENDATIONS
 The Board is requested to:
        Note the contents of the paper.
        Approve the appointment of the Medical Director to be the
         Responsible Officer for NHS Westminster


Alison Hill
Medical Director
9 November 2010
\\wpct.local\userdata\MBR_Mydocs\hilali\My Documents\board
papers\nov 2010\RO november Board paper 2.4.doc




                                                                                4
                                                                       ANNEX A




                                                                    Appendix 1
Roles and Responsibility of the Responsible Officer
   1. The role of the RO will primarily be to ensure that systems within their
      organisation support doctors in delivering quality care that is constantly
      improving. Where a doctor falls below the standards set, the RO will
      need to ensure that appropriate action is taken to bring the doctor back
      on track while ensuring the safety of patients. The regulation of doctors
      is, and will remain, a matter for the GMC. Decisions about a doctor’s
      fitness to practise will be taken by the GMC only after the appropriate
      procedures have been followed.
   2. The RO will be answerable to the GMC and to their appointing
      organisation for ensuring that there are appropriate systems and
      processes in place for collecting and holding information that informs
      the evaluation of fitness to practise. This will include ensuring there are
      robust systems of appraisal in place to support doctors in improving
      their practice. Where conduct or performance is falling below the usual
      high standards that doctors are expected to work to, it is important to
      identify them early and take the appropriate action to avoid potential
      harm to patients and to support doctors to get back on track. It is the
      responsibility of the organisation to ensure that these systems are
      properly resourced, reviewed and maintained.
   3. To carry out their functions, ROs will need to ensure:
      they maintain a list of doctors for whom they are responsible ;
      there is an integrated system for monitoring doctors’ performance,
       recognising good practice, encouraging and supporting development
       and learning;
      effective systems and processes of appraisal are in place; and
      appropriate action is taken to remedy identified areas of weakness.
   4. The RO has to ensure that the organisation is advised of the resource
      consequences in terms of time, the processes for collection of relevant
      supporting information, the staff and funds needed for rigorous
      processes of appraisal and for continuing professional development
      (CPD).
   5. Medical Royal Colleges and Faculties will offer support to responsible
      officers in evaluating the specialist practice of doctors. The RO will
      want to ensure that there is appropriate liaison between their
      organisation and the relevant Medical Royal Colleges and Faculties to
      seek their input to the appraisal process as required, in terms of
      specialist practice. The RO will decide when he or she needs advice on
      specialist practice.
   6. In the event of concerns being raised about a doctor of a sufficiently
      serious nature to call into question the doctor’s fitness to practise, the
      RO will need to consider referral of the doctor to the GMC. ROs will be


                                                                                5
                                                                       ANNEX A


       accountable for the oversight of all associated processes. The RO is
       expected to co-operate with the GMC in establishing the
       appropriateness of the referral and will oversee the collation of the
       relevant information.
   7. The RO is also accountable for overseeing doctors whose practice is
      supervised and/or limited under conditions imposed by, or undertakings
      given to, the GMC. It is up to the RO to monitor the compliance of the
      doctors they are responsible for with any conditions imposed upon the
      doctor by the GMC.


Additional responsibilities relating to clinical governance for
responsible officers
   8. ROs also have a duty to ensure the robust, efficient and reliable
      functioning of systems of clinical governance. Clinical governance has
      been defined as “a framework through which healthcare organisations
      are accountable for continuously improving the quality of their services
      and safeguarding high standards of care, by creating an environment in
      which excellence in clinical care will flourish”. This definition reinforces
      the concept that, for the great majority of doctors, the focus of clinical
      governance systems should be on quality improvement, in terms of the
      quality of care not only delivered by each doctor but also by the entire
      team of which the doctor is part. The function of appraisal, therefore,
      remain formative – but only after an objective and confident judgement
      has been made about the quality of the doctor’s practice. In the vast
      majority of cases, this judgement will be affirmative, but, in the small
      number of instances where there is cause for concern, robust
      processes must be in place to ensure early identification and rapid
      remedial action.
   9. In addition to the duties outlined above, the RO must ensure that
      doctors are supported by the organisation in their efforts to improve
      their own performance and the quality of care they provide to patients.
      They must also ensure that:
      medical practitioners have qualifications and experience appropriate to
       the work to
      be performed and that appropriate references are obtained and
       checked;
      doctors’ performance and conduct is monitored; and
      appropriate, timely action is taken when concerns about shortcomings
       in performance or conduct are identified.

   10. The RO duties in monitoring clinical performance and reporting
       concerns when they arise will also involve him or her in providing
       professional leadership and leading the cultural change that must take
       place in the organisation to support and allow the systems of
       celebrating and spreading best practice.



                                                                                6
                                                                        ANNEX A


   11. Safeguarding patients begins when doctors are admitted to a
       Performers List. The RO will have a statutory responsibility to ensure
       that there are robust systems within the organisation for:
      undertaking appropriate employment checks for medical appointments;
      obtaining appropriate references and resolving any issues that may
       arise; and
      recording the results of the checking process.
   12. Identifying a concern is merely the start of a process to safeguard
       patients. It is crucially important that appropriate action is taken at the
       appropriate time. The RO has a personal responsibility for initiating the
       action in relation to issues that arise from the conduct and performance
       of doctors. These actions may include:
      initiating an investigation, with appropriately qualified investigators
       separate from the decision-making process;
      co-ordinating and co-operating with other concurrent investigations into
       broader systems failure;
      initiating further monitoring;
      initiating remediation, which may include re-skilling and rehabilitation
       training and development, mentoring, peer support, coaching or
       supervision; and
      excluding a doctor or placing local conditions or restrictions on their
       practice pending further appropriate action.



Relationships and accountabilities of the responsible officer
   13. The RO has a relationship with, and is accountable to, the GMC on
       matters in connection with fitness to practise, including ethical issues.
       The RO should also be directly accountable to the PCT Board.
   14. Other key relationships will be with appraisal leads and trainers who
       will oversee the information processes and flows within the
       organisation. These individuals will be responsible for collating
       information on the performance of individual doctors to present to the
       RO. The RO will want to ensure that they are properly trained in
       appraisal and multisource feedback and demonstrate that they are of
       the highest calibre and integrity.




                                                                                   7
                                                                         ANNEX A


                                                                       Appendix 2
                          DRAFT JOB DESCRIPTION

Job Title:                          Responsible Officer

Responsible to:                     Chief Executive

Professionally accountable to:      The General Medical Council for his or her
                                    ethics and decision making.

Hours:                              To be confirmed

Duration:                           To be agreed

Salary                              Additional remuneration or time in lieu may
                                    be agreed by the organisation

 THIS JOB DESCRIPTION SHOULD BE READ AS AN ADDENDUM TO AND IN
CONJUNCTION WITH ANY EXISTING JOB DESCRIPTION FOR YOUR ROLE AS
                       MEDICAL DIRECTOR

1. REVALIDATION
The three core components of revalidation are to improve:

Patient safety               by ensuring that doctors are maintaining and raising
                             further professional standards
Effectiveness of care        by supporting a professional ethos to improve further
                             the effectiveness of clinical care
Patient experience           by ensuring that patients’ views are integral to
                             evaluations of a doctor’s fitness to practise

2. JOB PURPOSE AND SUMMARY
    To ensure that the organisation carries out annual appraisals on medical
     practitioners
    To establish and implement procedures to investigate concerns about a
     medical practitioner’s fitness to practise raised by patients or staff of the
     designated body or arising from another source
    To refer concerns about the medical practitioner to the General Medical
     Council where appropriate
    To monitor compliance with those conditions or undertakings where a medical
     practitioner is subject to conditions imposed by or undertakings agreed with
     the GMC
    To make recommendations to the GMC about medical practitioners’ fitness to
     practice
    To maintain records of practitioners’ fitness to practise evaluations including
     appraisals and any other investigations or assessments

 3. OVERALL DUTIES AND RESPONSIBILITIES
    To maintain a list of doctors the RO is responsible for
    To ensure there is an integrated system for monitoring doctors’ performance,
      recognising good practice, encouraging and supporting development and
      learning
    To ensure that effective systems and processes for appraisal are in place



                                                                                     8
                                                                            ANNEX A


      To ensure appropriate action is taken to remedy identified areas of weakness
      To ensure medical practitioners have qualifications and experience
       appropriate to the work to be performed and that appropriate references are
       obtained and checked
      To ensure doctors’ performance and conduct is monitored
      Appropriate timely action is taken when concerns about shortcomings in
       performance or conduct are identified

   3. KEY WORKING RELATIONSHIPS
         Chief Executive and Board members
         Professional Executive Committee (PEC)
         Director of Quality and Clinical leadership
         Relevant Human Resources staff
         Information analysts/managers
         Tutors
         Appraisal co-ordinator


   4. EXTERNAL RELATIONSHIPS
         General Medical Council (GMC)
         National Clinical Assessment Service (NCAS)
         Royal Colleges
         Responsible Officer Support Network
         Service commissioners (GP consortia)
         NHS London

4. OTHER DUTIES AND RESPONSIBILITIES
4.1 Appraisals
The RO must ensure that doctors obtain and include all relevant supporting
information for their appraisals, including that advised by the GMC and by the
relevant Royal College or specialty association. The RO should ensure that
information held by the organisation about doctors’ performance is shared with them
in a timely manner to contribute usefully to their appraisals. This information includes
data from reported adverse incidents, complaints and litigation as well as any
monitoring data the organisation holds on doctors’ efficiency and effectiveness. The
RO should ensure that doctors understand their personal responsibility to bring
information about all their areas of practice (including those outside the Trust and
outside the NHS) to their appraisal..

4.2 Contracts of employment
The RO must ensure that:
       Medical practitioners have qualifications and experience appropriate to the
         work to be performed
       Ensure that appropriate references are obtained and checked
       Take any steps necessary to verify the identify of medical practitioners
       Where the designated body is a Primary Care Trust manage admission to
         the performers list in accordance with the NHS (Performers Lists)
         Regulations 2004
       Maintain accurate records of all steps taken in accordance with the above.

4.3 Conduct and performance
In relation to monitoring medical practitioners’ conduct and performance the RO
must:



                                                                                      9
                                                                           ANNEX A


        Regularly review the general performance information held by the
          designated body including clinical indicators relating to outcomes to
          patients
        Identify any issues arising from that information relating to medical
          practitioners such as variations in individual performance
        Ensure that the designated body takes steps to address any such issues

4.4 Responding to concerns
In relation to ensuring that appropriate action is taken in response to concerns about
medical practitioners conduct or performance, the RO must:
          Initiate investigations with appropriately qualified investigators
          Ensure that procedures are in place to address concerns raised by patients
            or staff of the organisation or arising from another source
          Ensure that any investigation into the conduct or performance of a medical
            practitioner takes into account any other relevant matters within the
            organisation.
          Consider the need for further monitoring of the practitioner’s conduct and
            performance and ensure that this takes place where appropriate
          Ensure that a medical practitioner who is subject to procedures under this
            paragraph is kept informed about the process of the investigation
          Ensure that procedures under this paragraph include provision for the
            medical practitioner’s comments to be sought and taken in to account
            where appropriate
          Take any necessary steps to protect patients in line with Maintaining High
            Professional Standards in the NHS
          Where necessary, and as a neutral act, impose restrictions on a doctor’s
            practice, or temporary exclusion while an investigation is undertaken.
            Advice should always be taken from NCAS before exclusion of a doctor.
          Where concerns are substantiated, ensure that appropriate measures are
            taken to address these, including but not limited to-
            - Requiring the doctor to undergo training or retraining
            -     Offering rehabilitation services
            - Providing opportunities to increase the doctor’s work experience
            - Addressing any systemic issues within the organisation which may have
            contributed to the concerns identified
         - Maintaining accurate records of all steps taken in accordance with the
above.
     When concerns are identified relating to systemic issues within the
         organisation as a whole, the RO must raise risks through corporate risk
         monitoring process

4.5 Conflicts of interest
It is essential to ensure that there are checks and balances on the decision-making of
the RO and of appraisers so that where there is a potential conflict of interest that
may sway the process, and thereby potentially cause harm to patients, that this is
recognised and made explicit and that other arrangements are put in place. For
example if there is a conflict of interest an RO from another organisation may be
sought to handle the evaluation of fitness to practise of the doctor concerned.

5. REQUIREMENTS FOR THE POST
      The person must be a medical practitioner; and:
      The person must at the time of appointment, have been a medical
        practitioner throughout the previous 5 years and for this purpose ‘medical
        practitioner means a person who was fully registered under the Act


                                                                                     10
                                                                              ANNEX A


        A Responsible Officer must continue to be a medical practitioner in order to
         remain as a Responsible Officer.

5.1 Support
     While it is primarily the responsibility of individual doctors to collect the
       supporting information that they need for their appraisal, it is likely that in
       most organisations the resource required to collect and deliver to individual
       doctors relevant information that the organisation holds about them will be
       significantly greater than it was for old-style appraisal before the introduction
       of revalidation. The organisation should ensure that the RO has appropriate
       support for this

6. EDUCATION AND TRAINING
6.1   The RO will need to undergo initial and on-going education and training,
however
      initial interventions will vary according to the needs of the individual. The
      organisation will ensure that their RO is facilitated to take part in peer
      networking and other forms of learning and support, including periodic formal
      assessment of their performance in the role as it feeds into their own
      appraisal. This will be supported by the London Responsible Ófficers’
      Network. The post holder is therefore required to attend such training
      sessions as appropriate to meet the needs identified.

6.2   The RO will need to ensure that those appraising doctors have the
appropriate
      experience and training to do so, and to ensure through regular audit that
      doctors’ appraisal is being carried out effectively.
6.3   The RO will also need to ensure that doctors in the organisation understand
      the relationship between appraisal and revalidation, and receive appropriate
      education regarding how to make their appraisal effective and successful

7. COMPETENCIES OF THE RESPONSIBLE OFFICER
Recommended competencies are aligned with competency frameworks for medical
management, appraisers and appraiser trainers in England:
      Communication
      Managing the process of medical revalidation, appraisal, quality assurance
       of appraisers remediation mediation negotiation investigation and
       rehabilitation equality and diversity issues dealing with colleagues about
       whom there is concern
      Knowledge of regulation and the law as it relates to medical revalidation and
       of the specific underpinning processes. Understanding of principles of
       natural justice and the legal process, accountability and governance
      Maintaining the knowledge and skills needed for the role, consistency, rigour
       and accountability
      Strategic responsibilities of the RO, building and maintaining external
       relationships accessing the organisation’s resources
      Clinical governance, quality improvement and quality assurance of systems
       underpinning revalidation, information flows.
      High level of understanding of equality and diversity

8. ORGANISATION POLICIES
It is expected that the RO will adhere to all relevant local policies which may apply to
the role of Responsible Officer.




                                                                                       11
                                                                            ANNEX A


   Appendix 3
The Doctor’s Responsibility to a Responsible Officer

   1. The revalidation process and the RO. - Revalidation, when introduced, will be
      the process by which doctors will have to demonstrate to the GMC, normally
      every five years, that they are up to date and fit to practise and complying
      with the relevant professional standards.
   2. The core mechanism underpinning revalidation will be a strengthened
      appraisal system, which is being designed to elicit the necessary information
      about a doctor’s practice - see Figure 1.
   3. The RO will be accountable for ensuring that the systems for appraisal,
      clinical governance and for gathering and retaining other local relevant
      supporting information are in place and are effective. He or she will also be
      responsible for ensuring that systems are in place to record and collate all the
      necessary information, including a record of any practice undertaken by the
      doctor outside of the organisation.
   4. Every doctor will be appraised annually by a trained appraiser. Concerns
      about conduct or performance are unlikely to come to light for the first time
      during the appraisal process itself, but if they do, they will obviously need to
      be dealt with there and then. The RO should be informed by the appraiser
      about any significant concerns that arise, i.e. those of a sufficiently serious
      nature to call into question the doctor's fitness to practise, as these are likely
      to require specialist input from the appropriate Medical Royal College or
      Faculty, NCAS or other relevant body. Arrangements for remediation,
      supervision or suspension may also need to be put in place. If the RO is
      concerned at any time, including at the time of appraisal, that the doctor might
      present a risk to patients, the RO will refer the doctor to the GMC.

                          Figure 1 Revalidation process




                                                                                     12
                                                                              ANNEX B



               Accountable Officer Characteristics Health Act 2006

Accountable officers(AO) and their responsibilities as to controlled drugs:
(1)The relevant authority may by regulations make provision for or in connection with
requiring designated bodies to nominate or appoint persons who are to have
prescribed responsibilities in relation to the safe, appropriate and effective
management and use of controlled drugs in connection with—
(a)activities carried on by or on behalf of the designated bodies, and
(b)activities carried on by or on behalf of bodies or persons providing services under
arrangements made with the designated bodies.
(2)The person who is to be so nominated or appointed by a designated body is to be
known as its accountable officer.
This is subject to any regulations made by virtue of subsection (5)(e).
(3)In this Chapter “designated body” means—
(a)a body falling within any description of bodies prescribed as designated bodies for
the purposes of this section, or
(b)a body prescribed as a designated body for those purposes.
(4)The descriptions of bodies, or bodies, that may be so prescribed are descriptions
of bodies, or bodies, appearing to the relevant authority—
(a)to be directly or indirectly concerned with the provision of health care (whether or
not for the purposes of the health service), or
(b)to be otherwise carrying on activities that involve, or may involve, the supply or
administration of controlled drugs.
(5)Regulations under this section may make provision—
(a)for conditions that must be satisfied in relation to a person if he is to be nominated
or appointed by a designated body as the body's accountable officer;
(b)for a single person to be nominated or appointed as the accountable officer for
each of two or more designated bodies where those bodies are satisfied as to the
prescribed matters;
(c)requiring a designated body that has an accountable officer to provide the officer
with funds and other resources necessary for enabling the officer to discharge his
responsibilities as accountable officer for the body;
(d)for ensuring that an accountable officer, in discharging his responsibilities, has
regard to best practice in relation to the use of controlled drugs;
(e)for the persons required to be nominated or appointed as mentioned in subsection
(1) to be known by such name as is prescribed;
(f)for making such amendments of any enactment as appear to the relevant authority
to be required in connection with any provision made in pursuance of paragraph (e);
(g)for creating offences punishable on summary conviction by a fine not exceeding
level 5 on the standard scale or for creating other procedures for enforcing any
provisions of the regulations.
(6)The responsibilities that may be imposed on a designated body's accountable
officer by regulations under this section include responsibilities as to the
establishment and operation of arrangements for—
                                                                             ANNEX B

(a)securing the safe management and use of controlled drugs;
(b)monitoring and auditing the management and use of such drugs;
(c)ensuring that relevant individuals receive appropriate training and that their
training needs are regularly reviewed;
(d)monitoring and assessing the performance of such individuals in connection with
the management or use of such drugs;
(e)making periodic inspections of premises used in connection with the management
or use of such drugs;
(f)recording, assessing and investigating concerns expressed about incidents that
may have involved improper management or use of such drugs;
(g)ensuring that appropriate action is taken for the purpose of protecting patients or
members of the public in cases where such concerns appear to be well-founded;
(h)where required by regulations under section 18, the sharing of information.
(7)The arrangements mentioned in subsection (6) may be arrangements established
(according to the circumstances)—
(a)by the accountable officer,
(b)by the designated body (or any of the designated bodies) for which he is the
accountable officer, or
(c)by a body or person acting on behalf of, or providing services under arrangements
made with, the designated body (or any of the designated bodies).
(8)In subsection (6)—
(a)references to the management or use of controlled drugs are to the management
or use of drugs in connection with activities carried on by a body or person within
subsection (7)(b) or (c), and
(b)“relevant individual” means an individual who, whether as—
(i)a health care professional, or
(ii)an employee who is not a health care professional, or
(iii)otherwise,
is engaged in any activity carried on by a body or person within subsection (7)(b) or
(c) that involves, or may involve, the management or use of controlled drugs.
(9)A designated body may confer on its accountable officer such powers as it thinks
appropriate to enable him to discharge any of the responsibilities imposed on him as
accountable officer for the body by regulations under this section.
(10)Nothing in subsections (5) to (7) is to be read as prejudicing the generality of
subsection (1).
(11)In this section “prescribed” means prescribed by regulations under this section.
                                                                               ANNEX B




The Controlled Drugs (Supervision of Management and Use) Regulations 2006


Persons who may be appointed as accountable officers
   5.—(1) An English independent hospital may only nominate or appoint a person as
its accountable officer if—
(a)the person is—
(i)its registered manager, or
(ii)one of its officers or employees who is answerable to its registered manager,
and if the person is its registered manager, he must be answerable to the chief
executive, chairman or managing director of the hospital; and
(b)the person does not routinely supply, administer or dispose of controlled drugs as
part of his duties.
  (2) Two or more English independent hospitals may jointly nominate or appoint
one registered manager to be the accountable officer for both or all of the hospitals if
the registered manager—
(a)is registered as manager in relation to both or all of the hospitals; and
(b)does not routinely supply, administer or dispose of controlled drugs as part of his
duties.
  (3) A Scottish independent hospital may only nominate or appoint a person as its
accountable officer if—
(a)the person is—
(i)its manager, or
(ii)one of its officers or employees who is answerable to its manager,
and if the person is its manager, he must be answerable to the chief executive,
chairman or managing director of the hospital; and
(b)the person does not routinely supply, administer or dispose of controlled drugs as
part of his duties.
  (4) Two or more Scottish independent hospitals may jointly nominate or appoint
one manager to be the accountable officer for both or all of the hospitals if the
manager—
(a)is the manager of both or all of the hospitals; and
(b)does not routinely supply, administer or dispose of controlled drugs as part of his
duties.
  (5) Subject to paragraph (6), a designated body which is neither an English nor a
Scottish independent hospital may only nominate or appoint a person as its
accountable officer if—
(a)the person is an officer or employee of the designated body, and—
(i)a member of the board of directors, or the management or executive committee of
the designated body,
                                                                            ANNEX B

(ii)a member of the body (howsoever it may be called) that has responsibility for the
management of the designated body, or
(iii)is answerable to a person referred to in paragraph (i) or (ii); and
(b)the person does not routinely supply, administer or dispose of controlled drugs as
part of his duties.
   (6) Two or more designated bodies which are neither English nor Scottish
independent hospitals but which are of the same type may jointly nominate or appoint
one person to be the accountable officer for both or all of the bodies, if—
(a)the person satisfies paragraph (5)(a) in relation to one of the designated bodies;
(b)each designated body is satisfied that the person can properly discharge his
responsibilities in relation to it; and
(c)the person does not routinely supply, administer or dispose of controlled drugs as
part of his duties.


NPC

Implications of Regulations
Requirement to appoint an Accountable Officer
The Controlled Drugs (Supervision of Management and Use) Regulations 2006
require that all designated bodies must appoint an AO. Organisations who are
designated bodies but do not administer or hold CDs are still required to appoint an
AO, although their responsibilities will be reduced accordingly. CD designated bodies
include the following:
• PCTs
• NHS trusts
• NHS foundation trusts
• Independent hospitals*
* Independent hospitals: Establishments registered with the CQC under one or more
of the service user categories listed below fall under the definition of ‘An English
independent hospital’ for the purpose of the CD regulations, and hence are controlled
drug designated bodies (CDDBs) and are required to appoint an AO.
Acute hospitals (with overnight beds), acute hospitals (day surgery only), hospice for
adults, hospice for children, mental health establishments where people are not liable
to be detained, mental health establishments taking people liable to be detained.
Characteristics of an Accountable Officer
The Regulations specify who may be appointed as an AO. Irrespective of the
designated body, the AO cannot be a person who routinely supplies, administers or
disposes of CDs as part of his duties. They must be a senior person in the
organisation.
http://www.npci.org.uk/cd/public/docs/controlled_drugs_third_edition.pdf
http://www.legislation.gov.uk/ukpga/2006/28/section/17
http://www.legislation.gov.uk/uksi/2006/3148/contents/made

				
DOCUMENT INFO