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Clinical Procurement Strategy for Commissioning Services (including Policy) – September 2017 to September 2018 V1.1 FINAL East and North Hertfordshire Clinical Commissioning Group
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East & North Hertfordshire Clinical Commissioning Group
Clinical Procurement Strategy for Commissioning
Services (Including Policy)
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DOCUMENT CONTROL SHEET
Document Owner: Programme Director Document Author(s): James Wilks HRJ Solutions, and Denise Boardman Version: 1.1 Final Directorate: Commissioning Approved By CCG Governing Body Date of Approval: 21st September 2017 Date of Review: September 2018 or earlier should revision be required due to
any changes in regulations, rules and/or best practice.
Change History:
Version Date Reviewer(s) Revision Description
0.1 30/08/2016 Denise Boardman Initial review of document.
0.2 02/09/2016 Denise Boardman Review of document.
0.3 09/09/2016 Denise Boardman Review of document.
0.4 22/09/2016 James Wilks Updated document to include PCR 2015 and improve layout.
0.5 27/09/2016 Lauren Caslake Quality Assurance.
0.6 27/09/2016 James Wilks Quality Assurance.
0.7 28/09/2016 Lauren Caslake & Denise Boardman.
Updated document to include CCG Conflicts of Interest and Standards of Business Conduct in relation to procurement.
0.8 30/09/2016 Lauren Caslake Updated document to include CCG Conflicts of Interest and Standards of Business Conduct in relation to procurement.
0.9 06/10/2016 Lauren Caslake Quality Assurance.
0.10 17/10/2016 Lauren Caslake & Denise Boardman
Updated document to strengthen section on
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alternative procurement routes.
0.11 19/10/2016 & 28/10/16
Lauren Caslake & Denise Boardman
Final Quality Assurance.
0.12 15/12/16 Lauren Caslake & Denise Boardman
Amendments made following CCG internal audit. Reviewed appendices and ensured linkages to the main body of the document.
0.13 06/02/2017 Lauren Caslake Amendment made to document to confirm East and North Herts CCG now have 58 practices, not 59.
1.00 20/02/2017 Denise Boardman Amendment made to include reference to NHSE & NHS Improvement: The Integrated Support and Assurance Process (ISAP): an introduction to assuring novel and complex contracts.
1.1 TBC Denise Boardman Amendment made to include reference to NHSE Revised CCG COI Guidance 2017 & Annex K: Summary of key aspects of the guidance on managing conflicts of interest relating to commissioning of new care models.
Implementation Plan:
Development and Consultation
Initial document drafted by external procurement support (Nigel Gausden) Summer 2016 for the Director of Commissioning. September 2016 - Review of document by James Wilks (External Procurement Support), Director of Commissioning & Programme Director. Re-draft and updating of document by James Wilks, Denise Boardman supported by Lauren Caslake – September –
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November 2016.
Dissemination On approval will be uploaded on to the CCGs’ public website and staff intranet.
Training 9.00am-10.00am Development Slots - 16th, 23rd, 30th November 2016.
The same training will also be delivered to a Governing Body clinical workshop in the New Year, date to be confirmed.
Procurement expertise will be bound by the Chartered Institute of Procurement and Supply.
Monitoring Monitoring will be carried out via annual review of this guidance by the CCG Programme Director. Application of this guidance will be supported through dissemination and training as advised above.
Review November 2017.
Equality, Diversity and Privacy
October 2016 Quality and Equality Integrated Impact Assessment Process – Appendix 4.
Associated CCG Documents
6 briefings supporting this overarching document:
• Introduction: Why do CCGs need to understand procurement?
• Briefing 1: How does procurement fit with the different stages of commissioning?
• Briefing 2: What are the procurement options? • Briefing 3: Which rules apply to a procurement
process? • Briefing 4: How should a procurement
process be conducted? • Briefing 5: Summary of the decision-making process • CCG’s Constitution
References • NHS Improvement/ Monitor guidance: https://www.gov.uk/government/publications/procurement-patient-choice-and-competition-regulations-guidance
• NHS England guidance: http://www.england.nhs.uk/2012/09/14/procure-ccgs/
• Equality and Human Rights Commission:
• https://www.equalityhumanrights.com/en/advice-and-guidance/guidance-procurement
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• Cabinet Office: Procurement Policy Notes
• Department of Health Procurement Briefings 2012. • Local Government Association: Delivering Savings, better
outcomes and growth. • NHSE & NHS Improvement: The Integrated Support and
Assurance Process (ISAP): an introduction to assuring novel and complex contracts: https://www.england.nhs.uk/wp-content/uploads/2012/03/isap-intro-guidance.pdf
• NHSE: Managing Conflicts of Interest: Revised Statutory Guidance for CCGs 2017. June 2017.
• https://www.england.nhs.uk/commissioning/pc-co-comms/coi/
Document Status:
This is a controlled document. Whilst this document may be printed, the electronic version posted on the intranet is the controlled copy. Any printed copies of this document are not controlled. As a controlled document, this document should not be saved onto local or network drives but should always be accessed from the intranet http://www.enhertsccg.nhs.uk/policies
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Table of Contents
1 Introduction .................................................................................................................. 8
2 Scope ............................................................................................................................ 9
3 Purpose ...................................................................................................................... 10
4 Definitions .................................................................................................................. 11
5 Roles and Responsibilities........................................................................................ 14
5.1 East and North Hertfordshire Clinical Commissioning Group ................................ 14
5.2 Senior Responsible Owner (SRO) ........................................................................ 14
5.3 East and North Hertfordshire CCG Scheme of Reservation and Delegation and Authorisation Limits ......................................................................................................... 15
5.4 Authorised Procurement Representative(s) and Procurement Support Services ... 15
6 Process and Procedures ........................................................................................... 16
6.1 Pre-Procurement Activities .................................................................................... 16
6.2 Overarching Procurement Objective ..................................................................... 17
6.3 Local Objectives ................................................................................................... 17
6.4 Guiding Principles ................................................................................................. 17
6.5 How will the Overarching and Local Objectives be achieved? ............................... 18
6.6 Applicable Legislation ........................................................................................... 19
6.7 East and North Hertfordshire CCG Governance and Standards of Business Conduct .......................................................................................................................... 25
6.8 Transparency, record keeping and e-tendering ..................................................... 29
6.9 Managing Conflicts of Interest ............................................................................... 31
6.10 East and North Hertfordshire CCG’s statutory obligations ................................. 40
6.11 Risk Management ............................................................................................. 42
6.12 Ethical Considerations, Environmental Issues and Social Responsibility ........... 43
6.13 Dispute Resolution Procedure ........................................................................... 45
6.14 Alternative Procurement Routes ........................................................................ 46
6.15 Terminating Contracts ....................................................................................... 48
6.16 Summary Guidance on Section 256 Arrangements with Local Authorities ......... 49
Appendix 1 East and North Hertfordshire CCG Financial Authorisation Limits ........... 51
Appendix 2: Summary of East and North Hertfordshire CCG’s obligations under the 2013 Regulations .............................................................................................................. 52
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Appendix 3 Minimum Procurement Timelines as required by Public Contracts Regulation 2015 and EU Procurement Directive 2014 .................................................... 54
Appendix 4: Integrated Impact Assessment ................................................................... 56
Appendix 5: Declaration of Interest Form - Individuals .................................................. 76
Appendix 6: Declaration of Interest Form Bidders/Contractors .................................... 82
Appendix 7: The Register of Procurement Decisions and Contracts Awarded ............ 85
Appendix 8: Procurement Checklist ................................................................................ 87
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1 Introduction
NHS East and North Herts CCG (CCG) is an NHS body created by the Health and Social Care Act 2012. The CCG has received authorisation to commission healthcare services on behalf of the registered patients of 58 GP practice members of the CCG, this amounts to approximately 580,000 patients within Hertfordshire.
The CCG is clinically led by a GP Clinical chair, reporting to a Governing Body and a majority of clinicians representing their member practices. The executive team and directorates implement the strategies and policies of the Governing Body.
The primary purpose and responsibility of the CCG is to commission (plan, purchase and organise) health services on behalf of the 580,000 registered patients of the member practices in order to improve their Health and Well-Being. It does this in partnership and collaboration with member clinicians, other healthcare commissioners for health and social care services covering the same population, patients and the public who are registered patients in the CCG area.
The procurement strategy is within the CCG constitution, as an enabler to help deliver the Commissioning strategy of the CCG. This strategy provides the overview of the CCG approach to procurement in general and has been drafted to support the overall CCG strategy.
Procurement is central to commissioning that drives quality and value. It describes a whole life-cycle process of acquisition of goods, works and services; it starts with identification of need and finishes with the end of a contract or the end of useful life of an asset, and including performance management. Procurement encompasses everything from repeat, low-value orders through to complex healthcare service solutions developed through partnership arrangement.
This document has been written with current competition and procurement rules in mind and will be updated in line with any changes to UK and EU legislation. It is written in accordance with NHS procurement guidelines.
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2 Scope
This document applies to all clinical procurement activities within East and North Hertfordshire CCG. It does not cover the procurement of goods, unless those goods form part of the clinical services arrangement which is being procured.
The document must be followed by:
All CCG staff members, including Governing Body Members and Practice Representatives, involved in the CCG’s policy-making processes, whether permanent, temporary or contracted-in (either as an individual or through a third party supplier).
Individuals working on behalf of East and North Hertfordshire CCG, including independent contractors, sub-contractors and agents.
East and North Hertfordshire CCG will ensure, when applying this document that it complies with its duties under the Equality Act 2010, and does not discriminate directly or indirectly against staff or potential service providers on grounds of race, colour, age, nationality, ethnicity, gender, sexual orientation, marital status, religious belief or disability.
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3 Purpose
Procurement is an all-encompassing term to describe the activities of obtaining the right goods, works and/or services from the right provider, at the right time, in the right place, of the right quality and at the right price, generally via a contract.
This document describes NHS East and North Hertfordshire Clinical Commissioning Group’s (“East and North Hertfordshire CCG’s”) Clinical Procurement Strategy (“Strategy”). The purpose of the document is to ensure that when commissioning clinical services, East and North Hertfordshire CCG will:
Comply with the regulatory framework of all relevant legislation and guidance, its own Constitution, Standing Orders, Schemes of Reservation and Delegation and Prime Financial Policies;
Acts with a view to securing the needs of its local population, and improves the quality and efficiency of clinical services;
Treats providers fairly and equally and acts in a transparent and proportionate way; Provides best value for money; Meets its short and long term objectives and; Maintains high standards of public trust and probity in its use of public funds
This document is part of East and North Hertfordshire CCG’s governance structure, and provides the high level framework for the detailed guidelines and other documentation in the form of standards and procedures.
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4 Definitions
Term Meaning
2013 Regulations
The National Health Service (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013. Please refer to Appendix 2 for East and North Hertfordshire CCG’s obligations under the 2013 Regulations.
Authorisation Limits East and North Hertfordshire CCG’s authorisation limits as referred to in Section 5.3 and which are set out at Appendix 1.
East and North Hertfordshire CCG The statutory Commissioning body for East and North Hertfordshire.
East and North Hertfordshire CCG’s financial policies
East and North Hertfordshire CCG’s Prime Financial Policies together with the detailed financial policies which East and North Hertfordshire CCG has developed in support of its Prime Financial Policies.
Constitution
East and North Hertfordshire CCG’s Constitution which sets out in detail the arrangements East and North Hertfordshire CCG has in place to discharge its functions efficiently and effectively on behalf of its population.
Contract Management Team East and North Hertfordshire CCG’s contract management team whose responsibilities include those set out at Section 5.4.
EU Procurement Rules
• The Treaty on the Functioning of the European Union (“EU Treaty”);
• Directive 2014/24/EC and the Remedies Directive 2007/66/EC;
• The Public Contracts Regulations 2015 (as amended); and
• Relevant EU and UK procurement case
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Term Meaning
law.
Together the “EU Procurement Rules” including any updating European and/or UK legislation and case law which updates, amends or replaces them.
Governing Body
East and North Hertfordshire CCG’s Governing Body appointed pursuant to and having the responsibilities set out at Part 4 of its Constitution.
Guidance
Applicable guidance, direction or determination which East and North Hertfordshire CCG has a duty to have regarded to.
New Care Models
As defined by NHSE: “they are referring to any Multi-speciality Community Provider (MCP), Primary and Acute Care Systems (PACS) or other arrangements of a similar scale or scope that (directly or indirectly) includes primary medical services”
NHS Improvement The sector regulator for health services in England.
NHS England
NHS Commissioning Board being the body established by the NHS Act 2006 (as amended by the Health and Social Care Act 2012).
Operational Planning Framework
East and North Hertfordshire CCG’s Operational Planning framework which provides the framework to deliver CCGs Strategic Plan.
Document This clinical procurement strategy which applies to the East and North Hertfordshire
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Term Meaning
CCG’s clinical procurement activities.
Authorised Procurement Representative(s) The team responsible for procurement transactional work and those other responsibilities set out at Section 5.4.
Prime Financial Policies or PFPs East and North Hertfordshire CCG’s prime financial policies which are set out at Appendix 9 of its Constitution.
Programme Management Office Assures adherence of the process to deliver in accordance with the Board Assurance Framework.
PSED Public Sector Equality Duty being a duty under the Equality Act 2010.
Public Contracts Regulation 2015 The new regulations replace the Public Contract Regulations 2006.
Scheme of Reservation and Delegation
East and North Hertfordshire CCG’s scheme of reservation and delegation which is included within East and North Hertfordshire CCG’s Prime Financial Policies as set out at Appendix 9 of its Constitution.
Senior Responsible Owner or SRO
The East and North Hertfordshire CCG Director responsible for leading the clinical procurement process as referred to in Section 5.2 of this document.
Social Value Act Public Services (Social Value) Act 2012
Standing Orders East and North Hertfordshire CCG’s standing orders which are set out at Appendix 8 of its Constitution.
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5 Roles and Responsibilities
5.1 East and North Hertfordshire Clinical Commissioning Group
East and North Hertfordshire CCG is legally accountable for the commissioning of health services for its local patient population. Insofar as clinical procurement is a means of commissioning clinical services (including service redesign) East and North Hertfordshire CCG is responsible for:
• The outcome of the procurement process and; • Ensuring the process is carried out fairly and according to the law, whilst ensuring
improved health outcomes and value for money.
5.2 Senior Responsible Owner (SRO)
The East and North Hertfordshire CCG Director leading the clinical commissioning work is known as the Senior Responsible Owner (SRO) for both procurement exercise and for any follow up commissioning work needed, once the procurement exercise has been completed.
Directors involved in commissioning, in consultation with relevant stakeholders, are responsible for agreeing service and care pathway designs, and drawing up the specification of services required. Depending on the value of the new clinical services arrangement, the specification for a service may need East and North Hertfordshire CCG’s Governing Body approval, before a competition for the service is launched. Please refer to Appendix 1 of this document, for authorisation limits, which East and North Hertfordshire CCG Governing Body approval is required.
Wherever possible a procurement working group should be established by the SRO, to provide strategic oversight for the entire procurement process. The group is responsible for managing compliance in the following areas, against relevant national and local protocols, guidance and strategies:
• Governance • Finance • Tendering • Contract Monitoring and; • Contract Termination. • Quality
The East and North Hertfordshire CCG’s Corporate Office is available to the group to provide independent assurance. If issues of a sensitive nature emerge during the course of a procurement process, the East and North Hertfordshire CCG’s Chair and Lay Members should be advised immediately.
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5.3 East and North Hertfordshire CCG Scheme of Reservation and Delegation and Authorisation Limits
When authorising and approving clinical procurement decisions, East and North Hertfordshire CCG will comply with its Scheme of Reservation and Delegation as set out in its Constitution and the Authorisation Limits, set out in Appendix 1.
5.4 Authorised Procurement Representative(s) and Procurement Support Services
The Authorised Procurement Representative(s)1 provides procurement support services for East and North Hertfordshire CCG. The Authorised Procurement Representative(s) may be an East and North Hertfordshire CCG staff or a separate, legally distinct, commissioning support provider, contracted to provide commissioning support services to East and North Hertfordshire CCG.
The Authorised Procurement Representative(s) are responsible for:
• The delivery of procurement projects in line with the East and North Hertfordshire CCG’s requirements and;
• Providing East and North Hertfordshire CCG with advice and support on procurement issues.
The Authorised Procurement Representative(s) takes responsibility for the procurement transaction once a commissioning need has been identified, and approval has been given, to go to market.
The Authorised Procurement Representative(s) assists with market engagement (pre-procurement) and is responsible for all procurement transactional work.
East and North Hertfordshire CCG’s Contract Management Team is responsible for preparing the contract, to be included with the tender documents, contract finalisation with the selected bidder(s), mobilisation and subsequent contract management.
To enable the Authorised Procurement Representative(s) to carry out its role it requires certain information. This information informs the procurement route, and is needed to populate the relevant contract. It should include:
• A service specification completed within the National Standard Service Specification format where necessary;
• A copy of the Full Business Case Commissioning Proposal, which supports the service specification;
1 Reference in this document, to The Authorised Procurement Representatives(s) includes both an East and North Hertfordshire CCG staff and a legally distinct commissioning support provider (as the case may be).
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• Assurance that any necessary consultation has taken place; • Any activity and financial data relevant to the service to be procured; • Details of any previous or existing contracts for the service and; • Details of any applicable national policy or guidelines.
Wherever possible an Authorised Procurement Representative(s) should be involved as early in the business case development process as is feasible. This is to ensure the Authorised Procurement Representative(s) has a full understanding of the service requirements, and can input into the development process, from a procurement and contract management perspective.
6 Process and Procedures
6.1 Pre-Procurement Activities
Prior to commencing a clinical procurement process the approval process (as set out in East and North Hertfordshire CCG’s Operational Planning Framework) must be followed. This ensures the planned procurement will develop clinical services in line with the strategic goals of East and North Hertfordshire CCG.
Wherever possible the Authorised Procurement Representative(s) should be involved at the earliest possible stage to support East and North Hertfordshire CCG in its pre-procurement activities, and to ensure compliance with this document, procurement law and good practice.
In preparing for a clinical procurement, East and North Hertfordshire CCG should consider:
• The need to consult in accordance with its statutory obligations (including those under Section 3 of the NHS Act 2006, the Equality Act 2010 and the Public Services (Social Value) Act 2012. This should be assessed early in the process, as consultation may influence the service design or the requirements for the services to be tendered.
• The need to carry out market research, to better understand the provider market, to inform the procurement route and/or the service specification;
• Whether pre-market engagement with potential providers is appropriate to prepare for the procurement, to seek views on the draft service specification, and to inform potential providers of East and North Hertfordshire CCG’s clinical procurement plans and requirements. In carrying out any pre-market engagement with potential providers, East and North Hertfordshire CCG will ensure that this does not have the effect of distorting competition or breach the principles of equal treatment and transparency;
• Whether there are opportunities to collaborate with other commissioning organisations in the purchasing of clinical services, any opportunities identified should be explored and evaluated where these are consistent with achieving East and North Hertfordshire CCG’s statutory and local objectives (see section 6.2 & 6.3)
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• Any risks associated with the planned procurement including how risks will be identified and managed.
• The need to complete a Procurement Checklist (see Appendix 8) when procuring services from providers, to ensure full due consideration is given to the process of procurement.
6.2 Overarching Procurement Objective
The National Health Service (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013 (the “2013 Regulations”), provides that when East and North Hertfordshire CCG procures health care services for the purpose of the NHS, it must act with a view to achieving the following objectives:
(a) Securing the needs of the people who use the services,
(b) Improving the quality of the services, and
(c) Improving efficiency in the provision of the services;
Including through the services being provided in an integrated way.
This includes when East and North Hertfordshire CCG makes decisions about potential future clinical services contracts; or selecting providers to be appointed to a framework agreement; or those providers who qualify to provide services subject to patient choice.
6.3 Local Objectives
As set out in East and North Hertfordshire CCG’s strategic objectives and reference should be made to the current plan for further details.
6.4 Guiding Principles
The guiding principles which underpin East and North Hertfordshire CCG’s clinical procurement activities are:
Purpose - Clinical procurement decisions made by East and North Hertfordshire CCG’s managers, should contribute to the goals of the whole system, the overarching objective and local objectives. They should have patient interest and the wider public interest at heart. Service specifications should be driven by the needs of the population.
Transparency - Transparency is fundamental to accountability. East and North Hertfordshire CCG should conduct its clinical procurement activities openly and in a manner that allows its behaviour to be scrutinised. This includes:
• Publishing information on future procurement strategies and intentions;
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• Taking steps to ensure providers are aware of East and North Hertfordshire CCG’s intentions to procure particular services;
• Providing feedback to providers that have offered to provide services and have been unsuccessful;
• Publishing details of contracts awarded in a timely manner; and • Maintaining records of key decisions taken (including the reasons for those decisions).
Objectivity - Key decisions must be based wherever possible on objective data, information or criteria, or reasonable assumptions, and kept as public records for audit purposes, allowing for increased levels of transparency.
Proportionality - East and North Hertfordshire CCG’s actions must be proportionate to the value, complexity and clinical risk associated with the provision of the service in question. They should be based on objective information or reasonable judgements, and capable of withstanding public scrutiny and reporting.
Equal treatment and non-discrimination - East and North Hertfordshire CCG must treat all providers equally, and must not favour one provider (or type of provider) over another. Equal treatment also requires East and North Hertfordshire CCG to take into account relevant differences between providers.
Accountability - East and North Hertfordshire CCG’s managers should strive to align their authority and legal powers with their accountability and legal duties. It should be clear, in statute and in practice, who is accountable for what; and what authority those accountable have to control their areas of responsibility.
Subsidiarity - Decisions should be made by the lowest competent authority, in accordance with East and North Hertfordshire CCG’s Constitution, Scheme of Reservation and Delegation and East and North Hertfordshire CCG’s financial policies.
Consistency - Formulation and implementation of this document, and linked clinical procurement transactions should be internally coherent and consistent.
No ‘double jeopardy’ - Where possible, providers should not be held to account for the same issue by more than one institution. (E.g. CCG Contract Manager, Regulator or Government Department).
Interdependency – When assessing specific issues, East and North Hertfordshire CCG should understand and minimise the potential unintended consequences of any actions.
6.5 How will the Overarching and Local Objectives be achieved?
When procuring clinical services East and North Hertfordshire CCG, and having regarded to the guiding principles set out in Section 6.4 above, East and North Hertfordshire CCG aims to:
• Work with a wide range of service providers from the private, public, independent, voluntary and social enterprise sectors, who can offer high quality, diverse and acceptable choices for local service users;
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• Stimulate the supply market where intelligence suggests that a wider portfolio of services
or service providers is needed;
• Continuously review its existing contracts to ensure that they deliver in accordance with key performance indicators, offer maximum value for money and demonstrate continuous improvement in the quality, efficiency and range of services on offer, to meet the needs of East and North Hertfordshire CCG’s local population;
• Work with partners to ensure that buying power and economies of scale are maximised through collaborative procurement initiatives.
6.6 Applicable Legislation
6.6.1 Overview
The procurement of health care services by Clinical Commissioning Groups operating in the NHS is governed by the following two principle aspects of Regulation:
• The Public Contracts Regulations 20152;
• The National Health Service (Procurement, Patient Choice and Competition) (No. 2) Regulations 20133.
6.6.2 Public Contracts Regulation 2015
East and North Hertfordshire CCG must comply with the 2015 Public Contracts Regulations when carrying out its clinical procurement activities. On 26 February 2015, the Public Contracts Regulations 2015 came into force. The new regulations replace the Public Contracts Regulations 2006. With effect from the 18 April 2016 healthcare services within the meaning and scope of 6.10 of the legislation will be subject to the new ‘Light Touch’ regime of the Public Contracts Regulations 2015. See section 6.6.5 for an explanation of the ‘Light Touch’ regime.
Time limits imposed by the CCG on suppliers, such as for responding to adverts and tenders, must be reasonable and proportionate. Please refer to appendix 3 for Minimum Procurement Timelines as required by Public Contracts Regulation 2015 and EU Procurement Directive 2014.
2 http://www.legislation.gov.uk/uksi/2015/102/contents/made
3 http://www.legislation.gov.uk/uksi/2013/500/part/2/made
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Where there is only one provider capable of supplying the services required, the CCG will need to articulate the grounds for using the negotiated procedure, without a call for competition to record its decision making.
Following award of the contract the CCG must publish within 30 days of award a contract award notice. The new regulations also allow for a group award notice to be published on a quarterly basis. In this instance the award notices must be published within 30 days of the end of each quarter.
6.6.3 The National Health Service (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013
East and North Hertfordshire CCG must comply with the 2013 Regulations when carrying out its clinical procurement activities. The 2013 Regulations impose obligations on East and North Hertfordshire CCG to ensure good practice in the procurement of clinical services, to ensure the protection of patients’ rights to make choices and to prevent anti-competitive behaviour.
In particular the 2013 Regulations require East and North Hertfordshire CCG when procuring clinical services:
• To act with a view to securing the overarching objective (Regulation 2 - see Section 6.5);
• To comply with general requirements including to:
o Act in a transparent and proportionate way;
o Treat all providers equally and in a non-discriminatory way;
o Procure services from one or more providers that are capable of meeting the overarching objective, and provide best value for money in doing so;
o Consider appropriate means of improving the quality and efficiency of the services, including; through services being provided in a more integrated way, enabling providers to compete for the services and allowing patients a choice of providers; and
o Maintain appropriate records.
(Regulation 3)
The 2013 Regulations also govern the circumstances when East and North Hertfordshire CCG may award a new contract for clinical services without a competition. (Regulation 5). They provide that:
East and North Hertfordshire CCG “may award a new contract for the provision of health care services, and for the purposes of the NHS, to a single provider without advertising an intention to seek offers from providers in relation to that contract where the relevant body is satisfied that the services to which the contract relates are capable of being provided only by that provider”.
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When advertising an intention to seek offers for a clinical services contract, both the 2013 NHS Regulations and the subsequent 2015 Public Contract Regulations, require East and North Hertfordshire CCG to publish a contract notice on the following dedicated online portals:
Official Journal of the European Union (OJEU)
http://ted.europa.eu/TED/main/HomePage.do
Contracts Finder https://www.contractsfinder.service.gov.uk
The notice must include:
• A description of the services to be provided; and
• The criteria against which any bids for the contract will be evaluated.
East and North Hertfordshire CCG must also have arrangements in place which enable providers to express an interest in providing clinical services.
The 2013 Regulations also set out the role of Monitor4, including its investigation and enforcement powers, in relation to breaches or potential breaches of the 2013 Regulations.
Failure to comply with the 2013 Regulations can have serious consequences and result in serious sanctions for East and North Hertfordshire CCG. Please refer to Appendix 2 for East and North Hertfordshire CCG’s obligations under the 2013 Regulations.
Where there is doubt regarding East and North Hertfordshire CCG’s compliance with its obligations, legal advice should be sought through the CCG’s Company Secretary.
The full text of the Regulations is available at:
http://www.legislation.gov.uk/uksi/2013/500/contents/made
6.6.4 European and UK procurement legislation
When procuring clinical services, East and North Hertfordshire CCG will ensure that it complies with EU procurement law and the UK’s implementing Regulations, to the extent that these are applicable to the clinical services being procured. In particular, it will ensure compliance with the requirements of:
• The Treaty on the Functioning of the European Union (“EU Treaty”);
• EU Directive 2014/24/EC5 and the Remedies Directive 2007/66/EC;
• The Public Contracts Regulations 2015 (as amended); and
• Relevant EU and UK procurement case law.
4 Since April1 2016 Monitor has become part of NHS Improvement 5 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014L0024&from=EN
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• Together the “EU Procurement Rules” including any updating European and/or UK legislation and case law which updates, amends or replaces them.
6.6.5 The ‘Light Touch’ Regime
Under the EU Procurement Rules, the distinction between Part A services and Part B services has been removed and replaced with a ‘Light Touch’ Regime. A services contract will fall within scope of the Light Touch regime if it is for certain types of health, social and other services listed as Schedule 3 of the Public Contract Regulations 2015. The following link provides details of services listed at Schedule 3.
www.legislation.gov.uk/uksi/2015/102/schedule/3/made
The current threshold for mandatory advertising of services, under the light touch regime is €750,000 or approximately £620,000.
Although there are no stipulated time periods in the ‘Light Touch’ regime (and therefore not subject to the full scope of the Public Procurement regulations as set out in the Public Contracts Regulations 2015, the CCG, throughout the whole of a procurement process, will apply best practice. For example as detailed in Appendix 3: Minimum Procurement Timelines as required by Public Contracts Regulation 2015 and EU Procurement Directive 2014.
Where the new light touch regime applies, the CCG will publish in the OJEU and Contracts Finder, a call for competition or Prior Information Notice (PIN) for all contracts over the threshold.
To ensure compliance with Treaty principles of transparency, and equal treatment although the light touch regime does not impose any specific procedures, as defined within the Public Contracts Regulations 2015, to be followed, any procurement must confirm with the information provided in the OJEU advert (contract notice or PIN) regarding:
• Any conditions for participation; • Time limits for contacting/responding to the CCG and; • The award procedure to be applied.
The obligations applicable to Light Touch Regime services, and which the CCG will ensure it complies with, include:
• Treating providers equally and in a non-discriminatory way; • Acting transparently (including the duty to advertise a Contract Notice or Prior
Information Notice (PIN) in the Official Journal of the European Union (OJEU) and Contracts Finder);
• Complying with the rules on technical specifications, including that these do not favour particular providers or present unjustified obstacles to competition;
• Publishing a contract award (which will include Regulation 84 report as part of the Contract Award) notice in the Official Journal of the European Union
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(“OJEU”); and • The provision of statistical and other reports.
Failure to comply with the EU Procurement Rules can have serious consequences and result in sanctions for the CCG.
6.6.6 Equality Act 2010
The Equality Act 2010, sets out the anti-discrimination law in the UK. If identifies ‘protected characteristics’ namely: age, disability, gender reassignment, race, religion or belief, sex, sexual orientation, pregnancy and maternity and marriage and civil partnerships.
The Equality Act sets out the public sector equality duty (PSED) which applies to East and North Hertfordshire CCG. The PSED is a continuing duty and applies to East and North Hertfordshire CCG at each stage of the clinical procurement lifecycle (including when planning the procurement, developing the specification and contract, conducting the procurement process and following the contract award).
When making relevant decisions, and at each stage of the clinical procurement lifecycle, East and North Hertfordshire CCG will meet its obligations, under the Equality Act, by consciously considering the need to:
• Eliminate unlawful discrimination, harassment and victimisation and other prohibited conduct;
• Advance equality of opportunity between people, who share protected characteristics and those who do not; and
• Foster good relations between people who share a protected characteristic and those who do not.
6.6.7 Public Services (Social Value) Act 2012
The Public Services (Social Value) Act 2012 (the “Social Value Act”) applies to East and North Hertfordshire CCG when it carries out its clinical procurement activities. In accordance with its obligations under the Social Value Act, East and North Hertfordshire CCG will consider, at the pre-procurement stage:
• How the services to be procured may improve the social, environmental and economic well-being of its area; and
• How in conducting a procurement process, East and North Hertfordshire CCG might act with a view to securing that improvement, including whether to undertake a consultation on these matters (or as part of East and North Hertfordshire CCG’s wider statutory obligations to consult).
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6.6.8 Relevant Guidance
In meeting its obligations under the 2013 Regulations, the EU Procurement Rules, the Equality Act 2010 and the Social Value Act, and to ensure it adopts best procurement practice, East and North Hertfordshire CCG will have regard to any relevant Guidance produced by NHS Improvement (previously Monitor Guidance), NHS England, the Department of Health, the Equality and Human Rights Commission, and the Cabinet Office. Further details of current guidance can be found at:
• NHS Improvement/ Monitor guidance: https://www.gov.uk/government/publications/procurement-patient-choice-and-competition-regulations-guidance
• NHS England guidance: http://www.england.nhs.uk/2012/09/14/procure-ccgs/
• Equality and Human Rights Commission:
• https://www.equalityhumanrights.com/en/advice-and-guidance/guidance-procurement
• Cabinet Office: Procurement Policy Notes
• NHSE & NHS Improvement: The Integrated Support and Assurance Process (ISAP): an introduction to assuring novel and complex contracts: https://www.england.nhs.uk/wp-content/uploads/2012/03/isap-intro-guidance.pdf
• NHSE: Managing Conflicts of Interest: Revised Statutory Guidance for CCGs 2017. June 2017. https://www.england.nhs.uk/commissioning/pc-co-comms/coi/
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6.7 East and North Hertfordshire CCG Governance and Standards of Business Conduct
6.7.1 East and North Hertfordshire CCG’s Constitution, Standing Orders, Scheme of Reservation and Delegation and Financial Policies
When procuring clinical services, East and North Hertfordshire CCG will ensure that it complies with its duties under its Constitution (including its Standing Orders, Scheme of Reservation and Delegation and East and North Hertfordshire CCG’s financial policies). These include the information required to be included in the Constitution by Schedule 1A to the NHS Act 2006 (as amended by Schedule 2 of the Health and Social Care Act 2012).
Standing Orders and the Scheme of Reservation and Delegation ensure that decision-making is informed by intelligent information, covering the full range of corporate, financial, clinical information and research governance, are central to East and North Hertfordshire CCG's governance framework and are sustaining the highest standards of corporate and personal probity, accountability and openness. Good governance provides the bedrock for effective performance and assuring better health and health services for the people of East & North Hertfordshire.
Prime Financial Policies (PFPs) are included within East and North Hertfordshire CCG's Constitution, for the management of East and North Hertfordshire CCG's financial affairs. In support of these PFPs, East and North Hertfordshire CCG has adopted more detailed financial policies, referred to together with the PFPs as "East and North Hertfordshire CCG’s financial policies".
East and North Hertfordshire CCG's financial policies detail the financial responsibilities, policies and procedures adopted by East and North Hertfordshire CCG to ensure that East and North Hertfordshire CCG’s financial transactions (including procurement transactions) are carried out in accordance with the law and with Government policy. They are used in conjunction with the Schedule of Matters Reserved to the Clinical Commissioning Group and Scheme of Delegation adopted by East and North Hertfordshire CCG and included within the Constitution’s Scheme of Reservation and Delegation.
East and North Hertfordshire CCG's financial policies, identify the financial responsibilities which apply to everyone working for the East and North Hertfordshire CCG and its constituent localities.
Should any difficulties arise regarding the interpretation or application of any of East and North Hertfordshire CCG's financial policies, then the advice of the Chief Finance Officer must be sought before acting.
The failure to comply with Standing Orders and PFPs can, in certain circumstances, be regarded as a disciplinary matter that could result in dismissal.
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6.7.2 Standards of Business Conduct
East and North Hertfordshire CCG including its employees, members, committee and sub-committee members and members of its Governing Body (and its committees) will at all times comply with East and North Hertfordshire CCG’s Constitution, 6.7.3 and be aware of the responsibilities outlined in it. They should act in good faith and in the interests of East and North Hertfordshire CCG and should follow the Seven Principles of Public Life set out by the Nolan Principles.
https://www.gov.uk/government/publications/the-7-principles-of-public-life/the-7-principles-of-public-life--2.
East and North Hertfordshire CCG will also manage conflicts of interest in accordance with its Standards of Business Conduct including:
• Offers of gifts, sponsorship and hospitality; • Managing conflicts of interest in general and; • Managing conflicts of interest where GPs are potential providers of East and North
Hertfordshire CCG commissioned services (including East and North Hertfordshire CCG’s code of conduct for this).
The next section outlines the General principles for managing conflicts of interest, as set out in the East and North Hertfordshire CCG’s Standards of Business Conduct Policy, section 6.9 of this document provides conflicts of interest guidance, with specific relation to procurement activities.
East and North Hertfordshire CCG will adopt the following general principles:
• Doing business properly - East and North Hertfordshire CCG will strive to ensure that its needs assessments, consultation mechanisms, commissioning strategies and procurement procedures are right from the outset;
• Being proactive not reactive - East and North Hertfordshire CCG will seek to identify and minimise the risk of a conflict of interest at the earliest possible stage, and by ensuring that individuals receive proper induction and understand their obligations to declare conflicts of interest. East and North Hertfordshire CCG will establish and maintain registers of interests, and agree in advance how a range of different situations and scenarios will be handled;
• Assuming that individuals will seek to act ethically and professionally, but may not always be sensitive to all conflicts of interest - through the rules set out in East and North Hertfordshire CCG’s Constitution, and associated policies, individuals should volunteer information about conflicts and, where necessary, exclude themselves from decision making. However, East and North Hertfordshire CCG will ensure that there are prompts and checks in place which reinforce this; and
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• Being balanced and proportionate - East and North Hertfordshire CCG’s rules on managing conflict of interest will protect and empower people by ensuring decision making is efficient as well as transparent, and fair but is not overly complex or slow and does not impose unnecessary or disproportionate constraints.
• Safeguards and steps to manage conflicts of interest: A brief overview in relation to Business Conduct is provided here and section 6.9 provides full details of conflicts of interests and procurement. East and North Hertfordshire CCG has put in place the following safeguards and steps to manage conflicts of interest:
• Declarations of conflicts of interest - Potential providers: East and North Hertfordshire CCG will ensure that potential providers, (including sub-contractors, consortium members, advisers or other associated parties) are required to identify and declare any conflict of interest, or potential conflict of interest, which could arise if the potential provider takes part in any procurement process and/or provides services under, or otherwise enter into any contract with, East and North Hertfordshire CCG.
• For these purposes, East and North Hertfordshire CCG will use the template declaration included in Appendix 6 of this document or any template introduced by East and North Hertfordshire CCG to amend, update or replace this.
• Declaration of conflicts of interest - East and North Hertfordshire CCG members and employees: East and North Hertfordshire CCG will ensure that its members, employees, Governing Body members, committee or sub-committee members (including those of the Governing Body) declare any interest, which may lead to a conflict with the interests of East and North Hertfordshire CCG and the public for whom East and North Hertfordshire CCG commissions services.
For these purposes, East and North Hertfordshire CCG will use the template declaration included at Appendix 5 of this document.
• Maintaining a register of interests: East and North Hertfordshire CCG will maintain a register of interests in accordance with its statutory obligations and as provided for in its Constitution.
• Pre-procurement engagement with potential providers when developing service requirements and service specifications: East and North Hertfordshire CCG will ensure that it complies with the principles of equal treatment, non-discrimination and transparency and does not engage selectively with only certain providers and does not shape its requirements or specifications in a way which favours certain providers.
• Preserving integrity of decision making: Where East and North Hertfordshire CCG members or other individuals have a material interest they will either be excluded from relevant parts of meetings or join in the discussion but not participate in the decision making itself.
• Where it is not practicable to manage a conflict by simply excluding the individual (or individuals) concerned, for example, because of the number of conflicted individuals,
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East and North Hertfordshire CCG will consider alternative ways for managing the conflict, as provided for in its Constitution including through the involvement of independent third parties.
• Recording how conflicts have been managed: East and North Hertfordshire CCG will maintain accurate records of how any conflicts which have arisen have been managed.
Commissioning of Services where GP Practices are potential providers of CCG Commissioned Services: In the circumstances of commissioning of such services including Local Enhanced Services all individuals must comply with the principles and main content of the NHS England's Code of Conduct in this area. Arrangements for managing any such declarations of interest are set out in Section 6.9 of this document.
They must also comply with all current relevant guidance and policies including:
• East and North Hertfordshire CCG’s Dispute Resolution Procedure;
(http://www.enhertsccg.nhs.uk/sites/default/files/documents/Apr2015/20150421-Dispute-Resolution-Procedure-v.2.2-Final.pdf)
• East and North Hertfordshire CCG’s Anti-Fraud and Bribery Policy (Including their obligations under the Bribery Act 2010);
(http://www.enhertsccg.nhs.uk/sites/default/files/documents/Apr2016/2016-04-26-Anti-Fraud-and-Bribery-Policy-FINAL-3_3.pdf)
• East and North Hertfordshire CCG’s Disciplinary Policy and;
(http://www.enhertsccg.nhs.uk/sites/default/files/documents/Jun2016/HR008-Disciplinary-Policy-and-Procedure-FINAL-v3-HARMONISED.pdf)
• East and North Hertfordshire CCG’s Whistleblowing Policy.
(http://www.enhertsccg.nhs.uk/sites/default/files/documents/Mar2015/ENH%20CCG%20Raising%20Concerns%20at%20Work%20Policy.pdf)
6.7.4 Anti-Competitive Behaviour
The 2013 Regulations, and in particular Regulation 10, prohibits East and North Hertfordshire CCG from engaging in anti-competitive behaviour, unless to do so is in the interests of NHS health care service users.
• Regulation 10 also provides that an arrangement or contract for the provision of clinical services, must not include any terms or conditions restricting competition which is not:
• Necessary for the attainment of the intended outcomes which are beneficial for the people who use the services;
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• Or the overarching objective referred to in Regulation 2 (as set out at Section 6.6.3 above).
East and North Hertfordshire CCG will ensure that it complies with its obligations under Regulation 10.
6.8 Transparency, record keeping and e-tendering
6.8.1 Transparency and publicity obligations
Transparency is fundamental to accountability and, as set out in Section 6.4 of this document, East and North Hertfordshire CCG has a legal duty, when conducting its clinical procurement activities, to act in a transparent way. East and North Hertfordshire CCG should conduct its clinical procurement activities openly and in a manner that allows its behaviour to be scrutinised.
In addition to its legal obligations to act transparently, East and North Hertfordshire CCG will also comply with current Government guidance on transparency, to publish information on concluded contracts and East and North Hertfordshire CCG expenditure.
6.8.2 Documentation & Record Keeping
As set out elsewhere in this document, East and North Hertfordshire CCG will comply with its statutory obligations to keep and maintain appropriate records.
Accurate record keeping and documentation is also fundamental to any procurement process and is also consistent with East and North Hertfordshire CCG’s obligation of transparency. A robust audit-trail should be maintained, which records all steps and decisions taken (and the reasons for those steps / decisions). This assures East and North Hertfordshire CCG’s accountability, that its decisions can be scrutinised, and that it can accurately respond to formal complaints or challenges.
6.8.3 Retention of Procurement Documentation
East and North Hertfordshire CCG will comply with its statutory obligations regarding retention and disposal of procurement documentation. For example tender documents whether successful or unsuccessful are to be retained for 6 years.
For full details please refer to the Records Management Policy as set out on the CCG’s website at:
http://www.enhertsccg.nhs.uk/sites/default/files/documents/Mar2015/20150327%20Records%20Management%20Policy%20v4%201%20Final.pdf.
6.8.4 Document Version Control
Formal document version control should also be implemented, and all document versions retained in case of future need. This should follow the CCGs preferred or mandated system of version control.
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6.8.5 Storage of Tender Documentation
Tender documentation should be held in named and securely accessed areas of the CCGs file server. Consideration should be given as to which officers in the CCG should have access to the secure areas, where the documentation is held.
6.8.6 Provision of Full Audit Trail
Each procurement should have a full audit trail available. Once the formal process has started, the e-tendering and evaluation systems will provide this. Consideration should be given to the audit trail, in relation to the preparatory and post stages of the Procurement project too.
6.8.7 E-Tendering & Evaluation Systems
From April 2017 the current EU procurement Directive (2014/24/EC) requires (subject to a limited number of exceptions), that all communication and information exchanges for procurements falling within the scope of the Directive, be carried out electronically using products which are generally available, are interoperable and which do not restrict potential providers’ access to the procurement procedure.
In readiness for the new Directive, and subject to the exceptions set out below, East and North Hertfordshire CCG will use electronic systems when carrying out any clinical procurement exercise.
Tenders, tender documentation and communications with potential providers and bidders will be held and managed using the chosen procurement system.
These electronic resources will be managed by the Authorised Procurement representative(s).
In some circumstances, it may be necessary for East and North Hertfordshire CCG, to carry out a clinical procurement process, including communications with potential providers and bidders, and/or the evaluation of requests to participate and/or tenders, using non electronic methods. Where the use of non-electronic methods is proposed for a clinical procurement, and prior to the commencement of the formal procurement process this should be:
• Discussed with the Authorised Procurement Representative(s), including the processes and measures which will be put in place, to ensure accurate and auditable records can be kept, and any risks associated with the use of non-electronic means addressed;
• Approved by the Chief Financial Officer.
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6.9 Managing Conflicts of Interest
A conflict of interest occurs when an individual’s ability to exercise judgement or act in a role is, could be, or is seen to be impaired or otherwise influenced by his or her involvement in another role or relationship. In some circumstances, it could be reasonably considered that a conflict exists even when there is no actual conflict. In these cases, it is important to still manage these perceived conflicts in order to maintain public trust.
The management of conflicts of interest is vitally important in the procurement of clinical services, and managing them appropriately is paramount to the probity and accountability of East and North Hertfordshire CCG’s decision making, and will ensure that the principles of transparency, fairness and non-discrimination are upheld.
As an organisation led by GPs, East and North Hertfordshire CCG will be particularly subject to conflicts of interest or potential conflicts of interest when procuring clinical services. East and North Hertfordshire CCG will therefore adopt rigorous standards, in the identification and management of conflicts or potential conflicts of interest, to ensure that the above principles can be upheld. Such a conflict could arise:
• In carrying out a competitive tender: where GP practices or other providers in which East and North Hertfordshire CCG members have an interest are amongst those bidding; or
• When procuring clinical services through Any Qualified Provider: where one or more GP practices (or other providers in which East and North Hertfordshire CCG members have an interest) are amongst the qualified providers from which patients can choose.
• Where the CCG is proposing to commission services on a Single Tender basis from GP practices.
• Where the CCG is proposing to commission new care models.
In managing conflicts of interest East and North Hertfordshire CCG will:
• Comply with its statutory obligations in relation to the management of conflicts of interest;
• Have regard to relevant Guidance published by NHS England, and monitor in relation to the discharge of its statutory obligations; and
• Comply with its Constitution in relation to the management of conflict of interests including its: Managing Conflicts of Interest Policy (http://www.enhertsccg.nhs.uk/sites/default/files/documents/Jul2015/20150513%20Managing%20Conflicts%20of%20Interest%20Policy%20v6.pdf).
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6.9.1 Declarations of Interests in Relation to Procurement
Conflicts of interest need to be managed appropriately throughout the procurement. At the outset of procurement, the relevant interest of all individuals involved should be identified and clear arrangements put in place to manage any conflicts of interest. This includes consideration as to which stages of the process a conflicted individual should not participate in, and, in some circumstances, whether that individual should be involved in the process at all.
6.9.2 Members of East and North Hertfordshire’s CCG, CCG Committees / Sub-Committees, the Governing Body, Committees / Sub-Committees of the Governing Body or Other Decision-Making Groups
It is the responsibility of all individuals to declare, and keep up-to-date, details of any personal or business interests, which may influence, or may be perceived to influence, their judgement in relation to any procurement activities they are supporting. They should do this by completing and submitting the Declaration of Interest Form in Appendix 5 to the Company Secretary, which should be submitted as soon as a conflict is identified and no later than 28 days.
East and North Hertfordshire CCG will also ensure that individuals contracted to work on behalf of East and North Hertfordshire CCG or otherwise providing services or facilities to East and North Hertfordshire CCG, will be made aware of their obligation with regard to declaring conflicts or potential conflicts of interest, and that this requirement is written into their contract for services.
All potential bidders / contractors / service providers, including sub-contractors, members of a consortium, advisers or other associated parties (Relevant Organisation) are required to identify any potential conflicts of interest (Appendix 6) that could arise if the Relevant Organisation were to take part in any procurement process and / or provide services under, or otherwise enter into any contract with, the CCG, or with NHS England in circumstances where the CCG is jointly commissioning the service with, or acting under a delegation from, NHS England.
This allows Commissioners to ensure that they comply with the equal treatment and transparency. When a bidder declares a conflict, Commissioners must decide how best to deal with it, to ensure that no bidder is treated differently to any other. If any assistance is required in order to complete this form, then the Relevant Organisation should contact the Company Secretary.
A register of procurement decisions Appendix 7 will be maintained by the Governance and Corporate Affairs Team and will be available for public inspection via the CCG’s website. Please refer to section 6.9.9 of this document, for further information.
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6.9.3 Decisions taken where a Governing Body Member has an Interest
In the event of the Governing Body having to decide upon a question in which a Governing Body member has an interest, all decisions will be made by vote, with a simple majority required. A quorum must be present for the discussion and decision; interested parties will not be counted when deciding whether the meeting meets quorum. Interested Governing Body members must not vote on matters affecting their own interests, even where the use of the Waiver has been approved by the Chair and used.
All decisions under a conflict of interest will be recorded in the minutes of the meeting. The report will record:
• The nature and extent of the conflict;
• An outline of the discussion;
• The actions taken to manage the conflict;
• Use of the Waiver and reasons for its implementation.
Where a Governing Body member benefits from the decision, this will be reported in the Annual Report and Accounts as a matter of best practice. All payments or benefits in kind to Governing Body members will be reported in the CCG’s Annual Report and Accounts, with amounts for each Governing Body member listed for the year in question.
Independent external mediation may be used where conflicts cannot be resolved through the usual procedures.
6.9.4 Multiple Declarations of a Conflict of Interest
It is possible that all members of the Governing Body who are GPs, or other healthcare professionals from a member practice, might share a material conflict of interest in a particular Agenda item that prevents them from taking part in the decision making process.
This situation might occur where, for example, the CCG is proposing to commission services on a single tender basis from all of its member practices, or where it is likely that all or most practices would wish to be qualified providers for a service under the Any Qualified Provider (AQP) scheme. Where more than 50% of the members of a meeting are required to withdraw from a meeting or part of it, owing to the arrangements agreed for the management of conflicts of interests or potential conflicts of interests, the Chair (or Deputy Chair) will determine whether or not the discussion can proceed.
In making this decision the Chair will consider whether the meeting is quorate, in accordance with the number and balance of membership set out in the CCG’s Standing Orders.
Where the meeting is not quorate, owing to the absence of certain members, the discussion will be deferred until such time as a quorum can be convened.
Where a quorum cannot be convened from the membership of the meeting, owing to the arrangements for managing conflicts of interest or potential conflicts of interests, the Chair of
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the meeting shall consult with the Chief Executive regarding the action to be taken. This may include:
• Requiring another of the Group’s committees or sub-committees, the Group’s Governing Body or the Governing Body’s committees or sub-committees (as appropriate) which can be quorate, to progress the item of business, or if this is not possible;
• Inviting on a temporary basis one or more of the following to make up the quorum (where these are permitted members of the committee / subcommittee in question) so that the Group can progress the item of business: o A senior member of the CCG; o An individual appointed by a member to act on its behalf in the dealings between it
and the CCG; o A member of a relevant Health and Wellbeing Board and; o A member of a Governing Body of another CCG.
• In the case of the Governing Body, or where the above are not permitted members of the committee / sub-committee in question, inviting one or more of them to provide external scrutiny in relation to the discussions and decisions on that item of business;
• These arrangements will be recorded in the minutes or action notes of the meeting.
6.9.5 Managing Conflicts of Interest: Commissioning Services from GP practices
It is an essential feature of reforms that CCGs should be able to commission a range of community-based services, including primary care services to improve quality and outcomes for patients. Where the provider for these services might be a GP practice, the CCG will demonstrate that those services:
• Clearly meet local health needs and have been planned appropriately and; • Go beyond the scope of the GP contract; and that the appropriate procurement
approach is used.
The CCG will adopt the specific, additional safeguards set out in the NHS England Code of Conduct: Managing conflicts of interest where GP practices are potential providers of CCG-commissioned services in this regard, which are designed to:
• Maintain confidence and trust between patients and GPs; • Enable CCGs and member practices to demonstrate that they are acting fairly and
transparently – that members will always put their duty to patients before any personal financial interest; and
• Ensure CCGs operate within the legal framework and do not engage in anticompetitive behaviour.
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6.9.6 Managing Conflicts of Interest: Contractors and People who Provide Services
Anyone seeking information in relation to procurement, or participating in procurement, or otherwise engaging with the CCG in relation to the potential provision of services or facilities to the CCG, will be required to make a declaration of any relevant conflict or potential conflict of interest Appendix 5.
Anyone contracted to provide services or facilities directly to the CCG will be subject to the same provisions in relation to managing conflicts of interest. This requirement will be set out in the contract for their services.
6.9.7 Managing Conflicts of Interest: relating to commissioning of new care models.
The statutory guidance for CCGs is clear that any individual who has a material interest in an organisation which provides, or is likely to provide, substantial services to a CCG (whether as a provider of healthcare or provider of commissioning support services, or otherwise) should recognise the inherent conflict of interest risk that may arise and should not be a member of the governing body or of a committee or sub-committee of the CCG. Where t h e CCG is considering commissioning new care models 28, particularly those that include primary medical services, it is likely that there will be some individuals with roles in the CCG (whether clinical or non-clinical), that also have roles within a potential provider, or may be affected by decisions relating to new care models. Any conflicts of interest must be identified and appropriately managed, in accordance with this statutory guidance.
28 Where NHSE refer to ‘new care models’ in this note, they are referring to any Multi-speciality Community Provider (MCP), Primary and Acute Care Systems (PACS) or other arrangements of a similar scale or scope that (directly or indirectly) includes primary medical services.
In the case of new care models, it is perhaps likely that there will be individuals with roles in both the CCG and new care model provider/potential provider. These conflicts of interest should be identified as soon as possible, and appropriately managed locally. The position should also be reviewed whenever an individual’s role, responsibility or circumstances change in a way that affects the individual’s interests. For example where an individual takes on a new role outside the CCG, or enters into a new business or relationship, these new interests should be promptly declared and appropriately managed in accordance with the statutory guidance. There will be occasions where the conflict of interest is profound and acute. In such scenarios (such as where an individual has a direct financial interest which gives rise to a conflict, e.g., secondary employment or involvement with an organisation which benefits financially from contracts for the supply of goods and services to a CCG or aspires to be a new care model provider), it is likely the CCG will want to consider whether, practically, such an interest is manageable at all. This situation can arise in relation to clinical and non-clinical members/roles. If an interest
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is not manageable, the appropriate course of action may be to refuse to allow the circumstances which gave rise to the conflict to persist. This may require an individual to step down from a particular role and/or move to another role within the CCG and may require action to terminate an appointment if the individual refuses to step down. The CCG should a l s o ensure that their contracts of employment and letters of appointment, HR policies, governing body and committee terms of reference and standing orders are reviewed to ensure that they enable appropriate action to manage conflicts of interest robustly and effectively in such circumstances. Where a member of CCG staff participating in a meeting has dual roles, for example a role with the CCG and a role with a new care model provider organisation, but it is not considered necessary to exclude them from the whole or any part of a CCG meeting, he or she should ensure that the capacity in which they continue to participate in the discussions is made clear and correctly recorded in the meeting minutes, but where it is appropriate for them to participate in decisions they must only do so if they are acting in their CCG role. Any staff undertaking these roles should be identified as soon as possible and where staff might be affected by the outcome of a procurement exercise, e.g., they may transfer to a provider (or their role may materially change) following the award of a contract. T his should be treated as a relevant interest, and the CCGs should ensure they manage the potential conflict. This conflict of interest arises as soon as individuals are able to identify that their role may be personally affected. Similarly, the CCG should identify and manage potential conflicts of interest where staff are involved in both the contract management of existing contracts, and involved in procurement of related new contracts. The CCG should consider whether it is appropriate for the Governing Body to take decisions on new care models or (if there are too many conflicted members to make this possible) whether it would be appropriate to refer decisions to a CCG committee.
Primary Care Commissioning Committee
Where a CCG has full delegation for primary medical services, t h e CCG could consider delegating the commissioning and contract management of the entire new care model to its Primary Care Commissioning Committee. This Committee is constituted with a lay and executive majority, and includes a requirement to invite a Local Authority and Healthwatch representative to attend. Should this approach be adopted, the CCG may also want to increase the representation of other relevant clinicians on the Primary Care Commissioning Committee when new care models are being considered. The use of the Primary Care Commissioning Committee may assist with the management of conflicts/quorum issues at governing body level without the creation of a new forum/committee within the CCG. Where a CCG does not have a Primary Care Commissioning Committee, the CCG might want to consider whether it would be appropriate/advantageous to establish either:
a) A new care model commissioning committee (with membership including relevant non-conflicted clinicians, and formal decision making
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powers similar to a Primary Care Commissioning Committee (“NCM Commissioning Committee”); or
b) A separate clinical advisory committee, to act as an advisory body to provide clinical input to the Governing Body in connection with a new care model project, with representation from all providers involved or potentially involved in the new care model but with formal decision making powers remaining reserved to the governing body (“NCM Clinical Advisory Committee”).
NCM Commissioning Committee
The establishment of a NCM Commissioning Committee could help to provide an alternative forum for decisions where it is not possible/appropriate for decisions to be made by the Governing Body due to the existence of multiple conflicts of interest amongst members of the Governing Body. The NCM Commissioning Committee should be established as a sub-committee of the Governing Body. The CCG could make the NCM Commissioning Committee responsible for oversight of the procurement process and provide assurance that appropriate governance is in place, managing conflicts of interest and making decisions in relation to new care models on behalf of the CCG. The CCG also needs to give consideration to the need to amend its constitution if it does not currently contain a power to set up such a committee either with formal delegated decision making powers or containing the proposed categories of individuals. The NCM Commissioning Committee should be chaired by a lay member and include non-conflicted GPs and CCG members, and relevant non-conflicted secondary care clinicians.
NCM Clinical Advisory Committee
This advisory committee would need to include appropriate clinical representation from all potential providers, but have no decision making powers. With conflicts of interest declared and managed appropriately, the NCM Clinical Advisory Committee could formally advise the CCG Governing Body on clinical matters relating to the new care model, in accordance with a scope and remit specified by the Governing Body. This would provide assurance that there is appropriate clinical input into Governing Body decisions, whilst creating a clear distinction between the clinical/provider side input and the commissioner decision-making powers (retained by the Governing Body, with any conflicts on the Governing Body managed in accordance with this statutory guidance and constitution of the CCG). From a procurement perspective the Public Contracts Regulations 2015 encourage early market engagement and input into procurement processes. However, this must be managed very carefully and done in an open, transparent and fair way. Advice should therefore be taken as to how best to constitute the NCM Clinical Advisory Committee to ensure all potential participants have the same opportunity. Furthermore it would also be important to ensure that the advice provided to the CCG by this committee is
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considered proportionately alongside all other relevant information. Ultimately it will be the responsibility of the CCG to run an award process in accordance with the relevant procurement rules and this should be a process which does not unfairly favour any one particular provider or group of providers. When considering what approach to adopt (whether adopting an NCM Commissioning Committee, NCM Clinical Advisory committee or otherwise) the CCG will need to consider the best approach for their particular circumstances whilst ensuring robust governance arrangements are put in place. When considering its options the CCG will, in particular, need to bear in mind any joint / delegated commissioning arrangements that it already has in place either with NHS England, other CCGs or local authorities and how those arrangements impact on its options.
6.9.8 Placing of orders and contracts
Fair and open competition between prospective contractors or suppliers for CCG contracts (including where the CCG is commissioning a service through Any Qualified Provider) is a requirement of NHS Standing Orders and of EC Directives on Public Purchasing for Works and Supplies. This means that: • No private, public or voluntary organisation or company which may bid for CCG business
should be given any advantage over its competitors, such as advance notice of CCG requirements. This applies to all potential contractors, whether or not there is a relationship between them and the CCG, such as a long-running series of previous contracts.
6.9.8.1 Awarding Contracts
• Each new contract should be awarded solely on merit, taking into account the requirements of the CCG and the ability of the contractors to fulfil them and;
• No special favour is to be shown to current or former employees or their close relatives
or associates in awarding contracts to private or other businesses run by them or employing them in any capacity. Contracts may be awarded to such businesses when they are won in fair competition against other tenders, but scrupulous care must be taken to ensure that the selection process is conducted impartially.
6.9.9 Managing Contracts
An individual who has a conflict of interest (as per the definition at section 4) must not be involved in procuring, tendering, managing or monitoring a contract in which they have an interest.
Any contract monitoring meeting needs to consider conflicts of interest as part of the process, i.e. the chair of a contract management meeting should invite declarations of interests; record any declared interests in the minutes of the meeting; and manage any
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conflicts appropriately and in line with this guidance. This equally applies where a contract is held jointly with another organisation such as the Local Authority or with other CCGs under lead commissioner arrangements.
The individuals involved in the monitoring of a contract should not have any direct or indirect financial, professional or personal interest in the incumbent provider or in any other provider that could prevent them, or be perceived to prevent them, from carrying out their role in an impartial, fair and transparent manner.
CCGs should be mindful of any potential conflicts of interest when they disseminate any contract or performance information/reports on providers, and manage the risks appropriately.
Monitoring arrangements for such contracts will include provisions for an independent challenge of bills and invoices, and termination of the contract if the relationship is unsatisfactory.
6.9.10 Register of Procurement Decisions
East and North Hertfordshire CCG will maintain a register of procurement decisions taken, either for the procurement of a new service or any extension or material variation of a current contract. This will include:
• The details of the decision; • Who was involved in making decision (including the name of the CCG clinical lead,
the CCG contract manager, the name of the decision making committee and the name of any other individuals with decision-making responsibilities);
• A summary of any conflicts of interest in relation to the decision and how this was managed by the CCG; and
• The award decision taken.
The register of procurement decisions must be updated whenever a procurement decision is taken. The Procurement, Patient Choice and Competition Regulations 9(1) place a requirement on commissioners to maintain and publish on their website, a record of each contract it awards. The register of procurement decisions will be made publicly available and easily assessable to patients and the public by:
• Making the register available in a prominent place on East and North Hertfordshire CCGs website
• Making the register available upon request for inspection at East and North Hertfordshire CCGs headquarters.
6.9.11 Failure to Disclose/Declare
The CCG takes the failure to disclose such information as required by this document seriously.
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It is an offence under the Fraud Act 2006 for personnel to fail to disclose information to the CCG in order to make a gain for themselves or another, or to cause a loss or expose the organisation to a loss. Therefore, if an individual becomes aware that someone has failed to disclose relevant and material information, they should raise the matter with the Company Secretary in the first instance. The Anti-Fraud and Bribery Policy will be consulted and an appropriate referral made to the Local Counter Fraud Specialist where applicable.
Breaches of this document may result in a Governing Body member being removed from office in line with the CCG’s Constitution. A contractor may be prevented from obtaining further work with the CCG or an employee may face disciplinary action and dismissal in accordance with the Human Resources Disciplinary Policy and Procedure.
6.10 East and North Hertfordshire CCG’s statutory obligations
Section 140 of the NHS Act 2006 (inserted by the Health and Social Care Act 2012) requires East and North Hertfordshire CCG to:
• Maintain one or more register of interest of: The members of East and North Hertfordshire CCG, members of East and North Hertfordshire CCG’s Governing Body; members of its committees or sub-committees of its Governing Body, and its employees;
• Publish or make arrangements to ensure that members of the public have access to these registers on request;
• Make arrangements to ensure individuals declare any conflicts or potential conflicts in relation to a decision to be made by East and North Hertfordshire CCG, and record them in the registers as soon as they become aware of it, and within 28 days; and
• Make arrangements, as set out in East and North Hertfordshire CCG’s Constitution, for managing conflicts of interest, and potential conflicts of interest in such a way as to
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ensure they do not and do not appear to affect the integrity of East and North Hertfordshire CCG’s decision making process.
Regulation 6 of the NHS (Procurement, Patient Choice and Competition) Regulations 2013 requires East and North Hertfordshire CCG to:
• Manage conflicts and potential conflicts of interest when awarding a contract, by prohibiting the award of the contract where the integrity of the award has been or appears to have been affected by a conflict; and
• Keep appropriate records of how conflicts of interest have been managed in individual cases.
6.10.1 Conflicts of Interest and Dispute Resolution Procedure
East and North Hertfordshire CCG’s policy on Conflicts of Interest and Dispute Resolution Procedure sets out the approach which East and North Hertfordshire CCG will take to:
• Identify a Conflict of Interest • Declare and Register Interests • Manage Conflicts of Interest: General Principles • Manage Conflicts of Interest: Governing Body • Manage Conflicts of Interest: Contractors • Ensure transparency when Procuring Services
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6.11 Risk Management
In carrying out its clinical procurement activities East and North Hertfordshire CCG will ensure that it has adequate measures in place to identify and manage risk. Such measures may include ensuring:
• Clinical procurements are adequately prepared and planned;
• Each clinical procurement project has an SRO and that roles, responsibilities, reporting lines and channels of communication within the wider commissioning and Authorised Procurement Representative(s) are clear;
• The individuals involved have the necessary expertise, experience and training to match the requirements of the role and its responsibilities (and that this is kept up to date);
• Each project has a pre-agreed and end to end procurement strategy and timetable, tailored to the requirements of the project; the resources available, the business objective and which has identified and sought to minimise any risks involved;
• Adequate and appropriate records are kept to comply with East and North Hertfordshire CCG’s statutory obligations and to provide a robust audit trail of decisions and actions taken;
• A risk identification and escalation process is established at the outset, to include a risk register which is regularly reviewed and updated with appropriate risk management strategies to address each risk identified;
• The use of robust and up to date project and procurement documents, which are legally compliant, clear and unambiguous, and subject to a strict policy of version control; and
• The conduct of the entire process is in accordance with the law and key procurement principles namely: transparency; equal treatment; non-discrimination; proportionality and sound administration.
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6.12 Ethical Considerations, Environmental Issues and Social Responsibility
6.12.1 Ethical Considerations
When carrying out its clinical procurement activities, East and North Hertfordshire CCG will ensure that any provider that has the necessary abilities to be of service to the organisation has a fair opportunity to compete.
When working with its providers, and when problems arise with a provider’s performance or behaviour East and North Hertfordshire CCG will, wherever possible, work with the organisation concerned to help them meet the expected requirements.
East and North Hertfordshire CCG will strive to behave ethically and with integrity in all of its activities and to work with companies that uphold similar ethical standards and do not:
• Exploit child or sweated labour;
• Pirate the intellectual property of others;
• Wilfully and avoidably damage the environment or;
• Otherwise act in contravention of applicable laws.
East and North Hertfordshire CCG will encourage its providers to conform to the Ethical Trading Initiative Base Code (ETI Base Code).
6.12.2 Sustainability Issues
More than half of the carbon footprint of the NHS in England is associated with the products and services it procures. Carbon emissions associated with the extraction, processing, assembly, packaging, transport, storage and handling of products and materials that are consumed directly and indirectly by service providers account for 60% of the total carbon footprint.
East and North Hertfordshire CCG wishes to work with organisations that share a commitment to preserving the world’s natural resources. When carrying out its clinical procurement activities, insofar as is reasonably practicable and is consistent with procurement law and guidance, East and North Hertfordshire CCG will follow its:
Sustainable Development Management Plan
The CCG’s draft Sustainable Development management Plan defines Sustainable Development as 3 fold, encompassing the Social, Economic and Environmental Spheres. The Policy will be available on East and North Hertfordshire CCGs website once it is formally approved.
The Sustainable Development Unit has calculated that Commissioned health and social care services make up 98% of CCGs’ carbon footprint, although this analysis was carried out without CCGs’ direct spend on pharmaceuticals being factored into the calculation. [1]
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(2016: Sustainable Development Unit: Carbon Hotspots update for the health and care sector in England 2015 and direct correspondence with Imogen Tennison from the Sustainable Development Unit.)
The biggest improvement to the CCG’s environmental impact can therefore be made through more sustainable commissioning and pharmaceutical spend. This will help achieve social, and environmental benefits, as well as financial savings.
The principles set out in NHS Carbon Reduction Strategy: http://www.sdu.nhs.uk/corporate-requirements/nhs-carbon-reduction-strategy.aspx.
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6.13 Dispute Resolution Procedure
Where disputes arise, we would hope that in most cases these could be resolved informally without recourse to a formal process. If however the dispute cannot be resolved informally, the Dispute Resolution Procedure should be referred to, as set out in the East and North Hertfordshire CCG Constitution.
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6.14 Alternative Procurement Routes
6.14.1 Framework Agreements
Framework Agreements are pre-tendered agreements which are established in compliance with the EU Procurement Rules and which, once established, can be used by East and North Hertfordshire CCG to purchase certain products and/or services without the need to carry out a full procurement process. The advantages of using a framework agreement is that, once established, it can be used to save both time and cost.
Any Qualified Provider is a form of framework agreement.
A framework can be established:
• By East and North Hertfordshire CCG for its own use; or
• By another Clinical Commissioning Group, contracting authority or a central purchasing body such as the Government Procurement Service (GPS).
If East and North Hertfordshire CCG wishes to use a framework agreement established by another organisation, it should check that that the framework agreement has been established correctly, in accordance with any applicable obligations under the EU Procurement Rules; that East and North Hertfordshire CCG is entitled to use the framework and that it is fit for East and North Hertfordshire CCG’s purpose.
In particular, East and North Hertfordshire CCG should check:
• That it has been identified as a body which is entitled to use the framework;
• That its requirements fall within the specification of goods / services covered by the framework;
• That the term of the framework has not expired;
• That the terms and conditions applicable to call-offs made under the framework are acceptable to East and North Hertfordshire CCG (as East and North Hertfordshire CCG will be unable to make substantial modifications to these); and
• That the pricing under the framework is acceptable.
PCR 2015 offers a broad range of procurement routes. For complex or innovative projects, commissioners can also choose any of the following procedures:
• Competitive dialogue (CD) • Competitive procedure with negotiation (CPN) • Innovation partnership (IP).
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Competitive dialogue (CD) There is no longer an obligation to specify minimum requirements at the outset and PCR 2015 now expressly allows negotiations to be carried out with the preferred bidder (within certain limits) in order to confirm financial commitments or other terms before contracts are finalised. CD continues to be the most suitable procedure for highly complex procurements including those which involve third party finance (PF2 etc).
Competitive procedure with negotiation (CPN)
Alternatively, in the same circumstances commissioners can choose to use CPN. A version of this procedure has existed for some time but PCR 2015 has introduced changes. CPN allows commissioners to negotiate on initial tenders, including on price. However, commissioners can choose to reserve the right to award a contract on the basis of an initial tender without negotiation. CPN has been made available for use in a much wider set of circumstances than before and is therefore likely to be used more frequently for requirements that are not ‘off the shelf’. These need not necessarily be major projects.
Innovation partnership (IP)
The IP procedure is completely new. An IP is set up using a modified version of the competitive procedure with negotiation. The IP procedure enables commissioners to develop innovative products, works or services where no suitable solution exists in the market (sharing the risk with suppliers) and then to purchase the resulting products, services etc.
An IP could be used to develop new medical or environmental technologies, for example. But it could equally well be used to develop and purchase a new delivery model for a public service.
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6.15 Terminating Contracts
Any decision either to vary a contract or terminate a contract prior to its expiry date, must be carefully considered (including the consequences of doing so) and must be approved in accordance with the East and North Hertfordshire CCG’s Scheme of Reservation and Delegation, as set out in its Constitution and the Authorisation Limits and related link set out in Appendix 1.
Advice should also be sought before taking or approving such a decision as the legal and practical consequences of doing so can be significant.
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6.16 Summary Guidance on Section 256 Arrangements with Local Authorities
6.16.1 Background to Section 256 agreements
Section 256 of the National Health Service Act 2006, (as amended by the Health and Social Care Act 2012) enables Clinical Commissioning Groups to make grants to Local Authorities towards expenditure on specified Community Services, and any of the Local Authority functions specified below.
6.16.2 Community Services
In respect of community services, East and North Hertfordshire CCG may make payments to:
• A local social services authority in connection with any social services functions.
• A local education authority for the benefit of disabled persons or;
• A local housing authority in connection with the provision of housing.
6.16.3 Local Authorities Functions
In respect of Local Authority functions, East and North Hertfordshire CCG may make payments in connection with the performance of any of the local authority’s functions, providing that in the opinion of East and North Hertfordshire CCG the functions:
• Have an effect on the health of any individuals;
• Have an effect on, or are affected by, any NHS functions or;
• Are connected with any NHS functions.
6.16.4 East and North Hertfordshire CCG obligations in respect of Section 256
East and North Hertfordshire CCG must also meet a number of conditions when making a grant under Section 256; these are set out in the NHS (Conditions Relating to Grant Payments by NHS Bodies to Local Authorities) Directions 2013:
• East and North Hertfordshire CCG is satisfied that the payment is likely to secure a more effective use of public funds than the deployment of an equivalent amount, on the provision of health services;
• Where the grant payment is to meet all or part of the capital costs of a project, the grant amount must be determined before the project begins;
• Where the grant payment will be used by the Local Authority to fund part of a project, East and North Hertfordshire CCG must be satisfied that the Local Authority intends to meet the remaining costs of the project. East and North Hertfordshire CCG must also be
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satisfied that this will continue for as long as both East and North Hertfordshire CCG and the Local Authority consider the project to be necessary or desirable;
• East and North Hertfordshire CCG must ensure, so far as is practicable, that the payment is used by the local authority in such a way as will secure the most efficient and effective use of the amount paid;
• If during the course of the grant period, the Local Authority reduces the level of service it provides below the level originally agreed then East and North Hertfordshire CCG may reduce accordingly the amount of any further payments.
6.16.5 Audit Trail
To ensure financial probity and a clear audit trail Section 256 specifies two prescribed documents must be completed when making a grant.
6.16.6 A Certificate of Expenditure (Annual Voucher)
The Certificate of Expenditure must be completed by the recipient Local Authority. The auditors must certify that expenditure in relation to the project funded is fairly stated and in accordance with the relevant terms and conditions.
6.16.7 A Memorandum of Agreement
The second mandatory document is the Memorandum of Agreement. This must include:
• A statement of how the Section 256 transfer secures more health gain than an equivalent expenditure of money in the NHS;
• A description of the scheme. In the case of revenue transfers, the services for which money is being transferred, should be specified;
• Financial details and timescales. This should detail the total amount of money to be transferred under the grant and the amount that is to be transferred in each year. If this subsequently changes the Memorandum of Agreement must be amended and then re-signed; and
• Details of the evidence that will be used to indicate that the purposes of the grant, as outlined in the Memorandum, have been secured.
The Memorandum of Agreement must then be signed by both the CCG and the Local Authority.
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Appendix 1 East and North Hertfordshire CCG Financial Authorisation Limits Please refer to the CCG’s Detailed Financial Policies - July 2015. Section 13, page 15 Tendering And Contracting.
http://www.enhertsccg.nhs.uk/sites/default/files/documents/Aug2015/ENHCCG-Detailed-Financial-Policies-v3.pdf
Providing all the conditions and circumstances set out in the CCG’s Detailed Financial Policies have been fully complied with, formal
authorisation and awarding of a contract may be decided by the following staff to the value of the contract as follows:
a) Continuing Health Care team placement up to £1,000 per week
b) Individual Funding Request team up to £25,000
c) Designated budget holders up to £25,000
d) Directors up to £50,000
e) Chief Finance Officer up to £250,000
f) Accountable Officer up to £500,000
g) CCG Governing Body over £500,000
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Appendix 2: Summary of East and North Hertfordshire CCG’s obligations under the 2013 Regulations
Do the Regulations apply? What to build into your commissioning strategy
When must you advertise a contract?
What must you do as part of your tender?
What records should you be keeping?
The Regulations apply to NHS England, CCGs and any other organisation providing procurement support. The Regulations also apply to CSUs.
How decisions are reached regarding the potential market for a particular service.
How a procurement will improve quality and efficiency in the service.
Consider if there could be any conflicts of interest or potential conflicts and if so ensure there is a robust process for dealing with them.
Is there a market? If there is more than one possible provider capable of providing the service you must advertise.
Are you working in partnership with local government? If you are entering into a Section 75 agreement with a local authority you do not need to advertise.
Is there a material change to the contract? If there is and it is not mandated by NHS England you may need to advertise.
Advertise on OJEU and Contract Finder
Include in the advert a description of the services and the evaluation criteria.
Ensure you have put in place arrangements for providers to express an interest in a contract.
Ensure your qualification criteria and any other criteria to establish a framework or AQP list is transparent, proportionate & non-discriminatory.
Ensure your contract does not include any anti-competitive provisions unless necessary to achieve beneficial outcomes or the
A full audit trail of each procurement, including your evaluation model.
Keep a record of how each award of contract complies with your statutory duties as to effectiveness, efficiency, improvement in quality, and promotion of integration.
Your process for ensuring you do not engage in anti-competitive behaviour unless it is in the interests of patients.
How conflicts or potential conflicts were addressed in each process.
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Do the Regulations apply? What to build into your commissioning strategy
When must you advertise a contract?
What must you do as part of your tender?
What records should you be keeping?
first objective.
Overriding objectives
• Meet needs, improve quality and efficiency; • Act transparently and in a proportionate way; • Treat providers equally and in a non-discriminatory way; • Procure services from providers best placed to deliver the first objective and which provide best value for money and; • Not to act in an anti-competitive way unless you can demonstrate it is in the interests of patients.
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Appendix 3 Minimum Procurement Timelines as required by Public Contracts Regulation 2015 and EU Procurement Directive 2014
Choice of procedure and stage
Standard Timescales
Options for sub-central contracting authorities
Tenders submitted electronically
Requirement is urgent and longer time limit is impractical as a result
PIN published no more than 12 months and no less than 35 days from dispatch of contract notice
OPEN
Dispatch of contract notice to receipt of responses
35 days 5 day reduction
Period reduced to 15 days
Period reduced to 15 days
Standstill 10 days
RESTRICTED
Dispatch of contract notice to receipt of responses
30 days Period reduced to 15 days
ITT to receipt of bids
30 days May agree time-limit with tenderers –
5 day reduction
Period reduced to 10 days
Period reduced to 10 days
Standstill 10 days
COMPETITIVE WITH NEGOTIATION
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Choice of procedure and stage
Standard Timescales
Options for sub-central contracting authorities
Tenders submitted electronically
Requirement is urgent and longer time limit is impractical as a result
PIN published no more than 12 months and no less than 35 days from dispatch of contract notice
Dispatch of contract notice to expressions of interest
30 days Period reduced to15 days
ITN to receipt of initial tenders
30 days May agree time-limit with tenderers –
5 day reduction
Period reduced to 10 days
Period reduced to 10 days
Standstill 10 days
COMPETITIVE DIALOGUE
Dispatch of contract notice to expressions of interest
30 days
Standstill 10 days
INNOVATION PARTNERSHIP
Dispatch of contract notice to expressions of interest
30 days
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Choice of procedure and stage
Standard Timescales
Options for sub-central contracting authorities
Tenders submitted electronically
Requirement is urgent and longer time limit is impractical as a result
PIN published no more than 12 months and no less than 35 days from dispatch of contract notice
Standstill 10 days
Appendix 4: Integrated Impact Assessment
Quality and Equality Integrated
Impact Assessment Process
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Date: 19/02/2013 Version: 0.1
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Integrated Impact Assessment Tool Stage 1
The following assessment screening tool will require judgement against all six areas of risk in relation to quality and against the nine protected characteristics relating to equality. Each proposal will need to be assessed whether it will impact adversely on patients / staff / organisations.
Where an adverse impact score greater than eight is identified in any area, this will require a more detailed impact assessment to be carried out, using the escalation proforma.
If the assessment is negative, you must calculate the score for the impact and likelihood and multiply the two to provide the overall risk score. Insert the total in the appropriate box.
Title of scheme: Clinical Procurement Strategy for Commissioning Services
Project Lead for scheme: Denise Boardman & Harper Brown
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Brief description: CCG Clinical Procurement Strategy for Commissioning Services
The document describes NHS East and North Hertfordshire Clinical Commissioning Group’s -. Clinical Procurement Strategy for Commissioning Services Procurement is an all-encompassing term to describe the activities of obtaining the right goods, works and/or services from the right provider, at the right time, in the right place, of the right quality and at the right price, generally via a contract.
The document is part of East and North Hertfordshire CCG’s governance structure and provides the high level framework for the detailed guidelines and other documentation in the form of standards and procedures, which support this document.
The purpose of the document is to ensure that when commissioning clinical services East and North Hertfordshire CCG:
complies with the regulatory framework of all relevant legislation and guidance, its own Constitution, Standing Orders, Scheme of Reservation and Delegation and Prime Financial Policies;
acts with a view to securing the needs of its local population, and improves the quality and efficiency of clinical services;
treats providers fairly and equally and acts in a transparent and proportionate way;
provides best value for money;
meets its short and long term objectives; and
maintains high standards of public trust and probity in its use of public funds.
responsive to changes in legislation and supports innovation in service delivery
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Y/N Risk
Score
Comments Mitigating actions required
Monitoring mechanisms
Duty of Quality
Could the proposal impact negatively on any of the following: a) Compliance with NHS
Constitution b) Partnerships c) Safeguarding children or adults
N
0
The document complies with the CCG Constitution requirements – page 34, item 8.6.
The document describes the CCGs process for ensuring as part of its commissioning cycle it considers procurement of services; within current competition and procurement rules.
It provides the CCG with governance structure and provides the high level framework for the detailed guidelines and other documentation in the form of standards and procedures, which support this document.
Any service specifications developed as part of the procurement process would use the standard template which includes section for safeguarding. This would be reviewed by the safeguarding leads.
Good practice recommends the procurement document is reviewed annually to ensure it remains up to date with all regulations, rules and best practice and guidance. Review date can be found on page 1.
This Impact Assessment will also be reviewed annually as part of this process.
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Y/N Risk
Score
Comments Mitigating actions required
Monitoring mechanisms
NHS Outcomes Framework
Could the proposal impact negatively on the delivery of the five domains:
The document is to ensure that CCG staff (including partners in joint procurements) follows the correct procurement steps as informed by rules & regulations applicable to the NHS. This document does not have a direct impact on service delivery.
However the overarching procurement objectives include improving quality of services and securing the needs of people who use the services. These principles will be applied for all procurements.
Each individual procurement project that the CCG leads will have to have its own IIA completed as part of its business case development.
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Y/N Risk
Score
Comments Mitigating actions required
Monitoring mechanisms
1. Preventing people from dying
prematurely N 0 As above.
2. Enhancing quality of life N 0
3. Helping people recover from episodes of ill health or following injury
N 0
4. Ensuring people have a positive experience of care N 0
5. Treating and caring for people in a safe environment and protecting them from avoidable harm
N 0
Access
Could the proposal impact negatively on any of the following: a) Patient Choice b) Access
N Part of pre-procurement activities as outlined in the document in section 6 explains the tasks required to support pre-market engagement to include all stakeholders, which will include exploring these elements. This will also include
During business case development each procurement will need to complete its own IIA.
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Y/N Risk
Score
Comments Mitigating actions required
Monitoring mechanisms
c) Integration
Quality requirements, as a key purpose of procurement is to improve quality.
Through the procurement patient choice, equity of access and integration will be encouraged.
Strategy
Could the proposals impact negatively on the CCG’s strategic objectives
Duty of Equality
Could the proposal impact negatively on any of the following protected characteristics:
1. Age
2. Disability
N
N
0
0
The purpose of the document is to ensure that when commissioning clinical services East and North Hertfordshire CCG:
complies with the regulatory framework of all relevant legislation and guidance, its own Constitution, Standing Orders, Scheme of Reservation and Delegation and Prime Financial Policies;
acts with a view to securing the needs of its local population, and improves the quality and efficiency of clinical services;
treats providers fairly and equally and acts in a transparent and proportionate way;
Annual review of the document alongside the companion document – CCG Guidelines for procurement. This is to ensure both documents remain up to date including any changes in national regulations or guidance.
This Impact Assessment will also be reviewed annually as part of this process.
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Y/N Risk
Score
Comments Mitigating actions required
Monitoring mechanisms
3. Race
4. Religion or belief
5. Sex
6. Sexual orientation
7. Gender re-assignment
8. Pregnancy and maternity
9. Marriage and civil partnership
N
N
N
N
N
N
N
N
provides best value for money;
meets its short and long term objectives; and
maintains high standards of public trust and probity in its use of public funds.
This document does not have a direct impact on service delivery.
Any provider that wins a tender will be expected to have a Equalities policy approved by the CCG and comply with Equality legislation.
Please refer to Item 6.6.6 in the document which refers to the Equality Act 2010 and reinforces the need to meets this acts obligations as part of any procurement.
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Y/N Risk
Score
Comments Mitigating actions required
Monitoring mechanisms
N
Name of person completing assessment:
Position:
Signature:
Date of assessment:
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Reviewed by:
Position:
Signature:
Date of review:
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Step 1 – Calculate the Possible Impact When calculating the impact you should choose the most appropriate domain for the identified risk from the left hand side of the table then work along the columns in the same row to assess the severity of the risk on the scale of 1 to 5 (at the top of the column) to determine the impact score.
IMPACT 1 2 3 4 5
Domains Negligible Minor Moderate Major Catastrophic
Safety of patients, staff or public (physical or psychological harm)
Minimal injury requiring no/minimal intervention or treatment.
Minor injury or illness, requiring minor intervention
Moderate injury requiring professional intervention
Major injury leading to long-term incapacity/disability
Incident leading to death
No time off work
Requiring time off work for >3 days
Requiring time off work for 4-14 days
Requiring time off work for >14 days
Multiple permanent injuries or irreversible health effects
Increase in length of hospital stay by 1-3 days
Increase in length of hospital stay by 4-15 days
Increase in length of hospital stay by >15 days
An event which impacts on a large number of patients
RIDDOR/agency reportable incident
Mismanagement of patient care with long-term effects
An event which impacts on a small number of patients
Quality
Complaints
Peripheral element of treatment or
Overall treatment or service suboptimal
Treatment or service has significantly reduced
Non-compliance with national standards with significant risk to patients
Totally unacceptable level or quality of
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Audit service suboptimal
effectiveness if unresolved treatment/service
Informal complaint/ inquiry
Formal complaint (stage 1)
Formal complaint (stage 2) complaint
Multiple complaints/ independent review
Gross failure of patient safety if findings not acted on
Local resolution Local resolution (with potential to go to independent review)
Low performance rating Inquest/ombudsman inquiry
Single failure to meet internal standards
Repeated failure to meet internal standards
Critical report Gross failure to meet national standards
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IMPACT 1 2 3 4 5
Domains Negligible Minor Moderate Major Catastrophic
Human resources/ organisational development/ staffing/ competence
Short-term low staffing level that temporarily reduces service quality (< 1 day)
Uncertain delivery of key objective/service due to lack of staff
Non-delivery of key objective/service due to lack of staff
Unsafe staffing level or competence (>1 day)
Unsafe staffing level or competence (>5 days)
Ongoing unsafe staffing levels or competence
Low staff morale Loss of key staff Loss of several key staff
Poor staff attendance for mandatory/key training
Very low staff morale No staff attending mandatory training /key training on an ongoing basis No staff attending mandatory/
key training
Statutory duty/ inspections No or minimal impact or breech of guidance/ statutory duty
Breech of statutory legislation
Single breech in statutory duty Enforcement action Multiple breeches in statutory duty
Reduced performance rating if unresolved
Challenging external recommendations/ improvement notice
Multiple breeches in statutory duty
Prosecution
Improvement notices Complete systems change required
Low performance rating Zero performance rating
Critical report Severely critical report
Adverse publicity/ reputation
Rumours
Local media coverage – Local media coverage – National media coverage with <3 days service well below
National media coverage with >3 days service well below reasonable public
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reasonable public expectation expectation. MP concerned (questions in the House)
Potential for public concern
short-term reduction in public confidence
long-term reduction in public confidence Total loss of public confidence
Elements of public expectation not being met
Business objectives/ projects
Insignificant cost increase/ schedule slippage
<5 % over project budget 5–10 % over project budget Non-compliance with national requirements
10–25 % over project budget
Incident leading >25% over project budget
Schedule slippage Schedule slippage Schedule slippage Schedule slippage
Key objectives not met Key objectives not met
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1 2 3 4 5 Negligible Minor Moderate Major Catastrophic
Finance including claims
Small loss Risk of claim remote
Loss of 0.1–0.25 per cent of budget
Loss of 0.25–0.5 per cent of budget Uncertain delivery of key objective/Loss of 0.5–1.0 per cent of budget
Non-delivery of key objective/ Loss of >1 per cent of budget
Claim less than £10,000
Claim(s) between £10,000 and £100,000
Claim(s) between £100,000 and £1 million
Failure to meet specification/ slippage
Purchasers failing to pay on time Loss of contract / payment by results
Claim(s) >£1 million
Service/business interruption
Loss/ interruption of >1 hour
Loss/ interruption of >8 hours
Loss/ interruption of >1 day Loss/ interruption of >1 week Permanent loss of service or facility
Environmental impact Minimal or no impact on the environment
Minor impact on environment
Moderate impact on environment Major impact on environment Catastrophic impact on environment
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Step 2 – Calculate how likely the risk is to happen (likelihood)
Now work out the likelihood score. Look at the frequency and probability columns and identify which best describe how often you think the risk is likely to occur. Now make a note of the corresponding ‘risk score’ (1-5 in the right hand column).
Likelihood Description Risk Score
Almost Certain Will undoubtedly occur, possibly frequently 5
Likely Will probably occur but it is not a persistent issue 4
Possible May occur occasionally 3
Unlikely Do no expect it to happen but it is possible 2
Rare Cannot believe that this will ever happen 1
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Escalation proforma To be completed when the initial impact assessment indicates a high risk and a more detailed assessment is required.
On identification of a high risk business case, commissioning decision or business plan this proforma must be submitted along with the business case to inform the decision making process and ensure informed choice. A copy of the complete impact assessment must be submitted to the next available quality and outcomes committee to ensure scrutiny from a quality perspective.
Background and context of the business case/plan/decision for approval.
What are the benefits?
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What are the risks if the business case is not approved?
What are the high risks that the initial impact assessment indicates to certain groups or quality
What plans are in place to ensure identified risks are mitigated?
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After mitigation, what are the remaining residual risks?
Recommendations for the quality and outcome committee to consider.
Assessment completed by
Name:
Position:
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Date:
Line Manager Review
Name:
Position:
Date:
Appendix 5: Declaration of Interest Form - Individuals
Declaration of Interest Form (Individuals) This form shall be completed in accordance with the Managing Conflicts of Interest Policy.
Notes: Within 28 days of a relevant event, individuals need to register their financial and other interests. If any assistance is required in order to complete this form, then the individual should contact the Company Secretary. The completed form should be printed, signed, dated and then scanned and sent by email to the Governance and Corporate Affairs
Team of the CCG via [email protected] Any changes to interests declared must also be registered within 28 days of the relevant event by completing and submitting a new
declaration form. Individuals completing this declaration form must provide sufficient detail of each interest so that a member of the public would be able
to understand clearly the sort of financial or other interest the member or employee has and the circumstances in which a conflict of interest with the business or running of the CCG might arise.
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If in doubt as to whether a conflict of interest could arise, a declaration of the interests should be made.
Interests that must be declared: Roles and responsibilities held within member practices; Directorships, including Non-Executive Directorships held in private companies or PLCs (with the exception of those of dormant
companies); GPs must declare their involvement in a federation or their practice’s involvement in a federation and specify the details. Ownership or part ownership of private companies, businesses or consultancies likely or possibly seeking to do business with the CCG; Shareholdings (more than 5%) of companies in the field of health and social care; Positions of authority (e.g. trustee) in an organisation (e.g. charity or voluntary organisation) in the field of health and social care; Any connection with a voluntary or other organisation contracting for NHS services; Research funding / grants that may be received by the individual or any organisation they have an interest or role in; Any role or relationship, which the public could perceive would impair or otherwise influence the individual’s judgment or actions in their
role within the CCG. Whether such interests are those of the individual themselves or of a family member, close friend or other acquaintance of the individual; and;
Other specific interests.
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[INTENTIONALLY LEFT BLANK]
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Individual Declaration The information provided on this form with overwrite any previous Declaration of Interest.
Please tick 3 of 4 boxes below. ☐ I have read the Managing Conflicts of Interest Policy. This is available at http://www.enhertsccg.nhs.uk/managing-conflicts-interest-policy ☐ I have no interests to declare. ☐ I have interests to declare, which are listed below ☐ To the best of my knowledge and belief, the above information is complete and correct. I undertake to update as necessary the information provided and to review the accuracy of the information provided regularly and no longer than annually. I give my consent for the information to be used for the purposes described in the CCG’s Constitution and published accordingly.
Name: Position within or relationship with, the CCG or NHS England:
Date: Signature: (Must be signed by hand, not electronically.)
Type of Interest/s
Your Details / Company Details (Registered office address, Company number etc.)
Spouse, Partner, Family member, Close friend etc. Details
Nature of Conflict (eg. None perceived, both provider and commissioner, position of authority)
Roles and responsibilities held within member practices: • E.g. GP Partner or Salaried GP.
Directorships, including Non-Executive Directorships, held in private companies or PLCs:
• Please state full name and registered address of the company and the company number. The registered address is that registered with Companies House.
• For GPs – please state full details of your involvement with a
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Federation or your practice’s involvement with a Federation. E.g. “I am a director of….” Or “My practice is a member of…”
• Please state the nature of the business (e.g. Pharmaceuticals) Ownership or part ownership of private companies, businesses or consultancies likely or possibly seeking to do business with the CCG:
• Please state full name and registered address of the company and the company number. The registered address is that registered with Companies House.
• Please state the nature of the business (e.g. Pharmaceuticals)
Shareholdings (more than 5%) of companies in the field of health and social care:
• Please state full name and registered address of the company and the company number. The registered address is that registered with Companies House.
• Please state the nature of the business (eg. Pharmaceuticals)
Type of Interest/s Your Details / Company Details (Registered office address, Company number etc.)
Spouse, Family member, Close friend etc. Details
Nature of Conflict eg. None perceived, both provider and commissioner, position of authority)
Positions of authority (eg. trustee) in an organisation (e.g. charity or voluntary organisation in the field of health and social care):
• Please give full details and spell out any acronyms. • Please state the nature of the organisation (eg. Healthcare charity).
Any connection with a voluntary or other organisation contracting for NHS services:
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Research funding/grants that may be received by the individual or any organisation they have an interest or role in:
Any other role or relationship which the public could perceive would impair or otherwise influence the individual’s judgment or actions in their role within the CCG:
Other specific interests?
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Appendix 6: Declaration of Interest Form Bidders/Contractors
Name of Organisation:
Details of interests held:
Type of Interest Details
Provision of services or other work for the CCG or NHS England
Provision of services or other work for any other potential bidder in respect of this project or
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procurement process
Any other connection with the CCG or NHS England, whether personal or professional, which the public could perceive may impair or otherwise influence the CCG’s or any of its members’ or employees’ judgements, decisions or actions
Name of Relevant Person
[complete for all Relevant Persons]
Details of interests held:
Type of Interest Details
Personal interest or that of a family member, close friend or other acquaintance?
Provision of services or other work for the CCG or NHS England
Provision of services or
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other work for any other potential bidder in respect of this project or procurement process
Any other connection with the CCG or NHS England, whether personal or professional, which the public could perceive may impair or otherwise influence the CCG’s or any of its members’ or employees’ judgements, decisions or actions
To the best of my knowledge and belief, the above information is complete and correct. I undertake to update as necessary the information. Signed: On behalf of: Date:
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Appendix 7: The Register of Procurement Decisions and Contracts Awarded
Ref No
Contract/ Service title
Procurement description
Existing contract or new procurement (if existing include details)
Procurement type – CCG procurement, collaborative procurement with partners
CCG clinical lead
CCG contract manager
Decision making process and name of decision making committee
Summary of conflicts of interest declared and how these were
Contract Award (supplier name & registered address)
Contract value (£) (Total)
Contract value to CCG
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managed
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Appendix 8: Procurement Checklist
Service:
Question Comment/ Evidence
1. How does the proposal deliver good or improved outcomes and value for money – what are the estimated costs and the estimated benefits? How does it reflect the CCG’s proposed commissioning priorities? How does it comply with the CCG’s commissioning obligations?
2. How have you involved the public in the decision to commission this service?
3. What range of health professionals have been involved in designing the proposed service?
4. What range of potential providers have been involved in considering the proposals?
5. How have you involved your Health and Wellbeing Board(s)? How does the proposal support the priorities in the relevant joint health and wellbeing strategy (or strategies)?
6. What are the proposals for monitoring the quality of the service?
7. What systems will there be to monitor and publish data on referral patterns?
8. Have all conflicts and potential conflicts of interests been appropriately declared and entered in registers?
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9. In respect of every conflict or potential conflict, you must record how you have managed that conflict or potential conflict. Has the management of all conflicts been recorded with a brief explanation of how they have been managed?
10. Why have you chosen this procurement route e.g., single action tender?6
11. What additional external involvement will there be in scrutinising the proposed decisions?
12. How will the CCG make its final commissioning decision in ways that preserve the integrity of the decision-making process and award of any contract?
Additional question when qualifying a provider on a list or framework or pre selection for tender (including but not limited to any qualified provider) or direct award (for services where national tariffs do not apply)
13. How have you determined a fair price for the service?
Additional questions when qualifying a provider on a list or framework or pre selection for tender (including but not limited to any qualified provider) where GP practices are likely to be qualified providers
14. How will you ensure that patients are aware of the full range of qualified providers from whom they can choose?
Additional questions for proposed direct awards to GP providers
15. What steps have been taken to demonstrate that the services to which the contract relates are capable of being provided by only one provider?
16. In what ways does the proposed service go above and beyond what GP practices should be expected to provide under the GP contract?
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17. What assurances will there be that a GP practice is providing high-quality services under the GP contract before it has the opportunity to provide any new services?