This guide supports planning, decision making and advises on governance processes when PGDs are used within commissioned services .

Commissioning of NHS and publically funded health services has become increasingly complex with many services provided by a number of providers with sub-contracting or sub-commissioning arrangements; in addition to complex provider arrangements sometimes more than one commissioner may be involved.  When Patient Group Directions (PGDs) are used to provide commissioned services it can potentially become complicated when determining which organisation is responsible for developing, implementing, authorising, adopting and managing PGDs.  There is no ‘one size fits all’ model and varying systems have developed.

The PGD Board has frequently been asked for support in determining lines of responsibility for PGD governance in such complex arrangements.  As structures differ widely it is difficult to give specific advice but we recognise that commissioners and providers require support and guidance in determining the best process for their own local system.  The PGD Board has below posed a number of questions and considerations to support and guide both commissioners and providers (commissioned organisations) on the principles to consider when developing PGDs for NHS or publicly funded services which are being provided in such structures.  Not all questions posed will be relevant to all organisations and structures but readers are advised to consider the document as a whole to support and guide any decision making process and be mindful of their own organisation’s governance processes.

  Question Considerations
1 How has the service been commissioned? Where delivery of a commissioned service requires the use of PGDs it is important to know who the commissioner is. This could be a single organisations (CCG or Local Authority) or multiple organisations with one as a lead commissioner. The lead commissioner should take responsibility for PGDs but they may delegate some or all of their responsibility for this to the commissioned provider. The initial agreement laid out in a Memorandum of Understanding (MoU) or similar agreement should define this. The legal standing of the provider organisation will dictate the degree to which responsibility for PGDs can be delegated by the commissioner or lead commissioner.
2 Is there a Memorandum of Understanding (MOU) or contract in place between the organisations?  A MOU or contract (referred to only an MOU from this point) should be agreed before any PGD processes begin and this should be considered as part of the tender process.  A MOU should clearly state all the responsibilities involved in PGD development and use: from writing and authorising PGDs to adoption and implementation and should consider factors such as review, document management and any training requirements including which organisation will be responsible for each function. This must be agreed and recorded in each authorising organisation at Board level to ensure that the activity is accepted within each organisation’s clinical governance framework.
3 What if some organisations are Independent Healthcare Providers? Independent Healthcare Providers (IHPs) are not legally able to authorise PGDs for use by NHS or publically funded services; This is important when deciding who will authorise PGDs and will need consideration and agreement in any MOU. IHPs may produce PGDs if they have the necessary resource to do so.  In this case these PGDs then need to be authorised by the commissioner or lead commissioner – such arrangements should be set out in a MOU.  See below boxes for further detail.
3a Who will authorise the PGDs? (NB this is for NHS or publically funded services) Only the following organisations can legally authorise PGDs:

·       clinical commissioning groups (CCGs)

·       local authorities

·       NHS trusts or NHS foundation trusts

·       Special health authorities

·       NHS England

·       Public Health England

3b Can the commissioned provider organisation/s legally authorise PGDs? If the organisation is an IHP then the commissioning organisation will be required to authorise the PGDs.  The commissioning organisation may wish to retain this function and authorise the PGDs even if the provider organisation can legally authorise PGDs – this would need to be agreed as part of a MOU.   It may be decided that the provider organisation will authorise its own PGDs if it is legally able to do so – again this needs to be agreed as part of an MOU.
4a Is there more than one commissioner involved? Where multiple organisations are involved (i.e. one commissioner or multiple commissioners jointly commissioning the same service from one or more provider) all parties must be involved in an MOU and a lead commissioner may be identified as agreed.

Where a lead commissioner is identified to act to authorise a PGD/PGDs on behalf of other commissioning organisations it is essential that all involved organisations have the necessary governance processes in place to ensure any authorisations undertaken by the lead organisation are formally noted. This should be reflected in the MOU.

4b Is there more than one provider involved? Where multiple organisations are involved all parties must be involved in an MOU and a lead provider may be identified as agreed.

Where a lead provider is identified to act on behalf of other provider organisations it is essential that all involved organisations have the necessary governance processes in place to ensure any action undertaken by the lead organisation are formally noted. This should be reflected in the MOU.

If a provider is not involved in producing or authorising a PGD they must have a clear process for adopting the PGDs required to provide the service and this should be detailed in the MOU and agreed within the organisation’s governance processes.

5 Is the provider (or providers) sub-contracting all or part of the service provision? Where a provider sub contracts all or part of a service provision there should also be a MOU in place either between the provider/s and the sub contracted organisation/s.  If possible it should be part of a single MOU with the commissioner/s to ensure transparency and clear lines of responsibility.  All use of PGDs including adoption processes should be documented in each organisation’s governance processes.
6 Which organisation will produce the PGDs? This will need to be considered as part of a MOU agreeing who has the required resources and who will undertake this role.  This should also be considered as part of any tender process.
7 Can a PGD be authorised by more than one organisation? If there is more than one commissioner of a service or more than one provider all of whom are legally able to authorise PGDs then a single PGD can be authorised by multiple organisations.  Each organisation would need to complete their own governance process to authorise PGDs and this may become time consuming if multiple organisations are involved.  Any amendments or changes made to a PGD during its valid life would also need to be re-approved by all authorising bodies.  Alternatively one of the organisations can approve the PGD on behalf of all involved if this is agreed and detailed in the MOU (see 4a).
8a Does the organisation producing the PGD(s) have a robust PGD policy and a PGD working group structure in place? Any organisation producing PGDs should have the appropriate structure in place including any related policies and procedures.  See NICE MPG2 (2017) for further guidance https://www.nice.org.uk/Guidance/MPG2

 

8b Does the authorising organisation have a PGD policy in place to support this process? Any organisation authorising PGDs should have the appropriate structure in place including any related policies and procedures.  See NICE MPG2 (2017) for further guidance https://www.nice.org.uk/Guidance/MPG2

 

9 Who funds the PGD development? Consideration may need to be given to any funding of resources required to produce PGDs if no ‘in house’ resource is available or if additional resources would need to be funded.  This should be considered and agreed as part of the MOU and tender process.
10 Which organisational governance processes/committees will the PGDs be presented to?  This will need to be agreed depending on who is responsible for each part of the PGD process.  The organisation producing the PGD will require the approval of the PGD working group or other internal body before the PGD is submitted for authorisation.  The organisation authorising the PGDs will be required to ensure that the PGDs is submitted to the authorising body’s governance process as detailed in the local PGD policy.   It must be decided as part of a MOU how the involved parties who are not authorising the PGDs will also note the PGDs as part of their own governance processes when adopting PGDs produced/authorised by another organisation.  The time such processes take will need to be considered.
11 Who is responsible for updating PGDs both at the review date and as an on-going process in case of changes/amendments/updated versions? This is essential to ensuring the PGDs are well managed both in terms of timely planned reviews and also changes that are required during the lifetime of a PGD due to changes in SPCs and any supporting guidance.  The party responsible for these actions will also need to ensure all required governance processes are met.  Communication is an important factor at the time of either a completely revised PGD being issued or any amendments/changes to existing PGDs being made is ensuring communication to those who operate under the PGDs, to ensure they are always using the most up to date versions.  Consideration also needs to be given to intranet/internet sites which host the active versions of PGDs and who will be responsible for maintaining these resources.
12 Who is responsible for implementation of the PGDs? Usually the responsibility for implementation of PGDs would be with the provider organisation – however where there is more than one provider involved or there is sub-contracting of the service provision this will need consideration and clarification as part of the MOU.
13 Who will be responsible for any training required? Usually it would be the responsibility for provision of any training required for staff to operate under  PGDs would be with the provider organisation – however where there is more than one provider involved or there is sub-contracting of the service provision this will need consideration and clarification as part of the MOU.
14a Who is responsible for the document management of the PGDs final versions/updated versions/archive management? The responsibility for document management will need to be detailed within the MOU.  It would be expected that the lead commissioner would hold the final versions of the PGDs and be responsible for their on-going management and archiving.  All records must be held securely in line with records management guidance and local governance procedures.
14b Who is responsible for the document management of the PGDs maintenance of staff authorisation records? The responsibility for document management will need to be detailed within the MOU.  It would be expected that the provider holds the staff authorisation records and is responsible for archiving.  All records must be held securely in line with records management guidance and local governance procedures.