Legal authorisation of PGD

The Medicines and Health Regulatory Agency (MHRA) has advised that where a PGD is used for NHS/public health funded healthcare under arrangements made with an NHS or a local authority, the law requires that the PGD is authorised by that body.

This applies to PGDs used for the provision of NHS and local authority funded services under arrangements between NHS bodies/local authorities and CQC registered independent medical agencies.

Therefore, independent healthcare providers (IHPs) cannot provide organisational authorisation for PGDs used to deliver NHS or public health commissioned services.

The organisational authorisation in this case is the responsibility of the commissioning organisation who must be listed in the legislation as able to authorise a PGD in England. These are:

• Integrated Care Boards (ICBs)
• Local authorities
• NHS trusts or NHS foundation trusts
• Special health authorities
• NHS England
• UK Health Security Agency (UKHSA)

IHPs should note that each PGD must be authorised by each organisation which commissions the service. Commissioning in some circumstances may be across a number of organisational boundaries. Where this is the case, commissioners may wish to take advice to explore how to develop a formal agreement for sign off using a “single operating model” approach.

Commissioning of IHP services utilising PGDs

A number of scenarios exist for the development and authorisation of PGDs, depending on how services are commissioned and the organisations involved.

Consider the advice in the following SPS resources in addition to the organisational level responsibilities outlined below:

• Patient Group Direction use in services provided by multiple organisations
• Patient Group Directions in Complex Commissioning Scenarios
• How to develop a Patient Group Direction
• When to use a PGD
• When Patient Group Directions are not required

Responsibilities of commissioners and IHP providers

Responsibilities of both commissioning organisation and IHP

Collaborative working

For each PGD, the commissioning and provider organisation should collaborate to firmly establish local governance arrangements with clear lines of responsibility and accountability. Providers and commissioning organisations must agree and clearly allocate responsibilities for each stage of the process. These should be supported by local, formal agreements such as a Service Level Agreement (SLA) or a Memorandum of Understanding (MOU). Refer to Patient Group Directions in Complex Commissioning Scenarios

PGD processes

The commissioning organisation and IHP should have their own and a mutually agreed PGD processes and work programmes to cover specific responsibilities at different stages in the process. These should be shared between the organisations if requested.

Providers and commissioning organisations must agree and clearly allocate responsibilities for each stage of the process. Failure to do so could result in a significant risk to the organisation(s) involved and to delivery of services.

Antimicrobial PGDs

Where required the commissioning organisation may need to provide support to identify a local specialist in microbiology to enable the IHP to obtain relevant information regarding local antimicrobial formulary/guidelines.

Using national PGD templates (SPS or UKHSA)

Where national PGD templates are in place the commissioning organisation and the IHP must agree whether these will be adopted and the process for this. A national PGD may not legally valid until it has been authorised by the authorising organization and national PGD templates until they have been both clinically signed and then authorised. The IHP is responsible for having a process of adoption within their governance arrangements whilst it is the responsibility of the organisation that has legal authority to authorise the PGD to ensure that the legal and governance requirements are met.

Responsibilities of the Independent Healthcare Provider (IHP)

Adherence to national PGD guidance

Evidence should also be provided to the commissioning organisation that the IHP meets the requirements of NICE MPG2 PGDs. Such evidence would include the IHP organisational PGD Policy and evidence of PGD audit as well as any agreed data, such as audits.

Sub-contracting of service provision

Where a commissioned IHP organisation subcontracts part or all of the service provision this needs to be documented under an SLA or MOU and should, where possible, form part of the SLA/MOU the commissioner has with the IHP to ensure transparency and clear understanding of the responsibilities of all involved organisations.  Refer to Patient Group Directions in Complex Commissioning Scenarios

PGD clinical signatories

The IHP will normally be responsible for ensuring all PGDs submitted to the commission body are clinically signed – refer to Questions about signatories of PGDs which will clarify and support understanding of the responsibilities of signatories at a local and organisational level.

CQC registration

The IHP must comply with the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 and address the 5 key questions asked by the Care Quality Commission considering medicines safety. The IHP is advised to consider these requirements which the commissioner may request evidence of prior to agreement for PGD development or authorisation.

Responsibilities of the commissioning organisation for organisational authorisation of the PGDs

Provision of PGDs by the IHP

The commissioning organisation must ascertain at earliest possible stage in the process whether an IHP requires PGDs to provide the commissioned service, whether it has already has suitable, valid PGDs or has the appropriate resources to develop and review its own PGDs. Failure to determine this at an early stage can lead to unsafe service delivery or delayed service implementation and thus could impact on service provision.

The commissioning organisation must assure itself that that the provider has the relevant systems and processes in place to ensure compliance with NICE MPG2 PGDs. These arrangements may, for example, be supported by a service specification outlining key performance indicators or quality metrics to demonstrate that PGDs are being used appropriately and deliver a consistent level of care.

CQC registration confirmation

The commissioning organisation may wish to seek evidence from the provider that they comply with the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 prior to agreement of PGD use.

PGD authorising signatory

It is recommended that commissioning organisations refer to Questions about signatories of PGDs for detail of the responsibilities of signatories authorising PGDs.

Governance processes

As the authorising organisation, the commissioning organisation should also ensure that it has the relevant systems and processes in place to authorise PGDs through internal governance processes in line with NICE MPG2 PGDs.

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