The Governance Challenge – The Essential Elements of a Well Governed Service: PART 1

One thing is sure in healthcare; governance of patient services is a monumental challenge. But it isn’t an insurmountable one.

Like constructing a sustainable building, the appropriate foundations must be in place to successfully deliver the project. Point of care testing (POCT) services are no different and a series of articles hosted on this website will explore in further depth, the requirements to assure a well governed service. The guidance provided here will be open to interpretation, serving as a blueprint for the introduction of these concepts, and flexible enough to be adopted in all types of healthcare organisations.

Responsibilities and Expectations

The first document that needs to be in place is a POCT Policy which succinctly defines the responsibilities across the organisation for the delivery of the service and to deliver quality objectives. The policy must not read like a standard operating procedure, rather it should be a sequence of statements which define the roles and responsibilities for different elements of the service. The purpose of the policy is to lay down the foundation for how quality and safety is to be delivered within the service. The policy itself should be ratified by the medical director or an individual holding similar rank in the organisation.

One essential task is to identify the stakeholders and what is expected of them in delivering the service and which individuals are held to account when the quality and performance measures are not being met. This is by no means a blame game, but it is critical to establish multiple points of contact with the appropriate level of authority that can empower staff to adopt the improvements suggested by the POCT team.

The quality and performance measures will be defined elsewhere within the quality management system although it is extremely important to promote awareness of these measures and what they represent to all users. Key performance indicators and quality indicators should be defined locally by the clinical, quality and managerial teams involved in the oversight of the service, and monitored by the operational team.

Governance Groups

The committees that require assembling include a management group which will act to monitor the operational aspect of the POCT service. The membership of this group will include the POCT team along with the clinical and managerial leads for the service. The day to day activities which keep the POCT staff so busy must be monitored through a standardised system which generates a quality report to be reviewed at a monthly meeting, or other defined interval based on local requirements. At this meeting the actions taken to resolve service issues will be discussed, recorded and reviewed for effectiveness.

We will cover the content of the report throughout these articles. The main focus of the group is to ensure that the quality of all service elements is monitored and that issues are rapidly addressed or escalated. Anything that cannot be dealt with at this level, requiring additional support at a higher governance level will be transferred to the POCT Governance Group.  

The governance group membership will consist of representatives from the POCT team including the POC Co-ordinator, management and clinical lead plus specialty leads or nominees whom represent a cross section of the scope of the service. Gaining meaningful buy in from specialties such as intensive care, surgery, nursing, transfusion, the diabetic team, neonatal intensive care and emergency medicine is a must in order to balance the output from the group. The main remit of the group is to review the information presented and act to resolve quality and performance issues that the management group have been unable to address. This may require the intervention of senior managers in the organisations or indeed the executives.

The group will also be responsible for reviewing the clinical effectiveness of the service across multiple specialties, generating committee decisions on whether POCT is appropriately deployed, cost effective and efficiently used. All new requests for POC services should be reviewed by this group and universally agreed where possible. The functions of the group will be defined in the Terms of Reference.

Medical Laboratory Oversight

Where practical and achievable the POCT service should be formally overseen by the medical laboratory. There are a number of advantages to this including using the same quality management system and access to laboratory space, equipment and resources. It is not an absolute though, and many services will be able to operate with a safe level of governance as a standalone entity not directly linked to the medical laboratory.

The difficulties that may arise include defining the responsibility for the service on a clinical level which for some will have traditionally been the laboratory director, with the Chief Executive of the organisation delegating responsibilities to other staff as defined in the POCT Policy. Therefore, if the laboratory is not involved these responsibilities must be defined elsewhere and be demonstrated as being effective in managing the quality and safety of the service.

It would also be sensible for POCT services to be covered by the laboratory quality policy as well as the quality management system.

Quality Management System

The utilisation of a quality management system is essential in delivering an effective laboratory service. The same is true for POCT with the use of management and quality policies and procedures required to define how service objectives are delivered and maintained. A number of key elements, listed below, need to be embedded in the service to promote a full understanding of the level of quality and performance across the service:

• A library of policies and procedures describing how the service objectives are delivered
• Document control
• Non-conformance management
• Audit calendar
• Training and competency recording
• Clinical incident reporting
• Quality assurance processes
• Service continuity plans
• Annual Management Review
• Metrics, Key Performance Indicators (KPI) and Quality Indicators (QI)

The backbone of a sustainable service can be defined by these elements and once successfully implemented and maintained users can be assured of the ongoing quality of the services they access.

The implementation of an effective quality management system, demonstrating sustainability through evidence will form the basis of an application for accreditation to standards such as those assessed by the College of American Pathologists (CAP), and the United Kingdom Accreditation Service (UKAS). These include ISO 15189:2012 and ISO 22870:2016.

The Governance Challenge – The Essential Elements of a Well Governed Service: PART 2 The concepts listed above, and more, will be further explored in the next edition.