Clinical governance
Clinical governance, what it is and why it is necessary
The use of standards for delivering quality services
Introduction
Clinical governance is defined by the DH as ‘the system through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care, by creating an environment in which clinical excellence will flourish’.
Clinical governance
Why is clinical governance necessary?
Clinical governance was introduced in the UK following a series of well publicized lapses in patient quality in the 1990s as part of a broader government agenda to improve the quality of care delivered to patients by the NHS. It is a set of processes that healthcare professionals are expected to work within in order to learn from the successes and failures of both their own practice and those of others and to promote an open culture where experiences are shared to promote best practice for their patients.
When was clinical governance introduced?
The NHS document A first class service: Quality in the new NHS (DH 1998) introduced the term ‘clinical governance’, stating that, ‘for the first time, the NHS will be required to adopt a structured and coherent approach to clinical quality, placing duties and expectations on local healthcare organisations as well as individuals. Effective clinical governance will make it clear that quality is everybody’s business’.
What is clinical governance?
The NHS publication, Clinical governance in the new NHS (1999) outlines four main components of clinical governance. These are:
Clear lines of responsibility and accountability for the overall quality of clinical care
A comprehensive programme of quality improvement activities
Clear policies aimed at managing risks
Procedures for all professional groups to identify and remedy poor performance.
The publication also provides examples of quality improvement activities, including:
Audit programmes (see Ch. 12)
Ensuring evidence-based practice (see Ch. 20)
Implementation of clinical standards
Continuing professional development (CPD, see Ch. 6)
Monitoring of clinical care and high-quality record-keeping (see Ch. 51)
Research and development to promote ‘an evaluation culture’.
Clinical governance should underpin the practice of all healthcare professionals as they strive for the best quality of care for their patients and continually seek improvement in their practice. Practicing good clinical governance ensures a consistent approach to decision-making, minimizes risk and ensures that patients are the priority and focus of the professional practice of pharmacists and all other healthcare professionals.
Quality: Three main elements for improving quality in the NHS
Creating standards for quality
Standards are set by clinical guidelines, such as National Service Frameworks (NSFs). These are documents that serve as a practical aid to the implementation of treatment and service guidelines in a specific therapeutic area. They are developed by groups of experts, which include healthcare professionals and patients, along with the support of NICE. With these, decisions to prescribe medicines can be based on the best available evidence (see Ch. 20).
Delivering quality
Quality health care should be delivered by well trained and motivated healthcare professionals who are well managed and are committed to life-long learning through CPD (see Ch. 6). NHS staff should communicate openly with other healthcare professionals and should be encouraged to share best practice.
Monitoring quality
Quality of care should be monitored both nationally and locally through a process of clinical audit (see Ch. 12), with clear policies aimed at managing risks with involvement of patients in an open and transparent health service. NHS staff should be regularly appraised on their performance and underperformance should be identified and remedied. The NHS document, An organisation with a memory (DH 2000) requires that mechanisms are introduced for ensuring that, when errors or service failures occur and lessons are identified, the necessary changes are put into practice so that a wider appreciation of the value of analysing and learning from errors becomes the norm.
Clinical governance and pharmacy
The NHS document, Clinical governance in community pharmacy (DH 2001) first introduced clinical governance into community pharmacy, not as a terms of service requirement but by way of voluntary invitation to engage with clinical governance facilitators at a Primary Care Organization level. The NHS contract for community pharmacy launched in April 2005 included clinical governance requirements as one of the essential service components. Additional clinical governance requirements came into effect in July 2012 and include:
Patient and public involvement programme: including a patient satisfaction survey, displaying the results and acting upon them
Clinical audit: to check whether a service has reached required standards
Risk management programme: including use of approved patient incident reporting system
Clinical effectiveness programme: e.g. using protocols for appropriate self-care advice
Staffing and staff management programme: to include training and CPD
Premises standards: to ensure good design and cleanliness
Use of information: via access to effective IT links and appropriate reference sources.
Professional governance
Professional governance in pharmacy can be defined as:
The process by which the pharmacy profession works with its members to ensure that patients receive an optimal standard of pharmaceutical care and maintains confidence in the profession.
Professional governance works in tandem with clinical governance, the aim of which is to:
Duty of care
Pharmacists have a duty of care to their patients and are required by law to ensure that the public is protected. The law would expect that pharmacists practise pharmacy to a level of competence expected by the profession, and indeed that practised by the ‘average pharmacist’. Pharmacists are expected to exercise reasonable care when supplying the public and patients with medicines and professional advice.
In their practice, pharmacists are subject to criminal law (e.g. The Human Medicines Regulations 2012; Misuse of Drugs Act), administrative law (e.g. contractual agreements), civil law and the standards laid down by the GPhC in various documents.
The majority of care within the health service is of a high standard but it is inevitable that errors do occur. The vast majority of these are relatively minor and easily rectified without serious consequences. Unless a pharmacist causes deliberate harm to a patient, it is unlikely that he or she would be subject to criminal charges; although, in 2009 a pharmacist was given a 3-month jail sentence suspended for 18-months, following a dispensing error. The charge was brought under the labelling regulations of the Medicines Act 1968.
Negligence
If the mistake by a pharmacist causes harm, then a more likely charge of negligence may be pursued in a civil court. For a breach in a duty of care to be proven, then the prosecution must prove that a duty of care exists, that this duty of care has been breached and that the patient has suffered damages resulting from the breach. Often an expert witness from the pharmacy profession would be called to explain how a ‘standard’ member of the profession would have acted in this case.
Professional governance and regulation procedures in pharmacy
As mentioned above, one of the key components of clinical governance is that there must be ‘procedures for all professional groups to identify and remedy poor performance’. This role in the governance of the professional is vital to ensure that patients are protected and confidence in the profession is maintained. Originally, the responsibility of the Royal Pharmaceutical Society (RPS), this role now falls within the remit of the GPhC, the independent regulator for pharmacists, pharmacy technicians and pharmacy premises, since September 2010.
The GPhC now has responsibility to:
Set standards for pre-registration and post-registration education and training
Set standards for the conduct and ethics expected of registrants
Set standards for practice and performance
Approve courses, institutions and qualifications
Maintain registers of pharmacists, pharmacy technicians and premises
Establish initial fitness to practise of potential registrants and continue to monitor after registration
Investigate complaints and concerns and be prepared to adjudicate where there are issues of impaired fitness to practise.
Prior to the establishment of the GPhC, as a result of the publication of the Pharmacists and Pharmacy Technicians Order 2007, the RPS was tasked with setting up new committees to investigate ‘fitness to practise’ (FtP). This was a term used to describe a person’s suitability to be on the register and to satisfy the principle of FtP; individuals must exhibit the skills, knowledge, character and health to be able to do their job effectively and safely.
Currently, all registrants must complete an FtP declaration each year when they renew their registration and any changes in this status must to reported as soon as the change occurs.
Fitness to practise can be influenced by circumstances of misconduct, including convictions of a criminal offence, ill-health or lack of competence.
Investigating committee
The Investigating Committee meets in private and considers whether allegations referred to it (see Box 9.1) should be dismissed or forwarded to the Fitness to Practise Committee. It also has the power to:
Box 9.1 Criteria for referral to the Investigating Committee
Cases will not be referred to the Investigating Committee unless threshold criteria have been exceeded. These are based around the seven principles of the GPhC Standards of Conduct, Ethics and Performance and examples are shown below:
From Principle 1: Make Patients your first concern
From Principle 2: Use your professional judgement in the interest of the patient and the public
From Principle 3: Show respect for others
There is evidence that the registrant failed to maintain appropriate and professional boundaries in their relationship with patients.
From Principle 4: Encourage patients and the public to participate in decisions about their care
There is evidence that the registrant placed the best interest of the patient at significant risk by failing to communicate appropriately.
From Principle 5: Develop your professional knowledge and competence
From Principle 6: Be honest and trustworthy
From Principle 7: Take responsibility for your working practices
Fitness to practise committee
The Fitness to Practise Committee determines whether or not the FtP of the person of whom the allegation is made is impaired.
If the committee finds that fitness to practise is impaired it may:
Issue a warning to the person concerned and advice to any other person or other body involved in its investigation of the allegation
Give a direction that the person’s registration shall be conditional upon compliance with specified requirements that the committee thinks fit to impose for the protection of the public or in the person’s own interests
Give a direction that the person’s registration shall be suspended
Give a direction that the person concerned be removed from the register.
When things go wrong
Pharmacists are only human and, despite best intentions and safeguards, mistakes do happen. It is how mistakes are dealt with that will normally determine whether incidents are referred for further investigation.
When a dispensing error occurs, the pharmacist is ideally placed to determine the potential risk to the patient. When dealing with dispensing or prescribing mistakes, it is vital that pharmacists place the welfare of the patient first and seek immediate medical attention if necessary. An investigating committee would be unimpressed with a pharmacist who covered up a mistake, did not assess the risk of a mistake to the health of a patient or repeated mistakes where they have clearly not taken remedial action to prevent errors from recurring.
Dealing with errors
While this is not a comprehensive checklist, it may be helpful to consider the following when an error occurs:
Is there any immediate risk to the welfare of the patient? If yes, refer to GP/Accident and Emergency, phoning ahead if necessary
Who do I need to inform – e.g. patient’s GP, superintendent pharmacist, family member of patient, GPhC inspector, primary care commissioner? It is better to proactively raise the error with these stakeholders rather than them to hear of it from the patient, patient’s solicitor, etc.
Document what happened in an incident report and describe all steps taken to remedy the error
Make a report to the National Patient Safety Agency using their voluntary electronic reporting system
If significant, conduct a root cause analysis (RCA) to help understand the underlying causes, behind those that are immediate and obvious, and what could be done to prevent it re-occurring in the future.
Preventing mistakes
Ensure standard operating procedures (SOPs) for the supply of medicines are in place, adhered to, evaluated and reviewed.
Consider the use of sensible safe practices, including the following:
Ensure that one person is not responsible for all stages of processing prescriptions
Ensure that medicines with similar sounding names or with similar company livery are not placed next to each other
Separate different strengths of medicines from one another by placing another medicine between the two different strengths.
Recording and reporting medication errors
The document ‘Building a safer NHS for patients’ (DH 2004) suggested that to create a safer environment for patients, healthcare professionals needed to be more active in how they manage risk, including how pharmacy deals with errors.
Under the Pharmacy Contractual Framework, it is now a requirement to record medication errors, the level of which may depend upon the nature of the incident.
An error which has the potential for harm but does not actually reach the patient is termed a near-miss. The RPS created resources for recording these events and gives guidance on how teams working with pharmacies can review these logs for patterns and trends from which learning exercises can be made.
More significant events, especially where serious patient harm may have been caused, should be reported to the National Patient Safety Agency (NPSA) through its National Reporting and Learning System. Safety issues are collected and collated to allow analysis for the development of opportunities to reduce risk and improve patient care.
While all medication errors should be regarded as significant, the NPSA has provided definitions for grading patient safety incidents are shown in Box 9.2 (see also Examples 9.1 and 9.2).
Box 9.2 NPSA definitions for grading patient safety incidents
Incident prevented – any patient safety incident that had the potential to cause harm but was prevented, and no harm was caused to patients receiving NHS-funded care.
Incident not prevented – any patient safety incident that occurred but no harm was caused to patients receiving NHS-funded care.
Any patient safety incident that required extra observation or minor treatment and caused minimal harm to one or more patients receiving NHS-funded care. (Minor treatment includes first aid or additional therapy or medication)
Any patient safety incident that resulted in a moderate increase in treatment and that caused significant but not permanent harm to one or more patients receiving NHS-funded care. (Moderate increase in treatment includes a return to the surgery or unplanned re-admission to hospital)
Any patient safety incident that appears to have resulted in permanent harm to one or more patients receiving NHS-funded care. (Permanent harm directly related to the incident and not related to the natural course of the patient’s illness or underlying condition is defined as permanent lessening of bodily functions, sensory, motor, physiological or intellectual, including removal of the wrong limb or organ or brain damage)
Any patient safety incident that directly resulted in the death of one or more patients receiving NHS-funded care. (The death must be related to the incident rather than to the natural course of the patient’s illness or underlying condition)
Key Points
Clinical governance was introduced to improve the quality of care to patients
The four main components are: lines of responsibility, programme of quality improvement, risk management policies and remedying poor performance
Quality of care should be subject to clinical audit
The 2005 contract for community pharmacists included clinical governance as an essential requirement
During practice, pharmacists are subject to criminal, civil and administrative law
Currently the GPhC has committees tasked with responsibility in these areas
Mistakes will happen – how they are dealt with and learned from is important
Errors or near misses should be recorded, reflected upon and shared with others. This process should be part of SOPs within the pharmacy
When an error is made, the welfare of the patient is paramount