Essential Service: Clinical Governance
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As part of the Clinical Governance requirements, pharmacies have to participate in clinical audit of their services and have arrangements in place to verify the quality of advice provided to patients. They must have procedures for providing information to patients, obtaining views and dealing with complaints from patients. They must also implement relevant risk management measures.
Pharmacies must have staff management, training and development procedures in place for their staff, and ensure handling of all data meets legal and ethical requirements including confidentiality and data protection. Contractors are required to ensure that there are confidentiality policies in place for all staff and that they are appropriately trained.
Patients will have the opportunity to feed back on their level of satisfaction with their local pharmacy service by completing the Community Pharmacy Patient Questionnaire. A pharmacy will review the survey results and consider changes to improve service provision for the benefit of patients.
Changes to the clinical governance requirements in 2011/12
On 15th March 2011 NHS Employers and PSNC announced a number of service developments within the pharmacy contract that will deliver improved outcomes for patients; these follow our joint negotiation and agreement by the Department of Health.
The changes are being implemented during 2011/12. They include changes to the clinical governance requirements to strengthen and build upon the existing clinical governance regime and will, subject to appropriate DH clearance, be introduced in Regulations.
The key changes are:
- an addition to the existing requirement to publicise NHS services that are available at or from the pharmacy that clarifies that where a pharmacy advertises NHS Essential and Advanced services there should be an acknowledgement that these are funded by the NHS;
- an addition to the existing requirement to ensure that contractors reflect on the results of their annual patient satisfaction survey, take appropriate action and publish the results;
- all patient safety incidents should be reported to the NPSA or its successor organisation. Pharmacies will be expected to have a patient safety incident log and near-miss log;
- pharmacies should have a whistle blowing policy;
- patient safety notices, alerts and other communications concerning patient safety issued on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA), the National Patient Safety Agency (NPSA) or successor body, and the Department of Health should be acted upon within required timescales. Actions taken in response to the alerts should be recorded;
- pharmacies should keep patients, staff and visitors safe by having systems to ensure that the risk of health care acquired infection to patients is minimised. Cleanliness and infection control measures should be proportionate to the activities being undertaken in the pharmacy; and
- premises should provide a professional healthcare environment. There should be a clear separation between the healthcare environment (where patients will receive NHS services) and the non-professional area of the pharmacy.
PSNC and NHS Employers recognise that it will take time for contractors to implement the changes and we have allowed a six month "transition" period for contractors to comply with a number of the Regulations.
The Regulations were updated in October 2011 to reflect that agreed changes to clinical governance, however further fine detail (including 'approved particulars') on the changes is awaiting agreement from the Department of Health. Once this is agreed PSNC and NHS Employers will publish comprehensive guidance about the changes for contractors and commissioners, including examples of best practice and signposting to other relevant resources.
As interim support, PSNC and NHS Employers have published a document summarising the clinical governance changes.
Clinical governance requirements for community pharmacy (5th December 2011)
Further information on the other changes to the pharmacy contract
Service Specification
Click on the link below to download the Service Specification for Essential Service 8 - Clinical Governance:
Clinical Governance Service Specification
Related Resources
Audit
The RPS produced a number of audit templates which could be used by contractors. The RPS are currently in the process of updating their audit template toolkits, but the ones which are available (and a link to archived versions) can be found by clicking here.
Chaperone Policy
The PSNC briefing on Chaperone Policies summarises the Chaperone Guidance issued by the National Clinical Governance Support Team. It is not mandatory to have in place a chaperone policy, but pharmacy contractors may wish to consider the adoption of a policy in order to protect patients and staff.
Complaints
PSNC Complaints Briefing Paper and Recording Templates
Confidentiality
PSNC briefing on confidentiality, data protection and human rights
Confidentiality and Data Protection staff declaration
NHS Code of Practice on Confidentiality
RPSGB Guidance on NHS Code of Practice on Confidentiality
CPPQ (Patient satisfaction survey)
Community Pharmacy Patient Questionnaire (formerly Patient Satisfaction Survey)
Interventions
RPSGB guidance on the recording of interventions
Patient Safety Incident Reporting
Overview of Community Pharmacy Reporting to the NPSA
Report an Incident (NPSA NRLS Online Form)
PSNC Incident Reporting Form
NPSA Root Cause Analysis e-learning Package
Seven steps to patient safety for primary care
Guide to significant event audit
Practice leaflets
Safeguarding
RPSGB Guidance on Child Protection
RPSGB guidance on reporting sexual activity in children under 13 years
RPSGB guidance on protection of vulnerable adults
RPSGB guidance on raising concerns
SOPs
Additional Resources
Quality Improvement for Pharmacy Development website

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