The clinical governance requirements are classed as an essential service, meaning that all pharmacies must be compliant with them.
A number of changes to the clinical governance requirements contained within the NHS (Pharmaceutical Services) Regulations were introduced in October 2011 as part of the changes to the Community Pharmacy Contractual Framework for 2011/12.
The changes to the clinical governance requirements bring community pharmacy obligations in line with those for other healthcare professions. It is expected that compliance with the new clinical governance requirements will help to support the profession under the new commissioning architecture of the NHS, where primary care providers need to demonstrate certain quality standards. The changes were not intended to be overly burdensome to community pharmacy.
In 2012, NHS Employers and PSNC published updated guidance, covering both the new ( for 2011) and existing clinical governance requirements. The changes came into force on 1 October 2011 but pharmacies were given until April 2012 to become compliant with them. Revisions were made to two of the existing Approved Particulars and three new Approved Particulars were introduced. The Approved Particulars were effective from 1 July 2012 and can be downloaded from the Department of Health website. The Regulations are available to download from legislation.gov.uk
Some of the main changes include:
- Pharmacies are required to publicise essential and advanced services that are available at or from their pharmacy to acknowledge that these services are funded by the NHS. This requirement has been extended to ensure that when pharmacies publicise essential and directed services (advanced and enhanced) available at or from the pharmacy it is clear that the services are funded by the NHS.
- Pharmacies are required to report patient safety incidents to the National Patient Safety Agency (or its successor organisation). Pharmacies should keep a log of patient safety incidents and near-misses. This clarifies the existing requirement to have an incident reporting system and a process to analyse and respond to incidents.
- Pharmacies are required to identify and support pharmacy technicians' development needs, including continuing professional development (CPD) as pharmacy technicians are required to be registered with the GPhC.
- Pharmacies are required to have a written protected disclosure (whistleblowing) policy.
- Pharmacies are required to have an approved information governance programme (this replaces the requirement for a use of information programme).
- Pharmacies are required to act upon patient safety notices, alerts and other communications concerning patient safety within required timescales in line with the CQC standard C1b for “provider” sectors. Actions should be recorded.
- Pharmacies are required to have a system for maintaining cleanliness at the pharmacy, in a proportionate manner to ensure that the risk of healthcare acquired infection is minimised.
- Pharmacies are required to provide an appropriate environment in which to receive healthcare.