This document describes the standards and safe environment required for the use of point of care testing equipment and devices for diagnosis, monitoring and screening in community pharmacy. It is a guide for commissioners and community pharmacies delivering NHS services.

The NHS Long Term Plan highlights the importance of patients receiving care closer to home, shifting from a traditional model of hospital-based services towards a more adaptive community-based approach. As part of the Community pharmacy contractual framework agreement 2019-2024, NHS England committed to explore point of care testing (POCT) by community pharmacists.

Rapidly developing healthcare technology and changes in clinical practice mean that increasingly complex medical devices are being used in primary care. These devices and their users must comply with relevant legal requirements and meet the expectations of the public and other professionals to achieve high-quality care. In summary, the effective management of medical devices involves three principles:

• Buy it right: equipment must be fit for its intended purpose.
• Use it right: equipment function and operation must be understood by the users.
• Keep it right: equipment must be maintained in a safe and reliable condition.

This guidance signposts relevant legislation and resources to support the delivery of services and provides a structured approach to establishing POCT.

It follows three broad principles through the medical device life cycle that set out the need to:

• Identify best practice in the selection of equipment that ensures adequate safety and quality to optimise cost and minimise risk.
• Describe an operational management system applicable to community pharmacy that ensures POCT technology is efficiently maintained and competently used by trained operators, risks are effectively addressed, medical device performance is optimised, and a high standard of service is delivered.
• Establish a model of good clinical governance that satisfies independent regulators and meets applicable quality standards.

This document should be used as a reference and guidance when planning, designing, implementing, and providing POCT services in community pharmacies. Clearly defined expectations will help regulators and auditors maintain high standards, and community pharmacists will get clarification on the expectation for professional conduct and care.