The 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.
As part of the five-year Community Pharmacy Contractual Framework agreement, NHS England and Improvement 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,” says NHS England. “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.
The guidance signposts relevant legislation and resources to support the delivery of services and provides a structured approach to establishing POCT. It 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,” says the national commissioning body.