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Introduction

Point of Care Testing (POCT) is now high profile in all healthcare sectors within the UK and is increasingly adopted by users self-testing at home.

The necessity for reform within the NHS is raising awareness of the opportunities available by using such technology, and it is important that we continue to promote POCT as a safe and effective alternative to central laboratory testing. This can only be done by ensuring that the professional standards demanded of medical laboratories are embedded into the management of POCT.

This policy has been developed to ensure that National Guidelines on POCT from the Medicines and Healthcare products Regulatory Agency and NHS England are adhered to by the Trusts, taking into consideration local processes and procedures and the requirement for all pathology diagnostic testing to be compliant with ISO 15189:2012 (Medical laboratories – Requirements for quality and competence) and ISO 22870:2006 (POCT-Requirements for quality and competence).

 

Policy Details

Download: PDF version
Compiled by: Dr Kerry Whiting
Ratified by: Trust Executive Committee
Date Ratified: April 2015
Date Issued: June 2015
Review Date: April 2018
Target Audience: All clinical and laboratory scientific and technical staff
Contact name: Dr Kerry Whiting

 

See also:

  • Policy for Clinical Staff Medical Devices Training
  • Policy for management of Medical Devices
  • Policy for the Management and Reporting of Incidents
  • Performance Review and Development Needs Assessment (Appraisal)