8.4 This policy will be included in the <strong>Trust</strong>’s register <strong>of</strong> screeningdocumentation <strong>and</strong> maintained for inspection whilst it remains in force.8.5 This document can be made available on request in alternative formats,e.g. Braille, disc, audio cassette <strong>and</strong> in other languages to meet theneeds <strong>of</strong> those who are not fluent in English.9.0 Sources <strong>of</strong> Advice <strong>and</strong> Further Information9.1 Further advice <strong>and</strong> information regarding this document can be obtainedfrom the Chair <strong>of</strong> <strong>Point</strong> <strong>of</strong> <strong>Care</strong> <strong>Testing</strong> committee.10.0 References1 Department <strong>of</strong> <strong>Health</strong> (1999) Clinical Governance: in the New NHS.Department <strong>of</strong> <strong>Health</strong> (<strong>Health</strong> Service Circular: HSC (99) 065), London.2. Freedman DB. Clinical governance: Implications for point-<strong>of</strong>-care testing.Ann Clin Biochem 2002; 39: 421-423.3. <strong>Health</strong> Pr<strong>of</strong>essions Order 2001 Consolidated text incorporating repeals<strong>and</strong> amendments made up to 1st July 2009. Available from www.hpcuk.org.4. Price CP, St John A, Hicks JM. <strong>Point</strong> <strong>of</strong> <strong>Care</strong> <strong>Testing</strong>, Washington, DC:AACC Press, 2nd edition 2004.5. <strong>Point</strong> <strong>of</strong> <strong>Care</strong> <strong>Testing</strong> (Near Patient <strong>Testing</strong>) – Guidance on theInvolvement <strong>of</strong> the Clinical Laboratory, Institute <strong>of</strong> Biomedical Science,2004.6. MHRA Bulletin DB2010(02) Management <strong>and</strong> use <strong>of</strong> IVD point <strong>of</strong> caretest devices, February 2010.http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBulletins/CON0710827. Guidelines for point-<strong>of</strong>-care testing: Haematology. British Journal <strong>of</strong>Haematology 2008; 142: 904–915.8 Guidelines on point-<strong>of</strong>-care testing. Royal College <strong>of</strong> Pathologists. 2004.9 Guidelines for Safe <strong>and</strong> Effective Management <strong>and</strong> Use <strong>of</strong> <strong>Point</strong> <strong>of</strong> <strong>Care</strong><strong>Testing</strong>. Academy <strong>of</strong> Medical Laboratory Science, Association <strong>of</strong> ClinicalBiochemists in Irel<strong>and</strong>, Irish Medicines Board <strong>and</strong> RCPI Faculty <strong>of</strong>Pathology. November, 2007.10 BS EN ISO 22870:2006 <strong>Point</strong> <strong>of</strong> <strong>Care</strong> <strong>Testing</strong> – Requirements for Quality<strong>and</strong> Competence.11 BS EN ISO 15189:2003 Medical laboratories – Particular requirementsfor quality <strong>and</strong> competence.12. Clinical Pathology Accreditation (UK) Ltd (Version 2.01 March 2009)St<strong>and</strong>ards for the Medical Laboratory. CPA Ltd, Sheffield, UK.http://www.cpa-uk.co.uk/13. Clinical Pathology Accreditation (UK) Ltd (Version 1.00 Apr 10)Additional St<strong>and</strong>ards for <strong>Point</strong>-<strong>of</strong>-<strong>Care</strong> <strong>Testing</strong> (POCT) facilities. CPALtd, Sheffield, UK, http://www.cpa-uk.co.uk/14. <strong>Health</strong> <strong>and</strong> Safety at Work Act 1987.15. Department <strong>of</strong> <strong>Health</strong> Advisory Committee on Dangerous Pathogens(2003) Infection at work controlling the risk. Department <strong>of</strong> <strong>Health</strong>,London.<strong>Southern</strong> <strong>Health</strong> <strong>and</strong> <strong>Social</strong> <strong>Care</strong> <strong>Trust</strong>Management <strong>of</strong> <strong>Point</strong> <strong>of</strong> <strong>Care</strong> <strong>Testing</strong> Devices <strong>Policy</strong> V 2.0 February 2010Page 10 <strong>of</strong> 11
16. <strong>Health</strong> Services Advisory Committee (2003) Safe working <strong>and</strong> theprevention <strong>of</strong> infection in clinical laboratories <strong>and</strong> similar facilities. <strong>Health</strong><strong>and</strong> Safety Executive, HSE Books, Sudbury.17. <strong>Health</strong> <strong>and</strong> Safety Executive, Control <strong>of</strong> Substances Hazardous to <strong>Health</strong>(COSHH) 2002 ISBN 0 11 042919 2.18. In-vitro Diagnostics Medical Devices Directive 98/79/EC.19. Royal College <strong>of</strong> Pathologists <strong>and</strong> Institute <strong>of</strong> Biomedical Science. TheRetention <strong>and</strong> Storage <strong>of</strong> Pathological Records <strong>and</strong> Archives, 4 th edition(2009).<strong>Southern</strong> <strong>Health</strong> <strong>and</strong> <strong>Social</strong> <strong>Care</strong> <strong>Trust</strong>Management <strong>of</strong> <strong>Point</strong> <strong>of</strong> <strong>Care</strong> <strong>Testing</strong> Devices <strong>Policy</strong> V 2.0 February 2010Page 11 <strong>of</strong> 11