Guidelines for point‐of‐care testing: haematology

Abstract

SummaryThis guideline provides a framework for the arrangement of point-of-care testing (POCT) services, previously known as near patient testing (patient self-testing not covered). POCT is defined as any analytical test performed outside the laboratory. Primary users are often non-laboratory healthcare workers. The guidance applies to units within hospitals as well as general practioner surgeries, community clinics and pharmacies. The head of the haematology laboratory or a point of care coordinator must take responsibility for all aspects of the POCT service, including quality and training. Depending on the size and nature of the POCT practice, a local POCT manager may also be required. Equipment selected should have received a successful independent performance evaluation. If an independent evaluation has not been performed the purchaser should assess the device according to the protocol in this document. POCT devices should generate results that are comparable to those of the local laboratory. An accredited external quality assessment programme and internal quality control system must be established. Manufacturers promoting POCT devices designed for non-laboratory sites, e.g. pharmacies, should undertake training and annual competency assessment, perhaps using a web-based system. A diagram to illustrate the stages for the implementation of a POCT service is illustrated.Keywords: point-of-care testing, point-of-care committee, accreditation, external quality assurance, instrument evaluation.The purpose of these guidelines is to provide a framework for the provision of appropriate local arrangements for pointof-care testing (POCT) and to protect patients and staff. The guideline provides information and suggestions for good laboratory practice and for producing reliable results, regardless of where the test is performed. POCT may be defined as any analytical test performed for a patient by a healthcare worker outside the laboratory setting. This document is an update to the British Committee for Standards in Haematology (BCSH) guideline for Near Patient Testing: haematology (England et al, 1995) and embodies the philosophy agreed by the Joint Working Group (JWG) (1999) on Quality Assurance, the national standards required for clinical pathology accreditation (Clinical Pathology Accreditation (CPA) (UK) Ltd, 2007, revised Burnett et al, 2002 and the International Standards Organisation (ISO) POCT requirements for quality and competence (International Standard organisation, ISO, 2004a). There have been several evaluations carried out on the views of general practioners (GPs) to POCT and quality control procedures (England et al, 1995;Murray & Fitzmaurice, 1998). GPs do not always find POCT a useful addition to their resources and the challenges presented by community environments may mean that it is more difficult to adequately address all quality control issues (Department of Health, 1987;Hilton et al, 1994). Other important factors for consideration are the efficacy of the procedures being undertaken, medicol...

Point‐of‐care testing in haemostasis

“…POCT is frequently undertaken by nonlaboratory personnel both within and outwith the hospital setting and the last 10 years has seen a significant increase in its use, particularly in the field of haemostasis. The importance of POCT is highlighted by a recent publication from the This review summarizes POCT in relation to haemostasis, and complements a previously published guideline by the British Committee for Standards in Haematology on POCT in Haematology (Briggs et al, 2008). …”

Development and Evaluation of a Prototype of a Novel Clotting Time Test to Monitor Enoxaparin

“…Other clotting tests such as the HepTest and prothrombinase-induced clotting time test were designed as surrogate measures of plasma heparin concentrations and employ excess Xa (25,26). However, they are not specific for measuring heparin effect because the addition of hirudin (which produces an anti-IIa (anti-thrombin) effect) will prolong the clotting time (27).…”

Survey material choices in haematology EQA: a confounding factor in automated counting performance assessment

“…The use of non-commutable material however may have the same impact, where instrument grouping that results in only comparing analysers on a ‘like with like’ basis may not reflect true variation in performance. Immediate decisions are made on the basis of the results of the CBC, especially where the instruments are placed in acute care situations, and the provision of EQA for point-of-care instruments as well as those in automated laboratories is essential ( 39 ). Whether or not the scheme design includes POCT-placed instruments will affect the choice of assay material, since these instruments may not be located to allow the immediate testing of fresh material, for example they may be in remote sites, in clinics that do not operate a daily service or in community based services or emergency vehicles.…”