Bridging the gap between point-of-care testing and laboratory testing in hemostasis.
Point-of-care (POC) testing within hemostasis is an expanding field, with the most widely used test being POC international normalized ratio (INR). Many of these devices are being used in a nonlaboratory setting by staff with no laboratory training. In the United Kingdom, external quality assessment (EQA) is provided by the organization UK National External Quality Assessment Scheme for Blood Coagulation (UK NEQAS BC). Participants within the UK NEQAS BC POC INR program are largely based in primary care (77%), with the majority of EQA samples and patients tests being performed by nurses (70%). Many of these centers do not have support from the laboratory staff and may, therefore, not understand the requirement for a robust quality control (QC) system comprising both internal quality control (IQC) and EQA. From data acquired through a questionnaire of these UK NEQAS BC users, we observed that 2% of the centers never perform IQC tests, only 29% perform IQC tests when starting a new batch of test strips, and just 15% carry out IQC with each clinic as recommended by the UK guidelines. The imprecision of EQA tests was greater for POC users than in the UK NEQAS BC hospital laboratory program, with average coefficients of variation for a 2-year period of 11.0 and 7.3%, respectively. This may reflect the handling of EQA samples rather than the imprecision of the method, due to the lack of laboratory training amongst POC staff. POC INR in the UK could greatly benefit from more interaction and support from laboratories to these POC testers.