{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T06:26:55Z","timestamp":1777444015659,"version":"3.51.4"},"reference-count":19,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2015,10,20]],"date-time":"2015-10-20T00:00:00Z","timestamp":1445299200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Clin Biochem"],"published-print":{"date-parts":[[2016,3]]},"abstract":"<jats:p>ISO 22870 standards require protocols for performance of internal quality control for all point-of-care testing devices and training of users in its theory and practice. However, the unique setting of point-of-care testing (i.e. processes conducted by non-scientific users) means that laboratory internal quality control programmes do not easily translate to point-of-care testing. In addition, while the evidence base for internal quality control within the laboratory has been increasing, the equivalent literature surrounding point-of-care testing is very limited. This has led to wide variation in what is considered acceptable practice for internal quality control at the point of care. Indeed, it has been demonstrated that internal quality control is an area of deficiency in point-of-care testing. Internal quality control protocols used at point-of-care testing should be defined based on risk management. The protocol will therefore be dependent on analyser complexity and availability of inbuilt system checks, the risk associated with release of an incorrect patient result as well as frequency of use. The emphasis should be on designing an effective internal quality control protocol as opposed to the inherent tendency of introducing high-frequency quality control. Typically a simple pass or fail criterion is used for internal quality control in point-of-care testing based on whether internal quality control results fall within assigned ranges. While simply taught, such criteria can require broad internal quality control ranges to decrease the probability of false rejection (also reducing the probability of error detection). Customized internal quality control ranges, two-tier acceptance systems and assay-specific internal quality control can be used to improve error detection rates.<\/jats:p>","DOI":"10.1177\/0004563215615148","type":"journal-article","created":{"date-parts":[[2015,10,20]],"date-time":"2015-10-20T21:33:06Z","timestamp":1445376786000},"page":"233-239","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":21,"title":["Internal quality control in point-of-care testing: where\u2019s the evidence?"],"prefix":"10.1177","volume":"53","author":[{"given":"Helen","family":"Holt","sequence":"first","affiliation":[{"name":"Department of Clinical Biochemistry, Luton and Dunstable University Hospital NHS Foundation Trust, Luton, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Danielle B","family":"Freedman","sequence":"additional","affiliation":[{"name":"Department of Clinical Biochemistry, Luton and Dunstable University Hospital NHS Foundation Trust, Luton, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2015,10,20]]},"reference":[{"key":"bibr1-0004563215615148","volume-title":"Point of care testing","author":"Deemers LM","year":"1999"},{"key":"bibr2-0004563215615148","unstructured":"Clinical and Laboratory Standards Institute. Risk management techniques to identify and control laboratory error sources. In:\n                      Approved guideline\n                      . 2nd ed. EP18-A2. Wayne, PA: Clinical and Laboratory Standards Institute, 2009."},{"key":"bibr3-0004563215615148","unstructured":"Clinical and Laboratory Standards Institute. Laboratory quality control based on risk management. In:\n                      Approved guideline\n                      . 1st ed. EP23-A Wayne, PA: Clinical and Laboratory Standards Institute, 2011."},{"key":"bibr4-0004563215615148","unstructured":"ISO 22870:2006. Point-of-care testing (POCT) \u2013 requirements for quality and competence."},{"key":"bibr5-0004563215615148","unstructured":"Australasian Association of Clinical Biochemists.\n                      Guidelines for conducting quality control and external quality assurance for POCT\n                      . Alexandra, NSW: AACB PoCT Committee, 2010."},{"key":"bibr6-0004563215615148","unstructured":"Medicines and Healthcare Products Regulatory Agency.\n                      Management and use of IVD point of care test devices\n                      . London, MHRA, 2013."},{"key":"bibr7-0004563215615148","first-page":"S79","volume":"29","author":"Martin CL","year":"2008","journal-title":"Clin Biochem Rev"},{"key":"bibr8-0004563215615148","unstructured":"ACCU-CHEK\u00ae Inform II blood glucose monitoring system Operator\u2019s Manual V 4.0, 2014."},{"key":"bibr9-0004563215615148","unstructured":"IBMS Point of Care Testing (Near-Patient Testing) Guidance on the Involvement of the Clinical Laboratory. Professional Examinations and Awards Committee V 2, 2004."},{"key":"bibr10-0004563215615148","unstructured":"Abbot Point of Care. 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Cartridge and Test Information Sheet: Total CO2 (TCO2), 2013 Art: 716661-00G."},{"key":"bibr14-0004563215615148","doi-asserted-by":"publisher","DOI":"10.1258\/acb.2009.009045"},{"key":"bibr15-0004563215615148","unstructured":"I-STAT Technical Bulletin, liquid quality control schedule and lockout customization on the i-stat 1 handheld, 2014 Art: 730077-00D."},{"key":"bibr16-0004563215615148","unstructured":"Desirable Specifications for Total Error, Imprecision, and Bias, derived from intra- and inter-individual biologic variation, www.westgard.com\/biodatabase1.htm (accessed 25 September 2014)."},{"key":"bibr17-0004563215615148","unstructured":"Westgard S. Evaluation of four POC analyzers and one HbA1c Analyzer, www.westgard.com\/sigma-metric-analysis\/4-poc-southafrica.htm (2014, accessed 25 September 2014)."},{"key":"bibr18-0004563215615148","doi-asserted-by":"publisher","DOI":"10.1515\/CCLM.2011.149"},{"key":"bibr19-0004563215615148","doi-asserted-by":"publisher","DOI":"10.5858\/arpa.2011-0157-RA"}],"container-title":["Annals of Clinical Biochemistry: International Journal of Laboratory Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0004563215615148","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/0004563215615148","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0004563215615148","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:22:32Z","timestamp":1777378952000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/0004563215615148"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,10,20]]},"references-count":19,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2016,3]]}},"alternative-id":["10.1177\/0004563215615148"],"URL":"https:\/\/doi.org\/10.1177\/0004563215615148","relation":{},"ISSN":["0004-5632","1758-1001"],"issn-type":[{"value":"0004-5632","type":"print"},{"value":"1758-1001","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,10,20]]}}}