Assuring quality in point-of-care testing at the Sahlgrenska University Hospital

Anne-Marie Johannesson1,*, Ingrid Uttberg1, Maria Thornemo1

1Sahlgrenska University Hospital, Clinical Chemistry, Göteborg, Sweden

Introduction: In 2010 a public procurement of blood gas analyzers was done within the Västra Götaland region. According to an enforcement from the medical director of Sahlgrenska University Hospital 2012, the Clinical chemistry has the assignment to assure quality in point-of-care testing (POCT) on blood gas analyzers.

Objectives: Prepare for accreditation of the POCT by Quality assurance  according to “ISO 22870: 2006, 

Methods: A customer&POCT team consisting of experienced biomedical scientists was established within the Clinical chemistry laboratory. The team focused on clinical departments performing blood sampling and POCT. Customer suited educations and instructions were formed. Routines were established regarding introducement of the new procured instruments. The team established support both by telephone, remote control, e-mail and  visits to the department. The testresults were autovalidated when the posted criteria were fulfilled e.g. user-id, patient-id and accepted internal controls. The results were shown in the healthcare information system (Central register). The results are traceable with specific analysis codes showing that analyses were performed as POCT.

Results: Customer suited educations have been held for 1 300 persons during 2013. 25 analyzers have been placed as POCT instruments in different departments and are under the clinical chemistry assessment including technical validation. Education, that regularly is updated, has been formed. Customer suited routines and instructions are established at the departments and documented according to the rules of clinical laboratory Quality Assurance. All documentation has been introduced into our Documentation Management Systems  (RMT+).


Conclusion: By forming a customer&POCT team focused on education, preanalytical performance and documented routines a quality assurance for POCT has been established. To further assure the quality in POCT inquiry for accreditation according to ISO 22870:2006 has been done by the Clinical chemistry laboratory. 

Keywords: IT-oriented, Laboratory organization