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Setting up a POC testing workflow and Guidelines - Nisarat Opartkiattikul
In this informative webinar for the Roche Point of Care Academy, Prof. Nisarat shares her own experience of implementing a new POCT workflow and how her hospital’s journey to ISO22870 accreditation has influenced Thailand’s national guidelines.
It started with an emergency
At the beginning of the webinar, Prof. Nisarat recounts a patient case from 2005. A 60-year-old male was admitted to the emergency room at Siriraj Hospital in a coma. According to the non-connected blood glucose meter, he was within the normal range.and was sent to get a CT scan. However, the blood sample results from the central lab revealed that his blood glucose levels were too low, indicating hypoglycaemia. The patient was then treated and regained consciousness.
Prof. Nisarat shares this story to highlight the motivation behind introducing a new POCT workflow. The reason for the big discrepancy was that the ER had been using expired strips. At the time the Clinical Chemistry department was not involved in the glucose testing done at the patient bedside.
Ten steps to making significant changes
From 2007-2019, the POCT processes at the hospital underwent a transformation, one that led to improved internal quality control and increased patient, nurse and doctor satisfaction. It’s a process that Prof. Nisarat consolidates into ten steps, which she explains in more detail in the webinar:
- Situation analysis
- Studying international standards (CAP/JCI regulations)
- Performing a pilot
- Establishing a POCT committee
- Setting up policy & criteria for selection
- Purchasing
- Appointing POCT multidisciplinary team
- Implementation
- Evaluation / Opportunities for improvement
- ISO 22870 accreditation
Obtaining ISO 22870 accreditation
Siriraj Hospital received ISO 22870 accreditation in 2009. It was the first hospital in Southeast Asia to do so. This standard specifically refers to competency and quality in POCT and is intended to be used alongside ISO 15189 (the medical laboratories standard). You can find out more about the details of ISO 22870 here.
Beyond blood glucose monitoring
Today, if other departments want to set up POCT, there is a process that involves key stakeholders, a review of the benefits and a process for instrument selection. Once approved, there is a POCT office to manage instructions and training, plus a requirement for the department to submit annual reports.
Creating Thailand’s National POCT guidelines
After the transformation at Siriraj Hospital, Prof. Nisarat was invited, along with 17 other experts, to create the guidelines for Point of Care Testing in Thailand.
Prof. Nisarat acknowledges that meeting the standards of ISO 22870 accreditation may be out of reach for many of the hospitals in Thailand. Therefore, the guidelines have been created to support all hospitals so that it is possible to improve and standardise POCT operations at a national level. You can learn more about the resulting guidelines towards the end of the webinar.
The views and opinions expressed in this webinar are those of the speakers and do not necessarily reflect the views or positions of Roche or any other sponsors.
Biography
Prof. Nisarat is Chairperson of the Siriraj Institutional Review Board and was formerly Head of the Department of Clinical Pathology at Siriraj Hospital. She has held various positions as chairperson for national and international committees in pathology, with an interest in point of care. She has published over 90 national and international papers in clinical pathology and lab quality improvement.
Key points
- Implementing a POCT workflow under supervision of the laboratory has the potential to save time and costly diagnostic tools (for example the CT scan)
- It is important to fully understand the existing issues before trying to implement a new workflow and this includes being aware of international standards
- Training is crucial and has a significant impact on results
- Devices should be compared for precision and accuracy, and support connection to IT
- Key success factors: Good standards, good technology, good personnel, good communication and collaboration
Further reading
ISO. (2016-11). ISO 22870:2016 Point-of-care testing (POCT) Requirements for quality and competence.
https://www.iso.org/standard/71119.html (last accessed Oct 2022)Bureau of Laboratory Quality Standards. (2015). Thailand’s National Guidelines for Point-of-Care Testing.
http://blqs.dmsc.moph.go.th/assets/Userfile/POCTguideline.pdf (last accessed Oct 2022)Luenee P et al. (2021). Point-of-care Glucose Testing: Thirteen-year Experience of Quality Improvement at the 2,000 Bed Medical School Hospital. J Med Tech Assoc Thailand, Vol. 49 /no.1 April 2021.
https://he01.tci-thaijo.org/index.php/jmt-amtt/article/download/250972/169636/928986 (last accessed Oct 2022)Clinical and Laboratory Standards Institute (CLSI). (2006). Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline - Second Edition. CLSI POCT4-A2. Vol.2 No.30.
https://webstore.ansi.org/Standards/CLSI/pocta2-1157081 (last accessed Oct 2022)Clinical and Laboratory Standards Institute (CLSI). (2006). User Verification of Performance for Precision and Trueness; Approved Guideline - Second Edition. CLSI EP15-A2 (ISBN1-56238-574-7).
https://webstore.ansi.org/preview-pages/CLSI/preview_EP15-A2.pdf (last accessed Oct 2022)Burnett D. (2000). Accreditation and point-of care testing. Ann Clin Biochem 2000;37:241-243.
https://journals.sagepub.com/doi/10.1258/0004563001899203 (last accessed Oct 2022)Francis AJ and Martin CL. (2010). A practical example of POCT working in the community. Clin Biochem Rev 2010;31:93-97.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2924129/ (last accessed Oct 2022)Gill JP and Shephard MDS. (2010). The conduct of quality control and quality assurance testing for POCT outside the laboratory. Clin Biochem Rev 2010;31:85.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2924127/ (last accessed Oct 2022)AACB. (2019). Point of Care Testing Implementation Guide. Australasian Association of Clinical Biochemists.
https://www.aacb.asn.au/documents/item/155 (last accessed Oct 2022)