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Point of Care Testing (POCT)
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IFBLS Position Paper

Point-of-Care Testing (PoCT)

Definition

Point-of-Care Testing (PoCT) refers to diagnostic and monitoring pathology testing performed in close proximity to a patient, by healthcare professionals who have received appropriate laboratory training. When supported by appropriate supervision, training, and governance, PoCT can contribute to timely clinical decision-making and improved patient outcomes by enabling rapid access to results.

Scope

The increasing availability of PoCT technologies has expanded their use across many healthcare settings including but not limited to acute, community, and remote care. Its use should be limited to situations where the immediate availability of results provides a clear and meaningful benefit to patient management and where appropriate supervision and quality controls are in place.

Patient self-testing is outside the scope of this position paper.

The IFBLS takes the following position:

  • Point-of-Care Testing is an integral component of biomedical laboratory science practice, requiring structured supervision and oversight by laboratories, compliant with accreditation and regulatory requirements to support safe and reliable testing.
  • Biomedical Laboratory Scientists are responsible for the scientific and quality governance of PoCT services, including the establishment of supervisory frameworks, operator competency requirements, implementation of a quality management system, and ongoing performance monitoring, regardless of where testing is performed.
  • PoCT results are generally not accredited laboratory results; however, certain PoCT services (such as blood gas analysis) may operate within the accredited scope of a medical laboratory. In all cases, PoCT must be governed through laboratory-led quality and supervisory frameworks to ensure results are clinically reliable and fit for their intended use.
  • Personnel performing PoCT must be appropriately trained, competent, and authorised, to operate the devices, with training and competency assessment that is documented, device-specific, and maintained in accordance with recognised best practice for supervised PoCT services.
  • PoCT services must operate within a defined quality management framework, incorporating a risk-based approach to quality control, including internal quality control, participation in external quality assessment where appropriate, documented management of errors or non-conformities, and ongoing monitoring of operator and device performance.
  • The selection and use of PoCT devices must be subject to formal evaluation and approval processes, ensuring that equipment performance, operating conditions, and limitations are appropriate for the intended clinical context and user group.
  • PoCT results must be traceable and clearly identifiable, with documented processes for result recording, reporting, and information management that support patient care, audit, and medico-legal requirements.
  • PoCT services must incorporate risk management and safety considerations, including defined supervisory responsibilities, mechanisms for identifying and addressing errors or hazards, and alignment with organisational clinical governance structures.


Conclusion

PoCT is a valuable component of modern healthcare delivery when implemented within a supervised, laboratory-led governance framework. IFBLS affirms that Biomedical Laboratory Scientists play a central role in ensuring PoCT services are designed, supervised, and managed in a manner that supports patient safety, clinical reliability, and professional standards, consistent with international standards and national pathology policies.

View the IFBLS Position Paper on Point of Care Testing (2026)

 

 

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In 2008 members from the International Federation of Biomedical Laboratory Science (IFBLS) and the European Association for Professions in Biomedical Science (EPBS) took on the task to prepare guidelines for our members on Point of Care Testing.  

The Guidelines for Point of Care Testing and the EPBS Policy Statement approved at their annual meeting in October 2009 in Oslo were distributed as part of the Congress documents prior to Congress. Both documents serve an important purpose and were unanimously adopted by GAD 2010 Nairobi, Kenya.

 

View the IFBLS Position Paper on Point of Care Testing (2018)
View the IFBLS Guidelines on Point of Care testing (2010)
View the EPBS and IFBLS Policy Statement on Point of Care Testing (2010)

 

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Point of Care Testing (POCT)
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IFBLS Position Paper on Patient Safety

Revised: July 2026


The World Health Organization (WHO) identified patient safety as a global health priority in 2002. This mission has been fundamentally transformed by the WHO Global Patient Safety Action Plan 2021–2030, which shifts the focus from reactive error management to proactively building high-reliability health systems.

Modern healthcare delivery, including public health, must be safe, effective, person-centred, timely, efficient, and equitable. This requires laboratory services that are not only analytically accurate but also digitally secure, clinically appropriate, and underpinned by a robust safety culture. In this context, Biomedical Laboratory Scientists (BLS) are essential contributors to patient safety, leveraging their expertise across all laboratory phases. Following ISO 15189:2022, they ensure that the total examination process*—including point-of-care testing (POCT)—prioritizes clinical outcomes and overall patient well-being.

In light of evolving global standards, it is imperative for IFBLS to align its Position Paper on Patient Safety from 2020 with the new paradigms introduced by the WHO Global Patient Safety Action Plan 2021–2030 and the internationally recognized standards, such as ISO 15189:2022. The traditional approach based on reactive error management is no longer sufficient; modern laboratory medicine demands the systematic integration of proactive risk management, the promotion of a just culture, and leadership in diagnostic stewardship. This alignment ensures that BLS act not merely as providers of analytical data, but as essential guarantors of clinical suitability and digital security throughout the total examination process. By revising this position, IFBLS reaffirms its commitment to patient well-being as the ultimate priority, transforming laboratory practice into a cornerstone of a high-reliability healthcare system.

Note: *Total examination process (or the total testing process) is a comprehensive framework used primarily in clinical, medical, and public health laboratory settings to ensure accurate, efficient, and quality patient care. It encompasses the entire lifecycle of a test, spanning from the initial clinical question to the final interpretation of results (pre-examination processes, examination processes and post-examination processes).

It is the position of IFBLS that BLS:

1. Establish a safety and just culture
BLS are leaders in fostering an environment where safety is the ultimate priority, and this is done by: 

  • promoting a shared safety culture across laboratory teams and multidisciplinary partners, focused on preventing patient harm.
  • engaging in scientific research and quality improvement to identify safety risks, reduce preventable harm, and strengthen diagnostic safety.
  • advocating for non-punitive error reporting systems and structured safety learning frameworks. This ensures that personnel are encouraged to report "near-misses" without fear of retribution, focusing on systemic improvements rather than individual blame.
  • recognizing that patient safety is inextricably linked to health worker safety, BLS include workforce resilience and mental health support as essential components of laboratory safety systems.

2. Responsibility for the safety of the total examination process
BLS are responsible for ensuring safety across all laboratory phases by:  

  • Implementing risk-based thinking by applying a comprehensive risk management framework (e.g., ISO 15189:2022) and monitoring standardized laboratory quality indicators to identify, assess, and mitigate potential harm before it reaches the patient.
  • ensuring pre-analytical Integrity by adhering to relevant international standards and guidelines (e.g., CLSI PRE01 and CLSI PRE02) to guarantee robust patient identification, specimen stability, and minimization of diagnostic errors at the source.
  • ensuring examination and post-examination quality by validating examination processes rigorously and ensuring that post-examination processes prioritize the accurate and timely reporting of results to safeguard patient safety.
  • implementing a robust digital health governance framework that includes cybersecurity safeguards for laboratory information systems (LIS) to prevent diagnostic delays and protect patient privacy, alongside rigorous validation and transparency frameworks for artificial Intelligence (AI) to ensure data integrity and clinical safety throughout the examination process.
  • ensuring closed-loop communication of critical results to prevent diagnostic delays and ensure timely clinical intervention.

3. Responsibility for clinical effectiveness and efficiency
BLS ensure the clinical value of laboratory medicine by:

  • providing consultative expertise to clinicians to ensure the appropriate use of tests, preventing both over-utilization and under-utilization of resources.
  • optimizing Turnaround Times (TAT) by utilizing validated, high-quality analytical methods and automation to ensure rapid delivery of results.
  • leveraging technology to provide interpretative information that ensures maximum clinical benefit and timely intervention for the patient.
  • promoting environmental sustainability by implementing "Green Laboratory" principles by optimizing resource consumption, reducing chemical waste, and improving energy efficiency without compromising diagnostic quality.
  • utilizing Evidence-Based Laboratory Medicine (EBLM) to validate and verify new technologies, including AI-driven diagnostics and personalized medicine.
  • maintaining high standards for qualifications and mandatory Continuing Professional Development (CPD) focused on human factors and safety science.
  • eliminating defects through Continuous Quality Improvement (CQI), and real-time monitoring of quality indicators.
  • establishing diagnostic stewardship programs and test utilization management to ensure the right test is performed for the right patient at the right time.
  • ensuring the integrity and full traceability of data from the point of collection to the final interpretative report.
  • demonstrating laboratory leadership in clinical decision support through multidisciplinary collaboration with clinicians, pharmacists, and other healthcare professionals to optimize patient outcomes.

4. Responsibility for equity and person-centred care
BLS uphold ethical standards and patient rights by:

  • ensuring ethical handling of biological samples and respecting the patient’s right to informed consent and confidentiality, in accordance with IFBLS professional codes and relevant national and international standards.
  • expanding safety protocols to include precision medicine safety and the ethical management of genomic data, providing interdisciplinary interpretation support for complex diagnostic data.
  • strengthening diagnostic equity and supporting global laboratory capacity building to ensure laboratory infrastructure resilience in all healthcare settings.
  • providing clear, accessible and patient-friendly information regarding specimen collection and the clinical significance of laboratory investigations to the service users.

 

References:

  1. Clinical and Laboratory Standards Institute. Collection of Diagnostic Venous Blood Specimens. 8th ed. CLSI guideline PRE02. Wayne, PA: CLSI; 2025. Available from: https://clsi.org
  2. Clinical and Laboratory Standards Institute. Laboratory Quality Control Based on Risk Management. 2nd ed. CLSI guideline EP23. Wayne, PA: CLSI; 2023. Available from: https://clsi.org
  3. Clinical and Laboratory Standards Institute. Patient and Laboratory Specimen Identification Processes. 1st ed. CLSI guideline PRE01. Wayne, PA: CLSI; 2024. Available from: https://clsi.org
  4. International Federation of Biomedical Laboratory Science. Code of Ethics. Hamilton, ON: IFBLS; 2026. Available from: https://www.ifbls.org
  5. International Federation of Biomedical Laboratory Science. IFBLS Guidelines for Core Competence. Hamilton, ON: IFBLS; 2022. Available from: https://www.ifbls.org
  6. International Federation of Biomedical Laboratory Science. Position Paper - Point of Care Testing. Hamilton, ON: IFBLS; 2026. Available from: https://www.ifbls.org
  7. International Laboratory Accreditation Cooperation. Guidance on the transition to ISO 15189:2022. ILAC; 2023. Available from: https://ilac.org
  8. International Organization for Standardization. ISO 15189:2022 Medical laboratories — Requirements for quality and competence. 4th ed. Geneva: ISO; 2022. Available from: https://iso.org
  9. John GK, Favaloro EJ, Austin S, Islam MZ, Santhakumar AB. From errors to excellence: the pre-analytical journey to improved quality in diagnostics. A scoping review. Clin Chem Lab Med. 2025 Jan 28;63(7):1243-1259.
  10. Kumah A. Adverse event reporting and patient safety: the role of a just culture. Front Health Serv. 2025;5:1581516.
  11. Murray JS, Merchant NB. Promoting “just culture” among health professions learners in the clinical environment. Educ Health Prof. 2023;6(2):80-3.
  12. National Academies of Sciences, Engineering, and Medicine. Improving Diagnosis in Health Care. Washington, DC: National Academies Press; 2015.
  13. World Health Assembly. Resolution WHA55.18: Quality of care: patient safety. Geneva: WHO; 2002. Available from: https://apps.who.int/gb/ebwha/pdf_files/wha55/ewha5518.pdf
  14. World Health Assembly. Resolution WHA72.6: Global action on patient safety. Geneva: World Health Organization; 2019. Available from: https://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_R6-en.pdf
  15. World Health Organization. Charter: Health worker safety: a priority for patient safety. Geneva: WHO; 2020. Available from: https://www.who.int/docs/default-source/world-patient-safety-day/health-worker-safety-charter-wpsd-17-september-2020-3-1.pdf
  16. World Health Organization. Global patient safety action plan 2021–2030: Towards eliminating avoidable harm in health care. Geneva: WHO; 2021. Available from: https://who.int

 

 

View the IFBLS Position Paper on Patient Safety (July 2026)