Point-of-care testing (POCT) is testing performed near the patient, outside the central laboratory, where the result can change care straight away. Under ISO 15189:2022, POCT overseen by an accredited laboratory must follow the same quality principles as laboratory testing: clear governance, suitable devices, competent operators, quality control, external quality assessment and complete records.
This matters because POCT is usually done by nurses and doctors, not laboratory scientists, across many locations. A wrong glucose or INR result at the bedside goes straight into a treatment decision, often with no second check. POCT is frequently where hospital assessments find the most gaps.
What counts as POCT
- Blood glucose meters on wards, in emergency departments and clinics
- Blood gas and electrolyte analysers in intensive care, theatres and neonatal units
- INR meters in anticoagulation clinics
- Urine dipsticks and pregnancy tests in emergency and outpatient areas
- Rapid antigen tests for respiratory infections and other targets
Simple-looking tests are not low-risk tests. A dipstick read in poor light, or a rapid antigen test read outside the stated time window, can mislead just as easily as a poorly maintained analyser.
POCT in ISO 15189:2022
POCT requirements were previously published separately in ISO 22870:2016. The 2022 revision brought them into ISO 15189 itself, mainly through Annex A, which sets additional requirements for POCT. The core expectations are defined governance with clear responsibilities, a documented quality management approach, and a training and competency programme for every operator.
The laboratory normally provides scientific oversight, while clinical areas remain responsible for day-to-day use. How POCT scope is assessed varies, so confirm with your accreditation body (for example EIAC or DAC in the UAE, or NABL in India) and check any health authority requirements, such as those of DHA, DOH Abu Dhabi or MOHAP.
Governance and device selection
The POCT committee
Most hospitals meet the governance requirement through a multidisciplinary POCT committee: a senior laboratory scientist, a POCT coordinator, nursing leadership, clinicians from the main user areas, biomedical engineering, IT, infection control and procurement. It approves which tests are done where, signs off devices, sets training, QC and EQA policies and reviews performance. Write down its terms of reference and keep minutes, because an assessor will ask who can say no to a new device.
Choosing and verifying devices
First ask whether POCT is genuinely needed. If the laboratory can deliver the result in time, POCT adds cost and risk without benefit. If it is justified, assess devices for intended use in your patient groups, known interferences (such as haematocrit for glucose meters), operator lockout, QC and EQA availability, connectivity and compatibility with your disinfectants.
Before go-live, the laboratory verifies performance, usually precision and comparison with the laboratory method. Note that ISO 15197:2013 covers glucose systems for self-testing by patients. Hospital use, especially in critically ill patients, needs a device whose intended use covers that setting.
Operator training and competency
Every operator should be trained, assessed as competent and then authorised for each specific device. A good programme combines a practical session, a short knowledge check and an observed test with QC, recorded per operator. Competency is reassessed at defined intervals and after long absence or a device change.
Many devices support operator lockout: only staff with a current competency record can run a patient test. This turns a paper rule into a hard stop. Our guide to staff competency assessment covers assessment methods in more detail.
IQC, EQA and connectivity
Internal quality control works as it does in the laboratory: run control material, compare with acceptance limits, and do not release patient results while QC is failing. Frequency depends on the device, the manufacturer's instructions and your risk assessment. Many hospitals run liquid controls on glucose meters each day of use and after a new strip lot. Devices with built-in electronic checks still need a written policy on liquid QC.
Enrol each POCT test in a suitable external quality assessment (EQA) scheme where one exists, and rotate samples between operators and sites so the scheme tests real practice. Where no scheme exists, use split-sample comparison with the laboratory. See internal quality control in medical labs and EQA vs proficiency testing for the principles.
Connected devices send patient results, QC results and operator IDs through middleware into the laboratory or hospital information system, removing transcription and giving the coordinator a live view of compliance. Whatever the technology, keep records of device inventory, strip and control lots, QC, EQA, maintenance, operator competency and every patient result linked to patient and operator.
POCT risks and controls
| Risk | Example | Control |
|---|---|---|
| Untrained operator | Agency nurse uses a meter without training | Operator ID with lockout; competency list per ward |
| QC not performed | Meter used for days without QC | QC lockout; daily compliance report from middleware |
| Expired or poorly stored strips | Opened vials kept in a hot store room | Lot and expiry tracking; storage checks during audits |
| Wrong patient | Result filed on another patient's record | Barcode wristband scanning; two-identifier check |
| Result not recorded | Value given verbally only | Connectivity to the patient record; result audits |
| Device outside intended use | Self-testing meter used in ICU | Device approval by the POCT committee |
| Cross-infection | Shared meter not cleaned between patients | Cleaning procedure with approved disinfectant; spot checks |
Worked example: ward glucose meters in a Dubai hospital
A 300-bed private hospital in Dubai is replacing a mix of older glucose meters on 14 wards with one connected model. Its last ISO 15189 assessment raised findings on missing QC records and untrained users.
The POCT committee approves the project and appoints a coordinator from the chemistry section. The laboratory verifies precision and compares the meter with the laboratory glucose method using patient samples across the range, including low values. The manufacturer's haematocrit and interference statements are reviewed with the ICU team before ICU use is approved.
Link nurses on each ward are trained first and then support their colleagues. Each operator completes e-learning, a practical session and an observed test, and their staff number is enabled only after the coordinator signs off. Meters lock if QC has not been run that day or if the operator's competency has expired.
After three months, the middleware report shows near-complete QC compliance, with missed days traced to specific meters. Two meters with repeated QC failures are withdrawn and investigated with the supplier. At assessment, the team shows governance minutes, verification data, operator lists, QC and EQA records and corrective actions in one place.
Common mistakes
- Letting wards buy devices without POCT committee approval
- Treating POCT as only a nursing issue, or only a laboratory issue
- Training staff once and never reassessing competency
- Sharing operator IDs on a ward
- Running QC but never reviewing the data
- Skipping EQA because the device has electronic checks
- Using a self-testing meter in critical care without checking intended use
Key takeaway: ISO 15189:2022 expects POCT to run as a controlled extension of the laboratory. Get governance right first, select devices for their intended use, lock out untrained operators and missed QC, and keep every result traceable to a patient, an operator and a device.
Frequently Asked Questions
Is ISO 22870 still used for POCT?
ISO 15189:2022 now includes the POCT requirements that were previously published in ISO 22870:2016, so laboratories on the 2022 edition are assessed on POCT through ISO 15189 itself. Some organisations still refer to ISO 22870 for background. Check with your accreditation body how it defines POCT scope and which documents it uses.
Who is responsible for POCT in a hospital?
Responsibility is shared. Hospital leadership sets governance, usually through a multidisciplinary POCT committee. The laboratory provides scientific oversight, device verification, QC and EQA review and training support. Clinical areas are responsible for correct use, following procedures and keeping operators competent. These roles should be written down and agreed by everyone involved.
How often should QC be run on glucose meters?
There is no single frequency that applies everywhere. Follow the manufacturer's instructions, your risk assessment and any accreditation body or health authority requirements. Many hospitals run liquid QC on each day of use, and also after opening a new strip lot, after a meter is dropped or when a result looks doubtful.
Do POCT devices need external quality assessment?
Yes, where a suitable scheme exists. EQA shows whether a device and its operators produce results comparable with other users. Rotate samples between operators and sites so the scheme reflects real practice. If no scheme exists for a test, use an alternative such as regular split-sample comparison with the laboratory method.
Next steps
To build the quality system that POCT relies on, explore our ISO 15189 Advanced: Medical Laboratory Quality & Competence course. If you would like help choosing where to start, speak to a counsellor.
For related reading, see our ISO 15189:2022 checklist for medical labs and critical results reporting in clinical labs.
Looking for structured certification?
Explore Innoryx courses or speak to a counsellor about the right program for you.