POCT under ISO 15189: who is responsible?
Point-of-care testing (POCT) is testing close to the patient, such as a glucose meter on a ward or a blood gas analyser in intensive care. Since ISO 15189:2022, POCT falls under the same standard as the laboratory itself, and the separate standard ISO 22870 no longer applies. The laboratory remains responsible for quality, even when the device stands outside the lab. The RvA , the Dutch Accreditation Council, therefore assesses POCT during accreditation.
The difference from the old situation is big enough to arrange it carefully. Read the transition to ISO 15189:2022 first for the changes. For the main outline of the standard, start with what ISO 15189 is.
Short answer: the laboratory is responsible for POCT, even when the meter stands on a ward and nurses use it. Whoever operates the meter follows a laboratory procedure. The laboratory monitors the quality and records it.
What exactly is POCT?
POCT is any test carried out outside the laboratory that supports a decision about a patient. These are tests with a hand-held meter, a cartridge or a small device. They are fast and practical, but they are not reliable by default.
Examples from practice: a glucose meter on a ward, a blood gas analyser in the emergency department, or a quick urine test in the outpatient clinic. Each of those meters is a POCT device that the laboratory has a role in.
What changes with ISO 15189:2022?
In the 2012 version, POCT was in a separate standard, ISO 22870. In the 2022 version, POCT is included in ISO 15189, and ISO 22870 no longer applies. This means you no longer justify your POCT activities with a separate standard. They belong to the laboratory’s management system.
This change has a practical consequence: the assessor looks at POCT in the same audit as the laboratory. According to the RvA accreditation specification ASR101 , the way POCT is shown in the scope has been adjusted. Within the cycle, the RvA also checks a sample of the POCT sites. It wants to see that the meters, the users and the records are under control.
Who does what?
Several groups work together on POCT. It is sensible to record for each role what is expected of that person.
| Role | Responsibility |
|---|---|
| Laboratory | Ultimately responsible for the quality of the POCT and for supervising it |
| POCT coordinator | Day-to-day management of the meters, records and users |
| Head of ward | Makes sure staff are trained and follow the procedure |
| User (nurse) | Carries out the test according to the procedure and records the result |
| Supplier | Provides maintenance, software updates and user instructions |
Set the roles down in writing and have those involved sign to agree. For a meter, the assessor often asks who the coordinator is.
Example: a POCT register
The following is a fictional register for glucose meters on the wards of a hospital. It shows which data you record for each meter.
| Meter | Location | Responsible | Last quality control | Last maintenance | Users with authorisation |
|---|---|---|---|---|---|
| GM-01 | Ward A, nurses’ station | POCT coordinator | Today, check within limits | Last month | 14 |
| GM-02 | Ward B, day room | POCT coordinator | Yesterday, check within limits | Three months ago | 9 |
Each meter has its own line. A meter without a record of the last check is a finding. Make sure the register is immediately clear to the assessor.
Which requirements apply to the user?
The user must be authorised. That means documented training, and a login that only works for staff with valid authorisation. A user who operates the meter without training produces a result you cannot defend.
Quality control is also part of the process. A meter that is not tested with control material gives wrong results without anyone noticing. Record how often the check is done, and what you do when a check falls outside the limits.
For authorisation and training, see training and competence.
Common mistakes
Forgetting POCT in the scope. A meter that stands on a ward but is not on the list of examinations does not fall under the accreditation. Check the list.
No owner. If nobody is in charge, the checks disappear. Appoint a coordinator with a clear task.
Records kept outside the system. A paper log next to the meter that is not kept counts as not recorded in the assessment.
The supplier as the only one responsible. A supplier provides the device, but the laboratory remains responsible for how it is used.
Software updates without a check. An update to the meter can change the measured values or the settings. Check the quality after every update and record the result.
Users sharing a meter without a login. Without a personal login, you cannot later tell who carried out the measurement. That makes the authorisation check impossible.
How do you handle a meter that gives wrong results?
A meter that gives an unexpected value is a signal. The cause may lie with the meter, the test strip or cartridge, the user or the patient. The procedure must describe how you find out and who decides.
A workable order is: stop using that meter for patient work, check with control material, compare with a laboratory measurement of the same sample, and record the result. For a deviation that is not explained, report it as a deviation and start a root cause analysis.
Also make sure the user knows what to do. A nurse who does not trust a meter but uses the result anyway is a risk to the patient. That is exactly the kind of risk the 2022 version of the standard puts at the centre.
How do you handle a meter that is removed from the ward or replaced?
This also belongs in the register. A meter that is replaced gets a new line with the new quality control and the new responsible person. The old line is kept, so you can later see which meter was in use when.
A new meter also needs validation before you put it into use. Compare the results with the laboratory over a series of samples, and record the outcome. See training and competence for the authorisation of the users of that new meter.
How do you start?
Start with a list of all the meters in the hospital or the laboratory. Note the location, the responsible person and the last check for each meter. Then write the procedure and set the authorisations.
See also the audit page for what the assessor asks about a meter, and critical results if a POCT result must lead to immediate action.