Templates and records · ISO 15189 · Clause 6.7.2

ISO 15189 point-of-care testing (POCT) agreement

Ward glucose meters, ICU blood gas analysers or primary care coagulometers: who is accountable for them when the laboratory oversees them, and what has been agreed with those who use them.

In one sentence

The point-of-care testing agreement sets out, between the laboratory and each service using POCT devices under its oversight, the scope of testing, the responsibilities and authorities of each party, training and authorisation of operators, internal and external quality control, recording of results and incident management, because clause 6.7.2 of ISO 15189:2022 requires agreements defining those responsibilities and the standard incorporates the requirements that previously sat in ISO 22870.

Content reviewed on 17 October 2026

Where the standard requires it: ISO 15189 · Clause 6.7.2 Clauses are cited using the numbering of ISO 15189:2022, the edition in force since the transition ended in December 2025 and the same one the Academy uses.
Type of information: Mandatory document Documented agreement with users of point-of-care testing (6.7.2)
Who fills it in: Laboratory director and head of each service The laboratory's POCT coordinator keeps it up to date
When: Before each device is brought into use Reviewed when devices, tests or staff change, and at least annually
How long it is kept: Set by the laboratory ISO 15189 asks for the retention time of each record to be defined, taking into account legal and user requirements (8.4). Those forming part of the medical record also follow the applicable health regulations.

What the standard requires

What ISO 15189 demands and what it leaves to your judgement

Where the laboratory is responsible for testing carried out outside it, at the patient's side, the standard requires agreements with the services performing it that define responsibilities and authorities. With the 2022 edition, this testing forms part of the laboratory's accreditation and follows the same quality principles.

The agreement is the tool that ensures nursing or medical staff using the devices are trained and authorised, that controls are run and reviewed, and that results are recorded and identified with the patient and the operator.

The standard does not set a format. The practical approach is a framework agreement with annexes per service listing devices, tests, authorised operators and control frequencies.

Read it in context: Resource requirements, in the ISO 15189 Academy

Structure

Fields the template should include

Service, location and person responsible
Devices and tests included
Responsibilities of the laboratory and the service
Training, assessment and authorisation of operators
Internal quality control: frequency and owner
Participation in external quality assessment
Recording and identification of results with patient and operator
Maintenance, incidents and withdrawal of the device
Indicators and review of the agreement

Example

Example: blood gas analyser in an intensive care unit

Company, people and figures are fictitious: the example only shows what a properly completed record looks like.

Field	Content
Service	Hospital ICU (fictitious) · head of service and nursing supervisor
Device	1 blood gas analyser with lactate and electrolytes
Laboratory	Initial verification, control review, lot management and external assessment
Service	Use by authorised operators, daily maintenance and incident reporting
Operators	38 trained nurses · authorisation renewed every 2 years · access by personal code
Control	3-level internal control every 8 hours · weekly laboratory review
External assessment	Blood gas scheme, 6 distributions a year
Review	Annual · most recent on 10 January 2026

At the audit

Mistakes auditors commonly flag

Operators using the device with no recorded training or authorisation.
Quality controls that nobody in the laboratory reviews.
POCT results not linked to the patient or the operator.
POCT devices outside any external assessment.
An agreement signed once and never reviewed.

In Kimobox

How this record is kept in Kimobox

1The agreement is kept as a controlled document, with versions and read receipts for each service's staff.
2Operator training and authorisation are recorded in the employee portal.
3Calibration and maintenance of each device are scheduled with automatic reminders.

Frequently asked questions

What people ask us before getting started

Is ISO 22870 still in force?

No. Its requirements were incorporated into ISO 15189:2022 and the standard was withdrawn. Point-of-care testing under the laboratory's responsibility is accredited within ISO 15189.

Is the laboratory responsible for every POCT device in the hospital?

Only those under its responsibility according to how the centre is organised. For those, ISO 15189 requires agreements with the user services.

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