ISO 22870:2016 pdf free
ISO 22870:2016 pdf free.Point-of-care testing (POCT) – Requirements for quality and competence
The quality manager is responsible for the design, implementation and operation of quality control that ensures POCT conforms to the quality standards of the central laboratory. The relationship between values obtained in the laboratory and POCT shall be established and published or available upon request.
The quality manager may assign responsibility for quality control on a specific POCT instrument/system to an appropriately qualified person. When such activities are assigned, the quality manager shall remain accountable to the laboratory director, or designated person, for the quality of all POCT testing.
Where available, participation in an external quality assessment (EQA) shall be required (see ISO/IEC 17043). In the absence of an EQA scheme, the laboratory director, or designated person, should establish an internal quality assessment scheme involving the circulation of samples or replication of the test within the laboratory.
The laboratory director, or designated person, and the multidisciplinary POCT management group shall receive and review the external or internal quality assessment data. Suggested modifications arising from such review shall be incorporated into the POCT policy, processes, and procedures.
The laboratory director shall validate the following processes for service provision.
a) Trueness and precision and, where appropriate, linearity of the instrument response shall be verified by the QC programme.
b) Split patient samples, or other acceptable QC materials, shall be used to verify performance of POCT systems used in multiple sites.
c) Frequency of internal QC should be specified for each device.
d) Corrective action to be taken for out-of-control results shall be documented.
e) Action taken on nonconforming QC results shall be documented.
f) QC results shall be recorded for regular review by the quality manager or designated person.
g) Process control for consumable supplies and reagents shall be documented and monitored.
h) In-patient self-testing using POCT devices, if allowed, shall be monitored to validate the accuracy and comparability of the results to those of the central laboratory.ISO 22870 pdf download.
