EBMD (Outsourced Medical Biology Examinations) have just joined the activities accredited by Cofrac.
This activity, "which is also known under the acronym POCT (point of care testing), concerns the examinations which are carried out outside Medical Biology Laboratories (MBL), in public and private healthcare establishments and which are under the full responsibility of the laboratory", explains Pascale Liger-Garnier, accreditation manager at Cofrac's Healthcare section.
"In the context of medical biology reform in France, regulation now require MBL to be accredited for the medical biology examinations they carry out, including EBMD, making the laboratory clearly responsible for the results provided by this type of examination. In addition, it specifies that these examinations are carried out in care units, only in the context of "urgent therapeutic decisions". The changes to the regulation led to the first requests for accreditation. This activity is accredited according to the requirements of standard NF EN ISO 15189, completed by the requirements of standard NF EN ISO 22870 specific to EBMD.
In practice, these are "small" analysers which are provided to clinical services for urgent examinations that need a result quickly.
The main specific feature of EBMD lies with the fact that the result is read by a clinical doctor for a therapeutic decision to be made without a biologist validating the result first. This means that the MBL, which is responsible for the EBMD, manages and controls the whole examination process.
"Therefore, the establishments that are currently concerned and will be concerned in the coming months are essentially those which have emergency departments, such as resuscitation or obstetric care units to monitor labour", summarises Pascale Liger-Garnier.
The Saint Antoine hospital in Paris (accreditation No. 8-2542) and the Sainte Marguerite hospital in Marseille (accreditation No. 1-1739) are the first two laboratories to be accredited according to this new system.
During the assessment of the MBL in the EBMD context, several essential points are examined by the assessors, such as the designation of the multi-disciplinary examination management group responsible for the EBMD related provisions (laboratory representative, administration, clinical teams), the responsibility for managing equipment when put in place, its inspection and monitoring or even staff training. "This last point concerning training is crucial and is more difficult to control by the MBL", insists Pascale Liger-Garnier. "In fact, the staff who carry out these examinations belong to the clinical departments (interns, nurses, etc.) and are not directly attached to the laboratory. Also significant staff turn-over must be anticipated as much as possible, so that all new arrivals are well-trained and approved by the laboratory for using the equipment they will need to handle. This point is checked during the accreditation evaluation with a visit to the clinical departments concerned". During these assessments, Cofrac calls on technical assessors whose skills are recognised in this activity.
New perspectives are emerging through this new activity and due to new regulations. "We are receiving new accreditation requests in reproductive biology (biological medical procreation assistance activities) or in anatomy and pathological cytology (examinations carried out on tissue: biopsies, smear tests.)
New technical accreditation guides are being drafted to facilitate the MBL's entrance into the accreditation process for these activities and to guarantee harmonisation of technical assessors", specifies Pascale Liger-Garnier.