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Additional Criteria on Point of care (POC) Testing
- General Information
- Quality Policy and Strategy
- Organisation and Management
- Personnel
- Premises and Environment
- Equipment, Materials and Reagents
- Pre-Analytical Phase
- Analytical Phase
- Post-Analytical Phase
- Evaluation of the Quality System
The criteria formulated below are additional to the EC4 Essential Criteria
for Quality Systems of Medical Laboratories that have been published
in Eur J Clin Chem Clin Biochem 1997; 35: 123-132 and should be read
as an integral part of these.
1. General Information
(See Essential Criteria)
2. Quality Policy and Strategy
(See Essential Criteria)
3. Organisation and Management
3.1 Professional staff and other staffing.
The overall responsibility for the provision of POC testing should be with the appropriate laboratory specialist, (e.g. Clinical Pathologist, Clinical Biochemist, Clinical Biologist or Clinical Chemist) from an accredited laboratory. The appropriate laboratory specialist together with a representative of the clinical unit will be responsible for establishing/verifying the clinical need for POC testing. This should depend upon the result of a cost/benefit analysis, on the clinical effectiveness and the cost efficiency of a particular analysis, and on the ability of the laboratory to fulfil that need. There should be an interdisciplinary group on POC testing (laboratory staff (chair) and personnel, clinicians, nurse specialists, pharmacists etc as appropriate) established to organise and manage the different aspects of the service.
4.1 Job descriptions, duties and responsibilities.
The interdisciplinary group on POC testing should allocate responsibilities and designate staff undertaking POC testing. The allocation of duties and responsibilities of different groups of staff should be defined in the operating procedures.
4.2 Education, training and development of staff
The staff designated to undertake POC testing must have received adequate training under supervision of laboratory staff. This should include appreciation of the pre-analytical aspects of the analysis, a demonstrable expertise in the analytical procedure and an understanding of its limitations, operation and maintenance of equipment including cleaning and contamination. Also an understanding of internal quality control and external quality assessment procedures should be included, as well as an appreciation of post-analytical aspects of the analysis, an appreciation of the health and safety issues, and an understanding of the need for proper documentation. Staff who received training must be tested and certified as competent. A register of trained, tested and certified staff must be maintained and include a unique identifier of the competent person, details of instrument used and tests performed, a dated signature of the trainer and trainee. There should be a continuing education programme for certified staff.
5.1 Safety facilities
The premises and environment in which POC testing is undertaken should conform to national legislation with regard to the safety of the personnel and patients.
6. Equipment, Materials and Reagents
6.1 Administration of equipment
The appropriate laboratory specialist from an accredited laboratory should be responsible for the selection criteria for the procurement of equipment, materials and reagents. There should be an inventory of all POC testing equipment including serial number and unique identification, manufacturer, date purchased, service history including dates out of service.
6.2 Instructions for use and maintenance
There must be written procedures for the maintenance and operation of POC equipment.
6.3 Administration of materials and reagents
A record should be maintained of materials and reagents purchased for POC testing which allows an audit trail to be established with regard to a particular test performed.
7. Pre-Analytical Phase
(See Essential Criteria)
8.1 Working procedures
There must be written procedures for all POC testing assays that should include calibration, quality control and assessment procedures and in particular action to be taken when quality control results are outside agreed limits. The relationship between values obtained in the central laboratory and POC testing should be established.
8.2 Quality control and assessment
Where there is a quality assessment scheme available from outside the organisation in which POC testing is taking place, participation is recommended. In the absence of such an EQA scheme, the accredited laboratory should establish an internal assessment scheme, which could involve circulation of specimens or replication of a POC test within the laboratory. The interdisciplinary group should undertake regular reviews of external quality assessment data and incorporate that material in the training and updating programme for staff.
9.1 Archiving
There should be special emphasis on the importance of documentation of all results, including patient results and internal quality control and external quality assessment data. Patient results should be recorded on the analytical work sheet with an indication of the person undertaking the test (and where possible on the central laboratory information system) and in the patient record. Results recorded in the patient record should indicate that the result was obtained by POC testing.
10. Evaluation of the Quality System
10.1 Internal audit
Clinicians and laboratory staff should undertake periodic reviews of
the clinical efficacy of the POC testing services.