IN THE MANAGEMENT OF PROBLEMS WITH EQA PERFORMANCE OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
Drafted for Joint Working Group on Quality Assurance by BIVDA/EQA Forum
INTRODUCTION
These Guidelines are for use by External Quality Assessment (EQA) Scheme Organisers when dealing with analytical performance which appears to be a feature of the method employed and not a result of participants’ errors that could otherwise result in their referral for poor performance to a National Quality Assurance Panel (NQAAP). Such situations are best approached through constructive co-operation between all parties. However, Scheme Organisers must ensure that they do not breach the confidentiality that exists between the Scheme and all participants as defined by the Joint Working Group on Quality Assurance(1) , nor inappropriately divulge commercially sensitive information.
The Guidelines will be made available to Scheme Organisers, product suppliers and regulators.
Scheme Organisers are encouraged promptly to report adverse incidents to the Medical Devices Agency (MDA) in accordance with the requirements in the first Safety Notice of each year (2).
An adverse incident is defined as “an event which gives rise to, or has the potential to produce unexpected or unwanted effects involving the safety of patients, users or other persons” (2). This includes incidents associated with in vitro diagnostic medical devices, which may be instruments, reagents and associated software. Unexpected or unwanted effects might include delayed or inappropriate diagnosis or treatment.
MDA, an Executive Agency of the Department of Health, has responsibility to:
“take all reasonable steps to protect the public health and safeguard the interest of patients and users by ensuring that medical devices and equipment meet appropriate standards of safety, quality and performance and that they comply with relevant Directives of the European Union”
This, the Agency’s aim, has been approved by the Secretary of State for Health and is described in detail in the Agency’s Business Plans. (3)
PROCEDURE
If the Scheme Organiser, using professional judgement, detects an apparent problem (including a change) in EQA performance for a particular measurement procedure, the actions listed below may be activated. It is not expected that all of these actions will be essential to any given case, nor are the actions listed in order of importance.
Phase 1) Investigating the extent
If a significant number of participants in the category show the problem or change the Scheme Organiser should commence an investigation in collaboration with the manufacturer/supplier, other relevant Scheme Organisers, MDA and (where relevant) participants whose performance had previously been considered as being satisfactory. Amongst the actions that might be undertaken are:
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examine individual data for members of the method/instrument group to determine how many show the problem
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check company information for product changes that could be affecting performance
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contact laboratories affected to enquire about changes in procedures, servicing, software, IQC parameters
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determine whether the problem is seen in patients’ samples as well as EQA and/or IQC materials.
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contact the manufacturer/supplier to enquire whether their technical / customer support departments have received reports of performance problems, both in the UK and in other geographical areas
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enquire of other EQA Scheme Organisers if they also observe the problem
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inform the NQAAP as part of the normal reporting mechanism; the NQAAP may in turn inform Scheme Organisers of apparent problems seen in other EQA Schemes
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the Scheme Organiser should contact the MDA if there could be implications for clinical sample analysis (such as the potential for delayed or inappropriate diagnosis or treatment).
Phase 2) Determining the cause
- If the problem is only seen in EQA materials, with IQC and patient samples unaffected, the Scheme Organiser will need to investigate the relationship between the effects observed and the EQA materials.
- If the problem is seen in EQA and IQC materials, with patient samples unaffected, the Scheme Organiser will need to investigate the relationship between the effects observed and the EQA and IQC materials
- If the problem is seen also in patients’ samples, the Scheme Organiser should, in collaboration with the manufacturer/supplier, establish the extent of use of the affected product and assist in correlation of this with the extent of effects on patients’ results and EQA results.
- If new batches of the product, unaffected by a change are made available, the Scheme Organiser should facilitate comparison studies using the provision of EQA samples and advice, with the aim of restoring expected EQA performance and/or clinical results.
Phase 3) Conclusion
- All parties involved in the investigation should ensure that regular reports of progress are made available. If the cause of the problem cannot be established this fact must be reported.
When all parties are satisfied with the results of the investigation, the Scheme Organiser should give a summary report to the relevant Steering Committee or Advisory Group, the MDA, the NQAAP and participants if appropriate.
- If the manufacturer/supplier is reluctant to agree that the problem exists and cannot show that patient results are unaffected by it, this automatically falls within the definition of an “adverse incident” and thus the remit of the MDA. The Scheme Organiser should bring the matter to the attention of the appropriate Steering Committee / Advisory Group or equivalent and of the MDA (even if MDA have been notified previously) with the minimum of delay. The MDA will determine what other actions or investigations are required to resolve the issue. The Scheme Organiser will ensure the continuation of an appropriate EQA service to all participants. The relevant National Quality Assurance Advisory Panel will be informed, and its influence used where necessary to achieve a satisfactory outcome. The NQAAP may consider seeking advice and help from the Joint Working Group on Quality Assurance (JWG).
(1) "Conditions of participation by UK clinical laboratories in external quality assessment schemes”
Copies of reference (1) may be obtained from the JWG Secretary
(2) eg Safety Notice MDA SN2002 (01) “Medical devices - reporting adverse incidents and disseminating safety warnings“
(3) Medical Devices Agency Business Plan
Current versions of references (2) and (3) are available on the Medical Devices Agency website www.medical-devices.gov.uk, or may be obtained from MDA, tel: 0171 972 8000 email: mail@medical-devices.gov.uk
Drafted for Joint Working Group on Quality Assurance by BIVDA/EQA Forum in May 2002, published June 2003