» Technical Bulletin – Medical Laboratories: Maintaining UKAS Accreditation During Periods of Change
14 June, 2018
Change of Legal Entity
A change of legal entity is where there is a change to the entity which is financially and legally responsible for those activities performed under UKAS accreditation. Your Assessment Manager should be notified sufficiently in advance of any such changes to the legal entity to decrease the risk of accreditation being suspended or withdrawn. It is acknowledged that the NHS Improvement and NHS England changes currently proposed may look very different in each case but examples include:
- Hub and spoke models may be developed and the hub is responsible for all testing in the scope of the service that the group of laboratories provide
- Laboratories collaborate but the current accredited entities continue to be the organisation responsible for the service delivered before
- A network is developed and the scope of testing is amended significantly to streamline the service provided.
There will be other approaches to the changes but the principles remain the same; if the change of legal entity requires additional activities or sites to be added to the accredited scope this will be dealt with separately and will require the submission of an application for extension to scope. As such, it is important to identify the structure of any network, which entity is responsible for delivery of each area of the testing/service and when the change will start. Sufficiently in advance, the laboratory can ensure the management system is developed to encompass any sites or areas of testing as of a certain date and this can be assessed by UKAS well before the changes are due to start. Informing your UKAS Assessment Manager at the earliest possible opportunity (even if plans may be subject to change) will increase the likelihood of seamless accreditation.
The initial notification/discussion with your Assessment Manager will need to confirm why the legal entity is changing and when the change is expected to take place. It will also be necessary to confirm at this stage whether the new legal entity is prepared to accept all contractual, legal, financial and other obligations which relate to both the current and historic accredited activities. Where this acceptance is not possible, the accreditation cannot be transferred to the new legal entity and a new application for accreditation will need to be submitted. In such cases the new legal entity will not be able to retain the existing accreditation number or initial accreditation date from the existing legal entity. It is likely that the initial assessment process can be streamlined if there are not significant changes at the laboratory as a result of the change of legal entity.
Where it is confirmed that the new entity is prepared to accept all contractual, legal, financial and other obligations which relate to current and historic accredited activities, UKAS will request that a Notification Form for Change of Legal Entity is completed and submitted to email@example.com with the requested evidence detailed in that form.
Where the change of legal entity does not impact on the accredited service provided (e.g. where the management, resources, management system and procedures remain unchanged), the transfer of accreditation may be relatively straightforward. However, if it is evident from the information provided that the accredited service could or will be affected by the change then UKAS shall determine whether any additional assessment effort will be required to confirm ongoing conformity with the requirements of accreditation.
Change of Name
Where an existing accredited organisation is intending to change its name but the accredited legal entity is unaffected and there is no change to the laboratory’s accredited activities, a transfer of accreditation form is not required.
In the case of a name change please notify your Assessment Manager at the earliest opportunity and in advance of any change. A new UKAS Agreement will need to be signed and evidence of the new company name having been appropriately registered e.g. with companies’ house, charities commission. In the case of public bodies, a press release/official memo or notice from the applicable government department should be supplied.
Extensions to Scope
A scope (or schedule) is the official and detailed statement of activities for which the accredited body is granted accreditation. UKAS offers an extension to scope service for customers who wish to add to or change their range of accredited activities. This process is highly likely to be required when medical laboratories are implementing any changes, including those proposed by NHS Improvement and NHS England. This includes expansion into a new area of testing and inclusion of new laboratory locations.
Medical laboratories wishing to extend their scope of accreditation need to apply to UKAS to have the scope extension assessed using the relevant application form available on the website.
On receipt of an application for an extension to scope, UKAS will review the application to determine whether the activity can be accredited, and if so will consider the assessment approach and amount of effort required to assess it. The methodologies to be employed in assessing the extension to scope will depend upon a number of factors such as technical complexity, similarity to existing scopes, etc. An assessment of the extension to scope will be conducted within an agreed timeframe. Following successful assessment and closure of any non-conformities raised during the assessment the extension to scope will be granted and added to the published schedule of accreditation. Extending an accredited scope may give rise to an increase in the ongoing costs of maintaining accreditation from UKAS.
Should you require any clarification to the above please contact Ben Courtney (Accreditation Manager, Medical Laboratories) - Ben.Courtney@ukas.com
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