UKAS began hosting drop-in Q&A sessions for the SARCs project in May 2020. These sessions are joined by a variety of stakeholders who bring with them some interesting questions about the pilot process, FSR requirements and ISO 15189:2012 which are summarised below. This list is updated following new drop-in sessions.
- Are the Drop-In meetings specific for SARC pilot sites?
Not presently; we welcome all interested parties and invite them to ask questions about the project to accredit SARCs.
- Has registration to participate in the Pilot now closed?
No, the interested party meeting has taken place but applications to become a pilot site are invited, currently up to the end of June 2020. If organisations wish to apply, then they are welcome to do so.
- How has the UKAS Timeline been impacted by Covid-19?
UKAS timeline is an intent to meet project milestones but there is flexibility built into this. Covid-19 has impacted upon UKAS generally, on-site assessment activity has been replaced with remote assessments until October 2020. As on-site assessments were not planned to take place for this project, prior to that date, there should be limited impact in terms of the project. There has been no decision to stop any projects and time is being utilised to progress where we can. The Milestones have been set by FSR and as such those will have to be adhered to.
The FSR timeline for accreditation is by October 2023 so UKAS project timeline has been defined within that to support applicants to achieve accreditation within it.
- If there is a change of FSR will the project continue?
We expect the requirements of accreditation will be met regardless of a change in FSR. The only change is might be the timeline.
- Has anyone determined LE yet?
There were variable responses from the group but as, yet none had confirmed. One participant confirmed that whilst the SARC is police led it is a joint commission with police providing FME. The participant is in discussions with the Police Legal Teams and will share any outcomes with the group.
Alison Brodie drew the group’s attention to the requirements of ISO 15189:2012 on Legal entity and that it was up to the organisations to determine how those were met. It was noted that if the commissioners in each area selected an alternative provider to an accredited one then the accreditation of the new provider would also have to meet the requirements.
- Who needs to be the LE: Police-own building, NHSE – Lead Providers, Mountain Healthcare or a Forensic Provider?
Putting the ownership of the building to one side, who it is doesn’t matter. Who it is or how you do it, is down to each applicants needs. Go back to definition in ISO 15189, “SOMEONE WHO HOLDS ULTIMATE RESPONSIBILITY”. Who will be sued? Looking at the governance structure may help to determine this. It is about clarifying who has what roles and responsibilities in delivering the service and ensuring this is done competently.
- Is it true that whoever pays the application and UKAS associated fees owns the accreditation?
If someone is paying for the accreditation, it is usually Legal Entity. It will therefore be their name on the schedule of accreditation. If there is a switch in provider UKAS would have to assess this but they must do more than own the building.
- How much does it cost and what is a reasonable amount to allocate to cover the cost?
The application fee is £1500 which will give access to on-line learning modules and cover the cost of the initial contract review process and determination of assessment team and effort required. Dependent on complexity of the service offered the expected initial assessment fee is approximately £12-15K. The charge is based on site and office effort.
Once accredited the figure drops significantly to approximately £5K /year. There are several factors that will influence costs, and this includes, preparedness. This is one of the reasons UKAS has developed the UAAS approach to support applicants through the application and preparation for the assessment process. In addition, organisations should not forget costs that are not associated with UKAS fees and these include any additional resources that may be required for developing/implementing and maintaining the QMS that is a necessary part of achieving accreditation. Organisations should consider if any of these resources already exist within their structures e.g. for Police within Forensic Testing Laboratories and for NHS Trusts within Medical Laboratories. Are there opportunities to share resource?
- Participant X expressed interest in being part of the pilot but is expecting to move to a new building in 2021. Would moving prevent them from participating as a Pilot?
No – if an organisation was already accredited and planning a move, we would expect involvement of UKAS and a plan as to how this will take place to minimise the impact on accreditation. However, as the organisations are not expected to be accredited by that point then it should not prevent participation. Any subsequent change would be reviewed, and further assessment planned as required.
- Will Forensic providers have to be registered for ISO 15189 to provide environmental and decontamination monitoring?
No, we will assess the Legal Entity for how they manage this as a service being provided by a third party. As would be expected as part of any assessment the Legal entity will have to demonstrate how they select and monitor the performance of any service providers.
- Would you need a good CQC report to be able to join as a pilot?
No. As many SARCs have not yet been assessed by CQC then this would not be used to preclude a SARC from joining the pilot. It should be noted that the assessment would consider how any assessment by an external body feeds into the organisations’ QMS and is managed. This is particularly so if there are any significant areas for improvement, but it would not prevent the organisation joining the pilot.
Additional comment: due to the number of assessments that organisations must undergo it would be hoped that joint inspection could be aimed for in the long-term.
UKAS confirm that work is taking place between them and CQC to determine ways to reduce the burden of numerous assessments.
- After identifying the Legal Entity, when is the application fee due? What is the next fee requirement and when is it expected?
Applications are due by 1 July 2020. If a significant number are unable to achieve this then we may look at extending that timeline. The next instalment after that would be due after the initial assessment and is likely to be after May 2021. If an organisation applies and signs up to become a pilot but after a short while realises that they cannot work within the Pilot Timescale they will be able to transfer across to the UAAS process and be assessed in line with the timescales within the FSR milestones.
- What is meant by paragraph 4.2 Pilot Assessment Conditions document - It is a requirement that new applicants have a management system which is compliant with the requirements of ISO 15189 prior to application?
It was confirmed that it would be expected that in preparation for the Pilot the SARC would be conducting their own gap analysis to determine how their existing management system met the requirements of ISO 15189:2012. The group were advised to refer to the requirements within the standard itself and determine what was already in place, for example what is documented about the legal entity, what organisation charts are in place, who is the SARC Director and are those responsibilities documented. In addition, they were also directed to FSR-C-116 -Annex 1 -Self assessment. They were advised that progression of the pilot would not be restricted if some of these areas were not yet fully compliant if the intent to implement a compliant system was evident.
- Would there be scope to extend the Pilot application deadline?
It indicated that as with any project there must be a line in the sand for timescales in order to progress. There is some flexibility with the timescale for pilot applications and if there are significant difficulties for organisations then please liaise with UKAS and concerns will be addressed on a case by case basis. It may be possible to phase the pilot to one or two tranches if some are ready to commence but some organisations need a little more time. Despite, some flexibility we must be mindful of the FSR Milestone targets and working inside of those for the Pilot to enable lessons learnt to be established. It should also be noted that the submission of an application does not mean that everything needs to be in conformity and that there will be a lag between submission and assessment. The pilot is a programme of development and learning for UKAS and the sector.
- If the organisation is not part of the Pilot what are the timescales for the standard application and accreditation process?
The FSR has defined timescales for the progression to accreditation and referred to these as Milestones. UKAS has no control of those timescales. If an organisation cannot commit to be part of the Pilot, there remains the opportunity to declare an interest by way of registering for the UKAS Assisted Accreditation Scheme (UAAS). This then provides online access to the modules developed to help you to produce documents/implement your management system in a way that will demonstrate conformity with ISO 15189:2012 and the FSR codes. It will be up to the organisation to complete those Milestone Modules as and when works for them but ideally within/before the Milestone Targets set by the FSR. It was noted that this hadn’t been publicised more widely due to the focus on the Pilot and agreed that UKAS would publicise this as an alternative option for those SARCs wishing to begin to make progress but mindful that they may not yet be in a position to participate in the Pilot.
Given that a number of those present were concerned that they might not be able to submit a pilot application by the current deadline they were asked for their thoughts on a potential deadline they might be able to meet but this appeared varied dependent on the organisation and none were able to provide a clear alternative. UKAS encourages all those considering participating in the Pilot to contact UKAS if they are unable to apply by the current deadline.
- What guidance is available for commissioners determining legal entity when multiple entities involved in delivering the service?
An attendee highlighted that they have received several different responses and seem to be going around in a loop without being able to confirm who the legal entity is. The charity delivering the SARC service, as a result no longer feels that they can progress as a pilot. The main commissioner of the service is the NHS, who have indicated that the SARC work whilst commissioned by them is not their responsibility and that the FME activity is commissioned for the SARC, separately by the Police.
Funding may well come out of commissioning but in terms of the Legal Entity (LE), it is unlikely that the commissioner that would be LE. Responsibility is the delivery of work. LE needs to be sorted out by the organisation responsible for and delivering the SARC service; it is not one size fits all. The working model is the best starting point for determining those responsibilities. Contractual agreements should document the roles and responsibilities, but someone must be responsible for the delivery of the work. This is not something imposed by UKAS. There are several situations where the Police may “feel” they are responsible, but they are not/may not be responsible for delivering the work and therefore are not the LE.
It was reiterated that UKAS would not wish this to be a barrier to progression of the application to become part of the Pilot. If it is determined that the LE is later determined to be incorrect, there is a process in place where this can be changed. The benefit of participating in the Pilot is that UKAS can ask the questions that may help you to clarify who the LE is.
- Would the work involved in the pilot/standard process amount to a full-time position to co-ordinate and implement?
It is recognised that the preparation for accreditation for an organisation can include a significant time commitment. The time commitment for each organisation will depend on how the roles and responsibilities are divided and if there are cross-organisational resources that the SARC can draw on for example – Quality Managers, Quality Leads from already accredited Forensic Testing Laboratories or NHS Medical Laboratories. It was again emphasised that when considering costs as part of the commissioning of the services, these ongoing costs of implementing, maintaining and improving the systems in place should be factored in. It is recognised that this will differ from organisation to organisation.
- What have the NHSE agreed/ stated around the funding of the accreditation? Did they refuse to pay for the SARCS to undertake the process?
UKAS is not aware of any decisions made by NHSE re: funding at all. I think there is general acknowledgement that if accreditation is within the commissioning requirements (as it will need to be now the standard has been issued) that some element to increase funding would be required between commissioning partners.
- What level of detail about scope is required within the application form?
It was acknowledged that the existing application form may not be fit for purpose for the SARCs and this is under review. Regarding scope, the more information the organisation can provide the better the review process can be, but we do not need all policies/procedures submitting with the application. It was suggested that Annex A of FSR-C-116 would be completed and submitted and again that was viewed as acceptable.
Post Drop-In – attention is drawn back to the interested party meeting slide relating to scope – below is an example draft schedule – as you can see this is the information that we will need, to formulate the schedule of accreditation and what should be detailed within the body of the AC6 Application Form. You will note that the headings of the columns reflect the headings of the columns in the application form. The scope described may well be different for each SARC. If you have any specific queries, please contact the team.
- October 2023 deadline for accreditation - What is the implication of not achieving the deadline?
The Forensic Science Regulator has stipulated in her Statement of Requirements in the FSR Codes of Practice in Conduct FSR-C-100 v 5 that 1st October 2023 is the date SARCs should be accredited by. Once this deadline has passed, as per FSR Codes 28.2.1, all practitioners shall disclose in statements/reports intended for use as evidence their compliance or non-compliance with the Codes. Thus, once the deadline has passed, there is an inherent risk that evidence from an unaccredited organisation could be challenged.
The FSR will change in November 2020 which again can sometimes impact on deadlines and the FSR is due to be given statutory powers which will alter the impact of missing the deadline
- Where facilities do not meet the requirements of ISO 15189:2012 and FSR-C-116, will a risk assessment be enough to achieve accreditation?
It was confirmed that a risk assessment alone will not be enough. FSR C-116 states
“7.2.2 In order to meet the accommodation and environmental requirements if physical building changes or new build have been identified or are necessary, and where the timescale for these are beyond the implementation date for accreditation, the facility shall undertake the following.
- Complete a full risk assessment and identify areas for strict ongoing monitoring (8.4, 8.5 and 8.6 below).
- Implement the risk mitigation and record quality failures (6.3.1j above).
- Have a documented plan for improvements with timescales that are regularly reviewed.
- As a minimum disclose in all reports to CJS end users that the facility does not meet the requirements in this standard and detail what mitigation is in place (9.2 below).”
The assessment team will have to be assured that in the absence of meeting the requirements any risks are mitigated.
- As the deadline for submitting a pilot application has now passed, will UKAS accept any further applications
It was explained that we recognise the impact of Covid-19 and the ongoing Legal entity issues and so have not been strict in enforcing the deadline. We are happy to engage in discussions with individual SARCs regarding their timelines if they have a desire to participate in the Pilot process but there will have to be a point at which we draw a line. If there is further interest in being a pilot it may be possible to consider a second wave at a later date. We are aware of several SARCs that are preparing their applications for submission.
- Is UKAS aware of any further news from NHSE regarding funding of the accreditation costs?
None present at the meeting were aware of any further development regarding funding, furthermore, funding of accreditation does not fall within the remit for UKAS.
- Once the registration fee/application fee of £1500 has been paid when is the next amount of money due?
The next amount invoiced would be when the next piece of work – the pre-assessment- is complete. This can vary greatly dependent on the organisation. Typically, the pre-assessment would be completed within 3 months of application and would instigate an invoice for that piece of work. The next invoice would be issued upon completion of the initial assessment which could be between 3-6 months post pre-assessment.
The cost of those activities could also vary dependent on the number of sites being assessed, the complexity of the services offered e.g. Adult and Paediatric, the volume of work and level of staffing. In addition, the preparedness of the organisation impacts significantly on the effort to achieve accreditation. Where organisations are not well prepared there can sometimes be the need for extra visits to close out findings and to conduct additional assessment activity.
It is not unusual for the costs to be spread over a 2-year financial period due to the nature of the assessment process.
As part of the pilot there may also be other ways to reduce costs – for example a group pre-assessment of pilot sites rather than individual activity. This is of course dependent on those participating in the pilot being prepared to share information and outcomes.
There are many different options and as outlined previously it is dependent on each individual organisation.
Note – it was stressed that the fees should be considered as only part of the cost of accreditation and other associated costs such as additional staff resource, facilities maintenance improvement, ongoing maintenance of the QMS, should also be factored into budgetary considerations
- What are the advantages of a SARC being part being a pilot?
- Access to the project team with additional time and observation as part of the pilot assessment to discuss interpretation of requirements
- Opportunity to provide feedback on process to influence how the accreditation will be program will be implemented.
- High level of support from the project team available
- Collaborative approach
- Access to the UAAS online learning system to use modules to support pilot journey and ability to feedback and support improvements to those
- What is meant by multi-site?
A multi-site application is one with the same legal entity, policies, procedures across all sites with the legal entity having responsibility for staff at all other sites and protocols in place being controlled by the LE. Being able to demonstrate the implementation of a single QMS across all sites. For accreditation purposes, the schedule will have the Legal Entity name on the schedule and then all included sites listed below the legal entity. At assessment UKAS would then assess the QMS implementation across the sites and the inter-relationship between the sites including movement of staff, communication, method implementation. Assessment of multi-site applications is dependent on the organisation ensuring that they have standardised their procedures across sites and this can be challenging.
- What happens after registration as a pilot or joining the UAAS?
UAAS access for 12 months is provided. Applicant will be asked to provide email addresses for all those in the organisation they wish to complete the modules. Access to the Learning Management System will then be provided. Applicant then works through those modules, all designed based on the Milestones set by the FSR. Up to the applicant to decide how quickly they work through those. If a pilot applicant, we will be liaising with you to take forward to pre and initial assessment. If you are registered on the UAAS only, your progress is your responsibility.
- Can we join the pilot at any time?
Applications to join the pilot once we have commenced the pilot processes will have to be evaluated at that point in time and dependent on where the project is this may or may not be possible.
- What monitoring of the milestones will be implemented?
It was confirmed that UKAS will be reporting to the FSR regarding applications and confirmed that from October 2023 any SARC that is not accredited will have to declare this when making a statement or report to court. It was unknown if the FSR would be taking any action if Milestones are not met. UKAS to take to FSR.
- Will there be SARCs experts involved in the pilot assessment process and any advisory groups? During another meeting it was considered that membership of FFLM was essential rather than desirable.
We will be interviewing to determine if right experience/background. What is key for us is to understand the challenges of the sector and ensure that we have a team that has the confidence to challenge practice if it does not conform to the requirements and understanding, experience and knowledge to assess. We must be mindful of who we are assessing and ensure that the team has all the competence to fulfil the assessment.
It was suggested that if X has concerns about the technical assessors/experts they should consider applying themselves and/or encourage any known suitable individuals that fulfil those requirements to express an interest and consider participating as a technical expert in the pilots.
UKAS will email X regarding the technical expert/assessor role for her to forward to other potential technical experts/assessors. Any interested parties should then contact the development team to be considered for the technical expert/assessor role.
- Having mapped out the process and the accreditation requirements and CQC requirements X is concerned that there are some aspects that will remain outside of an accreditation and/or regulatory process for example records of injuries.
UKAS will assess what is included within the scope of the application against the requirements of ISO 15189:2012, the Forensic Codes and ILAC G:19. In that way if you are aware of gaps and can be part of the Pilot, it will enable us to determine if the assessment process addresses any such gaps and subsequently use the outcomes to aid discussion with the relevant parties.
- What time commitment is there to becoming a technical assessor?
During the pilot those appointed will be operating as technical experts under the guidance of a Lead Assessor so for training purposes there will be a technical assessor briefing and then commitment to undertake a pilot assessment (1-2 days), if an organisation has a pre-assessment (1 day) plus associated office time. Once operational technical assessors may be invited for Standard Awareness training and Technical Assessor Training (min 3 days), an observation visit 1 day, and they will then be asked to participate in an assessment – which may be 2-3 days. As part of agreeing a contract with a Technical Assessor/Expert their availability will be discussed. Once allocated to a SARC it would be hoped that the Technical Assessor/Expert would fulfil that commitment for the duration of the four-year cycle.
- Several new attendees to the drop-in session indicated that they would like to understand what they need to do and more about the process of accreditation.
Advised to visit the SARCs section of the UKAS website in the first instance. This includes past FAQs and references all relevant documents. The Pilot and Assisted Application Schemes were all outlined again, details for these are on the UKAS website. Cost is the same for both in the first instance. Identified that the key discussion point so far has been legal entity. UKAS is offering a Pilot and progressing that at the moment and doing an Assisted Application Scheme which includes access to on-line learning modules geared to help organisations to meet FSR Milestone requirements.
- How far has the plan progressed? Is accreditation by 2023 still required?
There has been no movement on the timescale on the FSR Milestone plan. We understand that is very unlikely to happen.
- Has the standard and guidance associated with ISO 15189:2012 been finalised?
Yes, SARCs should obtain a copy of ISO 15189:2012 and familiarise themselves with the contents as this is the standard that they will be accredited to and in addition the FSR Codes and Appendix documents FSR-C-116, FSR-G-212 and FSR-C-100 were published in May and June 2020 and are freely available at the following web link. Applicants are also advised to ensure familiarity with ILAC G:19 which is referenced within the FSR Codes and Appendices.
- Have the Pilot schemes progressed and are the names of the organisations participating available?
The Pilot is progressing, following an initial closing date for Pilot applications of 1 July 2020. Any potential applicants have been advised to contact UKAS. There are currently 2 in progress and a third expected imminently. Once these applications have been processed the names of the SARCs will be published on the UKAS website. It is expected that once the Pilot process for those 3 applicants commences, the initial phase of the Pilot will be closed. If there is the demand it may be possible to consider a further pilot phase, but this would be considered as and when required.
It was noted that X had submitted several questions by email to which X had responded. X was asked if there was anything further to follow up on and raised the following points.
- Whilst it is acknowledged that UKAS cannot provide consultancy regarding plans for SARC new builds, would it be reasonable to ask the FSR for advice?
FSR are unlikely to be able to advise but may well be able to direct X to an appropriate independent person/body that may be able to.
- FSR-C-116 Self-Assessment Checklist pg. 40/50 4.5 – is it correct that “The forensic area of the facility includes a dedicated bathroom/toilet facility, cleaned to DNA standards, accessed from the medical examination room and corridor…”?
This is what is stipulated in FSR-G-212 and in the checklist but the functionality will be assessed during an assessment visit. If the SARC is not able to meet these requirements what action have they undertaken to manage any risk in not having two access points? FSR-C-116 7.2.2 pg. 14/50 details what should be undertaken where an existing facility might not fully meet the requirements.
- FSR-C-116 Self-Assessment Checklist pg. 39/50 4.2 – is it correct that “There is an entrance for use by the patient and their companions that is separate and not open to the public.”?
As for previous question.
- Is it ok to have the medical examination room down the corridor from the waiting room?
Again, this is something that would have to be assessed at the time of assessment. The organisation should determine how the requirements of FSR-C-116 and FSR-G-212 are met and if they are unable to meet due to building requirements what mechanisms have been implemented to minimise risk and to meet FSR-C-116 7.2.2.
- Can we share practice/adopt good practice across SARCs
Several attendees agreed that if standardising approaches then this would be acceptable. Attendees shared contact details.
- Why is the cost of accreditation so expensive?
The cost of accreditation includes several activities over a number of years. Although overarching costs have been publicised, it should be remembered that this is split based on the activity conducted. UKAS is a not for profit organisation appointed by Government to conduct accreditation but not part of the Government and therefore not funded through them. As part of project feasibility studies, each new accreditation project is evaluated, and it must be demonstrated that it is in the public interest to develop the accreditation program in that area. Case studies in other areas of accreditation demonstrate the balance of the cost of accreditation against mistakes that lead to litigation. Accreditation supports the development of systems to get things right first time.
X indicated that they would be happy to discuss their experience in DNA labs and the impact that accreditation has had on costs with other attendees.
- In the process of creating own quality manual but wondered if there was a template available to do this?
It was noted that UKAS do not provide a template for the quality manual and that the required content is detailed in ISO 15189:2012 18.104.22.168. It was stressed that the quality manual should reflect how the applicant organisation meets the requirements and serve as a guide to existing and new staff as to how the organisation operates in conformity with ISO15189:2012. It should include/reference the policies that demonstrate how the requirements of ISO 15189:2012 are met and signpost to supporting procedures and instructions, that will demonstrate consideration of the FSR Codes, Appendices and Guidance documents.
It was noted that the UAAS includes the quality manual as a component to the Milestone 1 Modules. In addition, this will be touched on as part of the Workshop scheduled for September 2020.
- The application form indicates that the quality manual should be included with the application form. Will this prevent progression if not submitted at that time?
As this is a development project and a pilot, it will not prevent progression at the point of application. By pre-assessment it is helpful to have the bones of the quality manual available and by initial assessment it would be expected to be available and implemented.
- Have any police forces already achieved accreditation for SARCS?
None yet. This is due to where we are in the programme. There are now pilot applicants.
- Is the timescale for accreditation confirmed to be October 2022 or October 2023?
The FSR Milestone is for all SARCs to achieve accreditation by October 2023.
- What do we get for £5-6k each year to maintain accreditation?
The benefits of accreditation are trust, assurance, confidence to patients, the wider public, to commissioners, to government, to commissioners and to the judiciary. It provides a backbone, a framework for you to rely on to demonstrate your compliance and competence to an internationally recognised and used standard and that you are working correctly, consistently and with full traceability – who did what, using what, where and when. That external proficiency assurance is in place to enable you to demonstrate this. The important thing to understand is that the cost of a quality failure far exceeds the cost of implementing a quality system to assure that quality is “right”. Sometimes this is not easy to quantify, because with an implemented quality system in place you will log incidents, investigate root causes, implement corrective and preventive actions so those quality failures may be caught before they occur. There would therefore be less time investigating these failures, less time and money spent on compensation and having to implement remedial actions, and having cases thrown out of court. The price of quality is hard to allocate a figure against, but in terms of how this affects staff, and we get a lot of feedback on this, they have more confidence, the ability to challenge, correct resources, because this is a requirement of the standard. In terms of going to court, although this a rare, they are better protected in that they can reference procedures and the accreditation, have the contemporaneous notes to hand etc. and have reported that going to court is a lot better experience than it was before they had accreditation when they might have felt a little more on the “back foot”. We have had comments such as the service has been professionalised, the staff feel recognised and more professional. We have evidence of this in other sectors and will gather evidence of this in this area of the next few years and will document case studies to illustrate it.