UKAS began hosting drop-in Q&A sessions for Private Providers of Covid-19 Sampling and testing in 2021. This list is updated following new drop-in sessions.
- Will the slides presented at the drop-in session be available afterwards?
Yes, the presentation slides will be made available on our website along with the Q&As.
- Are providers able to start stage 3 when we are ready to, or do we need to wait until we are invited?
We have a very clear timeline on this as said before with Accreditation granted by June 30th, 2021, so the stage 3 assessment need to be completed in good time before then. We have a programme in place listing all of the providers. We will invite you for your stage 3 assessment and advise you of when that will take place. You will be given 2 date options for that. We are mindful that many providers would prefer a later date rather than an earlier date, so we are going to work through the list in date order of when applications were received and stage 2’s approved. You will receive correspondence from UKAS regarding the plans for your stage 3 assessment.
- The accreditation process has been very labour intensive, and time consuming with undefined financial benefits for the process. An estimation of the costs for the stage 3 assessments would be helpful in planning for the future?
UKAS are appreciative of the significant costs involved and our standard terms and conditions that UKAS works under are available on our website. When we are preparing for and planning assessments, we conduct a contract review, this is where we look at each organisation to determine what activities they perform, their size and complexity and use this information to select an appropriate assessment team to assess you, this then governs the costs involved as we charge on an effort basis – the amount of time that an assessment team needs to spend with you, charged per assessor per day, or part of a day. Our day rates are listed on the UKAS website along with a breakdown of typical fees for Private Providers of Covid-19 sampling and/or testing. We are cognisant that we keep costs to the minimum required and will support you through the process as far as is possible. Likely costs via an estimate of the effort required to complete your assessment will be discussed with you before the assessment is confirmed so that you are fully aware of those costs before you commit to the assessment.
- Will all of the stage 3 assessments be performed remotely?
The assessment required for the sampling providers will be fairly straight forward and we believe that these will be able to be assessed remotely (via MS Teams or Zoom). For large complex laboratories we may need to visit and go on site, this will be dependent on what activities are actually being performed. Whilst we are confident in our skills to assess remotely there are circumstances where we have decided that an on-site assessment is necessary, such as the for the assessment of the Lighthouse laboratories and other large Covid testing laboratories last year during lockdown.
- What time do these assessments usually begin and how long will you require to see our sampling process as we need to organise our clinical appointments. Could you kindly give us an overview of what the day will look like please and what to expect? Could you do a run through of the Stage 3 assessment Day. We have a date for ours. Have been sent the forms to complete, but not the agenda for the day? How long the day will be? Do we need the whole team involved to be available on the day? Could it be any longer than a day?
You will receive a copy of the PAT and your Assessment Manager will be in touch with you. The assessment will be 1 day in duration, it is likely to start at 9am and finish at approx. 5pm, your Assessment Manager will agree a time for the sampling assessment observation. We will try and work with you to arrange this at a suitable time. You will need to make sufficient staff available to guide us through the processes in place at your organisation.
- In previous sessions it has been discussed that preassessments were possible, how can these be arranged?
We are mindful that the deadline for this Accreditation is June 30th 2021, with that in mid we have made a plan to ensure that we can accommodate both the sage 2 reviews and stage 3 assessments – the initial assessments. Therefore, we have not factored in time to perform preassessments because they have been replaced by the stage 2 reviews. That said, if a provider really would like to have a preassessment, which is a chargeable event, we could look to factoring that in, but ultimately, the stage 2 reviews were used in place of that activity. Time is also very short for this is be arranged.
- Is there a timeline on staged accreditation?
There are 3 stages in this process – stage 1 the self-declaration stages, stage 2 the review stage with stage 3 being the assessment phase. DHSC have stipulated timelines for both stage 2 and stage 3, with the deadline that stage 3 assessments must be completed, and accreditation granted by the end of June 2021, 4 months after the stage 2’s have been received by UKAS.
- Post accreditation, what is the expectation with regards to changes? What changes must be submitted? What turnaround times for reviews are expected? And how long will it take to go from change notification to approval (accreditation)?
It will depend upon what the change is, so the key thing is that you inform us as soon as you start to plan the change so that we can work with you and advise you on the work that we will need to see to approve that change. If for example, you are a provider who is changing the laboratory that you use, or adding an additional laboratory to your process, that might be very straight forward, if that laboratory is already accredited. If you are a laboratory wanting to bring in a new test for your PCR then that would be a more comprehensive process for us to assess and accredit. The key is to notify us as soon as you start to plan these changes so we can advise you on what will be required and if a formal extension to scope will be required.
- For an ISO 15189 accredited laboratory who has already submitted an extension to scope application for SARS-COV 2, how does this fit in with stage 2 and stage 3 plans?
For stage 2, we may need to assess your organisation regarding TTR and General populations testing requirements – such as reporting mechanisms for TTR results and the independent validation of the methods. Where organisations sit in this process – stage 2 or stage 3 will depend on where they have progressed to, we will evaluate this and discuss with each organisation when planning their assessments.
- We are currently doing stage 2 application for POC sampling- passed all but the gap analysis- just unsure what it should look like or how detailed it should be?
Essentially depends on what service you are providing if sample provider some clauses won’t apply and likewise if you are a testing laboratory more of the clauses will apply. You need to review the clauses and sub-clauses of the standard(S) that you have applied for and highlight if you think you conform with the requirements, if not what you need to do and what your plan is for meeting those requirements so document what action you need to take, who will do it and the target date for completing it. The depth of the gap analysis has often been reflected in the number of rounds of evidence review we have had to do at stage 2. Remember that the gap analysis is for yourselves as when we get to stage 3, we have a lot more questions. Consequence of that could be numerous findings at initial assessment that might trigger the need for more assessment and/or large amounts of close-out effort. So, putting a lot of work into the gap analysis and making it a really useful thing is going to be a beneficial thing to do. When we review it, quite often people have put very limited information into the gap analysis and when we have looked at the responses to other requirements there have been significant gaps so it is not clear so have a think about what you get back at each stage and how that reflects on the gap analysis.
- I would like to ask about Stage 3 assessment, what is involved for an established doctor who has been swabbing for years for different reasons. How long is it and how much as it has already been pricy?
We appreciate that a lot of the sample taking providers are well experienced, competent and established in their roles, the difference here is that we are not asking you specifically about your competence as CQC do what we are asking that you are competent and conforming with the standard requirements and require evidence to be submitted to demonstrate that process. We have streamlined the process. You will all be accredited to an international standard and which is recognised across the globe as a high level of conformity. Not just in the case of sample taking but everything that surrounds that. In terms of the pricing, application is £1500, stage 2 prices have been provided and stage 3 will depend on how many sites you have and the complexity of what you are doing; so if you are just doing sampling on one site, it will be significantly less than if you have 50 sites. There will be a publication soon that will be added to the FAQs that outlines the example costs.
- If an organisation has applied for an extension to scope, and given the changes that are happening regarding DHSC requirements, can the organisation just submit further information, and would this delay the extension to scope process?
The key here is communication, so if any changes occur regarding your extension to scope then you should contact your assessment manager to discuss them so that they can work with you in order to manage that process. If the change is significant then it may require a separate, new extension to scope application. If the change is small, then we may be able to incorporate the change in the existing extension to scope and work with you to determine the most suitable approach, with the aim of ensuring that no undue delays were caused.
- What does the stage 3 visit entail? Is there an agenda and details of the documentation we require?
At the start of the process and next week we will be doing the first stage 3 assessment for providers that are not an already accredited lab and we’re working hard to put that into place and starting off with the most simplest assessments which is single site sample collection providers and doing it totally remote. We are issuing a provider assessment tool for use by both the providers to submit documents and for the assessment team to record the assessment. The assessment will be 1 day with both a Technical Expert and an Assessment Manager/Lead Assessor. The construct of assessment will depend on the scope of the application. There is no one-size fits all. If it is a Testing Laboratory, it will follow the standard route of assessment. However, we have streamlined this approach for sample collection providers with lots of information on how to do things.
- How long from requesting our stage 3 assessment will a date be issued?
This depends on what you are doing so someone will be in touch with a couple of dates and we will be assessing as early as we can to give you an opportunity to address any findings that are raised. In summary as soon as is possible.
- What are the dates and milestones for stage 3?
The intention is that we will conduct your assessment as soon as possible. We will, on that assessment, if we have any gaps that we identify we will raise findings that you will have to address and you will get 1 month to provide evidence for review, to clear those findings. In terms of a final deadline, the DHSC deadline of the end of June 2021, we are doing everything we can to meet their requirements. If you have lots of findings at an initial assessment, then you may need more than one round of evidence submission so we are going to try and work with you to make sure you understand exactly what the gaps are if there are any. We can’t tell you how to resolve them, but we can give you some guidance on what might be appropriate. We want to avoid multiple rounds of evidence submission and review where we can. The aim is that we work together to provide a clear and comprehensive assessment, ensure clarity regarding any findings so that you can submit appropriate evidence and we can work together to ensure we meet the timeframes in place.
- We are a mobile provider of testing. how would that work for stage 3 visit?
From our perspective, it doesn’t matter where you are, we will conduct the assessment remotely, using MS Teams or Zoom. What we would look at is that you have things in place, by submission of evidence in advance of the assessment and we would talk to you on the day of the assessment and we would look to witness what’s actually happening in terms of sampling. It doesn’t make any difference really where that would be. If you’ve got mobile sites, we would need to assess your general process for assessing the suitability of the site and meeting the requirements, which is completed prior to you visiting the site. We would work with you to get that to work.
- How much notice is given prior to stage 3 assessment?
For the lab you will get quite a bit of notice of assessment to ensure that we get all the information we need. This is primarily down to this being a much bigger assessment. A private provider we are offering you a couple of dates and someone will talk to you so you will have the opportunity to work the date out with them and we are trying to book as quickly as we can now so that is going to happen in the very near future.
- How do providers get access to the eLearning PASS modules?
All organisations who are either working towards stage 2 approval or have been stage 2 approved should now have received information on how to enrol for the PASS modules, please contact us if this is not the case and we will send you the link to input your details and enrol.
- How much guidance will be issued to help providers prior to stage 3? Will there be documents sent or webinars arranged?
You will all have had links to the PASS modules which takes you through the process in a step by step fashion and through the requirements that you will have to meet and it also talks about the assessment and how that will work including the provider assessment tool (PAT) which we will use to document your assessment as well. The PAT will be issued prior to the assessment with the assessment confirmation and you can input information into that. This will also provide you with guidance on the process and what we will be looking at. No plans to hold any webinars except for these drop-in sessions. No specific webinars on the assessment process. The PASS modules are there to help you with that and should take you through that.
- Is there an example of the PAT that can be shared?
Yes, the PAT is discussed and embedded into one of the PASS modules and a copy will be emailed out with your assessment confirmation letter for you to populate and return to us before your assessment takes place.
- Are the PASS eLearning modules optional or mandatory for stage 3 assessments, and are all staff required to complete them?
The PASS modules have been designed to support providers by explaining the processes that are place, breaking down the requirements and explaining what documentation is required – policies, procedures and records etc. It is not mandatory that the PASS modules are completed by the providers, however, it is very strongly recommended that they are.
- I have logged onto the Private Provider Application Support Scheme - eLearning Programme and am unable to get between the sections. Is there a best browser to use for this?
It may be that you either haven’t fully completed the module, or you have clicked the ‘x’ to close the browser, rather than the ‘x’ in the top right-hand corner of the module itself. Clicking out of the browser will not record your pass score, and therefore the next module will be locked.
- Are there timelines for visit post completion of stage two, also other than the Gap Analysis etc are there any documents templates we can use in preparation for your visit? We are extremely keen to make sure the assessment is positive thanks.
There is a form to complete with questions for you to embed evidence – the PAT. It goes through each clause and includes detail regarding what should be embedded/provided. Once your assessment is confirmed, following stage 2 approval, we will be arranging a stage 3 assessment. When that date is confirmed we will issue you with a confirmation of that assessment and along with that will be lots of information about the assessment itself, including what we call a Provider Assessment Tool (PAT) which is an excel spreadsheet with 8 different sheets included in it which goes through the entire assessment process with you and you can embed or upload information, documentation, photographs to address each of the requirements that we have listed for you. As much as we have detailed what we will/are likely to assess we have also included what evidence source that we would be looking for. In addition to that you will also have received a link to the PASS modules; a set of e-learning modules which takes you through the entire assessment process in terms of the requirements of ISO 15189 or ISO/IEC 17025 and what those requirements are and in each of those modules there is a section called “In preparation for assessment” where we document the kinds of things you are going to need to have in place to demonstrate how you meet the requirements that have been discussed in each module. So if you work your way through those PASS modules then when your visit is confirmed you get the PAT document as well and if you can populate that with as much information as you can to address each of the requirements as listed and return that to us so that we can prepare for your assessment. We are hoping that if this is completed comprehensively it will lead to a positive assessment and it will flow as quickly and as effectively as we need it to be.
- At what point do the action plans on the gap analysis need to be completed?
It will depend on the dates that you have met the different stages. We are doing assessments in the order that they have applied, and we are going to be doing work initially on the basic ones. Most of you that have applied are taking samples. Testing labs that are more complex are going along in parallel, but we are starting with the most direct easiest work which is the sample providers and that is starting next week. We will give you dates starting from then. If you’ve passed stage 2 and are ready for stage 3 it could start to happen fairly soon. There are a large number of providers so we are not able to tell you at what point that will be just expecting that you will all get ready in the short timeframes, so we have time for you to be assessed and address anything that needs to be addressed. In summary, action plans need to be completed in time or the stage 3 assessment.
- Regarding the authorised person for the release of results – what are the requirements for POCT, as the results do not require interpretation as such, the results are either negative, or positive, so teams send results to their employees, but how does this meet the requirements for authorised staff reporting results? Also, when the results are sent out, they are sent via email in a standard format, but this does not seem to be acceptable – what is acceptable?
In terms of sampling for the POCT LFT – the result is sent out to the employees, when you are assessed at stage 3, this will be assessed at each individual organisation and must be appropriate and meet the requirements of the standard, and we will discuss this with you. we will also discuss the reporting mechanism itself, in this case an email reporting system using a template format. We would review that approach and evidence with you on a case by case basis to determine if the requirements of the standard are met.
- Is there any plans to allow POCT test for any elements of the TTR process?
The current requirements are for TTR testing to be performed by the PCR method. So whatever testing is performed as part of the POCT must be via PCR and has to meet the requirements of independent validation.
- An organisation is developing a new method for Covid-19 detection where they rely not on swabs, but instead use saliva which is heat inactivated and then processed through PCR. Can this method be used for general population testing?
We would assess this, and any new method, to determine its robustness and the validation that has been completed as part of an extension to scope, or initial assessment process. Most people are using already developed methods for this testing, in which case they would just need to verify that the method works as required, and as expected in their laboratory. But if this is a brand-new method then you would need to take the responsibility for performing full validation for the method to demonstrate that it does work. In terms of general population testing there are some requirements for elements such as specificity, however it is TTR where these requirements are more stringent for specification of the test. We will accredit this, and you will still need to self-declare for General Population testing in this situation.
- If an organisation has signed up to participate in an EQA scheme provided by NEQAS is this enough to demonstrate that their method has been validated or do they need to sign up for other proficiency schemes, or complete other accreditation processes?
Signing up for an EQA scheme is great news and it is a clear requirement of ISO 15189 and ISO/IEC 17025. Validation and verification of a method as an activity is different from this, however EQA results can be used as part of your validation/ verification process but is certainly not enough on its own. Validation requirements differ depending on the purpose of the testing – whether it be general population testing or test to release, with the requirements for TTR being more stringent with specific requirements for the number of samples to be included for example. There is more information on the internet on how to validate or verify a laboratory method.
- Some private clinics are doing day 2&8 testing. We are turning a lot of patients away so why are some clinics doing this?
Day 2&8 testing is currently that DHSC require laboratories to declare on the DHSC website the clinics that they are working with along with the GPs and sampling providers that they are working with and they are listed themselves, so there is nothing to stop day 2&8 testing plans continuing, and no reason why that shouldn’t start once approved. The self-declaration has to have been submitted, and those records have to match, and have to be reviewed and approved for both the laboratory and the sampling providers in order that they can go onto the DHSC website. As things stand, there are no approved laboratories or providers on the DHSC website for Day2&8 testing, so by all means please let us know if there are any private clinics performing day 2&8 testing and we can take that up with DHSC.
- In preparation for TTR stage 3 validation compliance can you confirm if 150 clinical positive samples and 200 clinical negative samples are required to be swabbed directly from patients, i.e. patients swab themselves twice, then send one sample to the reference lab and one sample to the test lab, or can they be historically confirmed positive swabs that have been processed and stored in transport media?
Historically confirmed positive samples are fine to use for validation purposes.
- How can we ensure that reports are sent to the correct person, unique QR is used, along with barcodes and double check mechanisms with 2 member of staff – what else might be required here?
There is a clause in ISO 15189 – section 5.10 regarding validation of systems for reporting, so whether you are reporting by email, SMS or by post you are required to do some sort of testing to confirm that the reports are getting to the right people, and also that they are being received in the format in which they were sent out. This is sometimes done using dummy emails addresses and tested using those or asking a recipient for help in letting you know what has been received to ensure that that all is how it should be. If you are using an IT provider is that provider certified for data security and is this something you take into account when approving your suppliers in terms of validating the systems to ensure that they work correctly.
- Is there minimum requirements for the validation of reporting software?
Unfortunately, there is no black and white answer here, and the answer is “it depends” because it depends on the type of software in question. For example – if you are emailing PDFs out, this will require much less validation than if you are a laboratory with a large and complicated laboratory management system. It is then up to you to justify why your validation plan is sufficient and appropriate for the systems being validated and to assure yourselves, and UKAS that those systems are working correctly as planned.
- Can UKAS give an indication of when laboratories will be approved to offer day 2&8 tests. The current day 2 & 8 requirements appear to be of a lower standard?
The requirements for this testing is still very new and so this question may be better asked to the DHSC.
- Re venous blood sampling and whether the DHSC sees UKAS as a regulator as UKAS claims not. It took over from the CQC, is behaving as a regulator and if not a regulator then the questions for sample providers is whether they need any accreditation at all save that of the lab they're using - as in DHSC and UKAS cannot have it both ways - it is or it isn't?
UKAS isn’t a regulator it is The National Accreditation Body. The work that UKAS is doing is at the request of DHSC. In talking about venous blood sampling here so I am assuming that you are talking about antibody testing. DHSC inform us that antibody testing isn’t covered by the regulations whereas swab testing for antigens is so really this is something that you would need to go back to the DHSC about. In terms of whether you need accreditation for venous blood sampling for antibody testing our understanding is no because its not actually included in the regulation. Several arms in the DHSC for commissioning of prevalence testing and they will ask that you have accreditation for that work so from a commissioning point of view there may be requirements.
- For sample providers wishing to do Day 2 and Day 8 swab sampling, do we need to submit again something in addition to general testing and test to release 5 day? We're awaiting the laboratory getting confirmation from the DHSC re authorisation for this, but what do we need to do.? We have progressed to stage 3 for GT and TTR.
Regulations require that the laboratory submits the self-declaration on your behalf and that they take responsibility for that provision of the service so in terms of what you need to do it is minimal at this stage. When we get to the assessment, we will look at reporting but until that stage it is for the laboratory to take responsibility.
- When will it be illegal by law to provide swabbing of general public as this has not been put into an Act of Parliament?
This is a question for DHSC and not UKAS as it is DHSC and the government that have put this into place. Our understanding is that its not legal to provide the service now if you are not on the approved list. Check with DHSC.
- What does the stage 3 visit entail? Is there an agenda and details of the documentation we require?
At the start of the process and next week will be doing the first stage 3 assessment for providers that are not an already accredited lab and we’re working hard to put that into place and starting off with the most simply/straightforward assessments which is single site sample collection providers and doing it totally remote. We are issuing a provider assessment tool for use by both the providers to submit documents and for the assessment team to record the assessment. The assessment will be 1 day with both a Technical Expert and an Assessment Manager/Lead Assessor. The construct of assessment will depend on the scope of the application. There is no one-size fits all. If it is a Testing Laboratory, it will follow the standard route of assessment. However, we have streamlined this approach for sample collection providers with lots of information on how to do things.
- What is the procedure to add on a new laboratory on our application that we would like to work with as a sample taker (we are a GP Clinic)?
If you want to add on an additional laboratory send a formal email to [email protected] ensure that you include your UKAS reference number and project number that you have been provided with and state clearly which laboratory including the reference number you are intending to use and whether you are using them for general population testing and/or test to release (TTR). Ensure that if using a lab for TTR check that they meet their specifications.
- How can sample collectors show that laboratories used hold appropriate accreditation? Is the fact that they appear on the gov list of private COVID test providers sufficient?
If the lab is on the approved list it is ok to use. If we have any concerns, we will come back to the provider.
- The link on the gov.uk website for patients for day 2 and day 8 testing takes patients directly to the original provider. Please can this be looked at to ensure it's fair for all providers?
- In form F561 item 10 – what demonstration of evidence of software validation/verification is required?
This depends on what your software is doing. You need to ensure that it is doing what you expect it should do so for example if you are using software that collects client information and patient information, you need to have demonstrated that whatever they input into the system is what actually reaches you. If you do any testing, if you have any analysers and interfaces then again you need to demonstrate by testing that the result your analysers produce is what actually ends up in your system and then if you are reporting the result either to the client and patient or to PHE then you need to demonstrate that the result you issue is exactly what they receive. There are a number of ways of doing that and depends on what your software is but it can be as simple as for example you’re using an email system to send out your result for example if you are sending out PDFs, send out dummy pdf results to a known email address for example your own personal email for a sample of reports and then check them at the other end to ensure that what you think you have issued is reflected in what is received at the other end and similarly for information being input by the client use dummy details to challenge the system and check that is the information you receive. It depends on the software as to what information you can use to demonstrate to us and yourselves that it is working as it should work and as you expect it to work. If you make any changes to software, you would also check that after that had happened the system continued to operate as you expected it too.
- Good afternoon! First of all, thank you for all of these helpful sessions, they’ve been great. DHSC is now allowing private providers to test for day 2 and day 8 tests with certain requirements such as sequencing. Would that come under our accreditation to 15189 or will we need an extension ? We are a sample provider that uses a UKAS accredited lab?
Basically, what is going to be required is that the laboratory does all of that for you. They are going to need to make that service accessible and you are a customer of the laboratory as its seen in the self-declaration. They will contact you and you have to approve that they share the information and that together you meet the requirements. So, your assessment, if you are doing sampling, will largely be unchanged in that regard. The things that we would look at would be whether or not the report met requirements and things specifically for the day 2 and 8 however the sampling and most of the processes are common to whichever purpose the testing is to be done. We are currently determining how this will be represented on the schedule and this will include the intended purpose.
- Further information required regarding the regulation of venous sampling?
UKAS has asked for this to be raised at meetings with DHSC. As far as we understand it, regulations only cover swab or saliva for identifying Covid-19. In terms of the antibody testing our understanding is that this is not covered by the regulations, but providers have come back to UKAS to say they have approached CQC about sampling for antibody testing and they tell them that all Covid testing is covered by UKAS so its something that we need to clarify and add to the FAQs.
- Can I ask about the verification/validation requirements for Stage 3. I have been told that we need to provide info of 250 negatives and 150 positives. Can you clarify if this is info from the lab or from us as a clinic? We would struggle to have anywhere near 150 positives. What information are you actually looking to see?
It depends on what you are doing in terms of the test, this sounds like it specifically relates to test to release testing. That level of specification isn’t in the general population testing work. We are looking in general for some assurance that you can meet the performance claims of the manufacturer and that you are able to show that in your hands the test performs. If you are doing a lateral flow, then that will be very different from if you are doing a test on an analyser in a laboratory. There are inherently things that you could include in your verification so you could be looking at what the EQA provider provides. Many EQA providers provide material that is diluted and has specific sensitivity and when you look at the results this provides good data to show the performance of the assay; not just that you get the answer right but further information. There are materials that you can get that have reference values – positive controls or pooled materials so really, it’s a case of not just necessarily relying on your own material but integrating other things. If you do have positive results and you get them confirmed that again supports the evidence so not a one size fits all for validation and verification. It depends on what the test purpose is and the nature of the assay that you are doing and what the manufacturer is suggesting is appropriate in terms of what they have validated. If you are just sampling and sending to the lab it is up to the lab to provide evidence and have this available of their validation and verification to ensure that it meets the stated TTR requirements.
- Is the scope of software requirements that has been written out and evidence that it meets those requirements step by step sufficient?
Yes, that’s exactly what we want to see. Yes, what is the software supposed to do and what objective evidence have you got that it actually does what its intended to do. Just ensure that you have gathered that evidence together and brought it into a report so document what the software is supposed to do, how you’ve validated and verified it, this is the evidence, and this is why it meets requirements.
- If we are changing the scope of our accreditation to cover a different assay (one validated independently by DHSC) are we able to automatically increase the scope of our application to TTR without the need for an extensive validation? Does this also mean we are covered without the need to perform a verification for general testing?
Assuming that you are approved for Gen Pop testing at the moment. If you wish to increase this, you must inform UKAS, submit a new self-declaration and you must email UKAS to tell us what method you are using and send the independent validation report by the DHSC so no you can’t automatically increase the scope it is still got to be approved by UKAS first and we will check that independent validation to make sure that it meets the TTR criteria. In terms of verification, verification is different to validation; you always need to verify a method whether its for general population testing or for TTR so you would need to verify that method within your laboratory just to prove it works in your hands; that you can meet the manufacturers performance characteristics. General Population testing still requires verification that you can achieve the method developers/manufacturer’s claims before you used it.
- How are you looking at POC devices when used outside of the traditional lab setting?
Even though ISO 15189:2012 and ISO 22870 refer to a laboratory you don’t have to have a traditional laboratory to be accredited for POCT what you do need to do is still meet all the relevant clauses, either meet them or justify why you don’t think they apply and in terms of how we will assess POCT outside the laboratory, assuming that you have more than one location where you use the POCT devices we will conduct a sampling exercise and will look at the locations that you are doing the POCT, the key differences between the locations so for example for whether it be environmental or whether it be the type of staff that are doing the testing; whether it’s on different groups of patients and we will try to include these key differences in our assessment and we will decide on a sampling plan so we won’t look at every single location but we will pick a representative sample that covers those key differences. Will also expect to see the commissioning procedure so when you set up a new location for POCT what you would do to make sure that environment and those staff and that the equipment meets requirements and that’s the way we’ll be conducting the assessment. That will also apply if you have mobile locations, we would expect you to have a standard process for following that to make sure it was going to be suitable to ensure the validity of the results you release.
- DHSC said Test to release is not mandatory and not a replacement for day 2 and 8 testing. It can be booked in addition to mandatory day 2 and 8 testing. As they are separate schemes, they have different processes. We have been approved for general population testing and test to release but that does not mean we are automatically approved for day 2 and 8 testing as they have different minimum standards and requirements we have been told. So, presume we need to wait until the lab has been DHSC approved before we can offer D2/D8 swabbing?
The best thing to do is talk to your laboratory and ask them where they are in the process. Some labs may not do day 2 and 8 testing, they may decide they don’t want to do that. Some labs aren’t approved for test to release because they didn’t want to take it on in the first place. Talk to the provider and see where they are in the process, have they applied and where are they in the application, because similar to this process once the laboratory is approved then they can start to do the work. The process for getting approved is much the same as the other stage 1 approaches with them self-declaring on the DHSC website and answering the questions and if there are queries or information they haven’t provided for example, the independent validation they have provided doesn’t meet the requirements, they won’t be approved. Once they have got through there then you will be included in their application. So, talk to them now and be included on the list of their providers that they’re going to be supporting.
- Regarding Day 2/Day 8 - are there any labs that are approved for this yet. The labs that we are in touch with are not applying?
No-one approved yet. There are some marked in green on the UKAS list, but we are not aware of how the DHSC are going to publish that data. Again, this would be a good one to come back to with DHSC input. List of day 2 and 8 approved providers as identified on the DHSC website can be found through this link – https://www.gov.uk/guidance/providers-of-day-2-and-day-8-coronavirus-testing-for-international-arrivals#information-for-prospective-testing-providers
- How are you looking at accreditation when a sample is being taken and tested within a shop environment?
We haven’t had any applications from providers delivering a service within a shop environment. However, the answer given above also answers this question. Anything outside of a laboratory setting will still require witnessing in some shape or form, whether that be via remote witnessing or recorded video or us going on site at some point but we will have to visit the premises either in person or virtually essentially to see how/what the premises are like and why they meet requirements and watch the person doing the sampling and testing to ensure we are assured of competence of both the individual and organisation and to be able to ask questions of the sample takers and staff testing too. This is essentially no different to any other type of assessment. We appreciate that some environments are more difficult to assess than others, but we have all different types of assessment in place across UKAS.
- And if you have corporate clients you visit to test what has to happen with stage 3?
The assessment approach has to be fit for purpose as outlined in the response to questions about POCT. We would probably need to those sites in some shape or form and the way you work on those sites. Not unusual to UKAS. UKAS accredits certification services and it is not unusual to join those bodies at their customer sites to assess how they conduct their services. So, essentially, we can’t say exactly how we will do it, but we will need to assess it in some shape or form.
- What if you then want to do lateral flow tests. Do you have to do extra UKAS work for LFTs?
If you want to include lateral flow tests as part of the scope of your service and therefore your accreditation it would depend on how these are delivered. If you are taking the sample and running the test, then they would be considered to be POCT and would be assessed for conformity against the requirements of ISO 15189:2012 and ISO 22870:2016 as outlined in the question above.
- Are there any testing laboratories achieved accredited status?
There are quite a lot of labs that are accredited to do Covid testing; we have not as yet, accredited anyone for Covid testing and added the purpose of this to their schedule for example general population or TTR but that is the intention and some will be meeting requirements for that. If they are accredited our assessment will have covered the requirements for general population testing, but there are none yet that we will have covered specific TTR requirements as part of our assessment. So, you cannot assume that any lab, even if it is accredited for Covid-19 has met the TTR criteria.
- We are in the process of accreditation for 15189 sampling only, can we apply for extension for 22870 prior to completion of Stage 3. If we can what would be required for this application, do we use the same Gap Analysis doc and evidence as before or are there other forms.
Yes, you can add it on. Send a formal email to UKAS applications. Yes, you use the same gap analysis template, but it would probably be best if you do a separate gap analysis for POCT. Don’t forget that all of ISO 15189:2012 applies apart from a small number of clauses that have additional POCT requirements so ensure the gap analysis is to both ISO 15189:2012 and ISO 22870:2016. In terms of the application form, you probably submitted the sample only application form the first time round so you will probably need to submit an additional/amended application to detail what POCT kits/methods you are using and to tick the fields to indicate you are seeking accreditation to ISO 15189:2012 and ISO 22870.
- Are there any UKAS accredited External Proficiency Schemes for COVID testing?
There are several UK providers that are already accredited for PT schemes for Covid and most of them are PCR methods at the moment, in fact all of them are but the process for getting a PT scheme up for a new assay is always run through a pilot so at this point in time it may well be that the UK providers that are suitable for a particular assay may be only running a pilot. That would be acceptable at this stage. The people that are currently UK Providers are UKNEQAS Microbiology, UKNEQAS Immunology, WEQAS and QCMD. They are currently offering schemes. There is also EPTIS which is a web based database that lists PT providers who hold accreditation. You can probably find one for PCR but if you are doing other methods you will probably have to go for a pilot scheme. That is acceptable and sensible at this stage.
- Is the gap analysis template available? For stage 2
It is available at the applications section of UKAS website. Scroll to the bottom of the weblink below and you will see it in the list of documents. https://www.ukas.com/applications/
- For lateral flow test kits, what verification process is needed? We are a medical clinic. We have an EQA and IQC in place. Do we need to have any other process in place?
As outlined in an earlier response, verification is the process of demonstrating that you can achieve the manufacturer’s performance requirements with your staff, in your environment and under your testing conditions. You will need to collate evidence to demonstrate that you can achieve those performance characteristics by way of documenting what they are, what your acceptance criteria are and what evidence you have to demonstrate that they are being met. You may be able to use data from EQA, IQC and your patient population to do this.
- In terms of having procedures in place to deal with reporting and resolving adverse incidents, how do we (as a sample collector) provide an idea of how these are dealt with in practice when there is a wide range of issues that could occur? Is it essentially just saying that we need to have someone who will investigate such issues?
You will need to have a documented procedure, i.e. a description of, step by step, how you would identify an adverse incident, what staff should do when one occurs, where, how and when do they record this, where, how and when do you /they record the investigation into the incident. How does this feed into the organisation governance system? How do you ensure that anything reportable to an external body is done and recorded? How do you ensure awareness and learning from incidents? How do you communicate resolution to the individuals involved? How do you trend incidents? These are just some of the points to consider when documenting your procedure for management of incidents.