Localised Management of Lateral Flow Testing of Asymptomatic Staff
Version: 3.0
Ratified by: Clinical Reference Group
Date Ratified: 21/07/2021
Name & Job Title of Author: Managing Director/Assistant Director
Reviewed by Sub Group or Expert Group: Other Expert Group
Related Procedural Documents: See references/links in content of SOP
Review Date: 15/07/2024
Version Control Sheet
Version Date Author Status Comment
1.4 04.12.2020 Paul Cooke Reviewed Amendments made
1.5 08.12.2020 Paul Cooke Approved
1.6 11.12.2020 Paul Cooke Altered process for non-patientfacing staff
1.7 15.12.2020 Paul Cooke Approved Minor amends
2.0 22.2.2021 Paul Cooke Approved Refresh of SOP in light of a number of changes and confirmation of Phase 2
3.0 02/07/2021 Head of Quality and Safety Approved Update to ordering process
1. Background
On 11th November 2020, NHS providers were informed that routine testing of all ‘patient facing’ staff was to begin in the coming weeks.
On the 4th February NHS England & NHS Improvement (NHSE&I) confirmed the Lateral Flow Device testing programme would continue for a further 3 months and that additional stock of testing kits would be delivered w/c 15th February.
At the outset of the programme clear rationale was provided for taking the approach of routine testing of patient facing NHS staff:
Prevention of transmission and spread
Protection of NHS staff and patients
Improve the ability to prevent outbreaks and maintain operational service provision
During this time, routine testing has been and will continue to be carried out using a Lateral Flow Testing Device (LFD). Use of the lateral flow testing devices programme was piloted in a number of early adopter Trusts, prior to wider roll out This, together with a PCR (swab test), has provided an integrated testing approach and resilience in NHS staff testing.
The full evaluation report on Lateral Flow Device testing can be found at https://www.ox.ac.uk/news/2020-11-11-oxford-university-and-phe-confirm-lateral-flowtests-show-high-specificity-and-are and detailed the following for the Innova LFD unit, currently being issued in England:
Specificity - 99.68%.
Sensitivity - 76.8% for all PCR-positive individuals, but detects over 95% of individuals with high viral loads.
Minimal difference between the ability of the test to pick up viral antigens in symptomatic and asymptomatic individuals
Whilst the use of the test is voluntary it is strongly encouraged in order to protect patients and colleagues.
2. Aims & Objectives
The aim of this localised Standard Operating Procedure (SOP) is to detail the processes underpinning the establishment, roll-out and ongoing management of the routine testing. The SOP has been refreshed following the extension of the LFD testing regime.
3. Scope
Prioritisation of Staff groups
The processes described in this localised SOP apply to all staff defined as in scope and only covers the use of the Lateral Flow Test Device. In the initial wave of launching the LFD testing programme staff in groups 1 to 4 were invited as priority staff groups and required to either opt in (by registering) or opt out (see section 6 for more details).
As sufficient numbers of lateral flow test kits were received it was subsequently decided on 5th January by the Provide Incident Management Team to extend the invitation to all staff/workers. Staff in groups 5 to 7 were only sent joining details at individual staff member’s request to join the LFD testing programme
Staff groups in scope
1. All staff who may have direct face-to-face patient contact e.g. frontline clinicians and support staff that have patient facing contact e.g. housekeeping staff or estates staff. This list of staff has been provided by the HR department and reviewed by the respective Service AD’s to confirm accurate.
2. Patient-facing Bank workers – details supplied by HR and reviewed by Work Force Solutions
3. Agency workers – other than those engaged through WFS (see out of scope)
4. Clinical students on placements with community teams
5. Non-front-line workers if visiting patient-facing environments e.g. IT support staff, Senior Management.
6. Non-patient facing staff who do not visit patient facing environments.
7. Any staff on the weekly shift partner testing programme (such as Integrated Care Teams and Phlebotomy services). All such staff are required to continue with their weekly PCR swab testing and joining the LFD programme is not a replacement for this.
4. Out of Scope
Staff that work for the Provide Group and fall into one of the below groups are considered out of scope for the purposes of this testing programme:
Braintree Healthcare and Coggeshall Road as they are on the ECC LFD programme
Patient-facing agency workers who are engaged through WFS are required to undertake the LFD testing programme by accessing LFD testing centres in the 24 hours before their shifts bringing proof of their test results with them.
Any staff (including Bank) that are also employed by an NHS Trust and already part of a testing regime.
In addition, this guidance only covers the use of the Lateral Flow Test Device (LFD) and will not discuss the use of other tests that may become available in time, when additional guidance will be provided.
5. Distribution to Issuing Locations
Deliveries
In early December NHS England & NHS Improvement (NHSE&I) arranged for 623 testing kits to be delivered from National stock A further 513 testing kits were secured through mutual aid. After Phase 2 of the LFD testing programme was announced, NHSE&I advised a further 756 testing kits were being allocated. All testing kits have been delivered to St Peters.
During phase 2 core locations were agreed each with a nominated Administrative Lead who would oversee test kits delivered, stock level control and issue to staff. In exceptional circumstances postage/delivery of testing kits was used In all instances the Testing Kits were held in areas inaccessible to patients.
From 5 July 2021, the NHS will move to an individual ‘pull’ model of LFD supply. This means that, from this date, staff will replenish their tests by ordering a box online from https://www.gov.uk/order-coronavirus-rapid-lateral-flow-tests to be sent to them at home. However, Organisations will still receive a supply of LFDs for patient use as per existing use cases (emergency supplies were home delivery has failed, end of life care, visitors to inpatient units). This move will not only make best use of the supplies of LFDs currently available to NHS Test and Trace, but will also provide a greater level of assurance by organisation that devices are routinely being ordered and used.
Details of how to order can be found in section 8.
6. Staff Registration
Priority Staff registration
Under Phase 1, e-mail addresses for all staff in groups 1 to 4 (see section 3 of the SOP)
were added by Provide Digital to ‘ProvideMyResults’ and individual staff accounts created. These staff were then invited by e-mail to either opt out of the lateral flow testing programme or register using ‘ProvideMyResults’ (see section 11 for more details).
Priority Staff data cleanse
A data cleanse of those staff invited as part of wave 1 was undertaken toward the end of January 2021 and completed on 4th February. An up-to-date list of those staff in group 1 detailed in section 3 has been provided by HR and will be used to re-invite any staff who are neither on the ‘opted out’ or ‘registered’ list. This will be completed over the last week of February/first week of March.
Non-priority Staff registration
After testing kits were issued to priority staff in groups 1 to 4, staff from groups 5 to 7 were advised they needed to notify the provide.stafftesting@nhs.uk e-mail address if they wished to join the LFD testing programme. Upon receipt of this request, individual accounts are created by Provide Digital and an invitation to register e-mailed to each member of staff.
Staff/worker Service details on ProvideMyResults
In the event that staff are redeployed or they are not substantive employees they are required to ensure the details of the Service they are working in is up to date on their ProvideMyResults account This is a new requirement that will ensure accurate Service reporting as detailed in section 12.
If staff are unable to log in and are unable to register they will be directed to contact Provide Digital by e-mailing Provide.digital@nhs.net
Consent
Completion of the registration process will form the basis for staff consent and the provision of data required as part of the submissions to Public Health England (PHE). The original consent (as detailed in the Privacy notice) allows for data to be shared with:
Provide Group Managers
Provide employed staff that are involved in the processing of the information
Provide Digital staff involved in the development, support and maintenance of the app
Authorised staff of third-party partners involved in the maintenance and support of the app
NHS Public Health England where information is included in nationally mandated submissions
By signing up for the programme, staff must comply with a number of steps:
Responsible use of the test, for themselves only
Using the test in line with the issued procedure
Recording and reporting of results on the same calendar day (within 24 hours) the test is completed.
Returning any test boxes, if they decide they no longer want to take part in the programme.
ProvideMyResults app
Users are now able to download an icon for both desktop or mobile device as detailed in the below allowing for a simpler upload process:
ProvideMyResults
App Installation Guide on Desktop-Laptop and Mobile Phones.pdf
7. New Starters / Leavers
New Starters
An on-boarding process has been established for all new starters. New starter information will be routinely communicated to Provide Digital who will add the new users to ‘ProvideMyResults’
The LFD process will also be included in the Corporate Induction and instructions on how to order testing kits issued to new starters.
Leavers
HR will advise Provide Digital when a member of staff leaves and their account will be deactivated but the results up unto the point of leaving will continue to be included in the cumulative reporting
8. Issuing of Testing Kits
With effect of 5th July, Provide Group will no longer supply boxes of LFD kits to staff and they should order via https://www.gov.uk/order-coronavirus-rapid-lateral-flow-tests
Provide is not listed as an organisation in the system so you should select ‘Other NHS commissioned services’. You will need to include the postcode of Provide which is CO4 9YQ.
Once you have entered your home address you will be sent a box with 7 test kits, this is sufficient for 2.5 weeks when testing twice weekly. Delivery is usually within 48 hours. When you have 1 kit remaining you should reorder.
Please continue to record your test results onto the Providemyresults app as before. Please do not use the government website as instructed within the kit information. Provide will upload results on behalf of us all.
If you have any questions or experience any difficulties with self-ordering, please contact Provide.stafftesting@nhs.net
Provide will hold a restricted amount of stock of LFD kits for the purposes of visitor/patient testing within inpatient wards or clinic services and in cases of emergency were home delivery has failed.
All requests for access to these kits should be via Provide.stafftesting@nhs.net
Please note the core locations will no longer be issuing kits to staff.
9. Support & Training
Additional training and support can be sought by contacting the dedicated LFD e-mail address provide.stafftesting@nhs.net. Appointments will be with one of our trained Staff Testing Clinical Support
Over the course of the LFD programme should any new FAQ’s become apparent these will be published and made available to Provide staff.
As versions are updated they can be found at the below weblink: https://www.england.nhs.uk/coronavirus/publication/asymptomatic-staff-testing/
Current National FAQ’s: https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/11/C0913lateral-flow-antien-test-trust-faqs-v3-jan-2021.pdf
10. The Test
10.1 Test summary
Lateral flow antigen testing detects the presence of the COVID-19 viral antigen from a swab sample. The test is administered by handheld device producing results in 30 minutes and can be self-administered. Appendix A and B document the process
10 2 Testing kit contents
All eligible staff taking part will receive via the post a box with 7 test kits. This is enough for 2.5 weeks supply, when testing twice weekly. The testing kits will arrive in boxes, containing the following:
7 foil pouches containing the test cartridge and a desiccant
7 prefilled extraction buffer sachets
7 extraction tubes with tube caps
7 sterilised swabs for throat/nasal sample collection
Staff will need to store devices at a temperature between 4 degrees and 30 degrees, not in direct sunlight or in the fridge.
Restrictions of use
Tests must not be used:
Instead of a PCR swab test. If the lateral flow test is positive, or if staff have any signs or symptoms of COVID-19, a PCR swab test is still required.
To rule out COVID-19 if staff have any signs or symptoms of COVID
To test anyone other than the individual they were issued to.
As a reason not to fully comply with the Provide’s requirements for working safely e.g. wearing a mask when indicated or to self-isolate when indicated or instructed.
Testing requirements
Patient-facing staff will be advised to test themselves:
Twice a week, every three to four days.
Staff are required to undertake the test no less than 24 hours before their shift/next working day starts. This will allow any absence to be reported in a timely manner e.g. in the evening before the next day shift. Taking the test just prior to the shift may lead to an increase in short notice absences, which will impact on Provide’s ability to provide operational cover.
Taking the test, no less than 24 hours before their shift/working day starts will also allow an opportunity to redo the test where there is an Invalid result.
Staff are advised to continue self-testing during periods of annual leave.
Staff are advised to continue with the LFD testing even after a Covid vaccine has been received.
What to do if a positive PCR swab test result
If a positive result is received from a PCR swab test, lateral flow self-testing needs to be paused, and recommenced 90 days after the positive PCR swab test was taken. This is due to the likelihood of a false positive result sometime after the infectious period of COVID-19 has passed.
In the event of the above, staff will be not be required to return the unused LFD testing kits.
For any Bank workers who work in patient-facing environments who have had a positive PCR test in the previous 90 days, WFS will advise the booking Service Manager that the Bank worker will be unable to undertake the LFD tests and a decision made on suitability.
11. Result Capture
Once the staff have registered for the LFD programme they will be able to use
‘ProvideMyResult’ as a mechanism to upload their results via a web-based application so that all the relevant data Provide are required to submit can be captured in an automated manner. Results can be uploaded on any device that can connect to the internet.
Details staff will need to record are:
Date of test
Time of test
Test result – Positive, Negative or Invalid
Swab specimen ID (Lot number)
Support will be provided by the provide.digital@nhs.net email account if there are any problems with the platform use.
Staff with no IT to record results will be required to notify their Team Leader who will submit a daily summary of tests undertaken to the provide.stafftesting@nhs.net
Submission of timely results will be reported by the BI team daily and followed-up by the staff-testing team where staff have submitted their results on a different calendar day from when the test is undertaken. Should non-compliance continue then staff details will be passed to Service Managers for follow-up as necessary.
12. Reporting the Results
Statutory reporting requirements and data management
Whilst taking the test is voluntary, where it is conducted there is a statutory requirement to report the results.
The data will be kept confidential, and personal identifiable information will only be shared with line managers or any other department within Provide other than where these staff have a defined role in processing this information
In order to fulfil the statutory requirement, Provide will submit data on a weekly basis to Public Health England, using secure transfer.
It has been agreed a data capture window will be on a calendar day basis – midnight to midnight. It is therefore important for staff to report their results on the same calendar day that they took the test.
12 External Reporting requirements
Public Health England (Weekly)
On 6th February NHSE&I advised starting from 8th February positive and indeterminate COVID-19 test results will now be reported to PHE every Tuesday by 5pm using the below template
NHSStaffLFT_V2_DR AFT.xlsx
The staff testing team will supply data on a Monday for the stock level and the number of testing kits issued in the preceding week. Information required on test results will be supplied by Provide Digital.
NHS Digital Data Collection. (7 days a week)
New staff asymptomatic coronavirus lateral flow test (LFT) data collection, submitted by 2pm using the template NHSStaffLFTV1.
NHSStaffLFT V126112020.xlsx
12 Internal Reporting
A performance reporting framework for Corporate assurance has been developed with Business Intelligence and Provide Digital and consists of an automated process (run by Provide Digital) to email the below weekly reporting information to the Director of Operations (Group view), Assistant Directors (Business unit view) and Service Managers
(Service level view). The reports will include a summary level and also individual staff level results. The reports will be generated every Monday and show the stats for the last week i.e. previous Monday to Sunday.
Summary level reports - at Group, Business Unit and Service level
Number of staff signed up to LFD testing programme
Number of staff submitting at least 2 results in the last week
Number of staff submitting 1 test in the last week
Number of staff submitting a zero result in the last week
% of registered staff doing at least two LFD tests in last week
% of registered staff doing one LFD tests in last week
% of registered staff doing zero LFD tests in last week
Number of total positive LFD tests submitted in last week
Detailed level reports - at Group, Business Unit and Service level
Employee name
Date invited in
Date opted in
Test results by day for the last week
13. Adverse Incidents
Any adverse incidents, or concerns about the accuracy of results must be reported through the normal incident reporting system - Datix
