C-19 lateral flow device distribution service

C-19 lateral flow device distribution service

At the end of March 2021, a new Advanced service – the NHS community pharmacy COVID-19 lateral flow device distribution service (or ‘Pharmacy Collect’ as it is described in communications to the public) – was added to the NHS Community Pharmacy Contractual Framework.

This service, which pharmacy contractors can choose to provide, as long as they meet the necessary requirements, aims to improve access to COVID-19 testing by making lateral flow device (LFD) test kits readily available at community pharmacies for asymptomatic people, to identify COVID-positive cases in the community and break the chain of transmission.

The service is part of the Government’s offer of lateral flow testing to all people in England and it works alongside NHS Test and Trace’s other COVID-19 testing routes.

Read the PSNC news story announcing the new service


Click on a heading below for more information

Introduction

COVID-19 lateral flow antigen tests allow the detection of people with high levels of the COVID-19 virus, making them effective in identifying individuals who are most likely to transmit the virus, including those not showing symptoms.

With up to a third of infected individuals not displaying symptoms, broadening asymptomatic testing is an essential part of the nation’s fight against COVID-19. Increased use of lateral flow devices (LFD) can help identify more people who are highly likely to spread the virus, and therefore break the chain of transmission. On Easter Monday (5th April 2021), the Prime Minister, Boris Johnson, announced that everyone in England was to be given access to two free coronavirus tests a week from Friday 9th April 2021.

NHS Test and Trace research into routine mass testing shows participants prefer to access testing in the community, pharmacists are trusted by their local communities and unfamiliar new points of access are less well trusted; these findings have led to a Government decision to commission a distribution service from community pharmacies.

In NHS Test and Trace marketing and communications aimed at the public, the service will be referred to as Pharmacy Collect and it allows asymptomatic people to collect LFD test kits, free of charge, from community pharmacies, so they can undertake regular testing as part of the Government’s COVID-19 roadmap plan. All people in England can request test kits and some of the common circumstances that will prompt a person to undertake regular tests are:

  1. They are a child at school or are in a bubble with school children;
  2. They work at a school or are in a bubble with school staff;
  3. They have to leave the house for work;
  4. Their local council has advised them to test; or
  5. Their GP or another healthcare professional has advised them to test.

People self-administer the tests away from the pharmacy, e.g. at home.

The pharmacy is consequently not involved in the generation of test results, supporting the reporting of results or the next steps for the person taking the test.

The service will be reviewed at the end of June 2021. This will allow the service specification to be updated in light of possible insight from user engagement and the experience of contractors providing the service.

Overview of the service

Ordering and managing test kit stock

When a contractor signs up to provide the service, they should order test kits from a wholesaler. A list of participating wholesalers is available on the NHSBSA website. As of 29th March 2021, the participating wholesalers are:

  • Alliance Healthcare – Product name DHSC Innova COV19 Rapidtest(7) (DHSC COVID-19 test kits) PIP: 8943037
  • Phoenix Healthcare Distribution (Rowlands Pharmacies only)

Test kits will be supplied free of charge to pharmacies providing the service as part of their standard deliveries from the wholesaler.

The test kits are supplied in cartons containing 54 boxes, with each box (for an individual person) containing seven test kits. This allows the person to test themselves twice weekly over a three-week timeframe, with an additional test kit to factor in the potential for a void test.

The carton dimensions are 50 x 29 x 40.5 cm.

Initial demand for test kits for each pharmacy will be difficult to predict and pharmacy contractors will be able to re-order appropriate quantities of kits in line with the demand of the population they serve, up to an initial order limit of one carton per pharmacy per day. This is to support the equitable distribution of tests to all pharmacies and will be subject to review.

To support product recall, on receipt of cartons from wholesalers, contractors must make a record of the following, which is retained for 6 months from the date on which the stock was delivered:

  • Lot Number;
  • Quantity of cartons (outers – not the number of individual boxes of test kits within those cartons);
  • Supplying wholesaler; and
  • Date of receipt.

Download a form to make these records:        PDF          Microsoft Word

This data must also be entered into the NHSBSA’s Manage Your Service (MYS) portal by the close of business on the pharmacy’s last trading day of each week.

The test kits need to be stored in a designated area out of the reach of the public, away from direct sunlight, between 2°C and 30°C.


Supplying tests to the public

The test kits will be provided free of charge to people requesting them and contractors can supply one box of test kits per individual, with up to four boxes being provided per transaction (i.e. test kits for up to four individuals in one transaction).

  • There is no minimum age for use of LFD test kits;
  • The minimum recommended age for a person to collect LFD test kits is 18 years, but where necessary, professional judgement can be applied by contractors;
  • Tests must be conducted and results registered away from the pharmacy, as explained in the instructions inside the test kit; and
  • People undertaking a test can phone 119 for assistance with using the kit or to register their result.

Pharmacy staff must ask the person collecting the test kits the following three questions. The answers to questions 2 and 3 must be entered into the MYS portal by the close of business on the pharmacy’s last trading day of the week.

  1. Have you collected LFD test kits before?
  2. Why do you need tests? (one reason only – only in relation to the first person requesting a test)
  3. What is the age range of the person using the kit? (for each box supplied – up to 4 boxes per transaction)

Download a sheet detailing the questions to be asked (for use when talking to people requesting test kits)

The data entered into MYS will be used for evaluation and service improvement purposes and it will also populate the payment claim for the service with the number of transactions you have undertaken in the pharmacy being based on the number of answers to question 2 (Why do you need tests?).

It is therefore essential that only one reason for tests being requested is recorded for each transaction and then reported on MYS, so an inaccurate payment claim is not made.

The number of individual test kits supplied per transaction (up to the maximum of four) will be determined from the answers to question 3 (What is the age range of the person using the kit? – for each box supplied).

Download a data capture sheet (to record multiple supplies):          PDF        Microsoft Word

Download a data capture template (to capture data on individual supplies):          PDF        Microsoft Word


Information to provide to people being supplied test kits

Pharmacy staff must provide the person collecting the test kits with some key information:

Download a document containing the key information (to use when briefing people collecting test kits)


The full service requirements

The full service requirements are included in the service specification, which contractors must read before deciding whether to provide the service.

Download the service specification

Download a summary of the service

Preparing to provide the service

Once a contractor has decided they wish to provide the service, PSNC’s implementation checklist will guide them through the steps they need to take to prepare to provide the service:

Download the implementation checklist

Download a template Standard Operating Procedure for the service (to personalise for your pharmacy) (Microsoft Word)

Download a team briefing sheet for the service

Once contractors have undertaken the necessary preparatory actions detailed on the above webpage, they can start to provide the service.

This service has been developed at pace, as part of the wider national effort to support COVID recovery, so that pharmacy contractors can start to provide the service as soon as they are ready to do so.

NHS Test and Trace, the Department of Health and Social Care and NHS England and NHS Improvement all recognise that this time of year is very busy for pharmacy contractors and their teams, and as such it is unlikely that they will have time to consider offering the service until after Easter 2021. The public promotion of the service did not commence until after Easter 2021.

Promoting the service

Contractors who have signed up to provide the service will receive a pack containing 1 x A3 colour poster, 2 x A4 colour posters and a leaflet about the campaign by courier service, which will need to be signed for on arrival. The first batch of packs will be delivered on 8th April 2021 and packs will continue to be sent out as contractors sign-up to deliver the service.

Additional materials are available on Public Health England’s campaign resource centre including digital screens, a social media post (with suggested copy) and additional posters to print out, translated into 13 languages.

Funding and claiming payment

Funding for provision of the service is made up of the following elements:

  1. An early sign-up fee of £200 + VAT, for any contractors who sign up to provide the service by 23:59 on 18th April 2021. This payment will be triggered by completion of the registration declaration on the MYS portal by 23:59 on 18th April 2021.
  2. A one-off set-up fee of £250 + VAT, which covers set-up costs including creating an SOP for the service and training staff who will be involved in providing the service, and storage costs for the test kits ordered from wholesalers. This payment will be triggered by completion of the registration declaration on the MYS portal.
  3. A service fee of £1.50 + VAT per transaction (the supply of up to 4 boxes of test kits to a person requesting them). This payment will be made based on the weekly declarations submitted by the contractor on the MYS portal.

That means contractors signing up to provide the service by 23:59 on 18th April 2021 will receive £450 + VAT in up-front payments for the service, in addition to the service fee for each transaction undertaken.

The funding comes from outside the pharmacy Global Sum.

In line with the usual Drug Tariff requirements, the NHSBSA must receive claims for payments for this service by the fifth day of the following month. They will make appropriate payments, to the contractor, corresponding to the weekly reporting cycle, on the same payment date as other payments for NHS Pharmaceutical Services. The payments will be separately itemised on the FP34 Schedule of Payments.

Frequently Asked Questions

Preparing to provide the service and sign-up

Q. How do contractors sign up to the Lateral Flow Device Distribution Service?
Contractors can sign up to provide the service by completing the Lateral Flow Device Distribution Service declaration on the NHS Business Services Authority’s (NHSBSA) Manage Your Service (MYS) portal.

Q. Will the details of contractors signed-up to provide the service have to be manually entered on the NHS Test and Trace Site Finder map?
No. Contractors’ details will be automatically added to the map when they sign up to provide the service via the Manage Your Service (MYS) portal. All the details for pharmacy contractors will be managed by the NHS Test & Trace team.

Q. How long will it be, after signing up to provide the service, before my pharmacy’s details will be added to the NHS Test and Trace Site Finder map?
Pharmacy details will be added on a weekly basis to the NHS Test and Trace Site Finder map. Contractors who sign up to provide the service by close of play on a Sunday, will have their pharmacy details added to the NHS Test and Trace Site Finder map on the following Tuesday.

Q. How can contractors request amendments to their NHS Test and Trace Site Finder map data for their pharmacies providing the service?
They can email a request to PharmacyCollect@dhsc.gov.uk.

Q. Is it possible for contractors to manage their NHS Test and Trace Site Finder map data for their pharmacies providing the service?
Yes. If a contractor wishes to manage their data for their sites on the map, they can request to do so by emailing PharmacyCollect@dhsc.gov.uk. Contractors will need access to a mobile phone to support two-factor authentication used when logging in to the site.

Q. Do I need to UKAS accreditation to provide the service?
No. The UKAS FAQs on COVID-19 tests state:

For home-based tests that are sold [supplied] by the provider, but the provider does not collect the sample or analyse the test – so the test is analysed at home (i.e. new LFD technologies), the provider that sells [supplies] the tests does not require UKAS accreditation.

Q. When did the service officially start/go live?
The service commenced on 29th March 2021, however promotion of the service to the general public did not start until after Easter 2021.

Q. Will any marketing materials be provided to support the promotion of the service in pharmacies?
Yes. Contractors who have signed up to provide the service will receive a pack containing 1 x A3 colour poster, 2 x A4 colour posters and a leaflet about the campaign by courier service, which will need to be signed for on arrival. The first batch of packs were delivered on 8th April 2021 and packs will continue to be sent out as contractors sign-up to provide the service.

Additional materials are available on Public Health England’s campaign resource centre including digital screens, a social media post (with suggested copy) and additional posters to print translated into 13 languages.

Q. Do contractors need to update their NHS website profile and their DoS profile when they have signed up to provide the NHS community pharmacy COVID-19 lateral flow device distribution service to show that they are now providing this service?
No. The NHS Test and Trace Site Finder map is the website that the public will use to identify which pharmacies are providing the service.


Supply of tests kits to the pharmacy

Q. Will I need to provide my wholesaler(s) with any specific information or declarations to order test kits for the service?
No. The NHSBSA will provide wholesalers with a list of contractors that have signed up to provide the service.

Q. Can I order test kits from any wholesaler listed on the NHSBSA website?
Yes.

Q. At present (early April 2021), most pharmacies can only order test kits from Alliance Healthcare? Will other wholesalers be supplying the kits in due course?
Currently Alliance Healthcare are the only wholesaler supplying test kits (other than Phoenix Healthcare Distribution, who are only supplying kits to branches of Rowlands Pharmacy). DHSC and NHS Test and Trace are working with other wholesalers, with the aim of them agreeing to stock the kits. If other wholesalers come on line, PSNC will communicate this to contractors via our normal communications channels.

Q. Who will Alliance Healthcare supply test kits to?
All pharmacies in England (except Rowlands Pharmacy branches, which are being supplied by Phoenix Healthcare Distribution) signed up to provide the service are being supplied by Alliance Healthcare at this time (early April 2021).

Q. Will contractors incur a surcharge if they order test kits from Alliance Healthcare, but they are not the pharmacy’s main wholesaler?
No. There will be no surcharges incurred against orders for the test kits.

Q. Is there a limit to how many test kits we can order for our initial stock?
Contractors should initially order one carton of test kits and further stock can then be ordered as needed. As noted in the Service Specification initial demand for the service has been difficult to predict and order limits are being regularly reviewed to manage this. Therefore at the present time (early April 2021), supplies are initially being limited to one carton per pharmacy per day. This is to support the equitable distribution of tests to all pharmacies that sign up to provide the service. When supplies can be normalised at up to 12 cartons a week, this will equate to a maximum of 648 boxes of seven tests.

Q. If I need more than the limit, how will this get reviewed?
The weekly order limit for pharmacies providing the service will be reviewed on a regular basis to manage demand and capacity for the service.

Q. Do I need to maintain a record of stock received other than on MYS?
Yes. Contractors should maintain a record of stock received from wholesalers which is retained for 6 months from the date on which the stock was delivered to the pharmacy. A template to use to maintain these records is available above.


Storage of the test kits and stock management

Q. If I am ordering test kits from more than one source, are there any additional points to consider?
Yes. Where a contractor orders test kits from more than one wholesaler, they are advised to either store kits from different wholesalers separately or have some way to identify which stock has come from which wholesaler. This is to enable contractors to identify which stock may be affected in the event of a product recall linked to a lot supplied from a particular wholesaler.

Q. If my stock of test kits gets damaged, do I need to record and report this in any way?
If boxes of test kits are damaged and are not in a fit state to be distributed, the contractor should make and retain a record of the number of test boxes damaged, their lot number and the date and cause of the damage. This may be needed as part of any post-payment verification process.

Q. The service specification says if the pharmacy temporarily runs out of test kits or experiences a demand for test kits it cannot meet at that time, contractors have the option to change their information on the online NHS COVID Test Finder tool by emailing PharmacyCollect@dhsc.gov.uk and requesting for their site to be displayed as ‘out of stock’. When will that email address be monitored by the NHS Test and Trace team?
The mailbox will be monitored during normal working hours, Monday to Friday.


Providing the service

Q. Is ‘Pharmacy Collect’ and the NHS community pharmacy COVID-19 lateral flow device distribution service the same service?
Yes. Pharmacy Collect is the public facing name for the NHS community pharmacy COVID-19 lateral flow device distribution service.

Q. The service specification indicates contractors can hand out two boxes per transaction and up to four boxes where pharmacy teams are acting under the professional discretion of a pharmacist. Does the pharmacist have to authorise supplies each time more than two boxes are requested?
No. The pharmacist retains overall responsibility and discretion in the provision of the service and therefore can provide guidance to their team about how they want the service to operate. They can supply a maximum of four boxes per single transaction. Where there are any concerns in relation to a request for test kits, pharmacy teams should involve the pharmacist in the transaction.

Q. If the family, household or school bubble is larger than 4 people, can more than four boxes be provided in a single transaction?
No. The maximum number of boxes that can be provided in a single transaction is four. Where the family, household or school bubble is larger than 4 people, further supplies would need to be made as a separate transaction and at the discretion of the pharmacist.

Q. If I supply as one transaction, four boxes of test kits to a person requesting kits for four people, do I get paid four transaction fees?
No, a transaction fee is paid for each transaction, not each box of test kits supplied. A transaction can include the supply of up to four test kits.

Q. I have asked a person who wants to collect an LFD test kit why they need the tests, and their reason is not one of the ones listed in the service specification (school related, leave the house for work, local council advised them to test or GP/healthcare professional advised them to test). Can I still provide the tests?
Yes. Everyone in England can access two free coronavirus tests a week. If their reason is not one of the four listed in the service specification, pharmacy staff should select ‘Other’ and record the reason why the person is requesting the supply.

Q. If the person requesting test kits does not provide answers to the questions specified in the service specification, can they still be provided with the test kits?
No.

Q. A request is made for just one test. Can we split the boxes of 7 tests?
No. The minimum quantity that can be supplied is one box of 7 tests.

Q. Can I make supplies to a person under the age of 18 years?
Where the person requesting supplies is under 18, the pharmacist can make a professional judgement as to whether the supply is appropriate and whether the person collecting the test kits is competent to answer the questions required and understand the information provided.

Q. Can the pharmacy team administer a test to a person who has collected a test kit, if they are having trouble using the test kit?
No. The service is only for the distribution of kits. Tests must be conducted away from the pharmacy. Where a person requires assistance to perform a test, they should be referred to 119. Where a local testing service is in place (which may include supported self-testing in pharmacies, where local authorities have commissioned such a service), people unable to self-test, could be referred to that service.

Q. Are the key points of advice to the person collecting the test kits required to be provided each time they collect test kits?
The key points must be provided to the person collecting test kits where they indicate this is the first time they are collecting test kits. On subsequent collections, pharmacy teams can use their discretion to determine whether all points need to covered, for example, having determined whether the person had any problems using the tests or any outstanding questions. It is important to remind people of the importance of reporting their results, whether positive or negative.

Q How do I check if the person collecting test kits understands the key point?
This can be done by asking the individual if they have understood the advice and if they have any questions.

Q. Are contractors required to record any contact details for the person requesting the tests to assist in the event of a recall or concern?
No.

Q. Can contractors deliver test kits to people requesting them if they cannot visit the pharmacy?
The service is focused on people collecting test kits from their local community pharmacy. Generally people who wish to have test kits delivered to their home should order their kits from the GOV.UK website. However, home delivery is not precluded by the service specification, as long as all the other requirements of the service are fulfilled.

Q. Can a patient who lives in one of the other home countries, for example, Wales or Scotland, collect LFD test kits from a pharmacy in England?
Yes. There are no geographical restrictions placed on the provision of the service.

Q. Can an LFD test kit be used to test young children?
Anyone in England who does not have symptoms can now get regular LFD test kits to check for coronavirus; however, primary school-age children and younger do not need to be tested.

Q. Can distance selling pharmacies provide the C-19 lateral flow device distribution service?
Yes. A distance selling pharmacy may provide Advanced and Enhanced services on the premises. However, they must not provide any Essential services to any person present on their premises while providing the Advanced or Enhanced service.

A distance selling pharmacy can also offer home delivery of the LFDs (as can other contractors) as this is not precluded by the service specification, as long as all the other requirements of the service are fulfilled. However, the service is focused on people collecting test kits from their local community pharmacy. Generally, people who wish to have test kits delivered to their home should order their kits from the GOV.UK website.


Ramadan 

Q. Can coronavirus test kits be used during Ramadan?
BIMA has reviewed opinions from different schools of thought and advises that using a lateral flow device (LFD) test or polymerase chain reaction (PCR) test does not invalidate the fast during Ramadan, as per the opinion of most Islamic scholars.

Resources

 



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