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.

This webpage contains information on and resources for the current COVID-19 LFD distribution service . Information on the previous service can be found in the COVID-19 Lateral Flow Device Distribution Service Archive.


Changes to the service from 4th October 2021

Amendments to the service have been agreed and an updated version of the service specification was issued to contractors on 9th September 2021 via NHS England and NHS Improvement regional teams. The revised service specification is also available to download via the NHS Business Services Authority website.

Key changes

Changes have been made to the service to support the need for increase traceability of test kits and to continue to assist NHS Test and Trace with efforts to identify COVID-positive cases in the community and break the chain of transmission. The changes to the service specification apply from 4th October 2021 and they include:

  • A reduction in the number of packs of test kits contractors can supply per transaction from four to two, which brings the service in line with other providers of test kits;
  • The introduction of the requirement for citizens to register for a collect code via gov.uk/get-collect-code or 119 prior to making a collection from a pharmacy;
  • If citizens do not wish to register for a collect code, a supply can still be made as an anonymous collection, but people should be encouraged to use collect codes wherever possible;
  • Changes to the information to be captured and reported for each transaction: test kit lot number and quantity supplied;
  • A preference for daily entry of data to support NHS Test and Trace to identify areas of COVID-19 testing demand, support traceability and enable stock management, with a minimum requirement to enter data each week;
  • Additional guidance on stock control and quality control of test kits, with insight into how NHS Test and Trace will review contractor stockholding;
  • A reduction in the minimum recommended age for a person to collect LFD test kits to 16 years; and
  • Changes to the funding arrangements of the service.

When the updated service requirements come into effect on 4th October 2021, contractors already providing the service must comply with the new requirements unless they decide to stop providing the service and give notice.

Although the specification indicates that contractors who decide to stop the service must provide their notice of intention to withdraw by 19th September 2021, NHSE&I and NHS Test and Trace have agreed that notice of withdrawal can be submitted up until 23:59 on 26th September 2021.

Next steps

Contractors should read the updated service specification as soon as possible to ensure they understand all the revised service requirements. Updated resources to support contractors with the revised service can be found in the sections below.


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 led to a Government decision to commission a distribution service from community pharmacies.

Read the PSNC news story announcing the new service

The service 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.

Following a review of the service at the end of June 2021, NHS Test and Trace working with the Department of Health and Social Care, NHS England and NHS Improvement (NHSE&I) and PSNC published an amended service specification. The changes to the service, following agreement with PSNC, reflect experiences from the rollout of the service, insight from user engagement and wider changes in Government and NHS Test and Trace policy on COVID-19 testing.

Read the PSNC news story announcing the publication of the amended service specification

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.

From 4th October 2021, people requesting a test kit should register for a 16-digit collect code via gov.uk/get-collect-code or 119 prior to making a collection from a pharmacy.  A new 16-digit collect code must be requested for each transaction.

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.

Description 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 1st July 2021, the only participating wholesaler is:

  • Alliance Healthcare – Product: DHSC INNOVA COVID-19 test kits  PIP: 8943037
  • Alliance Healthcare – Product: DHSC FLOWFLEX COV test kits  PIP: 8033680

Test kits will be supplied free of charge to pharmacies providing the service as part of their standard deliveries from the wholesaler. The brand of test kits supplied will vary over time, subject to the contract for supply of kits which NHS Test and Trace has with manufacturers/suppliers.

The test kits are supplied in cartons containing multiple 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.

Pharmacy contractors can re-order appropriate quantities of kits in line with the demand of the population they serve, up to an order limit of one carton per pharmacy per day and a weekly limit of six cartons. This is to support the equitable distribution of tests to all pharmacies.

The weekly order limit is subject to review by NHS Test and Trace and may be amended on a case-by-case basis if there is sufficient evidence to suggest that supply is consistently impacted by demand. Contractors are advised to only order another carton when the last carton has been opened.

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.

NHS Test and Trace will monitor the quantities of test kits ordered from wholesalers and those supplied to the public from pharmacies. Contractors may be contacted by NHS Test and Trace if this data indicates a stockholding of more than three cartons. NHS Test and Trace also reserve the right to withhold further deliveries from being made should it appear that excess stock is being held without reason.

If a pharmacy contractor experiences a surge in demand that it cannot meet with the standard supply quantities, they can contact pharmacy.collect.queries@dhsc.gov.uk providing information on the cause of the surge and the approximate level of unmet demand.

Contractors may move stock between pharmacies within or outside their company only in exceptional circumstances (e.g. closure of a pharmacy contractor or mutual aid for an unforeseen surge in demand). When doing so, they must email pharmacy.collect.queries@dhsc.gov.uk, confirming the lot numbers, quantities of cartons and the ODS codes of the pharmacies involved to support batch traceability and stock monitoring.

Any stock which cannot be accounted for when comparing records of stock received and supplies made to the public (e.g. where it is suspected as being lost or stolen) must be notified to pharmacy.collect.queries@dhsc.gov.uk providing details of the quantity of test kits and their lot numbers.


Quality control

If any issues are identified on receipt of a carton of test kits, the pharmacy contractor should contact the wholesaler customer services team to address the issue.

Contractor must inform pharmacy.collect.queries@dhsc.gov.uk of any test kits which are damaged whilst at the contractor’s premises, including stock which may have been compromised due to storage outside of the manufacturer’s instructions.  Details of the quantity of affected stock, the lot numbers and a description of how the stock was damaged or compromised should be provided.


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 a maximum of two boxes of test kits supplied per transaction; this brings the service in line with the limit applied via other supply routes for the tests.

  • There is no minimum age for use of LFD test kits;
  • The minimum recommended age for a person to collect LFD test kits is 16 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.

From 4th October 2021, people requesting a test kit should register for a 16-digit collect code via gov.uk/get-collect-code or 119 prior to making a collection from a pharmacy.

A new 16-digit collect code must be requested for each transaction.

Pharmacy staff must ask the person collecting the test kits for their 16-digit collect code, which must be recorded.

If the person collecting the test kits does not have a collect code, pharmacy staff must encourage them to register via gov.uk/get-collect-code or 119 to obtain a code before collection. Pharmacy staff should explain that obtaining a collect code provides additional patient safety (particularly in the event of a product recall) and allows for a greater understanding of test use.

If the person collecting the tests does not wish to register, then pharmacy staff should still provide them with the required test kits and record this as an anonymous collection.

For every transaction, including anonymous collections, the pharmacy staff must record the following information:

  • the 16-digit collect code (where provided);
  • the lot number for the test pack(s) handed out;
  • the number of test packs handed out;
  • the date of the collection.

The record of this information must be retained for 6 months from the date on which the supply was made.

To claim payment for the transaction, this information must also be entered into MYS, ideally on a daily basis, as this will support NHS Test and Trace to identify areas of COVID-19 testing demand, support traceability and enable stock management.

As a minimum, contractors must enter each week’s data by the close of business on the pharmacy contractor’s last trading day of that week.

If no tests have been collected on a given date, contractors must enter a nil return on MYS.

Pharmacy contractors that do not record stock supplied to citizens, or complete a nil return, on MYS will be assumed by NHS Test and Trace to have given no stock out, and therefore any additional requests for stock may be seen as over-stocking.

Download an updated data capture template:       PDF                 Microsoft Word


Service monitoring

One of the key reasons for amending the service is to increase the degree of traceability to meet MHRA requirements. As a result, there will be an increase in the ongoing monitoring by NHS Test and Trace of the service and contractors may therefore be contacted by NHS Test and Trace should they:

  • Fail to report on time each week;
  • Report a higher number of anonymous collections which are significantly different to the local and national average; or
  • Show a significant number of mismatches following analysis of collect codes when matched with the database of those originally issued by NHS Test and Trace.

In each case, NHS Test and Trace will seek information from the contractor to understand why the issue has occurred.  Should the information provided by the pharmacy contractor be deemed as unsatisfactory, further action may be taken, including withholding further deliveries of test kits until the issue(s) is / are resolved.


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 updated service specification

Download a summary of the updated 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 for new providers of the service 

Download the updated implementation checklist for existing providers

Download an updated template Standard Operating Procedure for the service (Microsoft Word)

Review the changes as a result of the updated service specification to the template Standard Operating Procedure for the service (PDF)

Download an updated team briefing sheet for the service

Once contractors have undertaken the necessary preparatory actions detailed in the implementation checklist, they can start to provide the service.

Promoting the service

Contractors who have been providing the service  were previously sent a pack containing 1 x A3 colour poster, 2 x A4 colour posters and a leaflet about the campaign in April 2021.

NHS Test and Trace has sent new marketing materials to contractors providing the service to enable them to proactively inform people who use the service of the need to register for a collect code. The marketing materials consist of A3 and A4 colour posters and A5 flyers.

Where space permits, contractors are asked to display at least one the posters and to hand out the A5 flyers to citizens who are picking up a rapid COVID-19 tests in the run up to the change in the service.

These materials will be arriving via DX couriers from 6th September onwards, for use from 13th September 2021. The QR code and web page listed on the promotional material that will support citizens to register for a collection code will go live on 13th September 2021.

Contractors who do not receive their materials by 15th September should contact PharmacyCollect@dhsc.gov.uk stating the pharmacy name, ODS code and address.

Additional materials to promote the service 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.

Withdrawing from provision of the service

If a contractor decides not to provide the amended service from 4th October 2021, they are required to provide notice to NHS Test and Trace by emailing pharmacy.collect.queries@dhsc.gov.uk no later than 23:59 on 26th September 2021.

Although the specification indicates that contractors who decide to stop the service must provide their notice of intention to withdraw by 19th September 2021, NHSE&I and NHS Test and Trace have agreed that notice of withdrawal can be submitted up until 23:59 on 26th September 2021.

In the event that the pharmacy contractor elects to withdraw from provision of the service after 4th October 2021, they should give 4 weeks’ notice, and this will allow sufficient time for stock levels to be depleted.

Once notice has been given, no further stock orders should be made from the wholesaler. Pharmacy staff can continue to provide the service until the earliest of the following:

  • Distribution of all remaining stock;
  • Expiration of the notice period; or
  • 3rd October 2021 where a pharmacy contractor elects to not provide the updated Service.

Pharmacy staff should continue to report service provision data via MYS. The quantities and lot numbers of any unused stock remaining after the notice period expires must be reported to pharmacy.collect.queries@dhsc.gov.uk who will issue further guidance on handling that stock.

Funding and claiming payment

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

  1. 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.
  2. A service fee of £1.70 + an allowance for VAT per transaction using a collect code; and
  3. A service fee of £1.20 + an allowance for VAT per transaction using the anonymous collection route.

An early sign-up fee of £200 + VAT, was also available for contractors who signed up to provide the service by 23:59 on 18th April 2021.

The funding comes from outside the pharmacy Global Sum.

The payment of service fees is based on the weekly declarations submitted by the contractor on the MYS portal.

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

Resources

 



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