C-19 lateral flow device distribution service

C-19 lateral flow device distribution service

The COVID-19 lateral flow device distribution service was decommissioned on 31st March 2022.

This webpage contains information on and resources that were available to support the previous provision of the service.

Page last updated on 5th May 2022.


Please click on a heading below to access the archive information on the service.

Background to the service

At the end of March 2021, 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 as an Advanced service.

The service aimed 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 to assist in breaking the chain of transmission. The service was part of the Government’s offer of lateral flow testing to all people in England and it worked alongside NHS Test and Trace’s other COVID-19 testing routes.

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 was an essential part of the nation’s fight against COVID-19. Increased use of LFDs helped identify more people who were highly likely to spread the virus, and therefore supported in breaking 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 showed participants prefer to access testing in the community, pharmacists are trusted by their local communities and unfamiliar new points of access were 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 allowed asymptomatic people to collect LFD test kits, free of charge, from community pharmacies, so they could 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, reflected 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 could request test kits and some of the common circumstances that prompted a person to undertake regular tests at that time were:

  1. Being a child at school or they were in a bubble with school children;
  2. Working at a school or they were in a bubble with school staff;
  3. Having to leave the house for work;
  4. Their local council had advised them to test; or
  5. Their GP or another healthcare professional had advised them to test.

On 1st April 2021, the UK Health Security Agency (UKHSA), launched. It combined key elements of Public Health England with NHS Test and Trace

From 4th October 2021, people who requested 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 was required to be requested for each transaction.

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

The pharmacy was 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

The full service requirements are detailed in the service specification.

Service Directions & Determination
The Secretary of State Directions provided the legal basis for the provision of the service.

Changes to the service from 22nd December 2021

An updated service specification was published on 22nd December 2021 which contained a new requirement. The main change required that where a recall of test kits occurred, contractors had to comply with the instructions within the recall notice, including responding to any requests to confirm they had actioned the recall. The new requirement was aligned to the existing requirement in the Terms of Service for contractors which requires that they respond appropriately to any MHRA recall notices issued.

Changes to the service from 4th October 2021

Changes were made to the service from 4th October 2021 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 included:

  • A reduction in the number of packs of test kits contractors could supply per transaction from four to two, which brought 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;
  • Where citizens did not wish to register for a collect code, a supply could still be made as an anonymous collection, but people were encouraged to use collect codes wherever possible;
  • Changes to the information 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 would 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.

Ordering and managing test kit stock

When a contractor signed up to provide the service, they were required to order test kits from Alliance Healthcare.

Through the course of the service, the stock received by Alliance Healthcare included the following products, so contractors were advised to check availability of each product and order whichever was in stock at the time:

Product: DHSC INNOVA COVID-19 test kits  PIP: 8943037 (54 packs of 7 tests per carton)

Product: DHSC FLOWFLEX COV test kits  PIP: 8033680 (56 packs of 7 tests per carton)

Product: DHSC ORIENT GENE test kits PIP: 8943995 (59 packs of 7 tests per carton)

Product: DHSC SURESCREEN test kits  PIP: 8945040 (56 packs of 7 tests per carton)

Contractors were also advised that there may be periods when the products appeared out of stock, before more replenishment stock was received from the UKHSA; in those circumstances contractors were advised to check back later in the day to see if more stock had become available to order.

Test kits were supplied free of charge to pharmacies providing the service as part of their standard deliveries from the wholesaler. While in most cases, contractors received their orders for test kits within 24 hours, the service level agreement (SLA) associated with delivery of test kits from Alliance Healthcare means deliveries could take up to three working days.

The test kits were supplied in cartons containing multiple boxes, with each box (for an individual person) containing seven test kits. This allowed 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 could re-order appropriate quantities of kits in line with the demand of the population they served, up to an order limit of one carton per pharmacy per day and a weekly limit of six cartons. This limit was put in place to support the equitable distribution of tests to all pharmacies.

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

To support product recall, on receipt of cartons from wholesalers, contractors had to make a record of the following, which was to be 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.

A form to make these records was downloadable:        PDF          Microsoft Word

The data also had to 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 needed 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 monitored the quantities of test kits ordered from wholesalers and those supplied to the public from pharmacies. Contractors could be contacted by NHS Test and Trace if this data indicated that a contractor had stockholding of more than three cartons. NHS Test and Trace also reserved the right to withhold further deliveries from being made if it appeared that excess stock was being held without reason.

Where a pharmacy contractor experienced a surge in demand that it could not meet with the standard supply quantities, they were advised to contact pharmacy.collect.queries@ukhsa.gov.uk to provide information on the cause of the surge and the approximate level of unmet demand.

Contractors were able to 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 were required to email pharmacy.collect.queries@ukhsa.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) also had to be notified to pharmacy.collect.queries@ukhsa.gov.uk providing details of the quantity of test kits and their lot numbers.


Quality control

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

Contractor had to inform pharmacy.collect.queries@ukhsa.gov.uk of any test kits which were 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 were also required to be provided.


Supplying tests to the public

The test kits were provided free of charge to people requesting them and contractors could supply one box of test kits per individual, with up to a maximum of two boxes of test kits supplied per transaction; this brought the service in line with the limit applied via other supply routes for the tests.

  • There was no minimum age for use of LFD test kits;
  • The minimum recommended age for a person to collect LFD test kits was 16 years, but where necessary, professional judgement could be applied by contractors;
  • Tests had to be conducted and results registered away from the pharmacy, this was explained in the instructions inside the test kit; and
  • People undertaking a test could phone 119 for assistance with using the kit or to register their result.

From 4th October 2021, people requesting a test kit were required to 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 had to be requested for each transaction.

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

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

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

For every transaction, including anonymous collections, the pharmacy staff were required to 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 was required to be retained for 6 months from the date on which the supply was made.

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

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

If no tests had been collected on a given date, contractors was required to enter a nil return on MYS.

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

A data capture template was available for contractors to download and use:       PDF                 Microsoft Word


Entering lot numbers into MYS

The Manage Your Service (MYS) application was configured to require an eight-character lot number, but some of the newer LFD stock supplied by the UKSHA had shorter or longer lot numbers.

Where this was the case, contractors were advised to take the following approach:

SureScreen LFDs – lot numbers were between 10 and 12 characters long. Contractors were advised to omit the ‘COVN’ and ‘OM’ characters where these appeared and simply input the numbers as the lot number.

Orient Gene LFDs – lot numbers were 7 characters long, so contractors were advised to add the letter ‘G’ in front of the lot number to submit their data.

Evaluation kits (see below) – where a contractor received evaluation kits from the UKHSA, they were advised to record the first 8 characters of the lot number in MYS.


Evaluation of LFD tests

Each month the UKHSA sent some pharmacies, via Parcel Force, cartons of 15 combined COVID testing kits (containing both a standard LFD pack along with one polymerase chain reaction (PCR) test).

This was a part of ongoing assessments of LFD test kits, with citizens asked to take a PCR test alongside one of their LFD tests and to send it to a lab for testing. The kits contained full instructions for the citizen and pharmacy teams were asked to distribute them as with all other LFD kits supplied for use in the Pharmacy Collect service. There was no additional work for pharmacy teams to complete and contractors were remunerated in the same way as they were for distribution of the standard test kits.

Learn more about the evaluation


Service monitoring

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

  • Failed to report on time each week;
  • Reported a higher number of anonymous collections which were significantly different to the local and national average; or
  • Showed 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 would seek information from the contractor to understand why the issue occurred.  If the information provided by the pharmacy contractor was deemed as unsatisfactory, further action could have been taken, including withholding further deliveries of test kits until the issue(s) were resolved.


Information to provide to people being supplied test kits

Pharmacy staff were required to provide the person collecting the test kits with some key information:

A document containing the key information was available to download (to use to brief people collecting test kits)


The full service requirements

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

Service specification

A summary of the updated service

Preparing to provide the service

Once a contractor decided they wished to provide the service, PSNC’s implementation checklist could be used to guide them through the steps they needed to take to prepare to provide the service:

Implementation checklist for new providers of the service 

Updated implementation checklist for existing providers

Updated template Standard Operating Procedure for the service (Microsoft Word)

Contractors could also review the changes as a result of the updated service specification to the template Standard Operating Procedure for the service (PDF)

Updated team briefing sheet for the service

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

Promoting the service

Contractors who had been providing the service prior to the changes had previously been sent a pack containing posters to promote the service.

Additional materials to promote the service were also 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

In the event that a pharmacy contractor elected to withdraw from provision of the service, they were required to give 4 weeks’ notice, and this allowed sufficient time for stock levels to be depleted.

Once notice had been given, contractors were advised that no further stock orders should be made from the wholesaler. Pharmacy staff could 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 elected to not provide the updated service.

Pharmacy staff were advised to continue to report service provision data via MYS. The quantities and lot numbers of any unused stock remaining after the notice period expired had to be reported to pharmacy.collect.queries@ukhsa.gov.uk who would then issue further guidance on handling that stock.

Funding and claiming payment

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

  1. A one-off set-up fee of £250 + VAT, which covered set-up costs including creating an SOP for the service and training staff who were involved in providing the service, and storage costs for the test kits ordered from wholesalers. This payment was 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 came from outside the pharmacy Global Sum.

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

In line with the usual Drug Tariff requirements, the NHSBSA must have received claims for payments for this service by the fifth day of the following month. They then made 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 were separately itemised on the FP34 Schedule of Payments.

Final payment claims

Contractors had up to 30th of April 2022 to submit any claims for payment via MYS for kits distributed up to 31st March 2022. This included any distributions made in February 2022 that contractors may have been unable to claim at the beginning of March 2022.

Frequently Asked Questions

Resources

Service specification 

One page summary of the service

Implementation checklist for new providers

Implementation checklist for existing providers

Template Standard Operating Procedure for the service

Changes made to the SOP as a result of the updated service

Team briefing sheet

Record of stock received (PDF)

Record of stock received (Microsoft Word)

Data capture template (PDF)

Data capture template (Microsoft Word)

Key information sheet to use when briefing people collecting test kits

NHS Test and Trace map of sites where test kits can be collected

Official ‘Out of Stock’ poster

At PSNC’s request, the UKHSA issued a poster which pharmacies could print off and display when they were out of stock of test kits.

LFD test kits out of stock poster (colour)

LFD test kits out of stock poster (black and white)

Editable and A3 versions of the posters were available to download from the Campaigns Resources Centre.

Given the challenges with supply between November 2021 and January 2022 and the subsequent abuse that some contractors and their teams received from some members of the public, contractors were also reminded that NHSE&I had issued materials to be used in all primary care locations to encourage people to show respect to staff.

NHS Primary Care Staff Respect Materials

If having read the service specification and the information on this webpage pharmacy contractors had outstanding questions regarding the service, they were able to email them to services.team@psnc.org.uk.

Queries could also be directed to the UKHSA team by emailing pharmacy.collect.queries@ukhsa.gov.uk.

Closure of the service

Following the Prime Minister’s announcement on 21st February 2022 and the publication of the Government policy document – COVID-19 Response: Living with COVID-19 – free COVID-19 mass testing ended on 31st March 2022.

End of service preparations

PSNC, the UKHSA and NHSE&I worked together on the final plans for the end of the service. As a result of this work and in preparation for the service end, the UKHSA provided a checklist for contractors to use as a guide to support the closure of the service.

Service closure checklist (MS Word)

Service closure checklist (PDF)

Additionally, a summary of matters for contractors to consider including final deliveries of test kits, running down stock, final payment claims, marketing and how to provide feedback to the UKHSA was provided.

Read the summary

The UKHSA supplied materials for contractors to use to highlight to citizens when the pharmacy had run out of stock and would no longer be offering the service. The materials were available from the campaign resource centre and could also be downloaded via the below links.

Stock out poster (PDF)

Social media content (JPG)

Archive

Information on the previous service can be found in the COVID-19 Lateral Flow Device Distribution Service Archive.

 



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