COVID-19 Lateral Flow Testing Quality Plan...COVID-19 Lateral Flow Testing Quality Plan 3 Context...

COVID-19 Lateral Flow Testing Quality Plan

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Contents

Context ....................................................................................................................................... 3

Testing team .............................................................................................................................. 3

Quality checklist ......................................................................................................................... 4

Briefing the school community ............................................................................................... 4

Recruitment and training of staff ............................................................................................ 4

Wider communications ........................................................................................................... 5

Risk assessment .................................................................................................................... 5

Arranging supervision of pupils .............................................................................................. 6

Identifying suitable base......................................................................................................... 6

Setting up registration and recording system ........................................................................ 7

Securing consent for lateral flow testing ................................................................................ 7

Scheduling testing .................................................................................................................. 8

Taking delivery and storing equipment .................................................................................. 9

Setting up the testing base .................................................................................................... 9

Conducting a walk through .................................................................................................. 10

Conducting testing: registration ........................................................................................... 10

Conducting testing: swabbing .............................................................................................. 11

Conducting testing: processing ............................................................................................ 11

Conducting testing: recording of results .............................................................................. 12

Conducting testing: cleaning and waste disposal ................................................................ 12

Conducting testing: site culture and efficiency of end-to-end process ................................ 13

Managing positive cases ...................................................................................................... 13

Managing negative cases .................................................................................................... 13

Record keeping .................................................................................................................... 14

Compliance with GDPR ....................................................................................................... 14

Appendices .............................................................................................................................. 15

Appendix A1 Template: School’s COVID-19 testing team .............................................. 15

Appendix A2 Quality checklist (to be completed before first testing commences and

revisited if new team members join or a new testing base is established) ......................... 15

Appendix A3 Quality checklist (to be completed daily) .................................................... 15

Appendix B1 School test assistant / swabber competency assessment ........................ 15

Appendix B2 School processor competency assessment .............................................. 15

Appendix B3 School results recorder competency assessment ..................................... 15

Appendix C1 Template COVID-19 test register ............................................................... 15

Appendix D1 COVID-19 risk assessment: school based asymptomatic testing ............. 15


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Context

Schools are required to deliver mass lateral flow testing to pupils as part of their suite of

measures to stem the spread of COVID-19.

Additionally, schools are able to deliver serial testing to those pupils and staff who have

been identified as close contacts of someone within school who has tested positive for

COVID-19. If the recipient of serial testing has a negative result, they will not be required to

self-isolate.

Finally, weekly testing is available to staff so that the school has real-time knowledge of

whether members of its community have COVID-19 and can therefore take appropriate

action.

This quality plan has been devised to ensure that lateral flow testing is delivered safely and

effectively to the pupils and staff and thereby support continuity of face-to-face learning.

Testing team

The roles required to implement lateral flow testing are described in the COVID-19 National

Testing Programme: ‘How to Guide’ for schools and colleges.

Title of Role Role Description

Quality Lead /Team Leader Responsible for the overall on-site operations at the test site, including day-to-day workforce management. Ensures quality assurance, incident management, risks mitigation across the testing service.

COVID-19 Coordinator Signs off and schedules testing activities; ensuring communications and consents are actioned; management of positive cases as per school and college guidelines.

Registration Assistant Responsible for registering subjects on School’s COVID-19 Test Register, ensuring subjects have registered on NHS Test and Trace and distributing barcodes. Ensures orderly entry of subjects onto the testing site.

Test Assistant/s Provides guidance and supervision to subjects on swabbing as requested. Collects completed swabs and pass them to the Processor. Ensures cleaning of swabbing desks.

Processor/s Prepares test sample for analysis, conducts processing of LFD and interprets result. Provides results to Results Recorder. Ensures cleaning of processing desks.

Results Recorder Collates results from Processor and uploads to the NHS Test and Trace service and the School’s COVID-19 Test Register.

Cleaner/s Cleans the testing desks, and ensures waste is correctly disposed of, including working with waste provider to dispose of clinical waste.

The roles of Quality Lead and COVID-19 Co-ordinator could be combined.

It is recommended that more than one person is trained in each role to enable operation to

continue in the event of staff absence.

A template (Appendix A1) showing the composition of the school’s testing team should be

completed and kept updated.


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Quality checklist

Briefing the school community

Quality criteria Checked by Frequency/ nature of check

All staff informed of school’s participation in lateral flow testing and provided with information on how this will impact on their daily work.

Quality lead Before testing commences

All parents informed of school’s participation in lateral flow testing and its implications for them and their children.


All pupils informed of school’s participation in lateral flow testing and what this means for them.


Recruitment and training of staff

Quality criteria Checked by Frequency nature of check

Sufficient school staff identified to fulfil roles of:

• COVID-19 co-ordinator

• Registration assistant

• Results recorder

• Cleaner


Sufficient school staff or other personnel identified/recruited to fulfil roles of:

• Quality lead/Team leader

• Test assistant(s)

• Processor(s)


All members of the team who are in regulated roles have received satisfactory enhanced DBS checks.

Quality lead with support of DSL

Before testing commences

Arrangements in place for any members of the team who have not received enhanced DBS checks are supervised at all times on site.


All members of the Testing Team have completed the online training programme for their role. The certificates of satisfactory completion are checked and stored centrally.



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More than one person has received training to undertake each role in order that testing can be continued in the event of staff absence.


All staff have participated in a ‘walk through’ of the process prior to undertaking their roles.


All test assistants (swabbers) have satisfactorily completed competency assessment (Appendix B1) prior to being deployed.


All processing operatives have satisfactorily completed competency assessment (Appendix B2) prior to being deployed.


All results recorders have satisfactorily completed competency assessment (Appendix B3) prior to being deployed.


Wider communications

Quality criteria Checked by Frequency/nature of check

School’s insurers informed of school’s participation in COVID-19 testing programme.


Privacy notice placed on school’s website.


Body that deals with school’s waste disposal notified that school will be disposing of clinical waste.


Risk assessment


Risk assessment in place that covers all risks relating to COVID-19 testing (Appendix D1).


Reviews of COVID-19 risk assessment are scheduled and undertaken in a timely way.

Quality lead Weekly


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Arranging supervision of pupils


Procedures and supervision are in place for pupils identified as close contacts requiring serial testing to arrive at school and proceed to the testing base before they enter.

Quality lead Before testing commences then daily

Routes from classrooms to testing base and return are established.


Procedures for accompanying batches of pupils to testing base and returning them to classrooms are established.


There are sufficient staff to supervise pupils within the testing base.


There are sufficient staff to supervise pupils who need to wait for test results following serial testing.


Arrangements are in place to ensure that pupils register their details on the NHS Test and Trace website.


Identifying suitable base


Testing base is large enough to accommodate registration area, swabbing bays, processing desks and testing kits.


2 metres social distance can be maintained between individuals attending the testing base – adequate space between bays.


A holding area is available close to the base (or within it) to accommodate pupils/staff awaiting test results (during serial testing only).


Test kits and equipment are stored within or close to the testing base.


Testing base is well ventilated.


Testing base is well lit. Quality lead Before testing commences then daily


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Temperature of 15-30 degrees Celsius can be maintained in testing base.


Testing base has a non-porous floor.


All surfaces in the testing base can be easily cleaned with standard cleaning products.


Testing base is easily accessible from a school entrance.


One-way-system can be operated through the base (separate entrance/exit).


Setting up registration and recording system


Quality lead/ Team leader online registration completed (following instructions in Digital Guidebook for Schools and Colleges).


Online account set up by Quality lead / team leader (following instructions in Digital Guidebook for Schools and Colleges).


Details of results recorders are entered on NHS Test and Trace website (following instructions in Digital Guidebook for Schools and Colleges).


Appendix C1 Template COVID-19 Test Register on school device and adapted for school use.


Process established for subjects to be able to complete lite registration process for each test.


Securing consent for lateral flow testing


All parents and staff are issued with privacy notice to inform them about personal data handling.


All parents of pupils aged 16 or younger have been sent letters explaining process



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and requesting consent for testing.

Sixth formers have been provided with information and letters requesting consent for testing.


All staff have been provided with information and letters requesting consent for testing.


Additional information sharing sessions (such as webinars and, where necessary, individual phone calls) have been arranged/delivered.


Records of consent for testing of pupils and staff are recorded on the COVID-19 Test Register, which is maintained securely.

Quality lead Before testing commences then daily updates

Scheduling testing

Quality criteria Checked by Frequency/nature of checks

The capacity of the testing base is known (assume 1 test per bay per 4 minutes initially). Include breaks for testing team.


Manageable schedule is devised whereby:

• consistent bubbles are tested on the same weekday (mass testing)

• test slots for serial testing are allocated prior to start of school day (for 7 consecutive days per subject)

• weekly staff testing is arranged by appointment at convenient times


School staff are made aware of the testing schedule for each day so that they know when lessons may be disrupted.

Quality lead Before testing commences then daily updates


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Taking delivery and storing equipment


Deliveries from NHS Test and Trace are checked on arrival and lists of contents retained.


Testing supplies are safely maintained at temperatures between 2 and 30 degrees Celsius.

Quality lead Before testing commences then spot checks

Setting up the testing base


Testing base is cleaned and prepared for set up the day before testing commences (model layout provided in of the DFE / NHS ‘How to Guide’).

Quality lead Before first live testing then daily

The following items are provided by the school and put in position in the testing base according to the diagrams given in the DFE / NHS ‘How to Guide’:

• tables

• chairs

• hand sanitiser

• disinfectant wipes

• mop and bucket

• tissues

• laminated signage to indicate the different areas in the test base – registration, swabbing, processing, results recording, plus directional arrows

• clocks/timer

• mirrors

• trays to transfer tests to the processing table

• tube racks (can be microarray test tube racks)

• tape to separate bays

• first aid supplies

• stationery – paper, pens

• laptop for test results upload

• printer

• bar code readers

Quality lead Before first live testing then daily


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• COVID-19 Test Register for registration and reporting

The following items are provided by NHS Test and Trace and arranged in the testing base according to the diagrams given in the DFE / NHS ‘How to Guide’:

• lateral flow test kits

• bar codes

• waste disposal bags

• PPE – gloves, aprons, masks, visors

• bowls


There is 1 metre distance between the testing bay and the processing area.


Conducting a walk through


Following set up, all testing personnel conduct a walk through of the testing base before commencing their roles.

Quality lead Before first live tests and whenever new staff join team

Any questions arising are answered.

Quality lead Before first live tests and whenever new staff join team

Conducting testing: registration


Registration assistant wears mask.

Quality lead Daily

Registration assistant directs subjects to sanitise their hands.

Quality lead Daily

Registration assistant maintains social distance from subjects and emphasises that they should maintain distance in the testing base.

Quality lead Daily

Registration assistant checks that consent has been given for testing (and does not let subject proceed unless consent is in place).

Quality lead Daily

Registration assistant issues subject with bar code.

Quality lead Daily

Registration assistant manages the queue of subjects arriving at the testing base.

Quality lead Daily


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Registration assistant keeps the COVID-19 Test Register up to date.

Quality lead Daily

Conducting testing: swabbing


Test assistant wears correct PPE throughout procedure.

Quality lead Daily

Test assistant gives clear instructions in a courteous manner.

Quality lead Daily

Test assistant manages situations such as inability to swab.

Quality lead Daily

Test assistant administers swabbing safely and correctly if pupil cannot self-swab and consents to administered swabbing.

Quality lead Daily

Test assistant disinfects surfaces between each subject test.

Quality lead Daily

Conducting testing: processing


Processor wears correct PPE throughout procedure.

Quality lead Daily

Processor conducts mixing carefully, using squeezing action and checking for bubbles.

Quality lead Daily

Processor conducts sampling carefully – including applying bar code to LFD, sampling two drops on device and recording read time.

Quality lead Daily

Processor sanitises processing area between tests and discards wipes correctly.

Quality lead Daily

Processor sanitises hands and dons new gloves between each test.

Quality lead Daily

Processor reads and records results at the correct time.

Quality lead Daily

Processor seeks advice from quality lead when appropriate.

Quality lead Daily


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Conducting testing: recording of results


All subjects (staff and pupils being tested) are registered on COVID-19 Test Register and NHS Test and Trace.

Quality lead Daily

All results are logged on the COVID-19 Test Register.

Quality lead Daily

All results are reported on NHS Test and Trace website.

Quality lead Daily

All subjects who have been tested have their results reported by the end of the test day.

Quality lead Daily

Conducting testing: cleaning and waste disposal


Cleaner ensures that correct disposal bags are placed in each area (black bags for packaging; yellow/clear bags for swabs, discarded tissues and wipes and used test cartridges; tiger bags for used PPE, cleaning cloths and mop heads).

Quality lead Daily

Cleaner uses appropriate cleaning solutions and equipment which is assigned to the testing base.

Quality lead Daily

Cleaner maintains condition of testing base throughout the process.

Quality lead Daily

Cleaner keeps check on levels of sanitiser and availability of cleansing wipes in the testing bays and processing area, replenishing as necessary.

Quality lead Daily

Cleaner ensures that any spillages are quickly and appropriately cleaned up.

Quality lead Daily

Cleaner disposes of waste appropriately in correct bags.

Quality lead Daily


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Conducting testing: site culture and efficiency of end-to-end process


Bar codes are correctly affixed to LFDs and results are correctly recorded against the correct subject.

Quality lead Daily

PPE is donned and doffed correctly by all members of the team who use it.

Quality lead Daily

Handover process is carefully managed in the event that any members of the team leave the testing base to be replaced by other staff.

Quality lead Daily

Culture is positive, with good teamwork in evidence and willingness to learn from any mistakes.

Quality lead Daily

Managing positive cases


Positive cases quickly identified by the results recorder.

Quality lead Daily

Results recorder immediately informs quality lead of positive result.

Quality lead Daily

Quality lead initiates isolation of subject.

Quality lead Daily

Parent of subject (if a pupil) is contacted to collect subject from school and return home to self-isolate.

Quality lead Daily

Any pupil or staff member who tests positive is given a PCR test to conduct at home.

Quality lead Daily

Positive subject (if staff member) is contacted immediately and sent home to self-isolate.

Quality lead Daily

Identification of close contacts initiated swiftly.

Quality lead Daily

Managing negative cases


Pupils and staff who test negative continue their normal school day.

Quality lead Daily

Pupils or staff who test negative but who have been identified as close contacts

Quality lead Daily


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of a positive case engage in serial testing for seven days.

Record keeping


COVID 19 Test Register is kept of subjects tested and their results (identifiable via bar coding).

Quality lead Daily

Quality Checklist (Appendix A1) is completed before first testing commences and revisited if new team member join or a new testing base is established).

Quality lead Before testing commences and as necessary during the implementation process

Daily quality check sheets (Appendix A3 are retained).

Quality lead Daily

Notes are kept of any incidents that arise during the process and of the action taken in response.

Quality lead Daily

Compliance with GDPR


Data is securely maintained. Quality lead Daily

Personal data is maintained within the COVID-19 Test Register for a minimum of 14 days and destroyed within 1 month of the testing programme ending.

Quality lead Daily from checking COVID-19 Test Register


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Appendices

Appendix A1 Template: School’s COVID-19 testing team

Appendix A2 Quality checklist (to be completed before first testing

commences and revisited if new team members join or a

new testing base is established)

Appendix A3 Quality checklist (to be completed daily)

Appendix B1 School test assistant / swabber competency assessment

Appendix B2 School processor competency assessment

Appendix B3 School results recorder competency assessment

Appendix C1 Template COVID-19 test register

Appendix D1 COVID-19 risk assessment: school based asymptomatic

testing

COVID-19 Lateral Flow Testing Quality Plan...COVID-19 Lateral Flow Testing Quality Plan 3 Context...

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