Cignpost Diagnostics COVID-19 Testing SOP

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 Cignpost Diagnostics COVID-19 Testing SOP

CONTENTS
SECTION 1 PAGE
Background 2
Aims, Objectives and Scope 2

SECTION 2
Swabbing Protocol 3
1. Setting up 3
2. PPE – Donning procedure 4
3. Performing the test 4
3.1 Greeting the individual 4
3.2 Collecting the throat swab 5
3.3 Collecting the nasal swab 6
3.4 Storing the sample 6
3.5 Concluding the test 7
3.6 Changing PPE prior to the next test 7
4. PPE – Doffing procedure 7

SECTION 3
Workflow 1 –Swab testing 9
Workflow 2 – End to end overview 10

SECTION 4
Appendix 1 – Handwashing technique: soap and water 11
Appendix 2 – Handwashing technique: alcohol hand gel 12
Appendix 3 – PHE PPE recommendation for swab collection 13
Appendix 4 – PHE guide to donning / doffing PPE 14
Appendix 5 – Example of symptom declaration 15
Appendix 6 – Example of test consent 17
Appendix 7 – Screening process for attendance at events 18

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SECTION 1

BACKGROUND
In December 2019 a novel coronavirus (COVID-19), initiating from China, caused outbreaks
throughout the world, being declared a pandemic by the World Health Organisation in March 2020.
While most people infected with the COVID-19 virus will experience mild to moderate symptoms (or
remain asymptomatic) the disease can cause severe medical complications and lead to death in some
people. Older adults or people with existing chronic medical conditions are at greater risk of
becoming seriously ill with COVID-19.

The full lockdown imposed by the UK government on 23rd March 2020 was reduced on 12th May to
allow employees who cannot work from home to return to the workplace. As a key part of the
overall health and safety strategy adopted by our clients, Cignpost Diagnostics Ltd. has been
contracted to undertake point-of-care COVID-19 testing for all individuals who cannot maintain strict
social distancing.

Cignpost Diagnostics Ltd. offers on-site, or laboratory based molecular diagnosis of COVID-19 through
real-time RT-PCR assays based on oral and nasopharyngeal swabs. As part of this service Cignpost
Diagnostics Ltd. provides trained individuals to undertake the collection of test swabs, in addition to
laboratory personnel to process the samples. Cignpost Diagnostics can additionally provide training to
the clients own screening practitioners should this be preferred.

AIMS, OBJECTIVES AND SCOPE

This document sets out the standard operating procedure (SOP) for the collection of COVID-19 test
samples at events Cignpost Diagnostics Ltd. is contracted to attend. It also provides information on
the workflow established to facilitate individuals arriving for their swab test through to the delivery of
test results.

The aim is to ensure all practitioners deployed to conduct COVID-19 swab testing are appropriately
skilled to collect oral and nasopharyngeal samples as part of our capability and assurance framework.
In addition, it provides guidance on required infection control practices, including hand sanitisation
techniques and how to don and doff Personal Protective Equipment (PPE). Guidelines on sample
collection for COVID-19 testing are provided in line with the methodology recommended by Public
Health England (PHE) https://www.gov.uk/government/publications/wuhan-novel-coronavirus-
guidance-for-clinical-diagnostic-laboratories/novel-coronavirus-2019-ncov-sampling-requirements

The scope of this SOP is to cover all aspects of COVID-19 swab sample collection. The requirements
for the laboratory processing of samples using point of care PCR testing units falls outside the scope
of this SOP – please refer to the separate guidance should this information be required.

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SECTION 2

SWABBING PROTOCOL
COVID-19 testing involves taking swab samples from the throat and nose of any individuals deemed
to require a test by the organising client. All individuals who are working inside, or for whom
maintaining strict socially distancing is not possible, will be booked in to receive a COVID-19 test. The
service will be delivered by a team of practitioners wearing PPE. Frequency of repeat testing will be
as necessitated by the organising client, typically every four days.

In addition to the guidance provided by this SOP, each practitioner acting as a swab taker will receive
on-site, face to face training on the correct technique for performing throat and nasal swabs, donning
and doffing PPE, and hand sanitisation techniques. Subject to sign-off from an approved trainer you
will then be authorised to perform swab testing independently. Regular refresher training can also be
provided.

Please report to the organisations designated COVID-19 lead on arrival at the event location (contact
details will be provided in advance of each event). To provide sufficient time to undertake the face to
face training and an orientation to the testing venue, please arrive at least 45 minutes prior to the
session start time.

1. SETTING UP

Each COVID-19 practitioner will be allocated a testing station in which to undertake swabbing. The
exact format of these stations may vary based on the individual logistics of each event setting
however, on all occasions, stations will be suitably sized and located to maintain social distancing
between individuals being tested. Privacy will be maintained between testing areas using privacy
screens.

Each testing station will include the following equipment;

• Table and chair (testing location dependent)

• Nitrile gloves
• Tongue depressors
• Antibacterial hand sanitiser
• Clinical waste bag
• Chlor-clean disinfectant wipes / spray
• Box of tissues
• Spare surgical face masks

Make sure the testing area is clean and free from any unnecessary items. The clinical waste bag
should be attached to the table in a position that is out of the way of where the individual will be
seated/standing for the test.

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2. PPE – DONNING PROCEDURE

Before donning PPE make sure you are well hydrated and have been to the toilet. Hair should be tied
back, and you should ensure you adopt a ‘bear below the elbow’ dress code.
Wash your hands using soap and water following the instructions given on the ‘hand cleaning
technique’ poster in accordance with NHS guidelines (see appendix 1)

PPE equipment is as follows;

• A disposable apron
• Disposable, latex free gloves
• A face visor
• A face mask*
• A hair covering**
*PHE guidelines on PPE requirements for collecting nasopharyngeal swabs stipulates the requirement for only a fluid-
resistant (type IIR) surgical mask (See appendix 3). We have however chosen to provide all swab takers with a filtering face
piece respirator (FFP) mask due to the higher level of protection it provides.

**PHE guidelines do not require the use of a hair covering when performing nasopharyngeal swab collection. We have
chosen to provide hair coverings should your personal preference be to wear one and the use of this piece of PPE is down to
individual choice.

PPE must be put on in the following order (see appendix 4 for pictorial instructions);

1. Apron: put the apron over your head and fasten the straps behind your back
2. Hair covering (where preferred): put the surgical hat over your hair
3. Face mask: Place the face mask over your mouth and nose and ensure the elastic straps are
not twisted behind your head. Squeeze the flexible band to shape it across the bridge of
your nose.
4. Eye protection: Place the visor over your face
5. Gloves: Put on gloves and ensure they cover your wrists

3. PERFORMING THE TEST

3.1 Greeting the individual

On arrival at the event venue, attending individuals will be taken through a registration process
including a symptom declaration (see appendix 5), consent to COVID-19 testing (see appendix 6),
and a thermal temperature check. This is in addition to the guidance on the swab testing process
that will have been provided to individuals in advance of the screening day (see appendix 7).
Following this, an allocated person will chaperone individuals in turn through to an available testing
station. The individual will have been provided with their swab testing kit ready to give to you when
they arrive at the testing station.

NB: There are two possible types of swab testing kit depending on whether the swab is being process
at one of our off-site labs or within a mobile laboratory on-site. Both types comprise a sterile test
swab and a sterile vial containing an inactivation solution which preserves the genetic integrity of the
sample whilst completely inactivating any infectious agents. The process for storing samples using
both types is described below in section 3.4.

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Each individual will be assigned a unique identification number by the organising client to ensure
confidentiality during the testing process. This unique identifier should be labelled on the sterile vial
using a permanent marker.

Each test usually takes less than 5 minutes to complete. You must begin by explaining the procedure
to the individual and inviting them to ask any questions they may have. Ensure the individual is at
ease and confirm that they are happy to proceed with the swab collection.

A suggested script is as follows;

“Hello my name is….. and I am one of the practitioners taking swab samples.

The process of screening involves taking a swab sample from the back of your throat and then,
using the same swab, a sample will also be taken from one of your nostrils.

Both can feel a little uncomfortable and, as we must take the sample from the very back of your
throat, it may cause you to gag. This is normal so do not worry if it does.

Do you have any questions and are you happy for me to proceed? (Consent will already have
been gained during the registration process; however, you should ask again at this point and
inform the organisations COVID-19 lead should consent be declined).

Before I start are you aware of any mouth ulcers or cuts in your mouth or nose so I can aim to
avoid these areas? (If yes, you can continue but be careful to avoid the broken skin with the
swab).

Inform the individual they should raise their hand at any point during the procedure if they are
about to cough or sneeze.

3.2 Collecting the throat swab

1. Ask the individual to face you and tilt their head back, open their mouth wide and say ‘ah’ so you
can see the back of their throat. If the back of the throat is not accessible you can ask them to
give a big yawn and hold the shape or, if needs be, use a tongue depressor to keep their tongue
away from the back of the throat.
2. Remove the swab from the sterile packaging. NB; The swab needs to be kept dry before taking
the sample. It is important to avoid touching surrounding structures including the teeth, gums,
tongue, or cheek surfaces.
3. Let the individual know you are about to take the sample and remind them it may make them
gag.
4. Rub the swab across the following areas (rotating as you rub);
• The left pharyngopalatine arch (marked in green on the below image for clarity) from the
uvula (the dangly bit) round to the tonsil (if present)
• The right pharyngopalatine arch (marked in green on the below image for clarity) from the
uvula (the dangly bit) round to the tonsil (if present)
• The back of the throat (this may cause a gag reflex)
5. Withdraw the swab
Pharyngopalatine
Pharyngopalatine
arch
arch

Tonsil Back of throat

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3.3 Collecting the nasal swab

1. Inform the individual you are now going to take the nasal swab from within one of their nostrils
and that this may also feel a little uncomfortable.
2. Insert the same swab that you used to swab their throat gently into one nostril, until you feel
slight resistance (usually at around 2 cm).
3. Rotate the swab for 10-15 seconds, with gentle sideways movement.
4. Withdraw the swab.

NB: The test is inaccurate unless all four areas are swabbed (the left pharyngopalatine arch, the right
pharyngopalatine arch, the back of the throat and the nasal passage).

3.4 Storing the sample

The method for storing samples will depend on the type of swab being used;

A. Disposable swab and buffer solution (where samples are processed within an onsite lab);
1. Remove the cap from the container.
2. Swab is then placed in deactivating buffer tube, already labelled with individuals unique
identification number, for 30 seconds.
3. This deactivating buffer kills any virus on the swab, so swab can be safely discarded in medical
waste bin.
4. The tube with deactivating buffer is then sealed tight ready to go to the lab.
5. The sample is now ready to be taken to the on-site laboratory. The arrangements for this will
depend on the venue and lab location. The samples should be placed in a biohazard bag for
transportation.

B. Snap-off swab and transport medium (where samples are sent off to an external lab for
processing);
1. Remove the cap from the container holding the universal transport medium.
2. Place the swab into the liquid.
3. Snap off the excess handle at the indicated break point.
4. Replace and close the cap on the container with the swab in-situ.
5. Dispose of only the swab handle in the clinical waste bin.
6. The sample is now ready to be taken to the laboratory. The
arrangements for this will depend on the venue and lab location. A medical courier will be
organised to collect the samples. They should be placed in a biohazard bag for transportation. If
the snap-off swabs and transport medium come with their own individual biohazard bags these
can be placed inside the larger biohazard bag for transportation to the laboratory.

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3.5 Concluding the test

Thank the individual for attending the test and offer them a tissue should they require it (the test
can make some individuals eyes water slightly). Explain to them they will be notified by text/email
once their test results are ready. Should their result be positive they will be notified by phone by the
clients Medical Officer or another suitably qualified medical professional assigned by the client and
given advice on what to do. This is usually within 4 hours if the lab is on-site and 24 hours where the
samples are couriered to a permanent laboratory facility. In the interim they can continue with their
normal role; however, they need to wear a mask and follow social distancing guidelines and should
perform regular hand sanitisation.

Provide the individual with a mask (if they do not already have one). Remind the individual to
practice social distancing and conduct regular hand sanitisation throughout the day.

Wipe down any items the individual contacted using chlor-clean surface disinfectant.

3.6 Changing PPE prior to the next test

1. Remove your gloves being careful to avoid cross-contamination (see appendix 4 for illustration
of correct technique) and dispose of them in the clinical waste bin.
2. Sanitise your hands using antibacterial hand gel (see appendix 2 for correct hand sanitisation
technique using hand gel in accordance with NHS guidelines).
3. Don fresh gloves.
4. Signal that you are ready to test the next waiting individual.

NB: There is no need to change any other elements of your PPE unless it has become damaged,
soiled/contaminated, wet, or uncomfortable. If this is not the case, other PPE can be worn safely for
the duration of each session.

4. PPE – DOFFING PROCEDURE

PPE must be taken off in between each screening session and at the end of your shift. It should also
be removed if it has become contaminated or compromised.

The correct order in which to remove PPE is as follows (see appendix 4 for pictorial instructions);

1. Gloves: Remove your gloves and then sanitise your hands using alcohol gel and place in the
clinical waste bag
2. Apron: Carefully pull off your apron without touching the front and place in the clinical
waste bag
3. Eye protection: Remove eve visor by holding the headband at the back of your head and set
to one side and sanitise your hands using alcohol gel
4. Face mask: Remove your face mask by holding the elastic at the back of your head whilst
leaning forward slightly and place in the clinical waste bag
5. Hair covering (where applicable): carefully remove and place in the clinical waste bag then
sanitise your hands using alcohol gel
6. Clean visor: Wear a clean pair of gloves to clean your visor with Chlor-clean disinfectant
ready for the next session and then remove the gloves and place in the clinical waste bag

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 Hang the visor to dry ready for the next session. At the end of the day if can be discarded in
the clinical waste bag
7. Wash hands: Sanitise your hands, preferably using soap and water

There will be a supply of surgical face masks for you to wear between sessions should these be
required based on the environment/location, i.e. if indoors, or if outside but unable to maintain
social distancing.

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SECTION 3

WORKFLOWS

1. COVID-19 TESTING WORKFLOW – SWAB TESTING

Task # Timing Description of Activity Equipment / Tools

1 Prior to each session Ensure testing station set-up with required equipment Table and chair (where appropriate)
Gloves
Hand sanitizer gel
Tongue depressors
clinical waste bag
Disinfectant spray / wipes
Box of tissues
Spare surgical face masks
2 Prior to each session Don PPE in allocated area Apron
Hair covering (personal preference)
FFP face mask
Visor
Gloves
(All PPE)
3 During Testing Greet the individual, check unique ID is on container All PPE
Perform introduction and explanation of the test Sealed, sterile swab
4 During Testing Remove swab from sterile packaging, position All PPE
individual and collect the throat and nasal swab Sterile swab
5 During Testing Place the swab in the container in accordance with the All PPE
storage requirements for the type of swab/container Completed swab
being used
6 During Testing Explain process for acquiring results along with social All PPE
distancing and hygiene guidance
7 Between Testing Disinfect testing area, doff gloves, and dispose in All PPE (gloves to be changed)
clinical waste bin. Sanitise hands. Disinfectant spray / wipes
Remaining PPE should be left in-situ. Clinical waste bag
Hand sanitizer gel
(All part of initial set-up)
8 Between Testing Don new gloves & signal readiness for next individual All PPE (with fresh gloves)
to be tested
For next individual arrival, return to task #3
9 Testing Session End Doff PPE, clean face visor for re-use and dispose of all Clinical waste bag
remaining PPE Hand sanitizer gel / soap and water
10 Testing Day End Doff and dispose of all PPE (including face visor) Clinical waste bag
Hand sanitizer gel / soap and water

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2. COVID-19 TESTING WORKFLOW – END TO END OVERVIEW

Pre-Event Registration

Responsible Party: Event Organisers

• Client registers individuals for PCR testing

• Attending individual provided with an appointment time.

Registration

Responsible Party: Cignpost Diagnostics Ltd. / Event Organisers

• Symptom declaration completed (see appendix 5) & thermal temperature check by allocated practitioner NB: This occurs every day the
individual attends the venue
• Where swab required – consent gained (see appendix 6)
• Individual directed to swab collection area on days when swab testing required (e.g. first day on site and every subsequent four days)
with swab and buffer container (with unique identification number)

Swab Collection

Responsible Party: Cignpost Diagnostics Ltd. / Assigned Screening Practitioner

• Practitioner checks collection tube is labelled appropriately with unique identification number
• Swab samples collected
• Completed swab prepared for transportation to laboratory
• Individual released and given advice on social distancing and hygiene precautions

Laboratory Processing

Responsible Party – Cignpost Diagnostics Ltd.

• Sample logged
• RNA extraction procedure
• PCR analysis
• Results logged and results passed to event organisers

Result Distribution

Responsible Party – Event Organisers

• If test is positive for COVID-19 individual notified by Client Medical Officer and provided with advice
• If test is negative for COVID-19 individual notified by text/email

Daily Checks

Responsible Party – Event Organisers

• Symptom declaration completed & thermal temperature check. Access granted if both negative. If positive referred to Client Medical
Officer

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SECTION 4

APPENDIX 1

Correct Handwashing Technique – Soap and Water

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APPENDIX 2

Correct Handwashing Technique – Alcohol Gel

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APPENDIX 3

Public Health England PPE Requirements for the Collection of Nasopharyngeal Swabs in all Settings

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file
/886370/COVID-19_Infection_prevention_and_control_guidance_Appendix_2.pdf

Contains public sector information licensed under the Open Government Licence v3.0.

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APPENDIX 4

Public Health England Guide to Donning and Doffing PPE

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file
/877658/Quick_guide_to_donning_doffing_standard_PPE_health_and_social_care_poster__.pdf
Contains public sector information licensed under the Open Government Licence v3.0.

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APPENDIX 5

Example of Symptom Declaration – Individual clients may use their own variations & some may
request this is completed prior to arrival on site

Cignpost Diagnostics – Guidance for On-Site Symptom

Declaration & Temperature Checking
A symptom declaration must be completed daily, either before arrival on site, or at
the entrance to the event location.

Everyone must declare verbally they have no symptoms of COVID-19 which are
described below:

• high temperature – feeling hot to touch on their chest or back

• new, continuous cough – this means coughing a lot for more than an hour, or 3
or more coughing episodes in 24 hours
• loss or change to your sense of smell or taste – this means they have noticed
they cannot smell or taste anything, or things smell or taste different to normal
• new shortness of breath

In addition to the symptoms of COVID-19 please ensure the following questions are
asked.

• Have you had contact with anyone with COVID -19 in the past 14 days
(defined as being within 1.5 metres of them for >15 minutes)?

• Does anyone in your household have any of the above symptoms?

A daily temperature check must also be performed each day at arrival on site.

• The temperature result should be below 37.8oC

Management of individuals who pass the declaration

Individuals should be advised to adopt the following precautionary measures.

• Wear face coverings in public areas

• Use hand sanitiser/ wash hands regularly
• Maintain social distancing wherever possible
• Report any symptoms to the designated event medical representative
• Avoid public transport if able

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Management of suspected COVID-19 case

A person suspected of having COVID-19 MUST be isolated until cleared or,

appropriate disposal.

Any suspected case of COVID-19 will require assessment by the Client Medical
Officer or other suitably qualified health professional.

PPE (mask and gloves) should be provided to the person with suspected COVID-19,
and an assessment undertaken within a designated isolation room onsite, which
should ideally be near the screening services at the designated client venue.
The person doing the assessment must wear adequate PPE.
A full assessment of symptoms, a temperature check and, if confirmed as being
appropriate, an Antigen test should be arranged.

The Client Medical Officer must follow the client’s agreed processes for managing a
suspected COVID-19 case.

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APPENDIX 6
Example of Swab Testing Consent – Individual clients may use their own variations

Consent Form
(Studio/Media)

Cignpost Diagnostics Ltd. strive to provide a safe environment amidst this COVID-19 pandemic.

It is a requirement that you agree to undertake a COVID-19 swab test to determine the probability of
whether you may or may not currently have COVID-19.

You accept that you must follow strict social distancing and precautionary measures as indicated
within the ‘Screening Process for Attendance at Events’ document whilst waiting for your results and
that you will be required to undergo repeat swab testing every four days (whilst on site).

The equipment and processes used to deliver COVID-19 results are highly accurate and include
multiple positive and negative controls to ensure veracity. Despite this, no test is 100% guaranteed
and by consenting to be tested you accept this and agree to comply with the social distancing regimes
necessary to reduce your likelihood of being infected or passing on the virus to others. With your
participation we aim to make you and your co-workers as safe as possible from COVID-19.

By signing this document, you confirm you have read and understood the above consent and the
guidelines as detailed in the ‘Screening Process for Attendance at Events’ document.

Signed:

Name:

Date:

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APPENDIX 7
Example of Guidance Prior to Attendance at a Screening Event – Individual clients may use their
own variations

Cignpost Diagnostics – Screening Process for Attendance

at Events (Studio/Media)
All individuals attending studio/event locations will be required to undergo COVID-19 testing
administered by Cignpost Diagnostics. The screening will take place twice a week (a maximum of four
days apart) at a location mutually agreed between the organising client and Cignpost.

The Screening Process

The screening we are undertaking is the most accurate available and it takes about five minutes to
perform the test. The sample taken is a swab of the nasal passage and the inside of the mouth. Once
we have taken the sample it is then analysed either in one of our permanent laboratories, or within a
mobile laboratory should this have been arranged to be on site. For samples sent to one of our
permanent laboratories results will be available within 24 hours and, where using our on-site point of
care PCR testing units, results will be available within 4 hours.

Before you are screened you will be required to make a declaration that you are free of the symptoms
of COVID-19 (see below).

You will also be scanned by an infrared thermal imaging camera which checks your temperature.

Symptom Declaration

The exact process and timing for providing your symptom declaration will vary as per each
organisation’s internal processes, but will always involve you declaring that you have none of the
following symptoms of COVID-19:

• high temperature – this means you feel hot to touch on your chest or back (you do not need
to measure your temperature)
• new, continuous cough – this means coughing a lot for more than an hour, or 3 or more
coughing episodes in 24 hours (if you usually have a cough, it may be worse than usual)
• loss or change to your sense of smell or taste – this means you have noticed you cannot smell
or taste anything, or things smell or taste different to normal
• new shortness of breath

In addition, you will be asked to confirm the following.

• Have you had contact with anyone with COVID -19 in the past 14 days (defined as being
within 1.5 metres of them for more than15 minutes)?

• Does anyone in your household have any of the above symptoms?

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After you have been tested
After your test, you will be asked to adopt the following standard precautions.

• Wear face coverings in public areas

• Use hand sanitiser/ wash hands regularly
• Maintain social distancing
• Report any symptoms to the designated event medical representative
• Avoid public transport if able

Getting your results

Your results will be communicated to you by a member of your organisations medical team.

Most people’s tests will be negative.

If you are POSTIVE for COVID you will be told what you must do by your organisations medical team.

Follow-up screening
You will be required to complete a symptom declaration each day you attend the studio/event
location and have your temperature checked before being allowed access on site.

A repeat COVID-19 swab screen will be conducted every four days (when on site).

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