The template Standard Operating Procedure (SOP) below should be read in conjunction with the NPA’s Chlamydia Testing Service Resource Pack. Ensure you have read the guidance document “Starting a chlamydia testing service” and undertaken any relevant training before writing your SOP.
SCOPE
This procedure covers the provision of private chlamydia testing. It does not cover any locally commissioned services remunerated by the PCO, nor does it cover the sale of treatment for confirmed chlamydia infection.
PURPOSE
To ensure that the chlamydia testing service is carried out in accordance with local and national guidelines.
PROCESS/PROCEDURE
In this resource, steps in each process are suggested as examples, but you will need to adapt these to your own circumstances.
Set up

Make sure you have an appropriate, valid e-mail address.

Register on the GLG website www.glgresults.co.uk
.

The laboratory will validate the registration and activate the secure IT link.

Complete set-up procedures and training outlined in the guidance document included in this pack.

Order chlamydia test kits from the wholesaler.
Accessing the test
Patients presenting in the pharmacy for chlamydia testing are likely to access the service in more than one way e.g. they may request a kit, self-select a kit to be purchased or you or your staff may offer the testing service as part of another consultation. Therefore, your Standard
Operating Procedure (SOP) needs to take this into account. Remember patients may be embarrassed about asking for the service and many will not wish to have a consultation. You will need to consider how to handle patients who do not wish to engage in discussion, for example, by giving them a leaflet with the test kit.
Chlamydia Testing Service

In this pharmacy, the chlamydia testing kits are situated [insert location].

When a patient presents a kit at the counter, or requests one by name, ask whether they would like to use the consultation area or a private area of the pharmacy if the consultation area is not available.

If a patient requests EHC, advise them they may be at increased risk of sexually transmitted infections (STIs) and ask if they would also like to be tested for chlamydia.

Young women under the age of 25 presenting prescriptions for oral contraceptives may also be at increased risk of STIs and may be offered the service.

Ask the patient whether he/she would like to speak to the pharmacist.

If the patient does not wish to engage in discussion, ensure they receive a leaflet with their purchase.
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The consultation (if appropriate/relevant)

Put the patient at ease by introducing yourself, and explain that discussions will be confidential.

Tell the patient what chlamydia is, including the lack of symptoms, and its possible long-term complications such as pelvic inflammatory disease (PID) and infertility.

Explain to the patient that before selling the test kit you will need to ask some questions to check whether the test is suitable.

Advise the patient of the cost of the kit before going any further.

Explain that chlamydia may take up to fourteen days to show up in tests after infection, so if the episode of unprotected intercourse was within the last two weeks, they may purchase the test kit but should be advised to wait two weeks before using it.

If the patient is aged under 25 years, they may be eligible for testing under the National
Chlamydia Screening Programme in England and this should be offered as an equal choice.

If the patient cannot afford the test or does not want to buy it, refer them to the GP,
GUM clinic or other local NHS service provider.

Ask the patient whether they are experiencing any of the following symptoms which may indicate a higher risk of having chlamydia or another STI (see below): o Genital itching o Pain on passing urine o Unusual vaginal discharge o Penile discharge o Pain during sexual intercourse o Abnormal spots or lumps o Fever o Abnormal bleeding (between periods or after intercourse) o Pain in the lower abdomen

Explain that you will not be able to provide the result immediately but that the patient needs to post a urine sample to the laboratory.
Patient experiencing symptoms or aged under 16

If the patient is experiencing any of the symptoms above, explain that they may have a higher risk of having other STIs and will need to go to their GP, GUM clinic or other
NHS sexual health provider to be tested.

If necessary, check the age of the patient (it is not necessary to ask for proof of the patient’s age). If the patient is under 16 years old, or you believe that they may be under
16 years old, explain that you are not allowed to test them and need to refer them to a
GUM clinic, other NHS provider or to their GP. Refer to the section on children in the guidance document, “Starting a chlamydia testing service”, for further information on child protection and confidentiality issues in children and adolescents.

If the patient presents with a partner notification slip (issued because one of their sexual partners has tested positive for chlamydia), discuss whether a test is necessary, as national clinical guidelines state that partners can be treated without the need to have a test due to the high probability that they will also be infected. This is known as
‘epidemiological treatment’. Some partners may still choose to have a test. Partners presenting with a partner notification slip should be treated in the pharmacy if appropriate or referred to their GUM clinic, other NHS provider or GP for treatment.
(Note: It may be useful to find out the local policy for treating partners and add this information here.)

Give the patient the details of their nearest and most appropriate testing service (see
Appendix 1 – Information for patients page 8).
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Patient aged over 16 or not experiencing symptoms

If the patient is over 16 years old and does not have any of the symptoms above or a partner who has tested positive for chlamydia, you can proceed with the sale of the test kit.

Explain how to use the test kit, including how quickly results can be expected [see below].

Explain to the patient that they should abstain from sexual contact until the test result has been received.

Explain that patients can have their results sent to the pharmacy or to their home address, whichever they prefer. Emphasise that the result will be kept confidential and not shared with the GP unless they request it.

Ask the patient to return to your pharmacy once they have the results, even if the result is negative, so you can explain what to do next.

Explain the need to complete the test request form.

Emphasise the importance of keeping the patient tear-off slip in a safe place as it contains the URN and the patient will not be able to access their results or treatment if they do not bring it to the pharmacy.

Explain that you can help them with any questions they may have about their sexual health.

Ask the patient if they have any further queries about the kit, or about chlamydia.

Advise the patient to contact the pharmacy if they have any questions.

Once the patient is happy, complete the sale.
How to use the chlamydia testing kit
Where appropriate reinforce the following key points with the patient when selling the kit:

Ensure that the name, and unique reference number (URN) is written on the sample bottle. It is easier to do this before producing the sample.

The test request form (enclosed in each test kit) needs to be completed by the patient.
Highlight the need to complete the minimum data fields (highlighted in red on the form)
– FIRST NAME, FAMILY NAME, ADDRESS, POSTCODE, DATE OF BIRTH AND
GENDER.

Patient indicates on test request form whether they want their test results sent to them by letter or to return to a pharmacy to obtain the results.

The urine sample should always be the first pass urine of the day (i.e. first thing in the morning), to ensure optimal testing. Collect the first amount of urine passed as the sample. Do not overfill the bottle, just over half full is sufficient.

Blood stained samples will not be processed due to the small chance of erroneous results. Therefore, females should be discouraged from providing a sample whilst menstruating. If they are, then care should be taken when collecting the sample.

Keep the patient tear-off slip from the test request form in a safe place as it will be needed to obtain the result and, if appropriate, treatment, as it contains the URN.

Do not be concerned about posting the bottle – the packaging complies with Royal Mail requirements for urine samples.

Post the bottle as soon as possible but be sensible and do not post at weekends or
Bank Holidays.

Results should be received within seven days.

Advise patients to return to the pharmacy if they have not received their results within seven days.

If the patient chooses to have the result sent to their home, encourage them to return to the pharmacy, even if the result is negative.
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Patient returns to the pharmacy for the result

Patient presents with the patient tear-off slip with the URN from the test request form.

Ask the patient for two other identifiers such as year of birth and first part of the postcode.
 Access the laboratory’s secure website to check the result against the above two points.

Results are listed by URN so cross check the number on the patient tear-off slip.

Follow the procedure below depending on whether the result is positive or negative.
Patient returns with a positive result

Patient presents with a letter from the laboratory informing them they are positive for chlamydia.

Ask the patient to confirm their details to ensure you are talking to the correct patient.

Explain that a positive result means the patient has chlamydia at the time the sample was tested and this will need to be treated.

The treatment for chlamydia is a short course of antibiotics, and patients can either purchase treatment in the pharmacy or go to their GUM clinic or other NHS sexual health service provider for treatment on the NHS.

If the patient does not wish to purchase treatment, give them details of their nearest and most appropriate NHS sexual health service.

If the patient wishes to purchase OTC azithromycin treatment, access the laboratory’s secure website to confirm the positive result against the URN and follow the pharmacy’s
SOP for sale of the appropriate product.

If the patient is pregnant or believes that she may be, advise her that she will have to visit her GP or GUM clinic for treatment.

Advise the patient that they should contact all of their sexual partners within the past six months (or previous partner if no partner within this time), explaining why this is important (their partners are very likely to have the infection; it can help prevent reinfection; o it can prevent spread of the infection in the community; o it is an important public health issue; chlamydia is a communicable disease). o If the patient does not want to do this themselves, the local GUM clinic or NCSP venue may be able to do this for them.

If the patient wants NHS help with partner notification, signpost them to the appropriate local NHS venue (GUM or NCSP). Give the patient sufficient partner notification slips to pass on to their sexual partner(s) and explain that usually partners of patients who test positive can purchase treatment confidentially from a participating pharmacy or receive it from an NHS provider without the need to be tested. Explain that the partner will need to take the partner notification slip with them to obtain treatment without a test. Partners may undertake a test if they choose to.

Provide general information about sexual health and the risk of other STIs.

Encourage the patient to attend the GUM clinic, other NHS sexual health service provider or GP for further testing for other STIs if appropriate and signpost to available local services.

Advise the patient that they and their partner(s) should avoid sexual contact until they have been treated, and for seven days after both have finished treatment, otherwise they may become re-infected.

Counsel the patient on the use of protection, for example condoms, in the future.

Remind the patient they can return at any time for information if they need it.
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Patient returns with an equivocal (ambiguous) result
Occasionally equivocal (ambiguous) results are obtained when testing for chlamydia. This means that results cannot be determined and the test must be repeated. This is not the fault of any party and so the laboratory will re-test the patient free of charge. Please note that some substances in urine may cause the result to be equivocal. For example, hormones in pregnancy, or some lubricants used in sexual intercourse.

The patient presents with an equivocal result and a report advising them to return to the pharmacy OR

When the pharmacy accesses the IT link, an equivocal result is returned.

Ask for the patient tear-off slip which contains the URN.

Log on to the secure GLG website and use the URN to check the equivocal result.

Tick the box on screen to indicate that the client has been given another test kit. This activates the pharmacy’s free replacement test kit from GLG.

Select another chlamydia testing kit from stock.

Open the new test kit and tick the box for equivocal re-test.

Issue the replacement test kit free of charge.

Advise the patient on its correct use as above.

The new test can be used immediately.

The repeat test uses a new URN.
If the repeat test is also equivocal, GLG will report this on the database as a second equivocal.
This will flag to the pharmacist that the individual has had two consecutive equivocal results.
Any individuals with second equivocal should be referred directly to the GUM clinic or GP.
Patient returns without the tear-off slip

Take patient to a quiet area of the pharmacy or to the consultation area.

Advise patient that they cannot obtain their result or purchase treatment without the tear-off slip or result letter.

If necessary, show the patient that this is highlighted on the test kit box, instruction leaflet and test request form.

Advise the patient on how to proceed:
– They can purchase another test kit.
– If they do not purchase another test, advise them they can obtain an NHS chlamydia test free of charge and signpost them to the local GUM clinic, other
NHS sexual health service providers or GP.

If the patient is still not satisfied, advise them to write to the laboratory at the following address:
Gordon Laboratory Group
Sedgefield (Head Office)
Salter’s Lane
Sedgefield
Stockton-on-tees
TS21 3EE
Patient queries

If patients have questions about the test that cannot be answered in the pharmacy (e.g. technical queries about the testing process or about test results), the pharmacist should contact GLG helpline: 0800 011 2857
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Please note: This number is for pharmacists only do not give out to the patient.
Hours of operation for the GLG helpline are 10am – 10pm weekdays; 10am – 8pm weekends and bank holidays. For professional and clinical queries, contact NPA Information Department:
01727 891800.
NPA Tips

Occasionally patients may request another test (a re-test) because the result of the first test was negative. If the first test was carried out less than two weeks after unprotected intercourse, there is a possibility that the patient may be infected. It can take up to two weeks for infection to be detected by NAAT tests so advise the patient to have a re-test two weeks after the episode of unprotected intercourse.

If the previous test was carried out correctly (at least two weeks after unprotected intercourse) patients may request another test because they have had another incident of unprotected intercourse or because they wish to check that the original infection has cleared following treatment. In the first scenario, advise the patient of the two week window between unprotected intercourse and testing. In the second scenario, advise the patient that another test is not necessary. However, if the patient still chooses to have another test, allow six weeks to elapse after treatment has finished before performing another test.

You may initially decide to carry out a few consultations before advertising the service.
This will allow you to prepare what you are going to say in advance, so that when you have requests later you will feel more confident.

Print out and photocopy a list of other local services, e.g. GUM clinics, NCSP venue
(England), community clinics etc offering chlamydia testing (see Appendix 1). You can give a copy of this to customers.

Contact your local Primary Care Organisation for details on where to obtain patient leaflets.

If you offer the service to a patient and they decline, give them a leaflet on chlamydia.
They may consider the information and return for a test another time.

When discussing chlamydia, you will need to ensure the patient has all the facts about the risks and possible complications of the disease without promoting alarm.

There is no evidence that someone with chlamydia will also have another STI. However, they may be at increased risk and you should always recommend they get checked just in case.

Ensure you sign-post to the appropriate local venue (Appendix 1).

Patients should be counselled on practising safe sex. This means using a condom during vaginal or anal sex, and using a condom or dam during oral sex. Sex toys should be washed or covered with a new condom each time they are used.

Full instructions on how to use the kit are included in each individual chlamydia test kit – it is essential you familiarise yourself with these instructions. It would be useful for the patient if they are given a brief explanation at the time of sale. Although the pack is not sterile, some patients may not be happy knowing the kit has been opened. For this reason, do not open the kit in front of the patient unless they specifically ask you to. It would be a good idea, however, to familiarise yourself with the contents of the kits when they initially arrive in your pharmacy. Perhaps you could open one kit and use this for training purposes and counselling patients.
Resources

NPA Brief Guide to Pharmacy Sexual Health Services – useful tool for pharmacies interested in commissioning an NHS funded chlamydia testing service – available from
NPA Professional Services, email: m.mcdonald@npa.co.uk

Further references and sources of information are listed in the accompanying guidance
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document, ‘ Starting a chlamydia testing service’ .
Sexual Health Key Contacts List
There will be patients who present in the pharmacy for chlamydia testing who need to be referred to another healthcare provider e.g. for treatment, patients with symptoms or for further testing for other STIs. Use Appendix 1 to compile a list of local services and other information that patients may find useful. You can use this information when referring patients to local services and you may also want to photocopy this list so it can be handed out to patients.
National Pharmacy Association
Mallinson House
3842 St Peter’s Street
St Albans
Herts AL1 3NP
01727 832161
01727 840858 npa@npa.co.uk www.npa.co.uk
NPA © mwbs chlam 10.08
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Appendix 1 – Information for patients
Details of local services for sexual health are below:
Genito-Urinary Medicine (GUM) clinic
……………………………………………………………………………………………………………
Opening hours: ……………………………………………………………………………………………
Local GP surgeries
1
……………………………………………………………………………………………………………
…………….…………………………………………………………………………………………………
2 ……………………………………………………………………………………………………………
…………….…………………………………………………………………………………………………
3 ……………………………………………………………………………………………………………
…………….…………………………………………………………………………………………………
4 ……………………………………………………………………………………………………………
…………….…………………………………………………………………………………………………
Local Family Planning Clinic
………………………………………………………………………………………………………………
Opening hours: …………………………………………………………………………………………
National Chlamydia Screening Programme service provider (England only)
Free chlamydia testing for people aged 16-24 years
………………………………………………………………………………………………………………
Other……………………………………………………………………………………………………
Further information on chlamydia is available from:
FPA Helpline
England and Wales: 0845 122 8690 9am to 6pm Monday to Friday
Northern Ireland: 028 90 325 488 9am to 5pm Monday to Thursday 9am to 4.30pm Friday www.fpa.org.uk
NHS Direct (England and Wales) 0845 46 47 www.nhsdirect.uk
NHS24 (Scotland) 08454 24 24 24 www.nhs24.com
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