standard operating procedure (sop) for the provision of … · 2019-11-06 · title hepatitis b...

SOP for Peterborough Blood Borne Virus Service

Version: PS 323 001 of 19 Created: 01/02/2016

© 2017 Lloyds Pharmacy Limited. All Rights Reserved

Standard Operating Procedure

(SOP) for the provision of

Peterborough

Blood Borne Virus Service




Contents

Standard Operating Procedure ............................................................................................... 3

1. Local contacts and inter-professional relationships ........................................................ 4

2. Operator training ............................................................................................................ 4

3. Vaccination ...................................................................................................................... 4

4. Client inclusion ................................................................................................................ 5

5. Service advertisement ..................................................................................................... 5

6. Facilities and in-store equipment required ..................................................................... 5

7. Pre-test, consent and data recording .............................................................................. 6

8. Perform the blood test .................................................................................................... 9

9. Obtaining results ........................................................................................................... 11

10. Post-test advice and referral ..................................................................................... 11

11. Confidentiality ........................................................................................................... 14

12. Control of infection.................................................................................................... 14

Appendix 1 – Required in-pharmacy equipment for dried blood spot testing ..................... 16

Appendix 2 – Images of testing kit paperwork ..................................................................... 17

Appendix 3 – Image of the appointment card ...................................................................... 18

Appendix 4 – Record of completion form ............................................................................ 19




Standard Operating Procedure

Title Hepatitis B & C screening using dried blood spot samples

SOP number PS 323 001

Issue date April 2016

Purpose To define the procedures of the Hepatitis B & C screening service

using dried blood spot samples (the Service) in order to ensure that

the Service is conducted in a consistent, discreet, professional and

accurate manner.

Scope These Standard Operating Procedures provide a template agreed by

LloydsPharmacy. It is the responsibility of the pharmacist providing

the Service to ensure these are appropriate to their pharmacy and

make and agree any necessary changes with LloydsPharmacy.

Title Print Name Signature Date

Written by Service Development Pharmacist

Charan Kaushish

March 2016

Approved by 1. Professional Standards

Pharmacist

Sarita Nanda

March 2016

Authorised by Superintendent Pharmacist

Reviewed & amended by

Contract Manager Anna White

April 2017

Reviewed & approved by

Professional Standards Pharmacist

Asad Shabir

April 2017

Implementation date

April 2016

Review date March 2019




1. Local contacts and inter-professional relationships

1.1. The pharmacist on duty and trained members of staff involved in the provision of

the Service (the Operators) must establish a good working relationship with the

commissioned services local manager, specialised substance misuse treatment

services and the team of nurses at CGL Aspire.

1.2. The Operators must be aware of the availability and contact details of similar facilities and all drug service agencies in the local area.

1.3. Refer to the Service Specification for a list of all contacts.

2. Operator training

2.1. All Operators must have read and be familiar with this Standard Operating

Procedure and undertake any other training required within the contract. Following

which the Record of Completion training form (see Appendix 5) must be completed

and kept in the Service folder.

2.2. All staff must be briefed to treat all users of the Service (the Clients) with respect

and courtesy.

2.3. Once the Service is in operation, any new members of staff should be briefed of its

existence on their first day of service. Staff must meet the minimum requirements

(as stated above) within three months of joining the pharmacy, if they are to

provide the Service.

2.4. Staff offering pre-test advice and conducting the dried blood spot test are required

to attend a training event prior to offering the Service.

3. Vaccination

3.1. All staff are strongly advised to be vaccinated against hepatitis B prior to the

introduction of the Service. The immunity level should be confirmed with a follow-

up blood test after the last injection.

3.2. Any new members of staff who join the pharmacy after the Service has commenced

should be advised to acquire a hepatitis B vaccination.

3.3. Hepatitis B vaccination is available in some GP surgeries free of charge. Operators,

who are unable to get it for free from their GP, may use the Online Doctor Service

to obtain the vaccination. Refer to Your Online Doctor Easy Guide to Hep B

Vaccinations for LloydsPharmacy Employees.




3.4. If a member of staff decides not to have the vaccination, the pharmacist should

ensure that the staff member concerned is fully aware of the risk.

4. Client inclusion

4.1. This Service must be offered and promoted ONLY to Clients as instructed by

CGL Aspire.

4.2. CGL Aspire will email a list of Clients who require to be screened for hepatitis B and

C.

4.3. Any substance misuse Client currently not undergoing treatment (for example

needle exchange clients) who are identified as potentially being at risk of

developing a blood borne virus must be referred directly to CGL Aspire (see the

Service Specification for contact details).

5. Service advertisement

5.1. It is not necessary to include information about the Service in the practice leaflet.

5.2. The Operator is required to display various materials relating to the Service, as

provided by the Commissioned Services team.

5.3. No other signs or advertisements relating to the service should be displayed

without the agreement of the Commissioned Services team.

6. Facilities and in-store equipment required

6.1. The Service should be offered in a private area of the pharmacy where the Clients

can request the Service and seek advice from the Operator without being easily

overheard by other customers, such as the consultation room.

6.2. A sharps container should be safely located so that the Operator can safely dispose

of used lancets. The container should not be easily seen nor accessed by other

customers.

6.3. A clinical waste collection service should be in place to collect the sharps containers

from the pharmacy regularly. The frequency of this will depend on the uptake of

the Service and will need to be agreed and reviewed on a regular basis.




6.4. The following items should be available for dealing with contaminated waste:

Disposable latex gloves

Disposable non-latex gloves for staff and Clients who are allergic to latex

Disposable goggles

Disposable apron

A long tweezer

A disinfectant spray

6.5. Refer to the company procedure on how to deal with discarded sharps, body fluid

spillage, sharps injury and abusive clients.

6.6. The following equipment is required for the dried blood spot test (refer to

Appendix 1 for a recommended list and information on how to order):

Disinfecting spray

Paper towels/tissues

Surgical gloves

Cotton wool swabs

Alcohol swabs

Waterproof plasters

Clinical waste bags

Single use safety lancets

Sharps containers

Blood spot collection cards

Barcodes

Dried blood spot sample

form

Prepaid envelopes

7. Pre-test, consent and data recording

7.1. The Operator must give the Client a copy of the pre-test leaflet and discuss the

following points:

The possible risk factors associated with hepatitis B and C and reasons for testing

How to reduce the risk of becoming infected or infecting others

Explain the benefits of early diagnosis and treatment

Risks of contracting HIV and recommend a screening test if necessary

Advise 3 month window period for re-test if recent exposure

An overview of the dried blood spot test process

Explain that the test is strictly confidential and information is covered by the

Data Protection Act

Procedure for results and follow up appointment

Ascertain if the Client is happy to receive a reminder phone call, email or letter if

they fail to attend the follow up appointment

How a positive or negative result will impact their life, household members and

sexual partners




Explain that Hepatitis B and C are notifiable diseases and that this is treated

confidentially

7.2. Operators must signpost Clients to the nurse team at CGL Aspire (see the Service

Specification for contact details) if they wish to get further information or support

whilst they wait for their test results. Alternatively Clients can seek advice from

NHS Choices, British Liver Trust support and Hepatitis C Trust.

7.3. The Client must give consent for their GP, CGL Aspire and the Health Protection

Agency (HPA) to be notified of their test results for both hepatitis B and C.

7.4. Clients who refuse to provide consent for their GP, CGL Aspire and the HPA to be

notified of their results must not be tested.

7.5. Pre-test data must be recorded on PharmOutcomes (refer to the Service

Specification).

7.6. Documentation must be kept in the pharmacy for 8 years.




Identify Client as requested by CGL Aspire

Give the Client a copy of the pre-test leaflet

This form must be kept safely andsecurely in the pharmacy for 8

years Once completed, print out a copy of the pre-test form

An image of the Dried Blood SpotSample form can be found in

Appendix 2

Place a barcode on both copies of the Dried Blood SpotSample form

Where “XXXX” is your pharmacy’sunique ID and will be sent to you

via email

Complete the Customer ID box with “XXXX”

Complete the Donor ID using the Client’s initials, date ofbirth and gender. For example James Butler born on 4th

May 1981 would be JB040581M

Forms that are not completed infull cannot be processed by the

laboratory

Fill in the Client’s date of birth, gender, todays date, yourname and the pharmacy telephone number

Take out all the test equipment required for the driedblood spot test including the sharps bin and clinical waste

bag

Tear off the top copy of the Dried Blood Spot Sample formand staple it to the pre-test form, for your records

An image of the Concateno BloodCollection Card can be found in

Appendix 2

Fill in the Client’s Donor ID and today’s date on theConcateno Blood Collection Card

Place one of the barcodes provided on the back of the card

7.7. Follow the flow below to gain consent and prepare the Concateno Collection Card

and sample form.

Clients must provide consent for

their GP and CGL Aspire to be notified if they test positive

Complete the pre-test form on PharmOutcomes with the Client, ensuring they fully understand the importance of

this test

Ensure a “X” is not marked next to HIV. This service is NOT testing for

HIV

Mark a “X” next to the tests required: Hepatitis B (Surface Antigen), Hepatitis C (Antibody), Hepatitis B (Core Antibody) and Hepatitis C PCR (Virus Detection)

Open the Concateno Blood Collection Card and lay it on a firm, flat work surface. Do not touch the sample collection area of the card which is indicated by an outline of eight

circles




8. Perform the blood test

8.1. The Service should only be carried out by the Operators as specified in this SOP.

8.2. Ensure Operators wash their hands, cover any cuts, put on a pair of gloves and

conduct the test as instructed below.

8.3. Single use safety lancets must always be used and disposed of in a sharps bin

immediately after use.

8.4. Ensure gloves and all items that may have come into contact with blood are

disposed of in a clinical waste bag immediately after use.

8.5. Ensure the testing area is disinfected with a disinfecting spray immediately after

the appointment once the Client has left.

8.6. An accredited pharmacist does not need to conduct the test or be present when

the test occurs, providing a responsible pharmacist is on the premises. However,

the pharmacist will be responsible for ensuring that any staff member conducting

the test is competent to do so and has undertaken the required training.




8.7. Follow the flow below to perform the blood test.

Ensure samples are mailed on the day of the test

If the Client’s hands are cold, ask them to rub their hands together or run them

under warm water

Ensure the chosen finger is cleansed with the pre-injection swab and wipe it dry with a piece of cotton wool

It is best to avoid the index finger and thumb as these are used the most during

the day

Prime the single use lancet, press down firmly and prick the top of the Client’s finger

It contains some tissue fluid which may affect the accuracy of the test

Wipe the first drop of blood away with cotton wool and dispose of the cotton wool into a clinical waste bag

Ask the Client to completely fill all eight circles on the Concateno Blood Collection Card, with hanging drops of

blood, by intermittently squeezing their finger

DO NOT allow the Client’s finger to touch the card

Ensure the circle is filled and the underside of the paper is saturated, without overlapping the drops

Once the sample has been obtained, apply pressure on the sampling site with a piece of cotton wool to stop the

bleeding. Apply a plaster if necessary

Carefully place the Concateno Blood Collection Card in a dispensing basket and allow the blood spots to dry

The sharps bin and clinical waste bag must not be overfilled and must be sealed

when three-quarters full

All items that may have come into contact with blood or body fluids must be disposed of in a clinical waste bag

immediately. Disposable gloves must also be disposed of in a clinical waste bag after each test

An image of the appointment card can be found in Appendix 3

Complete an appointment card and hand it to the Client

Drying may take up to 3 hours at ambient temperature. DO NOT use heat to assist drying, keep away from sunlight and out of reach and sight from other customers.

An indication of dryness is a colour change from red spots to dark brown

spots

Once the blood spots are completely dry, close the Concateno Blood Collection Card and place it back in the

clear re-sealable bag and seal

Place the bagged card into the Dried Blood Spot Sample form bag

Ensure that you cover any broken skin with a waterproof dressing and wear disposable gloves before proceeding

Dispose of the lancet directly into the sharps bin

Arrange a mutually convenient follow-up appointment with the Client in 2 weeks, to discuss results

Place the form in the pre-paid postage bag provided and seal it ready to post




9. Obtaining results

9.1. The pharmacist must be informed when the email arrives.

9.2. The Results report must be printed as soon as a member of staff has seen the

email.

9.3. All copies of the report must be kept safely and securely with the Client’s pre-test

form.

9.4. Follow the flow below to obtain results

10. Post-test advice and referral

10.1. If the Client fails to attend the follow-up appointment for their results, the

Operator must contact them via phone, post or email to encourage them to contact

the pharmacy and arrange for another appointment time. If the Client does not

present within a week the Operator is expected to try to contact the Client on at

least two occasions by telephone to arrange an appointment.

10.2. Results must be given by a Pharmacist who attended the training event.

10.3. The Operator must give the Client a copy of the post-test leaflet and discuss the

following points:

If negative,

o Advise Client on how to avoid infection in the future

o Recommend repeat testing due to 3 month window

Staple the report to the Client’s pre-test form

Check emails regularly

Once an email from “Lab Results <[email protected]>” appears in your inbox open it

Open the attached PDF document which contains a Client’s laboratory results report

Print out a copy of the laboratory results report for pharmacy records

Keep all printed copies safely and securely with the Client’s pre-test and sample form

mailto:[email protected]




If positive advise client,

o Not to donate blood or carry an organ donor card

o To stop or reduce alcohol consumption

o To not share any injecting equipment and avoid sharing razors or

toothbrushes

o Sexual transmission can occur, use condoms to minimise risk

o To inform any regular sexual partners in being tested

10.4. If the Client tests positive on hepatitis B or C PharmOutcomes will automatically

send a referral letter to their GP. The Operator is required to follow this up with a

phone call.

10.5. If the Client tests negative on hepatitis B and will benefit from a hepatitis B

injection the Operator must refer the Client to CGL Aspire – referral is automated

via PharmOutcomes if ‘CGL Aspire for hepatitis B vaccination’ is selected.

10.6. If the Client tests positive but does not attend their follow-up appointment (after

following instructions as stated in 10.1) the Operator must complete the post-test

form on PharmOutcomes and submit as normal.

10.7. A printed copy of the Client’s pre-test form, sample form, laboratory results report

and referral letter (if they have been referred) must be kept in the pharmacy for 8

years.




10.8. Follow the flow below to offer the Client the correct referral process.

Ensure a copy of the Client’s pre-test form, sample form, laboratory results report and post-test form is retained in

pharmacy for eight years

Client presents for their follow-up appointment

Locate and refer to the Client’s pre-test form, sample formand laboratory results report

Complete the post-test form on PharmOutcomes with theClient, ensuring they fully understand their results

Give the Client a copy of the post-test leaflet and talk themthrough the most relevant advice

Refer the Client accordingly based on their results

Negative hepatitis Cmarker

Negative hepatitis Bmarkers

Positive hepatitis Bmarkers

Positive hepatitis Cand positive or

negative PCR result

If the Client is at risk of hepatitis

B refer the Client to CGL Aspire

for a hepatitis B vaccination and

confirmation blood test – referral

is automated via PharmOutcomes

if ‘CGL Aspire for hepatitis B

vaccination’ is selected.

If the Client is at risk of hepatitis

B refer the Client to CGL Aspire

for a hepatitis B vaccination and

confirmation blood test – referral

is automated via PharmOutcomes

if ‘CGL Aspire for hepatitis B

vaccination’ is selected.

Results and a referral letterwill be sent automatically

via PharmOutcomes to theClient’s GP, requesting for

further assessment andmanagement. Follow-up

with a phone call.

Results and a referral letterwill be sent automatically

via PharmOutcomes to theClient’s GP, requesting for

further assessment andmanagement. Follow-up

with a phone call.

Once completed, print out a copy of the post-test form




11. Confidentiality

11.1. Confidentiality is of paramount importance, as with any other services we are

offering. Please refer to the Medicines, Ethics and Practice for further information.

11.2. The Operator must ensure that any conversation with the Client is not overheard

by anyone in the pharmacy.

11.3. All forms and paperwork containing the Client’s personal details and information

must not be left unattended and must be securely kept in a folder when not in use,

to prevent any unauthorised access to the data.

11.4. Ensure the Client understands that the test is confidential and that the information

that they choose to give the Operator will be covered by the Data Protection Act.

11.5. The Client must be informed that their recorded personal details/information will

only be accessible by the Operator undertaking the testing.

11.6. The Operator must inform the Client that their information will be kept securely

and will not be shared with their GP without their consent.

12. Control of infection

12.1. Operators who may come into contact with blood and secretion may be exposed to

pathogens including blood-borne viruses such as HIV, hepatitis B and C. It is not

always possible to identify people with an infection. Therefore, all body fluids

should be treated as potentially infectious.

12.2. Cuts and abrasions on any area of exposed skin should be covered with a

waterproof dressing.

12.3. Hand washing with bactericidal soap and water must be carried out after the

removal of gloves, between customer contacts and after contact with blood and

body fluids.

12.4. Disposable gloves must be worn when carrying out the blood test to minimise risks

relating to viral permeability. The gloves must be disposed of as clinical waste after

each test.

12.5. Take care during the use and disposal of sharps (e.g. lancets). Do not re-sheath the

sharp. Dispose of all sharps and any waste contaminated with blood or body fluids




at the point of use into the appropriate container. Seal the containers when three

quarters full and store securely.

12.6. Refer to the company procedure on how to deal with discarded sharps, body fluid

spillage, sharps injury and abusive clients.




Appendix 1 – Required in-pharmacy equipment for dried blood spot testing

The items listed below can be ordered via AAH using the codes provided:

Equipment Where to source/order

Disinfecting spray Pharmacy to source

Paper towels Pharmacy to source Surgical gloves: Non-latex small Non-latex medium Non-latex large

GLO0365R GLO0497T GLO0498P

Cotton wool balls Pharmacy to source

Sharps containers (1 litre) Pharmacy to source

Confidential waste bags (small) Pharmacy to source

The Blood Borne Virus screening kit contains the following items and is available to order from the commissioned services local manager via [email protected]

Adhesive dressings x2

Single use safety lancets x2

Alcohol swabs x2

Blood spot collection cards

Barcodes x5

Dried blood spot sample form

Prepaid envelopes

Surgical gloves

If additional single use lancets are required, order the Haemolance+ from AAH link code LAN261D.

mailto:[email protected]



Appendix 2 – Images of testing kit paperwork


Below are images of Concateno Collection Card

Front Back

Below is an image of the sample form



Appendix 3 – Image of the appointment card




Appendix 4 – Record of completion form


Record of completion

Provision of Blood Borne Virus Service in conjunction with CGL Aspire

Complete all fields when an employee has read, understood and is familiar with this

Standard Operating Procedure and the Service Specification.

I have understood all elements of the training that has been provided and had the

opportunity to raise any questions or issues regarding the safe delivery of the service.

Name (Block capitals)

Training undertaken Date of completion Employee’s signature

Signed: Date:

The person signing the above (usually the pharmacist) has ensured all named employees are

competent to deliver this service and have read and understood the Standard Operating

Procedure and the pharmacy toolkit.

Please keep a copy of this form for reference in your pharmacy in the folder provided for

this Service

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standard operating procedure (sop) for the provision of … · 2019-11-06 · title hepatitis b...

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