SCHEDULE[JW1]A8: HEPATITIS B, HEPATITIS C AND HIV TESTING

SCHEDULE A8: HEPATITIS B, HEPATITIS C AND HIV TESTING

1.Introduction and Summary

2.Service Aims

Objectives

Outcomes

3.Service Requirements

Eligibility Criteria

Patient Criteria: testing

Referral

Equipment

Patient Care

Pre-test Discussion:

Consent

Patient Testing – Blood Spot Test

Patient Testing - Analysis

Patient Testing - Follow up

Positive Results:

HIV Positive Test Result

Other Notification

Staff Training/Protection

4.Performance Management

Data Collection

Schedule A8a: Key Performance Indicators

Schedule A8b: Payments

1.Introduction and Summary

1.1The Authorised Officer for this service is Rod Watson.

1.2Increasing levels of testing of Hepatitis B (HBV), Hepatitis C (HCV) and Human Immunodeficiency Virus (HIV) in the population and decreasing the proportion of infections which are undiagnosed are important components of prevention programmes. The Pharmacy setting can provide an accessible and convenient place from which testing for these diseases can occur.

2.Service Aims

2.1The aim of the service is to deliver a HBV, HCV and HIV testing service in a Pharmacy setting.

Objectives

2.2The objectives are to:

  • Identify patients with previously undiagnosed HBV, HCV and HIV through targeted testing of the local population;
  • Refer patientswho have tested positive to HBV, HCV and HIV in a community pharmacy setting to specialist services as quickly as possible.

Outcomes

2.3It is anticipated that this will lead to decreased onward transmission in the community as well as improvement in health outcomes for individuals who are diagnosed positive.

3.Service Requirements

Eligibility Criteria

3.1The service is targeted to the following groups:

  • People over the age of 18 years who are resident in the City or Hackney and registered with a Hackney or the City GP.
  • People living outside Hackney but registered with a Hackney or the City GP.
  • People living in Hackney not registered with a GP can access the service but should be directed to register with a GP.

Patient Criteria: testing

3.2Pharmacists will both opportunistically and through referrals offer HBV, HCV and HIVtesting to people living in City and Hackney who fit the “at-risk” groups listed below:

  1. Current injecting drug users
  2. Former injecting drug users
  3. Sexual partner of a current or former injecting drug user
  4. People at risk through sharing of drug paraphernalia such as notes, straws and pipes
  5. Person born in a high-prevalence country[1]
  6. Person who has received medical or dental procedures in a high-prevalence country
  7. Recipients of blood products/organs in UK prior to September 1991
  8. People given tattoos, piercings or acupuncture in unregistered premises or with possibly unsterile equipment
  9. People at risk through needle-stick injury, sharing of razors or toothbrushes with someone with HBV/HCV, contact sports where blood may have been present.
  10. Men who have sex with men.

Referral

3.3Referrals can be accepted from anywhere, including self referral for testing, howeverthis service does not offer an alternative to a GP consultation. If a patient has a clinical problem, then they must be referred to their GP.

Equipment

3.4Equipment required for the delivery of the Service is sourced from Concatena and will be providedto the Pharmacy at the training session.

3.5Equipment will include the following items:

  • Paper towels / tissues
  • Surgical gloves
  • Cotton wool swabs
  • Blood spot testing kits (including safety lancet, blood spot testing cards, plastic/paper sleeve and prepaid envelope, alcohol swabs, waterproof plaster).

Patient Care

3.5When a client attends the Pharmacy requesting testing, the PharmacyStaff will:

  • Introduce themselves to client and give them a copy of the at-risk check list to read/read through with them.
  • If the client informs the pharmacist that they feel they have been at risk from HIV and/or HBV and/or HCV the client will then be escorted to the private testing room

3.6At each contact point, Pharmacists shall advise patients who indicate no obvious risk factors that testing is not required.

Pre-test Discussion:

3.7The Pharmacist will carry out a pre test discussion with the client, taking 5 minutes. This discussion will:

  • Give a copy of the pre – test leaflet to the client
  • Outline the blood spot test to the client.
  • The procedure for giving results will be explained and a mutually convenient follow-up appointment will be made at the pharmacy within 2 weeks.
  • Explain that, with the patient’s consent, positive test results will be notified in writing to the patient’s GP and/or appropriate local health service, as well as the local Health Protection Unit. The HPU will be responsible for contact tracing.
  • Ascertain if the client would be happy to receive a reminder letter or text message if they fail to attend their follow up appointment to receive their results.
  • Explain that the test is confidential and that the information that they choose to give the staff will be covered by the data protection act.
  • Explain that information will be written on an individual record for each client for reference and audit. Client’s personal details / information will only be accessible by staff undertaking the testing, analysis and for audit purposes. This information will be kept securely in order to maintain strict confidentiality. This information will not be shared with the client’s GP without their consent. Audit information will be compiled but this data will be anonymous.
  • The staff will answer any questions the clientmay have.
  • If drug-use is disclosed, discuss referral to drug services.

Consent

3.8The Pharmacist seeks confirmation that the Patient is happy to give their consent to be tested bythe client agreeing to sign and date the consent section of the written testing record.

3.9Patients will also be asked to give consent to a letter being sent to their GP or the BBV team if they are a client of theirs if they are tested positive for HIV, HBV or HCV. If the Patient is not registered with a GP, the Pharmacist shall direct them to a local GP for registration and care.

3.10Additionally, the Pharmacist shall notify North East and Central London Health Protection teamof all positive HIV, HBV and HCV cases as they will take responsibility for contact tracing. North East and Central London Health Protection Team’s number is 020 7811 7100; email:

3.11No letter shall be sent to the GP if the client is tested negative for HIV, HBV or HCV.

Patient Testing – Blood Spot Test

3.12The Pharmacist will follow the procedure below when taking a blood swab test for Patients.

  • The Pharmacist will wash his/her hands and wear surgical gloves
  • The Patient’s finger/thumb will be swabbed with an alcohol swab.
  • The Patient’s finger/thumb will be pricked with a safety lancet from the testing kit.
  • The Pharmacist will place 5 blood spots onto the testing strip of the blood spot card.
  • The Patient’sfinger/thumb will be swabbed with a cotton wool ball and secured with a waterproof plaster.
  • The Pharmacist will label the testing card with patient’s details or identification number for those wishing to remain anonymous.
  • The Pharmacist shall allow the blood spot card to dry and then place the card in the plastic sleeve in the prepaid envelopefor posting
  • The Pharmacist shall additionally recordthe test on a testing log for reference and audit.
  • The Pharmacist shall dispose the lancet safely in the sharps container and the cotton wool balls, surgical gloves and all other equipment in a plastic waste disposal bag for incineration.
  • The Pharmacist shall complete the documentation pack and ensure that the patient knows when they need to attend the Pharmacy again to receive their results and that they have all the written information they require.
  • The Pharmacist shall ensure the documentation pack is stored securely in a locked cupboard until the test results are returned when these should be attached to the patient record.
  • Pharmacy Staff shall ensure that once the test is completed that theconsulting area is treated with disinfecting spray and prepared for next use.

Patient Testing - Analysis

3.13The Pharmacy shall ensure the prepaid envelope containing the testing strips is posted to the laboratory at end of the day. The results will be returned to the Pharmacy within 2 weeks by email.

Patient Testing - Follow up

3.14The Pharmacy shall provide patients with a follow up appointment to receive their results 2 weeks after the date of the test.

3.15If the patient fails to attend the follow-up appointment for results the Pharmacy shall endeavour to contact the patient in order to schedule another mutually agreeable appointment time.

3.16The same named Pharmacist that took the test shall, wherever possible, conduct the follow up meeting.

3.17Where tests are positive for Hepatitis C, patients shall be given all test results together including antibody result, PCR and genotyping.

Positive Results:

3.18The Pharmacist shall provide sensitive but detailed information to patients who have tested positive for HIV, HBV and/or HCV, ensuring their questions are answered with reference to the post test leaflet.

3.19The Pharmacist shall provide advice to patients on how to prevent passing HIV, HBV or HCV to other people, with reference to post test leaflet.The need to contact trace significant contacts will be discussed and the patient reminded this will be done by the Health Protection Unit.

3.20With the patient’s consent the Pharmacist shall send a letter to their GP and/or other appropriate local health service with the results (with a copy of the laboratory result).The patient will be given a copy of the letter.

3.21If the patient tests positive but does not attend their follow-up appointment to collect their results from the pharmacist and does not respond to the reminder, the Pharmacy shall send a letter with the diagnosis to the patient’s GPprovided consent was given.

HIV Positive Test Result

3.22Should the patient test positive for HIV, the Pharmacy should fast-track their treatment by contactingthe Department of Sexual Health (DOSH)at Homerton Hospital on 07659183201or07817806293as soon as the results from the lab are received, to inform the HIV consultant of the results and when to expect the client.

3.23As best practice, the Pharmacy shall endeavour to arrange for the client to be seen by the HIV Consultant within 24 hours of them being given their result. A leaflet about being diagnosed with HIV should be given to the client and re-assurance about what the diagnosis means.

HCV Positive Test Result

3.24Should the patient test positive for HCV, the Pharmacy shall give the patient a leaflet containing basic information on HCV, the relevance of different genotypes on the length of treatment required and the chances of viral clearance. The Pharmacy shall then refer the client to the Blood-Borne Virus (BBV) team via email: or Fax: 020 8121 5351and clearly state what the risk factor was for contracting HCV. The BBV team will review their records and if the client is registered with them they will support the pathway; if the client is unknown to the service the BBV team will transfer the referral to the Hepatology Unit at Bart’s and the London Hospital. A member of either the BBV team or the BLT will contact the Pharmacist about the patient’s appointment

HBV Positive Test Result

3.25Should the patient test positive for HBV, the Pharmacy shall refer the patient to the BBVteam via email: or Fax: 020 8121 5351and clearly state what the risk factor was for contracting HBV. The client’s GPshould also be notified. The BBV team will review their records and if the client is registered with them they will support the pathway; if the client is unknown to the service the BBV team will transfer the referral to the Hepatology Unit at Bart’s and the London Hospital. A member of either the BBV team or the BLT will contact the Pharmacist about the patient’s appointment.

Other Notification

3.26For HIV positive, HCV positive or HBV positive test results, the Pharmacy shall inform the patient’s GP (if consent given) and the Public Health department of the London Borough of Hackney.

3.27The Pharmacist shall remind the patient thatfamily members will need testing and vaccination (for HBV).These include sexual partners,children living at home and any other family members living in close proximity with the client. This will be arranged via the GP following a discussion and assessment by the Health Protection Unit. A leaflet containing basic information on HBV should be given to the patient. Ensure emphasis is placed on the need to avoid all risk activities.Advise use of barrier methods of contraception / condoms until their sexual partner has been tested and vaccinated or to use condoms if not currently in a permanent sexual relationship.

3.28Should the patient be co-infected with HIV and either HBV or HCV, the Pharmacy shall follow the same care pathway as for an HIV diagnosis – ie. as set out in 3.22 and 3.23 of this specification.

Negative Result

3.29Should the patient’stest result return as negative, the Pharmacist shall recommend a re-test if they have been at risk recently (3 month window period).The Pharmacist shall give advice on how to prevent infection with HIV, HBV or HCV in the future, with reference to the pre-test leaflet.If the patient remains at risk from Hepatitis B, the Pharmacist shall recommend a course of vaccination which the patient can arrange via the practice nurse at their GP surgery.

Staff Training/Protection

3.30Pharmacists providing this service must complete the training session organised by London Borough of Hackney Public Health.

3.31Pharmacists must undergo a super accelerated course of hepatitis B vaccinations (if they are not already vaccinated) at 0, 7 and 21 days with a follow up blood test to ensure adequate antibody levels have been achieved.

4.Performance Management

Data Collection

4.1The Pharmacy shall record the following information for audit purposes using the monitoring forms provided:

  • The number of clients accessing the service
  • Client’s demographics
  • How they heard about the project
  • The number of clients declining to participate in the service when offered to them
  • The number of HIV, HBV and HCV positive test results
  • Referral pathway provided
  • The number of clients who were advised that testing is not required (worried well)
  • General feedback from pharmacy staff about project
  • Patient satisfaction information

4.2The Pharmacy shall return the data collected to the Authorised Officer Mr Rod Watson at monthly frequencies OR data entry shall be made via WebStar.

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Schedule A8a: Key Performance Indicators

Objective / Reason for Status / Rationale / Performance Indicators / Target / Reporting Frequency
Offer HBV, HCV and HIV screening / Increase early diagnoses and reduce the number of undiagnosed positive people / Number of people offered the test / 20 people per month / Quarterly
High level of takeup of testing offer / As above and demonstrates success of approach / Number of people tested / 10 people per month / Quarterly

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Schedule A8b: Payments

The Pharmacy shall receive the following fees for delivery of the HCV, HBV and HIV Testing Service.

Service/Result / Reimbursement
Service price per patient tested / £9.70
Price per patient for a confirmed diagnosis of HBV, HCV or HIV with referral to specialist services. / £19.40

The Pharmacy shall additionally receive reimbursement for the cost of the BBV kits and lab testing as follows. Tests will be entered on the Webstar System. Appendix A8i sets out the general setup of reimbursements.

Test / Product / Reimbursement
All Tests - Plus / Dried Blood Spot BBV Test & Handling Charge including delivery cost / £10.48
HIV / HIV Screen / £4.75
Hep C / Hepatitis C Screen
Hepatitis C PCR (Qualitative) / £8.55
£38.00
Hep B / Hepatitis B Core Antibody Screen
Hepatitis B Surface Antigen Screen / £3.80
£2.85


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[1]Any country from the following parts of the world: Asia, Africa, South America, Pacific Islands, Eastern Europe, and the Middle East

[JW1]