Gateshead / South Tyneside / Sunderland (delete those which do not apply)

PRIMARY CARE TRUST

LOCAL ENHANCED SERVICESEASONAL INFLUENZA IMMUNISATION PROGRAMME

2011/12FOR LOCAL COMMUNITY PHARMACY

Contents:

1. Finance Details

2. Signature Sheet

3. Service Aims

4. Targeted Population

5. Criteria

6. Accreditation

7. Ongoing Measurement & Evaluation

8. Integrated Governance

9. Information Management/Requirements

10. Funding & Payment Method

11. Contract Management

12. Review, Variation and Re-commissioning Process

13. Termination of Agreement

14. Disputes – Conciliation, Arbitration and Appeals

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1. Financial Details

1.1 This agreement is to cover the twelve months period commencing 1st April 2011 – 31st March 2012.

1.2 The community pharmacy (contractor) must submit a claim form for each at-risk patient to who the (contractor) has administered an influenza vaccine. The form should be forwarded to Directorate of Public Health, South Tyneside PCT c/o Mrs Cath Clark, Clarendon, Hebburn, NE31 1AT, email cath.clark@sotw.nhs.uk This claim would include the date of birth, sex, name of his/her GP, and relevant clinical condition, and the date of immunisation of the at-risk patient who has been immunised. Only one payment will be made per vaccine given regardless of whether the patient is included in one or more of the at-risk groups identified at section 4.1.

1.3 A claim must be made for each at-risk patient immunised in the period detailed in section 4.

1.4 For payment purposes the immunisation programme will cover the period from 1st

December 2011 – 31 January 2012.

1.5 On agreeing a service plan with the PCT for the two months, the contractor will receive:-

A fee of £15.50 for each at risk patient immunised. This would cover vaccine cost and administration (including VAT), waste collection for sharps, relevant documentation and reporting.

1.6 Payment arrangements under this scheme will apply to all at-risk patients who are immunised during the two month period 1st December 2011 – 31st January 2012.

1.7 The eligible groups “clinical at-risk groups” are described in section 4.

1.8 It is for each contractor to identify the patients concerned (repeat prescription scheme) and this should be consistent with the patient’s record in their relevant GP register.

1.9 Payment will only be made upon receipt of contractor signature sheet.

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2. Signature Sheet

2.1 This document constitutes the agreement between the community pharmacy (contractor) and the PCT in regards to this local enhanced service.

Signature on behalf of the Contractor:

Address:

Signature Name Date

Nominated Flu Campaign Lead for Pharmacy: _________________________________

Signature on behalf of the PCT:

SignatureName Date

Please sign this form and forward it to Directorate of Public Health, South Tyneside PCT c/o Mrs Cath Clark, Clarendon, Hebburn, NE31 1AT, email cath.clark@sotw.nhs.uk, by 1st December 2011.

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3. Service Aims

3.1 The purpose of the local enhanced services is to cover the provision of seasonal influenza immunisations for patients with clinical conditions, which put them more at risk from the effects of flu (clinical at risk groups). This is to reduce the serious morbidity and mortality from influenza infections by immunising those most likely to have a serious or complicated illness should they develop influenza infection. This can avert the need for the patient to be hospitalised.

3.2 Despite our relatively high uptake by national and international comparisons, NHS South of Tyne and Wear has nonetheless fallen short of the World Health

Organization (WHO) recommendations. Significantly improving uptake in the clinical risk groups will be challenging.

3.3 The purpose of the Local Enhance Service for Seasonal Influenza Immunisation Programme 2011/12 is to commission local community pharmacy to provide influenza immunisation service in addition to the current arrangement with local GP practices under Directed Enhanced Services.

3.4 The community pharmacy (contractor) will be an additional provider supplementing local GP practices’ efforts in targeting those at high risk patients who have difficulty in accessing influenza immunisation services.

3.5 The contractor must put in place a system for recording and maintaining a register of all at-risk patients to whom it offered and delivered influenza vaccine injection.

3.6 This service will go live on 1st December 2011 – and continue until 31st January 2012.

4. Targeted population

4.1 Patients will be eligible to receive their flu vaccination from a contractor if he/she is suffering from an underlying medical condition (s), as specified below, and who has not received a flu vaccine via his/her GP or any other provider within the last 6 months.

chronic respiratory disease (including asthma), chronic heart disease, chronic kidney disease, chronic neurological disease, diabetes, immunosuppression.

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For further details please see Annex A (see footnote)1

5. Criteria

5.1 The contractor must have a robust approach and assessment for identifying eligible patients as defined in section 4.1, and accurate recording if they are participating.

5.2 The contractor must offer immunisations against influenza infection to at risk patients;

a. to concentrate the immunisation programme on eligible patients having difficulties in accessing seasonal influenza immunisation service.

b. to make that offer during the period from 1st December 2011 to 31st

January 2012.

5.3 The contractor must develop and implement a proactive and preventative strategy for offering these immunisations to clinical at-risk patients with the aim of;

a. maximising the uptake in the interests of at-risk patients,b. meeting any public health targets in respect of such immunisations.c. informing patients about its immunisation programme with the aim of raising

awareness and improve uptake to those at-risk patients about immunisation. d. written information should be provided by the contractor where appropriate.

5.4 The contractor must nominate a named person(s) within the community pharmacy who will be responsible for the administration of the influenza campaign and advise NHS South of Tyne and Wear of the name of this person (s).

5.5 The contractor must ensure that the vaccine is given following protocols laid out in the NHS South of Tyne & Wear Patient Group Direction for Influenza Vaccine, a signed copy of which must be kept in the pharmacy.

5.6 The contractor must ensure that:

a. their pharmacy makes their own arrangement with suppliers to ensure they have sufficient vaccine for their needs;

b. all vaccines are stored in accordance with the manufacturer’s instructions; c. all refrigerators in which vaccines are stored have a maximum/minimum

thermometer and that readings are taken and recorded from that thermometer on all working days;

d. have appropriate resuscitation equipment and anaphylactic kit available for use by healthcare professionals providing services under this specification in case of anaphylactic reactions.

5.7 The contractor must report all significant events relating to services provided under this specification to NHS South of Tyne and Wear in accordance with the Risk and

1 In the context of this SLA pregnant women and children under 18 years old are excluded if they are already identified as being in an at risk group.

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Incident Reporting Policy across Gateshead PCT, South Tyneside PCT and Sunderland TPCT.

5.8 The contractor must record any relevant information and in particular include:

i. any refusal of an offer of vaccination;ii. where an offer of vaccination was accepted;

a) details of the consent to the vaccination or immunisation;b) the batch number, expiry date and name of the vaccine;c) the date of administration of the vaccine;d) the route of administration and the injection site of vaccine;e) any contraindications to the vaccination or immunisation;f) any adverse reactions to the vaccination or immunisation.

5.9 The contractor must take all reasonable steps to ensure that the lifelong medical records held by an at-risk patient’s general practitioner are kept up-to-date with regard to their immunisation status, this would involve copying the details of the vaccinations that are provided to the at risk patients to GP practices in a timely manner (within two working days). Please see Annex B This is important for clinical reasons (e.g. if there are any adverse events) and also means that these vaccinations will be included in the vaccine uptake data collections.

5.10 The service can only be provided in an approved pharmacy, which must have a suitable area for consultation with the patient. This suitable area

must be a quiet area within the shop where it is cordoned off and not be accessible to other members of the public.

must be clear of any items placed there for storage. must have impermeable flooring for Health and safety reasons. must have a chair for patients to sit in following the flu jab; it must likewise

have impermeable seating, which is able to tolerate a chlorine releasing agent for disinfection purposes.

must also have facilities for patients to be able to lie down in the event of a simple faint or an anaphylactic reaction.

Must have a dedicated hand washing facilities with liquid soap and disposable paper towels in a wall mounted paper towel dispenser and foot operated pedal bin. Ideally this should be in the consultation area. Where it is not, infection control procedures and hand hygiene procedures must be followed rigorously.

must have vomit bowls available in the vaccination area. must have a sharps bin and a sharps collection and disposal procedure in

place and in compliance with NHS South of Tyne and Wear Sharp disposal policy.

6. Accreditation

6.1 The contractor must satisfy the PCT it is capable of meeting its obligations under these arrangements including under any plan agreed under those arrangements and, in particular, has the necessary facilities, equipment and properly trained and qualified health care professionals and staff to carry out those obligations.

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6.2 The contractor must ensure that any health care professional who is involved in administering a vaccine has:

a) attended a formal immunisation program and has the necessary competencies, skills and documented evidence with regard to the administration of the vaccine (this includes ensuring that training and skills are maintained and regularly updated at least every year );

b) training with regard to the recognition and initial treatment of anaphylaxis (at least every year);

c) training with regard to the maintenance of the cold chain and infection control measures.

7. Ongoing Measurement & Evaluation

7.1 The contractor must supply NHS South of Tyne and Wear with influenza uptake information (Annex C) as it may reasonably request for the purposes of monitoring the contractor’s performance of the influenza immunisations service and processing the payment.

7.2 The contractor is encouraged to undertake patient’s satisfaction survey with a view to assess the quality of the service (Please see Annex D for further detail).

8. Integrated Governance

8.1 Clinical Governance

Governance is a mechanism to provide accountability for the way an organisation manages itself. Clinical Governance (CG) is a system through which healthcare organisations are accountable for continuously improving the quality of their services and safe-guarding high standards of care, by creating an environment in which clinical excellence will flourish. CG should be integrated into the organisation’s whole governance arrangements. Integrated Governance (IG) is a collection of systems, processes and behaviours by which healthcare organisational objectives, safety and quality of service and in which they relate to patients and carers, the wider community and partner organisations. The contractor is required to have, or adopt, a system of IG, that incorporates key elements of CG and organisational learning, to ensure that there is the safe delivery of the services to patients.

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8.2 Equity of Access

All contractors providing the service will:

Not discriminate between patients on the grounds of age, sex, sexuality, ethnicity, disability, or any other non medical characteristics.

Comply with the requirements of the Race Relation Act 1976, Race Relation Act (Amended) 2000, Disability discrimination Act 1995, the Sex Discrimination Act 1975, the Sex Discrimination Act (Amended) 1986 and the Equal Pay Act 1970 and shall not discriminate against any person or organisation, or supplier on the ground of race, gender, sexual orientation, disability or culture. The Commissioner would expect the provider to be able to demonstrate evidence of accessibility.

Implement Royal National Institute for the Blind and Royal National Institute for the Deaf guidance as amended from time to time to ensure patients who have relevant disabilities and/or communications difficulties are able to receive the Services.

Offer to all non English speaking users professional translation services during consultations.

Be expected to be proactive in identifying and delivering the service to eligible patients who have difficulties in accessing seasonal influenza immunisation service, including but no limit to the following:o those who do not understand written or spoken English; o those who cannot hear or see, or have other disabilities; oworking single parents; oasylum seekers or refugees; oblack or minority ethnic communities; o those who have mental illnesses; o those who misuse alcohol or illicit drugs; ando those who belong to a lower socio-economic class, or who are

unemployed.

8 .3 Patient Dignity & Respect

The contractor will:

ensure that the provision of influenza vaccine and the contractor premises protect and preserve patient dignity, privacy and confidentiality; ensure that contractor staff behaves professionally and with discretion towards all patients and visitors at all times.

8.4 Informed Consent

The contractor will comply with NHS requirements in relation to obtaining informed consent from each patient prior to commencing treatment including the following as amended from time to time:

Immunisation against infectious diseases (Green Book), Chapter Two. Department of Health Good Practice in Consent Implementation Guide:

Consent to Examination or Treatment 2002; Health Service Circular HSC 2001/023; and

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Seeking Patients' Consent. The Ethical Consideration: GMC November 1998.

8.5 Confidentiality

The contractor and their staff will not disclose to any person other than a person authorised by the PCT and relevant GP, any information acquired by them in connection with the provision of the services which concerns:

The identity of any patient; The medical conditions of, or the advice received by, any patient.

8.6 Audit

The contractor will allow the PCT’s internal and other nominated auditors access to all or any papers and service records relating to this Agreement for the purposes of audit and consent to the disclosure of relevant information for the purpose of fraud prevention, detection and inspection.

The contractor is to undertake an audit of the service as defined by the PCT.

8.7 Complaints

The contractor is required to have a system in place for the handling of complaints in line with NHS South of Tyne and Wear complaints procedure.

The contractor is required to ensure patients are informed they have the right of complaint to PALS (Patient Advice and Liaison Service) at the PCT. All information shall be provided to the patient in order for them to access the NHS South of Tyne and Wear complaints procedure.

Complaints in relation to the service are to be notified to the PCT.

8.8 Significant Event Reporting

In the event of any ‘adverse incident’ or ‘near miss’ relating to the provision of this service, the contractor will complete the appropriate incident reporting form and forward a copy to the PCT.

8.9 Equality Statement

The contractor shall at all times comply with the requirements of the followingo Race Relations Act 1976, o Race Relations Act (Amended) 2000, o Disability Discrimination Act 1995, o the Sex Discrimination Act 1975, o the Sex Discrimination Act (Amended) 1986, and o the Equal Pay Act 1970,

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The contractor shall not discriminate against any person or organisation, or supplier on the grounds of race, gender, sexual orientation, disability, age or religious preference.

8.10 Obligations of the Contractor

The contractor is responsible for the delivery of the service as detailed in the service level agreement.

The contractor has a duty to ensure that staff involved in the provision of the service has attended a recognised immunisation training programme, and has the relevant qualification (with documented evidence) knowledge and skills for the operation of the service.

The contractor has a duty to ensure and demonstrate that all staff involved in the provision of the service is aware of and act in accordance with local protocols and national guidance as appropriate.

The contractor is responsible for ensuring the PCT is informed of the details of any external agency providing the service on behalf of the contractor.

The contractor is required to maintain appropriate records to ensure effective ongoing service delivery and audit.

Overall responsibility for ensuring the eligibility of patient and suitability of the vaccine provision to the patient, in accordance with local procedures and National guidance (CMO letter dated 25 May 2011), lies with the contractor.

The contractor will be responsible for ensuring promotional materials provided by or on behalf of the PCT are utilised appropriately in the promotion of the service.

The contractor will have standard operating procedures in place to support the service.

8.11 Obligation of the PCT

The PCT will ensure that appropriate systems are in place to ensure the contractor is supported in the delivery of the service as defined in the SLA.

The documentation required to deliver the service will be provided by the PCT.

The PCT will provide any framework for the recording of relevant service information for the purpose of audit and the claiming of payment.

The service will be reviewed annually by the PCT.

The PCT will ensure prompt payment.

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8.12 Care Quality Commission

The contractor will be required to provide information requested by the PCT in relation to assessments and or special reviews as specified by the Care Quality Commission.

8.13 Indemnity

The contractor must notify their professional indemnity insurers and maintain adequate insurance cover for their participation in this service.

9. Information Management / Requirements

9.1 The contractor will maintain appropriate records as specified in the Service Specifications to ensure effective service delivery and audit. Records will be confidential and should be stored securely and retained for a period of eight years.

9.2 All contractors must be available on request for inspection by the PCT or its agents for the purpose of audit.

9.3 The contractor must have a system for collecting data on adverse incidents, which should be aligned to the relevant guidance contained in NHS South of Tyne and Wear Incident Reporting Policy. (The PCT will provide a copy of the policy upon request and training can be arranged). Adverse incidents should include, but are not limited to, incidents relating to:

Death occurring on the premises; Patient complaint; Vaccine-related events; Other health professional; Other administrative; and Other incidents.

9.4 When appropriate, the contractor must put in place appropriate governance and security for the IM&T Systems to safeguard patient information.

9.5 The contractor must ensure that the IM&T Systems and processes comply with statutory obligations for the management and operation of IM&T within the NHS, including, but not exclusively:

Common Law Duty of Confidence; Data Protection Act 1998; Access to Health Records Act 1990; Freedom of Information Act 2000; Computer Misuse Act 1990; and Health and Social Care Act 2001.

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9.6 The contractor must meet prevailing national standards and follow appropriate NHS good practice guidelines for information governance and security, including, but not exclusively NHS Confidentiality Code of Practice.

 9.7 The contractor shall provide the information specified in section 5.7, 5.8, 5.9, and

Annex B to the patient’s GP practice in a timely manner (within two working days) and in any event within the applicable time period set out and shall ensure its accuracy and completeness.

9.8 The Commissioner may from time to time notify the contractor of what further information it may reasonably require in order to monitor the contractor’s performance of this Agreement and the contractor shall supply such information as soon as reasonably practicable. Where such information is required by the Commissioner on an ongoing basis, the Parties shall vary this Agreement to give effect to the Commissioner’s ongoing requirement.

10. Funding & Payment Method

10.1Terms and FeesOn agreeing the service level agreement with the PCT for the year 2011/12, the contractors will receive payment as specified in section 1.5.

10.2Payment Methodo Payment will be authorised and processed on submission of the claim

by end- February 2012.o Payment will be made at the end of the Seasonal Influenza Campaign

2011/12 (31 March 2012) and will be based on achievement during the two month period (December 2011 - 31 January 2012).

o Payment for the service will be made by BACS/cheque to the participating contractor.

PAYMENT WILL ONLY BE MADE UPON RECEIPT OF COMPLETED SIGNATURE SHEET RETURNED TO THE PCT BY 1 st DECEMBER 2011.

11. Contract Management

11.1 For the purpose of the provision of seasonal influenza immunisation service, the Directorate of Public Health, based at South Tyneside Primary Care Trust, is the commissioner of the service.

11.2 The named contact for the service is Mrs Cath Clark, South Tyneside Primary Care Trust, Clarendon, Hebburn, NE31 1AT, email cath.clark@sotw.nhs.uk telephone number 0191 2831290.

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12. Review, Variation and Re-commissioning Process

12.1 Monitoring of the service will be on-going and will inform the end of year service review to advise future commissioning intentions.

12.2 Contract variations will be discussed and agreed by both parties in line of national guidance.

13. Termination of Agreement

The agreement may be terminated, without penalty, if either party gives the other party three weeks notice, in writing.

If a contractor has their commissioned status withdrawn.

The PCT will be entitled to terminate this agreement forthwith in the event that the contractor or their staff commits a serious irremediable breech of his/her obligation in providing the service arising out of or in connection with the provision of the said service.

The agreement may be terminated by either party if the terms of the agreement are broken.

14. Disputes – Conciliation, Arbitration and Appeals

In the event of disagreement or dispute, the PCT and the contractor will use the best endeavours to resolve the dispute without recourse to formal arbitration. If unsuccessful, the matter will be determined in accordance with normal contract dispute resolution procedure.

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Groups eligible for the seasonal flu vaccine for 2011/12

The list of eligible patients who should be offered the seasonal flu vaccine by local pharmacists during this year campaign 2011/12. Trivalent seasonal flu vaccine should be offered in such cases.

Eligible groups Further detail

Inclusion criteria The seasonal flu vaccine should be offered to any patient with any underlying medical condition (s), set out in the table below, who has not received yet flu vaccine via his/her GP or any other provider during this year.

Exclusion criteriaChildren under 18 years oldPregnant women

Chronic respiratory disease Asthma that requires continuous or repeated use of inhaled or systemic steroids or with previous exacerbations requiring hospital admission.Chronic obstructive pulmonary disease (COPD)including chronic bronchitis and emphysema;bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary dysplasia (BPD).Children who have previously been admitted to hospital for lower respiratory tract disease.

Chronic heart disease Congenital heart disease, hypertension with cardiac complications, chronic heart failure, individuals requiring regular medication and/or follow-up for ischaemic heart disease.

Chronic kidney disease Chronic kidney disease at stage 3, 4 or 5, chronic kidney failure, nephrotic syndrome, kidney transplantation.

Chronic liver disease Cirrhosis, biliary artesia, chronic hepatitis

Chronic neurological disease Stroke, transient ischaemic attack (TIA). Conditions in which respiratory function may be compromised (e.g. polio syndrome sufferers).

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ANNEX A

Clinicians should consider on an individual basis the clinical needs of patients including individuals with cerebral palsy, multiple sclerosis and related or similar conditions; or hereditary and degenerative disease of the nervous system or muscles; or severe neurological disability.

Diabetes Type 1 diabetes, type 2 diabetes requiring insulin or oral hypoglycaemic drugs, diet controlled diabetes.

Immunosuppression Immunosuppression due to disease or treatment.Patients undergoing chemotherapy leading to immunosuppression. Asplenia or splenic dysfunction.HIV infection at all stages. Individuals treated with or likely to be treated with systemic steroids for more than a month at a dose equivalent to prednisolone at 20mg or more per day (any age) or for children under 20kg a dose of 1mg or more per kg per day.

Further guidance on the list of eligible groups and guidance on administering theseasonal flu vaccine, can be found in the updated influenza chapter of the GreenBook: Immunisation against infectious disease

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_079917

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NOTIFICATION OF INFLUENZA VACCINATION

Date:

Dear Doctor,

Please find enclosed information detailing your patient’s recent influenza vaccination.

The vaccine was administered by myself. The patient did not experience any problems during or after the vaccination.

Name of patient: _________________________________________________

Address of patient: ________________________________________________

Date of Birth: _____________________________________________________

Date of Vaccine Administration: _______________________________________

If you would like to know more about our service do not hesitate to contact me.

Yours sincerely

Name:

Title:

GPhC registration number: ________________________________

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ANNEX B

PHARMACY STAMP

Gateshead / South Tyneside / Sunderland (delete those which do not apply) PRIMARY CARE TRUST

LOCAL ENHANCED SERVICE SEASONAL INFLUENZA IMMUNISATION PROGRAMME 2011/12

FOR LOCAL COMMUNITY PHARMACY CLAIM FORM

PHARMACY NAMEAND ADDRESS

DATE: ______________________

Date of Birth

Male/Female Clinical at Risk Group

Registered GP Date Vaccinated

* Please copy & use additional sheets if more patients are vaccinated.

The PCT will pay £15.50 per immunisation (which includes 1.16 VAT per vaccine) Pharmacist Signature ________________________________ Date_______________

Name in Block Capitals ________________________

For PCT Use OnlyAuthorised by __________________________________ Date_____________

Please return claims to:-Cath Clark, NHS South of Tyne and Wear, Public Health, Clarendon, Hebburn, NE31 1AT

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ANNEX C

PHARMACY ADMINISTERED FLU VACCINATION – PATIENT EXPERIENCE SURVEY

About YouDate of Birth / /

Reason for Vaccine (please tick)Chronic Respiratory disease

Chronic Heart Disease Chronic Kidney Disease

Chronic Neurological Disease

Diabetes Immunosuppresion

Q1. How satisfied are you with the quality of the service you have received?Very satisfied Quite satisfied Not satisfied

Q2. Was the flu vaccination administered as well by the pharmacist, as by other health care professionals in the past? e.g. GP or nurse.Yes NoQ3. Do you feel that the pharmacy premises are appropriate for administering immunisations?Yes No

Q4. Would you use this service again in the future to receive your flu vaccination?Yes No

Q5. Would you be happy to have other vaccinations administered by a pharmacist in the future?Yes No

Q6. What did you like best about this service ?Close to home No need for an appointmentConvenient opening times Convenient to get toOther Please explain

Q7. How did you hear about this service?Word of Mouth Poster in Pharmacy NewspaperFrom GP/Nurse Poster in GP Practice From PharmacistOther Please explain

Many thanks for your time in completing this survey!

For the Pharmacist- Please keep on record for audit purposes.

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ANNEX D