SERVICE LEVEL AGREEMENT BETWEEN NHS England (London) AND. (Organisation Name)

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1 SERVICE LEVEL AGREEMENT BETWEEN NHS England (London) AND (Organisation Name) 1. General Information 1.1 This Agreement is made between NHS England London (The Commissioner) and the above organisation (The Provider). 1.2 The Provider will not assign the whole or any part of the Agreement or sub-contract the supply of services without the previous consent in writing of the Commissioner, unless special conditions are included elsewhere in the Agreement. 2. Definitions The Provider: The Service: This is the contractor as listed on the pharmaceutical list held by NHS England Services provided by the Provider, as specified in this Agreement. The Commissioner: NHS England 3. Purpose and Period of the Agreement 3.1 The purpose of the Agreement is to set out the responsibilities of both the Commissioner and the Service provider. 3.2 The Agreement is effective from September 1 st 2014 March 31 st 2015 unless terminated earlier in accordance with the provision below, or varied in accordance with provision below. 4. Service Specification 4.1 The Service will be known as the London Pharmacy Vaccination Service. 4.2 The Service to be provided is as set out in the Service Specification in Schedule Responsibilities of NHS England 5.1 To provide funding, as set out in the Schedule To provide agreed information within mutually agreed time scales.

2 5.3 The Professional Pharmacy Advisors, will work with the designated lead officer of the Organisation for the purpose of monitoring the level and quality of service provided under the terms of this Agreement. 5.4 To provide authorised Patient Group Directions to enable the administration of vaccinations by community pharmacists for the 2014/15 campaign. 6. Responsibilities of the Organisation 6.1 To run and manage the Service effectively and efficiently. 6.2 To ensure that suitable staff/volunteers are recruited and trained. 6.3 To satisfy quality and performance standards as set out in the service specification. 6.4 To provide monitoring and financial information to the NHS England Head of Immunisation Service, or delegated officer within mutually agreed time scales. 6.5 To advise NHS England of any difficulty in relation to this Agreement e.g. where the Service falls below target levels or major staffing problems occur such as prolonged sickness absence, or potential SUIs. 6.6 To comply with all statutory requirements 6.7 To indemnify NHS England against all actions, claims, demands, costs, charges and expenses whatsoever in respect of any breach by the Organisation of this Agreement. 6.8 Any litigation, resulting from an accident or negligence on behalf of the organisation, is the responsibility of the organisation who will meet the costs and any claims for compensation, at no cost to the NHS England. 7. Funding 7.1 Funding is for a specific period as set out in Schedule T h e Organisation must inform NHS England via the designated lead officer, within seven days of any significant change in its financial or managerial circumstances, which may materially affect the ability of the Organisation to supply the Service covered by this Agreement. 8 Employees 8.1 The Organisation will employ appropriately qualified and experienced staff/volunteers to maintain the Service to the agreed specification. 8.2 The organisation will have in place agreed employment policies such as: - Terms and Conditions of Employment, Grievance and Disciplinary, Health and

3 Safety, Equal Opportunities, Recruitment and Retention and any other appropriate policies necessary. Copies of policies will be provided to NHS England on request 8.3 The Organisation will maintain and operate good employment practice ensuring that full Job Descriptions and Contracts of Employment are issued to all members of staff. 8.4 The organisation must ensure that any staff involved in providing the service has undertaken any required training and has the appropriate support to enable them to carry out their role effectively. 8.5 It is the responsibility of the Organisation to take appropriate measures to protect the public when recruiting staff/volunteers. All employees will have been appropriately vetted by the Organisation and hold accredited qualifications where appropriate. References and police checks where appropriate, will have been taken up in all cases. It is the responsibility of the Organisation to judge the suitability of applicants on the basis of such procedures. The Professional Advisor will have the right to make random spot checks on behalf of NHS England to ensure that the procedure of vetting is being carried out. 9 Contract Monitoring by NHS England 9.1. During the period of this agreement this contract will be monitored weekly. 9.2 NHS England reserves the right to request any information from the Provider to assist in the monitoring of the Service, as is deemed necessary to ensure that the standard of the Service complies with the Schedules of this Agreement, especially where a concern has arisen about the provision of the Service. 10 Insurance 10.1 The Organisation is required to arrange adequate insurance cover consistent with the Service provided. This must include Public Liability and Employers Liability Insurance, evidence of which will be required on request. 11 Complaints Procedure 11.1 The Organisation will have a written procedure for dealing with complaints in line with the current NHS England Complaints Procedure. These procedures must include a record of all complaints and the action taken on them. The record will be available at any time for inspection by the appropriate NHS England. The complaints procedure must be prominently displayed for patients/clients and easily accessible The Organisation must inform NHS England of any complaint received in relation to the service within 7 days of receiving the complaint. 12 Equal Opportunities

4 12.1 The Organisation is required to have an Equal Opportunities Policy outlining principles of Equal Opportunities and is expected to demonstrate its effectiveness in this area, particularly in relation to the provision of the Service covered by this Agreement The Organisation will ensure that their recruitment procedure for any new staff/volunteers involved in the service adhere to equal opportunities policy. 13 HEALTH AND SAFETY 13.1 The Organisation is required to have a written policy on Health and Safety, covering the Service and this should be made available on request. The policy should include: Reporting, recording, investigating of accidents Fire precautions and evacuations procedures First aid arrangements Training of staff in Health and Safety matters Update health and safety policy when needed Premises 14 Confidentiality 15.1 The Organisation and its staff/volunteers may be receiving personal and confidential information from service users. The Organisation s staff/volunteers must not disclose any information which comes into their possession in the course of providing the Service except as may be required by law, or where the express consent of the individual concerned, has been obtained. This includes information acquired through complaints procedures The Organisation will ensure policies/procedures are in place to prevent unauthorised disclosures. Disclosure of information which has not been authorised will be considered as a serious breach of the terms of this Memorandum of Agreement and could result in the termination of the Agreement as outlined in paragraph The organisation must be compliant with the NHS Information Governance Toolkit v9 (April 2014) All communications with General Practice must be secure via SONAR, or a secure messaging system via an N3 connection for audit purposes. Any s that include patient identifiable, or otherwise confidential, information must only be sent from and to nhs.net addresses. 16. Statutory Requirements 16.1 The Organisation shall conform to all existing and new legislation, which may be applicable to this Agreement.

5 17 Major Incidents and Business Continuity Planning 17.1 The Organisation is required to have an effective Business Continuity Plan. 18 Variations in the Terms of the Agreement 18.1 Variations in the terms of this Agreement will be agreed by both parties and confirmed in writing by the NHS England. Variations will normally require at least one months notice. 19 Breach of the Agreement 19.1 If the Organisation believes that the NHS England has broken the terms of this Agreement it will submit written details of the alleged breach and, unless the matter is otherwise resolved, a meeting will be arranged between the appropriate NHS England (London Region) Head of Immunisations and the Organisation to discuss the alleged breach If there is Agreement that a breach has taken place, action to be taken to remedy the breach and the time scale for such action will be agreed and confirmed in writing by NHS England 19.3 If there is no agreement, the alleged breach will be referred to the Head of Public Health and Health in the justice System at NHS England (London Region) for a suggested resolution. This will be agreed with the Organisation and confirmed in writing by NHS England Breaches by the Organisation will be dealt with as set out in either Section 20 or Section 21 depending on the nature and severity of the breach. 20. Shortfalls or Deficiencies in Service Provision 20.1 Where shortfalls or deficiencies in service provision have been identified or where other conditions of this Agreement are not being met, the Organisation will be notified and a meeting will be arranged between the Organisation and the appropriate lead officer. If a breach has occurred, a course of action to rectify the breach will be agreed; this will be confirmed in writing by NHS England Where there is a failure to rectify the shortfall or meet the conditions within the agreed time-scale, the matter will be referred to Operations and Delivery Director of NHS England London Region to decide what further action should be taken If there is persistent and serious failure to fulfil the terms of the Agreement then the designated lead officer will refer the matter to the Operations and Delivery Director of NHS England London Region with a view to terminating the Agreement. 21 Termination of the Agreement 21.1 The Agreement may be terminated immediately in the event of any of the

6 following: A permanent cessation of the Service A persistent failure to fulfil the terms of the Agreement A serious breach of the terms of the Agreement The performance of the service is unsatisfactory and documented to be so There is a substantial change to the service, which NHS England has not approved The Agreement can otherwise only be terminated by either party on written notice of one month. However, in fairness to both parties to this Agreement, and at the first indication of any such possibility, the implications of not being able to fulfil their obligations should be discussed without prejudice at the very earliest opportunity Where the Agreement is terminated following notice under paragraph 21.1 the rights accrued by either party at the date of termination are not affected and there shall be a full accounting between the parties at that date or within three months of the date. 22 Additional Notes 22.1 NHS England must protect the public funds it handles and so may use the information the Organisation have provided under this Agreement to prevent and detect fraud. NHS England may also share this information for the same purposes, with other organisations that handle public funds Publicity: The Organisation is expected to consult with NHS England officers about any publicity, whether adverse or positive, for any work funded through the NHS England SLAs. The Organisation is expected to take full advice on the handling of such matters from NHS England s communication team.

7 Schedule 1a SERVICE SPECIFICATION The Aims and Objectives of the Service: Aims London Pharmacy Vaccination Service The aim of immunisation programmes is to minimise the health impact of disease through effective prevention of cases Objectives The aim will be achieved by delivering population-wide, evidence based, immunisation programmes that; Identifies the eligible population and ensures effective timely delivery with optimum coverage based on the target population appropriate for each programme, introducing new initiatives informed by evidence Commission services informed by patient choice and ensure Every Contact Counts by offering co-administration opportunities across programmes i.e. individual receives two or three vaccinations in one contact if eligible Are safe, effective, of high quality and is independently monitored Drive improvements in quality by using available levers Are delivered and supported by suitably trained, competent healthcare professionals who participate in recognised on-going training and development Manages and stores vaccines in accordance with national guidance to maximise health benefits for populations by the effective use of medicines Are supported by regular and accurate data collection using the appropriate returns 1. Service Provider Description of Service: Providers will be authorised to provide the service based on the following criteria: 1.1 The service will be provided in an approved pharmacy with a designated consultation room/area or provide the service in alternative premises; 1.2 The service will be provided by an accredited pharmacist, working for the

8 Provider, who has completed the training detailed below and signed an authorised copy of the NHS England C o r e Patient Group Direction for the Administration of the 2014/15 Vaccinations as well as each of the individual PGDs for the vaccinations included in Schedule 1b. 1.3 Vaccines must be stored in a suitable fridge with the storage capacity and temperature monitoring systems described below; 1.4 The service may only be provided from the pharmacy premises on the pharmaceutical list that meet the requirements set out below, with the exceptions also set out below. 1.5 The provider should also ensure that a copy of the most recent version of the Anaphylaxis Algorithm, produced by theresuscitation Council (UK) is available (can be downloaded from ). It should be noted that the service this year includes the vaccination of children from 2 years of age, and therefore all pharmacists providing the service should be aware of the dose of adrenaline required for the management of anaphylaxis in different age groups. 1.6 The service provider must ensure that the pharmacist has access to at least 2 ampoules of Adrenaline (Epinephrine) 1:1000, including the necessary syringes and needles required for administration for all age groups. Where this is provided as a pen device, then two pens of each of the 150, 300 and 500 microgrammes strengths should be stocked. Emerade pre-filled pens are available in all three of these strengths; Epipen Auto-Injector is available as 300 and 150 micrgrammes strengths. 2. Pharmacist Accreditation and Staff Training Pharmacists providing this service must meet the following criteria: 2.1 The pharmacist providing the service is registered with the GPhC.; 2.2 The accredited pharmacist works regularly for the Provider at a pharmacy that meets the premises criteria specified in this agreement; 2.3 The pharmacist is able to vaccinate at least 20 persons during the relevant period; 2.4 To be eligible to participate in the NHS England London Region Pharmacy Vaccination Service, ALL pharmacists must complete the Declaration of Competence (DoC) for Vaccination Services (the London Service). This includes signing and retaining the certificate entitled Personal Declaration of Qualifications and Competence to deliver a Vaccination service. The DoC will be valid for three years. However if changes are made to the service in future years especially if additional vaccinations are added there may be a requirement to update training and competencies. As part of the DoC, pharmacists will be required to complete and pass CPPE e- assessments on immunisations. The Part 1 assessment covers vaccination procedures, vaccine storage and anaphylaxis management as well as administration of inactivated influenza vaccine. The Part 2 assessment covers the extended range of vaccines that

9 NHS England London Region intends to commission (ie live influenza vaccine, pertussis and shingles ). Successful completion of Part 1 is mandatory to provide the service from the 1 st September When the service is extended to include the wider range of vaccinations Part 2 will become mandatory. Service providers will be kept updated on discussions on introducing the extended service. 2.5 Training must m e e t t h e N a t i o n a l M i n i m u m S t a n d a r d s f o r I m m u n i s a t i o n T r a i n i n g a n d t h e a c c o m p a n y i n g C o r e C u r r i c u l u m 1. I t m u s t provide pharmacists with the skills necessary for administering all of the vaccines set out in Schedule 1b. 2.6 The pharmacist has completed and passed a recognised Basic Life Support (BLS) training course, for both adults and children from 2 years of age, in the past 12 months, or an approved alternative update training (BLS training must be updated every 3 years); this update can be face to face or via e-learning. 2.7 The pharmacist has signed authorised copies of the NHS England Patient Group Direction for the Administration of the 2014/15 i n c l u d e d Vaccines by Community Pharmacists. This includes the Core PGD and each vaccine specific PGD. 2.8 Pharmacists should maintain clinical knowledge appropriate to their practice by attending relevant study days, courses and making themselves aware of appropriate literature; 2.9 Pharmacists providing this service should be aware of the need to have up to date hepatitis B vaccination The Provider will ensure that all members of pharmacy staff are trained on the operation of the scheme and full details will be made available to locum pharmacists. 3. Vaccines to be administered. Only vaccines set out in Schedule 1b will be provided through this service. Vaccines will be procured and managed through licensed wholesalers or from Manufacturers or via Immform as appropriate. N HS England will pay the c o s t s of t h e vaccine a s set out in Schedule Fridge Storage Capacity and Temperature Monitoring Systems 4.1 All pharmacists providing this service must be aware of and meet the requirements of the NPSA Rapid Response on Vaccine Cold Storage (NPSA/2010/RRR008) and any subsequent alerts in relation to vaccine storage; 4.2 All Providers must have their contemporaneous Standard Operating 1 ntrainingresources/

10 Procedures on ordering, storage, stock control, disposal and procedures for remedial action in place prior to commencing the service. 4.3 All Providers must ensure that they have sufficient cold storage capacity to ensure the proper storage and integrity of the vaccines. 5. Suitable Premises 6.1 The pharmacy p r e m i s e s f r o m w h e r e t h e s e r v i c e i s p r o v i d e d m u s t m e e t t h e r e q u i r e m e n t s s e t o u t b e l o w. 6.2 The pharmacy shall have in place the following systems: a. Safe storage of vaccines, ensuring that the cold chain is maintained. Fridges used for the storage of vaccines must be monitored for minimum, maximum and actual temperature on each working day, and a record kept according to GPhC guidelines (ref. Fridge Temperature Monitoring). b. Safe disposal of sharps and clinical waste (as a minimum small 5L sharps bins). c. Effective prompt management and follow-up in the event of a needle-stick injury (in work hours consult the Health Protection Unit for advice or present at an A&E department if out of hours or at weekends. 6.3 There must be appropriate infection control arrangements in place. 6.4 Vaccinations should only take place in a consultation room which is large enough to allow: a. The vaccination to be administered safely; b. Sufficient workspace to allow for preparatory work, easy access to the sharps container, and easy storage of any paperwork; c. Immediate access to anaphylaxis pack and anaphylaxis algorithm; In the event of a severe anaphylactic reaction the pharmacy shall have a facility to call for ambulance assistance immediately without leaving the patient unattended d. The individual to be vaccinated to, where necessary, remove and store any garments, with privacy and dignity, to allow safe vaccination; e. The management of any anaphylaxis or patient collapse, including putting a person into the recovery position and/or carrying out Basic Life Support. Before vaccinating, the pharmacist makes sure that a member of staff is aware that the pharmacist will be administering a vaccine, and the pharmacist has made arrangements to contact that member of staff to call for help if necessary. 7. Vaccinations away from the pharmacy premises. Where a Provider receives a request to administer vaccinations away from the pharmacy premises, Appendix 1 to this Schedule must be followed. NHS England will not make any payments for vaccinations provided away from the pharmacy premises where the requirements of the Appendix have not been followed.

11 8. Recording 8.1 The identified pharmacist will complete all necessary data recording to enable monitoring and evaluation of the scheme; 8.2 The pharmacist must ensure that the appropriate record form (proforma) on the Sonar platform is completed when any of the vaccines in Schedule 1 have been offered / administered. All the required information in the proforma must be completed. 8.2 The pharmacist must ensure that the appropriate record form (proforma) on the Sonar platform is completed when any of the vaccines in Schedule 1 have been offered / administered. All the required information in the proforma must be completed. 8.3 Providers are encouraged to also record relevant information on their electronic Patient Medication record (PMR). However where a PPV vaccination has been offered, this must be recorded in the PMR for future reference, so as to allow for identification by the pharmacy in future years of those who have been vaccinated with PPV. 8.4 Records must be kept by the Provider for 8 years; 8.5 Where provisions have been made by NHS England, the Provider will comply with using and s e c u r e l y transmitting information electronically, and will maintain software suitable to support the IT system; This is required by automated secure via Sonar 8.6 To minimise the risk of patients receiving double immunisation, the Provider must ensure that details of those who have been immunised are uploaded on to Sonar to enable sending to the patient s GP via automated secure within 48 hours of immunisation. NHS England require data transfer to General Practices for this service via secure e -mail and not through secure fax this year. 8.7 The Provider must also inform GPs of patients who decline immunisation; Information must be transmitted or provided in a secure manner via the Sonar platform. 8.8 The Provider will provide additional data to NHS England for audit purposes on request if required to do so. 9. Patient confidentiality The patient must sign the declaration form that they consent to information being sent to the GP and to the NHS England. This must be kept on file for 7 years 9. Service Promotion 9.1 In general, all at risk patients should be encouraged to attend their GP practice for immunisation in the first instance; 9.2 It is considered good practice for the Provider to communicate with their local GP practice(s) to inform them of their participation in the scheme and discuss: a. Details of the scheme

12 b. Eligible patient population for the pharmacy service c. Direction of patients between practice and pharmacy. In some cases GPs may wish to provide their local pharmacy with a list of patients who have failed to attend for immunisation. 9.3 It is a requirement that the Provider develops a proactive approach to offering these immunisations to identified target patients; 9.4 It is a requirement that the Provider actively participates in any re le vant National or local vaccination health promotion campaigns and maintains an adequate stock of promotional materials to give to patients. 10. Patient Satisfaction Surveys NHS England requires the Provider to request a minimum of 10% of patients vaccinated to complete and return an agreed Patient Satisfaction Survey. These surveys need to be uploaded on to Sonar regularly on a weekly basis. 11. Adverse Incidents In the event of an adverse incident (significant clinical events, dispensing errors, adverse drug reactions), or near miss, it is imperative that the pharmacist will fill in an incident reporting form and forward a copy to the NHS England within seven days. 12. Quality Specification Required The Provider should be able to demonstrate that standard operating procedures for operation of the scheme, documentation of consultations and monitoring of the standards of service provision can be achieved.

13 Appendix 1 to Schedule 1a Responding to a request to vaccinate at a setting outside the authorised pharmacy Request from GP/ care/ residential setting for vaccinating offsite comes to the pharmacy. Pharmacy should NHS England (immunisation-submissions.london@nhs.net ) with the following details; Name & Address of setting for vaccinating Reason for request to vaccinate offsite That the patient s GP (s) have been contacted and are happy that the pharmacist will vaccinate them offsite That the pharmacist has checked with/ notified their professional indemnity insurance provider That the pharmacist(s) have a valid DBS check That the contractor has confirmed waste management for the vaccinations That the contractor has ensured the settings for vaccination are suitable (as per requirements of the Service Specification) That there is appropriate infection control in the settings for vaccination That the contractor has suitable cold chain arrangements for the transport of vaccines Please note that there will be no displacement costs associated with this service. It is the contractor s responsibility to cover all costs. NHS England gives the pharmacy contractor approval to vaccinate offsite. Pharmacist arranges date/time with the care/residential setting, and prepares all consumables, paperwork etc for the vaccinations. Please read annex 1, for notes on preparation and set up. Once pharmacist has completed all vaccinations, please ensure that all data from the completed patient proformas are uploaded onto Sonar so that they are sent to the patients GP practice by secure automated within 48 hours. For any questions, please contact your LPC or a member of the vaccination team in the first instance.

14 Annex 1: Preparation and set up Please follow the principles in the SLA and NHS PGD Procedure A. Preparation and set up 1. Pharmacists must notify their Professional Indemnity insurance provider, such as the NPA, that out of premises vaccinations will be provided and that risks are indemnified. 2. Prior to the visit, pharmacists or support personnel should contact the patient/carer to organise a convenient time for the administration of the vaccine. At the same time, re-check eligibility and any reason for exclusion for each vaccine that is to be administered. 3. Pharmacists should consider being accompanied by a trained Medical Counter Assistant or dispenser during visits. The primary role of the assistant is to assist in the event of an emergency. They would also be responsible for general administrative tasks such as completing consent forms, a review of the vaccination suitability, completion of documents and overseeing the waiting area, as well as being available as a chaperone if required. 4. Ensure that you have ordered and take sufficient consumables, as well as anaphylactic kits, to the setting. B. Cold Chain Pharmacists must ensure that the cold chain storage of the vaccines must be maintained at all times Trained pharmacists must check the packaging for any tampering or damage and confirm the vaccines have been appropriately stored and the cold chain has been maintained at +2ºC to +8ºC. Required vaccines should be collected and removed from the drug fridge on the day of administration, just before use and transferred to an appropriate validated cool box (as supplied by a medical company) for transportation. The vaccines should not be used after the expiry date shown on the product. Vaccines should be transported to the administration location in a validated cool box with the appropriate insulation to keep the temperature between +2ºC to +8ºC. The vaccines should be kept in their packaging and insulated (e.g. bubble wrap) from the cooling system to avoid the risk of freezing. Any unused vaccines should be returned to pharmacy fridge within 8 hours of first removal. It is pharmacists responsibility to keep the vaccines stored between +2ºC to +8ºC at all times. C. Waste Arrangements

15 Pharmacists must ensure that they have organised adequate waste bins for the vaccinations, and the subsequent collection of waste bins post the vaccination session. Please check with your waste contractor to ensure you are complying with all environmental and legal aspects of waste arrangements. D. Documentation You should consider the following documentation (this list is not exhaustive); Sufficient patient proforma documents for the relevant documents (download and print from the Sonar platform Patient information leaflets Patient satisfaction surveys 1. The proforma from the Sonar platform must be completed for each vaccination and then uploaded onto the Sonar/ platform to enable transfer to the GP by automated secure within 48 hrs. 2. Should you notice a problem with the online notification, ensure a copy of the paperwork is hand delivered or is faxed to the surgery. 3. File away any relevant paperwork 4. Report any incidents in line with the requirements of the SLA and Service Specification.

16 Schedule 1b Vaccinations to be Provided Under this Service 1. Background In 2013/14 NHS England London Region commissioned approximately 1,100 community pharmacies to support the seasonal flu vaccination programme. A key element in commissioning the service was the joint working with Local Pharmaceutical Committees (LPCs), who represent the community pharmacy contractors in London. As a result almost 70,000 people were vaccinated in the pharmacies a figure which helped maintain the overall percentage of eligible people in London when nationally this figure fell. In addition, London saw an increase in the number of under 65s at risk and pregnant women. It is also recognised that a significant number of people who are eligible for the seasonal flu vaccination are also eligible for a number of other vaccines. NHS England London Region has indicated its desire to commission community pharmacies in London to administer the full range of seasonal flu vaccinations for all eleigible persons from 2 years of age, as well as those eligible for pneumococcal polysaccharide vaccine (PPV), shingles and pertussis for pregnant women. However access to a number of these vaccines are restricted, and NHS England is in discussion with the Department of Health and Public Health England to identify a solution that allows community pharmacies access to these stocks. As a result, from 1 st September 2014 the Service will involve the administration of those vaccines that are not restricted. These are listed below. 2. Vaccines to be administered from 1 st September All persons set out in in Appendix C of the Flu Plan 2014/15 2, except those who would receive the live attenuated nasal vaccine or the intradermal vaccine (refer to Chapter 19 of the Green Book for further details 3 ) should be offered one dose of an inactivated influenza vaccine listed in Annex H of the tri-partite letter issued by PHE, NHS England and the Department of Health 4. A summary of this list is set out below: o people aged 65 years or over (including those becoming age 65 years by 31 March 2015) o all pregnant women (including those women who become pregnant during the flu season) o people from 2 years of age with a serious medical condition (refer to Table 19.5 of the Green Book for further details) such as: chronic (long-term) respiratory disease, such as severe asthma, chronic obstructive pulmonary disease (COPD) or bronchitis chronic heart disease, such as heart failure chronic kidney disease at stage three, four or 5 chronic liver disease chronic neurological disease, such as Parkinson s disease or motor neurone disease

17 diabetes splenic dysfunction a weakened immune system due to disease (such as HIV/AIDS) or treatment (such as cancer treatment) o When specifically authorised to do so by NHS England, people living in long-stay residential care homes or other long-stay care facilities where rapid spread is likely to follow introduction of infection and cause high morbidity and mortality. o People who are in receipt of a carer s allowance, or those who are the main carer of an older or disabled person whose welfare may be at risk if the carer falls ill. o Household contacts of immunocompromised individuals, specifically individuals who expect to share living accommodation on most days over the winter and therefore for whom continuing close contact is unavoidable. o Front-line health care workers. In addition to the above Seasonal Flu immunisation can be administered (via presentation of an appropriate NHSE voucher) to all the following staff cohorts in order to supplement the Green Book and in efforts to break the chain of infectious disease in London :- o NHS England staff as Flu Champions and clinical leadership o Public Health England staff as Flu Champions and clinical leadership o Prison staff o Special Schools staff to have synergy with the child flu pilots in all special schools 2.2 The people eligible for pneumococcal polysaccharide vaccination under this service are patients who have not been vaccinated since aged two with PPV23, who are aged 65 and over and those patients aged two to 64 on 31 March 2015 defined as at-risk in Chapter 25 of the Green Book 5, excluding those with cerebrospinal fluid leaks 6. The pharmacist should verbally check before administration that the person has not been vaccinated with PPV23 in the past. The outcome of this verbal check should be recorded on the proforma. The people eligible for vaccination under this service are also outlined below. Eligible Groups People aged 65 years and over Chronic respiratory disease aged 2 to 64 years Chronic heart disease aged 2 to Further Details Sixty-five and over is defined as those aged 65 years and over on 31 March 2015 (i.e. born on or after 31 March 1950) Asthma (only if so severe it requires continuous or frequently repeated or use of systemic steroids). Chronic respiratory disease including chronic obstructive pulmonary disease (COPD), chronic bronchitis and emphysema, bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary dysplasia (BPD). Children with respiratory problems caused by aspiration or a neurological condition (e.g. cerebral palsy). Congenital heart disease, hypertension with cardiac Whilst these are eligible under the Green Book and NHS England PGD, pharmacists should refer any such patients to their GP for a full clinical assessment. It is unlikely that a community pharmacist will have sufficient information to be able to properly identify this group of patients.

18 64 years complications, chronic heart disease, chronic heart failure, individuals requiring regular medications and/or follow-up for ischaemic heart disease. Chronic kidney disease aged 2 to 64 years Chronic liver disease aged 2 to 64 years Chronic kidney disease at stages 4 and 5, nephrotic syndrome, kidney dialysis and those with kidney transplantation Chronic liver disease, cirrhosis, biliary atresia, chronic hepatitis Diabetes aged 2 to 64 years Immunosuppression & asplenia or dysfunction of the spleen aged 2 to 64 years Individuals with cochlear implants aged 2 to 64 years Diabetes mellitus require insulin or oral hypoglycaemic drugs NOT diabetes that is diet controlled Immunosuppression due to disease or treatment, chemotherapy bone marrow transplant, asplenia or splenic dysfunction, HIV infection at all stages, multiple myeloma or genetic disorders affecting the immune system (e.g. IRAK-4, NEMO complemented deficiency) and individuals likely to be on systemic steroids for more than a month at a dose equivalent to prednisolone at 20 mg or more per day (any age), or for children under 20 kg, a dose of 1 mg or more per kg per day. It is important that it does not delay the Individuals with cochlear implants. The vaccine used against pneumococcal disease in those aged two and over is the 23- valent plain pneumococcal polysaccharide vaccine PPV23 (Pneumovax II), manufactured by Sanofi Pasteur MSD. Adults previously unvaccinated with PPV23 aged 65 and over should be offered a single dose of PPV23. Children aged two and over and adults in a clinical risk group who have not previously received a PPV23 vaccination should also be offered a single dose of PPV23. Unlike the seasonal influenza vaccination, PPV23 is not repeated annually. No further doses are required, except for individuals with no spleen, splenic dysfunction or chronic renal disease who will require boosters at five year intervals. However re-vaccination of these patients is NOT included in this year s service, and such patients, where identified, should be referred back to their GP.

19 Schedule 2 Financial Specifications Payment arrangements under the scheme will apply to persons immunised between 1 st September 2014 and 31 st March NHS England shall, in consideration of the pharmacist providing the services, pay the Provider the appropriate fee, for the activity carried out; Payment to the Provider by NHS England will be made on a monthly basis on receipt of fully completed claims; NHS England shall notify the Provider as soon as practicable if it considers a claim submitted by the Provider is incorrect or that the stated services have not been provided in accordance with this Agreement and in such circumstances NHS England shall be permitted to withhold any payment, subject to the outcome of any dispute resolution, due where there has been o A breach of the agreement o A cessation of the service o A shortfall or deficiency in service provision NHS England has the right to claim back any overpayments where it is demonstrated that the Provider was not entitled to those payments. The Provider will be paid an agreed Tariff 7 for each vaccination administered. The Provider will be re-imbursed the cost of the vaccine a t a n a g r e e d p r i c e 8. Subject to meeting a specified threshold in activity, providers will also be reimbursed for the purchase of the required adrenaline products as set out in clause 1.6 to Schedule 1, at the current list price plus VAT at the prevailing rate. This will include any replacement costs where any of the products are used for the purposes of managing an anaphylaxis reaction as a consequence of this service. Such an occurrence would be expected to be recorded and reported as an incident. NHS England will fund any exceptional clinical waste contract which cannot align to existing contracts or dovetail into another scheme, where the Provider has obtained authorisation from NHS England in advance of making any arrangements. 7 This Tariff will be agreed with the London Local Pharmaceutical Committees prior to commencement of the service 8 These prices will be agreed with the London Local Pharmaceutical Committees prior to commencement of the service and will include VAT at the prevailing rate.

20 Lead Officers for Agreement Schedule 3 The L e a d C o m m i s s i o n e r for the NHS England and the address for mailing invoices and monitoring forms are as follows: Name: Position: Kenny Gibson Head of Early Years, Immunisations and Military Health (NHS England, London Region)) Immunisation-Submissions.London@nhs.net The lead officer for the Provider is: Name: Position: Address:..... Telephone:. . Signing of the Agreement This document and the attached notes comprise the Agreement concluded between NHS England and the pharmacy named above. Signed:. Date:..... Signed:. Date:.....

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