SERVICE LEVEL AGREEMENT BETWEEN NHS England London- Region AND... (Organisation Name, Postcode & ODS Code for Premises) 1. General Information This Agreement is made between NHS England London (The Commissioner) and the above organisation (The Provider). 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 2.1 The Provider: This is the contractor as listed on the pharmaceutical list held by NHS England London Region. 2.2 The Service: 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 2016 March 31 st 2017 unless terminated earlier in accordance with the provision below, or varied in accordance with provision below. 1
4. Service Specification 4.1 The Service will be known as the London Pharmacy Vaccination Service 2016/17 and is a top up service to the National NHS England Flu service under the advanced services of the contractual framework. This local London service can be provided by any pharmacy in London that is also signed up to delivering the National Advanced Flu service. This local London service will cover the National Advanced Flu service in the instance the national service is not operational at any time during the period of September 1st 2016 to March 31st 2017. This service also covers the Pharmacy Enhanced Service in London for the additional patient groups for flu and additional immunisations such as Pneumococcal Polysaccharide that fall outside the national advanced service. 4.2 The Service to be provided is as set out in Schedule 1 of the Service Specification. 5. Responsibilities of NHS England 5.1 To provide funding, as set out in the Schedule 2. 5.2 To provide agreed information within mutually agreed time scales. 5.3 The Professional Pharmacy Advisors & Contractual Leads at NHSE, 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 included in Schedule1 by community pharmacists for the 2016/17 campaign. 5.5 To ensure robust differentiation between the National Advanced Flu service and the Flu component within the Local Enhanced London Pharmacy Vaccination service. 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. 2
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, which will meet the costs and any claims for compensation, at no cost to the NHS England. 6.9 To ensure NHSE Incident Reporting processes are followed when needed 7 Funding 7.1 Funding is for a specific period as set out in Schedule 2. 7.2 The funding for the National Advanced Flu service and Local Enhanced London Vaccination (flu component) service is different see Schedule 2. 7.3 The 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 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. 3
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. 11.2 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 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. 12.2 The Organisation will ensure that their recruitment procedure for any new staff/volunteers involved in the service adhere to equal opportunities policy. 4
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: 13.1.1 Reporting, recording, investigating of accidents 13.1.2 Fire precautions and evacuations procedures 13.1.3 First aid arrangements 13.1.4 Training of staff in Health and Safety matters. 13.1.5 Update health and safety policy when needed. 13.1.6 Premises 14 Confidentiality 14.1 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. 14.2 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 20.1 14.3 The organisation must be compliant with the NHS Information Governance Toolkit version14 (2016/17). 14.4 All communications with General Practice must be secure via SONAR, or a secure messaging system via an N3 connection for audit purposes. Any emails that include patient identifiable, or otherwise confidential, information must only be sent from and to nhs.net addresses. 15. Statutory Requirements 15.1 The Organisation shall conform to all existing and new legislation, which may be applicable to this Agreement. 16 Major Incidents and Business Continuity Planning 16.1 The Organisation is required to have an effective Business Continuity Plan. 5
17 Variations in the Terms of the Agreement 17.1 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. 18 Breach of the Agreement 18.1 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. 18.2 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. 18.3 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. 18.4 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. 19. Shortfalls or Deficiencies in Service Provision 19.1 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. 19.2 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. 19.3 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. 6
20 Termination of the Agreement 20.1 The Agreement may be terminated immediately in the event of any of the following: 20.1.1 A permanent cessation of the Service 20.1.2 A persistent failure to fulfil the terms of the Agreement 20.1.3 A serious breach of the terms of the Agreement 20.1.4 The performance of the service is unsatisfactory and documented to be so. 20.1.5 There is a substantial change to the service, which NHS England has not approved. 20.2 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. 20.3 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. 21 Additional Notes 21.1 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. 21.2 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. 21.3 NHS England London Region expects the Organisation to be providing the National Advanced Flu Vaccination service as the majority of patients eligible for flu vaccinations are expected to be vaccinated under this service; the local London Enhanced service is commissioned from the Organisation as a top up service to open up vaccinations to expanded and other groups who would benefit from influenza and other vaccinations e.g. Pneumonia. 7
Schedule 1A SERVICE SPECIFICATION London Pharmacy Vaccination Service 2016/17 The Aims and Objectives of the Service: Aims 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 a population- wide, evidence based, immunisation programme 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 commissions 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. Is safe, effective, of high quality and is independently monitored Drives improvements in quality by using available levers Is 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 Ensures that the negative impact for patients resulting from any, though unlikely this year, delay to the start of the National Advanced Flu service is minimised by implementation of the local enhanced London Pharmacy Vaccination service for vaccinating ALL those at risk from 1st September 2016, until the national service is in operation. Ensures that pharmacists (with special authority from NHSE London Region) are able to vaccinate off- site in certain situations e.g. where there is the likelihood of a particular group of at risk patients remaining unvaccinated - where these are not covered by the national advanced service Through the notification of vaccinations to the GP practice, help facilitate the recording on the practice register, of all those carers who are either the main carer, or help look after someone who is older or disabled and whose welfare would be at risk if this help was not available. Description of Service: 8
1. Service Provider 1.1 The service will be provided in an approved pharmacy with a designated consultation room/area approved by NHS England. The service may be provided to certain patient groups in alternative premises (offsite vaccinations) in certain circumstances with prior authorisation. 1.2 The service will be provided by an accredited pharmacist, working for the Provider, who has completed the training detailed below and signed an authorised copy of the NHS England Core Patient Group Direction for the administration of 2016/17 Vaccinations as well as the individual PGD for Pneumococcal Polysaccharide (PPV23) and the stand alone PGD for Inactivated Seasonal Influenza vaccination both as listed 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 (2015) of the Anaphylaxis Algorithm, produced by the Resuscitation Council (UK) is available (can be downloaded from https://www.resus.org.uk/resuscitation- guidelines/ ). It should be noted that the enhanced London service 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 micrograms 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 micrograms 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. 9
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 2016/17, ALL pharmacists will need to complete, EVERY TWO YEARS, the Declaration of Competence (DOC) self assessment framework and statement of declaration for Immunisation (Not Advanced Flu) services via CPPE. This can be accessed at: https://www.cppe.ac.uk/services/declaration- of- competence2?srv=18#doc Pharmacists will also be required to give NHS England access to their CPPE viewer to enable it to confirm completion of the DOC. Instructions on how to do this will be available on the CPPE website. Pharmacists are responsible for reassessing their competence to deliver the service at least once every 2 years. Those pharmacists who have already fully completed a DOC in 2015/16 are therefore not required to complete this again this year. However it is recommended that pharmacists review their declaration statements to satisfy themselves that each statement is still valid. 2.5 The DOC for Immunisation (Not Advanced Flu) is necessary for the London LES as this covers other vaccines besides just seasonal flu. The pharmacist must ensure that they have completed learning in line with the other vaccines being administered eg pneumococcus polysaccharide. 2.6 Training must meet the National Minimum Standards for Immunisation Training and the accompanying Core Curriculum. It must provide pharmacists with the skills necessary for administering all of the vaccines set out in Schedule 1b. 2.7 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; this update can be face to face or via e- learning. 2.8 The pharmacist has signed authorised copies of the NHS England Patient Group Direction for the Administration of the 2016/17 included Vaccines by Community Pharmacists. This includes each vaccine specific PGD. 2.9 Pharmacists should maintain clinical knowledge appropriate to their practice by attending relevant study days, courses and making themselves aware of appropriate literature. 2.10 Pharmacists providing this service should be aware of the need to have up to date hepatitis B vaccination. 2.11 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. 10
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. NHS England will pay the costs of the vaccine at list price (Drug Tariff) for the brand of vaccine used See Schedule 2. 4. 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 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 The pharmacy premises from where the service is provided must meet the requirements set out below: 5.1 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). 5.2 There must be appropriate infection control arrangements in place. 5.3 Vaccinations should only take place in a consultation room that 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 11
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. 5.4 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. 6. Vaccinations away from the pharmacy premises. Where a Provider (with permission granted for offsite vaccinations) wishes to administer vaccinations away from the pharmacy premises, it is recommended that the good practice guidance within Annex1 to this Schedule be followed. NHS England may review payments for vaccinations provided away from the pharmacy premises where the good practice guidance within Annex1 has not been followed. 7. Recording 7.1 The identified pharmacist will complete all necessary data recording to enable monitoring and evaluation of the scheme. 7.2 The pharmacist must ensure that the appropriate record form (proforma) on the Sonar platform is completed when any of the vaccines in Schedule 1 has been offered / administered. All the required information in the proforma must be completed. 7.3 Providers are encouraged to also record relevant information re vaccinations 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 in the pharmacy. 7.4 Records must be kept by the Provider for 8 years; 7.5 Where provisions have been made by NHS England, the Provider will comply with using and securely transmitting information electronically, and will maintain software suitable to support the IT system. This is required by automated secure email via Sonar. 7.6 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 email within 24 hours of immunisation (48 hrs over weekends and Public Holidays). NHS England 12
requires data transfer to General Practices for this service via secure e- mail and not through secure fax. 7.7 The Provider must also inform GPs of the reason for vaccinations of the patients, through the notification process; This will be required also for carers who help look after someone who is elderly or disabled and have been identified as a carer by the person who they look after or self declared. This information must be transmitted or provided in a secure manner via the Sonar platform. 7.8 The Provider will provide additional data to NHS England for audit purposes on request if required to do so. 7.9 Where a pharmacy is signed up to and has access to the Summary Care Record (SCR) then the SCR is accessed in line with agreed process to check vaccination status prior to vaccination e.g. for status for Pneumococcal vaccination. 9. Patient confidentiality The patient must sign the declaration/consent 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 10. Service Promotion 10.1 In general, all at risk patients should be encouraged to keep any appointments already made for vaccination at their GP practice in the first instance. 10.2 It is considered good practice for the Provider to communicate with their local GP practice(s) to inform them of their participation in the service and discuss: o Details of the service o Eligible patient population for the pharmacy service o 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 or for domiciliary vaccinations for the housebound (permission will need to be granted by NHSE prior to vaccination). 10.3 It is a requirement that the Provider develops a proactive approach to offering these immunisations to identified target patients. 10.4 It is a requirement that the Provider actively participates in any relevant National or local vaccination health promotion campaigns and maintains an adequate stock of promotional materials to use and to give to patients. 13
11. Patient Experience Surveys NHS England London requires the Provider to request every patient vaccinated to complete and return an agreed Patient Experience Survey. There are different patient experience surveys for flu and for PPV for the London service to enable them to be kept as simple as possible. NHSE London has arranged for Sonar to manage the Patient satisfaction surveys for the London Vaccination Service 2016-17 and make available a facility for patients to complete online post vaccination if they choose to. For this the system will automatically send a link to the patient (by email and/or SMS) post vaccination, to do the survey on- line. To enable this it will be mandatory to take the patient s mobile number or their email address on the record form. This facility is being developed and more information re how it works will be made available in due course. All completed surveys on paper need to be uploaded on to Sonar daily. Note that the patient experience surveys for national service patients has a different facility for completing electronically via another IT platform. 12. 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 (available on Sonar) and forward a copy to NHS England within seven days. 13. 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. 14
Preparation and set up for Vaccinations Away from Pharmacy (Off- site) Please follow the principles in the SLA and NHS PGD Annex 1: Procedure Preparation and set up 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. Prior to the visit, pharmacists or support personnel should contact the patient/carer/manager 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. 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. Ensure that you have ordered and take sufficient consumables, as well as full sets of anaphylactic kits, to the off- site setting. 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. 15
It is pharmacists responsibility to keep the vaccines stored between +2ºC to +8ºC at all times. Waste Arrangements Pharmacists must ensure that they have organised adequate waste bins for the number of 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. Note: there is a payment of 1.50 per vaccination within the funding that contributes towards waste management, anaphylaxis, training costs etc Documentation You should consider the following documentation (this list is not exhaustive); Sufficient patient data forms (Consent and Record forms) copies for all the relevant documents (download and print from the Sonar platform) Patient information leaflets Patient experience surveys for those completing hard copy surveys The consent and record forms 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 e- mail within 24 hours (48 hrs over weekends and Public Holidays). Should you notice a problem with the online notification, ensure a copy of the paperwork is hand delivered or is faxed to the surgery. File away any relevant paperwork. Report any incidents in line with the requirements of the SLA and Service Specification. 16
Schedule 1B Vaccinations to be provided under the London Pharmacy Vaccination Service 2016/17 Background Over the last two years, NHSE London Region commissioned pharmacies in London to provide pneumococcal vaccinations in addition to seasonal flu. The numbers of patients that were offered the second jab and found to be eligible, never having previously received the pneumonia vaccine was quite significant. Over 8500 people were co- administered pneumococcal vaccine with seasonal flu in 2014/15 and 5,500 in 2015/16. This demonstrated pharmacy teams were able to make every contact count and raise awareness of the benefits of other vaccinations that patients could benefit from and indeed; co- vaccinate where possible. In May 2016, NHSE announced the continuation of the National Flu Vaccination service under the advanced service component of the community pharmacy contractual framework. This national service will once again cover the majority but not all of the eligible cohorts of patients that the London Pharmacy Vaccination service covers. The national service covers eligible patients from 18 years of age whilst the London service covers eligible patients from 2 years of age. From 1 st September 2016 the London Pharmacy Vaccination Service will involve the administration of seasonal flu (inactivated) and Pneumococcal Polysaccharide vaccines once again. The seasonal flu vaccine will be delivered to a wider range of cohorts of patients who are not covered by the national advanced service. NHSE London region require a particular focus on vaccinations for eligible people with mental health, learning disabilities and those who are homeless, unregistered (without a GP), carers who help care for others who are at particular risk and pregnant women. Both services will be managed through the Sonar IT platform - The National Advanced Flu service will be reimbursed through the Community Pharmacy Contractual Framework and the Enhanced London Vaccination service will be paid locally. 17
Vaccines to be administered from 1 st September 2016 under the London Pharmacy Vaccination Service 2016/17: Community pharmacies in London are commissioned to vaccinate as part of the Flu Plan Winter 2016/17 1. This will comprise of:- 1) An inactivated seasonal flu vaccine to be offered to all persons set out in paragraph 1 of Appendix C the Flu Plan (Page 41&42), apart from children who are to be vaccinated with the live attenuated intranasal vaccine as first line, Front line health workers and any other group of persons named in the NHS England service specification 2) A Pneumococcus Polysaccharide Vaccine (PPV) to be offered to all adults over 65 years of age and anyone in an at- risk group that is aged two years and over (as defined in the Green Book), who has not previously received this vaccine. 2.1 Seasonal Flu (Inactivated) Vaccinations can be offered at NHS expense to the following groups: 2.1.1 Cohorts of patients covered under the National Advanced Flu service: People aged 65 years or over (including those becoming age 65 years by 31 March 2016) People aged from 18 years to less than 65 years of age with a serious medical condition 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 five, Chronic kidney failure, nephrotic syndrome, kidney transplantation. Chronic liver disease, cirrhosis, biliary artresia, chronic hepatitis. Chronic neurological disease, such as Parkinson s disease, polio syndrome, motor neurone disease, multiple sclerosis, cerebral palsy or learning disability Diabetes Splenic dysfunction A weakened immune system due to disease (such as HIV/AIDS) or treatment (such as cancer treatment) All pregnant women (including those women who become pregnant during the flu season) 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. (This does not include, for instance, prisons, young offender institutions, or university halls of residence). Applies to 18 years and over. People aged 18 and over who are in receipt of a carer s allowance, and/or those who are the main carer of an older or disabled person whose welfare may be at risk if the carer falls ill. 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. 1 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/525967/annual_flu_plan_2016_to _2017.pdf 2 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/263318/green-book-chapter-25-v5_2.pdf 18
NB: Offsite vaccinations for the above patient groups are only permissible under the national advanced service in a long- stay care home or other long stay residential facilities. Note that: 1) All of the above cohorts are covered under the National Pharmacy Advanced Flu Service 2016/17 2) All the cohorts below are covered by the London Pharmacy Vaccination service 2016/17 at all times between 1 st Sept 2016 and 31 st March 2017. 2.1.2 Cohorts of patients covered under the London Pharmacy Immunisation Service: All those at risk as in 2.1.1 above, who are 17 years old and their 18 th birthday is after 31 st March 2017 All those at risk as in 2.1.1 above, who are aged from 2 years to less than 17 years of age in whom Fluenz Tetra is contraindicated or unsuitable for any reason (NB: Vaccine of choice in this instance is Fluarix Tetra) People aged from 2 years to less than 17 years of age in whom Fluenz Tetra is contraindicated or unsuitable for any reason (NB: Vaccine of choice in this instance is Fluarix Tetra) and have a serious medical condition such as: o Chronic (long- term) respiratory disease, such as severe asthma, chronic obstructive pulmonary disease (COPD) or bronchitis o Chronic heart disease, such as heart failure o Chronic kidney disease at stage three, four or five o Chronic liver disease o Chronic neurological disease, such as Parkinson s disease or motor neurone disease, or learning disability o Diabetes o Splenic dysfunction o A weakened immune system due to disease (such as HIV/AIDS) or treatment (such as cancer treatment) Housebound patients at the specific request of the GP for those housebound patients who are not on district nurses case load (nb: permission req d from NHSE). Front line health care workers including primary care and Acute, Community & Mental Health Trusts - - in order to break the chain of infectious disease in London. NHS England staff as Flu Champions and clinical leadership ((identified by a voucher and/or by NHS England ID badge) Public Health England staff as Flu Champions and clinical leadership (identified by a voucher and/or by Public Health England ID badge) Special Schools staff to have synergy with the child flu pilots in all special schools (identified by a voucher and/or ID badge) People between their 17 th and 18 th birthday before 31 st March 17, who are in receipt of a carer s allowance, and/or those who are the main carer of someone whose welfare may be at risk due to old age, frailty, disability, physical or mental ill health or substance misuse, who might not get by without their help if they fell ill. All those who help care for someone whose welfare may be at risk due to old age, frailty, disability, physical or mental ill health or substance misuse who might not get by without their help if they fell ill i.e. may not be the main carer as covered by 19
the national service under 2.1.1 above (identified by voucher / self declaration or the person who they help care for) 2.2 Pneumococcal Polysaccharide Vaccine can be offered at NHS expense to patients who have not been vaccinated since age two with Pneumococcal Polysaccharide vaccine, who are aged 65 and over and those patients aged 2 to 64 at the time of vaccination defined as at- risk in Chapter 25 of the Green Book 2, excluding those with cerebrospinal fluid leaks 3. The pharmacist should verbally check before administration that the person has not been vaccinated with Pneumococcal Polysaccharide vaccine in the past. If a known patient of the pharmacy, their PMR record should be checked in case they were administered this vaccine in the last two years in the pharmacy. Those pharmacies registered for SCR should check this in line with agreed processes. The outcome of this verbal & PMR or SCR checks should be recorded on the proforma. The people eligible for vaccination under this service are outlined below along with some further detail. Eligible Groups for PPV23 People aged 65 years and over Chronic respiratory disease aged 2 to 64 years Chronic heart disease aged 2 to 64 years Chronic kidney disease aged 2 to 64 years Chronic liver disease aged 2 to 64 years Further Details Sixty- five and over is defined as those aged 65 years and over at the time of vaccination. 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 complications, chronic heart disease, chronic heart failure, individuals requiring regular medications and/or follow- up for ischaemic heart disease. 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 2 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/263318/green-book-chapter-25-v5_2.pdf 3 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. 20
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 Pneumococcal Polysaccharide Vaccine Sanofi Pasteur MSD. Adults previously unvaccinated with Pneumococcal Polysaccharide vaccine aged 65 and over should be offered a single dose of this vaccine. Children aged two and over and adults in a clinical risk group who have not previously received a Pneumococcal Polysaccharide vaccination should also be offered a single dose of this vaccine. Unlike the seasonal influenza vaccination, Pneumococcal Polysaccharide 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 Pharmacy service, and such patients, where identified, should be referred back to their GP. 21
Financial Specifications Schedule 2 Payment arrangements under the scheme will apply to persons immunised between 1 st September 2016 and 31 st March 2017. 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 (NB: an automated claim system will be operated via Sonar for this but this applies just to the London Vaccination service). 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 a fee for each vaccination administered See the fee structure below. The Provider will be reimbursed the cost of the vaccine at the list price (Drug Tariff). An allowance at the applicable VAT rate will also be paid. Fee structure The funding for the National Advanced flu service and Local Enhanced London Vaccination (Flu component) service are different (this is different from last year) see below: National Service: Pharmacy contractors will receive remuneration of 7.64 per administered dose plus an additional fee of 1.50 per vaccination to recognise expenses incurred by the pharmacy in providing this service. This includes training, anaphylaxis kits, clinical waste disposal etc). 22
In total pharmacies will receive 9.14 per administered dose of vaccination as well as reimbursement of vaccine costs (as in the Drug Tariff) with the added element for VAT component. London Service: Pharmacy contractors will receive remuneration of 7.64 per administered dose plus an additional fee of 1.50 per vaccination to recognise expenses incurred by the pharmacy in providing this service. Additionally in recognition of the added work involved in targeting the particular groups for focus in London, namely the unregistered, homeless, patients with mental health and learning disabilities and carers, an addition of 66p per vaccination will be payable on ALL vaccinations covered by the London service. In total pharmacies will receive 9.80 per administered dose of vaccination (seasonal Flu and PPV) as well as reimbursement of vaccine costs (as in the Drug Tariff) with the added element for VAT. Fees for co- administered vaccines will also be at the same rate. 23
Schedule 3 Lead Officers for Agreement The Lead Commissioner for the NHS England and the address for mailing invoices and monitoring forms are as follows: Name: Kenny Gibson Position: Head of Early Years, Immunisations and Military Health (NHS England, London Region)) Email: Immunisation- Submissions.London@nhs.net The lead officer for the Provider is: Name:. Pharmacy Name.. Position:. Address for Premises... ODS Code for these premises: F... Full Postcode.. Telephone:. Email:. Signing of the Agreement This document and the attached notes comprise the Agreement concluded between NHS England (London) and the pharmacy named above. Signed:. Date:..... Signed:. Date:..... 24