SERVICE LEVEL AGREEMENT BETWEEN NHS England (London) AND ………………………………………………………………… (Organisation Name) 1. General Information This Agreement is made between NHS England London (The Commissioner) and the above organisation (The Provider). 2. Definitions The Organisation: This is the contractor as listed on the pharmaceutical list held by NHS England The Service: Services provided by the Organisation, 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 1st 2013 – February 28th 2014 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 Influenza Vaccination Community Pharmacy Enhanced Service. 4.2 The Service to be provided is as set out in the Service Specification in Schedule 1. 5. Responsibilities of NHS England 5.1 To provide funding, as set out in the Service Specification. 5.2 To provide agreed information within mutually agreed time scales. 5.3 The Professional Pharmacy Advisors , named in Schedule 3, 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. 1|Page Flu Immunisation Community Pharmacy Enhanced Service 2013/14 5.4 To provide an authorised Patient Group Direction for the administration of seasonal influenza vaccines by community pharmacists for the 2013/14 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 appropriate The NHS England Head of Immunisation Service, or delegate officer. 6.5 To advise The NHS England, via the Professional Adviser, 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 consult with The NHS England before any significant changes to the structure, function, staffing or duration of the Service. 6.7 To provide agreed information within mutually agreed time scales. 6.8 To comply with all statutory and other provisions to be observed and performed in connection with the Services and indemnify the NHS England against all actions, claims, demands, costs, charges and expenses whatsoever in respect of any breach by the Organisation of this Agreement. 6.9 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 2. 7.2 The NHS England has the right to suspend funding in the event of: 7.2.1 The Organisation failing to attain the agreed level of activity of service. 7.2.2 A cessation of the Service 7.2.3 A failure on the Organisation’s part to fulfil the terms of this Agreement. 2|Page Flu Immunisation Community Pharmacy Enhanced Service 2013/14 7.2.4 Commissioned services support or assist activities which are political or of an exclusively religious nature or which may bring The NHS England or any funders into disrepute. 7.3 It is a requirement of the Agreement, that the Organisation immediately informs the NHS England via designated lead officer, 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 the 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 Staff should be offered suitable training and 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 The NHS England to ensure that the procedure of vetting is being carried out. 9 Contract Monitoring by NHS England 9.1. NHS England will conduct contract monitoring visits in accordance with the Community Pharmacy Contractual Framework. Pharmacies failing to achieve standards required for essential services may not continue to provide enhanced services. 9.1 Following a monitoring visit, the designated officer will write to the Organisation detailing any areas of concern arising out of the visit, and any further action required by the Organisation. 9.2 NHS England reserves the right to carry out any additional monitoring of the Organisation and the Service, as is deemed necessary to ensure that the 3|Page Flu Immunisation Community Pharmacy Enhanced Service 2013/14 standard of the Service complies with the specification in Schedule 1 of this Agreement. 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. 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 Associate Director. The complaints procedure must be prominently displayed for patients/clients and easily accessible. 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 project 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: 13.1.1 13.1.2 13.1.3 13.1.4 13.1.5 13.1.6 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. 4|Page Flu Immunisation Community Pharmacy Enhanced Service 2013/14 15.2 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 15.3 The organisation must be compliant with the NHS Information Governance Toolkit v9 (April 2013). 15.4 All communications with General Practice must be secure via SONAR or WEBSTER, or a secure messaging system via an N3 connection for audit purposes. 16. Statutory Requirements 16.1 The Organisation shall conform to all existing and new legislation, which may be applicable to this Agreement. 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 the NHS England (London Region) Head of Immunisations and the Organisation to discuss the alleged breach. 19.2 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 the 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 the NHS England. 19.4 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. 20. Shortfalls or Deficiencies in Service Provision 5|Page Flu Immunisation Community Pharmacy Enhanced Service 2013/14 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 the NHS England. 20.2 Where there is a failure to rectify the shortfall or meet the conditions within the agreed time-scale, the matter will be referred to Director of the NHS England to decide what further action should be taken. 20.3 If there is persistent and serious failure to fulfil the terms of the Agreement then the designated lead officer will refer the matter to a Director 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 following: 21.1.1 A permanent cessation of the Service 21.1.2 A persistent failure to fulfil the terms of the Agreement 21.1.3 A serious breach of the terms of the Agreement 21.1.4 The performance of the services is unsatisfactory and documented to be so. 21.1.5 There is a substantial change to the service, which the NHS England has not approved. 21.2 The Agreement can otherwise only be terminated by either party on written notice of six months. 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. 21.3 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. 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. The NHS England may also share this information for the same purposes, with other organisations that handle public funds. 22.2 Publicity: The Organisation is expected to consult with the 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 6|Page Flu Immunisation Community Pharmacy Enhanced Service 2013/14 advice on the handling of such matters from The NHS England’s communication team. 7|Page Schedule 1 SERVICE SPECIFICATION Community Pharmacy Seasonal Influenza Vaccination Enhanced Service The Aims and Objectives of the Service: The aim of the service is to provide influenza immunisation for patients aged 65 years and over and those under 65 years in other at-risk groups. This is to reduce the serious morbidity and mortality from influenza by immunising those most likely to have a serious or complicated illness should they develop influenza. This can avert the need for the patient to be hospitalised. The objectives of the service are: 1. To increase access to influenza immunisation 2. To offer patients choice of provider for their annual seasonal influenza immunisation; 3. To decrease morbidity and mortality rates from incidences of seasonal influenza; 4. To increase uptake of influenza vaccination in frontline health and social care staff employed in London. 5. To include at-risk groups covered by this service are those who are listed in the Inclusion Criteria of the NHS England Patient Group Direction for the Administration of the 2013/14 Seasonal Influenza Vaccines by Community Pharmacists. 6. Those living in care homes, long-stay residential or other long-stay facilities and halls of residence, predicated upon exceptions requests by authorisation by NHS England. 7. Undertaking the service in prisons is being considered. 8. Those who are in receipt of a carer’s allowance, or those who are the main carer for an elderly or disabled person whose welfare may be at risk if the carer falls ill. Register Carers, at GP practice, to be prioritised in this programme 9. Local Authority carers are not, at this juncture, covered. 10. Pregnant women at any stage of pregnancy; 8|Page Flu Immunisation Community Pharmacy Enhanced Service 2013/14 Description of Service: 1. Service Provider Organisations 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 Pharmacy Contractor (service provider), who has completed the training detailed below and signed an authorised copy of the NHS England Patient Group Direction for the Administration of the 2013/14 Seasonal Influenza Vaccines by Community Pharmacists ; 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 service provider must ensure that the pharmacist has access to at least 2 ampoules of Adrenaline 1:1000, including the necessary syringes and needles required for administration. Where this is provided as “Epipen” then there must be at least 2 “Epipens” available. The provider should also ensure that a copy of the most recent version of the Anaphylaxis Algorithm, produced by the Resuscitation Council (UK) is available (can be downloaded from http://www.resus.org.uk/pages/anaalgo.pdf ) 1.6 The service 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. Pharmacist Accreditation 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 contractor 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 The pharmacy contractor will ensure that any pharmacist who is involved in administering a vaccine has successfully completed a training course that meets 9|Page Flu Immunisation Community Pharmacy Enhanced Service 2013/14 the requirements of the National Minimum Standards for Immunisation Training (published by the Health Protection Agency). Pharmacist can access resuscitation update via e-learning module, PHE e-learning module (On-line immunisation training modules is available Skills for Health Core Learning: https://corelearning.skillsforhealth.org.uk/local/sfhadmin/login/index.php and NPA e-learning module or approved alternative update training. Training providers that meet the National Minimum standards for immunisation training and that have been approved by NHSE include; ECG Novartis/AAH Burrage Ayres Pharmadoctor Charles Bloe Ltd The Pharmacy Training company Clockwork Medical Health Centre 2.5 Training must provide pharmacists with the skills necessary for administering intra-muscular injection, including: a. Needle length and needle bevel – research findings on the significance of this; b. Body mass and choice of needle length; c. Intramuscular sites and the rationale for this choice; d. How to administer an intramuscular injection, including patient assessment, side effects and contraindications to influenza administration; e. Anaphylaxis – recognition and treatment. 2.6 The pharmacist has completed and passed a recognised Basic Life Support (BLS) training course in the past 12 months, or approved alternative update training (BLS training must be updated every 3 years);this can be face to face or via e-learning. 2.7 The pharmacist has signed an authorised copy of the NHS England Patient Group Direction for the Administration of the 2013/14 Seasonal Influenza Vaccines by Community Pharmacists 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 having f up to date hepatitis B vaccination. (according to local arrangements) 10 | P a g e Flu Immunisation Community Pharmacy Enhanced Service 2013/14 Staff Training The pharmacy contractor 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. Vaccinations Flu Vaccines will be procured and manage by licensed wholesalers or from manufacturers and NHS England will pay for the vaccine invoice and anaphylaxis (1:1000 Adrenalin) costs NHS England will Fund any exceptional clinical waste contract which cannot align to existing contracts or dovetail into another scheme. 4. Fridge Storage Capacity and Temperature Monitoring Systems 1.5 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; 2.5 All contractors must have their contemporaneous Standard Operating Procedures on ordering, storage, stock control, disposal and procedures for remedial action to the NHS England prior to commencing the service. 3.5 All contractors 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 shall only provide this service from an NHSE/PCT approved private consultation area. 6.2 The pharmacy shall also 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 only for use in the provision of an NHS commissioned service (small 5L sharps bins). 11 | P a g e Flu Immunisation Community Pharmacy Enhanced Service 2013/14 c. d. Hold an injectable form of adrenaline on site for the management of anaphylaxis (e.g. EpiPen) 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 Appropriate infection control 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. f. 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. Under certain circumstances, the NHS England may agree to vaccinations being undertaken in alternative premises, for example within a care home. The contractor should ensure that the environment within which vaccination will take place meets the above criteria. The contractor should contact the NHS England to request permission to undertake vaccinations at an alternative location with infection control, waste collection and data collection must be satisfied. With infection control, waste collection and data collection must be satisfied. 6. Recording 7.1 The identified pharmacist will complete all necessary data recording to enable monitoring and evaluation of the scheme; 7.2 The contractor must develop and maintain a record of patients to whom the influenza vaccine has been offered / administered. Data should include: a. Any refusal of an offer of vaccination, with reason; b. Where an offer of vaccination was accepted: c. details of the consent to the vaccination or immunisation, d. the batch number, expiry date and title of the vaccine, e. the date of administration of the vaccine, f. any contraindications to the vaccination or immunisation, 12 | P a g e Flu Immunisation Community Pharmacy Enhanced Service 2013/14 g. any adverse reactions to the vaccination or immunisation; 7.3 Data can be recorded via the individual contractor’s electronic PMR (patient medication record) system, or “SONAR” and other e-platforms can report, Client records must be kept by the accredited pharmacy contractor for 8 years; 7.4 Where provisions have been made by the NHS England, the pharmacy will comply with using and transmitting information electronically, and will maintain software suitable to support the IT system; 7.5 To minimise the risk of patients receiving double immunisation, contractors must ensure that details of those who have been immunised are returned to the patient’s GP within 24 hours of immunisation. Pharmacists must also inform GPs of patients who decline immunisation; Information must be transmitted or provided in a secure manner via IT platform agreed on. 7.6 The pharmacist will provide additional data to NHS England for audit purposes on request if required to do so. 7. Patient confidentiality The patient must sign the declaration form that they consent to information being sent to the GP and to the NHS England. 8. Service Promotion 1.9 In general, all at risk patients should be encouraged to attend their GP practice for immunisation in the first instance; 2.9 It is considered good practice for each service provider to meet with their local GP practice(s) to inform them of their participation in the scheme and discuss: a. Details of the scheme b. Eligible patient population 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. 3.9 It is a requirement that the pharmacy contractor develops a proactive approach to offering these immunisations to identified target patients; 4.9 It is a requirement that the contractor actively participates in any National or local Flu health promotion campaigns and maintains an adequate stock of promotional materials to give to patients. 9. Monitoring All contractors delivering this enhanced service will be expected to comply with requests for audit information from NHS England as appropriate throughout the year. Progress with enhanced services will be discussed at planned NHS England /Pharmacy annual and any other review meetings on an on-going basis. 13 | P a g e Flu Immunisation Community Pharmacy Enhanced Service 2013/14 10. Adverse Incidents In the event of an adverse incident (significant clinical events, dispensing errors, adverse drug reactions), or near miss, the pharmacist will fill in an incident reporting form and forward a copy to the NHS England within seven days. 11. Quality Specification Required The pharmacist 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 | P a g e Flu Immunisation Community Pharmacy Enhanced Service 2013/14 Schedule 2 Financial Specifications Payment arrangements under the scheme will apply to all over 65s and under 65s in other at risk groups who are immunised between the 1st September 2013 and 28th February 2014; NHS England shall, in consideration of the pharmacist providing the services, pay the pharmacist the appropriate fee, for the activity carried out; Payment to the pharmacist by NHS England will be made on a monthly basis on receipt of fully completed claims; NHS England shall notify the pharmacist as soon as practicable if it considers a claim submitted by the Pharmacist is incorrect or that the stated services have not been provided in accordance with this Agreement and in such circumstances the NHS England shall be permitted to withhold any payment due. Contractors will be paid a fee of £7.51 per vaccination administered plus the cost of the vaccine reimbursed at £5.90 per vaccination plus VAT at the prevailing rate. Contractors will be also be reimbursed for the purchase of two Epipens and two Epipens JR at current list price plus VAT at the prevailing rate and for their replacement costs should it be necessary to use either preparation for the purposes of the NHS flu vaccination service”. 15 | P a g e Schedule 3 Lead Officers for Agreement The Professional Adviser 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: [email protected] The lead officer for the Organisation is: Name: ……….………………………… Position: ……….………………………… Address: ……….………………………… ……….………………………… ……….………………………… Telephone: ……….………………………… Email: ……….………………………… 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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