POLICY FOR THE HANDLING STORAGE AND CARE OF VACCINES

Transcription

1 POLICY FOR THE HANDLING STORAGE AND CARE OF VACCINES Version: 2 Ratified by: Medicines Management Committee Date ratified: 27 th September 2010 Name of originator/author: K.Plocica Version 1 written by Drs A Derso and A. Phillips Adapted with permission from NHS Highlands Policy for the Handling and Storage of Vaccines. Name of responsible committee/individual: District Immunisation Committee Date issued: Review date: February 2013 Target audience: All PCT-employed staff and Wolverhampton City PCT GP practice staff If you require this in a different format e.g., larger print, different languages, audio tape etc, please contact Equality and Diversity Office on or equality.diversity@wolvespct.nhs.uk Policy for the Handling Storage and Care of Vaccines 1 September 2010

2 Version Control Policy for the Handling Storage and Care of Vaccines Reference/ version. August 2010 Category Corporate Version 2 Document purpose: Intended for use by: To provide pct with a framework for the development of a robust risk management process throughout the organisation to enable it to deliver assurance to the Board All Trust Staff Author(s) responsible for document upkeep Consultation process Karen Plocica Julie Plant, Debbie Pickford, Amanda Manley, Linda Forrester, Roz Jervis, Naveed Syed, Mark Edwards Sponsoring Director: Mari Gay Approved by: District Immunisation Committee Dated: August 2010 To be reviewed before: Implementation arrangements: February 2013 Via Intranet and Stop Press Monitoring Arrangements E.g. The implementation and effectiveness of this policy will be reviewed by risk management leads on an ongoing basis, by checking whether the policy is being used and receiving feedback on current effectiveness and possible future revisions. Policy for the Handling Storage and Care of Vaccines 2 September 2010

3 VALIDITY STATEMENT This document is due for review on the latest date shown above. After this date, policy and process documents may become invalid. The electronic copy of this document is the only version that is maintained. Printed copies may not be relied upon to contain the latest updates and amendments. Policy for the Handling Storage and Care of Vaccines 3 September 2010

4 Contents Section Page 1 Purpose 5 2 General 5 3 Objectives 5 4 Duties Definitions 6 6 Consultation and Communication with Stakeholders 6 7 Ordering Storage of Vaccines Transportation of Vaccines 9 10 Vaccination Sessions Disinfection and Spillages Disposal of Vaccines Hazard and Incident Reporting Disruption of the Cold Chain Development Plan Dissemination, Implementation and Access Performance Management Document Control including Archiving Arrangements Monitoring Compliance References 13 Appendices Appendix 1 Daily Fridge Temperature Recording Chart 14 Appendix 2 Vaccine Stock Control Chart 15 Appendix 3 Cold Chain Disruption Flow Chart 16 Appendix 4 Audit Tool Equality Impact Assessment Risk Assessment Plan for the Review of Procedural Documents Checklist for the Review and Approval of Procedural Document Policy for the Handling Storage and Care of Vaccines 4 September 2010

5 1. PURPOSE Vaccines need to be stored at the correct temperature, usually 2ºC to 8ºC and not allowed to freeze, to ensure that the products are effective. Failure to maintain a system for transporting and storing vaccines within a safe temperature range may result in a vaccine that is not only ineffective but also potentially harmful when administered to a patient. The Primary Care Trust is a large diverse organisation and this policy covers the handling, storage and care of vaccines in a range of clinical areas. 2. GENERAL 2.1 The efficacy of vaccines depends on maintaining the cold chain. The cold chain is the system of transporting and storing vaccines within the safe temperature range of 2ºC - 8ºC. It begins when the vaccine is manufactured, and ends with the local immunisation provider at the time of administration Inadequate temperature control during storage and transport of vaccines can reduce the efficacy of the vaccine and result in failure to produce a satisfactory level of immunity. Freezing can cause deterioration of the vaccine. Freezing can also lead to hairline cracks in the ampoule/vial/prefilled syringe with the potential for the contamination of the contents. 3. OBJECTIVES To ensure the cold chain is maintained for vaccines transported, stored and handled in all areas within Wolverhampton PCT. To ensure vaccine waste is handled safely within Wolverhampton PCT. 4. DUTIES 4.1 Vaccines are Prescription Only Medicines; therefore within the managed service a Pharmacist should have overall responsibility for their purchase supply and 4.2 Wherever vaccines are stored there should be a named designated person and deputy to: Order, receive and supply vaccines Monitor the storage and delivery of vaccines Training should be given so that they understand the importance of complying with the following procedures. 4.3 Wherever vaccines are stored e.g. pharmacy departments, community clinics, G.P. practices, the following reference documents should be available. Immunisation against Infectious Disease' (Green Book) Current edition. Please consult the online version to ensure access to up-to-date guidance: enbook/index.htm Policy for the Handling Storage and Care of Vaccines 5 September 2010

6 UK Guidance on Best Practice in Vaccine Administration. 4.4 The procedures followed should be audited regularly to ensure that they comply with the written guidelines. 5 DEFINITIONS Cold Chain: The vaccination cold chain refers to all materials, equipment and procedures involved in maintaining vaccines under the required storage conditions from manufacturer to administration. For vaccines to be effective, it is important that they are stored within the temperature range recommended by manufacturers (+2º C to +8ºC) to ensure that they remain potent. 6 CONSULTATION WITH STAKEHOLDERS This policy for the handling, storage and care of vaccines, adapted with permission from the NHS Highlands policy for the handling and storage of vaccines, was developed with individual members of the District Immunisation Committee. It was circulated to GP practices for comment by Public Health, with a recommendation they adopt it. It has subsequently been discussed several times at District Immunisation Committee meetings to clarify arrangements for the safe disposal of waste/expired BCG vaccine and addition of agreed temperature recording documentation. 7. ORDERING Vaccines stocks should be monitored by the designated person(s) to avoid over ordering or stockpiling. It is recommended that only one month s supply is ordered at any one time. This will ensure that stock does not become outdated. It will also help to ensure that fridges are not overfilled. Deliveries should be signed for and refrigerated immediately on receipt; must never be left unattended. vaccines Each practice/premises should have one trained individual and at least one trained deputy responsible for the receipt and storage of vaccines. The signed, dated receipt, stating the time of delivery, should be kept for audit purposes. 7.1 Deliveries should be clearly labelled "Vaccines Urgent Refrigerate immediately" and should be signed for on receipt. 7.2 Deliveries should be inspected for leakages and damage. Affected products should be returned or destroyed with prior agreement with the Suppliers. 7.3 Goods received should be checked against the order and/or delivery note and any discrepancies reported to the supplier immediately. Policy for the Handling Storage and Care of Vaccines 6 September 2010

7 7.4 Manufacturers labelled storage conditions should be checked before they are put away. 7.5 Records should be kept (for five years) of manufacturers, batch numbers and expiry dates. This will allow information to be readily available in the event of any batch recalls or if any vaccine becomes out of date. Appendix 2 8. STORAGE OF VACCINES 8.1 Vaccines should be stored according to the manufacturer's recommendations. 8.2 Vaccines should be stored in a medical / pharmaceutical refrigerator which is lockable or which is in a room which is locked when not in use. There should be restricted public access to the area. Before being brought into use the refrigerator should be validated. This will involve obtaining an assurance that the temperature is reasonably even throughout the cabinet and that any fluctuations of temperature through the refrigeration on/off cycle are within acceptable limits. Domestic refrigerators are not designed for the storage of vaccines and should not be used. Food drink and clinical specimens should never be stored in the same refrigerator as the vaccines. 8.3 Refrigerators should not be sited near a heat source e.g. radiator, hot pipes, which will adversely effect their working, nor in an unheated area, as temperatures below 12 C will be detrimental. There should be sufficient space for air to circulate freely around the back of the refrigerator. 8.4 Wherever possible the refrigerator should be wired directly into the socket to ensure that there can be no unintended loss of power. If this is not possible a switchless socket should be used and a cautionary notice should be placed on plugs and sockets. 8.5 Refrigerators should be monitored daily by a named designated person (or their deputy), by means of a maximum/minimum thermometer, a time/temperature logger or a chart recorder. Chart recorders should be calibrated as per manufacturer s instructions. Thermometers should be reset after each reading. Temperatures should lie between 2-8 C. Every individual taking readings should understand how to read and reset the thermometer and why it is necessary and complete documentation. Appendix Individuals taking readings should understand when and how to take action when readings are out of the 2ºC- 8ºC range. 8.7 The thermometer should be left in the refrigerator at all times, except when being read. It should be rotated through all shelves in order to confirm that even temperatures are maintained throughout. If using a digital thermometer with a probe, the probe should be placed inside the vaccine packaging of one of the vials that is stored on the middle shelf of the refrigerator. It is preferable for an electronic one to be used that is readable from outside the refrigerator. Policy for the Handling Storage and Care of Vaccines 7 September 2010

8 Temperature indicators such as a dial on the refrigerator door should not be relied upon. Records of daily temperature readings must be retained indefinitely. Refrigerators should have the manufacturer s warranty in place. 8.8 There should be an emergency storage procedure should the refrigeration plant fail. Ideally the refrigerator should have an alarm which is activated when the temperature exceeds 8 o C or falls below 2 o C. During a power failure of four hours or less, the refrigerator door should be kept closed. 8.9 Any refrigerator falling outside the 2-8 o C range should be reported to the Pharmacy Team for the managed service and to your nominated manager on site or nominated person on call. All cold chain incidents should be reported and recorded. All localities must have in place a policy for this contingency to ensure that appropriate action is taken Any vaccine exposed to elevated temperatures should be marked as having been exposed to elevated temperatures. In the managed service this should be reported to the Chief Pharmacist and in GP practices this should be reported to the Pharmaceutical Adviser. Refer to Appendices 3. Individual areas may wish to develop their own chart(s) Vaccines must not be frozen and must not be used if they have been frozen 8.12 Refrigerators should be serviced annually. If they are of the type that are not self defrosting, defrosted and cleaned on a regular basis. The service record notice should then be displayed on the front of the refrigerator. Records should be kept of any servicing or defrosting. It is strongly recommended that refrigerators used for storing vaccines should have automatic defrost cycles. Otherwise defrost monthly When defrosting the refrigerator, move the vaccines to a second refrigerator. This temporary storage refrigerator must also be monitored to ensure the correct temperature (2ºC-8º) is maintained. Alternatively, place the vaccines in an approved cool box with the recommended cool packs. Continue to monitor the inside of the container until the normal vaccine refrigerator is ready for use again Vaccines should not be tightly packed; room should be left for the circulation of cold air. Stock should not be placed in trays unless they have a mesh construction that allows the passage of air Vials or ampoules should not be removed from their original packaging so as to retain information on batch numbers and expiry dates and protection from light Vaccines should not be placed in storage compartments of the refrigerator door There should be established stock rotation and expiry date check systems. Out of date stock should be disposed of as pharmaceutical waste using yellow sharps boxes which are ultimately incinerated. The only exception would be BCG vaccine which should be disposed of as cytotoxic waste using a purplelidded yellow sharps box. Policy for the Handling Storage and Care of Vaccines 8 September 2010

9 9. TRANSPORTATION OF VACCINES Designated vaccine portabags with correct cool packs, not ice packs, should be used when moving vaccines as per manufacturers instructions. This includes any movement of vaccines from one fridge to another or from one site to another. 9.1 Vaccine portabags should be kept in a cool room and cool packs stored in a fridge. 9.2 The time that vaccines are exposed to room temperature during packing should be kept to a minimum. 9.3 Where large amounts of vaccines are transported, temperatures should be monitored during transit and during actual sessions to ensure the cold chain is maintained. 9.4 In the event of a planned or unplanned power outage refer to the flow chart Appendix All movement of vaccines should be documented on stock control documentation. Appendix VACCINATION SESSION 10.1 Vaccines should only be removed from the base refrigerator at the beginning of the session when they will be used. They should be returned to the base refrigerator immediately after the session All vaccines required for a session should be removed from the refrigerator at the same time to avoid frequent opening and closing of the refrigerator door Vaccines should be out of a refrigerator for as short a time as possible, and certainly no longer than two hours. Therefore only the required number of doses should be taken Vaccines should be packed as previously stated if being taken to an outside clinic, school or for a domiciliary visit. Only stock required should be taken and this should be transported in a designated vaccine portabag with cool packs. Containers must not be left in a parked car that may be exposed to direct sunlight On arrival at the outside destination, the vaccines should be left in the closed portabag until required Freeze-dried vaccines should be reconstituted immediately prior to use and used within the manufacturer's recommended period The identity of the vaccine should be confirmed, and a visual check made for the absence of particles, also its colour (see manufacturers package insert) and expiry date Check that the correct storage conditions have been observed. Policy for the Handling Storage and Care of Vaccines 9 September 2010

10 10.9 Date of vaccination, title of vaccine, manufacturer, batch number of vaccine and diluents should be recorded in the patient's records Once opened, multi-dose vials must be disposed of at the end of the session, unless otherwise stated by manufacturers and Department of Health. 11. DISINFECTION AND SPILLAGES 11.1 If spillage of vaccine occurs, gloves should be worn and the spillage soaked up with paper towels. The area should be cleaned according to the Wolverhampton Decontamination Infection Control Policy Spillages on skin should be washed with soap and water Affected eyes should be washed with 0.9% Sodium Chloride Solution Sterile and medical advice sought. 12. DISPOSAL OF VACCINES 12.1 Vaccines, other than BCG, must only be disposed of as pharmaceutical waste by incineration. Yellow sharps boxes should be used for disposal of all vaccines and vaccine-contaminated waste. BCG vaccine must be disposed of as cytotoxic waste using a purple-lidded yellow sharps box At the end of each vaccination session any opened multi-dose vials or prepared unused vaccines must be disposed of as pharmaceutical waste unless otherwise stated by the Department of Health Guidelines Any vaccines that have reached their expiry date should be disposed of as pharmaceutical waste. Destruction of stock must be included in stock documentation records. All documentation relating to vaccines should be kept indefinitely. 13. HAZARD AND INCIDENT REPORTING 13.1 Practices must have mechanisms in place to communicate and action recalls and product warnings that may be received. If any member of staff discovers or suspects a problem with any vaccine product this should be reported without delay to the Senior Pharmaceutical Adviser. 14. DISRUPTION OF COLD CHAIN Do not use any vaccine that has been out of the cold chain. If the cold chain has been breached, the vaccine becomes unlicensed. If the disruption of the cold chain occurs within the managed service, please telephone the Chief Pharmacist. If the disruption occurs within GP practices, please telephone the Senior Pharmaceutical Adviser. Flow chart pertinent to specific areas must be followed Appendices 3. Policy for the Handling Storage and Care of Vaccines 10 September 2010

11 Cold Chain Breach Guidance should be sought from the Organisation wide policy for the Management of Incidents. Including Management of Serious Untoward Incidents (Appendix B). This includes clinical incidents escalation protocol. Guidance may also be sought from the Health Protection Agency document investigation of a Cold Chain Incident Guidance DEVELOPMENT PLAN 15.1 An audit tool to support the monitoring of compliance with and the effectiveness needs to be developed for this policy. The Head of Healthcare Governance will be responsible for ensuring a suitable tool is developed for roll out to both PCT Provider Services 15.2 Within PCT Provider Services, directorate managers in collaboration with their clinical leads will be responsible for implementation, training and audit within their directorate. 16. DISSEMINATION, IMPLEMENTATION AND ACCESS 16.1 The policy will be disseminated to staff that are deemed competent to undertake this procedure Dissemination of this guideline will be undertaken by publishing on the intranet and given to the staff that are deemed competent to undertake this procedure Staff will be directly informed if additional further specific training sessions are to be conducted. An Implementation check list is available on National Patient Safety Agency Vaccines Cold Storage Alert (Jan 2010) 17 PERFORMANCE MANAGEMENT Audit process through Quality and Governance. Audit tool Appendix DOCUMENT CONTROL INCLUDING ARCHIVE ARRANGEMENTS 18.1 The location of the register/library of procedural documents can be accessed via the trust intranet of master documents The Web Content Manager is responsible for maintaining the register/library of procedural documents, including the recording, storing and controlling current procedural documents The Web Content Manager is responsible for the identification of where information on archived documents can be found and how copies of achieved documents can be obtained. Policy for the Handling Storage and Care of Vaccines 11 September 2010

12 Public Health Immunisation Lead will take responsibility for version control and archive arrangements. 19 MONITORING COMPLIANCE The procedures followed should be audited regularly to ensure that they comply with the written guidelines. This will be the responsibility of clinical governance. Policy for the Handling Storage and Care of Vaccines 12 September 2010

13 REFERENCES 1. Brown DR, Samsum CJ. The transportation of vaccines: Is the cold chain integrity maintained? Pharm J 1992; 249: CDC (2003) Guidelines for Maintaining and Managing the Vaccine Cold Chain. Morbidity and Mortality Weekly Review volume 52 No Grassby PF. Safe storage of vaccines: Problems and solutions. Pharm J 1993; 251: Health Protection Agency Investigation of a Cold Chain Incident Guidance March (2010) 5. HMSO "Immunisation against Infection Disease" Current Edition should always be referred to. Department of Health. Also available at: (Policy and Guidance/Health and Social Care Topics/Immunisation and Vaccines) 6. Immunise Australia (2001) Keep it Cool: the Vaccine Cold Chain. Guidelines for Immunisation Providers on Maintaining the Cold Chain. 2 nd edition. Commonwealth Department of Health and Aged Care. 7. National Patient Safety Agency (2010) Vaccine cold storage Supporting Information. 8. Pharmacy Management. Medicines Management and the Cold Chain. (Supplement) October Primary and Community Care Pharmacy network. The Vaccine Cold Chain from Manufacturer to Patient. Aventis Pasteur MSD. 10. Steward M, Brown PW, Allwood MC. An assessment of insulated carriers for transport of vaccines. Int J Pharm Pract 1991; 1: Tayor J. Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products. Pharm J 2001; 267: Vaccine Administration Taskforce (2001) UK Guidance on Best Practice in Vaccine Administration. Shire Hall Publications. Available at: Veasey J (2004) Is the vaccine cold chain in general practice adequately maintained? An observational study. Unpublished MSc dissertation, University of Glasgow. Policy for the Handling Storage and Care of Vaccines 13 September 2010

14 APPENDIX 1 Temperatures should be between +2 C and +8 C DAILY REFRIGERATOR TEMPERATURE MONITORING DATE TIME CURRENT TEMPERATURE MAXIMUM TEMPERATURE MINIMUM TEMPERATURE DISC CHANGE (TICK) PRINT NAME AND SIGNATURE W:clinicalsuite/form/dailyrefrigeratortemperaturemonitoring Policy for the Handling Storage and Care of Vaccines 14 September 2010

15 APPENDIX 2 VACCINE STOCK CONTROL FRIDGE NO: Manufacturer Name Designation Date And Batch No. Expiry Date Quantity taken Returned (Number) Destroyed (Number) Number Received Running Total Policy for the Handling Storage and Care of Vaccines 15 September 2010

16 APPENDIX 3 ACTION IN THE EVENT OF AN INTERRUPTION OF POWER TO VACCINE REFRIGERATORS NOMINATED MANAGER ON SITE OR NOMINATED PERSON ON CALL TO BE INFORMED. TELEPHONE NUMBER. NOMINATED MANAGER TO ESTABLISH LENGTH OF POWER INTERRUPTION. AND ADVISE IF VACCINES HAVE TO BE DESTROYED OR MOVED AS PER POLICY. PHARMACY LEAD CAN BE CONTACTED FOR ADVICE.TELEPHONE NUMBER. VACCINE MANUFACTURES TELEPHONE NUMBERS.. IF VACCINES CAN BE MOVED ENSURE ANOTHER ALTERNATIVE REFRIGERATOR IS AVAILABLE OR SHORT TERM CAN BE PLACED IN VACCINE PORTABAG WITH APPOPRIATE COOL PACKS.COLD CHAIN SHOULD MAINTAINED AT ALL TIMES IF VACCINES HAVE TO BE MOVED OFF SITEALL BOXES SHOULD BE LABELLED WITH SITE NAME AND ADDRESS AND DATE DESIGNATED PERSON TO ENSURE NUMBER OF BOXES COUNTED AND RECORDED OUT ON STOCK SHEET WHEN THE REFRIDGERATOR IS WORKING CORRECTLY AND IS AT THE CORRECT TEMPERATURE VACCINES CAN BE RETURNED AND RECORED BACK IN ON TO STOCK SHEET. RISK ASSESSMENT NEEDS TO BE CARRIED OUT TO FIND OUT THE CAUSE OF THE POWER DISTRUPTION AND ANY ACTIONS THAT NEED TO BE TAKEN TO ENSURE NO FURTHER INCIDENTS OCCUR IN THE EVENT OF AN INTERRUPTION OF POWER TO VACCINE REFRIGERATORS: GUIDANCE SHOULD BE SOUGHT FROM THE TRUST RISK MANAGEMENT POLICY AND THE INVESTIGATION OF A COLD CHAIN INCIDENT DOCUMENT W/clinical suite/procedures/poweroutage March 2010 Policy for the Handling Storage and Care of Vaccines 16 September 2010

17 APPENDIX 4 Handling, Storage and Care of Vaccines Audit 2010 / 2011 GP Practice: Date of audit: Fridge number if more than one fridge in use (Complete Audit template for each fridge) : AUDIT CRITERIA Derived from the WCPCT Policy for the Handling, Storage and Care of Vaccines, V2, August 2010 POLICY REF. RESPONSE NOTES 1 There is a named designated person to order, receive and supply vaccines, and monitor the storage and delivery of vaccines There is a named designated deputy to order, receive and supply vaccines, and monitor the storage and delivery of vaccines A current copy of Immunisation against Infectious Disease (Green Book) is available in the practice or access available on the internet UK Guidance on Best Practice in Vaccine Administration is available in the practice or available on the internet Records of manufacturers, batch numbers and expiry dates are maintained for five years The practice uses a medical/pharmaceutical refrigerator which is lockable or in a room which is locked when not in use The fridge is used to store vaccines and cool packs only (no food, drink or clinical specimens) The fridge is sited in a heated area away from any heat sources 8.3 Policy for the Handling Storage and Care of Vaccines 17 September 2010

18 AUDIT CRITERIA Derived from the WCPCT Policy for the Handling, Storage POLICY RESPONSE NOTES and Care of Vaccines, V2, August 2010 REF. 9 There is sufficient space for air to circulate freely around the back of the fridge If the fridge is not wired directly in to the socket, there is a cautionary notice on the plug and on the sockets 11 Appendix 1 Daily Refrigerator Temperature Monitoring is completed daily or evidence of alternative recording system Appendix 1 (or alternative recording system) must be retained indefinitely There is knowledge of how to use the thermometer The fridge manufacturers warranty is readily available The fridge service record displaying annual servicing, is displayed on the front of the fridge 16 If the fridge does not have an automatic defrost cycle, is there evidence of monthly manual defrosting Vaccines are stored with adequate room for circulation of cold air Designated vaccine portabags with correct cool packs are used when moving vaccines (including any movement of vaccines from one fridge to another or from one site to another) 19 All movement of vaccines is recorded on Vaccine Stock Control document (Appendix 2) 20 There is a list available of named staff to be contacted in the case of Hazards/Recalls. Appendix 3 has been adapted locally Policy for the Handling Storage and Care of Vaccines 18 September 2010

19 The following Action Plan has been agreed with the Named Designated person for vaccination services in the practice : Audit Criteria Action to be taken Lead for Action Timeframe Completed As a result of the audit undertaken, the practice has been assessed as: PASSED Continue to provide vaccination services FAILED Review needed as per Action Plan FAILED Vaccination services to be stopped immediately, immediate action needed Policy for the Handling Storage and Care of Vaccines 19 September 2010

20 Wolverhampton city PCT Equality Impact Assessment Initial Screening of Policy/Strategy Pro Forma Completion Guidance: Please ensure that all the questions on the pro-forma are completed and that written evidence is provided. Should you have any problems when filling out the pro-forma then please contact the Equality and Diversity Department. * Policy includes; strategies, procedures, functions, guidance and guidelines Name of policy * Policy for the handling, storage and care of vaccines Aim of policy * Provide corporate policy and guidance to staff about maintaining the cold chain for vaccinations Name of Accountable Director [TITLE] Mari Gay, Director of Nursing, Healthcare Governance and Infection Prevention and Control Name of Responsible person/people [TITLE] Head Nurse and Public Health Impact Assessment Does the policy* target or exclude a particular equality target groups listed? Please delete / NO as appropriate Ethnicity NO Please provide an explanation for Disability NO your answer below and evidence as appropriate Gender NO Age NO Sexual Orientation NO Transgender NO Religion or Belief NO Policy for the Handling Storage and Care of Vaccines 20 September 2010

21 Does the policy* affect any of the equality target groups listed disproportionately? [Insert Equality group followed by text] Are there barriers which could inhibit access to the benefits of the policy*? e.g. Communication/information, physical access, location, sensitivity etc. No Ethnicity NO Please provide evidence for your Disability NO answer below Gender NO Age NO Sexual Orientation NO Transgender NO Religion or Belief NO Please provide evidence for your answer Does the policy* give different groups the same choices as everybody else? Yes Please provide evidence for your answer Policy for the Handling Storage and Care of Vaccines 21 September 2010

22 What evidence has been Demographic data and other statistics, including census findings Please provide any used to make these Recent research findings including studies of deprivation evidence that you feel judgements? may be appropriate Results of recent consultations and surveys Results of ethnic monitoring data and any equalities data from the local authority / joint Please tick one or more services in column 3 Information from groups and agencies within Wolverhampton Comparisons between similar functions / policies Analysis of PALS, complaints and public enquires information Analysis of audit reports and reviews This policy is based on current NHS guidance and legislation. In both cases all sections of the community are treated equitably. How is the effect of the policy* on different equality target groups going to be monitored? Please specify for each equality group Ethnicity n/a Please provide Disability n/a evidence for your answer Gender n/a Age Transgender Sexual Orientation Religion or Belief n/a n/a n/a n/a Policy for the Handling Storage and Care of Vaccines 22 September 2010

23 Impact Group Level of Impact Evidence What level of impact will this policy* have? Please tick one or more in column 4 Ethnicity Low level Impact can be rectified by small actions being taken Please provide High level / Adverse Impact Impact cannot be rectified without evidence for your significant changes to the policy or strategy answer Disability Low level - Impact can be rectified by small actions being taken High level / Adverse Impact Impact cannot be rectified without significant changes to the policy or strategy Gender Low level - Impact can be rectified by small actions being taken High level / Adverse Impact Impact cannot be rectified without significant changes to the policy or strategy Age Low level - Impact can be rectified by small actions being taken High level / Adverse Impact Impact cannot be rectified without significant changes to the policy or strategy Sexual Orientation Low level - Impact can be rectified by small actions being taken High level / Adverse Impact Impact cannot be rectified without significant changes to the policy or strategy Transgerder Low level - Impact can be rectified by small actions being taken High level / Adverse Impact Impact cannot be rectified without significant changes to the policy or strategy Religion or Belief Low level - Impact can be rectified by small actions being taken High level / Adverse Impact Impact cannot be rectified without significant changes to the policy or strategy Policy for the Handling Storage and Care of Vaccines 23 September 2010

24 No effects anticipated other than alternative formats being provided for those unable to read the document Policy for the Handling Storage and Care of Vaccines 24 September 2010

25 Actions Please give details of the actions you will take to address the issues highlighted in this assessment and when you will complete them by (all these actions should be incorporated into you Equality Scheme Action Plans) Equality Target Group Action Lead Person Timescale Policy for the Handling Storage and Care of Vaccines 25 September 2010

26 Risk Assessment This form is to be used when risk assessing single issues for clinical/non-clinical risk assessment Risk Issue: Failure to comply with this policy could result in vaccines being stored or distributed without maintaining the cold chain, thus rendering the vaccine unusable. Patients are potentially at risk if they receive vaccines which have been stored or distributed incorrectly. Suggested Action: Do you recommend the risk issue is: (please tick) Risk Score (L X C) + controllability 3 x 3 = 9 ACCEPT AVOID REDUCE Will the risk impact upon a Corporate Objective? If yes please give details:- Comply with the law and national directives. Does this risk pose a breach in SFBH compliance? No Controls already in place/other influencing factors: Policy for the handling, storage and care of vaccines Version 1 on the Trust Intranet. Some areas within the Trust have received training on vaccine care. Some areas within the Trust are using required documentation. Action Plan: 1 Proposed Actions(s) and Target Date(s): Policy to be reviewed and amended as required by lead author and practice group September Policy to be accepted by ratification group September Policy to be added to intranet site once ratified. Stop Press News Monitor compliance with records and audit Extend training to all areas to include GP practices within the Trust. Post Action Risk Score (L X C) + controllability 2 x 3 = 6 2 Resource Requirements and Costs: Minimal costs 3 Responsibilities: Head Nurse. Intranet Manager Policy for the Handling Storage and Care of Vaccines 26 September 2010

27 Children s Community Nursing Team Public Health 4 Monitoring and Review Head Nurse Risk Assessment Review Date: COMPILED BY: Karen Plocica DATE: August 2010 Target Risk Score (L X C) + controllability 1 x 1 = 1 ACCEPT The risk identified is controlled to the lowest practicable level AVOID The risk identified should be avoided REDUCE The risk identified should be reduced by implementing identified action plan Policy for the Handling Storage and Care of Vaccines 27 September 2010

28 Appendix 7 Plan for Dissemination of Procedural Documents To be completed and attached to any document which guides practice when submitted to the appropriate committee for consideration and approval. Title of document: Policy for the handling, storage and care of vaccines Date finalised: August 2010 Dissemination lead: Previous document already being used? Yes Print name and contact details Tel If yes, in what format and where? Policy for Handling and Storage of Vaccines Proposed action to retrieve out-of-date copies of the document: To be disseminated to: How will it be disseminated, who will do it and when? Paper or Electronic Comments Julie Plant Karen Plocica Electronic Associated Documentation to support dissemination Dissemination Record (to be used once document is approved.) Date put on register of procedural documents Date due to be reviewed Policy for the Handling Storage and Care of Vaccines 28 September 2010

29 Checklist for the Review and Approval of Procedural Document To be completed and attached to any document which guides practice when submitted to the appropriate committee for consideration and approval/ratification Title of document being reviewed: 1. Policy for the Handling Storage and Care of vaccines Is the title clear and unambiguous? Is it clear whether the document is a guideline, policy, protocol or standard? 2. Rationale Are reasons for development of the document stated? 3. Development Process Is the method described in brief? Are people involved in the development identified? Do you feel a reasonable attempt has been made to ensure relevant expertise has been used? Is there evidence of consultation with stakeholders and users? 4. Content Is the objective of the document clear? Is the target population clear and unambiguous? Are the intended outcomes described? Are the statements clear and unambiguous? 5. Evidence Base Is the type of evidence to support the document identified explicitly? Are key references cited? Are the references cited in full? Are supporting documents referenced? 6. Approval Does the document identify which committee/group will approve it? If appropriate have the TNC approved the document? Yes/No/ Unsure NO Comments Policy for the Handling Storage and Care of Vaccines 29 September 2010

30 Title of document being reviewed: 7. Dissemination and Implementation Is there an outline/plan to identify how this will be done? Does the plan include the necessary training/support to ensure compliance? 8. Document Control Yes/No/ Unsure Comments Stop Press to be informed of updated policy. It will be put on the intranet as soon as it is ratified. Does the document identify where it will be held? The policy will be put on the intranet as soon as it is ratified. Have archiving arrangements for superseded documents been addressed? 9. Process to Monitor Compliance and Effectiveness Are there measurable standards or KPIs to support the monitoring of compliance with and effectiveness of the document? Is there a plan to review or audit compliance with the document? 10. Review Date Is the review date identified? Is the frequency of review identified? If so is it acceptable? 11. Overall Responsibility for the Document Is it clear who will be responsible for co-ordinating the dissemination, implementation and review of the document? Individual Approval If you are happy to approve this document, please sign and date it and forward to the chair of the committee/group where it will receive final approval. Name Karen Plocica Date 5 th August 2010 Signature Committee Approval If the committee is happy to approve this document, please sign and date it and forward copies to the person with responsibility for disseminating and implementing the document and the person who is responsible for maintaining the organisation s database of approved documents. Name Date Policy for the Handling Storage and Care of Vaccines 30 September 2010