COLD CHAIN POLICY. Review Date May 2016 Related Policies & other documents MMP001 Control of Medicines Policy Freedom of Information category Policy
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1 COLD CHAIN POLICY Policy Details NHFT document reference MMP-014 Version Version 2-6/5/14 Date Ratified Ratified by Trust Policy Board Implementation date Responsible Director Medical Director Review Date May 2016 Related Policies & other documents MMP001 Control of Medicines Policy Freedom of Information category Policy Cold chain policy 1 of 12 Implementation Date: 07/05 /14
2 TABLE OF CONTENTS 1. DOCUMENT CONTROL SUMMARY INTRODUCTION PURPOSE DEFINITIONS DUTIES Medicines Management Committee Ward or unit manager Nurse in charge of the shift/ designated person Nurses working out of non-nhft sites POLICY MAIN BODY Transport From Acute Trust to NHFT sites From departments to satellite clinics/berrywood pharmacy to inpatient wards/units Management of vaccines in clinics where no refrigerator is available Storage Cleaning the Interior Monitoring DISRUPTION OF THE COLD CHAIN Disposal TRAINING Mandatory Training Specific Training not covered by Mandatory Training MONITORING COMPLIANCE WITH THIS DOCUMENT REFERENCES AND BIBLIOGRAPHY RELATED TRUST POLICY APPENDIX 1 FRIDGE MONITORING CHART Cold chain policy 2 of 12 Implementation Date: 07/05 /14
3 1. DOCUMENT CONTROL SUMMARY Document Title Document Purpose (executive brief) Cold Chain Policy To support the safe storage and use of all medication which are required to be stored between 2 and 8 degrees Status: - New / Update/ Review Areas affected by the policy Policy originators/authors Consultation and Communication with Stakeholders including public and patient group involvement Review All patients/departments within Northamptonshire Healthcare NHS Foundation Trust Russell ParsonsSenior Pharmacist Community Services Medicines Management CommitteeDistrict nursing teams, Immunisation coordinator, infection control Archiving Arrangements and register of documents Equality Impact Assessment (including Mental Capacity Act 2007) Training Needs Analysis See section 7 The Trust Policy Lead is responsible for the archiving of this policy and will hold archived copies on a central register See MMP001 Control of Medicines Policy Monitoring Compliance and Effectiveness Meets national criteria with regard to NHSLA NICE NSF Mental Health Act CQC Other Further comments to be considered at the time of ratification for this policy (i.e. national policy, commissioning requirements, legislation) If this policy requires Trust Board ratification please provide specific details of requirements See section 8 N/A N/A N/A N/A N/A N/A NPSA/2010/RRR008 Vaccine Cold Storage Trust Policy Board Cold chain policy 3 of 12 Implementation Date: 07/05 /14
4 2. INTRODUCTION This policy applies to all medicines that must be refrigerated between 2-8ºC. The cold chain is the process of maintaining medication at this temperature throughout the supply chain. Temperatures outside this range may reduce potency leading to lack of desired response e.g. reduced immunity. Freezing can cause deterioration of refrigerated medicines and also lead to hairline cracks in the ampoule, vial or pre-filled syringe, which potentially allows the contents to become contaminated. Note - Storage outside of these temperatures during any part of the cold chain renders the product unlicensed 3. PURPOSE To provide assurance to Northamptonshire Healthcare Foundation Trust and its patients that medicines requiring cold storage are transported, stored and administered within the limits set and as such are supplied and administered with optimal benefits. 4. DEFINITIONS NHFT - Northamptonshire Healthcare NHS Foundation Trust LTF- Locality Health Visitor Team Facilitator GP- General Practice 5. DUTIES 5.1. Medicines Management Committee Will approve the policy prior to being ratified by the Policy Board. Is responsible for the implementation and dissemination of this policy 5.2. Ward or unit manager It is the responsibility of the ward/unit manager/health visitor to ensure: a member of staff is designated as responsible for the fridge in that area a member of staff is designated as cover in times of absence the fridge temperatures are checked and recorded daily and that the fridge thermometer is calibrated annually records of fridge temperatures are accessible for easy reference and kept for one year in the event of fridge temperatures falling outside of the temperature range e.g. due to fridge failure/breakdown or when there is any disruption of the cold chain, an incident form is Cold chain policy 4 of 12 Implementation Date: 07/05 /14
5 completed. Within Community Services this should be reported to the appropriate senior nurse and manager Nurse in charge of the shift/ designated person It is the responsibility of the nurse in charge of the shift/ designated person in charge to ensure: all products requiring cold storage, received during the shift, are handled and stored appropriately any issues with storage or the fridge temperature are reported to the ward/unit manager as soon as possible 5.4. Nurses working out of non-nhft sites Where mediciness are stored in a fridge which is not the responsibility of NHFT (e.g. vaccines in a GP practice) it is the responsibility of the administering nurse to ensure: the vaccines have been stored at the appropriate temperature and are fit for purpose. all concerns are reported to GP Practice manager and an incident form completed. 6. POLICY MAIN BODY 6.1. Transport From Acute Trust to NHFT sites All medication requiring cold chain transport will be transported between the acute trusts and NHFT in line with the Cold Chain Policies of the Acute Trusts. Responsibility for the medication becomes the responsibility of NHFT when: o It is accepted for delivery and transported by NHFT staff o It is accepted within ward/clinical areas. Where concerns are identified regarding the suitability of the medication it should not be accepted by staff. Once accepted by NHFT staff vaccines/medication should be taken to the end destination as soon as possible and unpacked and placed in a fridge immediately From departments to satellite clinics/berrywood pharmacy to inpatient wards/units Cold chain policy 5 of 12 Implementation Date: 07/05 /14
6 Only the minimum quantity of vaccine or medication should be transferred between sites Rigid type cool boxes should be used for transportation Cool boxes and packing material should be stored at the lowest temperature possible prior to packing Vaccines/medication should be placed in the cool box as late as possible before departure to minimise exposure time out of the fridge Appropriate cool packs should be used relevant to the type of cool box. Where frozen cool packs are used these must be insulated to prevent direct contact with the drugs Cool packs should be arranged in accordance with the manufacturers instructions or on the top and the bottom of the cool box Space left within the cool box should be loosely filled to minimise air circulation On arrival at clinic contents should be transferred to a refrigerator Management of vaccines in clinics where no refrigerator is available Contents should remain in the closed cool box until required During large vaccination sessions access to the cool box should be minimised to reduce the risk of temperature variation Any unused vaccine should be marked with the date of return and replaced in the base fridge as soon as the clinic session is over. If the appropriate storage procedure has been followed the returned refrigerated medicines may be taken out on one further occasion. Care should be taken to use these returned refrigerated medicines first. If they are not used at the second session, they must be discarded. If there is any doubt concerning the appropriateness of storage temperatures during transit, the vaccine should be discarded at the end of the day Storage The refrigerator must not be used to store food or drink nor for any pathology specimens. Pharmacy grade fridges must be used. Domestic fridges are not designed for the storage of refrigerated medicines and should not be used, as the temperature in different parts of the fridge may vary. The refrigerator should have a lock which must be used. Cold chain policy 6 of 12 Implementation Date: 07/05 /14
7 The refrigerator must not be over filled as this will stop air circulating and may result in hot spots within the refrigerator. Consideration should be given to year-round needs (influenza programmes). Medicines requiring refrigeration must be stored in line with manufacturers recommendations Stock should be rotated to ensure medicines with the shortest expiry dates are used first. Expiry date checks should be done on a monthly basis with medicines approaching expiry clearly labelled. Vials, ampoules or pre-filled syringes must not be taken from their packaging during storage. In addition to possible loss of information on batch number, expiry date etc., this could lead to damage of some medicines by exposure to light. Steps must be taken to ensure the fridge is not switched off accidentally. Plugs should be clearly marked with a Do not switch off label Cleaning the Interior Refrigerators must be cleaned and defrosted monthly and a record kept of this. NB If the refrigerator is a pharmacy grade auto defroster then it will only require to be cleaned monthly Before using for the first time and after defrosting, the interior of your appliance should be cleaned. Switch off and unplug from the mains supply. Remove all the shelves, baskets and door fittings. Wipe the inside with a soft cloth dampened with a solution of a teaspoon of bicarbonate of soda to one litre of warm water. Rinse with clean warm water and dry thoroughly. Avoid water getting into any electrical fittings, switches, lights etc as this may cause serious electrical damage. The magnetic door seal may be cleaned using warm soapy water and then dried thoroughly. Do not use wire wool, scouring powders or disinfectants of any kind Monitoring The fridge must have a maximum/minimum thermometer The temperature of each refrigerator should be recorded every working day. There should be a record for each refrigerator, detailing the following: a) Minimum and maximum temperatures b) Current temperature c) Signature of person who has performed the checks d) Date of cleaning e) Date of defrost (if applicable) Once all information has been recorded the maximum and minimum temperatures should be reset. THIS SHOULD OCCUR EVERY WORKING DAY. Cold chain policy 7 of 12 Implementation Date: 07/05 /14
8 See appendix 1 for example Temperatures outside the range 2-8ºC must prompt a check on the operating conditions of the fridge. If there is reason to believe that the temperature has been outside 2-8ºC range see below DISRUPTION OF THE COLD CHAIN (i.e. temperatures outside 2-8ºC) Do not use any vaccine that has been outside of the temperature range of 2 0 C to 8 0 C until suitability to use has been confirmed If the fridge failure is discovered out of hours move medications to a working fridge but ensure they are marked up Do not use stored outside of temperature range In the event of fridge failure the designated person/nurse in charge of shift must make a thorough assessment as follows: The plug should be checked to see if it is connected to the socket and whether the failure is a short-term electricity failure. Check the temperature of the refrigerator for vaccine viability. Take appropriate action to ensure a repair engineer is organised Where temperatures are out of range and the applicance has not been unplugged The temperature of refrigerator should be checked to establish how long the refrigerated medicines have been outside the correct temperature range. Make a list of all the refrigerated medicines affected including the manufacturer. (This may also be useful for subsequent insurance claims). Contact the pharmacy/local medicines information service immediately to check if the medicine can still be used. The following information will be required: How long the refrigerator has been switched off or has been malfunctioning if known. The actual, minimum and maximum temperature readings recorded on the thermometer. When the correct temperatures were last recorded. What the refrigerated medicines are. Complete and incident for in line with CRM002 policy for the Management of Incidents. A copy of the Fridge Temperature Monitoring form should be attached. For vaccines complete an on line wasted vaccines ImmForm Incident form (see Reorder refrigerated medicines according to need. If medicines are still viable for use, remove to another working refrigerator or suitable container Cold chain policy 8 of 12 Implementation Date: 07/05 /14
9 Once the vaccine refrigerator is working again and the correct temperature maintained replace the medicines into the refrigerator. Any stock destroyed should be replaced with new stock. All failures should be recorded, and the reasons for failure, in the record book. An incident form should also be completed Disposal When recommended by the manufacturer or pharmacy, either due to expiry or failure of cold chain, medicines must be disposed of in line with waste disposal policy: Sharps bins should be returned to the base clinic after each session unless they can be stored in a suitable locked cupboard with a key held by approved personnel. 7. TRAINING 7.1. Mandatory Training There is no mandatory training associated with this policy Specific Training not covered by Mandatory Training Ad hoc training sessions based on an individual s training needs as defined within their annual appraisal or job description. o Staff working to PGDs for immunisation and vaccinations will undertake training, including cold chain training in line with requirements of the PGD o Designated people responsible for fridge maintenance will undergo Cold Chain training o Cold Chain is also covered within Medicines Management Training 8. MONITORING COMPLIANCE WITH THIS DOCUMENT The table below outlines the Trusts monitoring arrangements for this document. The Trust reserves the right to commission additional work or change the monitoring arrangements to meet organisational needs. Aspect of compliance or effectiveness being monitored Method of monitoring Individual responsible for the monitoring Monitoring frequency Group or committee who receive the findings Group or committee or individual responsible for Cold chain policy 9 of 12 Implementation Date: 07/05 /14
10 or report completing any actions Temperature Monitoring Incident forms audit Chief Pharmacist Annually Medicines Safety Group Medicines Management Committee Spot checks on monitoring forms on wards/units 9. REFERENCES AND BIBLIOGRAPHY NPSA 2010 RR008 Vaccine Cold Storage DH Immunisation against Infectious Disease (The Green Book) Chapter updated version. Accessed on line February Accessed on line February 2014 UK Guidance on Best Practice in Vaccine Administration RELATED TRUST POLICY MMP-001 Control of Medicines Policy CRM-002- Policy for the Management of Incidents Cold chain policy 10 of 12 Implementation Date: 07/05 /14
11 APPENDIX 1 FRIDGE MONITORING CHART The temperature of the fridge should be monitored on a daily basis Once temperatures have been recorded reset the maximum and minimum temperature. All temperatures outside of the range of 2 o C to 8 o C should be reported immediately to line manager or pharmacist. Do not use any stock stored outside of this range until authorised to do so. Month..20. Date cleaned.. Date Time Current Temperature o C Max o C Min o C Checked by Thermometer reset ( ) Action taken if discrepancy Cold chain policy 11 of 12 Implementation Date: 07/05 /14
12 Policy for the Production and Management of all Policies Within NHFT 12 of 12 Implementation Date: / /
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