MMP014 COLD CHAIN POLICY

Transcription

1 MMP014 COLD CHAIN POLICY MMP014 Cold Chain Policy (Mar17 - Mar20) Page 1 of 11

2 Table of Contents MMP014 COLD CHAIN POLICY... 1 MMP014 COLD CHAIN POLICY... 3 Why we need this Policy... 3 What the Policy is trying to do... 3 Which stakeholders have been involved in the creation of this Policy... 3 Any required definitions/explanations... 3 Key duties... 3 Management Committee... 3 Ward or unit manager... 3 Nurse in charge of the shift/ designated person... 4 Staff nominated to receive TSCAN electronic notifications... 4 Nurses working out of non-nhft sites... 4 Policy detail... 4 Transport... 4 Management of vaccines in clinics where no refrigerator is available... 5 Storage... 5 Cleaning the Interior... 6 Monitoring of fridge temperatures where TSCAN not approved for use... 6 Monitoring of fridge temperatures where TSCAN is approved for use... 7 DISRUPTION OF THE COLD CHAIN (i.e. temperatures outside 2-8ºC)... 7 Disposal... 8 Training requirements associated with this Policy... 8 Mandatory Training... 8 Specific Training not covered by Mandatory Training... 8 How this Policy will be monitored for compliance and effectiveness... 8 Equality considerations... 9 Havard Reference Guide... 9 Document control details Appendix 1 - Fridge Monitoring Chart MMP014 Cold Chain Policy (Mar17 - Mar20) Page 2 of 11

3 MMP014 COLD CHAIN POLICY Why we need this Policy To support the safe storage and use of all medication which are required to be stored between 2 and 8 degrees. 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 What the Policy is trying to do To provide assurance to Northamptonshire Healthcare NHS Foundation Trust and its patients that medicines requiring cold storage are transported, stored and administered within the limits set by Summary of Product Characteristics for each product Which stakeholders have been involved in the creation of this Policy Management Committee, District nursing teams, Immunisation coordinator, infection control Any required definitions/explanations NHFT - Northamptonshire Healthcare NHS Foundation Trust GP- General Practice TSCAN: is a web based temperature monitoring system installed to assist with the monitoring of medicine fridge temperatures. Key duties Management Committee Will approve the policy prior to being ratified by the Policy Board. Is responsible for the implementation and dissemination of this policy 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 MMP014 Cold Chain Policy (Mar17 - Mar20) Page 3 of 11

4 a member of staff is designated as cover in times of absence that the fridge thermometer is calibrated annually the fridge temperatures are checked and recorded daily (where TSCAN is not approved for use) records of fridge temperatures are accessible for easy reference and kept for one year(where TSCAN is not approved for use) Where TSCAN is approved for use ensure that there is a robust mechanism to receive and act on notification in a timely manner 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 completed and this is escalated to the appropriate senior 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 Staff nominated to receive TSCAN electronic notifications It is the responsibility of all staff nominated to receive TSCAN electronic notifications to check their account during a shift ( at least daily) investigate and act on any notifications in a timely manner Nurses working out of non-nhft sites Where medicines 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. Policy detail Transport From suppliers to NHFT sites All medication requiring cold chain transport will be transported between the medicines supplier and NHFT in line with the Cold Chain Policies of that supplier. Responsibility for the medication passes to NHFT when: o It is accepted for delivery and transported by NHFT staff o It is accepted within ward/clinical areas. MMP014 Cold Chain Policy (Mar17 - Mar20) Page 4 of 11

5 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 Only the minimum quantity of vaccine or medication should be transferred between sites Cool boxes approved for vaccines should be used for transportation, e.g helipet or vaccine porter. 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 helipet or vaccine porter until required. Temperature must be monitored using a maximum / minimum thermometer inside the helipet/vaccine porter. During large vaccination sessions access to the cool box should be minimised to reduce the risk of temperature variation and ideally this should not be opened more frequently than every 15 minutes. The temperature must be read at each opening and the thermometer reset. Temperatures recorded during the session should be recorded using the proforma in appendix 1. 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. Any vaccine that has been stored outside the range of 2-8 for more than 15 minutes must be discarded unless there is clear recommendations from the manufacturer that it remains safe to use. 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. MMP014 Cold Chain Policy (Mar17 - Mar20) Page 5 of 11

6 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). 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 weekly 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. Where TSCAN monitoring is approved for use the temperature monitoring probe must be fitted according to manufacturer s specifications. Where data loggers are used these must be used according to PHE recommendations. 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 of fridge temperatures where TSCAN not approved for use 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. 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. MMP014 Cold Chain Policy (Mar17 - Mar20) Page 6 of 11

7 Monitoring of fridge temperatures where TSCAN is approved for use The fridge must have a maximum/minimum thermometer The TSCAN system will monitor fridge temperature constantly and will send an to nominated individuals if the temperature is outside the range of 2-8 ºC for 15 minutes Upon receiving a notification from TSCAN a manual check of fridge temperature must be performed using the fitted thermometer. 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. MMC will request information from the responsible manager after each notification that the temperature is outside of the range 2-8 ºC as to the actions taken on receipt of the notification and outcomes. To provide additional assurance teams will be requested by MMC to perform manual checks of fridge temperatures for one week every 6 months and submit these for comparison against the TSCAN record DISRUPTION OF THE COLD CHAIN (i.e. temperatures outside 2-8ºC) Do not use any medicine 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. Take appropriate action to ensure a repair engineer is organised. Where temperatures are out of range and the appliance has not been unplugged The monitoring log or TSCAN record should be checked to establish how long the refrigerated medicines have been outside the correct temperature range. For areas where a manual system is in use it should be assumed that the temperature has been out of range since the last check. Make a list of all the refrigerated medicines affected including the manufacturer. (This may also be useful for subsequent insurance claims). Contact the immunisation team or pharmacy 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 or printer TSCAN record should be attached. MMP014 Cold Chain Policy (Mar17 - Mar20) Page 7 of 11

8 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 Once the medicines 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. 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. Training requirements associated with this Policy 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. Staff working to PGDs for immunisation and vaccinations will undertake training, including cold chain training in line with requirements of the PGD Designated people responsible for fridge maintenance will undergo Cold Chain training Cold Chain is also covered within Management Training How this Policy will be monitored for compliance and effectiveness 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 Temperature Monitoring: TSCAN areas Method of monitoring Annual report Collating information received from managers on actions taken following TSCAN Individual responsible for the monitoring Safety Pharmacist Monitoring frequency Annually Group or committee who receive the findings or report Safety Group Group or committee or individual responsible for completing any actions Management Committee MMP014 Cold Chain Policy (Mar17 - Mar20) Page 8 of 11

9 Aspect of compliance or effectiveness being monitored Method of monitoring notifications Individual responsible for the monitoring Monitoring frequency Group or committee who receive the findings or report Group or committee or individual responsible for completing any actions Temperature monitoring where TSCAN is not approved for use Quarterly submission of monitoring records to safety pharmacist safety pharmacist Annually Safety Group Management Committee Equality considerations See MMP001 Control of medicines Policy. Havard Reference Guide 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 2002 MMP014 Cold Chain Policy (Mar17 - Mar20) Page 9 of 11

10 Document control details Author: Senior Pharmacist Community Services Approved by and date: Trust Policy Board, 4 th October 2016 Any other linked Policies: MMP001 Control of Policy number: MMP014 Version control: Version Version No. Date Ratified/ Amended Date of Implementation Next Review Date Review Reason for Change (eg. full rewrite, amendment to reflect new legislation, updated flowchart, minor amendments, etc.) Review with amendments to clarify process MMP014 Cold Chain Policy (Mar17 - Mar20) Page 10 of 11

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 and 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 ( ) MMP014 Cold Chain Policy (Mar17 - Mar20) Page 11 of 11