VACCINE STORAGE AND ADMINISTRATION PROCEDURES

Transcription

1 VACCINE STORAGE AND ADMINISTRATION PROCEDURES Document Summary To ensure vaccines are stored and administered appropriately DOCUMENT NUMBER POL/001/013/006 DATE RATIFIED January 2017 DATE IMPLEMENTED January 2017 DATE AMENDED August 2018 NEXT REVIEW DATE February 2019 ACCOUNTABLE DIRECTOR POLICY AUTHOR Director of Quality and Nursing Chief Pharmacist and Immunisation co-ordinator Important Note: The Intranet version of this document is the only version that is maintained. Any printed copies should therefore be viewed as uncontrolled and, as such, may not necessarily contain the latest updates and amendments.

2 TABLE OF CONTENTS 1 Scope Introduction Statement of Intent Definitions Duties Vaccine Storage, Stock Control and Cold Chain Procedures ORDERING, CHECKING AND STORAGE OF VACCINES VACCINE REFRIGERATOR AND STORAGE ACTION TO BE TAKEN IN THE EVENT OF A FAILURE OF THE COLD CHAIN (I.E. OUTSIDE +2 TO +8 C) STOCK CONTROL MOVEMENT OF VACCINE WITHIN THE CLINIC OR PRACTICE MOVEMENT OF VACCINES TO ALTERNATIVE SITES (I.E. SCHOOLS) TRANSPORTATION OF VACCINES TO PATIENT S HOUSES PROCEDURE AT IMMUNISATION SESSIONS PREPARATION PRACTICAL ADMINISTRATION OF VACCINE IMMUNISATION IN PATIENTS HOME (ACTIONS SPECIFIC TO HOME VACCINATIONS) DISPOSAL OF NEEDLES, SYRINGES AND OTHER WASTE PRODUCTS REASONS FOR REFERRAL OF CHILDREN TO HOSPITAL FOR IMMUNISATION REFUSAL OF VACCINATION DEFECT REPORTING AND RECALL OF DEFECTIVE PRODUCTS Training INITIAL TRAINING UPDATE TRAINING Monitoring Compliance with this Document References/ Bibliography Related Trust Policy/Procedures Appendix 1 - Childhood Immunisation Refusal pathway Appendix 2 - Refrigerator Temperature Monitoring Chart Appendix 3 - RECORD OF VACCINE RECEIPT Appendix 4 - VACCINE STORAGE GUIDANCE To be displayed on the fridge Appendix 5 - HPA guidance - Individuals with incomplete vaccination history Vaccine Storage and Administration Procedures Page 2 of 18 POL/001/013/006

3 1 SCOPE This policy applies to all employees of the Trust including bank staff and agency staff working in the Trust; it also covers employees not working on Trust premises. The policy also applies to members of staff who are not directly employed by the Trust but who act in a professional capacity within the Trust through a service level agreement. All NHS contractors registered with the Trust should also be compliant with this policy. It is written to be consistent with the North Cumbria University Hospitals Trust (NCUHT) and University Hospitals of Morecambe Bay Trust (UHMBT) medicines policies, to avoid any potential difficulties for staff who work across organisational boundaries. Any significant differences or discrepancies between the acute and Trust policies should be pointed out to the authors. 2 INTRODUCTION These procedures are for use as a practical guide for all those involved in the vaccination and immunisation process within the Cumbria locality. They outline a set of minimum standards that should be adhered to and should be read in conjunction with the following documents: The Green Book, which can be accessed via the following link: Paper copies should no longer be in use and should be destroyed. National Patient Safety Agency NPSA/2010/RRR008 Vaccine Cold Storage Public Health England Protocol for ordering and storing and handling vaccines, For other relevant references see section 9 3 STATEMENT OF INTENT These procedures are supplementary to the Trust Medicines Policy POL001/013 and should be read in conjunction with that policy These procedures provide additional guidance to ensure vaccines are managed and handled in accordance with guidance. Vaccine Storage Procedures Page 3 of 18 Ref: POL/001/013/006

4 4 DEFINITIONS Patient Group Direction (PGD) HPU A written direction relating to supply and Administration, or administration only of a prescription-only medicine to persons generally (subject to specified exclusions) and is signed by a doctor or a dentist, and by a pharmacist. Refer to PGD guidance Health Protection Unit. 5 DUTIES As Medicines Policy POL 001/013 and: Team Leader or Manager: Ensure a named person and deputy has responsibility for the storage of vaccines at the team base/practice. Ensure the named person and deputy understands their responsibilities for the correct ordering receipt, storage, temperature monitoring and disposal of vaccines according to these procedures. Ensure the named person & deputy is familiar with these procedures and knows who to contact in the event of a failure of the cold chain, or any other problems with the vaccine handling procedures. Ensure breaches of cold chain are reported on Trust incident reporting system. Named Person and Deputy: Ensure vaccines are stored & handled according to these procedures whilst in the team base/practice. Report breaches of cold chain on Trust incident reporting system. Additional duties relating to immunisation delivery in schools are identified in internal Trust SOPs 6 VACCINE STORAGE, STOCK CONTROL AND COLD CHAIN PROCEDURES. 6.1 Ordering, checking and storage of vaccines (See internal SOP on staffweb/sharepoint/shared drive for further details) Each practice, School nurse base, clinic or pharmacy, with a vaccine fridge, should have one trained individual with at least one deputy responsible for the ordering, receipt and storage of vaccines and recording refrigerator temperatures. Nursing staff within school health have responsibility for ensuring correct vaccine is ordered and delivered and that vaccine stock is rotated. All vaccines should be logged in and out of fridges Vaccines must be checked against the written order before signing for them and all vaccine details must be recorded at this time (See Appendix 3: Vaccine Storage Procedures Page 4 of 18 Ref: POL/001/013/006

5 Record of Vaccine Receipt). 6.2 Vaccine refrigerator and storage Vaccines must be stored in a specialised vaccine or pharmaceutical quality refrigerator immediately on receipt according to the manufacturers recommended temperature range of between +2C and +8C. Only vaccines and vaccine diluents, and other pharmaceutical products may be stored there. Precautions must be taken against accidental interruption of the electricity supply. The vaccine refrigerator should be wired directly into the mains, or have a warning notice on the plug stating Vaccine/medicines fridge - do not switch off. Refrigerators should be monitored daily, [working days for school health bases] with a digital minimum/maximum thermometer, to ensure temperature remains between +2C and +8C, defrosted according to manufactures directions, and kept clean and locked All large fridges containing vaccine should also have a data logger in place at all times to give back up more detailed information in the event of a problem The current temperature, minimum and maximum temperatures will be recorded daily, ideally at the same time, and recorded on the fridge chart. The data loggers will be checked to ensure no Alarm messages are visible The thermometer should be re-set after each recoding. The thermometer should be re-calibrated annually. Vaccines must not be frozen and must not be used if they have been frozen Staff should visually check the temperature is correct each time they remove vaccine. Vaccines should be stored in their original packaging. They should not be stored in the door, the bottom drawer or against the freezer plate of the refrigerator (pharmaceutical fridges do not normally have a freezer section). Sufficient space should be allowed in the refrigerator so that air can circulate freely. All vaccines are prescription only medicines (POM s) and the refrigerator will be locked at all times. Records must be kept of monthly cleaning, defrosting and servicing of the refrigerator, according to the manufacturers guidance. Vaccines may be stored in alternative refrigerator or an approved cool box when defrosting the refrigerator. Vaccine spillage and disposal should be managed according to the Trust Waste disposal policy. The name of the person responsible for monitoring and storage of vaccines and who to contact in an emergency should be clearly displayed on the refrigerator door (See Appendix 2 - Refrigerator Temperature Monitoring Chart) (See Appendix 4 - Vaccine Storage guidance - to be displayed on the fridge) Vaccine Storage Procedures Page 5 of 18 Ref: POL/001/013/006

6 6.3 Action to be taken in the event of a failure of the cold chain (i.e. outside +2 to +8 C). DO NOT USE any vaccine that has been kept outside the cold chain, unless you have received advice from pharmacy that the vaccines are safe to be used. Extra precautions may be needed in this case as vaccine may no longer be licensed [see below] Vaccines should be returned to the correct storage as quickly as possible to increase the chances of being able to continue to use them. They should be clearly marked as not for use until advice is received. DO NOT DISCARD VACCINE WITHOUT ADVICE Telephone the Immunisation Coordinator, local Pharmacy or NHS England for information [contact details on temp monitoring chart], or the manufacturer for advice, giving the following information: How long the refrigerator has been switched off/malfunctioning What are the actual maximum and minimum readings recorded on the thermometer plus data from data logger. Name and type of vaccines are affected and their expiry dates When the next immunisation session is If advice is that any vaccines may still be used, mark them clearly and ensure these are used first. Vaccines may still be considered to be effective by manufactures but since most are licensed only for storage at 2-8 it is likely the use of the Vaccine will have become Off-label. Staff using them will not be able to use Patient Group Directions, but will need individual prescriptions and patients will need to be informed so consent can be obtained. Leaflet on link below should be given to parents: /file/384575/9037_off_label_dl_factsheet_coldchain_12.final.pdf Incident report to be completed, for CPFT in the normal way and a copy sent to NHS England via immunisation coordinator Inform IMMForm re vaccine wastage and reorder as needed Stock Control Care must be taken in ordering vaccines especially if they are packaged in multiple quantities. Surgeries /Bases should only order enough vaccine for 2-4 weeks of vaccine clinics Vaccines should be placed in the refrigerator with the shortest expiry dates at the front. If possible children s vaccine should be stored separated from adult vaccines Any out of date stock should be destroyed immediately. Vaccines must never be used past their expiry date. Vaccine Storage Procedures Page 6 of 18 Ref: POL/001/013/006

7 6.5 Movement of vaccine within the clinic or practice The required number of doses of vaccine should be removed from the refrigerator immediately prior to the vaccination session. Alternatively at busy sessions a small fridge or a monitored cool box could be used to prevent frequent opening of the main refrigerator. 6.6 Movement of vaccines to alternative sites (i.e. schools) Validated cool boxes (with maximum-minimum thermometers or data loggers) and ice packs or cool packs from a recognised medical supply company should be used. Vaccines in these boxes should remain in their original packing and be wrapped in bubble wrap or similar insulation material to prevent movement during transportation. Frozen ice packs are not usually used but if they are it is important to ensure vaccines are insulated from them due to the risk of vaccines freezing. The cold box should be opened as infrequently as possible to maintain the temperature. Vaccines should be removed from the box in batches to last about half an hour. Any vaccine left at the end of the session should be marked for use first at the next clinic session and returned to the fridge. 6.7 Transportation of Vaccines to Patient s Houses A cool box or bag must be used and visits should be planned to allow for the vaccine to be out of the fridge for as short a time as possible. Any vaccines not used should be marked for use first on next visit. 6.8 Procedure at Immunisation Sessions See SOPs for detailed information on session planning and vaccine delivery for primary and secondary schools, staff vaccinations and mass vaccinations Unless the immuniser is an extended prescriber who can prescribe vaccinations, they must have copies of their signed patient group direction, or a written authorisation by a doctor for the named individuals prior to administering any vaccine. Check and identify the vaccine is due according to the Department of Health schedule in Immunisation against Infectious Diseases (Green Book) current edition. For individuals with incomplete vaccination history, Review past vaccine history: See internal trust SOP Vaccine Storage Procedures Page 7 of 18 Ref: POL/001/013/006

8 6.9 Preparation See internal trust SOP for more information re Schools The vaccination clinic should be held in a safe and suitable environment that is free from distractions. Ideally another responsible adult should also be available to summon help if necessary, (in the patient s home this may be a relative). A working telephone must be easily accessible, as a minimum standard a nurse working on their own must have a mobile phone with a signal before immunising a patient at home if a relative is not available. The nurse should ensure that all necessary equipment is available See internal trust SOP for specific requirements depending on vaccine setting The nurse should ensure that the vaccination clinic is held in a safe and suitable environment and appointment is long enough to: Assess patient s suitability for immunisation advise on possible side effects Answer patient queries Check that there are no contra-indications or allergies Ensure that the patient or parent understands all aspects of vaccination and written information is given where required Obtain informed consent (refer to consent policy) Consult the patient s records Prepare the vaccination Administer the vaccine Complete all documentation Check for any adverse effects post administration 6.10 Practical Administration of Vaccine Wash hands or use alcohol rub Adhere to bare below the elbows policy Each vaccine should only be reconstituted and drawn up when required. At large immunisation sessions when prefilled syringes are used individual health professionals are each responsible for preparing own syringes. Where necessary draw up vaccine using a green needle. Change needle prior to giving For administration a 25mm [blue] needle is preferable and is suitable for all ages, only preterm or very small infants should have a 16mm [orange] needle. A 25mm [orange] needle is also acceptable for babies but it must be 25mm in length In large adults a longer size needle may be required [green]. Individual assessment should be made. Check the vaccine to ensure that the right product and correct dose is used. Check expiry date. Do not use vaccine after expiry date. Before use the colour and composition of the vaccine must be examined to ensure that it conforms to the description as stated in its Summary of Product Characteristics [SPC]. Check SPC to see if the vaccine needs to be shaken before use or given at room temperature. Freeze-dried vaccines must be reconstituted with the correct volume of Vaccine Storage Procedures Page 8 of 18 Ref: POL/001/013/006

9 diluent. Unless supplied in a pre-filled syringe, the diluent should be drawn up using an appropriately sized syringe and 21g [green] needle and added slowly to the vaccine to avoid frothing. Any reconstituted vaccine that is not used must be destroyed by placing in appropriate yellow sharps box at the end of the immunisation session Position the patient safely. Do not immunise a patient in the standing position. Babies and children must be held securely by parents. Babies aged less than one year of age use anterolateral aspect of the thigh For older children and adults use the deltoid muscle (choice of vaccine site for children just over one year of age). When giving two or more vaccinations at the same time, use different limbs for two injections. If more than one injection is to be given in the same limb, they should be administered at least 2.5 cm apart and note which site was used for which vaccine in the patients notes. Documentation appropriate to the circumstances must be completed, including batch number, expiry date, vaccine type, patient s name or parent/carer, who administered and date of administration. The patient or parent/carer should be given information about the vaccine they have received. The nurse administering the vaccinations is responsible for ensuring the documentation is correctly completed The patient should be assessed to be feeling well before they leave Immunisation in Patients Home (Actions Specific to Home Vaccinations) Prior to vaccination the nurse must ensure they are able to call for help if necessary. This could be by using a relative, but a working phone with a signal must be available. Ensure GP records are double checked to establish that vaccination is required. Administer vaccination prior to any other nursing care required, to allow time for patient to fully recover before leaving. Observe patient for at least 5 minutes after vaccination and ensure they are able to call for assistance if they were to feel unwell. Record vaccination in patient notes Ensure GP practice are informed of vaccination and computer records updated 6.12 Disposal of Needles, Syringes and other Waste Products If spillage occurs, gloves should be worn and the spillage soaked up with paper towels. The area should be cleaned with alcohol wipe followed by detergent/hot water. Gloves, towels etc should go in clinical waste for incineration. Vaccine Storage Procedures Page 9 of 18 Ref: POL/001/013/006

10 To ensure safe practice as there is a risk of blood-borne viruses via bodily fluids, the nurse should be aware of the Waste disposal policy for Safe Disposal of Sharps and Infection Control guidelines. Spillage on skin should be washed thoroughly with soap and water Affected eyes should be washed with sterile 0.9% sodium chloride solution if available or water and medical advice sought. Vaccines should only be disposed of by incineration At the end of each vaccine session any opened multi - dose vials and any prepared unused vaccines must be disposed of by placing in blue lidded sharps bin for incineration Any other contaminated waste must be disposed of by incineration via an approved waste disposal container 6.13 Reasons for Referral of Children to Hospital for Immunisation The following referrals should be made from the GP to the Consultant Paediatrician for children s Out Patients: Previous severe adverse reaction Neonatal BCG: For at risk infants referrals can be made by nursing staff to the TB liaison nurses. Babies who remain in hospital for a long period of time may require immunisation while in Neonatal Unit or on Children s Ward 6.14 Refusal of Vaccination Follow flow chart in Appendix 1. Ensure parent/guardian/carer signs form Defect Reporting and Recall of Defective Products Refer to Medicines Management Policy Adverse Reaction and Critical Incident Reporting 7 TRAINING Adverse Event reporting: Should an adverse or suspected adverse reaction occur a yellow card should be completed. Incident Reporting: Should a critical incident occur this should be reported via the Trusts adverse incident reporting route and copying information to the immunisation coordinator. Full details of training requirements can be found in the Trust Training Needs Analysis. All staff who immunise or advises on immunisation should receive specific training in immunisation and should attend regular updates. Those new to immunisation Vaccine Storage Procedures Page 10 of 18 Ref: POL/001/013/006

11 should attend a formal taught course at the earliest opportunity and be supervised by an experienced immuniser until they have achieved the competencies as set out in the HPA National Minimum standard for vaccine training 171/National_Immun_Train_Stand1.pdf 7.1 Initial training See SOP for detail of training requirement for specific staff. New immunisers must attend a Two day Introduction to Immunisation training. New immunisers [district nurses/ practice nurses] who will not be giving vaccines as part of the childhood vaccination programme can either attend a shortened two day course or a specific one day introduction to immunisation. 7.2 Update Training All staff who administer vaccinations must update practical BLS and anaphylaxis annually. No staff may use PGD unless this requirement is completed. All staff who give vaccinations or advice about vaccinations must update annually. See SOP 8 MONITORING COMPLIANCE WITH THIS DOCUMENT The table below outlines the Trusts monitoring arrangements for this policy/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 Vaccines Incidents Monitoring method Record of incident reports Individual responsible for the monitoring Chief Pharmacist Frequency of the monitoring activity Annual Group/ committee which will receive the findings/ monitoring report Medicines Management Committee Group/ committee/ individual responsible for ensuring that the actions are completed Medicines Management Committee Cold chain incidents Record of incident reports Chief Pharmacist Annual Medicines Management Committee Medicines Management Committee Vaccine incidents and lessons learned will be shared with the Immunisation Coordinator Vaccine Storage Procedures Page 11 of 18 Ref: POL/001/013/006

12 9 REFERENCES/ BIBLIOGRAPHY The Green Book, which can be accessed via the following link (Paper copies no longer updated so should be destroyed. accessed 14/10/15 Protocol for ordering storing and handling vaccines, accessed 14/10/15 National Patient Safety Agency NPSA/2010/RRR008 vaccine cold storage and supporting information National Minimum Standards for Immunisation Training [Health Protection agency June 2005] 14/10/ /National_Immun_Train_Stand1.pdf Core Curriculum for Immunisation Training [Health Protection Agency June 2005], accessed 12/10/ /Core_curriculum_for_immunisation_training.pdf National minimum standards and core curriculum for immunisation training Health Care Support staff. PHE Revised September Accessed 14/10/15 Supporting the delivery of vaccination training RCN August Accessed 14/10/15 data/assets/pdf_file/0010/641917/rcnguidance_immuni sation_2015-update_web.pdf National minimum standards and core curriculum for immunisation training of healthcare support workers (Health Protection agency May 2012), accessed 14/10/ RELATED TRUST POLICY/PROCEDURES Medicines Policy Consent Policy Infection Control Guidelines & policies Waste Disposal Policy Relevant Patient Group Directions including treatment of anaphylaxis Policy for prevention and management of occupational exposure to Blood born Virus Standard operating procedure for anaphylactic shock packs (in draft currently Oct 2012) Vaccine Storage Procedures Page 12 of 18 Ref: POL/001/013/006

13 APPENDIX 1 CHILDHOOD IMMUNISATION REFUSAL PATHWAY Patient or Parent refuses Immunisation Child unwell defer immunisation or refer to GP Health care professional explores reason with Parent/Carer Refusal for all vaccinations Suspected or confirmed anaphylactic reaction to previous vaccine Lack of information about vaccinations Give further information seek specialist advice from HPU/Vacc & Imm Coordinator Refusal for specific immunisation due to concern re specific component of vaccine Provide information regarding vaccine HCW to give advice re this course of action and documentation Refusal remains Refer to GP Consultant Paediatrician Parent/Carer accepts advice, wants child immunised If still refusing discuss further with HPU, Vacc & Imm Coordinator and the Parent/Carer Parent/Carer asked to sign form stating reasons why refusing and for which immunisation Consent If unresolved Form copied to Child Health Record Immunisation in child notes inform child health so central record maintained Reassess at each child health surveillance contact Childs name removed from Immunisation Schedule for Immunisation refused Vaccine Storage Procedures Page 13 of 22 Ref: POL/001/013/006

14 APPENDIX 2 - REFRIGERATOR TEMPERATURE MONITORING CHART Refrigerator Temperature Monitoring Chart Team Location Responsible Person Fridge Number Month & Year Deputy/Monitor Temp o C Too warmtake action Strive for 5! Too coldtake action Current TEMPERATURE- Plot Max & Min on chart AND record current/ max / min below Date Max Min Room Delivery/Load Reset Initials (monitor) Countersigned(RN) Vaccine Storage Procedures Page 14 of 22 POL/001/013/006

15 Fridge Management- Practical Guidance to Best Practice 1. Each CPFT vaccine fridge has a burgundy number on the front do not remove, alter or swap this number. 2. On the front of each fridge you should have your current vaccine log and temperature monitoring chart. 3. In the immediate vicinity of each bank of fridges you should have your fridge management poster with up to date contact numbers. 4. Each fridge has a data logger identified with a corresponding number- do not swap these between fridges without speaking to the Immunisation Co-ordinator FIRST. 5. Each fridge should have a min of 2 calibrated thermometers (calibration certificates should be retained in the fridge file with a scanned copy saved electronically). One of these thermometers is for vaccine transport monitoring purposes; the other should remain in the fridge as a back up in case of failure of the inbuilt thermometer. 6. On top of each fridge should be a fridge file this should have any relevant calibration certificates, previous months temperature logs, previous vaccine logs (plus blank copies of each) and a colour printed Quarantine Notice 7. The room temperature should be monitored- this does not need a calibrated thermometer so expired thermometers will be adequate for this (please ensure they are labelled room only so they are not confused with your calibrated thermometers). 8. For every fridge there should be a nominated fridge manager and a fridge monitor this will be the (suitably trained) person responsible for checking the fridge. 9. A registered nurse is required to countersign any fridge monitoring recorded by admin staff at the earliest opportunity before removing any vaccines for use. 10. For the new fridges which have load temperature monitoring as well as air temperature monitoring, record the LOAD temperature but reset both readings each day. 11. Vaccines must be stored according to policy- no outer cartons/boxes or other packaging material; no vaccines to be touching the sides or back of the fridge; no overloading; no vaccines in the bottom basket (it is ok to keep the cool packs there). 12. Check where your probes are- they should be sited around the middle of the fridge, suspended from a rack (or secured to the top inner aspect of the fridge). If they touch the sides/back of the fridge they can [incorrectly] give a reading that suggests that the fridge has frozen which can lead to unnecessary vaccine wastage. 13. Note on the temperature chart any activity which may lead to blips in the monitoring (door open for vaccine delivery/ packing for session etc.) even if you have re-set the thermometer at the time (the data logger will still show the temp excursion when downloaded & checked). 14. Highlight any issues early- Fridges which regularly record in the outer range of safe (i.e. often min 3 or max 7 o C) need reviewing asapthis should be seen as an early warning sign that all is not well. Unreliable fridges must not be tolerated. Vaccine Storage Procedures Page 15 of 22 POL/001/013/006

16 Remember to strive for 5 Contact details CPFT Immunisation Coordinator / NHS England Screening & Immunisation Teams Cumbria & North East Lancashire & South Cumbria In case of temperature excursion 1. Review temp chart- deliveries/ loading? 2.Quarantine vaccines- clearly marked do not use but maintain at fridge temp 3.Contact Specialist Nurse for Immunisation for advice 4.Complete incident report 5. Plan ahead- look at planned work- do you need to re-order additional vaccine via ImmForm? 6. If vaccine is wasted ensure reporting via ImmForm is completed. Vaccine Storage Procedures Page 16 of 22 POL/001/013/006

17 APPENDIX 3 - RECORD OF VACCINE RECEIPT Record of Vaccine Receipt ( vaccine log ) To be kept on fridge door whist in use/ current Team Location Fridge Number Fridge Manager Use a separate log sheet for each type of vaccine Vaccine received Date Vaccine/ batch number/ expiry Number received (check against order) Signature Date Clinic/ School/ patient Number used Stock level remaining in fridge Signature To be kept on fridge door whilst current Retain this record in the team base/ practice for 5 years If vaccines are close to expiry date contact your line manager or vaccinationandimmunisation@cumbria.nhs.uk for advice Vaccine Storage Procedures Page 17 of 22 POL/001/013/006

18 Fridge Management- Practical Guidance to Best Practice 1. Each CPFT vaccine fridge has a burgundy number on the front do not remove, alter or swap this number. 2. On the front of each fridge you should have your current vaccine log and temperature monitoring chart. 3. In the immediate vicinity of each bank of fridges you should have your fridge management poster with up to date contact numbers. 4. Each fridge has a data logger identified with a corresponding number- do not swap these between fridges without speaking to the Immunisation Coordinator FIRST. 5. Each fridge should have a min of 2 calibrated thermometers (calibration certificates should be retained in the fridge file with a scanned copy saved electronically). One of these thermometers is for vaccine transport monitoring purposes; the other should remain in the fridge as a back up in case of failure of the inbuilt thermometer. 6. On top of each fridge should be a fridge file this should have any relevant calibration certificates, previous months temperature logs, previous vaccine logs (plus blank copies of each) and a colour printed Quarantine Notice 7. The room temperature should be monitored- this does not need a calibrated thermometer so expired thermometers will be adequate for this (please ensure they are labelled room only so they are not confused with your calibrated thermometers). 8. For every fridge there should be a nominated fridge manager and a fridge monitor this will be the (suitably trained) person responsible for checking the fridge. 9. A registered nurse is required to countersign any fridge monitoring recorded by admin staff at the earliest opportunity before removing any vaccines for use. 10. For the new fridges which have load temperature monitoring as well as air temperature monitoring, record the LOAD temperature but reset both readings each day. 11. Vaccines must be stored according to policy- no outer cartons/boxes or other packaging material; no vaccines to be touching the sides or back of the fridge; no overloading; no vaccines in the bottom basket (it is ok to keep the cool packs there). 12. Check where your probes are- they should be sited around the middle of the fridge, suspended from a rack (or secured to the top inner aspect of the fridge). If they touch the sides/back of the fridge they can [incorrectly] give a reading that suggests that the fridge has frozen which can lead to unnecessary vaccine wastage. 13. Note on the temperature chart any activity which may lead to blips in the monitoring (door open for vaccine delivery/ packing for session etc.) even if you have re-set the thermometer at the time (the data logger will still show the temp excursion when downloaded & checked). 14. Highlight any issues early- Fridges which regularly record in the outer range of safe (i.e. often min 3 or max 7 o C) need reviewing asap- this should be seen as an early warning sign that all is not well. Unreliable fridges must not be tolerated. Remember to strive for 5 Contact details CPFT Immunisation Coordinator / In case of temperature excursion 1. Review temp chart- deliveries/ loading? 2.Quarantine vaccines- clearly marked do not use but maintain at fridge temp Vaccine Storage Procedures Page 18 of 22 POL/001/013/006

19 NHS England Screening & Immunisation Teams Cumbria & North East Lancashire & South Cumbria Contact Specialist Nurse for Immunisation for advice 4.Complete incident report 5. Plan ahead- look at planned work- do you need to re-order additional vaccine via ImmForm? 6. If vaccine is wasted ensure reporting via ImmForm is completed. Vaccine Storage Procedures Page 19 of 22 POL/001/013/006

20 APPENDIX 4 - VACCINE STORAGE GUIDANCE TO BE DISPLAYED ON THE FRIDGE THIS FRIDGE CONTAINS VACCINES The person responsible for the Vaccine storage in this fridge is, and in their absence, their deputy is. Vaccine fridge must be used for storing vaccinations Domestic fridges must not be used for the storage of vaccines under any circumstances. The vaccine refrigerator should be wired directly into the mains, or have a warning notice on the plug stating Vaccine/medicines fridge do not switch off. Each fridge must have a thermometer in place, preferably integral to the fridge, but if not available a calibrated digital external thermometer can be used. Data loggers should also be in place in fridges where vaccine is stored. Electrical and calibration tests must be completed on all vaccine fridges annually The temperature readings must be taken on every working day (see appendix 3) to include: current temperature maximum and minimum time of reset signature of individual taking reading comment box to include what actions are taken if reading recorded out with the range + 2 to + 8 C. Individuals taking the readings must understand how to read and reset the thermometer and understand why this is necessary. Individuals taking readings and using vaccines must understand when and how to take action when readings are outside the range + 2 to + 8 C: Record on the log any known reasons for fluctuations in temperature, e.g. when stocking up the fridge; Quarantine any exposed stock until assurance received; Contact appropriate person for advice giving details of temperatures and time exposure; Ensure manufacturers responses are documented; If issue with temperature control cannot be resolved promptly, then vaccines must be moved to another suitable location. If the fridge is switched off accidentally, the person(s) named above must be notified Individuals responsible for receipt and management of vaccine stock must understand the need for close stock control and careful stock rotation. Practices and teams should have no more than two to four weeks of stock at any time. This will be sufficient for routine provision. Vaccine Storage Procedures Page 20 of 22 POL/001/013/006

21 All practices teams must ensure that they have access to and refer to Chapter 3 of The Green Book, Immunisation against Infectious Diseases. (Department of Health) Ref: NPSA/2010/RRR008 Vaccine Cold Storage Vaccine Storage Procedures Page 21 of 22 POL/001/013/006

22 APPENDIX 5 - HPA GUIDANCE - INDIVIDUALS WITH INCOMPLETE VACCINATION HISTORY Vaccine Storage Procedures Page 22 of 22 POL/001/013/006