Health Authority Abu Dhabi Document Title: HAAD Standard for Safe Vaccine Handling and Cold Chain maintenance in the Emirate of Abu Dhabi Document Ref. Number: HAAD/VHCC/SD/0.9 Version 0.9 Approval Date: 28 December 2011 Effective Date: January 2012 Last Reviewed: New first issue Next Review: December 2012 Revision History Document Owner: Applies to: Classification: N/A Public Health and Policy, Communicable Diseases section Healthcare Facilities and Professionals licensed by HAAD in the Emirate of Abu Dhabi Public 1. Purpose 1.1. This standard mandates the requirements to assure safe and highest quality vaccine handling; it sets out the necessary procedures to maintain cold chain requirements. 2. Scope 2.1. This Standard applies to all Healthcare Facilities and Professionals licensed by HAAD in the Emirate of Abu Dhabi and providing vaccination services as well as licensed vaccine stores. 2.2. This standard refers to all vaccine handling and cold chain activities at health care facilities. 3. Duties for Healthcare providers 3.1. Healthcare providers (facilities and professionals) providing vaccine services and stores must: 3.1.1. Have in place policies and standard operating procedures to meet the requirements specified in this standard, including but not limited to: 3.1.1.1. Roles and Responsibilities of professionals; 3.1.1.2. Maintaining sufficient cold store capacity; 3.1.1.3. Resources including appropriate equipment for transportation and storage of vaccines, as specified in this standard; 3.1.1.4. Ordering and management of vaccine stocks; 3.1.1.5. Storage and transportation of vaccines at the correct temperature; 3.1.1.6. Temperature monitoring and recording; 3.1.1.7. Emergency plan and management of emergencies; 3.1.1.8. Maintenance and care of equipment; 3.1.1.9. Storage and security of vaccine product related documentation (for a minimum of 3 years).
3.1.2. Comply with HAAD requests to inspect and audit premises and records and cooperate with HAAD authorised auditors, as required and when requested for inspections and audits by HAAD; 3.1.3. Report and submit data on handling and storage of vaccines to HAAD in accordance with the requirements of this Standard. Reporting on vaccination and healthcare services must comply with the HAAD Reporting of Health Statistics Policy and the HAAD Data Standards and Procedures (found online at www.haad.ae/datadictionary); 3.1.4. Reporting of cold chain failure; and 3.1.5. Comply with HAAD policies and standards on managing patient medical records, including developing effective recording systems, maintaining patient records, maintaining confidentiality, privacy and security of patient information, and Patient Rights and Responsibilities charter. 3.2. In addition to requirements of 3.1 vaccine stores must have: 3.2.1. Pre-shipment and shipment arrival vaccine procedures. 4. HAAD Role 4.1. HAAD will: 4.1.1. Develop, and from time to time revise, the standards for safe vaccine handling and cold chain; 4.1.2. provide guidance and training to support the effective implementation of the Standards and services; 4.1.3. monitor compliance with the Standards and the effectiveness of Cold Chain processes using a variety of means including collecting required information and inspections and audits; 4.1.4. receive notification of Cold Chain failures and other reports as may be specified and requested by HAAD and give appropriate feedback and recommendations; 4.1.5. create action plans to address and rectify issues identified in order to assure compliance with the standard and improve quality and safety of storage, handling and management of vaccines; 4.1.6. ensure continuous high quality vaccine supply for Emirate of Abu Dhabi; and 4.1.7. monitor, assess and reduce vaccine wastage in the Emirate of Abu Dhabi to maximize efficient use of vaccine to deliver the target Public Health outcomes (reduce/prevent communicable disease in community). 5. Enforcement and Sanctions 5.1. HAAD may impose sanctions in relation to any breach of duties under this standard in accordance with the [HAAD Policy on Inspections, Complaints, and Appeals & Sanctions]. 6. Abbreviations and Definitions: Page 2 of 7
BCG CCM/VCCM CFC Cold Chain Conditioned Icepacks DPSC DPT DT FSM HAAD HCFC Bacillus, Calmette and Guerin (against tuberculosis) Cold Chain Monitor/Vaccine Cold Chain Monitor Chlorofluorocarbon The cold chain is a network of cold/freezer rooms, refrigerators, freezers & cold boxes organized and maintained by teams of people throughout the world to ensure that vaccines are kept at the correct temperatures to retain its potency, from when they leave the vaccine manufacturer, through shipping and storage, until it is administered. The icepacks allowed to sit at room temperature until the ice begins to melt and water starts to form inside Disease Prevention & Screening Center Diphtheria, Pertussis and Tetanus Diphtheria and Tetanus toxoid Freeze Sensitive Monitor (freeze tag, freeze watch) Health Authority Abu Dhabi Hydrochlorofluorocarbon Hep. B Hexavalent Hib HPV IPV MMR OPV PCV13 Pentavalent Td Tetravalent Hepatitis B Diphtheria, Pertussis, Tetanus, Hemophilus Influenza Type B, Inactivated Polio and Hepatitis B vaccines combination Hemophilus Influenza Type B Humen Papilloma virus Inactivated Polio vaccine Measles, Mumps and Rubella Oral Polio Vaccine Pneumococcal Conjugate Vaccine 13 valent Diphtheria, Pertussis, Tetanus, Hemophilus Influenza Type B and Hepatitis B vaccines combination Tetanus toxiod and Diphtheria ( reduced component) toxoid Diphtheria, Pertussis, Tetanus, and Hemophilus Influenza Type B combination vaccine Vaccination unit The place at health care facility where vaccination services are provided Vaccine Central Store Vaccine Regional Store Vaccinee VVM The primary vaccine store where the bulk of vaccines are received to be distributed to the regional vaccine stores The secondary vaccine store where the vaccines are received from the central vaccine store to be distributed to the health care facilities The vaccinated person Vaccine Vial Monitor (VVM) is a heat sensitive indicator placed on some vaccine vials/ampoules (e.g. OPV) to enable the health care worker to know whether the vaccine has been damaged by heat. The nurse should inspect VVM before use of vaccine. Page 3 of 7
WHO TT World Health Organization Tetanus Toxoid vaccine Safe Handling of Vaccines and Cold Chain Service Specifications 7. Standard 1 Health Professionals 7.1. The healthcare facility must designate at least one HAAD licensed healthcare professional to be responsible for vaccine handling and cold chain activities. 7.2. All HAAD licensed healthcare professionals who have responsibilities associated with vaccine handling and cold chain defined in this standard must be: 7.2.1. Appropriately qualified and experienced; and 7.2.2. trained to comply with the requirements of vaccine safe handling and cold chain procedures in compliance with this Standard and all other relevant HAAD Policies and Standards. 8. Standard 2 - Vaccine packaging and transportation: equipment and temperature 8.1. Vaccines must be : 8.1.1. Packed in accordance with specifications described at Appendix 1; 8.1.2 transported at temperatures between + 2 C and + 8 C in cold boxes or vaccine carriers that comply with WHO/UNICEF specifications or HAAD recommendations as detailed in Appendix 1. 8.2 For vaccine stores vaccines must be shipped as per manufacturer instructions. 8.3 Transportation of vaccines must include the following measures to protect the cold chain: 8.3.1 All drivers being instructed clearly on measures to protect the vaccines; 8.3.2 use of the shortest, most direct route with no stops en route for all transportation; 8.3.3 keep cold box and vaccine carriers protected from direct sunlight in the front compartment of an air conditioned car /vehicle; 8.3.4 document the time of departure and time of delivery using the HAAD standard form provided at Appendix 2 or a form providing identical information; 8.3.5 monitor the temperature during and at end of transportation using a data logger / Max-Min Thermometer and freeze sensitive monitors, such as those described at Appendix 3; and 8.3.6 use a Cold Chain Monitor (CCM) for journeys longer than 6 hours, such as that detailed at Appendix 4. 9 Standard 3 - Vaccine storage Standard Operating Procedures 9.2 In the facility/store, vaccines must be stored in a: 9.2.1 Medical refrigerator; or 9.2.2 domestic refrigerator, (non-frost type); or 9.2.3 cold room; or 9.2.4 freezer room/freezer for specific vaccines (only at central or regional store level). Page 4 of 7
9.3 All vaccine storage equipment must: 9.3.1 Be in accordance with the requirements of Appendix 1; 9.3.2 ensure year-round optimum temperature conditions for vaccines; 9.3.3 have solid doors, i.e. not transparent; 9.3.4 be CFC and HCFC free; 9.3.5 have no internal lights except the cold room /freezer room; and 9.3.6 not use solid drawers or shelves (ensure ventilation through spaces/holes), 9.4 Refrigerators must be installed in accordance with Appendix 5. 9.5 All vaccines must be stored : 9.5.1 Between 2 º C and 8 º C except that detailed at 9.5.2; 9.5.2 OPV must stored at -15 º C to -25 º C at regional and central stores in accordance with Appendix 9; 9.5.3 immediately on receipt at the facility/store; and 9.5.4 away from the evaporator in the refrigerator/cold room (for freeze sensitive vaccines) in accordance with Appendix 21. 9.6 All vaccines must be monitored for temperature status: 9.6.1 During transportation; 9.6.2 on receipt at the facility/store; 9.6.3 at the facility at the start and the end of each working day and daily at the store; 9.6.4 using the Data logger and FSM as at Appendix 3; and 9.6.5 using the daily temperature record charts at Appendices 6 and 7 (or charts with the same fields). 9.7 Vaccine Stock and resources must be sufficient for both regular use and National Immunization Campaigns. 9.8 Vaccine Stock levels must be maintained in alignment with requirements of Appendix 10 including at least: 9.8.1 Recording of stock levels on receipt, after use and on dispatch of all vaccines; and 9.8.2 completing the forms at Appendix 14 and Appendix 20, or hard copy or electronic forms that document the same information. 10 Standard 4 - Equipment maintenance 10.2 Policies and procedures should be in place for periodic preventive maintenance of: 10.2.1 Cold chain equipment according to biomedical engineer/ manufacturers recommendations; 10.2.2 thermometers and calibration equipment (Minimum annually); and 10.3 Cleaning of cold chain equipment regularly ; 10.4 Processes should include: 10.4.1 Documentation of all maintenance and of cleaning activity on the form at Appendix 11 (or a form with the same fields); 10.4.2 protection of equipment from direct sunlight to prevent damage and deterioration; and Page 5 of 7
10.4.3 equipment drying before storage and re use. 11 Standard 5 : Vaccine use at vaccination unit 11.2 During the immunization session measures must be taken to ensure the safe use of the vaccines in accordance with Appendix 13. 11.3 Multi-multi dose vaccine vials and vials with VVM must be used in accordance with the specifications at Appendix 12 &22. 11.4 Review and complete Checklist for safe vaccine handling and cold chain on monthly basis (Appendix 19). 12 Standard 6 Cold Chain failure and Emergency management 12.2 Prevention of cold chain failure and detection of temperatures outside the safe range must be minimized by the following actions: 12.2.1 Regular inspection of the vaccine refrigerator /cold room; and by inspecting the FSM and refrigerator temperature; 12.2.2 recording the results of inspection on the daily temperature record (Appendix 6 or 7); 12.2.3 development and implementation of an emergency plan based on Appendix 15 must be created and implemented at the healthcare facility/ store; and 12.2.4 storage of vaccines in accordance with Appendix 21. 12.3 In the event of power/ refrigerator failure or other incidents in which vaccines are exposed to unsafe temperatures, the staff responsible for vaccine handling and coordination must: 12.3.1 take appropriate actions to minimise failure of the cold chain and protect safety of the vaccines in accordance with Appendix 16, in particular decision whether to: 12.3.1.1 Move the vaccine supply and temperature monitors to another refrigerator unit/vaccine cold box or carrier, as soon as possible; 12.3.1.2 keep the vaccine supply in refrigerator without opening the door; 12.3.1.3 keep vaccines suspected in the refrigerator in a box and labeled Do not use ;and 12.3.1.4 assess the freeze sensitive suspected vaccines as indicated by using shake test as described in Appendices 17 and 18. 12.3.2 Complete the cold chain failure report provided at Appendix 8 and send to HAAD electronically or by fax. 12.3.3 Ensure availability of vaccine to ensure continuity in the service. 12.3.4 Do not use the suspected vaccines; HAAD feedback on the cold chain failure report has been received. Page 6 of 7
Table of Appendices Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 Appendix 7 Appendix 8 Appendix 9 Appendix 10 Appendix 11 Appendix 12 Appendix 13 Appendix 14 Appendix 15 Appendix 16 Appendix 17 Appendix 18 Appendix 19 Appendix 20 Appendix 21 Appendix 22 Vaccine cold chain equipment Vaccine Demand and Issue Voucher Temperature monitoring devices CCM or VCCM Use Refrigerator installation Daily temperature record General daily temperature record Vaccine cold chain failure report Recommended vaccine storage temperatures Vaccine stock management Cold chain equipment maintenance and cleaning record Use of Multi-dose vaccine vials Management of immunization sessions Vaccine stock record form Cold chain emergency back-up plan Refrigerator breakdown checklist Shake test poster Shake test learning guide Checklist for safe vaccine handling and cold chain List of vaccines available in refrigerator Heat and freeze sensitive vaccines Interpretation of vaccine vial monitor (VVM) Page 7 of 7