Vaccine Storage and Handling

Transcription

1 Approved by: Vice President and Chief Medical Officer; and Interim Vice President and Chief Operating Officer Corporate Policy & Procedures Manual Number: Date Approved September 9, 2016 September 16, 2016 Next Review (3 years from Effective Date) September 20 Purpose To outline key components necessary for proper storage and handling of vaccines at the recommended temperature range. Policy Statement Vaccines shall be handled to reduce wastage and to ensure maintenance of cold chain for protection of biological potency and stability. Applicability This policy and procedure applies to all Covenant Health facilities, staff, members of the medical staff, volunteers, students and any other persons acting on behalf of Covenant Health. Responsibility Covenant Health staff will demonstrate their commitment to patient safety and maintaining the effectiveness of vaccines by following the procedures and principles outlined in this policy. Principles The recommended temperature for vaccine storage and handling is +2ºC to +8ºC. Some vaccines require protection from exposure to light. Loss of potency may result in failure to stimulate an adequate immunologic response, leading to lower levels of protection against disease. Staff involved with immunization programs shall have an understanding of recommended vaccine storage and handling practices. All personnel, including non-health professional staff, who handle vaccines in any way, shall receive appropriate training. Sites shall have personnel, equipment, information and written protocols in place to respond to situations which may compromise vaccine storage conditions. Situations such as (but not limited to) equipment failure, power outages and/or natural disasters can occur unexpectedly. Procedure 1. Management Each site where vaccine is stored shall have a designated vaccine coordinator who will be responsible for ensuring vaccines are handled correctly and that procedures are followed and documented. An alternate person as a backup is recommended. (See Appendix A) Sites should maintain no more than a one month supply of vaccine at any time. Avoid over-ordering or ordering early. Do not stockpile vaccines, as any loss will be more costly in the event of a power outage or refrigerator failure so that the risk of wastage from expired product is increased.

2 Page 2 of Each location/unit where vaccine is stored shall have a designated staff member who will be responsible for ensuring vaccines are handled correctly and that procedures are followed and documented for each specific location/unit. 2. Vaccine Storage Requirements Vaccines are sensitive biological products that may become less effective or destroyed when exposed to temperatures outside the recommended range or inappropriate exposure to light. Vaccines shall remain in the refrigerator, except when being administered or transported. In the case of a power outage, refrigerator failure or refrigerator maintenance, alternate storage that has the capacity to maintain the cold chain is acceptable. Laboratory grade refrigerators are required for storage of vaccines when the value of vaccine is $5,000 or more at any time. Domestic refrigerators may be used for storage of vaccine provided the value of vaccine stored in that refrigerator will not exceed $5,000. o Acceptable domestic combination refrigerator and freezer units must have separate external doors for the freezer and fridge. o Manual and cyclic defrost refrigerators should not be used due to the significant temperature variations and the risk of vaccines freezing. Some domestic frost free refrigerators can be used but may require modification to store vaccine. For example, vaccines can only be stored in certain areas of the refrigerator and precautions should be taken as temperatures may fluctuate in different compartments of the refrigerator (See Appendix B). Bar refrigerator units are not to be used for continuous vaccine storage (i.e. eight hours or longer). Refrigerators shall be connected to a dedicated electrical circuit that is not used for other appliances. Steps shall be taken to protect the power supply (e.g. safety-lock plug, warning signs, labeling fuses and circuit breakers). o Sites where $10,000 or more of vaccine is stored at any time shall have backup power at the site or written agreement with an alternate storage facility with backup power that can provide storage units to maintain the recommended storage temperatures. Refrigerators where vaccines are stored shall not contain food and/or beverages. o For refrigerators where vaccines share space with other refrigerated medications, consideration shall be given to the frequency of access to these medications. Frequent access may compromise the temperature

3 Page 3 of stability of that storage unit. Refrigerators shall have regular maintenance checks (cleaning coils, checking door seals). o At a minimum, maintenance should be performed annually and records (i.e. a log book) should be kept. o Documentation of maintenance will be critical when an equipment malfunction occurs. (See Appendix C, Appendix D) Cold chain shall be maintained when vaccine is not stored in the refrigerator. Appropriately pack vaccine in vaccine bags including a temperature-monitoring device to ensure the cold chain is not broken. o Vaccine bags shall be replaced periodically based on usage (e.g. every two years), due to material break down and decreased effectiveness of maintaining temperature. o Vaccine bags shall be inspected for integrity prior to each use. If the vaccine bag is showing signs of wear due to material break down or damage, it must be replaced. o Vaccine bags shall be tested for their ability to maintain a stable temperature between +2.0⁰C and +8.0⁰C. 3. Vaccine Transport The Cold chain shall be maintained during transport to another location. Vaccines shall be packed for transport taking into account the type of transport, the amount of vaccine to be transported, the external air temperature, and the length of time the vaccine will be in an insulated container. Packing configurations will vary on a seasonal basis. It is most important to prevent vaccines from freezing. o Do not transport vaccine if outside temperatures are expected to reach C and colder or C and warmer unless there is an urgent need for vaccine delivery. The temperature shall be monitored during transport (e.g. Data Logger, Cold Chain Monitors or a Minimum/Maximum Thermometer), depending on the type of transport and the estimated time in transport. Each site shall have written standard operating procedures regarding receiving, storing, unpacking, packing and transporting vaccine shipments. (See Appendix E) When a vaccine shipment is received, it shall be examined and refrigerated immediately. Check for evidence of physical damage, freezing or excessive heat and read and/ or stop the recording of the temperature monitoring device upon receipt to determine if it has been activated or alarmed.

4 Page 4 of If there are any concerns about the shipment, mark each package/vial of vaccine and diluent as DO NOT USE and store in Cold Chain conditions, but apart from other vaccines, until the integrity of the vaccine and diluent is determined. Staff responsible for packing vaccine for transport shall receive appropriate training. Dedicated insulated coolers (vaccine bags) able to maintain cold chain conditions with ice/gel packs and insulating materials shall be used to transport vaccine. 4. Temperature Monitoring All refrigerators where vaccine is stored shall have at least a Minimum/ Maximum Thermometer for temperature monitoring. Thermometers shall be calibrated within at least ± 1.0ºC by the manufacturer. All thermometers shall be checked twice yearly to ensure the temperature measurement is accurate, batteries are functioning, cables or probes are not damaged and there is an adequate supply of graph paper and ink pens for Chart Recorders. Fluid-filled bio-safe liquid (bottle) thermometers, bi-metal stem thermometers, and household thermometers are not acceptable. Refer to Summary of Cold Chain requirements (see webpage link in References). At minimum, the temperature shall be recorded at the beginning and end of each business day for each refrigerator storing vaccine even if chart recorders, data loggers or alarm systems are used. (See Appendix F) Sites where $5,000 or more of vaccine is stored at any time shall have continuous temperature recording devices (e.g. Chart Recorders, Data Loggers). Temperature logs and data recordings shall be retained for 5 years. 5. Alarms Vaccine refrigerators where $10,000 or more of vaccine is stored at a time shall have alarms that are monitored 24 hours a day and seven days a week. An alarm temperature monitoring system can prevent substantial financial losses in the event of an equipment malfunction that occurs outside of regular working hours. It is recommended that alarm settings be programmed to alarm at: low 3.5 C; high 6.5 C. This ensures adequate time for action that may be required to prevent a cold chain break. A stable temperature of 4.5 C to 5.0 C is the optimal environment for vaccine storage.

5 Page 5 of 6. Cold Chain Break Each site storing vaccine shall have detailed, written and easily accessible vaccine cold chain protocols for routine day to day operations. Staff who monitor and record vaccine storage temperatures shall immediately report a cold chain break to the designated site vaccine coordinator. Affected vaccines shall be isolated and marked as DO NOT USE as soon as a cold chain break is discovered. Do not assume that vaccine inappropriately exposed to light or to excessive temperature is unsalvageable. Affected vaccines must be returned to storage between +2.0ºC to +8.0ºC as soon as possible following a cold chain break, and must remain in cold chain until the integrity of the vaccine is determined by Alberta Health. All known exposures of vaccine to temperatures outside +2.0ºC to +8.0ºC or inappropriately exposed to light must be reported by completing and sending the Alberta Health Cold Chain Break Report Form (CCB Reporting Form see link to current to Alberta Health as soon as possible or within five business days of the occurrence. Alberta Health will provide direction regarding the use of exposed vaccine. The direction provided by Alberta Health is for the specific incident and shall not be applied to other similar incidents since stability information may change. Each separate cold chain incident requires submission of an individual cold chain report. When vaccines are involved in more than one cold chain break, the report shall include the dates and locations of the previous cold chain breaks, in order for Alberta Health to accurately assess the time out of refrigeration. Vaccines that have experienced a cold chain break and have been determined to be usable must be clearly labeled and must be used at the first opportunity. They may need to be redistributed to higher use areas if it is anticipated they cannot be used within the time frame stipulated by Alberta Health. If the affected vaccine is not used within the time frame stipulated, Alberta Health must be consulted to reassess. Following a cold chain break greater than $2,000, or repeated similar incidents (e.g. human error, refrigerator failures), a separate report shall be provided to Alberta Health identifying the root cause of the break and corrective steps that have been taken; this report should be provided within one month of occurrence of the cold chain break. All wasted/expired vaccines will be disposed of in sharps containers at your site. You will be required to record this vaccine in the Alberta Vaccine Inventory (AVI) system as wasted and in addition record this vaccine as wasted on your vaccine

6 Page 6 of specific reporting forms. When vaccine is involved in a cold chain break and it is determined the vaccine is not viable, it should be disposed of in a sharps container at your site. Record the doses as cold chain break in AVI. 7. Staff Education All staff handling vaccine shall be made aware of: o the importance of the cold chain and the implications of cold chain break incidents; o recommended vaccine storage and handling practices; and o the immediate and appropriate action to be taken in the event of a vaccine exposure to temperatures outside the recommended storage conditions. A comprehensive information and education strategy on vaccine Cold Chain maintenance for their staff will be provided. Orientation should be provided upon hire and an annual review of vaccine storage and handling. 8. Quality Assurance Sites shall regularly review storage conditions, including vaccine refrigerator temperature logs and chart recordings. (See Appendix D) Sites shall investigate all reports of cold chain breaks within eight hours (or next business day) of receiving a report of such an incident and determine if an on-site inspection is required. Vaccine distribution to sites may be withheld where vaccine handling equipment or practice is not in accordance with the Alberta Vaccine Cold Chain policy. Periodic audits by AHS, which may include on-site inspections, will be conducted to assess cold chain practices.

7 Page 7 of Definitions Alarmed Temperature Monitoring System: A continuously-monitored alarm system monitors temperature in vaccine refrigerators 24 hours a day and seven days a week. The alarm must be either a voice or electronic message that will be telephoned to on-call staff or security service or a recognizable audio tone that is monitored during office hours by staff and after hours by a security service. The alarmed temperature monitoring system should have a battery back-up system in case of an electricity disruption. Bar Refrigerator: Small single-door fridge. Chart Recorders: A device in which the refrigerator temperature is marked by ink pens on graph paper continuously 24 hours a day. Cold Chain: Refers to the process used to maintain optimal conditions during the transport, storage, and handling of vaccines, starting at the manufacturer and ending with the administration of the vaccine to the client. Cold Chain Break: The vaccine has been exposed to temperatures outside the recommended range. Continuous Temperature Recording Devices: An electronic device that measures temperatures and records the results. This can include devices such as a Chart Recorder and Data Logger. Data Loggers: Miniature, battery-powered, stand-alone temperature monitors that record hundreds of temperature readings. They can indicate when the exposure occurred and how long the vaccines were exposed to the minimum/maximum temperatures. Multipleuse digital data loggers are accompanied by software that is installed in a computer allowing the user to set the frequency of the temperature readings, download data from the device, and calculate temperature averages, minimums and maximums, as well as the time spent at each temperature. Domestic Refrigerator: Combination refrigerator and freezer units. Also referred to as kitchen-style refrigerators. Laboratory Refrigerator: The standard for storing larger amounts of vaccine. Also referred to as pharmacy, purpose-built, laboratory, lab-style or industrial-quality refrigerators. Minimum and Maximum Thermometers: Thermometers that show the current temperature and the minimum and maximum temperatures that have been reached since the last time the thermometer was reset. Shall: Indicates a mandatory directive that may be based on legislation or minimum requirements as per current recommendations in literature. Vaccine Bags: Insulated bags used to transport vaccine.

8 Page 8 of Resource Cold Chain Break Reporting forms/algorithm References Alberta Vaccine Cold Chain Policy March 2015, Government of Alberta Summary of Cold Chain Requirements Alberta Health Services. (2015, June 1). Vaccine Packing Checklist Public Health Agency of Canada. (2015, December 14). National Vaccine Storage and Handling Guidelines for Immunization Providers Chronological Revision Date(s) N/A

9 Page 9 of Appendix A Role of the Site Vaccine Coordinator Each location or program that orders vaccine needs one staff member designated as the primary vaccine coordinator and another staff member as backup in case the primary is unavailable. The vaccine coordinator s duties include: Ensure protocols and training are in place for appropriate handling of vaccine during disasters or power outages. Arrange for designated staff members to have 24-hour access to the building and vaccine storage units. Track inclement weather conditions that might cause power outage. If possible, set up and maintain a monitoring and notification system in anticipation of times of inclement weather or other conditions that might cause power outages. If a backup generator is present, ensure sufficient battery power is on hand to allow the generator to run continuously for at least 72 hours. If no backup power is available, plans should be in place to move vaccines to another location with access to backup power supply for the duration of the event.

10 Page 10 of Principles of Vaccine Storage Appendix B Store vaccine in the middle of the compartment, away from coils, walls, floor, and cold-air vent. Do not store vaccines in the refrigerator door or vegetable bins. If possible, organize vaccines in breathable plastic mesh baskets that are clearly labeled by type of vaccine. (Air must be able to circulate around the vaccines at all times). Never place vaccines in solid plastic trays or air-tight containers Each container should only store vaccine of the same type If baskets are used, store them 5 to 8 cm from refrigerator walls and from other baskets. Group vaccine by product: Store vaccines with similar packaging in different locations of the refrigerator Store vaccines with similar sounding names in different areas (such as dtap and Td) Rotate vaccine stock weekly and with vaccine shipments so vaccine closest to its expiration date is stored to the front of its basket/shelf and used first. Expiration dates are printed on all vaccine and diluents containers. The vaccine or diluents may be used up to midnight on this date Use vaccines that were involved in a cold chain break but still deemed viable by public health should be placed in front of and used before unexposed vials Store vaccine in original individual packaging until ready to use. Avoid over packing the storage unit, as this prevents proper airflow. Place the sensing device of the fridge temperature monitor in the center of the vaccine storage unit, away from any walls, doors, floor, coils, and fans. If using a probe, the probe should be suspended in the center of the compartment and placed in a diluents or vaccine box, in order to ensure that air flow around the sensor is not blocked. The monitor portion of the thermometer should be placed in an easily accessible location, preferably mounted on the outside of the unit. Help stabilize the temperature in the refrigerator and freezer by storing water bottles in refrigerator door and bins (domestic fridges) and ice packs in the freezer compartment. No food or drink is to be stored in the refrigerator. Minimize the number of times the refrigerator is opened during the course of the day.

11 Page 11 of Vaccine Refrigerator Maintenance Log Appendix C Date Site: Site Vaccine Coordinator/Back-up Coordinator: / Refrigerator Details: Refrigerator Type: Year Received: Model Number: Serial Number: Location of refrigerator: Maintenance (minimum annually): Motors and coils Door Seals checked Defrost (Manual Defrost Refrigerators only) Refrigerator Repairs Calibration of built-in fridge thermometer Additional Details: Preventative Maintenance (minimum annually) by a qualified Technician: Evaporator and condensing coils are clean Fan motors are running at optimal speed Fan blades are clean to reduce drag Airflow around the coils is not restricted All electrical connections are intact No damage or decay in the insulation on suction lines between condensing unit and evaporator coils No tears in door sweep and the door seals properly Door hinges are intact and lubricated

12 Page 12 of Gaskets between panels are not cracked or weathered Additional Details: Min / Max Thermometer Maintenance / Replacement (check twice a year) Thermometer Type: Battery replaced or changed: Probes / cables checked: Calibration or replacement: Date Received: Results/Action taken: Other temperature monitoring devices should be checked at least twice yearly to ensure the devices are functioning correctly. Depending on the replacement cost of the device, it may be more economical to replace the unit rather than calibrating it when temperatures are not displaying accurately. Twice yearly checks should ensure: Temperature monitoring devices are accurate within +/- 1 C or better. Change batteries twice a year. Cables and probes are not damaged

13 Page 13 of Routine Maintenance of Vaccine Storage Equipment Appendix D Routine maintenance of vaccine storage equipment is required in order to ensure equipment operates properly, to maintain required temperatures, and to extend the useful life of the equipment. Maintenance Log Books Vaccine storage equipment log-books must be stored with each vaccine refrigerator and freezer. The following information about each piece of equipment should be included in the log-book: Date of installation, serial number, and model number Equipment instructions and a list of required routine maintenance tasks Dates of any routine tasks performed (such as cleaning or maintenance) Dates of repairs or servicing, including invoices The name of the person, company, and contact information of the company providing the service Maintenance Guidelines: Vaccine Refrigerators / Walk in Coolers Maintenance Coils and Motor Door Seals Examination and cleaning of coils and motors: Vaccine storage unit coils should be examined and cleaned at least annually to ensure the unit continues to run efficiently. Cleaning the refrigerators coils and motors may be done by contracted staff and/or according to refrigerator specific manufacturer instructions. Avoid cleaning the coils and motor before a weekend or prolonged absence of staff. Accidental damage to the coils could cause a problem that may not be detected until the next work day. Notify Alarm Company (if applicable) that maintenance is taking place. Unplug the vaccine refrigerator unit. Use a soft brush, cloth or vacuum cleaner with an attached hose to remove any dirt or dust from the surface of the coils. After cleaning, plug in the unit and document the power interruption on the vaccine refrigerator temperature log. Monitor the temperature until it is stable. This process should only take a few minutes; therefore, it is not necessary to transfer the vaccines to another storage unit as long as the doors remain tightly closed for the duration of the procedure. Check that the drip pan is not plugged and clean it with warm water and mild detergent. Check integrity of door seals: this is to be done at least annually Door seals should not be torn or brittle and there should be no gaps between the seals and the body of the unit when the doors are closed.

14 Page 14 of Preventative Maintenance Doors should open and close properly and fit squarely against the body of the refrigerator. Check for build-up of debris and dirt, particularly along the lower track and clean as needed. If there are any problems with the door seals, consult a technician as necessary Other maintenance items: It is recommended that preventative maintenance for refrigerators storing vaccine be performed at least annually by a qualified service technician to ensure the following: Evaporator and condensing coils are clean Fan motors are running at optimal speed Fan blades are clean to reduce drag Airflow around the coils is not restricted All electrical connections are intact No damage or decay in the insulation on suction lines between condensing unit and evaporator coils No tears in door sweep and the door seals properly Door hinges are intact and lubricated Gaskets between panels are not cracked or weathered Thermometers and Temperature Monitors Cleaning Maintenance Check the manufacturers recommendations for specific instructions for cleaning a particular thermometer. Temperature monitoring devices should be checked twice yearly to ensure they are functioning correctly. Items to check include: Cables or probes are not damaged Thermometer batteries are changed Temperature calibration is accurate, and devices are accurate within +/- 1 C or better o Thermometer calibration due dates provided by the manufacturer are to be followed, and the thermometer must either be re-calibrated or replaced when due. Calibration certificates provided by the manufacturer must be kept to ensure accurate records. Vials of fluid that the probes sit in are intact and have adequate volume Adequate supply of graph paper and ink pens for chart recorders (if applicable)

15 Page 15 of Insulated Containers Cleaning Check the manufacturers recommendations for specific instructions for cleaning a particular insulated container or material. Insulated containers with wipe-able fabric/material: The inside should be cleaned with a cleaner/disinfectant wipe a minimum of monthly (more often depending on use and visible soil). The outside of the insulated container should also be cleaned with a low level cleaner/disinfectant (pre-moistened wipes or ready-to-use liquid) on a regular basis, at least quarterly, and when visibly soiled. Insulated containers used for hospital immunization and taken in to the hospital should have the outside cleaned immediately upon return to the site/office prior to being placed back on a shelf. Check the cleaner/disinfectant product monograph for compatibility and the appropriate contact time. Insulated containers should NOT be immersed in water or other liquid. Maintenance Insulated containers should be stored off the floor. Vaccine bags must be inspected for integrity prior to each use. If it is showing signs of wear due to material break down or damage, it must be replaced.

16 Page 16 of Packaging, Transporting, and Receiving Vaccine Shipments Appendix E Packing of Vaccines for Transport Containers: An insulated container must be used for transport. This container must demonstrate the ability to maintain the temperature between +2 C to +8 C for the desired length of time and must be large enough to store vaccines and packing materials. External surfaces must be intact, strong, durable, clean, and the lid tight fitting. Examples of containers suitable for use include: Qualified hard-sided, plastic insulated containers Styrofoam coolers with at least 2-inch thick walls (thin-walled, recreational-use Styrofoam coolers are not acceptable) Qualified soft-sided, purpose-designated vaccine bags The container must be clearly identified as containing valuable and fragile vaccines. Vaccine should be packed in layers using the following materials: refrigerated and/or frozen packs, insulating barrier (e.g. bubble wrap, crumpled brown packing paper, Styrofoam peanuts), vaccine, a temperature monitor, and filler materials (may be the same as those used as insulating barriers) to prevent shifting of the contents during transport. The number and placement of refrigerated or frozen packs inside the container will depend on container size, outside temperature, and jurisdictional variations in storage and handling materials. Frozen ice/gel packs: Must be stored in freezer a minimum of 24 hours and completely frozen prior to use. Do NOT use bagged or loose ice. Refrigerated gel packs: Must be stored between +2 C to +8 C. Must be stored in refrigerator a minimum of 24 hours prior to use. Refrigerated and frozen packs need to first be conditioned prior to packing: Condition refrigerated packs in the refrigerator Condition frozen packs by leaving them at room temperature until the edges have defrosted and the packs look like they have been sweating. If frozen packs are not conditioned, they can freeze the vaccine. Be sure to place an insulating barrier (e.g. bubble wrap, crumpled brown packing paper, Styrofoam peanuts) between the refrigerated or frozen packs and the vaccines to prevent accidental freezing. Pack vaccines in their original packaging on top of the barrier. Do not remove vaccine vials from boxes. Be sure to fill any spaces between vaccine boxes with crumpled paper or other filler to prevent shifting of contents in the insulated container. Use a properly placed min/max thermometer, data logger, or cold chain monitor near the vaccine. The temperature-monitoring device should be placed in the middle of the vaccines and should not come in contact with the refrigerated or frozen packs. Record vaccine type(s), lot numbers, brand names, quantity, date, time and originating facility on a packing slip on the inside of the container.

17 Page 17 of Attach labels to the outside of the container to clearly identify the contents as being valuable, fragile, and temperature sensitive biological products that require refrigeration immediately upon shipment arrival. Packing of Vaccines for the Clinic Setting Vaccines should not be in direct contact with frozen ice packs Only the amount of vaccines likely to be used should be placed in the insulated container. This will reduce magnitude of loss if exposed to cold chain excursion. Vaccine should be kept in their original packaging to protect against breakage, light exposure and direct contact of frozen packs. If less than a full box is required, alternative ways of protecting against breakage, light, and/or frozen pack exposure must be implemented Diluents that are stored at room temperature must be refrigerated at least 24 hours if placed in insulated cooler with vaccines as room temperature diluents placed in insulated coolers with vaccines may raise the temperature of the cooler. If not cooled in refrigerator, they must be transported separately from vaccines. During the clinic, keep the container closed as much as possible. Vaccines are to be returned to the refrigerator at the end of clinic. Transporting of Vaccine During transport of vaccine, it is important that the cold chain is maintained at all times. When transporting vaccines using a vehicle: Do not place the vaccine bag inside the trunk Avoid placing the bag in direct sunlight or in line with air from vehicle s air conditioner or heater Do not leave the vaccine unattended in the vehicle Receiving Vaccines Unpack, examine and refrigerate vaccines immediately upon arrival. Read and document the current, minimum, and maximum temperatures. Check for evidence of physical damage, freezing or excessive heat. If present, immediately label the products as DO NOT USE, quarantine under cold chain conditions and contact your Site Vaccine Coordinator for further direction. Crosscheck the contents with the packing slip to be sure they match. Remove all contents of the shipping container before returning or storing the shipping container to ensure that all vaccines have been removed and stored appropriately. If there are any discrepancies with the packing slip immediately notify the designated Site Vaccine Coordinator. Check the vaccine expiration dates to ensure that you have not received any vaccine or diluent that is already expired or that is short dated. Return documents to the originating source as per Zone guideline. When placing in refrigerator, First in, First out rule applies. Utilize oldest inventory first, but rotate stock according to expiry date so that the vaccine closest to the expiration date will be used first.

18 Page 18 of Vaccine Refrigerator Temperature Record Appendix F Date AM Time Current Temp High Temp Low Temp Initial PM Time Current Temp High Temp Low Temp Initial Maintain refrigerator temperature from +2 to +8 Celsius Check refrigerator temperature minimum twice daily Record the current temperature as well as the highest and lowest temperatures recorded by the thermometer since it was last checked and reset Retain this record for 5 years 8 9 If the temperature is below +2 or above +8 Celsius Call your Zone Vaccine contact as soon as possible following identification of temperature excursion Label vaccine Do Not Use and move to a functioning refrigerator Do not use or discard vaccine until instructed to by Public Health Note: Was the refrigerator door left open? Was the power unplugged? Monitor the refrigerator for 48 hours after any adjustments or servicing of the unit and before returning vaccine to refrigerator POWER OUTAGE Do not open the refrigerator door Brief outage (less than 1 hour) Leave vaccine in refrigerator, door closed Longer than 1 hour transfer to a functioning fridge or call Public Health for assistance STAFF MEMBER RESPONSIBLE FOR VACCINE: ALTERNATE:

19 Page of Instructions for use: Temperature Monitoring Log Temperature Monitoring Log Key Points: 1. Start a new form for each new month. 2. Fill in the fridge serial number (or other identifying information) along with the current month and year that the data is being recorded. 3. Record temperatures in º C twice a day (minimum). 4. Enter the digital temperature reading on the exterior of the vaccine fridge in the Fridge Current column. 5. Enter the current, minimum and maximum temperature readings from the minimum/ maximum thermometer. 6. Clear the memory of both minimum / maximum thermometers after every temperature recording. 7. Sign your initials as the recorder of the temperature reading. 8. Temperature monitoring logs must be kept for 5 years.