The Refrigerator Temperature Log form is a critical tool used for monitoring and documenting the temperatures within a refrigerator, specifically designed to ensure the safe storage of vaccines, including COVID-19 vaccines. It instructs on how to record temperatures, what actions to take if temperatures fall out of the recommended range, and emphasizes the importance of meticulous temperature monitoring to prevent vaccine spoilage. For those involved in vaccine storage and management, filling out this form diligently is essential for vaccine efficacy and safety. Ensure you're keeping vaccines at their required temperatures by filling out the form, available by clicking the button below.
In the world of healthcare and immunization, maintaining the correct refrigerator temperatures for storing vaccines is critical to ensure their effectiveness and safety. The Refrigerator Temperature Log form serves as an essential tool in this process, providing a structured and standardized way to record and monitor temperatures within the refrigeration units holding these vital medications. The form, which is designed to be used in conjunction with the CDC’s updated Vaccine Storage and Handling Toolkit, features sections for daily monitoring, staff initials, exact times of checks, and a system for documenting minimum and maximum temperatures. It emphasizes the importance of taking immediate action if temperatures fall outside of the acceptable range, specifically too warm (above 46ºF) or too cold (below 36ºF), by offering precise instructions on labeling exposed vaccines, recording out-of-range temperatures, and contacting the appropriate health department for guidance. Additionally, it instructs users to save each month's log for at least three years or longer if required by state or local jurisdictions. The form also includes a Vaccine Storage Troubleshooting Record for documenting any storage issues in detail, thereby facilitating a systematic approach to resolve any incidents of temperature excursions and to prevent future occurrences. Distributing this form across healthcare facilities underscores the collective commitment to safeguarding vaccine integrity and, by extension, public health.
F°
Temperature Log for Refrigerator – Fahrenheit
DAYS 1–15
For information on storage and handling of COVID-19 vaccines, see the COVID-19 Vaccine Addendum in CDC’s updated Vaccine Storage and Handling Toolkit at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html.
Monitor temperatures closely!
temps, document current temps twice, at
Month/Year
VFC PIN or other ID #
Page 1 of 2
1.Write your initials below in “Staff Initials,” and note the time in “Exact Time.”
2.If using a temperature monitoring device
(TMD; digital data logger recommended) that records min/max temps (i.e., the highest and lowest temps recorded in a specific time period), document current and min/max once each workday, preferably in the morning. If using TMD that does not record min/max
beginning and end of each workday.
3.Put an “X” in the row that corresponds to the refrigerator’s temperature.
4.If any out-of-range temp observed, see instructions to the right.
5.After each month has ended, save each month’s log for 3 years, unless state/local jurisdictions require a longer period.
Facility Name
Take action if temp is out of range – too warm (above 46ºF) or too cold (below 36ºF).
1.Label exposed vaccine “do not use,” and store it under proper conditions as quickly as possible. Do not discard vaccines unless directed to by your state/local health department and/or the manufacturer(s).
2.Record the out-of-range temps and the room temp in the “Action” area on the bottom of the log.
3.Notify your vaccine coordinator, or call the immunization program at your state or local health department for guidance.
4.Document the action taken on the attached
“Vaccine Storage Troubleshooting Record.”
Day of Month
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Staff Initials
am
pm
Exact Time
Min/Max Temp in Unit
(since previous reading)
Danger! Temperatures above 46ºF are too warm! Write any out-of-range temps and room temp on the lines below and call your state or local health department immediately!
temperatures
Aim for 41º
acceptable
46˚F
45˚F
44˚F
43˚F
42˚F
41˚F
40˚F
39˚F
38˚F
37˚F
36˚F
Danger! Temperatures below 36ºF are too cold! Write any out-of-range temps and room temp on the lines below and call your state or local health department immediately!
action
Write any out-of-range temps (above 46ºF or below 36ºF) here:
Room Temperature
If you have a vaccine storage issue, contact your state or local health department for guidance and complete the attached “Vaccine Storage Troubleshooting Record.”
DISTRIBUTED BY THE
IMMUNIZATION ACTION COALITION Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.org
Adapted with appreciation from California Department of Public Health
www.immunize.org/catg.d/p3037F.pdf • Item #P3037F (8/21)
DAYS 16 –31
Page 2 of 2
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Vaccine Storage Troubleshooting Record
(check one) □Refrigerator □Freezer □Ultra-Cold Freezer
Use this form to document any unacceptable vaccine storage event, such as exposure of refrigerated vaccines to temperatures that are outside the manufacturers’ recommended storage ranges.
A fillable pdf of this form is available at www.immunize. org/catg.d/p3041.pdf
Date & Time of Event
Storage Unit Temperature
Person Completing Report
If multiple, related events occurred,
at the time the problem was discovered
see Description of Event below.
Date:
Temp when discovered:
Name:
Time:
Minimum temp:
Maximum temp:
Comment (optional):
Title:
Description of Event (If multiple, related events occurred, list each date, time, and length of time out of storage.)
•General description (i.e., what happened?)
•Estimated length of time between event and last documented reading of storage temperature in acceptable range (2o to 8oC [36o to 46oF] for refrigerator; -50o to -15oC [-58º to 5ºF] for freezer; -80o to -60oC [-112º to -76ºF] for ultra-cold freezer (may be used for Pfizer COVID-19 vaccine).
• Inventory of affected vaccines, including (1) lot #s and (2) whether purchased with public (for example, VFC) or private funds (Use separate sheet if needed, but maintain the inventory with this troubleshooting record.)
•At the time of the event, what else was in the storage unit? For example, were there water bottles in the refrigerator and/or frozen coolant packs in the freezer?
•Prior to this event, have there been any storage problems with this unit and/or with the affected vaccine?
•Include any other information you feel might be relevant to understanding the event.
Action Taken (Document thoroughly. This information is critical to determining whether the vaccine might still be viable!)
•When were the affected vaccines placed in proper storage conditions? (Note: Do not discard the vaccine. Store exposed vaccine in proper conditions and label it “do not use” until after you can discuss with your state/ local health department and/or the manufacturer[s].)
•Who was contacted regarding the incident? (For example, supervisor, state/local health department, manufacturer—list all.)
•IMPORTANT: What did you do to prevent a similar problem from occurring in the future?
Results
• What happened to the vaccine? Was it able to be used? If not, was it returned to the distributor? (Note: For public-purchase vaccine, follow your state/local health department instructions for vaccine disposition.)
www.immunize.org/catg.d/p3041.pdf • Item #P3041 (8/21)
Vaccine Storage Troubleshooting Record (check one)
◯
Refrigerator
Freezer
Ultra-Cold Freezer
Use this form to document any unacceptable vaccine storage event, such as exposure of refrigerated vaccines to temperatures that are outside the manufacturers' recommended storage ranges.
Date: (see below)
45º F
Temp when discovered: 77º F
Name: Natalie Nurse
Time: (see below)
Minimum temp: 38º F
Maximum temp: 53º F
Comment (optional):temp is approx.
Title: VFC Coordinator
Date: 6/29/21
•Estimated length of time between event and last documented reading of storage temperature in acceptable range (2o to 8oC [36o to 46oF] for refrigerator; -50o to -15oC [-58º to 5ºF] for freezer; -80o to -60oC [-112º to -76ºF] for ultra-cold freezer (Pfizer COVID-19 vaccine only)
At 8 am on Tuesday (6/29/21) morning when clinic opened, identified 4 temperature excursions over the weekend in refrigerator with readings as high as 54°, 50°, 49° & 53°F in primary vaccine storage unit #1. Recordings taken every 15 min on calibrated digital data logger overnight. Data logger probe in glycol located in middle of refrigerator with vaccines.
Total time out of range: approximately 3 hrs — maximum temp 53°F (see attached document of continuous temp readings)
Inventory of vaccines: see attached
Water bottles in refrigerator door. No vaccine stored in freezer. No problems with storage unit prior to Saturday night. Thunderstorms in area over weekend may have affected power.
Vaccines currently stored appropriately at 41ºF. Refrigerator and vaccines labeled "Do Not Use."
My State Immunization Program contacted at 8:30 am. Spoke with Victor Vaccine. Provided Victor with details of event and list of vaccines. Vaccine to remain quarantined until we hear back from Victor.
Called electric company and confirmed 2 short power outages during weekend. Checked refrigerator seals called refrigerator maintenance company to replace seals.
Checked plug on unit placed tape over plug to prevent inadvertent dislodging. Plan to purchase plug guard.
Plan to follow up with Immunization Program on data loggers with alarms that could be sent to coordinator and back-up phones.
Late on Monday, I talked with Victor regarding continued use of vaccine. Victor had checked with manufacturers which confirmed that vaccine is acceptable for use. He told me that vaccine could therefore be removed from quarantine. I discussed the entire situation with Susie Supervisor and Dr. Director (clinic medical director) who agreed that we could put vaccine back in use.
Date:7/13/2021
28º F
Time: 8:00 am
Minimum temp: 28º F
Maximum temp: 42º F
Date: 7/13/21
When checked main clinic fridge (in lab) at 8:00 am on Tuesday, 7/13/2021, digital readout on data logger read 28ºF. Data logger located in center of fridge with probe in glycol . Review of computer readings (taken every 15 minutes) showed steady drop in temps from 42ºF at 8:15 pm (7/12/2021) to 28ºF reading discovered when arrived at clinic on Tuesday morning (7/13/2021). Readings hit 34ºF at 11 pm (7/12) and 32ºF at 2 am (7/13). Total time out of recommended storage temps = 9 hours, with 6 hours at freezing or below (see attached document of continuous temp readings). Inventory of vaccines attached.
Water bottles in refrigerator door and crisper area. No vaccines stored in freezer. No recent adjustments to temp controls and no previous temp excursions noted with this refrigerator before 7/13.
Upon discovery, vaccines marked “Do Not Use” and stored in 2nd clinic fridge (in exam room #3 at 41ºF). Also placed “Do Not Use” note on main fridge in lab. Notified Susie Supervisor about the issue. Contacted Victor Vaccine at My State Immunization Program at 8:30 am. Provided Victor with details of event and list of vaccines in fridge. Victor said to maintain vaccines in 2nd fridge and that he would check with manufacturers to determine next steps.
Called Jim’s Appliance Repair to examine fridge. Repairman found and replaced faulty thermostat in unit. Reset data logger on center shelf in fridge with probe in glycol .
After fridge thermostat repaired, monitored temps in empty fridge for 1 week, per state requirements. Fridge maintained 39º-41ºF temps for entire week. Submitted repair documentation and data logger readings to Victor Vaccine for approval and ordered replacement vaccines. Victor had checked with manufacturers who confirmed that all vaccines in fridge EXCEPT MMR were no longer viable and should be returned per state policy guidelines. MMR may be used because pkg insert allows storage down to -58ºF. Discussed entire situation with Susie Supervisor and clinic director, Dr. Director, who agreed on continued use of MMR . Will continue to monitor fridge closely to watch for pattern of temp fluctuations indicating potential problem with thermostat. If problems, contact Victor Vaccine for advice on purchasing new fridge meeting criteria for appropriate vaccine storage.
To maintain the integrity of vaccines, particularly those related to COVID-19, it is crucial to closely monitor refrigerator temperatures within specified ranges. The Refrigerator Temperature Log form has been designed to assist in this process. This step-by-step guide is intended to help ensure that temperatures are accurately recorded, and appropriate actions are taken when temperatures fall outside of the acceptable range. By diligently completing this form, facilities can help ensure vaccine efficacy and safety.
In instances where vaccines are exposed to temperatures outside their recommended ranges, completing the "Vaccine Storage Troubleshooting Record" becomes necessary. This form serves as a detailed report of the incident, capturing the date and time, temperature details, a general description of what occurred, and the actions taken in response to the event. The form also prompts for a discussion of measures implemented to prevent future occurrences. Accurate completion of this documentation is critical to assessing the viability of the affected vaccines and ensuring continued compliance with storage standards.
What is the purpose of the Refrigerator Temperature Log form?
The Refrigerator Temperature Log form is designed to help facilities accurately monitor and record the temperatures within refrigerators that store vaccines, including COVID-19 vaccines. It ensures vaccines are stored within the recommended temperature ranges to maintain their efficacy.
How often should refrigerator temperatures be recorded?
Temperatures should be documented twice each day, once at the beginning and once at the end of each workday. If using a temperature monitoring device (TMD) that records minimum and maximum temperatures, it's recommended to log these once each workday, preferably in the morning.
What should be done if a temperature reading is out of the recommended range?
If the temperature is above 46ºF or below 36ºF, immediate action is required. Label exposed vaccines "do not use," store them under proper conditions quickly, and do not discard them unless directed by health authorities or the manufacturer. Record the out-of-range temperatures in the "Action" area of the log, notify your vaccine coordinator or the local health department, and document the action taken on the Vaccine Storage Troubleshooting Record.
How long should the completed Refrigerator Temperature Logs be kept?
Each month’s log should be saved for 3 years after the end of the month, unless state or local jurisdictions require a longer retention period.
What should be included when documenting temperature readings?
When documenting temperature readings, include your initials in the "Staff Initials" section, the exact time of recording, and mark the refrigerator's current temperature. If any temperatures are out of range, also document them in the specified section along with any room temperature readings.
What is the role of the Vaccine Storage Troubleshooting Record?
The Vaccine Storage Troubleshooting Record is used to document any incidents related to vaccine storage, such as exposure to temperatures outside the manufacturers’ recommended ranges. This documentation is essential for assessing the viability of the vaccines and determining appropriate actions to prevent future incidents.
When and how should the Vaccine Storage Troubleshooting Record be used?
It should be filled out immediately upon discovering a storage event that could affect vaccine viability. The form prompts the user to describe the event, the length of time outside recommended temperatures, inventory of affected vaccines, and any actions taken to rectify the situation and prevent recurrence.
What steps should be taken after vaccines are exposed to inappropriate temperatures?
First, label and segregate the affected vaccines to prevent their use. Contact your state or local health department or the vaccine manufacturer for guidance. Next, take measures to return the storage unit to the recommended temperature range and document all actions on the Vaccine Storage Troubleshooting Record.
Who should be notified if a vaccine is stored outside the recommended temperature range?
Immediately notify your vaccine coordinator or the immunization program at your state or local health department. You may also need to contact the vaccine manufacturer(s) for further guidance.
How can future vaccine storage problems be prevented?
Regularly monitor storage unit temperatures, perform routine maintenance on storage equipment, train staff on proper storage procedures, and use temperature monitoring devices that can alert staff to temperature excursions. Also, document and review any storage issues to implement corrective actions that prevent recurrence.
One common mistake made when filling out the Refrigerator Temperature Log form is failing to record the initials and exact time of each temperature check. This oversight compromises the log's accuracy and reliability, as it's crucial for monitoring the stability and consistency of the temperature within which vaccines, such as the COVID-19 vaccines, are stored. Ensuring every temperature check is accompanied by the correct initials and timestamp allows for precise tracking and validation of the storage conditions.
Another frequent error involves misunderstanding the importance of documenting both the current and min/max temperatures daily, especially when using a temperature monitoring device (TMD). Min/max temperatures represent the highest and lowest temperatures recorded over a specific period, offering valuable insights into any temperature excursions that may compromise vaccine integrity. Neglecting to document these readings can lead to missed out-of-range temperatures, potentially risking vaccine efficacy without notice.
A third mistake often seen is inaccurately marking the refrigerator's temperature on the log form. The log requires an "X" to be placed in the row corresponding to the observed temperature, but mismarking or omissions can lead to incorrect assessments of temperature stability. This action is pivotal for identifying and addressing any deviations from the recommended temperature range between 36°F and 46°F.
Incorrectly handling or failing to take immediate action when out-of-range temperatures are observed is yet another critical error. The instructions on the log form clearly outline steps for labeling exposed vaccines "do not use," recording the out-of-range temperatures, notifying the relevant vaccine coordinator or health department, and documenting the incident in a Vaccine Storage Troubleshooting Record. Overlooking these steps can result in the use of potentially compromised vaccines, affecting their effectiveness.
Not retaining the completed Refrigerator Temperature Log forms for the required duration, typically three years unless stated otherwise by state or local jurisdictions, undermines compliance and accountability. These records play a crucial role in audit trails, problem-solving, and verifying that vaccines have been stored correctly throughout their lifecycle. Failure to maintain these logs can lead to challenges in verifying past storage conditions, should any questions arise regarding vaccine storage practices.
Lastly, underestimating the necessity of immediate communication and proper documentation in the case of exposure to out-of-range temperatures constitutes a significant lapse. The form advises immediate contact with state or local health departments and thorough documentation on the attached Vaccine Storage Troubleshooting Record. Delayed or inadequate response to such incidents hampers effective remediation and could result in the unnecessary disposal of vaccines that might have remained viable or the use of vaccines that should be discarded.
In the meticulous process of vaccine storage and management, the Refrigerator Temperature Log form plays a crucial role, providing a structured framework for recording and monitoring the temperature within vaccine refrigerators. However, to comprehensively manage vaccine inventory and ensure the vaccines' efficacy, several other forms and documents complement the Refrigerator Temperature Log. These documents facilitate a thorough approach to handling, storing, and troubleshooting vaccines, ensuring that they are administered safely and effectively.
Together with the Refrigerator Temperature Log, these documents create a robust framework for vaccine management. They support healthcare facilities in maintaining the integrity of their vaccine supplies, ensuring that vaccines remain effective until they reach the individuals who need them. Proper documentation and record-keeping are pillars of effective vaccine storage and management, contributing to the overall success of vaccination programs.
A document similar to the Refrigerator Temperature Log form is the Freezer Temperature Log form, used to track the temperature inside medical freezers. Both forms are crucial for ensuring that vaccines and other temperature-sensitive medications are stored at the correct temperatures to maintain their efficacy. The key difference lies in the temperature ranges being monitored, with freezers requiring lower temperatures compared to refrigerators. Regular monitoring, as well as actions taken in response to temperature deviations, are documented meticulously in both forms to ensure the safety and effectiveness of the stored items.
The Maintenance Log for Refrigeration Equipment is another document that bears resemblance. This log not only records temperatures but also tracks servicing activities, repairs, and maintenance schedules of refrigeration units. While the focus extends beyond just temperature monitoring, ensuring proper function through regular maintenance directly impacts the ability to maintain desired temperature ranges. This log helps in identifying patterns of malfunctioning, thereby preempting possible future issues with temperature regulation.
The Vaccine Storage Troubleshooting Record closely parallels the Refrigerator Temperature Log form by detailing steps taken in response to storage issues, such as exposure to out-of-range temperatures. This document focuses on the investigative and corrective actions undertaken following a temperature excursion, including a detailed inventory of affected vaccines, a description of the event, actions taken to rectify the situation, and measures implemented to prevent future occurrences. It's a deeper dive into the procedural aftermath of what the Refrigerator Temperature Log form initially flags.
The Daily Medication Temperature Log is used in pharmacies and medical facilities to record the temperature where medications are stored. Similar to the Refrigerator Temperature Log, this document ensures that medications are stored under conditions that keep them safe and effective. Though it may encompass a broader range of storage conditions beyond refrigeration, the principle of regular temperature checks to ensure compliance with storage guidelines remains constant.
The Food Safety Temperature Log serves a similar purpose in commercial kitchens and food service operations, tracking temperatures of refrigerators, freezers, and hot-holding units to prevent foodborne illnesses. Like the Refrigerator Temperature Log form, this log ensures that all perishable items are stored at safe temperatures, preventing spoilage and the growth of bacteria. Despite their different contexts, both logs focus on health and safety through diligent temperature monitoring.
An Equipment Calibration Log, while broader in scope, shares similarities with the Refrigerator Temperature Log form. This document records the calibration of various types of equipment, potentially including temperature monitoring devices used in refrigerators and freezers sustaining vaccines. Regular calibration ensures that the temperature readings are accurate, which is foundational to the reliability of the Refrigerator Temperature Log form's recorded temperatures.
The Laboratory Temperature Monitoring Log is akin to the Refrigerator Temperature Log form but is used within a laboratory setting to monitor and record temperatures of lab equipment such as incubators, refrigerators, and freezers. This ensures that samples, cultures, and chemicals are stored under optimal conditions. The systematic recording of temperatures and corrective actions in response to deviations is crucial in both contexts to uphold the integrity of stored materials.
Quality Control Records for Manufacturing, which document various parameters that need to be monitored and maintained within specific ranges, including temperature, also share a similar purpose. These records ensure that environmental conditions during the manufacturing process do not compromise the quality of the product. Temperature logs, as part of this suite of documentation, are critical for products sensitive to temperature fluctuations.
The Cold Chain Custody Log tracks the temperature and handling of products requiring temperature control throughout the distribution process, from manufacturer to end-user. Similar to the Refrigerator Temperature Log form, it ensures that products, especially vaccines and biologics, are transported and stored within specified temperature ranges to maintain their potency. Both documents are vital links in preserving the integrity of temperature-sensitive items.
Lastly, the Environmental Monitoring Log, which may cover various environmental conditions including temperature, humidity, and particulate levels in areas like clean rooms, shares the preventive intent of the Refrigerator Temperature Log. Monitoring and documenting these conditions ensure that products, especially in pharmaceutical and biotech industries, are manufactured, stored, and handled in an environment that maintains their quality and safety.
When working with the Refrigerator Temperature Log form, particularly in relation to storing sensitive items such as vaccines, precision and accuracy are vital. By adhering to a set of do's and don'ts, facilities can ensure vaccines maintain their efficacy and safety. Below are essential practices to follow:
Maintaining the integrity of vaccines is paramount. By following these guidelines, healthcare facilities can ensure vaccines are stored under optimal conditions, thereby protecting community health.
Misconceptions about the Refrigerator Temperature Log form, designed to monitor the cold storage conditions of vaccines, often lead to errors in its use and the mismanagement of vaccine viability. Correct understanding of this form is crucial in ensuring the efficacy of vaccines stored within healthcare facilities.
It's only for COVID-19 vaccines: While the form references COVID-19 vaccine storage, it's designed for monitoring the temperature of all vaccines stored in a refrigerator, ensuring they're kept within the recommended temperature range.
Recording temperatures isn't mandatory: Accurately documenting temperatures is essential, not optional. It helps in assessing if vaccines are stored at safe temperatures, which is crucial for their effectiveness.
Any out-of-range reading is acceptable if brief: Even short periods of temperature deviations can compromise vaccine potency. It's vital to document and act on all out-of-range temperatures as per the guidelines.
A digital data logger isn't necessary: Using a digital data logger is strongly recommended as it provides accurate min/max temperature readings, helping identify any temperature excursions promptly.
Staff initials and exact time recording are redundant: Documenting who recorded the temperature and when gives accountability and can be crucial in diagnosing issues with the storage unit or identifying human error.
Out-of-range temperatures don't always require action: Any deviation from the prescribed temperature range necessitates immediate corrective measures, as detailed in the form's instructions, to prevent the risk of administering ineffective vaccines.
Logs should be discarded monthly: Completed logs must be preserved for at least three years (or longer, if state/local jurisdictions require) to provide a history of storage practices and facilitate audits or investigations.
Room temperature documentation is unnecessary: Recording the room temperature alongside the refrigerator temperature can offer insights into why a storage unit may be experiencing temperature excursions, particularly in cases of HVAC failures or power outages.
If the temperature is just one degree out of range, vaccines are still usable: Vaccines exposed to temperatures outside the recommended range should not be used until they have been cleared by the manufacturer or a healthcare authority, as even slight deviations can impact their integrity.
It's sufficient to check temperatures only during workdays: Temperatures should be monitored continuously, as exposure to adverse conditions can occur at any time. Digital data loggers can record temperatures outside of normal working hours to ensure consistent vaccine storage conditions.
Understanding and addressing these misconceptions about the Refrigerator Temperature Log form is instrumental in safeguarding vaccine potency and, by extension, public health.
Maintaining the integrity of vaccines is a critical responsibility in healthcare settings, necessitating diligent monitoring and recording of refrigerator temperatures to ensure they are stored within the recommended ranges. The Refrigerator Temperature Log form is an essential tool in this process. Here are key takeaways about filling out and using this form effectively:
Effectively using the Refrigerator Temperature Log form is integral to safeguarding vaccine efficacy, ensuring that they are stored at optimal temperatures to maintain their potency and protect public health.
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