1. Storage and Record Keeping Requirements for Transfusable Blood Components
Created by S. Purcell

2. Objectives Transfusable Blood Component Temperature Requirements
Storage and Maintenance of Blood Components
Identifying, Investigating, and Documenting Deviations
Reporting Requirements
Hospital Inspections by Blood Center

3. Why is this important? Code of Federal Regulations Title 21, Part 600
Sec (a) ...the Red Blood Cells shall be placed in storage and maintained at a temperature between 1 and 6 deg. C.
Sec (a) …Platelets shall be placed in storage at the selected temperature range. If stored at 20 to 24 deg. C, a continuous gentle agitation of the platelet concentrate shall be maintained throughout the storage period.

4. Why do blood product storage deviations need to be reported to the FDA?
Sec Reporting of biological product deviations by licensed manufacturers.
You must report any event, and information relevant to the event, associated with…storage…if that event…
Represents a deviation from current good manufacturing practice, applicable regulations, applicable standards, or established specifications that may affect the safety, purity, or potency of that product.
Represents an unexpected or unforeseeable event that may affect the safety, purity, or potency of that product; and
Occurs in your facility or another facility under contract with you; and
Involves a distributed biological product.

5. Transfusable Blood Component Temperature Requirements
Storage Temperature Requirements
Blood in the body is typically maintained at a temperature of approximately 37C.
The body has a mix of gases such as oxygen and carbon dioxide along with other elements that are able to maintain the blood at a single constant temperature.
After the blood is collected, there are different storage temperature requirements. Research has established required temperature ranges to maintain the blood’s safety, purity, potency and quality for safe blood transfusions. Blood components have distinct storage temperature requirements due to their varying make-up and purposes as well.
In addition to blood components being maintained at certain temperatures, the blood can only be stored at those temperatures for a fixed period of time.

6. Transfusable Blood Component Temperature Requirements
All blood components have a shelf-life. After the shelf-life has expired the blood components can no longer be safely transfused and they are discarded or used for other purposes.
Definitions
Purity – uniform and free from foreign matter.
Potency - the ability of the blood component to produce the desired medical effects.

7. Transfusable Blood Component Temperature Requirements
Temperature Range
Shelf Life
Storage Unit
Whole Blood
1-6C
21 or 35 Days
Refrigerator
Red Blood Cells
42 Days
Cryo/Pooled Cryo
-18C or Colder
1 Year
Freezer
Plasma
Platelets
20-24C
5 Days
Incubator/Agitator or Monitored Room
The shelf life of the component can vary based on anticoagulants, additives and type of donation. The FDA requires hospitals to store frozen components at -18C or colder.

8. Transfusable Blood Component Temperature Requirements
Transportation Temperatures:
Generally the same as storage except for RBCs, which are 1-10C
Limited amount of time at 1-10C
If a box is used for storage, all storage requirements apply.

9. Storage and Maintenance of Blood Components
Storage unit configuration
Organized in an orderly fashion
Facilitates proper air circulation and even temperature distribution
Facilitates identification of units
Facilitates use of short dates first
Segregated based on unit status
Blood Type
Quarantine
Autologous
Directed

10. Storage and Maintenance of Blood Components
Storage unit configuration, continued
Top to bottom
Top: Available general inventory
Above Quarantine, below Available Inventory: Reagents
Bottom: Quarantine and/or biohazardous

11. Storage and Maintenance of Blood Components
Temperature Monitoring and Alarms
Temperatures within the storage units must be monitored at all times.
Automated temperature monitoring systems
Recording charts
Storage units must contain some type of temperature monitoring device (TMD) that constantly records the temperature inside the storage unit.
Small units only require one thermometer.
One thermometer must be in the same solution as the probe for the chart recorder or immediately adjacent
TMD maximum liquid volumes
Refrigerators 250ml
Platelet incubators 40 ml
Freezers 100 ml

12. Storage and Maintenance of Blood Components
Temperature Monitoring and Alarms
Recording charts require a daily reading and comparison of the internal TMD with the chart temperature
Refrigerators and Platelet Incubators must be within 1C of each other
Freezers must be within 2C of each other
Chart adjustment may be required if the variances are greater
Recording charts require:
Date, time, and initials of staff starting chart
Date, time, and initials of staff removing chart
Hospital Name and address
Unique identifier of equipment being monitored
Timely review
If the temperature monitoring system ever fails then temperatures must be manually taken and documented on the appropriate Daily Quality Control Record at least every four hours.

13. Storage and Maintenance of Blood Components
Temperature Alarms
All storage units must be equipped with an alarm that is set to trigger if the temperatures are close to drifting out of the acceptable range.
If an alarm sounds staff must respond and investigate immediately.
The alarm reason and investigation must be documented on the appropriate Daily Quality Control Record.
The alarm system must be monitored 24 hours per day.
On site staffing
Remote alarms

14. Storage and Maintenance of Blood Components
Unacceptable Storage Conditions
Outside of the acceptable temperature range
Unacceptable variance between a TMD and the recording chart
The recording chart stops recording
These require immediate correction and investigation
Was the door shut all the way?
Has it been opened frequently?
Is there power?
Are the probes in the solution?
Is the recording chart recording accurately?
If the problem cannot be resolved within 30 minutes of the last acceptable reading, components must be moved to an alternate location

15. Storage and Maintenance of Blood Components
If relocation is required
Use another monitored unit with the same temperature range if available. OR
Pack in UBS shipping containers (or other local blood center approved shipper).
Move to another location that maintains the same temperature range.
AND
Record the temperature at least every 4 hours.
Document all actions taken.

16. Storage and Maintenance of Blood Components
Maintenance of storage units
Routine preventative maintenance keep equipment operating efficiently
Review all operator’s manuals upon receipt of new equipment
Learn how to operate the equipment
Identify recommended maintenance and testing schedules
Follow manufacturers recommendations

17. Storage and Maintenance of Blood Components
Reading Temperatures
Record temperatures to the nearest increment
If the device reads in whole numbers, record temperatures in whole numbers
Round up if in the middle of two markings
Calibrate thermometers
Annually for most
Electronic thermometers may require more frequent calibration.
Refer to certificate and operators manual
Indicate next calibration due date on thermometer
Recording charts
Determine increments of recording chart
Read from the center (usually the highest temperature) outward (usually the lowest temperature)
Compare daily against closest thermometer
Verify date, time, and temperature increments before reading temperature

18. Identifying, Investigating, and Documenting Deviations
Respond appropriately to potential and actual temperature deviations.
Respond to warnings to prevent temperature deviations.
Properly handle products if they need to be moved.
Appropriately document activities, temperatures and comments.
Document on affected record or record location of documentation on record
It is not sufficient to attach records. You must explain the situation.

19. Identifying, Investigating, and Documenting Deviations
The majority of common errors generally fall into one of the following four categories:
Failure to respond to warnings or alarms
Untimely relocation of products
Failure to document activities, temperatures and comments
Lack of timely notification to the blood center

20. Identifying, Investigating, and Documenting Deviations
Problems causing temperature deviations and/or excursions
There is no documentation or insufficient documentation regarding what happened and what steps were taken when a temperature excursion occurred
Warnings are not addressed before temperature exceeds the acceptable limits
Equipment going through its normal defrost cycle along with a high amount of traffic causing a temperature excursion
A storage door being open too long or didn’t close completely
Equipment is under repair yet it is still being used to store product

21. Identifying, Investigating, and Documenting Deviations
Contributing Factors
Staff believe it is acceptable for temperatures to be out of range as long as the temperature is “close” to the acceptable range.
It is never acceptable for temperature excursions beyond the component limits.
The rules for rounding temperature measurements are difficult to interpret.
When necessary, temperatures must be rounded up.
Some product storage units have a combination of alarm delays and alarm set points that allow the unit to go out of the acceptable range without the alarm sounding.
Alarms must sound prior to temperature excursions beyond acceptable limits.
There is confusion about the length of time products can be exposed to temperatures beyond the acceptable range for storage.
Components must not be out of storage greater than 30 minutes.

22. Identifying, Investigating, and Documenting Deviations
What is an Alarm Signal?
Alarm – An electronic or mechanical device that serves to warn of danger or by means of a sound or signal.
How does this relate to what you do?
An alarm signal = a warning = an opportunity to prevent a deviation.
If corrective action will not or cannot prevent a deviation, the alarm allows you time to react such as; moving the product to alternate storage.
Remember: Alarms = potential/actual deviation = more documentation of:
Temperature and times
Individual(s) involved
Actions taken
When, where, how products are moved

23. Identifying, Investigating, and Documenting Deviations
Posted instructions for corrective action:
Is it current?
Does it present easy to follow instructions so staff can respond appropriately?
Is it visible?
Adequate documentation of an event must include:
Date
Time of all steps taken
Initials for employee(s) involved
Duration
Action Taken
Identification for; storage, thermometers, etc.

24. Reporting Requirements
Important numbers: 30
The number of minutes a component may be out of controlled storage. OR
The number of minutes a component may be exposed to unacceptable temperatures.
NOTE: The amount of time blood components are out of appropriate storage should be minimized. 4
The maximum acceptable hours between manual temperature recordings.
Usually satisfied through the use of a chart recorder or automated monitoring system.
If those are not available, manual temperatures are required.

25. Reporting Requirements
Dates and Times of all actions taken and observations made:
What time was the problem identified?
How long did it occur?
Were there components stored within at the time?
What time were they moved?
What were the temperatures of both the pre and post movement storage chambers?
Do you have a backup system that has been validated and QC is current?
What units were involved?
The blood center must be notified prior to returning or transferring any components that fall outside acceptable limits.
The documentation will be evaluated and you will be informed whether the units are acceptable for return.
What are your options if you cannot return?
Consult your Medical Director regarding the use of the components at your facility.

26. Hospital Inspections by Blood Center
What are we assessing?
We use three forms to inspect all storage areas. You can find each form (BS 983A, BS 983B, BS 983C) on the United Blood Services website. Use the forms to prepare prior to your inspection.

27. Hospital Inspections by Blood Center
What are the possible outcomes?
No findings
Findings requiring a written response within 30 days
Suspension of return privileges
Recall of affected components requiring reporting to the FDA

28. Please contact your local blood center
Thank you
Questions?
Please contact your local blood center