1. Storage and Record Keeping Requirements for Transfusible Blood Components
Presenter: S. Purcell

2. Objectives Transfusable Blood Component Temperature Requirements
Storage and Maintenance of Blood Components
Identifying, investigating, and documenting deviations

3. Objectives continued
Reporting requirements
Hospital Inspections

4. 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.

5. 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; or 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.

6. Transfusible 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, oxygen, carbon dioxide and other elements that are able to maintain the blood at a single constant temperature.
Once the blood is collected outside of the body though there are different storage temperature requirements, due to the blood being in a foreign environment.
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 maintained at those temperatures for so long, after collection.

7. Transfusible Blood Component Temperature Requirements, cont
This is called the shelf-life of the component. 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.

8. Transfusible Blood Component Temperature Requirements, cont
Temperature Range
Shelf Life
Storage Unit
Whole Blood
1-6C
21 or 35 days
Refrigerator
Red Blood Cells
42 Days
Frozen Red Blood Cells
-65C or Colder
10 Years
Ultra Cold Freezer
Cryo/ Pooled Cryo
-20C 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.

9. Transfusible Blood Component Temperature Requirements, cont
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.

10. 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

11. Storage and Maintenance of Blood Components, cont
Storage unit configuration, cont
Top to bottom
Top: Available inventory
Above Quarantine, below Available Inventory: Reagents
Bottom: Quarantine

12. 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 takes 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

13. 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.
Platelets also require constant agitation to facilitate air exchange and prevent clumping. The exchange of air flow helps prevent bacteria build up.

14. 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

15. 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

16. 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
Move to another location that maintains the same temperature range
AND
Record the temperature at least every 4 hours
Document all actions taken

17. Storage and Maintenance of Blood Components
Maintenance of storage units
Helps 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

18. 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
Electronics thermometers may require more frequent
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

19. 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, comments.
Document on affected record or record location of documentation on record
It is not sufficient to attach records. You must explain the situation.

20. Identifying, Investigating, and documenting deviations
The majority of errors that create storage temperature deviation(s) fall into one of the following four categories:
Responding to warnings
Appropriate and timely relocation of products
Documenting activities, temperatures, comments
Lack of timely notification to the blood center

21. 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
Staff had a door open too long or didn’t close it completely
Equipment is under repair yet it is still being used to store product

22. 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.
The rules for rounding temperature measurements are difficult to interpret.
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.
There is confusion about the length of time products can be exposed to temperatures beyond the acceptable range for storage.
If there was a way to indicate a storage unit temperature was actually acceptable, products would not have to be moved or go through the notification process.
There are reoccurring problems with storage units that have not been addressed i.e. defrost cycle that causes temperature to go out of acceptable range.

23. 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 and time to prevent a deviation OR if corrective action will not or cannot prevent a deviation; time to react and move product.
Remember: Alarm = potential/actual deviation = more documentation of:
Temperature and times
Individual(s) involved
Actions taken
When, where, how products are moved

24. Identifying, Investigating, and documenting deviations
Posted corrective action
Is it current?
Does it give staff the basics in order to respond appropriately to an alarm?
Is it visible?
Adequate documentation of an event
Date
Time of all steps taken
Initials for employee(s) involved
Duration
Action Taken
Units involved

25. Reporting Requirements
Important numbers 30
The number of minutes a component can be out of controlled storage OR
The number of minutes a component can be exposed to unacceptable temperatures 4
The maximum acceptable hours period between temperature recordings
Usually satisfied through the use of a chart recorder or automated monitoring system
If those are not available, manual temperatures are required

26. 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?
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 the 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

27. Conclusion
Recording charts are not always reliable
Recording charts can be used incorrectly
Consider a backup system such as automated monitoring

28. Thank you
Questions
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