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

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

Objectives continued Reporting requirements Hospital Inspections

Why is this important? Code of Federal Regulations Title 21, Part 600 Sec. 640.11 (a) ...the Red Blood Cells shall be placed in storage and maintained at a temperature between 1 and 6 deg. C. Sec. 640.25 (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.

Why do blood product storage deviations need to be reported to the FDA? Sec. 600.14 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.

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.

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.

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.

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.

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

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

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

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.

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

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

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

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

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

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.

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

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

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.

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

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

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

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

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

Thank you Questions ???