Strategic and Compliant Use of Refrigeration Devices

March 2022 - Vol.11 No. 3 - Page #18
Category: Refrigeration/Freezers

Q: What are the key regulations governing refrigerated storage devices used in the blood bank?

Doreen Atlak: The wording may differ among agencies, but certainly among the key elements of regulatory compliance for refrigeration devices are continuous temperature monitoring, audible alarms (eg, for open door, power loss, or malfunction), and quarterly alarm testing.

Q: How are your refrigeration units best arranged to delineate between uncrossmatched, crossmatched, and autologous RBCs, as well as quarantined RBCs?

Atlak: As a matter of policy, autologous and directed donor units are stored separate from general inventory. Likewise, quarantined units are stored on a separate shelf in a refrigerator that is clearly labeled for this purpose. Some institutions store crossmatched units in different refrigeration devices than uncrossmatched units. Instead, we label crossmatched units as such and indicate “Not Available” on the label. This process has been facilitated by automating inventory levels in our LIS, which maintains (via scan) the status of every blood unit as available, crossmatched, issued, or transfused.

Q: How are these products further separated from refrigerated devices storing patent samples and reagents?

Atlak: Blood and reagents are stored in separate and clearly delineated refrigerators. This is done both as a policy to keep reagents and other refrigerated materials separate from patient specimens, but also because their storage conditions differ from each other. Per US FDA’s Code of Federal Regulations,1 as well as other regulations from organizations such as AABB, blood is intended to be stored at 1°C- 6°C, whereas reagents are generally stored at 2°C- 8°C.2

Q: What common scenarios could lead to a temperature variation in a blood bank refrigeration device?

Atlak: Typically, temperature variations in a refrigeration device are caused by a mechanical disruption or failure (or power failure) or a simple door ajar. Fortunately, medical-grade refrigeration devices have several fail-safe mechanisms in place to alert staff of potential problems, allowing time to correct the situation before products and specimens are compromised. However, in the event the device cannot be fixed prior to a substantial increase in internal temperature (ie, above 6°C), certainly blood products must be transferred to a working refrigerator. This highlights the value of closely monitoring for trending temperature variations or repeated alarms.

Q: How are the blood bank’s refrigerated storage devices monitored for performance?

Atlak: All refrigeration unit temperatures are manually read and documented daily, and are specific to certain locations within each unit (ie, top left, lower right, internal glycerol housing the probe, etc). Furthermore, blood storage units have a continuously monitoring 7-day graph and a local alarm. In the event of an issue with a device, a remote alarm will also sound in our facility’s telecommunications department, from which a representative will contact the blood bank to confirm action is being taken. Likewise, freezers in the blood bank are monitored and maintained in the same manner as refrigerators.

Subsequent to these processes, all blood bank temperature monitoring documentation is required to be saved for a minimum of 10 years according to the New Jersey Department of Health and other regulatory and accreditation groups.3

Q: What staff members are responsible for the monitoring of blood component storage units?

Atlak: Night shift staff members record that day’s temperature documentation, but all blood bank staff are trained to monitor temperatures and respond appropriately to any issues. Beyond monitoring and remediation (eg, moving products in the event of a mechanical failure) the hospital’s engineering department is notified to investigate potential issues under their purview. With the integrity of blood products paramount, relocation is considered first if there is expected to be a delay in correcting mechanical issues.

Q: How often are blood component storage units inspected and how is that process performed?

Atlak: Blood bank staff performs quarterly alarm testing complimented by quarterly mechanical inspections by our hospital’s engineering department according to established policies and procedures (P&Ps). Key elements of refrigeration P&Ps include rigorous maintenance of appropriate temperatures, known locations of alternate and suitable refrigerator and freezer devices, as well as processes for transitioning of products between devices (eg, packing blood on ice).

Q: What devices or other technology is utilized to ensure blood component integrity during processing and transportation?

Atlak: The blood bank, hematology, and phlebotomy all utilize coolers for the transportation of blood and blood products, and the integrity of these coolers is also validated twice per year. Associated thermometers are validated yearly, but all staff are trained to visually inspect transportation containers for any damage or breakdown.

Q: How do these devices differ when processing and transporting platelets or frozen blood products?

Atlak: The primary difference involves proper temperatures. For example, dry ice is utilized when transporting frozen products, whereas containers used for platelets are designed to maintain room temperature (ie, 20°C - 24°C) by utilizing gel packs.4

Q: What is the strategy for placing blood products within a refrigerator or freezer?

Atlak: A basic strategy for placing blood products in refrigeration is first in, first out (or FIFO). Given that blood and blood products have an inherent expiration date, new products are placed and kept in refrigerated storage such that those with the shortest date of expiration are taken first, with the freshest products placed behind them.

Q: What other laboratory-centric practice areas, such as phlebotomy, have access to or responsibilities for refrigerated devices (including transfer of specimens)?

Atlak: There are numerous refrigerators and freezers utilized throughout the laboratory involving different temperature requirements for storage of patient specimens and samples, as well as reagents. Each of these practice areas and their related staff also have training on proper use of refrigerators and on the P&Ps that govern proper usage. That said, the blood bank is responsible for a blood refrigerator that is housed in the OR department, and a refrigerator in use at an offsite infusion center. Staff members from those practice areas relay device monitoring information to the blood bank in order to maintain proper records and compliance.

Q: What recommendations would you make for the key features to consider when purchasing refrigerators for use in blood bank and transfusion medicine?

Atlak: Given how vital the integrity of blood and blood products is to laboratory operations and positive patient outcomes, purchasing from a reliable vendor that manufactures refrigeration devices designed specifically for blood bank and related laboratory operations is essential. In most hospital blood banks, there is heavy usage of these devices with numerous accesses throughout any given day.

While the action of a refrigerator or freezer may seem simple in theory, the need for strictly maintained parameters is constant, and temperatures must be evenly maintained throughout an individual device. To enable this in perpetuity, compressors must be durable, and each device must have adequate and appropriate temperature monitoring capabilities. As with most technology in today’s medical laboratories, healthy training and adherence to established P&Ps go hand-in-hand with ongoing performance and reliability for consistent results.


References

  1. US Food & Drug Administration. Medical Devices. Code of Federal Regulations Title 21; Vol. 7. Sec.640.2 General requirements. Accessed 2/22/22: accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=640.2
  2. Laird Thermal Systems. Refrigeration Systems for Reagent Storage. Accessed 2/22/22: lairdthermal.com/thermal-technical-library/application-notes/refrigeration-systems-reagent-cooling
  3. New Jersey Department of Health. Public Health and Environmental Laboratories. Regulations; Chapter 8: Collection, Processing, Storage and Distribution of Blood. Subchapter 5: Records and Reporting Requirements. Accessed 2/22/22: nj.gov/health/phel/documents/chapter8reg.pdf
  4. US FDA. Medical Devices. Code of Federal Regulations Title 21; Vol. 7. Sec.640.24 Processing. Accessed 2/22/22: accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=640.24

Doreen Atlak, MS, MT(ASCP)SBBCM, is the blood bank manager at The Valley Hospital in Ridgewood, New Jersey, where she has worked for over 20 years helping to bring automation and technology to blood bank and laboratory operations.

WHERE TO FIND
Refrigeration/Freezers
For a full list of vendors offering Refrigeration/Freezers, go to: www.medlabmag.com/findit
Key Refrigeration/Freezers Suppliers
Follett
Follett high-performance refrigerators
Helmer Scientific
GX Solutions Laboratory Refrigerators
Aegis Fridge
Health Care Logistics
Norlake, Inc
PHC Corporation of North America
So-Low Environmental Equipment
VWR International

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