Blood Storage Temperature Monitoring:
Preserving Blood Product Efficacy & Safety

Reducing Risks in Blood Storage & Handling

In recent years, the infectious risks in transfusion blood have greatly decreased thanks to better record keeping and donor screening. Non-infectious risks, such as blood product storage, transport and processing methods are more complex.

Increasingly, blood banks and clinical research facilities are seeking more accurate, automated means for blood storage and blood processing. Blood products used for epidemiological studies, bio-technical research or banked for transfusion purposes must not only be processed, stored, and shipped to preserve their efficacy and safety, all parameters of storage must be recorded and reported for Quality Assurance.

Blood banks have strict quality assurance protocols, which include standard operating procedures and regular quality control reviews. To meet the QA standards and regulatory requirements of the FDA and The Joint Commission (formerly JCAHO) and save time and costs, blood storage and handling protocols must be automated wherever possible. Automation helps eliminate the risk of human error, but all records must be managed in accordance with current requirements of the FDA, CFR and CLIA.

Temperature Monitoring & Alarming for Blood Storage

Methods of Blood Storage Monitoring, Reporting & Validation

From chart recorders, to pen & paper manual systems, to centralized monitoring or thermocouple-based validation tools, there are numerous ways to ensure blood storage temperatures are within specifications.

Each method has inherent advantages and disadvantages.When looking at systems for monitoring blood storage temperature, an understanding of the risks inherent to each method of temperature monitoring and validation can help blood repository directors find a cost and time effective system for ensuring blood product quality.

Blood products are shipped to laboratories and bio-repositories at the temperature most conducive to its intended use, including ambient temperature, refrigerated or frozen; the two parameters most crucial to product preservation are temperature and time.

In addition, maintaining compliant and complete records of these parameters is key to ensuring quality and meeting regulations.While centralized systems can use network technology to monitor storage temperatures, if there is a power failure or the network goes down for any length of time, critical temperature data during the disrupted period will be irrevocably lost.

Simplicity— but not at the cost of Accuracy

A Fail-safe Solution: 24/7 Alarming, Gap-free data

This is where Veriteq's continuous monitoring solution, viewLinc™, provides a fail-safe method of ensuring blood storage temperature data is never lost. The browser-based system is based on standalone recorders, equipped with highly calibrated sensors.

Veriteq's data recorders operate independently of any power source or network connection, making critical temperature data immune to network or power failures.

Ideal for continuous monitoring and equipment validation, Veriteq’s recorders features 10-year battery, on-board memory, and user-selectable alarming options including: email and text messaging to cell phone, flashing PC alert, and dial out telephone notification.

While viewLinc uses your existing network, the autonomous recorders continue to record even during a network interruption, so the data will all be there when you need it, ensuring your records are complete.

Connects Seamlessly to Existing Networks

viewLinc is also easier to install and deploy than any other system. Simply place the loggers, install the server software and begin monitoring via either wired (Ethernet/PoE) or wireless (802.11/WiFi) connectivity.

Immune to network failures, with viewLinc you always have a full audit trail and comprehensive, customizable documentation that ensures compliance with all regulatory bodies including JCAHO, CAP, FDA (21 CFR Part 11) and AABB.

Highly scalable, the viewLinc system can be fit to your needs, from a single application to a whole facility. Because it's browser-based, any number of widely distributed remote locations can be monitored. Access temperature data from most standard Internet browsers. Use the data loggers to monitor or validate, or both.

For more information on current best practices for blood storage temperatures, visit the AABB's Summary of 21 CFR 640.4 on the Collection and Storage of blood.

To find out how Veriteq can create a blood storage temperature monitoring/validation system tailored to your requirements, please contact us.