Built on a 37-year history in apheresis collection, HemaCare Bioresearch Products and Services is a trusted research partner and leader in human primary cell and tissue collection, processing and cell therapy. Located in Van Nuys, California, HemaCare provides high-quality biological material derived from normal and mobilized peripheral blood, bone marrow and cord blood needed to ensure quality research outcomes that meet the unique needs of the scientific community.
As biomedical companies like HemaCare adapt to meet the growing needs of their customers, it is necessary to be flexible. For such companies operating in a heavily regulated environment, powerful yet configurable software can help meet these challenges and take advantage of new business opportunities. Today, Freezerworks’ sample management software plays an important role in managing the movement of blood products in a global market from production, storage, sale and shipment. And, because of Freezerworks’ configurable nature, HemaCare officials are now looking at ways to expand its use in a timely and seamless manner to meet those new opportunities.
The Challenge From Paper to Spreadsheet to Relational Database
Christine Lee, Manager of Regulatory Affairs and Quality Assurance for HemaCare, recalls how the company needed to improve its product inventory management.
“When we started providing cryopreserved blood products like mononuclear cells and stem cells for sale, it was a challenge to track inventory” Lee explained. “We had a paper system, but it became cumbersome and lacked efficiency for our growing business. We transitioned to managing with Excel spreadsheets, and while it was easier to manage, we needed to improve the traceability of the information.”
HemaCare selected Freezerworks software to streamline tracing the availability of its blood product line. Blood products have to go through a heavily validated process of testing and approval to move from production to quarantine to release for sale. And as vials are removed from inventory, Freezerworks gave HemaCare the ability to track product availability in real time, so that the sales staff could tell immediately on product availability. Powerful database search capabilities could further improve the task of locating inventory, compared with the tedium of searching through spreadsheets.
As a relational database, Freezerworks manages the connections between the Sample, its resultant Aliquots, and all Transactions performed (e.g., records of products shipped out for sale or testing.). Proper setup of the system to take full advantage of this structure especially helps to facilitate and simplify the process. (Today, Freezerworks provides the ability to easily track Patients/Donors, which is discussed later in this study).
Lee was recruited to manage the incorporation of Freezerworks software as she a) understood the operational workflow, b) knew how a QA department would want an inventory program to behave and c) could validate the software to satisfy regulatory requirements. Even though Lee had no prior training in information technology, with the guidance of the Freezerworks support department, she was able to successfully complete the task in about a six month timeframe.
To learn how to configure Freezerworks according to HemaCare’s needs, Lee attended a three day Freezerworks Training Camp. Following training, Lee was able to make needed improvements to HemaCare’s use of the software to meet its growing inventory management needs. She designed the Samples page so that each sample record represented one human donor. In this way, “each sample record has the characteristics that end users want to see in an easy to view format,” Lee explained.
From there, Lee formatted the Aliquots entry page, used for both assigning freezer locations to new product aliquots as well as tracking product availability in real time.
Building standardization into the data field relationships was the next task. The Freezerworks configuration model allows the institution to name and define its own fields, and to further build relationships between those fields without the need for a programmer. Lee was able to configure the HemaCare data fields so that as a field entry is selected, associated fields could be automatically populated based on the first entry. Lee focused on utilizing rules-based data fields that would limit users from entering invalid data for blood products, as well as restricting them from wrongly entering associated fields. The latter was done by allowing only certain values to be entered based on a definitional entry in another field. Automated entries like these streamlined the data entry task while dramatically improving data quality and integrity, meeting both Production and QA requirements.
Chain of Custody
As product is developed and entered into Freezerworks, additional testing for sample quality and other checks are required before the product can be released for sale. To protect “quarantined” (not ready for release) aliquots from removal and sale as well as give a quick indication of how much of each product is available to customers, Lee instituted use of the Check Out/Check In feature of Freezerworks. Quarantined aliquots were marked as “checked out”, designating them unavailable for distribution, while a checkmark icon emphasized this fact by indicating graphically on the screen the quarantined nature of the aliquot(s).
When the “Lot Status” is changed from “Quarantined” to “Released”, the aliquots are selected and “checked in” – indicating their availability for sale. Freezerworks’ configurable user defined fields allowed Lee to use color cues to allow users to quickly know the Lot Status (Green = Released, Red = Quarantined).
In these example screens, the category of the sample (Peripheral Blood) is indicated in the Samples Entry page (named “BioRepository”). When the product category is entered, the Aliquot Type, Product Name, and Cell Count fields are automatically defaulted for each aliquot record.
Lee pointed out how her background in quality assurance was critical in configuring the program.
“When I designed all these fields, I recognized what information was required for accuracy and traceability. If I’m going to perform an audit, I’m expecting a user to be able to show me from creation to distribution where a vial is throughout the process and how the entire process is documented,” Lee explained.
Running an Internal Audit
Six months after beginning the process, and with the new configuration in place, Lee measured a >98% traceability success rate from her own check as QA manager.
“I conducted an effectiveness check after implementation of the process by auditing our inventory. A trace audit was completed on selected vials. Each vial was tracked through the entire process from worksheet to inventory. The intent was to verify that users were following the correct procedures, using the drop down lists and fields correctly, and vials were located where Freezerworks indicated their location.”
Real time information access for the sales department
Integrating the new setup for use throughout company operations was a step in the goal of continual improvement by the HemaCare staff, from production to sales, to provide high quality products in a timely fashion. Prior to the new configuration, the sales staff would have to wait to obtain information on available products. Now customers can request up to date inventory volume and donor variety in real time and receive “just in time” ordering for faster use in their research. Locating the vials for an order could take time. Having real time access to product availability has resulted in increased productivity as their use of Freezerworks improves and increases.
Custom inventory and future developments
In the HemaCare business model, there are products for general sale to researchers, but also special collections that are provided for specific customers. For these special collections, with their unique fields and characteristics, Lee takes advantage of the ability to create multiple screens in Freezerworks. When fulfilling shipment requests
for special collections, the staff will go to a separate screen (see right). This feature helps assure HemaCare the system is flexible enough to meet growing market opportunities.
Anticipated cost savings in software purchases and development
Lee said she is looking forward to implementing the newly released upgrade (Freezerworks 2015) and its Summit Edition, which offers an additional patient table. Her participation in the beta testing of the Freezerworks 2015 upgrade has demonstrated that HemaCare will be able to utilize the same program for future developments. The ability of the patient table to link patient information to samples and aliquots can provide efficiency to HemaCare’s support of clinical trials in cell therapy.
“If Freezerworks did not allow for the flexibility to modify fields on demand, we might have had to look for different software just to manage the clinical trials. But with the new upgrade I can see Freezerworks being used for both,” Lee said. She pointed to HemaCare’s own history of moving from primarily blood banking to blood product provider as indicative of the need for software that is flexible.
“For HemaCare, it’s important to have a system flexible enough that we could adapt it on demand to meet the requirements of our business,” Lee said.