Based in Anchorage, the Blood Bank of Alaska is committed to meeting the blood needs of the US state’s sick and injured, providing 24-hour service to more than 20 hospitals over more than half-a-million square miles.
Q-Pulse provides blood operations like the Blood Bank of Alaska with a fully integrated compliance management solution that helps manage regulated activities including Document Control, Auditing, and CA/PA Management, in regulatory and compliance environments such as 21 CFR Parts 11, 210-211 and 600.
Based in Anchorage, the Blood Bank of Alaska is committed to meeting the blood needs of the US state’s sick and injured, providing 24-hour service to more than 20 hospitals over more than half-a-million square miles.
And with six different locations across the state as well as mobile crews, when the Blood Bank needed a solution in accessing up-to-date, FDA-compliant copies of their controlled documents securely and at the point of need, they chose Q-Pulse, from Gael Ltd.
Q-Pulse provides blood operations like the Blood Bank of Alaska with a fully integrated compliance management solution that helps manage regulated activities including Document Control, Auditing, and CA/PA Management, in regulatory and compliance environments such as 21 CFR Parts 11, 210-211 and 600.
At more than twice the size of Texas, Alaska is the largest state in the US, but, with few road connections compared to the rest of the country, most cities and villages in the state – including the state capital, Juneau – are accessible only by sea or air.
With recent advances in medical and surgical care driving an increasing demand for blood and blood products, the Blood Bank had to expand its services while maintaining high levels of quality and safety throughout the transfusion process.
‘Before choosing Q-Pulse, we’d researched available solutions,’ says Marilyn Jeffers, Project Manager for Quality Assurance. ‘As a relatively small organization, we needed a cost-effective, user-friendly solution that could be put into place in little or no time, but with which we’d be able to comply with FDA, AABB and CLIA standards and regulations.
In researching available solutions, the Blood Bank identified 3 key requirements that had to be met:
- controlled documents had to be accessible from a central location, with site managers able to manage and track all documents throughout the change control process
- each location had to be able to view documents and raise change requests, with staff able to distribute revisions and drafts for acknowledgement and approval to every location
- compliance with standards and regulations, including 21 CFR Part 11
As a member of America’s Blood Centers (ABC), the Blood Bank is licensed and regulated by the FDA. With FDA oversight of the blood industry increasing significantly, the Blood Bank had to make sure that the solution they chose enabled them to comply with strict FDA standards and regulations.
In addition, the Blood Bank is inspected and accredited by the American Association of Blood Banks (AABB) and the Clinical Lab Improvement Association (CLIA); as well as the FDA’s rigorous requirements, the Blood Bank had to make sure that the solution enabled them to meet AABB standards and CLIA-88 regulations.
‘Having looked at competitive systems, we found that Q-Pulse delivers real value for blood operations such as ourselves; Q-Pulse integrates easily with our existing systems and gives us exactly what we were looking for, for considerably less than comparable systems.’
According to Ms. Jeffers, Q-Pulse more than met the Blood Bank’s 3 key requirements.
‘We’ve made huge savings in time, effort and cost in terms of managing our information,’ explains Marilyn. ‘Q-Pulse lets us keep track of people and the activities and actions for which they’re responsible within our management system.
‘Management at the Bank can now take complete ownership of documents for which they’re responsible at every stage of the change control process, which will improve the accuracy of our records and the version control of our documents.
‘Q-Pulse has also helped us to reduce the time and effort spent throughout the change control process: identifying and tracking which documents are currently being revised and which have been approved can now be done at-a-glance by staff at each location.
‘For example, occurrence reports can now be signed off by multiple members of staff at each location, as well as management.
Q-Pulse can also help blood operations to comply with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures, with functionality including:
- robust passwords
- intruder lock-out and password expiration
- additional electronic signatures
- full audit trail in creating, editing and deleting records
With detailed audit trail and electronic record management, Q-Pulse gives blood operations everything they need to put the technical controls of a 21 CFR Part 11 compliant system in place, laying a foundation on which they can build the administrative and procedural controls for compliance with 21 CFR Part 11.
‘Q-Pulse gives us a centralized way of managing our QMS documents and records, including all of our SOPs, in line with the record-keeping requirements of the FDA, which require us to maintain centralized, up-to-date documentation,’ says Marilyn.
‘During FDA inspections when the inspector wants to see copies of all documentation, we will be able to provide immediate access to our centralized store of documentation through Q-Pulse.’
Conclusion
With the FDA oversight of the blood industry increasing significantly, blood operations are now required to ensure that the collection, testing, processing, storage and distribution of blood are all performed in a robust, quality-assured environment.
And with the penalties for failing to comply with laws and regulations also increasing, ensuring the safety and quality of more than 28 million units of blood and blood products – the amount received by patients last year in the US – is more important than ever.
To comply with strict FDA standards and regulations, including Title 21 CFR Parts 11, 210-211 and 600, as well as AABB standards and CLIA-88 regulations, blood operations must put systems in place that can help manage their compliance with legal and regulatory requirements.
A compliance management solution that fully integrates key regulatory functions such as Auditing, Document Control and CA/PA Management can help blood operations to maintain and improve regulatory compliance, as well as to streamline processes and reduce the duplication of effort by enabling the integration of compliance activities and actions.
Q-Pulse can also help blood service providers identify opportunities for continual improvement, from tracking corrective and preventive actions to measuring the effectiveness of the QMS.
Contact us now at bloodservices@gaelquality.com to find out how Q-Pulse can help you to reduce time and effort, reduce the duplication of effort and reduce resource expenditure.