Based at Ogden Regional Medical Center in Ogden, Utah, MountainStar BloodServices is an FDA-licensed blood center that supplies blood products to the Medical Center as well as to seven local hospitals within the regional hospital network.

With the network’s blood-dependent services, which include emergency surgeries, needing more than 2000 units of blood a month, MountainStar needed a solution that would enable them to maintain regulatory compliance.

Q-Pulse, from Gael, provides blood service providers like MountainStar Blood Services with an integrated compliance management solution that helps manage regulated activities including Document Control, Auditing and CA/PA Management in regulatory environments such as 21 CFR Parts 11, 210-211 and 600.

With more than 100,000 units of blood and blood products needed by patients annually in Utah, and with more than 20,000 units of those processed at the Center, MountainStar supply an ever-increasing demand for blood products whilst ensuring safe transfusions ‘from vein to vein’.

"As a small blood center within a hospital, probably the greatest challenge we faced was in finding a program that was user-friendly and within our budget," says Judy Francis, MountainStar’s Technical Supervisor at the Center. "To find a system that we could configure the way we wanted and that had an impressive customer base was perfect for us."

In researching available solutions, MountainStar identified three key requirements that had to be met:

• track and monitor controlled documentation including SOPs and quality manuals, with staff able to maintain revisions adequately and to verify what state of completion SOPs and other
  documents were in
• reduce reliance on paper documents and increase the efficiency of document routing
• compliance with standards and regulations, including 21 CFR Part 11

With the Blood Service currently the only Utah-based blood operation with an interstate FDA license, MountainStar had to make sure that the solution they chose enabled them to comply with strict FDA standards and regulations, including Title 21 CFR Parts 11, 210-211 and 600.

"As in every industry, there are so many aspects of blood banking that require control," says Judy. "Q-Pulse more than meets our needs, as it allows us to control many of our regulated activities with a single integrated system. Since we were completely relying on paper, controlling our operating procedures always seemed to be problematic. We had trouble controlling the number of manuals – at one time we had 13 in the field – and it was also very hard to maintain revisions adequately and to know what state of completion SOPs and other documents were in.

"Relying on paper also made routing documents really difficult with our previous system. I was only routing documents to 4 people, but with so many documents in the field it still became a huge nightmare, and I finally had to make a chart of where documents were so I could keep track.

"However, without direct access to the standalone system, departmental staff were unable to get information at the point of need, which restricted the effectiveness of the system and reduced the efficiency of the whole QMS."