Digitize For FDA Compliance

A nonprofit blood bank speeds up retrieval times, increases staff productivity, and reduces errors. Digitizing records also facilitates easier compliance with FDA guidelines.

SunCoast Blood Bank is a 501c3 nonprofit community blood bank supplying blood to nine hospitals across four counties. The organization has five collection sites, seven bloodmobiles, a warehouse and a transfusion service. They host over 1,000 blood drives annually, collecting 38,000 units (pints) of blood.

Moving from paper to secure digital donor records   

The organization used an offsite, secure facility to store paper records. This method of record retrieval was slow, information was not searchable and the long-term storage costs were unsustainable. SunCoast wanted a digital solution providing fast, secure and seamless access to their data as well as sophisticated search functionalities. 

Lightning-fast document retrieval 

SunCoast is required to store donor records for ten years. However, if blood is unusable, that record must be stored indefinitely. If a donor updates the record with travel information or if test results disqualify the blood from being used, SunCoast must immediately amend that donor record and contact the hospital to locate that unit of blood.  “With DocuWare Cloud, our turnaround time to pull up a donor’s record to verify or edit information, or post test results, happens in seconds when before it was a 24 hour wait,” said Robert Harper, Director of Quality Assurance. 

SunCoast’s IT staff do not have to implement or maintain the solution  

SunCoast chose DocuWare Cloud because it frees their small IT staff from spending time to maintain it and the solution fits within their tight budget. 

Records are now searched, updated and re-filed digitally 

Staff at the donation centers now have digital access to Standard Operating Procedures manuals (SOP) with clear guidelines for screening donors. “With the SOP manuals in DocuWare, we no longer need to worry about missing pages, or the need to call the main office with questions. Because the staff at each mobile location refer to the manual multiple times a day, having a digital searchable version speeds our intake screening process and aids us with improving accuracy, eliminating errors and calls back to the main office,” said Harper. 

Secure digital files meet FDA compliance regulations  

When there is an FDA reportable error regarding a unit of blood, the blood bank has 45 days to submit the report online and provide evidence of corrective action. Failure to do incurs FDA imposed fines and shutdowns.  Electronic documentation makes regulatory compliance much easier.