Blood Community Meets to Discuss Priorities


Clearly, there is no substitute for blood. There is no substitute for safety in handling blood, either. From donations at blood and tissue centers to transfusions in hospitals, the primary concern is for the purity of this life-giving fluid. The Food and Drug Administration (FDA) requires that blood establishments face some of the toughest regulations and standards today to ensure the safety of the blood supply.

  • 4.5 million Americans would die each year without life saving blood transfusions.
  • Approximately 32,000 pints of blood are used each day in the United States.
  • Every three seconds someone needs blood.
  • Blood makes up about 7% of your body's weight.
  • Much of today's medical care depends on a steady supply of blood from healthy donors.
  • People who have been in car accidents and suffered massive blood loss can need transfusions of 50 pints or more of red blood cells.
  • About 12.6 million units (including approximately 643,000 autologous donations) of whole blood are donated in the United States each year by approximately eight million volunteer blood donors. These units are transfused to about four million patients per year.

Clearly, there is no substitute for blood.  There is no substitute for safety in handling blood, either.  From donations at blood and tissue centers to transfusions in hospitals, the primary concern is for the purity of this life-giving fluid.  The Food and Drug Administration (FDA) requires that blood establishments face some of the toughest regulations and standards today to ensure the safety of the blood supply.

Blood banks and transfusion centers are covered by a number of regulations, including the FDA's 21 CFR Parts 600, 606, 21 CFR Parts 210-211, 21 CFR Part 11 (for those maintaining electronic record-keeping systems), and the Clinical Laboratory Improvement Amendments (CLIA). In addition, many blood establishments affiliated with hospitals adhere to quality standards by the College of American Pathologists (CAP), a professional organization that provides voluntary accreditation.

Electronic document systems are quickly becoming an integral part of quality systems at blood banks and transfusion centers across the United States.  Eva Quinley, a 33-year veteran of the blood banking business who serves as interim senior vice president of quality and regulatory for biomedical services at the American Red Cross, says she foresees more automation in the future for blood banking.  “Automation allows distribution of documents in a timely fashion and ensures that those documents are up to date.  A good document distribution system is critical to the blood industry because we must have the right documents on hand the moment we need them.”

Quinley says the American Red Cross uses an electronic document system in its daily work.  “I remember working the old-fashioned way,” she says.  “We used paper copies that were in various books in various places.  Every time a change was made, we had to make copies and be sure we placed one in each book.”  She says it was laborious and time-consuming. “I think electronic documentation is the way the blood industry is going,” she continued.

Quinley also believes the FDA would be pleased to see more blood organizations using electronic documentation.  “I think the FDA likes to see our industry do anything we can to make documents available to staff in a timely and accurate fashion.”

Beth Kinard, director of operations for Community Blood Center of the Carolinas, is another advocate of electronic documentation. Her organization has 50 employees and serves ten counties and 14 hospitals.  They collect about 18,000 units of blood a year and supply the Charlotte area with 90 percent of its blood requirements.

"We’ve moved all our SOPs that relate to regulatory functions over to our electronic documentation system,” she says.  “We’ve been using the tool for about a year.  Now we’re enjoying the yearly review feature that reminds us to review all the SOPs that have been in place for a year.”

Kinard says FDA and the AABB require that all SOPs are reviewed yearly to ensure that the staff is still competent and trained on all procedures.  “This yearly review feature makes it easy to prove to these agencies that we really are doing what we say we are doing.”

Kinard explains that it’s easy to get behind on SOP reviews.  “When it’s time to make changes to SOPs, an electronic system is so much easier to deal with,” she says.  “We are constantly creating changes and new procedures.  The electronic systems forces us to read and review and it keeps the system really clean.”

Employee training is another area that is important to the safety of the blood supply.  Employees can easily make dangerous mistakes if they are not constantly trained on SOPs. 

“We have about ninety percent of our training set up on our electronic documentation system,” Kinard says.  “We’re very pleased with it.  An SOP won’t be released until employees have been trained on it.  That’s a good safeguard.  It gives us an opportunity to identify training comfort levels in our employees and shows us what areas we need to spend more time on.  Since the regulatory agencies are focused on training, this is very important to us.”

Further, she comments, Community Blood Center’s system minimizes paper shuffling and the mistakes that accompany it.  “We’ve become more efficient and aware of what’s happening in our business,” she says.  “We manage our time better in the office and because we are hooked up wirelessly, our employees can manage their time better in the field.  We do blood drives in the field, so during waiting times, our employees can pull up policies off the electronic system and stay current.  We used to have to carry huge volumes into the field; now we take our laptops and have everything we need.”

Kinard’s organization recently completed an AABB inspection.  “This was the AABB’s first inspection with an electronic documentation system,” she says.  “They were very pleased with it.  We set up an audit feature so they could see the system in action.  The result was a very good inspection and of course, we’re pleased with those results.”

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