Thursday, August 16, 2007

Blood Test

I discussed below the results of the unannounced survey by our accreditation body, the Joint Commission. We are also subject to inspections by other regulatory agencies. One is conducted by the Food and Drug Administration, to ensure that our handling of blood products (i.e., blood banking and transfusion) is carried out in accordance with federal standards. The inspections are completely unannounced. There are no black-out dates, so we are not given blocks of time for which we can expect an inspection.

The standard enforced by the FDA is called "current Good Manufacturing Practice" (cGMP). The rules of cGMP cover areas such as organization and personnel, facilities, equipment, supplies and reagents, standard operating procedures, labeling, compatibility testing, records, adverse reaction files, and deviation reporting. The goal, of course, is to ensure that the blood products we collect from donors, process, crossmatch, and transfuse to our patients high certain standards for safety, purity, potency, and labeling.

Our unannounced inspection started on August 7. The inspector spent 5 full days touring our facilities, interviewing staff in our Pathology Department and on the floors, observing operations, and reviewing documents and records. By touring the blood banks and the Infusion & Pheresis Unit, the inspector checked to see that our facilities were clean and orderly. During this inspection, the inspector observed an autologous whole blood donation in the Infusion & Pheresis Unit. In the blood bank, she observed our processes for receipt of blood from our outside blood suppliers as well as our processes for management of our inventory, including confirmation of the blood component ABO and Rh type. Additionally, she reviewed the functionality of our blood bank computer system related to product testing, patient testing and product distribution for transfusion.

The inspector also checked for proper storage and handling of blood products. Blood storage refrigerators and freezers were audited for proper temperature and proper labeling and segregation by ABO and Rh type. Records of temperature monitoring and alarm conditions were reviewed to ensure that products were maintained at the proper temperature at all times. Disposition records were reviewed to ensure that products not suitable for transfusion were destroyed.

Written standard operating procedures were also checked for evidence of timely reviews. Training records of new employees were reviewed, as were quality control records of equipment, such as the blood irradiator, and also for reagents used in blood typing and compatibility testing.

I am pleased to report that the FDA inspector found no reportable issues or recommendations. We are quite pleased with this result. We always want to be able to assure our patients that blood products they receive at this hospital have been prepared following good manufacturing practice in order to ensure the products’ safety, purity, and effectiveness.

8 comments:

Anonymous said...

Paul;

Sincere congratulations from a laboratorian who knows how great this really is. Often overlooked by patients and staff, good blood bankers are among the most compulsive people on earth, as well they should be. Until that far-off day when a viable blood substitute exists, they will be laboring in the basement (often) to keep patients safe.

Anonymous said...

Okay, let me guess. That anthropomorphized magenta tear drop in the accompanying picture is supposed to be a drop of blood, right? If that is what is coursing through me, no wonder my skin is reacting to it with rosacea!

Paul Levy said...

That's Reddy, the American Red Cross" mascot for blood drives.

Mark Graban said...

Paul, congratulations to you and your blood bank staff! As someone who often works with blood bankers, I know they are often "forgotten about" in the basement of their hospital (as anon 4:56pm said). It's stressful work since the impact of mistakes is so potentially harmful or fatal. It's great that you would share their accomplishments with everyone.

Paul Levy said...

Thanks, Mark.

Will said...

When I worked at a pharmaceutical manufacturing facility I was surprised to see someone from the Red Cross at a conference for people involved in GMP (or cGMP) training. I had assumed that the Good Manufacturing Practices wouldn't apply to blood products since I didn't see that as a manufacturing process, but the guy explained that the FDA treats blood products with the same standards as pharmaceuticals. It was a kick to think of a manufacturing process where people were both the supplier of raw materials and the manufacturing equipment, and that the body has such an efficient and self-contained method for making blood. Each person is like his or her own little factory. It made me realize just how valuable blood donors are -- this is a product we cannot manufacture any other way.

Anonymous said...

Its really comforting to know that the hospital of choice for my family is as good as we think it is and then some. I have a family member scheduled for surgery very soon and that can be stressful enough. Its really nice not to have one more thing to worry about.
Thanks

the sak said...

A thought experiment...
http://en.wikipedia.org/wiki/Thought_experiment
the strategy of let's get tested TOGETHER BEFORE we have sex for A VARIETY of sexually transmitted diseases http://notb4weknow.blogspot.com

The same testing that works for the safety of the blood supply works for potential sex partners.