Ellen Zeigler

We're a large university center. The OR has 3 refrigerators that are monitored on the blood bank system. There is also a large cooler on wheels for liver transplants that has been validated. The blood bank and the OR are 3 floors apart. Overall our blood wastage is low for the size and complexity of the facility, however, it appears to be creeping up. A large number of the products wasted are a result of apheresis platelets or cryo being thrown into bags with red cells to return to the blood bank. We end up with cold cryo and platelets and warm RBCs. For room temp products (not expecting the product labeling to be sufficient) we put a green fluorescent 2" X 3/4" on each product that says DO NOT REFRIGERATE . Any suggestions? Thanks

This surfaced about 9 months ago here (university center) from a different aspect in that the Orthopaedic Clinical practice is making their own in their office setting. After a bit of heartburn, I wrote their initial SOP so they could track supplies, etc. There are several FDA-approved devices that appear to be very simple (although I'll acknowledge that I have a blood center background). If you don't have any luck with moving the production to the office setting, the AABB Technical manual does have good instructions for making PRP. Good Luck

Once you're firm on the requirements, I would suggest that you contact the nearest donor center and talk to their [laboratory] education person to determine if you can audit the required sections. The donor center then provides [to you I believer]the necessary documentation.

You may want to search the FDA web site (devices) for Platelet rich plasma. We don't make it but there are some equipment systems that prepare it for the specifics of orthopaedics' practices (some of our sports medicine physicians do) that are FDA approved. They're making autolgous product not intended for coagulation correction, but for materials found in platelet granules

You may want to look at the package insert for the AHG that you use. Some have limitations that are specifically addressed to antibody screening, although there may be others that have/had limitations that would impact compatibility testing.

There are a couple of items that may be used to justify a blood type once each admission in addition to some of the others presented - it is a way to identify potential wrong blood in tube situations - in the current economy, patients are sharing their identities and this would be a way of at least knowing what type person you're transfusing - some Platletpheresis products and most FFP are larger volume products than they once were depending upon your supplier

I pulled the Immucor Anti-Human Globulin (Anti-IgG, -C3d; Polyspecific), Isnert Code 3002-1; 10/2007. A crossmatch is an indirect antiglobulin test (you just don't know the RBC antigen profile when you start). In the secion under Specimen Collection and PReparation, it refers to regulatory agencies, if yours has a limit and for red blood cells from donor units, you may go throughout the dating period of the red cells. The other issue to keep in mind is that evacuated tubes are medical devices and for most - 14 days is the limit. You can always chose to go shorter. We do all in patients as 3 days and up to 14 days for pre admit testing (with no transfusion or pregnancy history)

who's your antisera vendor?

As long as you have an accurate pretransfusion history, the issue becomes the licensure of your AHG antisera. Those with Antibody require the an AHG x-match so its in the hands of the Cooms sera package instert

I would stay away from putting labels on the bags. Adhesive would have to be FDA approved. at the moment my brain has gone blank as to its name but the vendors of BB labels would knw.

The ASQ.org web site has a section on certifications. Within that section are outlines referred to as "Body of Knowledge" for each certification that ASQ has. Ifyou are auditing the CQA is the way to go. If you want a braoder base, you may also want to look at the CMQ/OE - the long way of saying certified quality manager.

This is reportable to the FDA. This issue is not purity, etc, but the ability to track a product years from now if there is a lookback, recall or market withdrawal. The code is QC-97-19 The best way to get an idea of what is and is not reportable, is to look at the coding scheme. Obviously a lot are collection related issues, but not exclusively. If your crossmatch tags that are attached to the product are wrong, or you send out the wrong product, or patient. here's the link to the coding http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/ucm129721.htm and the specifics for the failure to electronically release that is under QC and distribution: QC-97-19 Product not documented or incorrectly documented as issued in the computer (computer documentation is final check of issue process)

One of our hospitals washes but only for limited situations. The typical product infused is CPD/CPDA-1, group O, leukoreduced, CMV neg, irradiated. For exchange transfusions or if blood less than 14 days old is not available, cells are washed. The intent is to remove K+ and metabolytes

The probability of the collecting organization collecting a donor that is not eligible is slim. QC is performed with that procedures as with all others. More likely is the size of the patient, a patient who is on a diuretic, one who is actively bleeding and the hgb/hct is drawn prior to equilibration, or incorrect collection of the first specimen. /COLOR]

I haven't looked at them in a long time, but preiously the only difference between a red cell (standard set ~ 170 u) and a component set was the length of the tubing.