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This is something I found on the CAP website: (For some stupid reason I did not copy the URL.) From the CAP website: Optimum timing of post-transfusion phlebotomy is critical for ensuring meaningful laboratory testing results, and medical judgment is required in making this determination. Several factors must be considered, including the type and amount of blood product given, purpose of the test (that is, the question it is intended to answer), and clinical setting. In general, it is best to perform phlebotomy when the patient’s circulatory system is in homeostasis. A patient who is bleeding or undergoing blood product transfusion, or both, is not in a steady state. Whenever possible, samples for laboratory testing should be postponed until bleeding has stopped and transfusion is complete. One obvious exception to this rule, however, would be the setting of massive transfusion, during which monitoring certain laboratory values, such as cell counts and coagulation parameters, is essential to guide ongoing therapy. Variables such as patient blood volume, cardiac output, renal function, and volume of blood products transfused affect how quickly homeostasis is achieved following transfusion. For the evaluation of post-transfusion increments in hemoglobin, hematocrit, and platelet counts, a practical approach is to draw blood samples within 10 to 60 minutes after completing transfusion, as this time interval is aimed at measuring peak recovery.1 Results determined from blood samples drawn later than 60 minutes post-transfusion are increasingly affected by confounding conditions, such as splenic sequestration, sepsis, and consumption.1,2 If the intent is to determine the extent of such confounding processes on red cell and platelet counts, one should combine a 10-minute post-transfusion sample with sequential samples drawn at one hour and 24 hours post-transfusion. Alterations in chemistry test results following transfusion are not usually a concern in the low-volume transfusion setting. However, assay results may be affected for varying periods following transfusion of large amounts of blood products, as seen in massive transfusion, red cell, or plasma exchange—particularly if the recipient has impaired hepatic or renal function. Banked storage of red cells results in elevated plasma levels of hemoglobin, potassium, LDH, and iron in the blood unit that may, particularly in the metabolically impaired patient, be reflected in the post-transfusion laboratory values. In addition, citrate anticoagulant present in blood products may result in transient hypocalcemia in the recipient.3 Therefore, following large-volume transfusions or exchanges, waiting 12 to 24 hours before drawing samples for chemistry assays will provide results that are more reflective of the patient’s underlying metabolic state.

If they have a historical type on file, you do not need a current T/S to issue plasma and platelet products. For RBCs you do need a current T/S.

In the long ago past, we had to make up our own validations. While not realizing we were doing so, we based them on risk assessments of the process. For instance, what is the risk of switching your Anti-A from one vendor to another? If you follow of the manufacturer's instructions, and they are both licensed by the FDA, the risk is close to zero. In my humble opinion ABO QC is a waste of time. In the tens of thousands of times I've seen it performed in our organization, it has never failed. Regardless, yes we perform QC. Now, you buy a complex analyzer, it is nearly impossible to develop a good risk assessment without the assistance of the vendor. I always start by asking the vendor for a validation plan. Some provide Word docs that you can edit for your own facility. We always do what they recommend at a minimum, and usually more. We've been lucky in that our vendors provides these plans. Moving forward, that will also be part of my negotiation for new equipment, that I will ask for them to include a validation plan.

We have had open heart surgeries here for years. A few years back, anesthesia and one of the heart surgeon got a wild hair to have TEG. It has been a major waste of time and money. We had the results feed live into the OR so that they could see them. The company came in a gave them all instructions on the system and how it could help them determine what blood products they needed. They have never used it to make decisions during surgery. Regardless of the results, if their patient is bleeding, they are going to want plasma, platelets, and possibly cryo. We are currently keeping 1 plt pheresis. 2-4 prepooled (5 cryo/pool) cryoprecipitate in house on the days that we have surgeries. We've started keeping 2 A plasma thawed at all times. Most CABG procedures require few products, Valves Replacements can be bigger users.

I would think that the rephrasing was to emphasize that is is the reagent in the vials (not just the vials themselves!) that expires after 7 days. I think it is clear that they are saying they claim the reagent is stable for 7 days after opening. If I were an inspector, I would interpret the new phrase as indicating that the "performance characteristics" end after being "maintained" for 7 days, which would mean that you cannot use a vial after that time. Scott