SMW

In the USA, the Hgb/Hct determination is generally performed using a sample from a finger-stick puncture and generally includes either a screening test utilizing Copper Sulfate or quantitative tests such as a spun microhematocrit or a Hemocue assay.

In my opinion, all components from this donation should be considered non-conforming and discarded. The donor has demonstrated that they are an unreliable historian and who knows what other questions were not answered truthfully! For this reason, the donor should also be permanently deferred and any prior donations from this individual recalled. More significantly, since it appears there was willful disregard to follow required policies and procedures when approving individuals for donation, ALL products from all donors qualified by this doctor should also be recalled/withdrawn. Willful disregard to followed required policies and procedures would generally be considered grounds for termination.

In my opinon, the only individual that should be transfused with this unit is the donor! In the USA (and I'm certain some other countries who can chime in), a Hgb or Hct is required to be perforrmed on the donor and must meet pre-determined acceptability criteria BEFORE a collection is even initiated.

Once you took the temperature and the temperature was outside the acceptable range, it should be a goner. If you have a validated procedure to defend the 30-minute time frame and did not take the temperature then you might have been OK. However, once you have documentation that you have a non-conforming product, it should be considered unacceptable and discarded.

It would be unlikely that the infant is D-negative. If the mother has an anti-c, she is most likely an R1R1 so would be contributing an Rh-pos gene to the infant. I realize the mother could be an R1r' so it is possible the infant could be D-negative. With that said, a plasma exchange is generally an automated procedure so is not really feasible on a neonate. The bulk of any passive antibody is attached to the RBC so it's more important to remove the sensitized RBCs which will be the source of the bilirubin. It would also be very difficult to obtain a Red Cell unit that is D-negative and c-negative. So has you mentioned, you could use D-positive, c-negative whole blood for the exchange or use D-negative, c-positive units and anticipate performing multiple exchanges if necessary. Whether the infant is a male or female may also influence your decision.

The FDA recommendations are buried in the guidance documents pertaining to each test or scenario. There is not one guidance document that summarizes all notification recommendations. See page 6 of the HCV guidance attached as an example. You may also find it helpful to review Blood component recalls and market withdrawals: frequency, reasons, and management in the United States by G. Ramsey published in Transfus Med Rev. 2013 Apr;27(2):82-90. Abstract In a previous article, we reviewed the management of blood component recalls and withdrawals (G. Ramsey. Transfusion Med Rev 2004;18:36-45). Since then, US rates of recall and biological product deviation for blood components have improved significantly, particularly with regard to reduced recalls for donor infectious disease risks or testing. However, analysis of the current data from the US Food and Drug Administration suggests that 1 (0.4%) in 250 blood components is involved in market withdrawals and quarantines, with 1 in 5800 components formally recalled. Most of these units, unfortunately, had already have been transfused. The U.S. Food and Drug Administration has issued several recent guidances that address transfusion service actions for dealing with specific infectious disease problems. This present article updates our 2004 recommendations as to when to notify physicians about transfused nonconforming blood components. FDA HCV Lookback.pdf

Just curious--what is the source of the information that they are using to retrospectively (non-concurrently) complete the forms?

I believe many eons ago the package insert for some of the fetal screen tests referenced the one hour time period but I do not have access to those to confirm. I believe the rationale was/is that if the fetal cells are ABO incompatible with the mother, the fetal cells will be destroyed by the maternal antibodies so a falsely low value of the amount of fetal bleed may be obtained. I know everyone here understands that ABO incompatible fetal cells actually provide some natural prophylaxis to the mother for the prevention of immunization to D so may be less of an issue if you're doing the test simply to determine RhIgG dosing. The same rationale could apply for early removal of D-positive fetal cells from the maternal circulation due to the presence of any prophylactic/antenatal anti-D. However if the test is being performed to determine the amount of fetal bleed as a diagnosis test for the treatment of the infant, one should be aware of these factors that may affect the result.

How would you respond or what objective evidence would you provide to meet AABB 5.1.8.1.2 "Tissue and derivatives shall be stored in accordance with the manufacturer's written instructions."?

For storage devices, they all have to be within the appropriate storage temperature for the device however the differences between them is not important. For refrigerated storage between 1-6 C, one could be at 1C and another at 6C and it would be acceptable. What references were provided by your sources?

Thawed Plasma is not recognized by the FDA so is not a licensed product and should not contain an FDA license number. If you make this product, all you would need to do is remove any license number(s) from the label.

The CLIA requirement is in 42CFR493.1281: If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites.

Some of the CFR requirements for tissues can be found in 21CFR1271. There are also some FDA guidance documents such as the attached for mandatory reporting of adverse reactions. Tissue Guidance.pdf

The AABB Tech Manual is a TEXTBOOK and does not necessarily represent the Standards, regulations, etc. and may simply be the opinions of the author of the particular chapter. You need to ensure you are complying with the regulations and not necessarily the Tech Manual.

The title of 5.16.2 was changed to "Use of Computer to Detect ABO Incompatibility" and details what needs to occur if you will be using this method to detect ABO incompatibility. The intent of this change was to allow either a serologic method or an electronic method to detect ABO incompatibility. For example, if a serologic xmatch is being performed using gel, it would be acceptable to use either an electronic xmatch (providing all the elements in 5.16.2 are met) or an initial spin tube test as the supplemental test to detect ABO incompatibility (which the gel test is not licensed to detect). Perhaps it's a matter of semantics for the test codes you are using. An "electronic xmatch" (only a check of ABO incompatibility) should not be permitted if there is the history of clinicially significant antibodies; however a serologic antiglobulin xmatch result used along with a validated system that detects ABO incompatibility at the point of issue would meet the intent of the Standards. (5.16.1.1 If no clinically significant antibodues were detected in tests performed in Std 5.14.3 and there is no record of previous detection of such antibodies, at a minimum, detection of ABO incompatibility shall be performed.)

I would be a little bit curious about why they're asking the question so you may want to get additional clarification. For example: Plasma and platelets could be infused using a straight administration set and would not necessarily need to be infused using a Y-type administration set with the 0.9% saline in one lead and the blood product in the other lead. However with the straight type of administration set a significant volume of the product may remain in the filter housing and lines once the product bag is empty so the patient would not be getting the full benefit of the infusion. If the plasma or platelet administration set is going to be flushed, 0.9% saline is the product that would need to be used. On the other hand, particularly prior to additive Red Blood Cells, it was common practice to use a Y-type administration set with 0.9% saline in one lead, the blood product in the other lead, and then to add some of the saline directly into the RBC bag to dilute the product a bit so it would not be so viscous and run easier and faster through the filter housing and set. Since the viscosity is not an issue with plasma and platelets it would not be necessary or recommended to add saline directly into these product containers. however it would be advantageous to use the saline to flush the line at the end of the transfusion.

Check the manufacturer's package insert for the dating period specified for the products collected using that particular product. For US, also see the FDA Code of Federal Regulations 21CFR610.53: Dating periods for licensed biological products. 21CFR610.53( "When the dating period begins. The dating period for a product shall begin on the date of manufacture, as prescribed in 610.50...". The date collected would be the date of manufacture.

As long as the product was collected within the expiration date of the collection set, the products manufactured can be dated and used through their normal expiration period. If the product was collected on March 20, 2014, the Red Blood Cells produced can be dated and used for the standard expiration period based on the anticoagulant and method of preparation, e.g, 42 days for an additive unit prepared in a closed system, Fresh Frozen Plasma for one year, etc. As a separate note, it would not be advisable to use expired bags even for therapeutic phlebotomies. Doing an invasive procedure on a patient using an expired product for which sterility can no longer be assured could be a risk management nightmare.

The CMS standards for a laboratory test report can be found in 42CFR493.1291. 42CFR493.1291.pdf

The GVHD risk would only be significant if it was a directed donation to/for a family member related to the individual performing the interview...and even if that was so, US facilities have policies to address identifying the risk associated with directed donations from related family members and taking appropriate preventative actions (irradiation). I also am not aware of a specific regulation, however you may want to include in your decision process (and remembering as others have suggested that some of the early cases of transfusion transmitted HIV infection were directed donations from a child to a parent), how would you personally feel about receiving a unit of blood from a relative that had their health history performed by their close relative or even other closely associated individual? Certainly would not be my preference............

Hi Amy--thanks for sharing your case. The results you report suggest the patient may be an A2B. The overwhelming majority of A2B (and A2) individuals do NOT produce an anti-A1, which if present is generally naturally occurring as you noted. Although anti-A1 is somewhat more frequent in A2B than A2 individuals, in the absence of a 37C reactive anti-A1, it is completely safe to transfuse group AB, A or B blood and is actually preferable to using group O units. The use of group O Red Blood Cell units would not be expected to be harmful to the patient, however since group O units are generally in limited supply, their out-of-group use is judicially reserved for those patients that must receive group O units.

Only about 25% of A2B individuals will have an anti-A1 detected by routine ABO testing methods.

By "plasma expanders" are you referring to non-blood products such as Hetastarch? These type of products can interfere with coagulation so perhaps that is what is meant/seen as a complicating factor for the surgical procedures.

Blood administration is not considered to be manufacturing so the example provided would not be an FDA reportable event. See excerpt from FDA BPD reporting webpage http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm073455.htm#EXAMPLESOFREPORTABLEANDNON-REPORTABLEEVENTSBYMANUFACTURINGSYSTEM For transfusion services, non-reportable events may also include: Inappropriate administration practices by the hospital staff in transfusing the patient;

Since group A plasma is compatible with group O and group A patients, group A plasma will be compatible with ~ 85% of your patients (US Caucasian, but even higher % for other ethnic groups). For that reason, I know of some places that do not even inventory or use group O plasma. Looking at the efficacy of the products, since group A plasma has higher levels of Factor VIII than group O plasma, you're actually getting more bang for your buck by using group A plasma products for group O patients. Group O red cell products would continue to be compatible with group O patients receiving group A plasma and group A and group O red cell products would continue to be compatible with group A patients receiving group A plasma. If anyone is still trying to justify the use of 5 day thawed plasma, group A plasma at 5 days has higher FVIII levels than group O plasma at 24 hours. By using group A plasma at 5 days, the O patient is getting an equivalent or greater dose of FVIII than they would if they received group O plasma within 24 hours of thawing. Have you ever had a physician ask what blood type the patient was before they determined how many plasma products they needed to order? There were some interesting discussions at the AABB meeting about the routine use of group A plasma for massive transfusion protocols when the patient type is unknown but that's a whole other discussion topic.