AB123

31st edition of the AABB Standards 5.1.1 Change Control:
The BB/TS shall have a process to develop new processes or procedures or to change existing ones.  This process shall include identification of specifications and verification that the specification have been met.  Before implementation,  the new or changed processes or procedures shall be validated. Stand 2.12 applies.
To show that your laboratory isn't changing things on the fly, it is important to have a controlled process in making changes.  AABB has a section on their website under the Accreditation Member Tools a Commendable Practices link.  You may be able to glean some information on how to set up a change control process for your laboratory.

You should have some standard operational things to review annually.   Plus, there probably are issues that arose during the year that could also be discussed.
In your Quality Plan you should have some reports that are due during the course of the year.  Make certain you have them and that they have been reviewed by your quality team.

Does your system allow you to "GROUP" all of the individual products(codes) under single headings (RBC, FFP, CRYO, PLTPH, etc)?  If so - then that is probably how you then build the Ordering screens to limit the Drs to the seeing the Groups only.  Anything special they have to put in comments - or your system may allow some questions and answers in the Order screens.  That is how Meditech does it and I think that is how Safe-Trace did it too.  You see all the product codes in Blood Bank - but the Order screens don't - that would be complete chaos!!  The system on your side also has to recognize the Groups so you don't have to line up each special product to a special order - also chaos!

If AABB accredited is there a minimum expectation from the AABB as to the Blood Bank topics discussed at the AMR? We have our AMR coming up shortly and are also starting our accreditation process with the AABB. I want to ensure we have covered all bases. 
Thanks
 

I think the point is in an emergency situation where you don't have time to either get the second sample or if you have the second sample and have identified a discrepancy then you should use group O until it is resolved.
What other option do you have? 
If it is not an emergency then of cause a third sample would be required to resolve where the error occurred as well as looking at any other patients on the same ward bled at a similar time to see if there are any other patients involved in the mix up. 
But I agree with your point that it should be all patients that have a second sample, we required 2 samples regardless of their blood groups. 

Someone above commented that a 2nd sample is only required in the U.S. for computer crossmatch (which used to be true). But with the 31st Edition of AABB Standards (effective April 1, 2018), this requirement was moved so that it now applies for all pretransfusion testing for allogeneic transfusions including all types of crossmatching (IS, AHG, and Computer crossmatching). This is more in line with CAP requirements and makes more sense in order to detect possible Wrong Blood In Tube (WBIT) events.
AABB Standards for Blood Banks and Transfusion Services, 31st Edition
5.14.5 Pretransfusion Testing for Allogeneic Transfusion  
There shall be two determinations of the recipient’s ABO group as specified in Standard 5.14.1.  The first determination shall be performed on a current sample, and the second determination by one of the following methods:
Testing a second current sample.
Comparison with previous records.
Retesting the same sample if patient identification was verified using an electronic identification system or another process validated to reduce the risk of misidentification.
Standards 5.11 and 5.27.1 apply.
 
Personal Note: If you intend to retest the same sample (by a different person or the same person), be prepared to show the AABB assessor your validation proving that your "another process" is actually validated to reduce the risk of misidentification (i.e. WBITs). 
 
CAP Checklist Requirements:
TRM.30575 Misidentification Risk
The facility has a system to reduce the risk of mistransfusion for non-emergent red cell transfusions.
NOTE:  Mistransfusion occurs from misidentification of the intended recipient at the time of collection of the pretransfusion testing sample, during laboratory testing and preparation of units to be issued, and at the time of transfusion.  Misidentification at sample collection occurs approximately once in every 1,000 samples, and in one in every 12,000 transfusions the recipient receives a unit not intended for or not properly selected for him/her.  The laboratory is expected to have implemented a plan to reduce these risks through implementation of a risk-reduction system.  Among options that might be considered are:  (1) Verifying the ABO group of the intended recipient on a second sample collected at a separate phlebotomy (including the recording of the result in the institution's historical record); (2) Utilizing a mechanical barrier system or an electronic identification verification system that ensures that the patient from whom the pretransfusion specimen was collected is the same patient who is about to be transfused.  Other approaches capable of reducing the risk of mistransfusion may be used.  The laboratory should participate in monitoring the effectiveness of the system that it implements.   The laboratory should also consider improvements in procedures and/or educational efforts as part of its program to reduce the risk of mistransfusion.
 
TRM.40670 ABO Group and Rh(D) Type Verification
The recipient's ABO group and Rh(D) type has been verified by repeat testing of the same sample, a different sample, or agreement with a historical type in the laboratory's records.
NOTE:  Repeat testing of the same sample may be inadequate unless the sample has been drawn using a mechanical barrier system or digital bedside patient identification system. For laboratories that employ computer crossmatching, serologic crossmatch techniques must be employed when ABO typing discrepancies are present (e.g. mixed field reactivity, missing serum reactivity, apparent change in blood type post hematopoietic stem cell transplant).

I have used the Sarstedt SAHARA III for many years and they are very good, with regards to limitations I am not aware of any as such, they use dry heat to thaw the plasma and I don't ever remember one breaking down in the 3 different labs I have used them in. Maintenance is limited to wiping down the unit every week and cleaning out when you get a burst bag but they have a tray in the bottom to catch any leakage, I would take one any day over any water bath options. My current lab has an Helmer, I find it very slow compared to the SAHARA.  

In my opinion, if we cannot select an antigen neg reverse cells, there are things we can do, it is  adsorbing the plasma/serum using pooled O cells, then do the reverse typing, to get a neat anti-A or anti-B result.

Without a doubt, we would follow your method srichar3, otherwise, what is the point of performing a reverse group on ANY sample?

This is directly from the AABB recommendations:
 
Consequences of current practice
Current practice for testing and interpreting Rh typing results appears to be highly successful in preventing alloimmunization to the D blood group antigen and Rh hemolytic disease of the fetus/newborn.4 However, there are unwarranted consequences associated with the practice of avoiding detection of weak D phenotypes, including unnecessary injections of Rh immune globulin and transfusion of Rh-negative red blood cells – always in short supply – when Rh-positive red blood cells could be transfused safely. If all pregnant women in the United States with a weak D phenotype were identified and their RHD genotype determined, an estimated 13,360 pregnant women who are currently managed as Rh-negative could be managed as Rh-positive, avoiding 24,700 injections of Rh immune globulin annually.1
Recommendation of the Work Group
RHD genotyping is recommended whenever a weak D phenotype is detected by routine Rh blood typing of pregnant women and other females of childbearing potential. The Work Group rates this as strong recommendation, based on high-quality evidence from observational studies (1A).5 The Work Group also considered a recommendation to standardize routine laboratory methods for Rh typing that would increase detection of all patients with D variant phenotypes, including partial D, as well as weak D phenotypes. While desirable, such a recommendation is technically complex, likely controversial, and would divert the focus from our advocacy for phasing-in RHD genotyping when a pregnant woman’s routine Rh typing detects a serologic weak D phenotype. The immediate benefit of determining the RHD genotype of pregnant women with a weak D phenotype will be fewer unnecessary injections of Rh immune globulin.
It's common for hospital blood banks to treat potential mothers who type Rh (D) positive at the weak D phase of testing as Rh negative. It's not uncommon to hear stories similar to yours where a patient has been told one time they are D- and then another time, D+.  
If you want to get a better handle on your D typing, request that your hospital sends it out for molecular testing.  It can be expensive...ballpark $300...but it is the only way to determine whether or not you truly need Rh immune globulin.

No you can buy inline filters for post storage leukocyte reduction, our blood supplier does not offer leukocyte reduction of platelets unless they bare apheresis units but they are not always available so we sometimes have to resort to using these filters. 
https://www.terumobct.com/imugard 
"MUGARD III-PL for Platelets
The IMUGARD III-PL filter is a hard-housing filter designed to remove leukocytes and microaggregates from platelet preparations. Each filter system is equipped with a spike, clamps and tubing. The filter housing material is semitransparent to make monitoring the filtration process easier.
Available in lab and bedside versions, the IMUGARD III-PL features a bypass line on the lab version to remove air from the transfer bag. The bedside version features a drip chamber and a roller clamp below the filter to adjust flow to the patient.
Filters platelet concentrate for volumes equivalent to platelets produced from six Buffy Coats Offers greater than 90 percent platelet recovery" The efficiency is reported to be not as good as pre storage with these but this is not an option we always have. My issue is currently we are giving the filters to the nurses to do at the bedside which I don't feel is the best option and I would like to bring it into the lab, mainly because of training as its much harder to train all the nurses to do it properly than it is for the lab and of cause the lab can QC the process which would be impossible at the time of administration. 

So the A1 cells are reactive, but the O cells are nonreactive. Interesting. I would have guessed autoanti-H, but that doesn't fit. Have you tested A2 cells ? Might be a weird compound antibody like anti-HI - needs the presence of both antigens to react well. Have you looked at something simpler, like anti-M, for instance ?
The DAT results suggest IgM/complement binding, but as you imply, further testing is required.

When leukodepletion first became "popular" in the UK, before the NHSBT and other Blood Services performed universal leukodepletion, we used to provide the ward with an "in-line" filter.  As Ensis01 says above, there were several drawbacks with this, but, in terms of whether it was actually efficacious, it was marginal then, because part of the problem involved with febrile non-haemolytic transfusion reactions (this is a problem separate from the fact that we want to prevent "HLA" type sensitisation) is the release of such things as cytokines, in particular tumour/tissue necrosis factor-alpha, interleukin-1-alpha, interleukin-1-beta and interleukin-6.  These are released from white cells upon storage and, of course, by the time the platelet concentrates reach the hospital blood bank, these will already have been released, and so it is too late, and leukodepletion will not prevent FNHTR.

Sorry, but can I just point out that you should be sending out the tests if the patient is a female of child bearing POTENTIAL, rather than child bearing age.  If the female is four (for example), she is not likely to be of child bearing age, but she will be one day, and if she is an individual who has a Partial D type who can produce an anti-D, she deserves as much care as does a female of, for example, 25 years.

But what is the acceptable temperature limit for a 30 minute excursion? If it was in a validated transport box with a logger inside that remained between 1oC and 6oC then it wont be considered to have left cold storage hence the 30 minute rule wouldn't apply.  We have transport boxes validated for 8 hours that we send to OR. So that fact that a limit to "30 minutes rule" exists suggests that the unit does not need to be kept at cold storage temperatures, but what would be acceptable? temperature for the unit to reach for 30 minutes? For example UK guidelines state that a unit of PRBC can be used with temperature excursion of up to 10oC for up to 5 hours. 
Some interesting info in this document for the UKBTS reviewing the evidence of various studies,
https://www.transfusionguidelines.org/document-library/documents/change-notifcation-no-33-2016/download-file/Change Notification No 33 2016 - Removal of red cells from a controlled temp.pdf
Ramirez-Arcos and colleagues from the Canadian Blood Service reported on two studies
using red cells in SAGM. In the first study, a single five hour exposure to room temperature
showed no immediately significant effects on the in vitro quality of the red cells, although six
days after the exposure ATP and K+ levels were significantly lower than in unexposed
controls[22]. In the second study, units were exposed to room temperature for 30 minutes
on each of five separate days, and no significant effects on in vitro red cell quality markers
were reported[23].
 
Steve
 
 

The father John.  He may not be the father!

As I am on the "wrong side of the pond", I'm not sure I should answer this, but I'll have a go!
We say a titre of 32 for anti-Fya and any Rh antibodies (but we perform concentrations on anti-D and anti-c, rather than titres, and for them we begin to worry if the anti-D levels go above 4IUmL-1 and anti-c lvels go above 7.5IUmL-1), however, I cannot recall seeing any real problems with anti-Fya below a titre of 128.
Anti-K (and other Kell-related antibodies) are a different kettle of fish.  After battling for years with poor correlation between anti-K titres and the severity of HDFN, and thinking it was poor titration technique, and then finding it wasn't, and finding out that it was more to do with how the antibody attacks the precursor red cells, we sort of gave up, and now we refer any pregnant women with anti-K to a foetal medicine unit for screening, just to be sure (unless cell free foetal DNA shows that the foetus lacks the KE L1 gene).
This is all based on British Committee for Standards in Haematology (BCSH): White J, Qureshi H, Massey E, Needs M, Byrne G, Daniels G, Allard S.  Guidelines for blood grouping and red cell antibody testing in pregnancy.  Transfusion Medicine 2016; 26: 246-263 (doi: 10:1111/tme.12299) and Royal College of Obstetricians and Gynaecologists (RCOG).  The management of women with red cell antibodies during pregnancy.  Green-top Guidelines No.65; May 2014.  https://www.rcog.org.uk/globalassets/documents/guidelines/rbc_gtg65.pdf.

Just found this from the BBTS;
https://www.bbts.org.uk/downloads/bbts2016/presentations/15.00_wed_qs_3_kate_aplin_bbts_2016.pdf/

All the blood in our hospital is leucoreduced, and we have classified this as "CMV safe". But is this actually the case? Is leucoreduced blood the equivalent of CMV negative blood? For the following patients would you just give leucoreduced blood, or leucoreduced blood that is also CMV negative?
Intra-Uterine Transfusion
Exchange transfusion for a baby
Top-up transfusion for a premature baby
Top-up transfusion for a full term baby
 

No elutions here unless DAT is positive and we don't have mother's specimen or the DAT is positive w/ no apparent reason (no ABO incompatibility, mom's antibody screen is negative). In all the years I've worked here, we've never actually needed to do this.

When I started here we performed elutions on all positive DATs as well, but when I became supervisor we put an end to that.  Busy work for no real benefit; like your Pediatrician, they treat the babies the same.  Just this year, our Pediatric Subsection decided to start performing cord blood evaluations on all babies of O Pos moms.  I know there are several facilities that do the same, but we never have.  I asked our Mother/Baby nursing coordinator for the evidence they used to make this change and have had no response.  I have never understood the long standing practice of performing the cord blood workups on jaundiced babies either.  It seems to me this is all academic and of no real clinical value, but what do I know.  Does anyone have any Best Practice guidelines with supporting evidence for any of these practices?  The only thing I can come up with is that if the baby turns out to be O as well, that may steer them to investigate alternate explanations for the jaundice; but even then, unless the baby is having continued problems, is the information actually used to determine treatment?

Under routine circumstances, we do not prepare an eluate from positive DAT cells from a neonate because identity of the antibody can be determined from the mother's sample.
Of course, if a neonate with a Positive DAT arrived without a mother, no maternal sample, or from a Group AB mother with a Negative Antibody Screen, we would likely prepare and test an eluate to aid the pediatrician with his/her care plan.  (For the latter case we would request a sample from the father to determine if the mother is producing an antibody to a low incidence (aka private) antigen passed on to the infant by the father.)  But, that's a whole 'nother conversation!

Wlecome

Welcome srichar3.

Hi Steve,
Products for exchange transfusion or “reconstituted” products are encoded as red blood cells with the plasma added attribute. When selecting an appropriated ISBT 128 code for these products all applicable core conditions, attributes, and modifiers still apply. For help with the terminology, section 2 of the ISBT 128 Standard Terminology for Medical Products of Human Origin (ST-002) document contains the current blood component terminology and definitions that is used for ISBT 128 product descriptions.
I would be happy to work with you to narrow down the appropriate ISBT 128 product description. If you are able to provide more information about your product, we should be able to determine an appropriate product description code for your product or initiate a request for a new code to be added (if necessary). Please feel free to DM me or contact the ICCBBA office with a description of your processing steps if you wish not to make such information public on these forums.
I also see that the reconstituted red cell guidance was shared earlier in this thread – the short document (also linked here) reflects the current thinking on labeling these products in the US. You may need to refer to your national/local authority for any coding/labeling guidance and requirements for such products in the UAE. You may also need to reference your accrediting organization for any additional requirements.
Kind Regards,
Kaytee from ICCBBA (Organization that maintains and develops the ISBT 128 Coding and Labeling Information Standard)