Dansket

No!

I agree wholeheartedly with Joanne Croke about the "least incompatible" issue. I'm not a fan and no longer use the term here. We either give compatible units, or make our physician sign for incompatible.

I like to run an ABO compatible cord cell or 2 when I do a cold screen.  I will run 3 screening cells, an auto, and 2 cord cells at immed spin, after 5 minutes at room temp and then again after 5 min at 4C. I may also run an A1 and A2 cell if the pt is an A or AB and I suspect anti-IH - just for fun.  You have to read the 4C tubes very quickly after centifugation because you are not blasing them with cold as Donna does.  If you let them sit around the rxs will disappear rapidly as they warm up (if they were even there to begin with).

This was one of many multiple choice questions on an Antibody Identification competency assessment quiz.  A new CLS in training who answered the question incorrectly complained to the Laboratory Director. She wondered if it was a trick question.  When pressed by the director, the CLS could not offer any explanation as to why he thought his choice (#1) was the correct answer.
 
The correct answer is #2, other choices were "Leave it for the day shift" and "None of the above".

Meditech users:
 
We have just installed a custom (not a rule but custom hard code) in C/S version 5.66 that causes all specimens to expire at 2359 regardless of the time of specimen collection.  It will not be generally available as a DTS.
 
If you want this feature, you will have to press Meditech for it.

Meditech users:
 
We have just installed a custom (not a rule but custom hard code) in C/S version 5.66 that causes all specimens to expire at 2359 regardless of the time of specimen collection.  It will not be generally available as a DTS.
 
If you want this feature, you will have to press Meditech for it.

This was one of many multiple choice questions on an Antibody Identification competency assessment quiz.  A new CLS in training who answered the question incorrectly complained to the Laboratory Director. She wondered if it was a trick question.  When pressed by the director, the CLS could not offer any explanation as to why he thought his choice (#1) was the correct answer.
 
The correct answer is #2, other choices were "Leave it for the day shift" and "None of the above".

# 2 ...there is no doubt #1 is no no.
 
& not a trick question.

We implemented this because of a non-fatal ABO hemolytic transfusion reaction. 
 
We had the exact same issue for patients who arrive in Surgery (both elective and urgent) and no one ordered pretransfusion compatibility testing. 
 
We also made in clear to everyone (for consistency house-wide) that the Blood Bank determines if a second venipuncture is required and that Blood Bank does not accept unsolicited blood samples.  We do not require a second venipuncture if the current blood sample types group O.
 
If Risk Management is driving this policy, they need to address the issue with the Surgery Department.

Hear Ye! Hear Ye! 
 
Also Meditech does not allow electronic crossmatch for blood unit issued uncrossmatched.   Meditech forces you to do serological crossmatches, even after that patient has two blood types on file, a current blood type, a current negative antibody screen and no history of clinically significant antibody!

We implemented this because of a non-fatal ABO hemolytic transfusion reaction. 
 
We had the exact same issue for patients who arrive in Surgery (both elective and urgent) and no one ordered pretransfusion compatibility testing. 
 
We also made in clear to everyone (for consistency house-wide) that the Blood Bank determines if a second venipuncture is required and that Blood Bank does not accept unsolicited blood samples.  We do not require a second venipuncture if the current blood sample types group O.
 
If Risk Management is driving this policy, they need to address the issue with the Surgery Department.

http://www.cbbsweb.org/enf/2012/cordbloodwash.php
Since not all samples are contaminated with Wharton's jelly, I've heard of some places only washing if they get a cord blood that types as AB Pos to rule out contamination.
We don't wash because we perform ours on automation (Tango).

The following reference may be pertinent to your question:
2010 Ask the FDA and CLIA Transcript



Ask the FDA and CMS/CLIA
October 11, 2010
AABB 2010 Annual Meeting
Baltimore, Maryland

FDA

Jay Epstein - Director, Office of Blood Research & Review, CBER
Ellen Lazarus - Director, Division of Human Tissues in the Office of Cells, Tissue and Gene Therapy, CBER
Hira Nakhasi - Director, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research & Review, CBER
Paul Mied - Deputy Director, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research & Review, CBER
Judy Ciaraldi - Consumer Safety Officer, Division of Blood Applications, Office of Blood Research & Review, CBER
Lore Fields - Consumer Safety Officer, Blood & Plasma Branch, Division of Blood Applications, Office of Blood Research & Review, CBER
Sharon O'Callaghan - Program Surveillance Branch, Office of Compliance & Biologics Quality, CBER

CMS

Penelope Meyers - Division of Laboratory Services, Survey & Certification Group, Center for Medicaid & State Operations at CMS

Moderator

M. Allene Carr-Greer, Director, Regulatory Affairs, AABB


Question 4: We perform all routine testing using gel technology. We also perform electronic crossmatches. For patients in whom clinically significant antibodies have been identified, is it sufficient to perform only a gel antiglobulin crossmatch? Does this satisfy the CLIA requirement to perform a test to detect ABO incompatibility?

MS. MEYERS: For this question, before I start, I would like to just make the comment that the answers that I will be giving to the questions today are based on the CLIA regulations. However, I would like to remind the audience that many laboratories choose to obtain their CLIA certification through a CMS-approved accreditation organization, of which there are six. One of which is AABB. These laboratories must follow all the requirements of their chosen accreditation organization which may be more stringent than the CLIA requirements.

Now back to the question. Actually, these CLIA requirements for crossmatching are based on the FDA requirements for crossmatching, and FDA and CMS have collaborated in preparing the answer to this question. The simple answer is that the IgG gel card does not fulfill the requirement to demonstrate ABO incompatibility. There are two issues involved here. First, the labeling clearly indicates that the IgG gel card is for direct and indirect antiglobulin tests. In other words, detection of cell-bound IgG antibodies. While the limitation section of the package insert states that some IgM antibodies may react, this limitation should not be interpreted to mean that the card is capable of detecting all IgM antibodies, particularly ABO antibodies. Secondly, the IgG gel card is a low ionic test system and there have been reports that ABO incompatibilities, due to IgM antibodies, can be missed when the antibodies are weak and the test is low ionic strength. While we acknowledge that there is continuing debate on this topic, but with the knowledge of these reports and in the absence of data from the reagent manufacturer to support the use of a low ionic strength system for detection of ABO incompatibility due to IgM antibodies, we believe it is not appropriate for users to omit some kind of test to detect these incompatibilities. And for eligible patients, an electronic crossmatch would fulfill the requirements. An immediate spin crossmatch, of course, is an acceptable method for all patients.

MODERATOR: Thank you, Penny. Can I ask, because I could not hear everything that you just said, but did you respond to the part about sufficient to perform only the gel antiglobulin crossmatch, that first part?

MS. MEYERS: No, it is not sufficient to perform only the gel antiglobulin crossmatch because that does not fulfill the requirement to detect ABO incompatibilities.
PANEL MEMBERS:

We do the same.  There is no way a physician can diagnose over the phone whether or not a patient is receiving a serologically incompatible blood transfusion!

We have in place the following:
1. If the patient exhibits signs/symptoms related to transfusion reactions (there's a list), there is no choice ... the transfusion is discontinued and a Transfusion Reaction Investigation is ordered.  Period. 
This is because the transfusion is under the license of the BB Medical Director who is thereby responsible for it.  Besides, if MDs have the powers to 'instantly know' whether the symptoms are due to the transfusion or not and that the blood was completely compatible or not causing any allergic, TRALI, Overload, etc. without any testing/rechecking/investigation, then  why do we need the Blood Bank investigations at all?  It is safer to stop and do the investigation than to rely on a variety of MD 'instincts'.  As much as they like to think they are, they (especially the residents) prove over and over again that they are not the experts in these matters.  (e.g. some of them are not aware of the symptoms or how to treat TRALI.)  I always think about 'how would this look in court?'  The only exception is 'Hives Only'.  If this happens, the infusionist is instructed by SOP to pause the transfusion, see if the hives subside, confer with MD to see if they want to administer medication, and then continue the transfusion.  
2. When a Transfusion Reaction Investigation is ordered, a specimen is drawn that becomes a) the 'Post Reaction' specimen for comparison studies (color, DAT, etc.) and the new pretransfusion specimen for subsequent transfusions.
All units that were crossmatched with the original specimen are released (i.e. not allocated to the patient anymore.) (n.b. we are on a BB Band system so each specimen is a separate entity) During the investigation, no units are issued unless the attending MD documents that there is a life/death situation where only the continuance of the transfusions will sustain life.  We haven't had this happen yet, but when it does, we plan to issue the prior compatible units with this documentation ... not sure if we should call this 'Emergency Release' or not ... now that I'm focusing on it, we probably should.

Haven't run an autocontrol with every antibody screen since CAP dropped it as a requirement 20-30 years ago.  There was a large study (800+ eluates from patients with a positive autocontrol) done by John Judd out of University of Michigan that scientifically refuted the value of the routine autocontrol.

How was your validation of DATs on the ProVue.  Did you note any discrepancies?  I would stick with one method for all. 

Currently we are updating from Meditech C/S 5.64 to Meditech C/S 5.66.  During a validation scenario, I discovered that it is possible for a user to enter and file serological test results that do not match the calculated blood type!  I reported this to Meditech and they offered this solution (overnight Saturday-Sunday  ).
 
Background
Whenever a Blood Type calculation is created in the BBK Calculation Dictionary, Meditech inserts generic code below into the Calculation Formula field:
 
Existing code
[bbk truth table]^X,
IF{'X [bbk err msg]("Invalid blood type calculation.")},
X;
 
Enhanced code
[bbk truth table]^X,
IF{'X [bbk err msg]("Invalid blood type calculation.")},
IF{'X [f bres delete]^X},
X;
 
The introduction of the line IF{'X [f bres delete]^X},  tells the system when the answer is not equal to the calculation for X then delete the calculated result for the target test, BT.
 
As a result, whenever an “Invalid blood type calculation” warning is displayed, system also erases the currently displayed blood type calculation, preventing a user from filing serological test results that do not match the calculated blood type.
 
I strongly encourage Meditech users to take advantage of this enhanced code to prevent the potential for ABO incompatible blood transfusion.
 
 

1. Currently in a small facility with an average census of <50 patients.  Active, ER, OB and Surgery. Average of 74 Type and Screens monthly. Transfuse 100-120 RBC monthly.
 
2. Our goal of 70 minutes is met 80-85% of the time.
 
3. Receipt to Verify.  Samples are delivered directly to Blood Bank unspun.  Centrifuge for 3 minutes with Statspin.
 
4. Two (2) ProVues, no manual testing (tube or gel) is done.
 
5. We are using Meditech 5.64 going to 5.66.  Have a custom NPR report to download data and then sort in Excel.
 
6.  We have similar situation as LCoronado as a barrier to reducing TAT

There are two diluents, MTS Diluent 2 and MTS Diluent 2PLus that should not cause or prevent agglutination.  If you are doing QC to determine that the diluents are inert in all situations, you would have prepare test cells suspended in each diluent. 
 
You would then have to test the cells in MTS Diluent 2Plus against each gel reagent (anti-A gel, anti-B gel, anti-D gel, Buffered Gel (immed-spin xmatch), Monoclonal Gel) and test cells in MTS Diluent 2 against anti-IgG gel (both DATand -IgG xmatch) using a test cell that gives a positve result and also a test cell that give a negative result.

John, the only caveat to issuing type specific blood in an emergency is, in everyone's haste, they give it to the wrong patient.  Then it is more likely to do damage than universal donor.   I think that would be more of a concern in the ED than in OB/Gyn but I wanted to throw that into the pot.

I thoroughly agree with everything Terri has posted here, but would, also, re-quote some very wise words from Dr. Brian McClelland MD ChB ND Linden FRCP(E) FRCPath, a now retired Consultant Haematologist of the Scottish National Blood Transfusion Service (with a world-wide reputation) that are,
 
"Transfusion has risks, but bleeding to death is fatal."

Who is your accrediting agency?  Do you use a computerized laboratory information system? 
We don't require phlebotomist initials/signature on the blood sample container label because that information is captured in the LIS in the Collect/Receive blood sample routine after entry by the phlebotomist.

Unless something has changed recently which I am not aware of, (the amount of info that changes daily that I am not aware of is truly staggering) a FDA inspector would be very unlikely to consider your use of coolers as transport.  They would be more likely to consider them storage and therefore insist on a storage temp range of 1 - 6 oC.  Especially since the blood is not packed by you and does not leave the blood bank in the coolers. 

If you implement semi-automated blood bank testing, you must also consider 'backup' when your semi-automated instrument is out of service..  I prefer gel because both manual and automated methods use the same reagents.  If you use manual tube Plus a semi-automated instrument, you have to maintain two reagent inventories, and maintain staff competency with two methods.  In a small facility, I prefer to minimize the 'overhead' associated with multiple testing methods..  Use manual gel to backup instrumented gel or better yet, have two automated instruments to backup each other!