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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.
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In the UK the MHRA who are the UK equivalent of the FDA licence all blood facilities and hospital blood banks. One area they are very big on is change control. I just wondered how much the AABB focus on this area as at the moment our laboratory does not have a specific documented process for change control. Thanks
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Solid Phase Dependent Antibodies
Malcolm Needs replied to bloodybanker's topic in Transfusion Services
It MUST be remembered that not all antibodies react by all techniques, but, equally,it MUST be remembered that not all antibodies are clinically significant. I remember way back in the 1980's, when I was working at a hospital in Croydon, Surrey, UK, we had an anti-S that we could only detect by tube technique. We sent this around to a whole bunch of other hospitals, who also used a mixture of techniques. Not one of them could detect the antibody by either microplate techniques or column agglutination techniques, both thought to be more sensitive than tube techniques, but all of those who also used tube techniques were able to detect the anti-S. I also remember having an anti-E that did not react with enzyme-treated red cells, but only reacted by IAT with untreated red cells. This was confirmed by the International Blood Group Reference Laboratory. Antibodies do not read books, particularly text books! Antibodies are only clinically significant if they react strictly at 37oC, and even then, not all are clinically significant. Think about the antibodies against antigens in either the Knops or Chido/Rodgers Blood Group Systems. -
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I've seen a similar issue with gel, in that you have sprinkled agglutination within the two-cell screen that ends up resulting negative later on with tube. The lab has been attributing these weak pos in gel to be of little significance until proven positive in a tube two-cell screen. Judging by the comments on this thread, that thinking seems problematic . We currently do not have gel wells to test specific antibodies, although I know C,E,K gel cards exist and perhaps will be used in the future. Before we came up with the sequential tube testing, some samples would get an initial panel (based on tech discretion). Sometimes a 0+, 1+ screen would result in a specific allo on an 11-cell panel, and sometimes it would all be negative. Interesting reads here.
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To answer simply, option #3. However, normally we have documentation filled out to express the intentional deviation from procedure that denotes it was per MD approval. These sort of things end up becoming a larger discussion between the transfusion medicine doctors and the pt care team, and then the lab is notified one way or the other. If the MD selects specific products to use, those products and Unit Numbers are also documented.
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Just from a safety standpoint, receiving products transported from an outside facility should be retyped, regardless if that outside facility is in your "network." For example, even if a historical donor donating at a regular frequency gives red blood cells directly to Hospital B, the unit itself is still retyped at that given point and before transfusion.
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At my clinic, in cases where the first drawn tube on a no hx patient was not properly electronically collected, then a second sample is required. We use Sunquest and Collection Manager to track that. Oftentimes, the nurses and phlebs tend to argue why a second sample is needed, so they don't really know ahead of time to draw two tubes and stealthily send the second tube later. I'm not sure the workflow of the phlebs and their side of the software and whether they ID the patient at the time of electronic entry and draw. However, when you cannot verify confidently that a sample was collected and verified by a tech at the time of draw, a second sample is ordered and sent at a later time.
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I will check to see if that is causing the problem. Thank you for the suggestion.
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If your centrifuge has a brake and it is in use this: could be causing your delineated button problem.
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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.
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The Trauma patients are assigned MR# when they arrive and banded. Usually the request is for what we call a R-Pack(resuscitation) which includes 6 O red cells, 4 A liquid plasma and a platelet pheresis. Either a OR runner or ED Tech comes to pick up the blood product bringing a ADT label which has the patient's MR# , Doe name, and generic dob. The blood is issued in millennium documenting location, reason, transporter's employee number. The same log for issuing regular old blood products is use which has the patient's identifier, the two Techs issuing(reader and listener), the transporter's number(or full name) and the number of each product that is issued. There is also a refrigerator between the 2 trauma bays that has 4 O+ red cells and 2 liquid plasmas. The nurses have to scan their badges(employee id) and enter the Patient's MR# to get access. There is a huge computer screen in the BB that shows that the refrigerator has been opened and we can see what got removed, who removed it and who it went to. However, I don't recommend this feature it is a pain in the behind ): -
Neonatal Exchange Transfusion due to elevated bilirubin
David Saikin replied to edmoad's topic in Transfusion Services
typically you are going to make modified whole blood w a hct of ~50% (your neonatology folks will give you the target hct they want - this should be standard and not subject to the MDs whims at the time). You will need the average hct of a unit of stock rbcs (and you will use this number all the time, unless you plan on doing a hct on every unit you are going to use). A sterile docker is not essential but will allow your product to have more than 24 hour exp date. You should be able to discover the formula for adding plasma (to get the desired final hct) in the Technical Manual. -
Non cellular component transfusion and historical ABO/Rh
ANORRIS replied to rosi0017's topic in Transfusion Services
We must have a current ABO/Rh done on the current visit. -
Welcome mchurch.
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Hello mchurch, Welcome to PathLabTalk. Please feel free to browse around and get to know the others. If you have any questions please don't hesitate to ask. mchurch joined on the 06/24/2019. View Member
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Non cellular component transfusion and historical ABO/Rh
Dansket replied to rosi0017's topic in Transfusion Services
You are correct. However, in a facility with a very low volume of transfusion <1000 units annually, we elected to standardize the criteria for collection of pretransfusion blood samples, i.e., collecting a blood sample within 3 days of the intended date of transfusion for both red cell and non-red cell transfusions. -
Welcome abriese79.
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Hello abriese79, Welcome to PathLabTalk. Please feel free to browse around and get to know the others. If you have any questions please don't hesitate to ask. abriese79 joined on the 06/24/2019. View Member
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Much to our dismay we do it in Blood Bank. I vote for Hematology :)
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While TRALI can be caused by both HLA class I and II antibodies (these antigens are present on most cells (class I) and antigen presenting cells (class II) and HNA (human neutrophil antigens present only on neutrophils in most cases), most respiratory distress after transfusions is caused by other mediators (lipids, CD40L and probably free hemoglobin and heme) and does not require any specific workup of the donor as antibodies are involved only in a few cases (we haven't seen one in years). Some folks in the field do wish to perform antibody studies, but I think they are largely a waste of time, except for transfused or multiparous patients. Others are extremely unlikely to have antibodies in the donor blood. As evidence for these controversial remarks, one need only examine the hemovigilance data from Quebec which found that red cells were primarily involved, which argues against antibodies as a cause in most cases, as there is very little plasma in red cell concentrates. But you might as well follow the standard of practice in your area as to donor workup. I would only send out antibody testing on donors who have a history of transfusion or pregnancy.
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Non cellular component transfusion and historical ABO/Rh
Townsend replied to rosi0017's topic in Transfusion Services
The standard in 5.14 quoted above states that pre-transfusion requirement for any allogeneic component is an ABO group and Rh type. It does not state that this has to be done within 3 days or on the current admission. As we can see by the responses, some facilities are requiring confirmation on the current admission and others will go with historical ABO/Rh for a plasma/plt/cryo transfusion, and I can definitely see arguments for either side; bottom line is, this is not a regulatory requirement and must be defined by your facility. There is a standard that requires the pre-transfusion testing within 3 days if transfused or pregnant (5.14.3.2) - but the entire section for 5.14.3 is regarding the antibody screen for WB/RBC/Gran transfusions, not the ABO/Rh only. -
Yes and this is what I've gone with, think its the easiest all round and the way I'm used to working. Thanks
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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!
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This is such a complex question - I don't even know where to start. Meditech is a basic system (DOS based) that ties the unit to the patient after ordering and resulting. The system then "issues" the unit that has been crossmatched in an ISSUE screen that lists the patient, the unit, the date/time (and who crossmatched the unit) of the crossmatch, the date/time and people involved in the issue process and then transfers the unit to transfused status in the system - all tied to the patient. So I guess the basics of what you need would be: Patient - full ID (name, DOB, system IDs (medical record #, etc.); Pt's group and type - ideally, the system should also list any pt. antibodies on the tag also. Blood Bank ID band numbers (if you use one of those systems) and/or any other required identifier for your hospital Unit number and Group and type - the system should be built to help you restrict units to type specific/compatible units only Ideally the system should be able to list any antigen testing on the units. Who did the crossmatch and when (so you can keep track of expiring crossmatches) When the unit is issued- by who and to who Our Meditech Issue/Transfusion tag is also built to print out a blank form (this is the bottom half of the tag) for Nursing to list; Transfusionists (transfusing RN and secondary ID check RN), the times and vitals for pre, 15 min, 1 hour and End for the transfusion - but if you do this some other way - say in the computer itself - you may not need that. Does that help? In any computer system, this data has to be linked to so many different areas in a Blood Bank system that getting that data to a new form is where the challenge comes it. Best of luck.
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Annual Management Review meeting. Although AABB just refer to it as scheduled management review in the standards, I've only ever know them to be done annually unless AABB expect more frequent?
