Dansket

Prior to transfusion of any blood component, we require ABO grouping on blood samples from two different venipunctures for all non-group O patients with no historical ABO on file.

My situation is very similar, we are not a trauma center and 35 miles from the donor center (typically 1+ hours for a delivery). Our minimum inventory level for ONEG is also 8 units. If we exhausted the ONEG rbcs, I would switch to OPOS (minimum inventory level of 18 units) before I would issue uncrossmatched non-group O rbcs. Who knows what Nursing will do, particuarly if there is more than one patient needing uncrossmatched blood at the same time?

Malcolm, There is an article titled "Debunking the 30-Minute Rule" in the May 2010 edition of AABB News published by the American Association of Blood Banks. The author states, "It is unacceptable to use the 30-minute rule as an absolute and universal rule. It is acceptable, however, to include a specific time frame for the reissue of blood products in a facilitiy's policies and procedures if the time frame has been validated in that facility". Furthermore article states that it has not been acceptable to use any other metric but temperature since the AABB published specific requirements for the reissue of blood in the eighth edition of the AABB Standards in 1976. From a regulatory standpoint (AABB standards in US), it is unacceptable to reissue whole blood or red blood cells that have been allowed to warm above 10C or cool below 1C.

All, With the sudden onset of apparent life-threatening hemorrhage, patient care systems are stressed to the limit and it becomes a potentially dangerous situation that can become a sentinel event. I really don't understand blood bankers who boast how rapidly they can produce an ABO typing on an individual so that they can issue "Type-Specific" uncrossmatched blood. You cannot harm a patient issuing group O Red Blood Cells, it is virtually impossible. You can harm a patient by issuing non-group O Red Blood Cells for a variety of reasons! Why is it thought that a patient is better served by transfusion of "Type-Specific" Red Blood Cells as opposed to group O Red Blood Cells as a life-saving treatment? I'm very interested in hearing the argument from those who practice issue of "Type-Specific" Red Blood Cells during resuscitation. Thanks, Dan

I stopped using polyspecific antiglobulin antiserum and switched to monospecific Anti-IgG reagent in 1980. We also have been using solely EDTA blood samples with Gel technology for past 16 years. Current thinking is that red cell antibody only detectable by anti-complement-complement reaction in the test tube is probably very, very rare. Use of Gel technology also eliminates subjectivity and variation associated with manual tube testing that probably contributed more to failure to detect incompatibility than the use of EDTA blood samples or monospecific anti-IgG antiglobulin antiserum. Additionally, we use computer crossmatch, eliminating 98% of anti-IgG crossmatches.

See this: http://www.aabb.org/events/government/fdaliaison/bloodcomponents/Pages/flm041212.aspx FDA Liaison Meeting – 4/12/12 Food and Drug Administration staff from the Center for Biologics Evaluation and Research (CBER) met with AABB's FDA Liaison Committee to discuss topics of mutual concern in the areas of donor and patient safety and product manufacturing. The committee includes liaisons from AABB, the Advanced Medical Technology Association (AdvaMed), America's Blood Centers (ABC), the American Red Cross, the Armed Services Blood Program, and the College of American Pathologists. Effective date of new requirements vs. discontinuation of requirements no longer in effect The final rule published January 2012, titled "Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma" (effective date July 2, 2012) includes updates to several regulations that will eliminate the need to use variances related to ISBT labels and expiration time of thawed FFP. As with any rule or guidance document, new requirements or recommendations must be implemented by the effective date and may be implemented prior to that time.

Are your patients and donor units intermingled into the same database or separate databases for each facility? If unit of blood is physically delivered to facility A and logged into that computer system, does that unit also display as available in the computer inventory of facility B? Can facility A see the unit confirmation test results entered into the computer by facility B? If your donor units are not in a database shared by both facilities, then I would re-confim the unit serologically. It may be simpler than making a bunch of computer transactions as a work-around.

Deny, The process that I will describe is how I am implementing antibody identification in my current facility. We have been successfully participating in the CAP Proficiency Testing Survey JAT (includes antibody identification) for the past three years. We transfuse fewer than 1500 blood components annually. Prior to implementation, it was the policy to send all specimens with a positive antibody screen to a reference laboratory (90 miles distant). We do not stock reagent antisera (too expensive), rbc antigen typing of patients will continue to be done by the reference lab and donor units by the donor center (35 miles away). All testing is done on ProVue (2). The computerized antigen-ruleout program is AntigenPlus-ID version 7.4.5. We are using Meditech C/S version 5.64 with electronic crossmatch implemented. We have two flow charts that I call Step One and Step Two. Staff are required to color-highlight the pathway they follow. Step One is used to determine if antibody identification is indicated. Step Two concludes after running Panel A only or after running Panel A and Panel B, that the reference lab is requested to do additional antibody identification or to do only rbc antigen typing on the patient. We routinely do antibody identification on all antibody-screen-positive prentatal patients, all other patients with a positive antibody screen excepting patients with a history of clinically significant antibody when antigen-negative screen cells and antigen-negative donor rbcs are not agglutinated. These decisions are incorporated into the flow chart Step One. Step Two flowchart is used only when antibody identification is indicated by Step One and guides the user in the decision to initially run Panel A only or to run both Panel A and Panel B simultaneously. Results of two-cell and three-cell screens and Panel A are entered into the antigen-ruleout program. Program indicates which antigen(s) cannot be excluded and the number of times a specific antigen was excluded. User is required to not only color-highlight pathway used but to also document the specificity of antigens that have only 1 or 2 rule-outs on the Step Two flowchart. User then totals the number of antigens excluded by the program plus the number of antigens with only 1-2 ruleouts. If the total is greater than one, then Panel B must run. If after running a total of 16-27 cells, only one antigen cannot be excluded then user instructs the reference lab to type the patient for that antigen. While antigen typing is being done, user must color-highlight all the panel cells that are agglutinated and highlight all the panel cells that are positive for the single antigen. If there are no discrepancies and the reference lab reports that patient is antigen-negative then it is concluded the patient has the antibody. If there are discrepancies or the patient is antigen-positive, the reference lab is instructed to do full antibody identification according to their protocol. This is a very conservative protocol (a baby step) that has reduced reference lab fees significantly and improved service to our patients. If patient has mulltiple antibodies or it is not a clear-cut single antibody or all the panel cells are agglutinated, we instruct the reference lab to do antibody identification. As Blood Bank Supervisor, I am an active participant in this process being on-call 24/7/365. I tell my staff that everything they need to know to effectively process a patient with a positive antibody screen is on the flow charts and in our Meditech antibody identification results entry protocol.

Anyone have any experience with Resolvigen?

I'm with Malcolm on this, I don't use p values in my antibody identification process. At my current facility, there is little knowlege of blood banking among the generalists. So I developed a process using a commercially available computer program that automates the antigen rule-out process. Use of this program with a flow chart enables our generalists to come to appropriate conclusions for patient safety, i.e., whether to send specimen to reference lab for antibody identification or limit it to antigen typing. The above process makes everything transparent and provides me with an audit trail of all the activities associated with antibody identification and at the same time provides the staff with a step-wise process that does not require any memorization. Everything they need to know is on the computer screen and on the flow charting document.

Are you required by management to implement both systems simultaneously? Do you have separate teams to assign to each project? I would focus on Meditech first and then Immucor after go-Live with Meditech. You can have multiple methods with Meditech, but you should define two sets of T-Tests to manage both manual and automated test results, e.g, anti-A manual and anti-A automated.

From the CAP Transfusion Medicine Checklist (07.11.2011): TRM.31400 Antisera/Reagent Red Cell QC Records document acceptable reactivity and specificity of typing sera and reagent cells on each day of use, including a check against known positive and negative cells or antisera, or manufacturer's directions for daily quality control are followed. I assume you used the underlined portion of this CAP requirement to challenge your inspection. I am curious which reagent manufacturer does not require testing for specificity (pos and neg controls) each day of use for anti-A, anti-B or anti-D? Thanks

Malcolm, Appreciate your conversation. Thanks, Dan

Malcolm, In your laboratory, do you control your anti-A antiserum with A, B and O red blood cells on a daily basis?

Manufacturer's Instructions for Use state "To confirm the reactivity and specificity of the microtubes containing Anti-A and Anti-B, it is recommended that each lot of cards be tested each day of use with antigen positive and antigen negative red blood cells." Do you interpret this statement that Anti-A should be tested against group O red blood cells as well as group A red cells and group B red cells to demonstrate reactivity and specificity, i.e., Anti-A agglutinates only group A red blood cells and does not agglutinate group O or group B red blood cells?

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:

Is your Transfusion Service accredited by STATE, CAP, AABB, JCAHO? Your accrediting agency (ies) may require that you possess a current copy of their CLIA license in order to use a specific reference laboratory test result for your facilites patients. Do you have a Blood Bank computer system? If so, even if the test result form is compliant with the above, how would you get their ABO/Rh into your computer system in a reliable and timely manner? Direct entry of an ABO/Rh from a foreign document into your computer system bypasses all the ordinary checks and balances that your current processes incorporate. We do a Type and Screen in advance and routinely collect a second blood sample (if indicated on the morning of surgery).

In our facility, ABO typing is done on ProVue. A/B/D Reverse Grouping gel cards are tested against group A1 red cells (positive control) and group B red cells (negative control) using commercially available simulated whole blood controls.

That practice is arbitrary, not evidence-based and cannot be justified with current standards/regulations. The best way to address this issue is to create processes the insure that Nursing does not pick up blood before they have documented patient consent, measured pretransfusion vitals, know that the patient is not scheduled for a procedure, have a patent iv, etc, that is they are truly ready to start the transfusion.

In the case of Anti-A1 lectin reagent, the purpose of the controls are to demonstrate that the reagent can correctly distinquish between A1 and A2 cells.. In a facility where appropriate controls cannot be tested and the test is being done to resolve an ABO discrepancy in a patient who may require blood transfsion, one could make a case for that situation to routinely select group O red cells for transfusion. Then send the specimen to a reference lab.

Our Provue (software version 3.2) prompts user to load Anti-IgG gel cards whether the test PanelCFicin-IAT.gru or the test PanelC-IAT.gru is ordered. If the test PanelCFicin-37C.gru is ordered, Provue prompts user to load Buffered Gel cards. Is this not what you're seeing on your ProVue?

You are very welcome. CONFIRM is our name for an LIS Order Group configured as an Order Type of ADD and a Spec Type of NEW. On page 2 of the LIS Order Group dictionary the BBK test entered is also named CONFIRM. The Anti-A,B test in the BBK Test dictionary is configured for test results of 1+, 2+, 3+ and 4+ defined as positive test results and 0 (zero) is defined as a negative test result. On page 5 of the BBK Test dictionary for the test CONFIRM, the Reflex Order Group CONFIRM is entered for test results 1+, 2+, 3+ and 4+. The test CONFIRMO is entered for a test result of 0(zero). CONFIRM or CONFIRMO is reflexed by Medtech after the user files and saves the test results of the anti-A,B test. Hope this helps. Dan

I use the BBK History Backup Status routine to monitor patient history backup. We have it configured to back up to two different PCs in the Blood Bank. These PCs are always powered-on.

3rd party payers will not reimburse for the second ABO, they consider it quality control. We don't charge.

Not a problem, we are not AABB accredited