conwaysbb

The package insert for Fludarabine, states the following: TA-GVHD has been observed after transfusion of non-irradiated blood in Fludarabine Phosphate for injection, USP treated patients. Fatal outcome as a consequence of this disease has been reported. Therefoe, to minimize the risk of TA-GVHD, patients who require blood transfusions and who are undergoing. or who have recived treatment with Fludarabine Phosphate for injection, USP should recieve irradiated blood only. It is also recommended for patients receiving other purine analogues, such as Claribine, Deoxycoformicin, and Campath and patients on anti-lymphocyte globulin should also recive irradiated blood products. in fact, thier have been some law suits against hospitals that did not follow this policy, as the package inserts state this in the Warning statements for the drugs. We have arranged with the pharmacy departmetn to get a list of any patients on therapy of any of the drugs stated above. The question I am posing is does anyone know if this is a permanent special requirement/instruction for irradiation of blood the patient or is this a temporary one and if so how long after the patient stops the treatment with these drugs should the special irequirement/instruction for irradiation stay with the patient

We perform a bacterial contamination workup immediately, without waiting for our pathologist's request, when the temperature rises 4 degree F above the baseline. The standard orders are for a stat gram stain of the unit, blood cultures on the unit and blood cultures on the patient. The floor is to be called to order the blood culture of the patient immediately and also to draw the blood from a separate access than that used for the IV access line used to transfuse the patient. This is to eliminate the possibility of a bacteria coming from a contaminated IV access line. Also, the patient's blood culture should not be delayed as antibiotic therapy may be started from the increased temperature seen during transfusion. A bacterial contamination workup can also be ordered by the pathologists during his/her review of the transfusion eraction work up and is often requested when symptoms are rigors and chills with a rise in temp > 2 degrees F. If there is a positive gram stain result, this is immediately called to the floor, to the pathologist and to the blood bank manager. It is one of our panic values.

Fortunately for us, I have access to at least 4 blood centers that want my business. Hospitals around our area (Northern NJ) change Blood Suppliers based upon "What can do for us now". Definitely pricing is the major issue, especially because of the high cost of living, which results in a high cost for blood and components in our area. Because of this, the blood centers are becoming very competitive in their pricing, so I have been able to reduce my costs/unit on several blood components. I also need to have at least one extra blood supplier for my needs, as there are also a ton of hospitals vying for blood products. As DNV follows ISO standards and Supplier Qualification is a big part of the ISO standards, I need to develop some quality indicators to determine how well my supliers are doing, with lookback and recalls being suggested by our inspector. Knowing that changes in deferrals have constantly been increasing, I would agree that determining a baseline % of recalls/lookbacks and then stipulating that the recall rate should not increase more than a certain % would be an appropriate practice and 5% is reasonable. Thanks for the comments.

We have changed our hospital accreditation form the JCAHO to DNV. One of the inspectors asked me during the DNV inspection whether I evaluated my blood suppliers on the number of recalls and/or lookbacks recieved from them during the year as part of the Supplier Qualifications (they follow ISO standards). I am bringing this issue here as I have no idea if anyone has a benchmark for the number or percentage of recalls/lookbacks recieved from a blood supplier. Alhtough I know that there have been several additional reasons added because of deferral requirements, most of the recalls I get are because of incomplete medical evaluations or errors in manufacturing, and would certainly be a valid issue to be looked at when performing annual supplier qualifications. Of course, I will be asked where I got my information for the bench marking. Would anyone know if this issue has been bechmarked any where this information can be assessed? Does anyone hava na opinion on this? If so are you a Transfusion Service/Blood Bank or a Blood Supplier? Just for comparison, I have a hospital based donor room which supplied us with 1800 units last year we issued unfortunately 2 recalls for a recall/lookback rate of .11%. However, with a total of 10, 000 received from my blood suppliers I received a total of 42 recalls and 1 lookback resulting in a recall/lookback rate of 0.40%. Thanking you in advance for your thoughts and direction.

Not to cause anyone to have a stroke, however, there have been some transfusions of what we would normally consider ABO incompatible transfusions via intrauterine transfusions. I believe the specific article I saw was an A Negative washed red cell transfusion from a mother with anti-D and other multiple antibody specificities to her baby that was O Positive and severely affected with HDN. This was done several times during the pregnancy and the baby was finally delivered with a blood type of A Negative who subsequently reverted back to O Postive

Having changed myself from Hemocare to Sunquest in the last two years, I personally would not recommend this system to anyone!!! Here are a couple of reasons. The primary reason is that Sunquest does not have a QA warning for when an individual has either a present antibody or a history of an antibody from performing just a immediate spin x-match. In order for this to be accomplished in any form, you need to purchase the electronic crossmatch module and even then it is not complete. If I had known this one issue, I would have highly reccommended that we not go back to Sunquest. (we previously had used sunquest prior to hemocare). This is a very basic idea and requirment!!! All the other systems I had looked at had this basic QA warning. The reply form Sunquest that my staff have some responsibility to know that they need to include an AHG phase of testing, is just plain ignorant. There is no QA warning when you send a unit back to your supplier for an unacceptable reason and you get the same unit back (they told me this would never happen. I guess they forgot about Murphy's Law). At this time, when you modify a unit changing the ISBT product code, there is no QA check for extending the expiration date and/or time of the modified product from the original product. I.E. irradiating a unit/ splitting a unit, etc. This problem has been known for several years. There was even a bulletin sent out to tall Sunquest users (happened before my going live, so I didn't know about this issue). In addition they stated it was slated for an enhancement at a later date. When they finally admitted to me there was an issue and sne t me the bulletin, they still hadn't even begun to work on getting this into a future release and could not tell me when they would. Having to bring this up on to different facilities, there were some other issues that are unique to a multi-system site. If you would like to contact me, please e-mail me at conwaym at sjhmc dot org. The assistance during implemetation is OK. Not any better or any worse from any other system I have ever implemented. However, after implementation, the assistance and follow-up is poor. The actual cost of the system from what they stated is also not what it cost us to re-build it to our needs as there was additional assitance to what we needed. As we were also coming back to Sunquest we had old codes in there that we could not get rid of so our maintenance files are enormous. With the requirement that you can only use up to a certain amount of characters, this is also problematic. Of course you also know that this is not a true windows based platform and maintenance files and reports are also still a roll and scoll (menu) driven system. But that is just my opinion :-). Alas, because this was our legacy system and we use Sunquest as our main LIS, it was far cheaper to go with Sunquest and since we were in a financial bind that is what we did. I guess the old adage that you get what you pay for still applies.

As our blood suppliers only supply us with apheresis platelets we normally never have any trouble with having to use surrogate testing to detect bacterial contamination, as the blood supplier performs bacterial testing on all thier apheresis platelets. However, about 3 times a year we will have to take bacterially untested platelets from our supplier during a time of short supply and high usage. We have used both the PH and glucose strips as our surrogate test, but also must find an alternative test as the AABB ( 01/31/2011) and CAP (6/2011) will no longer allow this surrogate testing. As the Verax Platlet PGD test is used for whole blood derived platelets, is there another FDA approved test for testing single units of apheresis platelets for bacterial contaminiation when recieved in a hospital untested? Would the EBDS system mentioned above be acceptable for this purpose? Does anyone know where I can get information about these systems, including who makes them?

This is of course based upon hand-writing label at the patient bedside. Preprinted computer generated labels, using a barcode scanner that generates the patient label at bediside, handwritten labels, typenex or additional blood bank numbering; it doesn't matter what you use, if the label is not placed on the specimen at patient bedside. As for allowing additions or changes to the specimen label after reciept, we have made it a policy that no changes can be made. If there is a complaint from a physician or nurse, only the blood bank manager or the medical director can approve the exception. My staff is not authorized to make these decisions. If the error includes either the patient name or medical record number, no exception is made and a new specimen is requested. Reponses to physicians or nurses telling us the patient will bleeed to death, is to inform them that emergency release blood is always available, but the paitent's physician will have to sign the emergency release form. Exceptions are made in regards to date or initials, but on irretrievable specimens (neonatal specimens where the patient is extremely anemic; patient in OR and bleeding). However, the only individual that can come down and correct/add is the individual whp drew the specimen,, which includes physicians, so we document on the request form that specimen was corrected in blood bank. We also have the support of a NJ State Dept of Health regulation , which specifically states " In the case of a discrepancy or doubt, another specimen shall be obtained and used for these procedures". So we have the law to back us up. I regularly educate medical students about specmen errors due to patient ID errors or specimen lableing errors. 1 specimen error in 100 specimens is 99% compliance. 1 in 1000 specimen errors is 99.9% compliance, 1 in 10,000 specimen errors is 99.99% compliance...pretty good odds. However, no one wants to be that 1 patient who recieves that wrong unit of blood. there goes my diatribe on the subject

Since you mentioned molecular testing, has the FDA approved this technology to be used for resulting antigen typing on units? From my knowledge, molecular testing is still used for research only.

We use the Sunquest blood bank system and each unit is brought in to the system by supplier, unit # and ISBT 128 product code so we can easily distinguish both units. I have decided, for the exact same reasons as mentioned here, to be consistent and not have too many exceptions, so we will be antigen typing each unit of a double red cell unit. As we have a large sickle cell population and tend to transfuse multiple units, it is to the patient's advantage (and to ours to a certain extent) to be transfused both units of a double red cell transfusion to reduce donor exposure (most of our multiple antibody patients ar sickle cell patients). We also give RH and K matched units to these patients and it helps when a unit of a double red cell collection is found to be that match. We just look in our inventory to see if we have the other unit available. It would be even better for our budget, if I didn't have to antigen type that second unit. Again thank you all for you replies.

My staff has asked a question that has stumped me. :-) We have been getting both units of a double red cell collection. When you antigen type one unit of a double red cell collection can you use the results obtained for the other unit or do you have to repeat the testing on an integral sample from the second unit. Part of me says that when we do donor testing on the donor specimen collected at the time of donation, we use these results to release both units of a double red cell collection. Part of me says that even though they share the same unit number, they both should be tested separately using an integral segment obtained from each unit at time of testing. I am leaning towards having each unit tested, as I would still require a x-match be performed from an integral segment from both units and I retype of both units. What say you?

I would defer you to the manufacturer's information on the particular platelet collection system that is used to collect the platelets that you receive, as there are several different platelet apheresis systems out there, for information on how much residual red cells may be contained in a apheresis platelet product. This is the information that they have supplied to the FDA and has come from hundreds of products that were collected. As the volume of apheresis platelet products vary greatly, the very term "Visibly Tinged" is highly subjective and may indicate a vast difference in red cell contamination of the product transfused. I am sure if you contacted the platelet collection system manufacturer's technical support line you could get this information and then use it to make your decision. I am equally sure your blood center will be able to provide the phone number of same. My understanding is that you will never get visibly tinged apheresis platelets, as these platelets would be non-leuko-reduced and not be able to have bacterial blood cultures performed. but I may be wrong :-)

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On page 586 of the 16th edition of the AABB Tehnical Manual, it talks about giving RhIg to prevent D alloimmuniztion when giving Rh Positive platelets to Rh Negative patients. Even platelet apheresis products can contain an immunogeneic dose of red cells. From past experience, the manufacturer of the apheresis sets and collection system indicates that there may be up to 2 mL of RBCs in a unit of apheresis platelets. Therefore, attempts should be made to provide Rh negative recipients with platelets from Rh Negative donors (although the platelets do not have the Rh antigen). ALthough the clinical magnitude of this issue is less than one might expect, the production of anti-D in the female patient of child bearing potential is of concern, so most facilities would recommend RHIG to these patients if Rh Positive platelets were transfused. This would support AABB Standard 5.20. In past AABB Technical Manuals there was a formula for how much RhIg to reccomend. as follows "A full dose of RhIG, which is considered immuno-prophylactic for up to 15 mL of Rh Positive RBCs, should protect the red cells in a minimum of 30 units of Rh Positive Platelets or 7 units of platelets apheresis" Pg 457, 14th Editiion, AABB Technical Manual.. As for ABO matching, it is preferable to give ABO matched platelets first, then ABO compatible and as a last resort, ABO incompatible. The rise in platelets is higher in ABO matched platelets. In Pediatric patients is is more critical as ABO incompatible plasma may have more serious effects due to the reduce blood volume of the recipient. If ABO matched or compatible plateles are not available, we would give volume reduced incompatible after the patient's physician is notified and they agree to transfuse. We also titer the ABO anitbody and only transfuse if the titer is less than 1:100. Of course in the end, we would rather take care of the underlying condition and save the life of the patient and worry about what happens later than not give incompatible platelets ,if they were the only ones available. Incidentially, we have had two serious hemolytic transfusion events when we have transfused ABO incompatible platelets. Both cases the titer of the offending ABO antibody was greter than 1:1250. Both cases the supplying blood center was notified and they removed the donor from their apheresis platelet program.

On page 586 of the 16th edition of the AABB Tehnical Manual, it talks about giving RhIg to prevent D alloimmuniztion when giving Rh Positive platelets to Rh Negative patients. Even platelet apheresis products can contain an immunogeneic does of red cells. From past experience, the manufacturer indicates that there may be up to 2 mL of RBCs in a unit of apheresis platelets. Therefore, attempts should be made to provide Rh negative recipients with platelets from Rh Negative donors (although the platelets do not have the Rh antigen). ALthough the clinical magnitude of this issue is less than one might expect, the production of anti-D in the female patient of child bearing potential, most facilities would be inclide to recommend RHIG to these patientsif Rh Positive platelets were transfused. This would support AABB Standard 5.20. In past AABB Technical Manuals there was a formual for how much RhIg to reccomd. as follows "A full dose of RhIG, which is considered immuno-prophylactic for up to 15 mL of Rh Positive RBCs, should protect the red cells in a minimum of 30 units of Rh Positive Platelets or 7 units of platelets apheresis" Pg 457, 14th Editiion, AABB Technical Manual.. As for ABO matching, it is preferable to give ABO matched platelets first, ABO compatible and as a last resot, ABO incompatible. The rise in platelets is higher in ABO matched platelets. In Pediatric patients is is more critical as ABO incompatible plasma may have more serious effects do to the reduce blood volume of the recipient. If ABO matched or compatible plateles are not available, we would volume reduce after notifying the patient's physician. We also titer the ABO anitbody and only transfuse if the titer is less than 1:100. Of course in the end, we would rather take care of the underlying condition and save the life of the patient and worry about what happens later than not give incompatible platelets ,if they were the only ones available.

Recently we had a FDA inspection in which they focused on equipment preventive maintenance and quality control. They requested from us a list of equipment for the blood bank and reviewed our QC SOPs and also the manufacturer's Operator and Service Manuals. When the Operator's or Service Manual listed a recommended quality control or preventive maintenance the FDA looked for these and cited us for not having some of these recommended PMs in place, as well as, for not documented these recommendations. In the case of the Helmer Plasma Thawer, there is a preventive maintenance schedule indicating the frequency of performance with the statment by the manufacturer "Maintenance tasks must be completed according to the following schedule". For the "QuickThaw Plasma Thawing System", that we use, it requires weekly cleaning of the chamber and basket, quarterly lubrication of the moving parts, quarterly temperature calibration for the temperature controller readout, quarterly high temperature alarm and annual checking of the bearings for the basket. Also, we have our annual electrical check that is required. They actually spent over 3 days just on equipment alone and we had to work very closely with our contracted Bio-Medical department to correct our deficiencies, as Bio-Medical department was documenting performance electronically and not very well (documenting the PMs and QC that they were responsile for was done, but not what the readings were or not documenting electronically who performed testing). It was quite an experience, as there were some preventive maintenance recommendations that were impossible for my staff to perform. Some of the citations were resolved after phone calls to the manufacturer indicated that our original Service manual was outdated and the preventive maintenance shcedule was changed so that an anuual preventive maintenance performed by the manufacturer covered a particular preventive maintenance requirement (from semi-annual to annual). Also, although we had a cleaning schedule defined in some of our SOPs, we did not document these cleanings, so we had to develop a new form or revise forms for documenting these cleanings (if it wasn't documented, it wasn't done). But I digress.... We have our high alarm going off at 36.7 degrees and our set point at 35.5, which in our case the actual temperature is a little higher (within 0.5 temperature allowable difference). We thaw both FFP and Cryo in this thawer. When I looked in the CFRs, temperatures of storage are not listed as 1.0 degrees or 6.0 degrees, but simply as 1 and 6 degrees. We all know that if we listed the storage temperature of blood as 6.1 degrees, we would be cited because it would be out of range. Using the same logic, if you have your high alarm point set up as 37.1 or higher, then these temperatures would be out of range and potentially you could effect the potency of the thawed product if it reached 37.1 degrees, which the FDA could construe as being a reportable error. Remember, it just has have the potential to effect the potency of the unit to be reportable. If someone would like to put this question to the FDA, be my guest.

That is awesome. Hopefully this will lead to bigger and better things!!!

I remember a long time ago I had to develop a Competency Assessment Program following cGMP requirements. I referenced a FDA article, so I went looking for it on the FDA website and found it. On page 7 of the GUIDELINE FOR QUALITY ASSURANCE IN BLOOD ESTABLISHMENTS it states: Competency Evaluation To ensure that all staff are trained and maintain their competency to perform all assigned tasks, the QC/QA Unit should implement a formal regular competency evaluation program. A competency evaluation program should evaluate theoretical and practical knowledge of procedures including, but not limited to, the following: (1) Direct observations of performance of routine and quality control procedures including, as applicable, donor suitability, sample handling, processing, testing, labeling, and instrument preventive maintenance; (2) Monitoring the recording and reporting of test results by reviewing work sheets, quality control records, preventive maintenance records, and other records and entries (both manual and automated); (3) Written tests to assess problem solving skills, knowledge of SOPs, and theory; and (4) Assessment of performance using internal blind specimens and external proficiency test specimens. Minimum acceptable scores, performance, and remedial measures to correct inadequate performance on competency evaluations should be documented and retained in personnel records. Evaluation summaries provide useful information to correct individual or group performance problems. The specific website is: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM164981.pdf. Although this is from 1995, it is still appropriate today and I have never had anyone question my competency assessment program. I and my senior level staff who perform training and competency assessments, do not directly observe every single task. Howwever, as we review all QC records, PM records, transfusion reaction workups, antibody workups, Computer exception reports, Testing worksheets/logs, etc. we use these as part of the competency assessment. I also give every member of the staff a 20 question, open book quiz. As the whole purpose of SOP manuals is for staff to review and read if they can't remember every step in a procedure, then letting them look up the answer in the SOP manuals is appropriate too. We do give all testing personnel Tech Chek samples from Immucor or a CAP specimen. Of course I have minimum acceptable scores for the written quizes and the Tech Cheks/CAP samples. We have done crossword puzzles, but instead of having to do the crossword diagrams myself, there are some free crossword internet sites that will actually just allow you to enter a list of words and it will create the crossword for you. Much easier to do, then trying to do it yourself. :-)

I actually sent a question to " BP_Deviations@fda.hhs.gov" in regards to this. The contents of the e-mail were as follows: To whom it may concern. This scenario has come up as a question whether it would be reportable or not. A request for 10 units of red blood cells comes in as a stat for a bleeding patient. The patient has special instructions to have all cellular products irradiated. The blood bank technologist calls the medical director of the blood bank and the medical director tells the blood bank technologist to release the blood without irradiating it and documents his decision to not irradiate the blood. The medical director however does not consult with any of the patient’s physicians that are treating the patient /requesting the 10 units of blood. Is this reportable as a BPD? Subsequent to the event, the physician in charge of the patient states, if he was informed of the special instructions that he would have wanted at least some of the units to be irradiated, if the blood bank could have provided irradiated blood in the time frame available, as he didn’t take all 10 units at once. Upon further review, the facility has an in-house blood irradiator and it was determined that based upon the time line presented 4 of the 10 units could have been irradiated, but as the physician in charge was not consulted this option was not presented. Is this reportable as a BPD. This question is being presented on a message board and there are many comments. I thought I would present it to you for your thoughts. Please reply at your convenience. Thanking you in advance. This morning I received a phone reply on this. The individual responding said that this e-mail was discussed with several inidviduals at the agency for some length and the following are their answers: 1) If the blood was released as emergency release and you have the requesting MDs signature than this is not reportable. 2) If the medical director consulted with the requesting MD and they both agreed that they could not provide irradiated RBCs in the time frame needed, this would not be reportable. 3) However, if the Medical Director did not discuss this with the requesting MD and it was not an emergency release, then they would want this reported, as this could effect the safety, purity or potency of the product to the patient. Again, I do not know the situation of the patient, as the original post said the patitient needed 10 untis of blood in an "emergent" situation. Further information would be needed, such as: Was the blood to be released as emergency release blood? Was the requestiing MD called to see if they needed all 10 units at once or could they give some units immediately and have time to irradiate the other blood? Does the facility have an in-house blood irradiator and if so, how long does it take to irradaite one unit? multiple units? If not, how long would it take to get irradiated product in? Did the Medical DIrector consult the requestign MD prior to release of the blood? As I said in my first response, I was playing the devil's advocate, as is my wont :-). However, managing blood banks in large institutions, primarily Trauma centers, we have come across these similiar situations, whether it was for a patient needing irrdaited blood, sickle blood, antigen negative blood and the first call is to the requesting MD to find out the situation of the patient, to see if they really need all 10 units right away and are they aware of the special requirements of the patient. The first call is not to the medical director. The medical director is usually called after speaking with the requesting MD to both notify him of the situation and/or to have the medical director consult the requesting MD

Thanks for all the replies. So far two of the vendors have agreed and we will be sending them to official training. One vendor needs more information before agreeing, so I need to get my protocol in place. While all three of the vendors recommend plasma samples, all three also can use serum samples for antibody screens and panels. In fact, since I am still using serum, we have been used as a source for serum samples by one of the vendors for validation purposes of their methodology, and these samples used were frozen prior to sending them for testing. However, for ABO/Rh they all require plasma samples so we will be using EDTA samples most likely from CBC samples sent. I am probably going to also look at the CBC specimens for plasma samples to store for patient's identified to have antibodies from our serum samples, plus my other smaller hospital uses manual gel and is collecting specimens in a pink top, so they too are freezing samples. I have informed my vendors that if they don't want to participate, they will not be considered when choosing vendor for automation. This is similiar to what I did when I sent an RFI for our blood bank systems. Makes a good incentive for participation, especially since I will be makiing the decision for a multi-hospital system. I am still looking for any protocols for evaluation if anyone has one. Thanks for all the replies so far and I will keep everyone updated. I just have had a spate of inspections recently including the FDA, AABB and now the State Dept of Health.

That is fantastic!!! Although it was many years ago, I remember when I received my letter telling me that I passed (I am dating myself). I only had to wait about 3 weeks till I found out. lol I was so estatic, especially since I didn't pass by 2 points my first time around (Darn coag questions). It truly is a tremendous accomplishment and hopefully it will open many more doors and opportunities like it did for me.

Just to play devil's advocate here...Just because a Medical Director documents it is his/her medical decision not to irradiate the blood due to the emergent situation of the patient, does not make the decison correct or not reportable, especially if he/she did not consult the transfusing/ordering physician before making his decision. As this is a documented event, the QA unit must determine whether (A) there was a consultation between the ordering physician and the medical director and if so did the ordering physician concur with that decision. Accordingly, If the ordering physician has a standing order that the patient only recieve irradiated products and still insisted that the patient receive these products even in the emergent situation, then the medical director would have to document it was impossible to irradiate any of the blood in the available time required to get all 10 units to the patient. ( Whether there is a exisiting policy in place that has been approved by the Transfusion/Blood Utilization committee for for these types of situations (example automatically switching from RH Neg RBCs to RH Pos RBCs); © whether the facility has access to an in-house blood irradiator and what the irradiation time is to determine whether you can iirradiate any and/or all of the units being given in the available timeframe. While I am sure most medical directors are competent in making these types of decision, I have met a medical director or two, who have made hasty decisions, which upon investigation of the event(s) were determined to be the wrong decision.

We are in the beginning stages of moving towards automation. I have requested from Ortho, Immucor and Bio-Test/Bio-Rad to bring their insturments in at the same time so that I can do a parrallel comparison. We currently use LISS tube methodology with a serum specimen and have been freezing serum specimens with identified antibodies. While I have a good idea on how I want to do the comparisons, I am askign for opinions on what evaluation protocols could/should be used. If anyone here could suggest protocols, even to the point of sending me any that you have used or recommend I would appreciate it. We are looking at July to start the evaluation. Also, if you could identify any pitfalls that may occur, in your experience, I would appreciate it. I know that one of the pitfalls that might occur is our serum samples instead of plasma samples. How much of a problem will this be and what have others done to rectify this. As a former mentor told me the first day I met her, there are no stupid questions, only stupid answers. :-)

Having had to revise our Fetal Screen Testing SOP recently I had to go to our product insert for the Fetal Bleed Screening test that we use. I was also surprised from having supervised previous facilities how different the SOP of my current establishment, was from my previous establishments, even though we were using the same reagent, Immucor's Fetal Bleed Screening Test. Specifically the product insert has in the Intended Use section, that the test is intended for use in the detection of D-Positive red blood cells in D Negative mothers after delivery. Therefore for the use of this specific test, the use of this test is only indicated in post partum testing and not in cases of traumatic injury to the mother or fetus, amniocentesis or other invasive prenatal testing that may cause feto-maternal hemorrhage.. There is also the issue of determining the blood type of the newborn, as babies with the Weak D may not detect a feto-maternal hemorrhage exceeding 30 ml of whole blood. ( Other than for donors, this is one of the only times the Weak D test is required to be performed) As many of our requests from the ER for the fetal Screen test is to determine whether the mother has had a larger than normal feto-maternal bleed, and not to give Rhogam, the appropriate test to order would be the Kleinhauer-Betke test. Of course if the fetal screen test is used in this instance, you will get a false negative result for a feto-maternal hemmorhage if the fetus is Rh Negative. That is how our Policy and Procedure is set up now and it is only performed other than for paost partum patients only at the specific request of the patient's MD. Ironically enough, we had a big to do about this issue from one of our OB/GYNs when a fetal screen that was performed was negative and the Kleinhauer-Betke test that was performed was Positive. The OB/GYN insisted that the laboratory had made a mistake and that the Blood Bank's result was in error. Had to do a presentation to the OB/GYNs on these two tests and why they could have different results (even the Kleinhauer Betke could be incorrect depending on the mother's Hemoglobin type). In regards to the 48 hour recommendation for giving RH Immune Globulin, we normally use 72 hours as a rule, but if not given within 72 hours, it doesn't hurt to give it later than 72 hours. In fact the 72 hours is an arbitrary time frame and is associated with the original research of RH Immune Globulin on Rh Negative male prisoners. (that is another story). Finally on this issue, and specifically for Immucor's product, in the Specific Performance Characteristics section of the product insert it states "The performance of this product is dependent on adhering to the recommended methods found in the insert". Legally that means if you use the product for anything other than post partum specimens, and you get a false positive or false negative result, you are on your own and must leave Immucor blameless. What other manufacturer's Fetal Bleed Screening test are there, other than Immucor's?

The antibody identified was a clear cut microscopic anti-E which was further enhanced by PeG. In addition an eluate was performed and anti-E was identified. The Pathologist interpreted this as a serological event rather than a hemolytic event. I believe what I will be doing will be requiring a antibody ID be performed and if negative a repeat of the antibody screen using the same screening cells but with PeG as the potentiator/additive. Of course a consultation with a senior tech or myself would be required to change the final result. This would all be documented in the patient's record with the information that results have been changed and the name of the nurse or MD that had been notified included in a blood bank comment. In addition, we always use something like this as a training tool or continuing education event. It is always valuable to observe how the individual shakes out the tube, as the interpretation of gentle shaking means different things for different individuals :-). It was observed that the individual continued to shake the tube between the initial observation of tube in the agglutination viewer and the observation under the microscope. :-(. Again, I am awaiting approval for automation so that variations in technique will not come into play and according to all the different manufacturers of automation, sensitivity will also be increased by using their products. My entire staff is looking forward to this.