shelleyk482

Who does your facility allow to be the 2nd person (the first being a tech) checking out blood from the Blood Bank? Our current policy is that an RN must be the second person doing the check out procedure. For the floors this translates to only allowing RN's to come to pick up blood products. OR & ED can send a PCT, aide or transporter to pick up blood but if they do, then 2 med techs must do the check-put procedure. I am wanting to change the policy to allow nursing personnel (RN's, PCT's, Aides & transporters) to be the 2nd person doing the check out procedure because tying up 2 techs (we're a relatively small lab) slows down TAT during trauma's and massively bleeding surgery cases.

The last place I worked we called the "serologically incompatible" to indicate that they were incompatible in the test tube but not necessarily incompatible in the patient.

I haven't worked in a hospital that requires this in many years. Has to be in the patient's medical record, not in the Transfusion Service.

We use the industrial strength velcro. We also use 2 timers per cooler; one goes on the cooler, the other is kept on a white board in the blood bank with the patient/room information. Blood Bank is then aware of when the timer is about to go off and they call the OR room if the cooler isn't back. If there is no answer in OR then they have security open the room and retrieve the cooler. OR has a position that is designated as responsible for making sure the cooler is returned and if we have to have security retrieve the cooler, it is an automatic disciplinary action so it has only happened once or twice.

That makes sense. In the other facilities where I have worked we had non-professional couriers pick up products for both inpatient and outpatient. We required a "Blood Product Requisition" form that had the patient name, medical record number, wristband number and the product type & number required. This form was required for all transfusions; inpatient & outpatient. The couriers were also required to do the full dispense procedure regardless of where the product was being dispensed to.

My understanding has always been that this is a facility specific preference . In most of the facilities I have worked in (all but one in Texas), there have always been couriers (non-professional) that transport blood to an off-site facility. In my opinion, it is a significant waste of money & time to have a high-dollar nurse or tech, who should be doing something else, transporting the product. Of course, there needs to be an appropriate transport container and training of the transport concerning the importance of promptly delivering the product where it needs to be. I would be interested in seeing what JCAHO standard the adminstrator is refering to.

My personal feeling is that with using the temperature indicator and a validated cooler, you are taking the temperature continuously and since the indicator is nonreversible, if it's still in range when the unit is returned its pretty conclusive that the cooler was in range at the 4 hour time period. So, if you document that the unit was at an acceptable temperature at release and still at an acceptable temperature at return (using the irreversible temperature indicator), you have met the requirements for monitoring the temperature of the cooler for the period of time that the unit was in the cooler.

We use IgG for cords only. All non-cord samples are tested using a polyspecific reagent.

Get with your blood supplier and have them help you develop a packing system that is consistent with their requirements. We occasionally ship to some smaller related facilities and by utilizing a packing configuration approved by our supplier, we are able to retain our return priviliges.

I'm not trying to be an alarmist or negative, but I have not had the good experiences that Kate has had. In a hospital setting in which we washed RBC's and irradiated, whenever the FDA came in to inspect they looked at everything- testing, products, QC, maintenance, etc. Each inspector I've dealt with (I've tried to count and I think there have been 7 or 8 different inspectors through the years, in different facilities) has taken the SOP and sat down with at least one of my techs and watched as they did the testing to assure that the testing (# of drops, incubation period, # washes) etc. matched what was in the SOP. The inspector normally talks to different bench techs asking the same question in several different ways to make sure that the same answer is given. They have looked at all of the equipment validation, calibration, maintenance (to include pipettes, refrigerators, platelet incubators, MTS centrifuges, etc) and all log sheets. Don't get me wrong, FDA inspections are manageable as long as you are always prepared. CAP & AABB give you a specific timeframe so you kind of know when they are coming. I've had FDA in 6 months before and up to 8 months after I expected them. If your SOPs match what you actually do & your documentation is complete, legible and thorough, you should be fine. Make sure you are up on the CFRs that relate to BB and make sure that your staff has periodic cGMP training. I would not count on the fact that the inspector will only look at those activities directly involved with the reconstitution of the whole blood; the FDA finds a way to tie all BB activities into the manufacture of the product. This is one of those situations in which "you hope for the best and expect the worst". I truly hope that my experiences have been the exception and not the rule and that your inspections are like what Kate has related.

You can expect the FDA to visit at least once every 2 yrs. They will look at everything you do in the blood bank. The biggest thing to remember is that your written procedure MUST match what you are actually doing and your procedure MUST match manufacturers directions unless you have extensive data to support not following manufacturer's instructions. This sounds easy in theory BUT in practice it can be a nightmare. There is no wiggle room for missing a weekly review (if your SOP requires it), or a late pipette validation, etc. FDA inspections are unannounced and extremely thorough; they tend not to be educational (at least in my experience), they are more punative in nature. I have spent more than 20 yrs in FDA registered/licensed facilities and am very happy not to have that to worry about now. I fully realize that even though the facility I am in is not FDA registered/licensed that they could choose to come visit if they so desired, but the likelihood of that happening is very small since they are having a hard time keeping up with the facilities they have to inspect.

I worked at 2 facilities that did neonatal/infant ECMO. At both places, we provided blood in an aliquot bag rather than a syringe. We would pre-aliquot bags usually in 100 cc aliquots (depending on the size of the infant). I agree that you need to determine what the expiration of the RBCs should be; I've always used CharterMed and they specify 24 hours as long as the syringe is stored at the proper temperature.

You should definitely fight the deficiency. The supervisor at our sister hospital called CAP concerning this and the answer she got today was that QC was NOT required for expired cell panels. The person she spoke to said that personnally she thought it was a good idea but the standard was not intended to be applied to expired cell panels.

Our supplier will furnish reconstituted whole blood however we are more than 2 hours away from them (in a snow-prone area). Our procedure is written to state that the preferred product is purchased from our supplier but it goes on to define an in-house process of making the product. It is clearly stipulated that this is to be used only if the medical situation is so critical that the delay (which would be a total of 4 hours on a good day) in product availibililty would be life-threatening for the neonate. Our medical director must consult with the neonatologist prior to the product being made in-house and since the medical director is well aware of the implications of this being done in-house on a routine basis without FDA registration, it would take a lot for him to approve. In the year since we made this new policy, we have not had an order for an exchange transfusion. Our feeling is that since this would be such a rare occurrence that when it does happen, it can be handled as a medically emergent procedure, and it would be thoroughly documented as such, that FDA registration would not be required. If we start producing the product on a fairly routine basis (probably more than 3/yr) then we would look at the necessity for FDA registration. From my understanding, after speaking with FDA inspectors in the past, concerning "rare" events such as this, that it is an acceptable approach. You just need to continually review the number of occurrences and assure that it is truly a "rare" occurrence that is used in life-threatening situations where the are no viable alternatives. It has been quite some time since I have broached this general topic with an FDA inspector so I can't guarantee that this is still FDA stance, but to me this is an approach that makes sense and that I would feel fully comfortable in defending.

We have used the Antibody Check software since the first of the year. It is easy to use and it definitely helps the staff (mostly generalists) feel more comfortable with doing rule-outs. I have found the company to be helpful and professional. I have no issues with recommending the use of the software. Shelley Keller, MT(ASCP)SBB Flagstaff Medical Center Flagstaff, AZ 928-214-3874

I don't know that age has anything to do with it, at least it didn't at the children's hospital I was working at. The dosage recommendation is 10-15 ml/kg, assuming a 350 ml RBC and 15 ml/kg, the patient would need to weigh at least 23 kg. The dosage recommendation is from the AABB Pediatric Transfusion: A Physician Handbook.

We sterile dock syringes to a plateletpheresis and pull out the amount ordered by the physician. I assume the physicians are determining dosage using body weight. The recommended dosage is 5-10 mL/kg (Pediatric Transfusion: A Physician's Handbook).

The facility that I'm at now is fairly small and has never been AABB accredited. The 2 previous facilities that I worked, were both AABB accredited and while I was there, each facility dropped the AABB accreditation. My feeling is that when AABB went to the Quality Plan approach, the tools they decided upon were not really relevant to a Transfusion Service; for most hospital based TS, this became an exercise in paperwork that had little to no impact on quality. I have never had the luxury of working in a facility where I had the time or the staff to dedicate to a process that does not seem contribute to the concept of quality patient care. I do CAP inspections and for the most part, when I go into facilities their quality plan is "just a document that they had to write to meet regulatory standards". The manual is not used and is only updated immediately prior to an inspection. Once AABB comes up with a tool that is useful for a hospital setting and doesn't take a dedicated Quality person, I may reconsider my position. Until then, I will keep my personal membership and continue to write and enforce policies and procedures that adhere to AABB standards without the cost and inordinate amount of paperwork of a facililty membership.

We are changing our primary method from manual gel to the TANGO. In doing our parallel studies we have had numerous cases of nonspecific reactions in gel that did not show on the TANGO; we sent these to a reference lab and without exception the reference lab did not identify a clinically significant antibody. Yesterday, while training, we ran a patient on gel and the antibody screen was negative however the TANGO antibody screen was 3+ positive. Another tech repeated the gel screen and 3 of us (all with > 15 years experience each) called the screen negative. We then increased the plasma:rbc ratio and extended the incubation time to 45 minutes and was able to get a 2+ positive gel screen. The gel antibody panel was inconclusive, the TANGO panel was a clear cut anti-K. In reviewing the patient's history, we had done antibody screens 2 other times in the past 6 month, all negative, luckily she did not receive a transfusion either time and according to both her and her physician, she has not been transfused nor has she been pregnant (fullterm or miscarriage) during this time frame. My staff is insisting on running all tests by both methods until our pathologist signs off on the validation, which I totally agree with-- they have lost confidence in the gel methodology. It has caused a lot more work than necessary with the numerous nonspecific reactions and then to have it miss an anti-K was the last straw in our facility.

The last facility I was at (Methodist Hospital, San Antonio, TX), we changed to Rhophylac probably 3 1/2 yrs ago. The nursing staff liked the ability to decide at bedside whether to give it IM or IV. The Ortho rep. came to me about a year after we made the switch and made some noise about the 1/2 life of Rhophylac being less than the 1/2 life of Rhogam so I did a retrospective study (6 months for each product) looking at the number of our prenatal patients who came back positive anti-D at delivery. I also looked at the mean time between prenatal injection and delivery anti-D. I found no difference between the 2 products; I'll admit is was not a "scientific" study, it was just a simple QA assessment but the pathologist and laboratory administration were comfortable with the results. The facility that I'm at now is pretty well stocked (maybe a year worth) with Rhogam but as we start going through the stock, I will be looking at changing to Rhophylac here also. Paying a lower cost, for an equivalent product that also has flexibility in the route of administration, just makes good sense to me.

I would appreciate a copy also. shelly.keller@nahealth.com

One homozygous or 3 heterozygous.

We've been having this problem for the last few lots; a lot of positive SSII reactions that end up being nothing. It's costing us a lot of tech time and money but it had validated our choice of purchasing the TANGO rather than staying with the gel technology (PROVUE). We are in the processing of validating the TANGO so we are running the samples using Gel and on the TANGO and then sending them to a reference lab to "break the tie". My biggest problem with having this type of issue is that we have gotten to where we tend to discount 1-2+ reactions on SSII and one of these days we won't do a complete workup (we do a panel and if it is negative, we don't look any further) assuming that it's just the junky or nonspecific reactions.

Jody, We started using a commercially built program (not the one you mentioned) and it has helped the techs become more confident with doing rule-outs and select cells. Our facility is also staffed by generalists who rotate through the department so it may be a month or so between times that they need to do an antibody workup and they were never really comfortable with anything but the absolutely clear cut single antibodies so our reference lab bill was horrible. We have been able to cut the reference bill in half in approx. 6 months. The program that we are using only rules out on homozygous cells and we use 3 heterozygous or 1 homozyogous cell to rule out so the techs still have to get into cell panel and analyze. In short, the use of the software has been a great teaching tool and raised the staff's confidence level in doing antibody identifications. It also makes it much easier for me to review panels every morning. Shelley

Here is the abstract from an article in Transfusion (1997, Nov-Dec, 37, pgs1169-1172) that I have used in 3 different facilities to prove that it is extremely important that specimens be labelled totally correctly or they need to be recollected. Adherence to a strict specimen-labeling policy decreases the incidence of erroneous blood grouping of blood bank specimens JA Lumadue; JS Boyd; PM Ness Department of Pathology, Johns Hopkins Hospital, Baltimore, Maryland, USA. Copyright ABSTRACT BACKGROUND: To assess the effectiveness of a system of preventing incompatible blood transfusions resulting from the misidentification of patient specimens, a prospective analysis of all blood samples submitted to a laboratory was performed. STUDY DESIGN AND METHODS: Incorrectly labeled specimens (rejected samples) were tested for ABO and Rh type, and routine antibody screens were performed. Test results were compared to historic patient data or patient data obtained from subsequently submitted (correctly) labeled specimens. For comparison, all discrepant serologic results from appropriately labeled samples were also recorded. RESULTS: Specimens that failed to meet the criteria for specimen acceptance were 40 times more likely to have a blood grouping discrepancy. CONCLUSION: Strict adherence to the labeling requirements results in a significant decrease in erroneous blood grouping. This would accordingly diminish the likelihood of transfusing out-of-group blood components. Hope it helps.