hmust1

Thanks EWEVANS! I just checked with our Maternity Dept and our newborns are all being screened for galactosemia! I would never have thought to check on that without your suggestion...besides, it's so hard to let go of the things "we've always done that way" in the Laboratory, isn't it?!? I think we could easily get our pediatricians to approve only performing the Clinitest by physician order. That will signficiantly reduce our volume of testing as well. Thanks again!

I'm totally confused now. Here is a snipet from a 2010 AABB Annual Meeting during an "Ask the FDA and CMS/CLIA" presentation (note the underlined section which seems to indicate that anyone who is designated by a laboratory policy can perform the annual review) The respondant, "Ms. Meyers," is a CMS representative: Question 6: The medical director of our blood bank is not the laboratory director listed on our CLIA certificate. Will we be compliant with CLIA if the medical director reviews and signs off on the blood bank's SOPs? MS. MEYERS: No, you will not be compliant. 42 CFR 493.1251(d) states, "Procedures and changes in procedures must be approved, signed and dated by the current laboratory director before use," and that means the laboratory director whose name is on the CLIA certificate. Now thereafter, any other reviews that are required by laboratory SOP, such as in an annual review, may be performed by other individuals according to the laboratory's policy. Our LAB and BBK Medical Director are one and the same and he is on the CLIA certificate. The Laboratory is CAP accredited. We have a Laboratory policy that states the MD's desigee for annual BBK procedure review is the BBK Supervisor (me), AND the MD signs all new and revised procedures. (CAP's requirement now is actually every two years, not annually, even for Blood Bank...but I was planning to continue the annual review to be safe with all other agencies.) My question is, given all of the above circumstances...are we compliant? And if not, can someone please indicate, specifically, why not?

I really appreciate all of this new information and discussion! I'm certainly not well-versed in regulatory agencies, but doesn't CAP also have deemed status with JC? In 14 years as a Med Tech, and 5 years as the Blood Bank Supervisor, I've never seen a JC inspector in our Laboratory, let alone the Blood Bank. Technically, we are a small community hospital "Transfusion Service", not a "Blood Bank" (according to FDA criteria). We do not collect donors and the only products we alter are pooled platelets and we thaw/pool cryo. Does that change anything with regard to the CLIA/TJC procedure signing issue? Our Medical Director does sign all new/revised procedures, but no CAP inspector (nor a CAP checklist, as I'm also doing CAP inspections) has ever even suggested that the MD should be the person signing procedures annually. Perhaps I missing something in the CAP checklist? Or are the organizations just not keeping in line with one another?

Our hospital is JC accredited, but the Laboratory is also CAP accredited (CAP only, no AABB). Is that why this set up works for us? Or do you think we are missing something by only having the Medical Director sign once with subsequent BBK SPV annual review (per our designee policy)?

I understand that Bayer is no longer manufacturing the Clinitest tablets (as happend previously with their Acetest tablets). However, screening for reducing substances in children <1 yr with a negative urine glucose is required by CAP. What are everyone's plans for dealing with this new tablet shortage?

You may have solved this problem already, but we have the Medical Director sign every policy/procedure when it's created and/or revised. Then we have a Laboratory policy that states who the Director's "designees" are for certain areas, so that others may sign off on the annual reviews. For example, the Blood Bank Supervisor is listed as the Director's Designee for Blood Bank and, therefore, reviews/signs the procedures annually in lieu of the actual Director. Something like this may work for you as well.

With any manufactured panel, you might encounter a situation where you don't have the right combination of antigens to rule in/out every possible antibody. Additionally, antibody identification policies may differ from institution to institution. If your facility actually has a policy that says you need to use 3 reactive and 3 nonreactive cells per antibody, I'd personally consider that overkill. I've worked at both large facilites (that only rule out antibodies based on one heterozygous antigen expression alone) and small facilities (that religiously follow a 3 hetero/1 **** rule, regardless of how many seleted cells they have to run). Personally, I think that somewhere in between is still quite a safe alternative for the patient. Remember, you always have the AHG crossmatch to fall back on. We've used our Echo for antibody identification for almost 3 years now and I've never felt like the automated panels have left us completely in the dark. I require 1 homozygous or 3 heterzygous rule outs on the major antibody classes and fewer for the low frequency antibodies depending on the pattern of reactivity. On a rare occasion, depending on the antibody (or combination thereof), we do resort to pulling out the tube panel and running a few selected cells. Frankly, this just 'makes us feel good.' The sensitivity of the two methods is SO far apart. Even heterozygous cells will react stronger on the Echo than homozygous cells will react in tube...in my experience. Also keep in mind, that there is no requirement (that I'm aware of) from AABB to meet a certain 'p-value' when ruling in/out antibodies. In fact, with regard to known antibodies, the AABB technical manual specifically says that it is not necessary to test antigen positive cells to re-confirm previously identified antibodies. So, that alone might greatly cut down the number of circumstances that you feel you need to have the '3 reactive cells.' Just some ideas...hope this helps.

I work in a <120-bed hospital and we draw FMHS specimens on demand, 60-90 minutes post-delivery. How many new moms are fast asleep an hour after they've delivered a baby? In my mind, risk always trumps inconvenience when you're talking about patient safety. Need documentation? Survey some moms and find out whether they would rather be inconvenienced by an overnight blood draw or face the risk of not being able to have any more children.

We have Meditech as both the Hospital and Laboratory (including Blood Bank) Information System. I don't have a problem with it...other than I wasn't the one to originally set it up for Blood Bank. Unfortunately, sometimes it's harder to fix problems than just deal with them.

Like L106, we require an order to be placed in the hospital computer system before any product is prepared for issue. For each order (regardless of ordering location), a hard copy prints in the blood bank (the order is visible on an electronic pending tracking screen as well). When the product is 'ready', as indicated in the electronic medical record once we result the crossmatch, the nursing unit knows to come and get the unit. For the OR, we have a refrigerator in their area, and we deliver the ordered products directly to them. The OR staff then signs blood out from their refrigerator on a log. In the beginning we got a lot of, "It's the OR, we don't have time to put orders in the computer." But, in this electronic day and age, and when faced with delaying their patient's surgery for lack of product readiness, they're usually willing to learn/comply pretty quickly.

I am just about to role out our validated Echo phenotyping. We ran 20 (mix of POS and NEG) samples for each antigen (C, c, E, e, K). I accomplished this easily by pulling historically neg/pos units that were getting shipped in from our blood supplier, as our shipping reports contain the historical antigen typing info. for each unit. Something to remember when deciding whether or not to automate a process is to perform an overall value analysis. Not every cost savings measure consists of lowering "direct" costs (as in the amount of money spent on reagents each year). There is a significant time savings brought about by automation and therefore "indirect" costs are saved and that can add up too. For example, even if you might spend slightly more $$ on reagents each year, you might in turn free up several minutes of tech time each day. If this is the case, the time savings might allow your department to absorb higher test volumes without increasing staff...which will in turn have a direct $$ benefit to your facility.

I have tried the Biotest anti-e (after Immucor's supply was on backorder for many months) and I like it very much. We see good strong 4+ reactions and haven't had any trouble with it. FYI - Immucor reagents are very competitively priced if you automate with them. Which seems odd, considering once you automate, you HAVE to use their reagents, so they've sort of got you...but I'll take it!

I agree that you first need to evaluate the reasons you want to switch to 'gel.' If it's to increase sensitivity over the tube method, then you might also consider the solid phase red cell adherence (SPRCA) method. If you want to improve productivity in your blood bank (while increasing sensitivity) then you should consider automating (with either Gel or SPRCA method).

I just want to chime in here on an issue that is near and dear to my heart. It can be confusing to associate the 4-hour infusion 'start' time with the 'spiking' of the unit. The 4-hour infusion time starts when the unit leaves the refrigeration unit in the blood bank (i.e. at 'issue'). We had a big problem with transfusions exceeding the 4-hour time limit in our facility. Therefore, I performed an intense incident monitoring review which revealed that everyone (Lab, RN's, Physicians) was aware of the 4-hour time limit...but everyone had a different idea about when 'start' time began. Nursing staff thought it started when they spiked the unit (even if that meant the transporter took 20 minutes to get the blood to the floor (running other errands with the blood in hand), and the RN took 20 minutes to hang the unit (busy with other patients, etc). So, we simply had to clarify the language in the nursing blood administration policy/procedure, provide some education, and transfusions exceeding the 4-hour time limit have all but ceased in our facility.

I am the Blood Bank Supervisor for a small community hospital and we infuse a handful of pooled platelets each month (in the absence of readily available apheresis units from our blood supplier). We currently use pH testing (performed on each plt unit within 24 hours of issue) as our method for detecting bacterial contamination prior to pooling. However, I just read in the CAP BDP survey, that CAP & AABB will no longer accept glucose & pH testing as methods for bacterial detection in platelets. Does this mean we can no longer use the pH testing at all? Or does it mean we just won't have a CAP survey material for proficiency testing of it? What other methods are available/recommended that would be cost effective in our circumstances? Thank you for any and all input! Heather

Does anyone know if there is a way to charge unit antigen typing (regardless of infusion) directly to a patient account using Meditech C/S v. 5.64? (Right now we pull a weekly "BBK History Audit Log" for antigens only and bill each patient manually by adding a charge type test to the XM requisition. However, it's sometimes difficult to tell which patient the antigen typing goes with, especially if we have multiple patients with the same antibody receiving blood at the same time. And it frequently results in late charges appearing on patient accounts.) Any other suggestions even if there isn't a way to do it automatically? Thanks!

I was considering having my Medical Director note that the lookback wasn't required for this one...but then I was afraid that as confusing as the FDA guidances are on this that maybe I had missed something. Thanks for your input Bill!

As a small community hospital, we get 100% of our blood products from a Community Blood Bank. I was just sent a consignee notification form from our blood supplier with "Lookback" (vs. Market Withdrawal) checked for a unit we received 4 years ago from donor who just now disclosed "jaundice at age 11; cause unknown and not disclosed at previous donations." I was under the impression that the FDA "Lookback" procedures were only indicated for confirmed positive tests for HIV &/or Hepatitis (and recommended for Chagas as well). Of course our own Lookback policy/procedure does not reference "jaundice of unknown origin" so I'm wondering if I need to edit our procedure and/or perform a true lookback and recipient notification for this one? What would you do? Thanks for any input!

For those of you who perform DAT's on the Echo with the Antibody ID panels, what is your protocol when the DAT is positive?

We use the 3-day time frame EXCLUSIVELY, meaning that we do not perform XM testing on ANY specimen older than 3 days including our pre-admission patients. We have a system in place to identify pre-admission orders, and then we have anything from a hold tube to a full crossmatch ordered, collected, and resulted again on the day of surgery. I'm sure there are arguments against this practice, but for us, it eliminates the entire paper trail for determining transfusion/pregnancy within the past 3 months and it prevents billing issues...2 problems that seemed to be at the forefront of this discussion. This process also eliminates the need to store specimens that are greater than 10 days old or edit the specimen expiration date in the computer.

I remember one episode of ER (must have been about 10 years ago) where a patient was receiving a blood transfusion and the "unit" of blood was nothing more than a transfer pack (there was NO label other than the manufacturer's label on the bag...there wasn't even a blood type) and the "fluid" in the bag looked like fruit punch. It was BRIGHT red and CLEAR!!

Yes, it is true that the Echo only performs an IgG DAT. The Capture method in general only detects IgG antibodies of any kind. Therefore, I only use it for cord blood DAT's. However, it is NOT true that it is qualitative only. The Echo does report out 1+, 2+, 3+, etc for the DAT result. Hope this helps! Heather

We have a validated Echo and are currently entering results into Meditech manually. We would like to interface now that it's up and running...Is there anyone who would be willing to talk briefly with my IT department regarding the Echo interface to Meditech? Our lab analyst was the former BBK supervisor...so I promise it won't be painful!). Please send any contact information to mainsh@hanoverhospital.org Thanks!! Heather

I just ran a prenatal antibody screen on my Echo. The screen was positive (one cell called "?" by the Echo, and visually interpreted as positive too). A scan of the antigram revealed a homozygous E on the positive cell. I ran the Ready ID panel (which also had a homozygous E cell) and the Echo called all wells negative. When looking at the **** E cell on the panel visually...it has a similar weakly positive haze around the cell button. I truly believe this patient has a brand new/weak anti-E. (One of my old-timers, who I'm training on the Echo today...couldn't believe that PEG wouldn't bring up this anti-E in tube...so I let her try. :-) Anyway, here's my question (now that we know it won't demonstrate in tube :-)... I have a preganant patient with an anti-E...and I can't titer it. Is it clinically significant? What would you do?? Of course I'm headed into my pathologist's office when I'm done typing this...but couldn't resist picking your brains too! I would appreciate any input! Heather

I, too, am just about to go live with an ECHO. And with regard to the antibody discussion...I'm curious to see when we'll stop referring back to the tube method as the "gold standard." Isn't it really a matter of "ignorance was bliss?" If there's one thing I've discovered during validation of Capture (and I'm sure Gel users would say the same...) it's that tube is by far the LEAST sensitive method (specificity discussion aside). If I'm getting a weak (1+ or 2+) reaction in Capture via the ECHO...I can't see it in tube at all (not even with different enhancement or longer incubation times). No method is perfect...but when deciding whether or not to worry about the few antibodies being missed by Gel or Capture...think of all those we've already missed in tube! Heather