Lcsmrz

We have CPOE, and phsycians enter special needs as comments. The BB tech enters the requirement into the patient's historical record when verifying the request, and I verify the marker was placed the following day in my daily audit. Our Blood Bank is responsible for complying with all historical requirements at crossmatch time. Obviously, if this is a first-time patient and the physicians fails to notify us of a special need, then we are absolved from responsibilty -- until CAP and AABB make mind-reading a personnel standard for BB techs. Occasionally, a HemOnc patient will come into ER for an unrelated event. The historical requirements for the patient still stand, unless the physician specifically waives the special need.

I used to prefer to infuse platelets as fast as the patient will tolerate it. My thinking is people occasionally react to the product, so the more that can be infused before they get a fever/chill reaction, the better. They rarely react to the platelets themselves, and our HemOnc patients are always well premedicated. Now that I think about it, I haven't seen a reaction to platelets in quite a while. We went to 100% leukodepleted products a few years ago ...

To the QA community, there is never such a beast as too much validation. As probable frustrated lawyers, "they" are content to make business life so onerous that no productive work or project could ever be accomplished or implemented. "They" fail to realize that it is impossible to test every software pathway unless you have the code in front of you, and even then, the number of pathways in a software function is enormous. Therefore, validation is only limited by "their" imagination. Sorry, I guess my baggage is showing ... Validation is generally defined by the quality community as producing evidence that confirms a product or service meets the requirements for which it was intended. However, the FDA thinks validation is "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes." The words "high degree"and "consistently" drive QA people nuts! Practically speaking, my definition of "enough validation" is that you have tested something with enough examples and in enough ways to allow you to sleep at night. To me, that means that the technical aspects meet my requirements, that the limitations are known and controlled in normal operations, that procedures are accurate and well-written, that people are well trained, and that there is a formal or informal audit of the function to watch the process after implementation. For a plan, I usually start with the vendor's validation guide, then expand it until I'm comfortable. To my Medical Director, he needs to know that my work was done with due diligence, that I covered all the relevant bases, that the clinical risk of continuing the old way is equal to or more than the risk of introducing the new way, and that he won't have to sign any BPD in the near future beause of it. To my Admin Director, she needs to know that it won't cost her any more money. Heaven forbid if expenditures increase without a bump in revenue! Some words of advice: first, make sure that the software is FDA-approved for eXM; your vendor should be able to supply this documentation. Second, play with the software, so you know what you're working with. Then, develop a plan and have everyone who will approve it sign off on the plan -- that way, they can't change the requirements (like the government does) in mid-stream or after the fact. Note that the validation guide that the vendor gives you is what they require for activation; it may not be enough for you! Conduct and document the validation, understanding that not everything will follow the plan exactly. Next, write up the final validation report for signature, summarizing everything that happened during the validation project. If the report mimics the plan, there should be no problem with the conclusion and approval. Finally, train, train, train before implementing! (Your validation SOP should say all this already.) Final word of warning: never, ever, do anything for the sole purpose of saving money or for handing to a future inspector, if requested. It has to be relevant for you and no one else!

During an assessment, I have to verify that internal audits are being performed as specified in their Quality Manual -- I usually ask to see summaries and any corrective actions, just to see if the facility can produce them. If I spy a repeated error, I check to see if a root cause was identified and how effectiveness of corrective action is being handled. The intent is always to assess the capture of errors, the process of error handling, and effective follow-up to prevent recurrences. I think the practice of refusing requests for internal audit documents stemmed from the past FDA practice of issuing a 483 for incidents discovered, investigated, corrected and (if necessary) reported by the facility before the investigator arrived.

Come to think of it, I have never seems a double-door freezer in any lab -- I'm sure one exists somewhere. I don't think I'd get one. Despite the reliability, if a problem occurred, you'd have to find alternate storage for all the contents. It's hard enough if it's a single-door freezer ...

Only two weeks after being assured in writing that our ER's "John Doe" system was alive and well at our facility, major wailing and gnashing of teeth occurred when our lab refused to draw blood without a trauma ID number. Apparently, no one in ER was aware that our stated, well-communicated and enforced policy is that no blood will be drawn and no blood products will be issued without a wristband (hospital or trauma) affixed to the patient. I had a great written policy in front of me, but unless it's implemented and practiced, it's just a piece of paper. I sincerely hope that the manager has corrected the problem, since I may be the next "John Doe" that rolls into or center in need of some uncrossmatched Onegs ...

The uncertainty of measuring devices at that temperature is quite high, so trying to meet +/- 2 C will be quite a chore. There is no regulatory requirement for a tighter range for LN2, other than doing temperature mapping when validating. We set rather wide ranges for freezers for normal use, as long as the temp is well within the storage temp, then tighten them under more standard conditions when cross-calbirating sensors.

So much depends on your facility acuity level and the experience level of the techs that a staffing standard will be hard to find. At a small rural hospital, one tech can run the entire lab, whereas you may need several veteran techs in the blood bank at an AHC with a trauma center. It would be better to poll similar facilties to yours for their staffing pattern.

Our policy is the same as Mr Saikin's.

At our facility (including general lab), anything that expires in "days" will expire at 2359 on the xth day. Antything that expires in "hrs" will expire in x hrs. You can always go shorter that the required expiration ...

I'm assuming you mean that the panel cells were all positive. Sickle Cell patient? Was the patient recently transfused? Was an eluate performed, and if so, any reactivity seen? Generally, if the patient has a warm auto ab (no specificity seen), then using LISS for screens and crossmatches is acceptable at our facility.

We are on Meditech CSv5.64 and have the same problem with our PAT patients. A little manual intervention is necessary on our part to get the system to work. We perform a T&S on the PAT sample to affirm eligibility and enter the results against the original order, but we cancel the RBC order. Our PAT nurses have a series of questions on the EMR checklist about pregnancies and prior transfusions. Once eligibility is confirmed, the patient is written on our schedule board for the surgery date. At our facility, the patient must wear the BBK wristband from sample collection until removal by hospital personnel at discharge. After the patient arrives for surgery, the BBK re-orders another T&S and the RBC order under the new encounter, retreives the sample, redoes the patient's ABO/Rh (but not the screen), and performs the IS XMs. The charge for the second T&S is cancelled, and there is no delay in product availability. This gives us 3 days after crossmatch to issue the products and allows TAR to work as designed. It has a minimal BBK intervention, is easy and safe, and makes everyone happy. Most important, it gives us a heads-up on positive Ab screens. Fortunately, we do this procedure only a few times a year ...

The recent literature seems to suggest that group-specific platelets are optimum for the patient. On the Rh side, you should give Rh-neg platelets to an Rh-neg childbearing female -- or some RhIg afterwards. So, knowing the ABO/Rh of the recipient is necessary, even if no ABO-specific, Rh-compatible platelet is available. Some sites also limit the number of ABO-incompatible platelets that a patient can receive in a 24-hr period. However, for outpatient platelet transfusions, our HemOnc patients have been tested so many times that another one is rather redundant. We order the products from historical records, but since all of our patients require BBK banding, we retest on the day of transfusion just before issue.

Our policy is multi-level: Supervisor, Manager/Director, HR, outside third-party. Same policy for safety concerns, corporate compliance, etc. During an inspection, I ask a tech about a hypothetical situation, just to see if it has been properly communicated. Interestingly, techs always feel comfortable taking concerns to Manager/Director.

We also do the same handling and crossmatching for all units, whether allogeneic, autologous or directed.

All transfusion services are required to report Blood Product Deviations. There is always a discussion over what is considered a reportable event ... http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/ucm129716.htm

Since going live on the online Transfusion Administration Record, the only way to issue a unit is in the computer. No form is generated or physically signed, and all nursing info is entered at a bedside terminal. It would be FDA-reportable at our site if the unit left the Blood Bank without being issued in the computer.

You don't say at how many weeks gestation the termination was performed. In the old days before FMH quantitation, we used the Weak D test to determine if a large bleed had occurred. We missed a few patients back then who should have gotten more RhIg ...

Our LIS Coordinator is getting married this Fall and will be moving to DC, where his fiance has a job she is refusing to give up. This guy is irreplaceable. I'm sooooooooooooo sad !!! While I continue to extol the virtues of a commuter marriage to him, I have to have a back-up plan. If anyone knows of an LIS-type person experienced in Meditech, please forward my email address. We are about 30 milrs outside Indianapolis, IN. Thanks. Larry Smrz, MBA, MT(ASCP)SBB, CQA(ASQ) lsmrz@mcmh.net

We try not to give Rh Pos platelets to any Rh Neg patient, but if we do, we append a comment suggesting RhIg (1 vial per 5 apheresis units in a 3 month period). Our oncologists never give it ...

You want the ID to be attached until at least the end of transfusion. Either a label sticky enough to adhere to a moist, cold bag or a tie tag affixed well will work. You don't want something that easily falls off or has to be removed for nurses to record vitals, etc.

I think it's a good thing to auto-close Meditech's windows as a security feature, and I vaguely remember a checklist question about this. There may be a setting that regulates the time before closing, though, so it's not timing-out too quickly.

Only our RNs and LPNs have been trained to transport units within the facility.

Your facility sounds about our size and distance from our supplier. Although we try to use group- and type-compatible units for routine transfusions, we have a liberal trauma policy on using Rh Pos RBCs for males and females > 50yo. We thaw plasma once an order to transfuse if received, and order platelets once the clinician knows it'll take 1-2 hrs to get them. Many of our trauma patients are stabilized only, then transported to "downtown", so we don't overorder. Our pathologist gets involved in trauma's and makes suggestions, depending on the clinical situation.

I've always thought prewarmed technique was used in unwarranted situations, mainly when not knowing what you're prewarming away. Too many facilities see reactions <2+ and prewarm to see if the reactivity goes away. It has its greatest utility when multiple antibodies are present, one warm and one cold. I like to know first what I'm dealing with: Anti-Le(a) barely reactive at IS, cold auto Ab reactive at RT or below, Anti-M that is nonreactive at IS but 2+ at RT, etc, etc. If I determine that the cold antibody is clinically insignificant, then prewarming is a valid technique to use to see if other, more significant antibodies are present..