Lcsmrz

Problem is the time at which the units stay at or below 6 C. We could get 4 hrs at or below 10 C, but only 1 hr below 6 C. Bummer ....

Whether it's LEAN, Six Sigma, or any other TDM-type program, anything that makes people revisit their processes and streamline them is worth it !!

I have one procedure that is used throughout the lab for all areas. Each type of reagent has its own receipt sheet, on which the requirements for on-receipt and for activation is printed, as well as follow-up actions if specifications aren't met. Groups of like reagents (Frozen, Refrig, RT, etc) are recorded by shipment, some are on individual sheets, and some are separated by use (reagent, calibrator, etc) -- whatever makes recieipt easier. Each reagent (cal/qc/etc) or supply (activate only) is red-tagged and dated on receipt -- we have a pricing gun to make it easy -- and when activated, the entire shipment of that reagent/supplies is green-tagged. We record that the reagent has met receipt acceptance when logged-in and has met usage acceptance before patient testing is done. It sounds like alot of work, but it's really not! The only difficult is consistency, since our shipment always seems to come in late Friday after day shift has already left, and we're already on weekend staffing ...

I hated giving up my auto control with Ab Screens, but "they" made me do it ... I found a few delayed transfusion reactions in my career that initially showed up as a mf auto control. BTW, mf = mixed field, so I wasn't cussing out the auto control !!

I can't think of any US regulation regarding the need for sodium amount on the label, unless these are generic or old labels that also addressed multiple situations or foreign country reguirements. Since they still meet current regs, they're still in the catalog (??)

A group-wide "Thanks" to Sheryl for watching this forum!! Sometimes we scientists try too hard to be compliant, yet miss the whole intent ...

I wish the poll question was stated differently ... We still handle RhIg, but have repeatedly encouraged Pharmacy to take it over -- they refuse !!

I guess I used the word "regulation" too loosely, as I occasionally do in conersations ... We based our "Expired Panel" SOP on several sources: First, CAP's TRM.31250 that says controls should be run if expired panels are used, and a policy is neessary. Second, some obscure FDA document mentioned on cbbsweb (http://www.cbbsweb.org/enf/2004/reagentcells_exp2.html), saying that a reactivity check was required. Last, a discussion in Standards Source a year or so ago -- sorry, I don't have that readily available today.

The regulation says that you have to have a policy for using expired panels and must run QC when used. To that I would add that the expired panels should be segregated and conspicuously marked. We use commercial antisera to QC expired panels. You'd have to validate the use of frozen patient samples as QC for expired panels, since their post-thaw performance and frozen outdating is unknown.

We are required to stock platelets on-site for our Open Heart program, so we're outdating 50% of apheresis units, since we don't have an Oncology program to keep our stock moving. Discards approach 100% over weekends ...

Like any BB technique, pre-warming has its use and misuse, and requires interpretation in light of the other facts surrounding the sample. Pre-warming (like its counterpart, the dreaded RT or cold panel) can play a wonderful role in separating antibodies if one is more cold-reacting and one is more warm-reacting, like an anti-M combined with an anti-Fya. However, I've worked for places that pre-warm just about every positive reaction, calling the pre-warm negatives a "cold antibody." Dangerous ... My last SOP called for cautious use of pre-warm technique in certain situations; my current one leaves it up to the judgment of the technologist.

We pool the two sides together just prior to issue, but I can't ever remember having one returned. Not sure if we'd place it back into storage, should one return to us.

We do not screen for C or E as well when transfusing someone with Anti-D. And other than residual RhIg, we're seeing less and less patients with an Anti-D, usually very old females.

I think our LDR staff uses a vacutainer-like setup for collecting cord blood through an unbilical vessel, eliminating the "dripping down the sides" and "milking the blood in" situation. The setup is gas-sterilized, so the plastic tubes are OK. I hear it's expensive to do it this way. There was some talk of trying to irradiate the packs at one time ...

Our computer uses an suffix on the unit number to keep track of aliquots. Unit A is split into aliquot B & remainder C, then C is further split into aliquot E and remainder D, and so on. Our NICU uses syringes, so we prefilter the aliquot for them, then slap on a syringe label with the appropriate information. Since the aliquot is not a licensed product and never leaves the facility, we print the syringe labels on our laser printer and use stock weatherproof labels from the local office supply store.

You may want to consider different discard rates for different components. With RBCs, you may be carrying too large an inventory or too many of the rarer groups -- and make sure your SOP allows giving compatible units (esp O+, O=) without jumping through hoops! We stock 2.5 weeks worth of average usage, respresenting 99% of our historical maximum usage; our blood center is 30 mins away for the remaining 1%. With FFP, it may be a communication thing. "Crossmatching" FFP does not always mean thaw and have immediately available. The 30 min wait to thaw is sufficient for most of our docs. And consider the "thawed plasma" option that is gaining popularity in Indianapolis, IN. Your transfusion committe may help here. With platelets, your service level may require you to stock them, even with no foreseeable use. With an active Oncology service, I've seen discard rates below 5%. At a cardiac-only facility, we threw away half, since we had no cancer patients to keep the inventory turning. Good luck!! Inventory control takes a lot of effort, but the payoff is financially worth while.

There are many ways to derive the value, but the most common I've seen is the number of components discarded for any reason over the number of components received (or over the ave daily inventory). Many facilities have a monthly spreadsheet for basic inventory tracking (begin inventory + units rec'd - units transfused - units returned to blood center - units discarded = end inventory) and follow various numbers to indicate how well they are handling their products. The value of the ratio is to determine if there is a trend or change in wasting units, esp platelets or thawed FFP. Even if you fanatically manage your inventory, you'll throw a few red cells away ever month, and if you are required to have platelets on hand at all times, you'll outdate some of them also. But blood products are expensive, so the transfusion committee must weigh availability and TAT against outdate potential for the service level of the facility. One place I worked discarded HALF of the platelets we were required to stock and that was considered acceptable by the medical staff, due to the acuity of the patients and the procedures they were undergoing.

I believe my SOP refers to the Tech Manual for guidance ...

Your centrifuge manual should have an RCF chart or a recommended starting point for hard and soft spins. For hard spins, I would leave the RPM setting fixed at your current setting and tweak the time settings up and down a bit and see what happens to the cold unit's hematocrits. The quickest time reaching the best hematocrit is your optimum setting. It could be different for each centrifuge ...

Nothing surprises me with antibodies anymore ...

Boy, am I glad not to be in a Trauma I center anymore ... We found our Lead Techs did a wonderful job second-guessing the situation, basing decisions on the surgeon's name and the initial lab results. We wasted very few components and always seem to have more products on the way when the order for more arrived. But we had no set protocol, which would have probably hindered decision-making when it was needed most!

You certainly have to define the word "validation" when discussing a topic like this. Some people may read here that validation is not required and freely substitute "equivalent" critical material without giving it another thought, while another thinks changing the color of their test tube racks means conducting a study that qualifies for FDA submission. Validation is documenting evidence that that the system consistently performs as expected; verification is confirming that the specifications have been met. My comfort level with a change varies with the criticalness of the process or the material and with the time I'm given to get it done. I love the phrase "... known to produce ..." Someone at the facility is charged with the responsibility to approve new and changed processes after reviewing the submitted packet of evidence. The level of documentation could be one page or take up volumes, depending on the level of evidence required. Whatever it takes to comply with SOP and get the final signature is "necessary." If a reagent is classified as a critical materiral and the SOP says all changes in critical material will be thoroughly evaluated, tested, documented, etc, then that's what's necessary. My SOP says validation is all activities that document the journey from initiation to implementation. It makes few exceptions and attempts to even document "common sense" that occurs along the way. To us old blood bankers, checking product inserts is second-nature, yet to a new grad given a first project, this step could be overlooked. We continually research and evaluate the available technology, yet I'm sure there are some who feel that the National Enquirer contains all the necessary information for the job. I like to see organized documentation that the facility gave some thought to a change, arrived at a scientifically-reasonable decision for what they did bsaed on that documentation, and obtained the appropraite signatures. In this example, just saying that it would save money with no further documentation would cause me to delve further into their validation efforts, present and past.

My experiences with BioMed people is that they are quite good at the mechanical part of the device, but lack the understanding and documentation necessary for cGMP environments. They get the "deer in the headlights" look if I ask them about clinical measures, such as testing for maximum effluent temp of blood warmers, about post-repair testing procedures, or about the rationale behind their PM schedule or validation. But I'm the first one to gladly give up blood warmer,etc QC/PM -- with a monthly BB review of their records, of course.

I'm throwing in a dissenting opinion ... Validation is necessary when changing any critical material -- I'm assuming specimen tubes would be a critical material -- and includes more than just checking for FDA-approval. There could be significant differences other than the anticoagulant formula and vendor, and the validation process should be designed to uncover them and to verify that your particular process accounts for them. And it needs to be documented ... Some examples: a review of the new tube's product insert may indicate different expiration dating, post-draw handling or storage requirements, and may require only a completely-full tube be used for testing. It may be FDA-approved for tube testing, but not for gel. It may have a slightly-different color cap, requiring changes in SOP and possibly some nursing education. The company's parallel study for the approval submission may have referenced one substantially different from the one I was using. Validation doesn't need to be as extensive as a 510(k) submission, but it needs to follow your change control procedure and to document your journey through the change, including approvals. Too many times, supply decisions are made by bean counters for cost reasons only, and later limitations are found that compromised patient care that should have been uncovered before initiating the change. In addition to verifying the company's insert claims are possible in your lab, validation procedures should be designed to uncover any difference from your existing processes and document your decisions about the differences. I seem to remember a posting somewhere that Greiner tubes underperformed in one person's validation study; that notation would cause me to more extensively parallel test the new tube, then a literature search that uncovered only positive comments. Just my $0.02 ...

Similar incident happened to me several months ago, with a transporter with no patient ID in her hands needed 2 units NOW on "ICU 5" where a code had just been called. I issued two O+ units on emergency issue, rather than take the time to find out who was really in ICU 5 or to send the transporter back up for an issue slip. I had the time to follow the transporter upstairs to confirm the identity of the patient, then reverted to the already-crossmatched units for subsequent issues under process-controlled circumstances. The physician at the bedside questioned the use of uncrossmatched blood when units were on hold, but understood my situation, once the facts were known. It's easy to be a "Monday morning quarterback" when reviewing an emergent situation, where variables become known quantities. It's also a great learning experience for everyone to review what happened, where decisions could have been better, and what questions could have been asked to clarify the situation better before responding. Makes us all better prepared for similar situations in the future ... and you can be assured something similar will happen in the future !!