SRMC BB

Is your BB medical Director aware of the problems? Do you have a corporate compliance hot line where you could report things anon? Are you AABB accrediated? You can report things to them or FDA or Joint Commission and be protected under the Whistleblowers policy. There are also greviance policies where you will not get in trouble for reporting these types of things--you are putting the safety of the patients 1st!!! You could also report things to your administrative representative (who your lab manager reports too) . I think they would be obligated to follow up on things to make sure action is taken. Good luck and I hope things work out quickly. Natalie

We've just completed our AABB assessment. We got a non-conformance for not having a written GMP training guide and documented training. Does anyone have a quick reference guide and test they do on an annual basis they would share? Thanks, Natalie

The JC inspector wanted to know in what way do we notify consignees and what way are we notified of any positive infectious diseases on blood units. He mentioned 48 hous or 7 days and he couldn't remember which. We draw our own donors so this was not a big issue, but occassionally we sell blood to a neighboring hospital. Our procedure states immediately notify by telephone and followup with a certified letter, but I don't have a time frame. I've looked in the AABB Tech. Manual and the JC standards and couldn't find anything. so....if anyone has a reference for the time frame of notification and method of notification that would help alot!!!! Thanks

We use the Temp-Chex Red Spirit thermometer manufactured by Streck Labs. They were purchased through our suppliers-- Infolab and Cardinal. Have not had any calibration issues with these against the NIST thermometer (which is sent out annually for calibration)

Hi, I need the recipe too nlamb@sampsonrmc.org

We provide blood to our local dialysis center. The center draws the blood and sends to us for crossmatch. A courier from the dialysis center picks up the blood and it is transported with activated hemotemps and in a small insulated cooler with ice. In our AABB facility pre-assessment information we received it asked us if we provided blood to a diaylsis center. This was new from the last one I filled out. I cannot find any standards that relate specificially to this, other that temperature during transport. Since we do not transfuse the unit, I do not know what policies the dialysis center uses. Does anyone know what AABB might be looking for with this? Do we need copies of their blood transfusion policies? ANy suggesstions would be greatly appreciated. Natalie

We are an FDA registered Blood Bank and have been approached by an out of state company to sell our recovered plasma to. Since we are unlicensed with the FDA, it was our understanding we could not ship out of state. I have checked with the FDA and they tell me if we are shipping recovered plasma out of state for further manufacturing of non-injectable products, it's okay. My problem is I cannot find it stated in the CFR's. I want to make sure I have documentation supporting our policy if we decide to sell out of state. Another issue I have is when I look up the "inspection of licensed and unlicensed blood banks...." it states that a registered BB must have a biologics license or an approved license supplement for each product it distributes in interstate commerce. Exceptions fall under 21 CFR 601.21 (products under development) and 21 CFR 601.22 (products under short supply). Non-injectable recovered plamsa doesn't fall under either of the exceptions, so I'm not sure if we can ship out of state. If any one can clarify this for me and give me the documentation in the CFR stating we can ship this product out of state, it will be most, most helpful!!!!!! Natalie

Sorry, should have been a little more clear. We don't add reagents to IS crossmatch. We based the 10 days on the reagent inserts for the type and screen. After 10 days, they will need a new sample for the retype and we will do the IS crossmatch off of that sample. A repeat screen is not done if no preg/trans in last 3 months.

We usually just ask the nurse or doctor, so it could be inaccurate, based on what the women tell us. Most of the time they will order a Quant. HCG.

We use Immucor reagents and the package inserts state that specimens can be tested up to 10 days after being drawn for refrigerated storage. (EDTA Samples) We also separate cells from plasma and store them labeled and banded together.

Hate to restart this discussion.....but.....I have night techs who are literally picking my procedure apart about fetal screen testing for miscarriages. They don't want to do the fetal screen for any miscarriages. My procedure is under 13 weeks no fetal screen needs to be done and over 13 weeks, do fetal screen & if pos do K-B stain. I've looked this up in the Tech Manual and find 20 weeks mentioned. Please let me know what your policies are in regards to fetal screen and should I change to 20 week cut off for testing. Also, we have one ER doc that will order RhIg for any woman presenting with preg & bleeding (threatened abortions) Do you give RhIg or are they referred to their OB doc to follow up.

I'm interested in a copy too

We got caught on an inspection once about not having our NIST thermometer certified....So, now its goes out annually to Barnstead international (Which is now Thermo Fisher Scientific) for a 3 point re-cal. They issue a certificate and when it's returned I check all the thermometers in the lab against it. Hope this helps!!!

Funniest reason we have is you don't need my blood type--I'm IB+ That's "I be positive you aren't getting my blood"

We use Immucor. We used to use Ortho's Fetal Screen before it was involved in a recalled in Jan 2005 due to performance with QC I believe. We never switched back. In the last year, we've switched all of our reagents to Immucor because of Ortho's pricing.

We keep and issue RhIg in Blood Bank. Pharmacy controls the derivatives, but the refrigerated ones are stored in BB refrig and we keep up with tracking and usage since the BB is responsible under AABB

We use clear bands with inserts for our surgical patients. They can be removed and reapplied. OR & ER understand that if they do not have an armband on the patient then the patient has to be restuck and a new band applied. Otherwise, the dr will have to sign an emergency release to get the blood and have a band placed on the patient at that time of collection. Our doc's don't like to sign emergency releases so they understand not to remove. I inservice the nurses in their yearly competency that if they must remove a BB armband to call us so we (BB) can fix a new band and apply to patient's limb. They don't like being told we have to work-up the patient again because of a lost BB armband, so they usually let us know.