Ann in CA

Also if you have implemented or updated your computer system, a new instrument/analyzer, or any other process be ready to show documentation regarding validation.

As a Safetrace TX user in a past life, I believe this system is superior to Cerner (which my current institution uses). Our Cerner build does not link the product orders to DINS and are just dummy orders. No product status is communicated to the HIS. We can’t have logic to enforce “Give O RBCS” for specified patients. And the list goes on. For patient safety I believe Safetrace Tx is a better system.

Hi Enamul, This is a known "Limitation" of the Vision Analyzer stated in the Operator's Manual-I've added the statement below. "When a sample is collected from a recently transfused patient, the potential exists for the transfused red cells to concentrate after centrifugation at the bottom of the sample tube below their autologous cells. The probe aspirates from the bottom of the tube where the transfused cells generally concentrate which may lead to an unexpected result." We actually have this statement in our SOP as it can be very confusing! ~Ann in CA

This "Note" to the CAP TRM.40670 requirement is lifted straight out of the FDA Computer Crossmatch Guidance of April 2011, page 6. I don't know of any BECS smart enough to block the computer crossmatch for these cases of ABO typing discrepancies, so we will have to rely on a policy statement in our procedure(s). I agree that this does not add value to patient safety, but rather confuses the poor bench tech with another If...then...policy statement in the procedure. Thanks MOBB for posting!

We are configured to save "Database and Column Images". This will enable us to restore instrument configuration settings and images, as well as test/qc results. The test results are in our LIS, but the images are not. QC reports will be either saved electronically on a network drive or printed (multiple sites implemented-their choice). We also document QC pass/fail on a daily log. We have enabled the Active automatic images synchronization, as this downloads images continuously to the backup folder/device, making the monthly backup time to process a bit shorter.

We never had one, then decided to make it 55 years-we blame it on Janet Jackson...

Hello, I think you posted the same question on the AABB Hub, in which I cannot figure out on how to reply! I have used both Haemonetics and Cerner products. I love Haemonetics, as it is very configurable to your needs. I would assess your patient population (oncology, pediatrics, SCD, general) and what your current problems are. How could the new system help? What would it miss? My Cerner team tells me that there is no way to configure patients to receive type O RBC products only (neonate, HPC transplants). Haemonetics has no problem in setting up such a rule. Once you determine your patient population, ask the vendor for a similar user site and do a site visit. Talk to the bench techs and ask them, where does the system fail? The vendor will tell you that it's all good, but the user's will tell you where the holes are in the system. Ultimately, it may be your purchasing team who makes the final decision. Once it's made, it's your job to fully understand the system and BUID IT RIGHT. Once it's built, it is hard to unbuild... Hope this helps somewhat, I found systems administration very interesting, and even taught myself how to query the database and write Crystal reports. Hopefully you'll have the resources to make the best decision and going forward and design the system for your unique patient population and their needs. Ann in CA

If you modify products and generate a isbt label with your current system you must have a downtime procees as well. There are standalone isbt label maker software on the market that can be purchased. Just make sure you have a good procedure written and warn your staff that their is no logic or checks that a correct label is being generated with the downtime software.

Hi, did anyone catch this in the AABB weekly report on 8/5/2016? FDA Updates Labeling Requirements for Test-Negative Blood Screened for ZIKV Under IND FDA updated the labeling requirements for test-negative blood screened for ZIKV under an IND. The update comes after FDA announced new labeling requirements for such blood last week, as reported in last Friday’s issue of Weekly Report. In the updated requirements, FDA has removed its earlier recommendation to obtain “appropriate acknowledgement or consent” prior to transfusing the unit to a high-risk recipient. In addition, the updated labeling requirements declare that test-negative blood components screened for ZIKV by NAT must be labeled as “negative for Zika virus by an investigational test.” This phrase must be added to each test-negative blood product label (i.e., ISBT 128 or equivalent label). FDA has also recommended additional labeling (via a labeling supplement or modification of the Circular of Information) to state “Units labeled as negative for Zika virus RNA were tested with an investigational nucleic acid test (NAT) and found to be nonreactive.” I can't find the FDA source for this and the blood suppliers haven't passed on this information to us either! We are overjoyed at this development as this was going to be an operational nightmare! Ann in CA