pdameron

The following is the requirement to train personnel who deliver blood products. **REVISED** 08/21/2017 TRM.40900 Blood/Tissue Sign-Out Phase II The procedure for signing blood and tissue out of the laboratory provides adequate protection for the potential recipient. NOTE: A person authorized by the transfusion medicine service must perform a clerical and visual inspection of each component immediately before it is issued. Transporters of blood components and tissue must be trained in prompt delivery. Training may consist of instruction at the time the procedure is dispensed. Evidence of Compliance: ✓ Written procedures for the issue of blood components and tissue AND ✓ Written policy for the instruction of transporters on the proper handling of the product

Don't forget that you must be registered with the FDA to manufacture blood products. Making reconstituted whole blood is manufacturing!

In reviewing the Operator's Manual provided with the Workstation, we identified another problem that I don't see mentioned in this post. Page 13 states "Note: The incubator must not be used if the timer or temperature is out of specification." See also page 18 "NOTE: The incubator must not be used if the timer is out of specification". At AABB last month, I asked an Ortho rep why the incubator must be taken out of service when the timer (that does not control the temperature) is not in calibration. The Ortho rep had no idea that the operator's manuals said this, claimed that it must be an error and recommended not following the operators manual. I also asked how to validate that the green light actually turns off when the incubator gets too hot. They had no suggestions. We discussed taking daily temperatures without wasting a large number of gel cards. They had many suggestions that did not follow the very specific instruction's in their operator's manual on how to achive this goal.

We have discovered after a couple years of these comparison studies at a multi-facility hospital system that PEG is much more sensitive than GEL. This really surprised us since we expected that they were very similar. Is your assumption (quoted above) still true for you?

We use the JAT survery from CAP. The only problem is that the whole blood samples hemolyze quickly. We advise that staff test the survey samples ASAP.

We use a datalogger in our coolers. We place the datalogger in a small ziplock bag which will prevents temperature fluctuations. Since we continuously monitor storage, we do not need to perform cooler validations.

For those who responded that they use temperature as the criteria for return to inventory, how are you taking the temperature? We use Safe-T-Vues to monitor temperature but it sounds like some of you are taking actual temps.

I TRIED to attach an example. Sorry

The 6 elements are required for testing methods. You can pick whatever method you want to do for competency assessment for non-testing tasks (dispensing, modifying, etc.). I am attaching an example of one of our test method competency. We have these created for all our test methods. We were inspected by AABB and CAP (not all our facilities are AABB) and the inspectors loved these documents. After the CAP inspection, the CAP lead (BB Medical Director) asked our Quality Director if she could have copies of our BB competency documents.

In my job, my team is responsible for the quality plan for an 11 facility hospital system. We create the processes (with input from the facilities) and write the procedures. In preparing for our next CAP/AABB inspections we have performed mock inspections at all facilities (6 AABB and 5 CAP). If I see another scribble on a record, improper error correction or unsatisfactory maintenance interpreteted as "S", I might scream! When the correct range is listed on the form and they still can't interpret a result... #$%#$&^%# (that's me saying inappropriate things). And then it gets reviewed by someone else who also accepts it!!! Makes me want to retire early.

I also have much experience with Cerner Classic and then Millennium (since 2004). It is not the DTA names that determine column width, the result selections in the dropdown list determine column width. We have one DTA that does not show the whole name without extending the column width because all the result options are really short.

I support a facility that stores platelets on a rotator and not in an incubator. We installed a Helmer room temp monitor at that site. This is probably more than you require (includes a temp chart) but they may have a different model that would suit your needs.

Normal practice is to shorten an outdate for a product that was entered in an open system to: 4 hours if it is to be stored at room temp (ex. reduced volume platelets, pooled platelets) 24 hours if it is to be stored at refrigerated temps (ex. RBC aliquots) It's been this way since I began my career 28 years ago.

You must prove that the kit functions as intended. This is standard practice for any new reagent used in the lab. Ref to CFR42.493.1253b1i

We intend to parallel test patients with the current kit and the new rapid kit, as well as creating some weak positives that we will also test with both kits.

Years ago my facility supported a woman with intrauterine transfusions through several pregnancies. I don't remember all the antibodies she had but they included anti-D, anti-C, anti-Dombrock B among others. The last 2 pregnancies we used short-draw autologous AB Neg units for the intrauterine transfusions since they were more compatible than anything we could find in the donor pool. About this time I formulated the brilliant idea that the blood bank should provide pre-marital antigen typings to assure that couples were truly compatible before getting married and making babies together.

The IT department for my company hired an independant outside company to perform a computer validation for an upgrade a couple years ago since my team (who would normally perform this task) was exceedingly busy with ISBT implementation. I won't say the name of the company used, but I am assuming that they were the lowest bidders. It took me longer to review their shoddy documentation than it would have taken me to validate in the first place. My 14 year old son could recognize the problems I was seeing. My time spent included writing an 88 (yes, 4 score and 8) page document listing the problems with the documentation provided. The company's response was to submit modified scripts to match the pictures they sent originally or ignore the issues I brought to light. Needless to say, I personally managed validating our most recent upgrade.

I assume you have figured out that there is absolutely no validation by Millennium that the temperature entered is acceptable to return the product to inventory. You can enter 100C and there is no override required to accept the product into inventory. This new field just gives a false sense of security to endusers that the computer is doing some checking on acceptability. This is a HUGE training point for our hospitals implementing the upgrade.

The requirement comes from the anti-D package insert. We test a control each time for AB+ patients or the computer will not recognize the reaction pattern as valid.

See also AABB Technical Manual 16th ed page 958: Note 2 for method 6-12 "Thawing and pooling cryoprecipitaed AHF" very clearly states that pre-pooled cryoprecipitate should be given an expiration of 4 hours whether it was created in an open or a closed system.