Patty

I am trying to write a Validation Procedure and need some help on what I should be looking for and how to define Pre/Post Implementation Analysis when performing a computer upgrade. Does anyone have a Computer Validation Procedure or a Pre/Post Implementation Analysis Form they are willing to share?

Blood Bank does not dispense RHIG. We report the number of vials of RHIG as part of the RHIG work-up based on the fetal screen or stain result. Pharmacy supplies RHIG based on our result.

I believe "the philosophy of not needing a transfusion at all if only one unit is needed" has changed since the transfusion triggers have decreased. I would like to institute a hgb prior to each Red Cell transfusion order.

We have the i Series Helmer incubator and have had no problems

Much to our dismay we do it in Blood Bank. I vote for Hematology :)

For manual Gel QC what QC material are you using? We are looking at using the Ortho Confidence system. When tesing it we found the Gel reaction for ABSC is 4+. I was thinking a weaker reaction would be a better QC result. Any comments or suggestions on this would be appreciated.

You could antigen type the patient pre-Darzalex and transfuse phenotypically similar blood with a deviation form signed. Or DDT treat and give least Incompatible K neg blood. DDT destroys K.

Report as Rh Indeterminate and treat as Rh+ for RHIG coverage of the Mom

Just curious to know how many labs interpret a Bioclone Anti-D tube reaction of 1+ as Rh Neg. The insert does state any agglutination is considered a positive result for D antigen.

All units tested. If tested for another patient though do not charge again for the second patient.

We update the patient record if Irradiated, CMV Neg, etc. blood is needed. The computer alerts tech if trying to allocate unit that does not meet criteria. It can be overrided but it goes on a QA log and if it is used requires a deviation form. It prints on Unit Tag and we read when issuing.

We use a RH + and Rh Neg 0.8% suspension from donor units mixed with low titer Anti-D for our +/- diluent control for our IgG cards. We make a 0.8% suspension out of our Coombs Control cells for a Positive control and one of the above 0.8% suspensions for our DAT Controls for our IgG/C3d cards.

I have noticed that if my gel reactions start to look hazy after centrifugation that the card I keep as a balance card may be getting extremely dried out. After I replace it with a new card my reactions are clearly negative. Could it be a problem with the balance of your centrifuge or it may not be level? We sometimes get the weak reactions that are absent after a second spin but they are mostly from OB patient's post midterm RHIG. We do not use a readings after a second spin.

I believe you are suppose to ask the patient to identify themselves if at all possible. Using the name and DOB are two things each patient is likely to know. If it is not on their label or armband how are you suppose to know what you are checking is accurate? I doubt patient's know their MR# or Accn#.

I am trying to revamp our BB Competency Program for 2019. Do you perform a complete 6 element competency after training a new employee before they are allowed to report on their own? Do you repeat the entire thing at 6 months and again at 12 months? How do you define annual thereafter? Any time during a calendar year to complete all test systems? 12 months +/- 30 days?

yes. Reportable once it leaves the BB.

CAP has a program you can use through MediaLab. It does require customization but it is all computerized and it sends out notices when the next competency is due. You put tasks, quizzes, observation checklists, etc... all 6 elements and document as you go.

Can you take away his ability to verify results in the computer ? Perhaps allow performance and have a senior tech or yourself verify after review? We sometimes do this with trainees.

I don't have a HemaTrax for making unit numbers or barcodes to scan. Any suggestions other than using expired supplier units and documenting that all transactions were used for testing and re-disposing of units after testing?

How do you make your fake ISBT numbers that can be loaded into the computer system? How do you rectify your inventory statistics after the fact. Units transfused, discarded, ER releases?

Weak D if fetal screen is strongly Positive out of curiosity or to explain results but this + result would still require a fetal stain. We would place a comment in the patient's file to alert future pregnancies of need of fetal stain for RHIG coverage.

Does anyone use Quotient Reagents for Blood Bank? Any problems? Pricing on antigen screening reagent looks good. If you change antigen screening reagent vendors what/how much validation would you do?

I would check with CAP again before reverting to your old procedure. I called them a while back and was told it only applied to Fetal Screen Kits and parallel testing was required. I also listened to a webinar where this was discussed and they said running old QC on the new lot or a previous lot patient was required for CAP. I have found in the past that you may get different answers to a question depending on who you talk to at CAP. I often write an email instead of calling and then I have their explanation on record for my inspection.

For tube testing Immucor states: Negative tests may be examined using an optical aid. Ortho states: Examine negative tests with an optical aid. I believe a concave mirror or a microscope would qualify as an optical aid. Our policy does not define optical aid though. If the tech feels they need to look under the scope we do not discourage for DATs.

We use ice/water for quarterly checks.