Modification of antigen negative units

[tricore]

When we irradiate we print a product date time label. This will cover up any antigen typings printed by the supplier on the lower right quadrant. I just found out that United Blood Services is going to start putting the antigen typings on the label.

What we need is for Sunquest to print the antigen typing when the new label is printed when a peoduct is modified in Blood Component Prep. There is a way for our standalone HemaTrax programs to print the antigen typings but it requires a tech to manually enter all information.

[Mabel Adams]

I see that the ARC example labels show both a license number and a registration number on some products.  It has been 5 years since I last worked where we used ISBT so I am rusty.  I think that in ISBT we do not have to mark off the ARC registration number when we modify a product.  Is that correct?  What of the license number that also appears on some products?  When do I have to mark that off?  Why is it only on some products?

 

Example:

ARC Name

ARC address

FDA Registration Number 1973042

US License Number 0190

[Eagle Eye]

 

  The rule is NEVER cover up the DIN and ABO/Rh when just changing product and expiration. 

 

This is what meant and new...but did not know exact regulation which is cited by other poster.

[goodchild]

I see that the ARC example labels show both a license number and a registration number on some products.  It has been 5 years since I last worked where we used ISBT so I am rusty.  I think that in ISBT we do not have to mark off the ARC registration number when we modify a product.  Is that correct?  What of the license number that also appears on some products?  When do I have to mark that off?  Why is it only on some products?

 

Example:

ARC Name

ARC address

FDA Registration Number 1973042

US License Number 0190

 

United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128

4.1.4.1 " A US License Number is only applied by licensed facilities to blood products they are licensed to produce; a US License Number must not appear on unlicensed blood products."

 

An example that I can think of from when I worked in apheresis donor center, we were licensed to manufacture double pheresis platelets on the Cobe but not on the Haemonetics, so our labels had to be printed accordingly. I honestly don't know where this regulation is off the top of my head but I'm fairly certain that unlicensed blood products can't be shipped across state lines. Anyone have a reference for that?

[Mabel Adams]

I'm clear now on the need to mark off the license number (or reprint a full label so it is lacking) but what of the ARC's registration number?  Do we need to show the original registraton number of the collecting facility on a modified (irradiated) product or only our own as the modifying site in the lower right quadrant?  If we don't need to show it, do we need to remove it if we have modified a product and our registration number is now present as the modifying site?