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Saline Lot #


bevydawn

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We do not although the lot# is recorded on our QC log. The bottle is labeled Saline Solution, Change Daily. In our QC SOP it states saline is replaced daily prior to running QC. We have never been cited for this by CAP or FDA. ?

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We change our saline daily also. But I once had someone from OSHA come into a lab and the guy said the rule was: you do not have to label the bottle if it is for your own use, but you must discard the contents when you leave, you must not pass it on to someone else. What I do is use a label maker to make labels with the name of the reagent (abbreviated), the lot number, the expiration date and the date the lot was opened. I put these labels around the lids, then add clear tape. This usually lasts about as long as the lot; but are easily replaced because I make a couple extra labels when I print them. I also do this for the wash solutions on the ProVue. I wrote this up in our QC procedure and specified the abbreviations. As you say, Blood Bank inspectors will not trouble us over this - but with this I'm ready for OSHA, I think.

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I would suggest it would be good practice (GMP) to include the lot number and the expiration date of the saline on any container it is transferred to for use. Internal and external auditors would expect to see traceability of this information to a scondary conatiner. If you have not been cited yet, it could be an issue in the future since more Quality System Regulations are being applied to blood banks.

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I was dinged by CAP for this at the hospital I was at previously. We fixed it while the inspector was there. We label as follows:

Certified Blood Bank Saline

From Stock/ Do not use if Turbid.

Lot#122334

Prepared by: Tech

Date: 9/18/08

Expires: (1 month from opening cube of saline).

We also keep the same lot number in all bottles and cell washer and change them all when we have to change the lot on a cell washer.

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