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Red Ink


SRTECH

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I am in the UK so I don't know about CAP or AABB but black is the colour of choice in patients notes as it photocopies / scans better than other colours

Only black is allowed on wards though in lab may sometimes see a bit of blue as well as black of course

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Thanks everybody. We are being inspected by CAP this week and my boss was going up the wall because I had signed off some QC with red ink. Anyway we ended up with one reccommendation...and it had nothing to do with my QC!!!

Actually, I use red ink for all my supervisor review of QC and other worksheets, to document corrections or my comments, etc.

Donna

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There is no requirement about ink color, but many folks have a record completion or documentation procedure that limits the ink color that can be used. The requirement to use blue or black ink goes back to the ability of other color ink to be copied or filmed. When documents used to be filmed for microfilm or microfiche colors like red just didn’t film well and so it was a big problem – heck I’m old enough to remember when photo copiers didn’t do a good job unless you used black and some dark blues! Now that we have moved to digital scanning the issue is less important. There is an AABB Standard (6.2.1.1) that requires if you are creating copies that you do need to verified your copy is completely represents the original, other than that, as long as you don’t violate your facilities requirements on ink color you can use whatever color is allowed.

Jeanne

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Exactly Jeanne, there are no agency regulations it depends on your facility requirements. I for one like red but I stopped because our Quality Officer may decide against it and I do not want to re - sign. I prefer blue to black to differentiate from photocopied material.

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We use blue or black for records. Review is always documented in red (easy to identify that it has been done!). I usually will sign things in blue because you can distinguish a photocopy from an original that way.

But with more and more color copiers it won't be long until that doesn't matter either! Time moves on and we keep having to find new ways to "win" :whew:

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  • 2 months later...

It is a cGMP Standard that you only use blue or black ink. I have been stressing that for years (have found otherwise, everywhere I go). Another cGMP standard (just throwing it in for free) has to do with Error Correction: the "correct" way to Correct Errors is to draw 1 line through the error; write the correct information; date and initial. That has also been an issue everywhere I have worked, with people scribbling out wrong answers. I always start out by educating staff on cGMP. When that doesn't work (and it usually doesn't), I start giving them back any documents I see where they did not make changes correctly, and asking them to correct it. Eventually, they "get it."

So the question would be then (don't have time to look right now); does the CAP Checklist refer to following cGMP Standards?

Brenda Hutson, MT(ASCP)SBB

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Oops, forgot one other example; see below...

It is a cGMP Standard that you only use blue or black ink. I have been stressing that for years (have found otherwise, everywhere I go). Another cGMP standard (just throwing it in for free) has to do with Error Correction: the "correct" way to Correct Errors is to draw 1 line through the error; write the correct information; date and initial. That has also been an issue everywhere I have worked, with people scribbling out wrong answers (and/or writing over another piece of information; sometimes you can't even tell what they meant the reaction to be because they may have written over a 0 with a 2 or vice versa). I always start out by educating staff on cGMP. When that doesn't work (and it usually doesn't), I start giving them back any documents I see where they did not make changes correctly, and asking them to correct it. Eventually, they "get it."

So the question would be then (don't have time to look right now); does the CAP Checklist refer to following cGMP Standards?

Brenda Hutson, MT(ASCP)SBB

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I can back up what Brenda said about proper error corrections, thanks to an FDA inspection several years ago.

I have always heard about the "only black & blue ink" rule, but I haven't been able to find that rule in the FDA's CFR (Code of Federal Regulations.) (Can anyone cite the specific regulation?)

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  • 1 month later...

Google cGMP... :rolleyes:

Brenda

I can back up what Brenda said about proper error corrections, thanks to an FDA inspection several years ago.

I have always heard about the "only black & blue ink" rule, but I haven't been able to find that rule in the FDA's CFR (Code of Federal Regulations.) (Can anyone cite the specific regulation?)

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Anyone know the exact reference to the error correction in the cGMP standards - I'd really appreciate it - I can't seem to locate the reference and my compliance officer is asking. Thanks!

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I'm guessing the "no red ink" dictum has its genesis from indelibility concerns. Written records need to be made with indelible ink (not erasable, not easily smeared or smudged, no pencil). I remember years ago that was a legit concern with many commonly used red pens - for whatever reason red ink was more susceptible to smearing (for example, the document got wet and it was wiped dry). However, I just did a highly scientific test i.e. made a red, blue, and black scribble; let the dry 15 seconds, licked my finger and tried to smudge the marks. No smudging/smearing with any. So, my 2-cents is if the red ink (or any color for that matter) is indelible then its good to go.

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