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comment_57298

I recently asked my techs not to use arrows for repeating information on forms.  Most have complied, but I was challenged by one tech.  I'm having trouble finding a specific resource that says not to use arrows.  Can anyone point me in the right direction?

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  • There is a certain delicious irony in a - very sensible - question about the non-use of arrows asking people to point you in the right direction ... 

  • ditto on getting the point on all this... Scott (aka " )

  • One inspector we had once called it "the line of death".  And then cited us for it, using a regulation about keeping legible/accurate records.

comment_57300

CMC if you ever find out either way, will you post the reference for the rest of us?

I've been curious of that as well. We've been using the lines/arrows for years.

comment_57301

No. we do not use the arrow and it is in the policy. Staff must comply with the policy. 

We allow it on one form and we have indicated on the form that Ok to use the arrow here. 

comment_57304

One inspector we had once called it "the line of death".  And then cited us for it, using a regulation about keeping legible/accurate records.

comment_57306

Are ditto marks then the "little marks of death"? (I like the line by the way, Terri). And, individual inspectorial preferences aside, it's a good question if there is a hard standard on the use of arrows/dittos or not.

 

We did had this same issue on a pre-computerized form (crossmatch logbook - think writing the same guy's name etc 50 times during his ruptured AAA) and an inspector suggested using a sharpie to block off a box of entries on the form, and have procedure state that the one date, name, MR# or whatever was for all the data in the box. No one ever took issue with that afterwards.

comment_57307

 

We did had this same issue on a pre-computerized form (crossmatch logbook - think writing the same guy's name etc 50 times during his ruptured AAA) and an inspector suggested using a sharpie to block off a box of entries on the form, and have procedure state that the one date, name, MR# or whatever was for all the data in the box. No one ever took issue with that afterwards.

So how is this better than arrows or a line?  I had an inspector cite me for use of these years ago, but don't remember the standard cited anymore.  We try to avoid it, but as you said, when issuing 50+ products for a rupture AAA, most people balk at writing the name that much.

comment_57309

After I posted the above, I was half tempted to go back and edit it to say what you just said, because I agree completely, I don't think it's really any different. I'm just passing on what the guy said (maybe because that's what they did in HIS lab), and that's why I asked if anyone had a black and white standard for this.

comment_57311

Is it an FDA regualtion?  i know they won't allow any lines, arrows, dittos, whiteout, etc.  Our blood supplier had to resubmit everything for their irradiator validation because they had used arrows and we can't use them in our irradiation log which is inspected by the FDA.  Would that make it cGMP standards?

comment_57313

You should define such usage or non-usage in a documents/records policy. If you say it is ok then it should be - you could fight a citation by stating it is approved policy. I don't think there is any regulation prohibiting it. I do know that the Feds do not care for the arrows, but they will accept the " " " if it is in policy.

comment_57314

There is a certain delicious irony in a - very sensible - question about the non-use of arrows asking people to point you in the right direction ...  :P

comment_57315

There is a certain delicious irony in a - very sensible - question about the non-use of arrows asking people to point you in the right direction ...  :P

 

You've just brightened a rough afternoon, thank you!

comment_57329

ditto on getting the point on all this...

Scott (aka " )

comment_57355

On a bad day you might ask - "what is the point of it all?" -

"      "   "     "     "       " also "  - "If I don't work, can I eat freash air?"

 

Ah point me to the retirement home! You (et.al.) will probably respond - "Ditto, Ditto etc,".

 

Gives the regulators something to find and something for us to argue with them about and use up time where they might find something that really mattered.

 

Mind you, I like neat forms, worksheets - but repetition sometimes becomes senseless & allows points of entry for errors.

 

Cheers

Eoin   :ph34r:

  • Author
comment_57361

There is a certain delicious irony in a - very sensible - question about the non-use of arrows asking people to point you in the right direction ...  :P

Ha!  I wish I could say I am that clever and I wrote it on purpose.  I'm glad that there is agreement, even if no one can come up with a standard.  I'm fairly new in my position and I think I still have a few people testing to see if I really stand behind what I am asking them to do (aka testing my boundaries!).  Thanks for the input.

  • 2 weeks later...
comment_57470

My initial question is, why did you ask your techs to not use arrows for repeating information?

 

In a previous life, much to my surprise, the Corporate Transfusion Service QA group actually were able to come up with a policy for the use of arrows / lines.  I'm stretching my memory here but I believe it was acceptable as long as you documented on the first and last of the column and the line/arrow connected the two. I'm sure it was a little more in depth than that but that should be the general gist of it.  Bottom line, I don't think there are any hard and fast rules against it out there but I'm pretty sure the general convention frowns on the practice.  :eyepopping:

Edited by John C. Staley

comment_57478

I too have been inspected when we used arrows as John described and the inspectors, inculding FDA, did not have problem. It makes for a much neater looking record.

comment_57490

Our inspectors stated that using arrows or "" increases the risk of a check being missed or signed off in error. There was a rather embarrassing case where one member of staff "" along a column and stated that all checks had been done, including QC - they couldn't possibly have been done as it was a new batch and they hadn't been input on the analyser. The inspectors didn't find that remotely amusing. Nor the """ on competancies where the wrong date had been put in and """"d throughout - date trained was 1m AFTER date competant. Ooops

  • Author
comment_57507

I do allow a line to drop repeating information as long as it was written on the first and last lines.  At my last job, we could not use arrows, just a line- I'm sure that part is just semantics.  The techs are using arrows when only 2 lines of data are being recorded.  This is still incomplete to me.  Lines or arrows can still only be used for dates, initials, etc.  NOT for reactions or interpretations.  

  • 2 weeks later...
comment_57732

So how do you think inspectors would feel about a the yearly review of SOPs being signed like that by the Medical Director?  Just courious...not that we have that issue or anything..... :ph34r: 

comment_57733

So how do you think inspectors would feel about a the yearly review of SOPs being signed like that by the Medical Director?  Just courious...not that we have that issue or anything..... :ph34r: 

 

 I'll tell you on Monday! 

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