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Posts posted by amym1586
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This procedure is a little old and needs some revamping but it got us through our most recent AABB inspection.
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4 hours ago, SMILLER said:
LOL! SOPs to define how you update SOPS! Don't you just love regulations!
Scott
Borderline insanity!
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On 4/27/2016 at 7:22 AM, AMcCord said:
One small thing I've added to the process of receiving reagents is a small self-inking stamp. It has checkboxes for the following: No Product Insert Changes, Change to Product Insert(s) (circle item # on invoice if new insert version), and Supervisor notified if changes to insert version. At the bottom are lines for the received date and tech initials. We have a log for all the important info - what, when, lot#, outdate, looks OK, QC performed, etc. In that log I have a document that lists the current insert version for all the reagents coming in so that the techs can do the insert version check. I keep that list updated and they keep me updated on lot changes. I'm in the process of adding a more detailed procedure for receiving reagents and supplies (trying to keep ahead of the inspection curve!).
The thing I KNOW I'm going to get complaints about is Ortho doesn't put package inserts in anything anymore. Just instructions on how to look up the package inserts. But they'll put a notice that they changed something, but they have a notice in their boxes from an updated they made Oct. 2015!
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OOOOOH. I see that now. She wrote 1 Non conformance for Standard 1.3 and then wrote 4 procedures that applied to it. I was thinking I needed to fill out a corrective action for each one she listed but since they all fall back on that one standard... I see that light now.
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On 5/4/2012 at 1:38 PM, SRMC BB said:
Does your process for SOPs describe how you review SOPs when a new edition of standards is published to ensure you are meeting new/revised standards? Does your SOP for SOPs describe how you check Standards when you write a new SOP to ensure you are meeting current standards? Then, of course, you have to have documentation that the review is performed when a new edition is published.
We currently do not have any of this in writing, we have the formatting of SOPs and who writes them , reviews them and how they get put into operation. But not wording on how we are handling new editions of standards. Could that be part of my corrective action as to why we didn't have a procedure written for a standard ?
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Sorry to bring this post back from the dead.. I'm doing this for the first time with no help.
It says List the objective evidence that supports the nonconformances.
What are they looking for here? Just proving our procedure wasn't up to standards ?
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Do you have a completely separate form for suspected transfusion reactions and suspected delayed transfusion reactions?
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Anyone willing to share their Delayed Transfusion policy?
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Last year we had pizza one day and no one even said anything about lab week. I think we've been depressed for a year! My staff got me a card thanking me for putting Lab Week together this year. It was pretty amazing
- Malcolm Needs and tbostock
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24 minutes ago, David Saikin said:
If you are having an AABB inspection they should not be using the CAP Standards. Granted, they are pretty close BUT for AABB you need to be in compliance with AABB Standards. And if you are, you will be in compliance with CAP (maybe not vice versa).
I'd call AABB and talk with the I&A folks about your inspector's interps on things esp using the CAP standards . . . The only other regulatory agency I would utilize during an inspection is the FDA.
Also - become an AABB Assessor. It's a pretty easy thing to do and will give you a better perspective on that process.
In one of the emails of hers that I read it had that we requested an AABB and CAP coordinated visit and it enclosed the CAP checklist for her to go over as well. I'm not sure if that's to keep the blood bank from getting inspected twice or not.
I have looked over some of things involved in becoming an AABB Assessor. I'd love to be able to see how other people do things and steal the good ideas!
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40 minutes ago, mollyredone said:
I am attaching a copy of our reagent quality assessment. We separate our products specifically and have a binder with all the package inserts and then document lot, receipt, in use, expiration date and inspection. This form goes behind the package insert, so we can see it.
Oh I like the idea of separating the products in a log book with the package inserts! I might have to steal that idea.
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Thank you! I know I'll be better at this next time with 2 more years under my belt. It is hard to sort out some times the inspectors suggestions/ nit pickiness based on actual standards and things we need to change.
We had written that we check the package insert for any changes but no wording with what the procedure is for if there is a new package insert. The same for product integrity. We check to see if the supplies look ok, no damage, spills etc. But no wording as to what we would do if the product was unacceptable.
They were cross referencing with CAP so sometimes it was also unclear if it was a CAP thing are an AABB thing.
Kind of hard to see that you have to have a package insert procedure out of "materials shall be received, inspected, and tested, as necessary, before acceptance for use".
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AABB wanted me to change our Supply log. They wanted a way to document if the supply was unacceptable. I had to add the In service date. And they want me to add something to the tune of whoever received in the supply is checking it to see if the package insert is the same or has it been updated. And then some wording in a procedure as to what we do if the package insert is new/updated.
We previously had OK to signify that we checked the package/ OK that we checked to package insert. They didn't like that.
I attached the one I'm working on but it may need help.
Any advice/helpful comments?
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I know Quotient sells a Competency Kit. It might only be for antibody screens. I'm not sure.
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For those of you who still keep paper procedure manuals, I wanted to get some feedback on how your manuals are formatted.
Currently we have a table of contents then a title page for each procedure followed by the procedure/policy.
The title page has the name of the procedure/policy, when and who it was written by, revised date, who approved it and when. Then several spots for a review name and date for every 2 years when it needs to be reviewed. Is this the norm? Or can someone give me an example of how your manuals are formatted.
Thanks!
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20 minutes ago, Malcolm Needs said:
One non-conformance? You should be hugely excited, very proud of your staff and yourself, and, in addition, getting yourself around the outside of a very large glass of champagne! Well done!!
Oh good! I feel better now. I think I was being a little too hard on myself.
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Well I just finished my first AABB inspection. I'm so glad it's over! We did get 1 nonconformance (seems pretty minor and an easy fix) but everyone here is happy with that. So I'm guess I'll try to be happy too.
- R1R2, dragonlady97213, David Saikin and 3 others
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6 hours ago, AMcCord said:
We are currently using Paragon (though not for much longer
) and I bill those extra reference charges manually with a CPT code. It's done in Patient Management under Daily Processing...Activity Posting. I was given access to that one function for billing purposes. It is not difficult to use. Our techs responsible for sendouts and I bill anything that isn't built into the system that way. If it isn't something that is sent out fairly frequently, it doesn't get built. If you can get your business folks to built those tests for you - BONUS!
Oh great! I already have access to Activity Posting and have used it to bill for other things in blood bank. Hope I can try it out soon. We sent a patient out last Friday to the ref lab.
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Anyone do this through Paragon? I'm new to this system. I assume if I try to charge with a CPT code. We'd have to have that code built in our system, yeah?
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1 hour ago, goodchild said:
I lost my button just thinking about Lab Week..
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oh good! I think my boss just assumed I would have to! But I figured I'd start with you guys to see what the deal is.
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Just added a Positive Thinking Day!
I bought everyone a lab themed button to wear. And everyone has to be positive. If you catch someone being negative you get to take their button. At the end of the shift whoever has to most buttons will win a prize. I think I'll do this on day 1 to start off lab week on a positive note!
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Our Anti-Leb antisera was expired and thrown away. Our normal supplier is on back order for 3 months.
I want to switch suppliers anyhow. How can I bring in a new anti-sera without doing correlations ?
) and I bill those extra reference charges manually with a CPT code. It's done in Patient Management under Daily Processing...Activity Posting. I was given access to that one function for billing purposes. It is not difficult to use. Our techs responsible for sendouts and I bill anything that isn't built into the system that way. If it isn't something that is sent out fairly frequently, it doesn't get built. If you can get your business folks to built those tests for you - BONUS!
Ortho Vision
in Equipment
Posted
How many type and screens do you do? How many would validate getting a Vision?