Chief Technologist

[swimmom]

Is it acceptable for Joint Commission inspections for the reference to say Current edition of AABB technical manual instead of changing each procedure references each time a new edition is published?

[goodchild]

I'm not a JC assessor but I think referencing the current edition technical manual as a supporting document for a procedure makes sense. If you cite the AABB technical manual for a specific guideline/verbiage/bit of info, then it doesn't make sense (to me) to state current edition, because the cited information could change.

[Dansket]

3 hours ago, swimmom said:

Is it acceptable for Joint Commission inspections for the reference to say Current edition of AABB technical manual instead of changing each procedure references each time a new edition is published?

I not inspected by JCAOH, but have been using the phrase "Current edition of the AABB Technical Manual" and "Current edition of the AABB Standards" for years being inspected by CAP without any citations.

[Marianne]

I have also always used the "current edition" phrase in my references to prevent constant changes.  I have never had an issue with FDA, AABB or CAP.  What you do need to have is some type of change management process and documentation that shows that when applicable regs change, that you reviewed and updated as needed.

[AMcCord]

My facility wanted the lab to use the same document control setup as everyone else in the place - same template for SOPs, same review timeline (not often enough for lab previously), same drive location as all other SOPs and available to all users, etc. (Why the rest of the hospital would want to read an SOP on how to do maintenance on an Echo or how to do a test on a Dimension, I don't really know.) We were able to show them that we were already using document control and had been for a very long time, that their template did not follow the style that we felt we needed to follow for our SOPs for regulatory reasons without doing some strange things to our procedures and that we had been reviewing our SOPs regularly and frequently for many many years. They allowed us to keep on doing what we were doing with the exception of SOPs that needed to be available for general hospital use, of which there are not a large number. 

One interesting thing that did come out of this discussion was the use of references, specifically the use of the edition and date of the reference. I told them that Blood Bank had been using 'current edition' for some time and that it was an AABB commended practice when I started doing that. They were not budging for quite awhile until I could get them to understand that there are specific dates when the Standards, for example, come into force, that new Standards are published pretty frequently, and that I could come up with those dates after the fact. I explained to them that what we do follows those standards - when the standards change, so do our SOPs. Ditto for CAP standards. Another thing that was discussed was referencing somebody else's procedure as one of your references. Nursing protocols apparently commonly use Such and Such Hospital, v #, date whatever, borrowing protocols from other facilities and then using that protocol as a reference. I had to explain that lab doesn't work that way - we have protocols based on manufacturers requirements, standards and book references for the most part, not what the neighbor does (with exceptions).

In the end, the agreement was that lab would continue doing what we were doing - they came to realize that we were doing a good job with document control and had been since dirt was invented. We could continue using our templates for SOPs unless the document needed to be part of the hospital manual. If that was the case, then we needed to follow the hospital template and follow the same format for references, including edition and publication date. In Blood Bank I have a few procedures that I share with surgery regarding bone and tissues, so that is one area where I do it their way. They feel very strongly about edition/date, stating Joint Commission as the reason. I have not seen the standard that would require it, but I am abiding by the game plan.

 

[Malcolm Needs ☆]

1 hour ago, AMcCord said:

My facility wanted the lab to use the same document control setup as everyone else in the place - same template for SOPs, same review timeline (not often enough for lab previously), same drive location as all other SOPs and available to all users, etc. (Why the rest of the hospital would want to read an SOP on how to do maintenance on an Echo or how to do a test on a Dimension, I don't really know.) We were able to show them that we were already using document control and had been for a very long time, that their template did not follow the style that we felt we needed to follow for our SOPs for regulatory reasons without doing some strange things to our procedures and that we had been reviewing our SOPs regularly and frequently for many many years. They allowed us to keep on doing what we were doing with the exception of SOPs that needed to be available for general hospital use, of which there are not a large number. 

One interesting thing that did come out of this discussion was the use of references, specifically the use of the edition and date of the reference. I told them that Blood Bank had been using 'current edition' for some time and that it was an AABB commended practice when I started doing that. They were not budging for quite awhile until I could get them to understand that there are specific dates when the Standards, for example, come into force, that new Standards are published pretty frequently, and that I could come up with those dates after the fact. I explained to them that what we do follows those standards - when the standards change, so do our SOPs. Ditto for CAP standards. Another thing that was discussed was referencing somebody else's procedure as one of your references. Nursing protocols apparently commonly use Such and Such Hospital, v #, date whatever, borrowing protocols from other facilities and then using that protocol as a reference. I had to explain that lab doesn't work that way - we have protocols based on manufacturers requirements, standards and book references for the most part, not what the neighbor does (with exceptions).

In the end, the agreement was that lab would continue doing what we were doing - they came to realize that we were doing a good job with document control and had been since dirt was invented. We could continue using our templates for SOPs unless the document needed to be part of the hospital manual. If that was the case, then we needed to follow the hospital template and follow the same format for references, including edition and publication date. In Blood Bank I have a few procedures that I share with surgery regarding bone and tissues, so that is one area where I do it their way. They feel very strongly about edition/date, stating Joint Commission as the reason. I have not seen the standard that would require it, but I am abiding by the game plan.

 

Marvellous, isn't it, how other people who have no idea about how to run a blood bank (and probably don't know what it does, or even where it is) know more about how the documentation should be written, etc, than do the people who have been doing it for years.  Of course, this very rarely happens, does it!!!!!!!!!!!!!!!!!!!!!!!!!

[SMILLER]

We have been dealing with this sort of administrative babble for years now--I think anyone who is part of a big system has to live with it these days. Every time we get rolled into a bigger and bigger system it gets worse.  Mostly the headaches fall on the managers, as regular changes in supply chain, HR, documentation, etc. are "improved" by whatever corporate system we are subjected to at the time (LEAN, Six Sigma, etc.). One can imagine administers all attending seminars or retreats or whatever and coming out with "Of course, just have everyone do everything the way we dictate it--that will clinch my bonus at the end of the year!"

Anyway... as far as the "chapter and verse" issue with references to such things as the AABB manual (in the US)--what is the problem with citing the edition numbers at the end of P&Ps?  Simply record the edition number at the time the P&P is written.   Changes in future editions that are significantly different (regarding how a procedure is written) is going to result in a rewrite of the procedure anyway, and at that time you can update the edition number in the reference.  Otherwise, I see no reason to update an edition number in a reference at all.  But I can see the point of having a precise reference from a regulators point of view.

Scott

Scott

[AMcCord]

1 hour ago, SMILLER said:

Anyway... as far as the "chapter and verse" issue with references to such things as the AABB manual (in the US)--what is the problem with citing the edition numbers at the end of P&Ps?  Simply record the edition number at the time the P&P is written.   Changes in future editions that are significantly different (regarding how a procedure is written) is going to result in a rewrite of the procedure anyway, and at that time you can update the edition number in the reference.  Otherwise, I see no reason to update an edition number in a reference at all.  But I can see the point of having a precise reference from a regulators point of view.

 

My only problem with the edition thing was that they wanted the edition updated whether there was a procedural change or not. So every time a new edition of Standards or the Technical Manual came out, I would have had to update every single procedure. That would be a lot of changing. They saw my point and compromised on that, for which I am thankful.

[KKidd]

I ran into this about 5-6 years ago with an AABB assessor.  Previous assessors had accepted "current edition"  but he required specific edition and wanted page# of the tech manual.   With every change, I add a statement to the end of unchanged procedures - references updated (date) no changes indicated and initial.  It is very time consuming.

[Marianne]

I would have called the AABB office to challenge that non-conformance.   It is not about what the assessor "likes" or "wants", it is about meeting the intent of the standards and no where does it specify you need to have those details in your SOPs.

 

[mcgouc]

Current edition is acceptable as long as you document you reviewed the current edition & no changes were required or you document you made the changes.  AABB makes this easy for Standards with the Changes in Standards.  We review that anyway to see if we need to make changes so just document the review.  We always review & document new versions of manufacturer's directions also.

 I am sure we have all shared policies but we know to make them site specific with correct references.  I was working in a corporation & asked to share all the Blood Bank policies with another hospital in the corporation because they had not updated their blood bank policies when they computerized & got an automated instrument.  Since they were not maintaining their policies, I wondered if they could reference my hospital's policies & make me responsible if they made an error.  

[AMcCord]

On 11/3/2016 at 10:31 AM, mcgouc said:

 I am sure we have all shared policies but we know to make them site specific with correct references.  I was working in a corporation & asked to share all the Blood Bank policies with another hospital in the corporation because they had not updated their blood bank policies when they computerized & got an automated instrument.  Since they were not maintaining their policies, I wondered if they could reference my hospital's policies & make me responsible if they made an error.  

Absolutely we share policies - why recreate the wheel when someone else has done a great job doing it in the first place. But as you said, we use them as a framework to create our own policies that are correctly referenced.

In your situation, I agree it would make me a little nervous for another facility to be using my policies lock, stock and barrel. If I was management it would also make me question the leadership (or lack thereof) of that lab.

[tbostock]

I use "current edition" for all of my SOPs and have a cover page in each SOP manual showing which version is being used currently, with the edition number and date started.  I've had a few inspectors challenge it over the years based on their personal preference, but they can't really find a way to cite you for this.

[AMcCord]

On 11/27/2016 at 8:53 AM, tbostock said:

I use "current edition" for all of my SOPs and have a cover page in each SOP manual showing which version is being used currently, with the edition number and date started.  I've had a few inspectors challenge it over the years based on their personal preference, but they can't really find a way to cite you for this.

I like this idea.

[mollyredone]

That sounds good to me as well.  Next time I review my procedures for their every two years review I'll change it.

[Mabel Adams]

Joint Commission has never cited us for using "current edition".