SOP format

[bmarotto]

Is anyone using a standard SOP format for both lab and Blood Bank? The format our lab wants to use works fine for analytical procedures, but the majority of our procedures are not analytical. Many are related to blood products (receipt, modification, storage, issue/return from issue, shipping, lookback, etc). They want us to force our procedures into the same format. Headings such as Clinical Signficance, Specimen Requirements, Reagents, Controls, Calibration, Reference Ranges do not apply to many of our procedures, yet they want us to include them and say Not Applicable. We recently finished a complete revision of all our SOPs (13 volumes worth) when we changed our Blood Bank computer system. All our SOPs adhere to the Blood Bank's SOP for writing and maintaining SOPs. Having to revise them all again does not seem to make sense. I can think of a lot of other projects to spend our time on.

Also, is there any requirement to have the City and State of the laboratory on the header of each SOP, worksheet, and form? We have always included this information but the lab wants it removed so our satellite locations in other cities can use the same documents. Again, this does not apply to Blood Bank procedures which are all done in the main hospital.

[Malcolm Needs ☆]

Is anyone using a standard SOP format for both lab and Blood Bank? The format our lab wants to use works fine for analytical procedures, but the majority of our procedures are not analytical. Many are related to blood products (receipt, modification, storage, issue/return from issue, shipping, lookback, etc). They want us to force our procedures into the same format. Headings such as Clinical Signficance, Specimen Requirements, Reagents, Controls, Calibration, Reference Ranges do not apply to many of our procedures, yet they want us to include them and say Not Applicable. We recently finished a complete revision of all our SOPs (13 volumes worth) when we changed our Blood Bank computer system. All our SOPs adhere to the Blood Bank's SOP for writing and maintaining SOPs. Having to revise them all again does not seem to make sense. I can think of a lot of other projects to spend our time on.

Also, is there any requirement to have the City and State of the laboratory on the header of each SOP, worksheet, and form? We have always included this information but the lab wants it removed so our satellite locations in other cities can use the same documents. Again, this does not apply to Blood Bank procedures which are all done in the main hospital.

Who are "They"?

Let me guess, "They" are people that have never worked in a Blood Transfusion Laboratory, are never likely to work in a Blood Transfusion Laboratory, but think that "They" know better than anyone who has worked in a Blood Transfusion Laboratory all their life.

I could tell you of a similar situation myself, but if my own bosses read the post, I would be sacked.

:mad::mad::mad::mad::mad:

[Marilyn Plett]

As someone who has written many SOPs, I totally agree with bmarotto. Standard formats for tests can work reasonably well in both lab and blood bank. However, many blood bank SOPs are really policies or protocols or investigations, not tests. At least one AABB quality guru has pointed out that sometimes flowcharts are the best way to give information! If your management insists on a standard format, let them provide the person to cut and paste all of your recently redone SOPs. If you point out the time and expense with actual numbers, you might prevail. Bean counters seem to respond to numbers. I believe that CLIA mandates the name and address of the testing facility on the patient report, but I haven't personally researched this.

[Lcsmrz]

We use the lab's standard SOP for SOP, extensively modified for BB use.

One advantage for doing that is for Generalists who rotate in BB -- information is in the same "place" within the procedure.

[bmarotto]

In what way have you extensively modified the lab SOP for SOPs?

We have dedicated Blood Bank staff on first and second shifts. On 3rd shift, there are six generalists out of a pool of twelve who rotate covering Blood Bank. The 3rd shift generalists have said the Blood Bank SOPs are the easiest to find and understand. I am concerned about fixing something that doesn't seem to be broken.

[Eagle Eye]

Our (blood bank) SOP format is different than our Lab and much better and easy to follow. I will never change my format to match general lab format ...Actually your format is easy to understand and better than lab.....Lab should adopt your format!!!!!!!

[John C. Staley]

In my previous life one of the clinical pathologists invented the SOP for SOPs. It had a standard template that ALL lab sections were required to utilize, the transfusion services included. What was allowed was if a heading or section was not needed for a specific SOP you could simply leave it out. In some ways it did make life a little easier and we discovered that with a big enough hammer you really can fit a round peg into a square hole.

One of the things I learned over the years was to pick my battles and fighting against the SOP for SOPs, no matter how inconvenient or ridiculous it was, was not a battle worth fighting.

[Malcolm Needs ☆]

In my previous life one of the clinical pathologists invented the SOP for SOPs. It had a standard template that ALL lab sections were required to utilize, the transfusion services included. What was allowed was if a heading or section was not needed for a specific SOP you could simply leave it out. In some ways it did make life a little easier and we discovered that with a big enough hammer you really can fit a round peg into a square hole.

One of the things I learned over the years was to pick my battles and fighting against the SOP for SOPs, no matter how inconvenient or ridiculous it was, was not a battle worth fighting.

I would tend to agree with you John, if the design of the SOP template is done with sympathy to all sections of Pathology. If, on the other hand, the design is so bias towards one particular section of Pathology that it becomes virtually impossible to use (and here I am thinking in terms of Processing, Testing and Issue in a Blood Centre, which is, and I'm going to get myself into trouble here, much more like "factory work", because of the need to produce quality products of similar criteria, against a Reference Laboratory, where you sometimes, not often, but sometimes have to think "outside the box), then I am prepared to fight on.

[clmergen]

We are in the same boat. But I really like the new format and it has worked out very well with the technical (cook book) procedures. We are just now starting to translate the other procedures into the new format. Hopefully we will get some good outcomes.

[LaraT23]

We just use the classic CLSI ( NCCLS) format. I just leave out the things that are not pertinent like reference ranges and criticals in some cases. It works really well for us. I can post an example if anyone is interested.

[adiescast]

The Lab went to a standardized format. I use the format where it makes sense for my procedures. Their "document control" however is very far behind ours and I flat out refused to go backwards. I offered to teach them mine, which they declined. I did integrate most of the header requirements, but I did not get rid of information that identified the document so I could match theirs exactly. I would never format my policies the way the Lab's policies are formatted if I have any choice in the matter.

Edited February 23, 2010 by adiescast
eliminate dangerous language