Paperless SOPs

[Terry]

Does anyone have their SOPs in a paperless format (meaning, on a community computer in the lab or on a thumb drive)? If so, how do you document annual review for each SOP?

[L106]

We are putting all of our Laboratory procedures (gradually, as they are reviewed or revised) on our hospital "Intranet" (accessible by all employees from any computer workstation in the hospital.)

Then each Lab Dept has Procedure Manuals available at the bench with the one paper master copy of each procedure. These manuals have a "Document Control Record Sheet" after each procedure where the Dept Supervisor (or Lab Director, etc) and the Pathologist sign and date their annual review and document any revisions that were made in the procedure and the reason for the revisions.

Edited June 2, 2009 by L106
Typing error

[Malcolm Needs ☆]

The NHSBT (formally the NBS) now has all of its Controlled Documents on computer only (with a very few exceptions for vital documents that are still released as paper copies in case of computer failure). The only real exceptions are the Health and Safety Documents, which are still issued on paper.

The are all on a computer system named QPulse 5, which also handles the review dates, sending an automated email to the document author about a month before the document is due for review. All of the reviewing is then performed "on-line".

I am told that this works.

[John Crumlish]

Terry,

The Irish Blood Transfusion Service has recently introduced a system similar to the NHSBT. Pilgrim software running EQMS system (electronic quality management system). This system stores most SOPs etc electronically, manages review dates and changes by sending emails to the relevant staff. It is hoped to introduce a training module shortly i.e. in order to be signed off as competent you will need to perform the required tests and be deemed proficient and then electronically sign the Procedure. Also we have hard copies for a few essential procedures in hard copy- controlled documents.

Was a bit troublesome to introduce- but seems to be working.

[RR1]

Hi Malcolm, your statement: " I am told that this works". worries me.

[Malcolm Needs ☆]

I have been told by the Quality Department that this works and that the MHRA are happy with the situation.

In my own Laboratory, we suffered a full electrical outing that took out our computers. At this stage, we had no hard copies of our vital SOPs.

I make no further comment, save to say that a recurrence of the situation would worry me too.

[RR1]

So if there was a powercut there would be no SOP on 'computer down procedures' ....maybe this one should be a hard copy??

But seriously, I think there are some critical procedures that would always need to be in a paper format, regardless of how well an establishment is computerised.

It's not about pleasing the MHRA ...but doing the correct and sensible thing (i'm sure that would actually please the MHRA even more!).

Edited June 3, 2009 by RR1

[Marilyn Plett]

Our laboratory has a controlled on-line system for SOPs and forms as well as a set of authorized paper copies. One reason, of course, is downtime. Another reason is the number of procedures that are performed less frequently and are time- and/or quantity-sensitive. I think it's difficult to go back and forth between SOP and data entry software, trying to remember exactly how many minutes or how many mLs. Of course, this may be a function of my age. I've been in blood bank forever.

[Malcolm Needs ☆]

Hi Marilyn,

Asolutely it is NOT a function of your age, but merely a function of the fact that you ARE intelligent and experienced enough to realise that there are SOPs that you do not use all the time and that, when you are required to perform unusual tests, it is vital to know exactly what you are doing.

If only the people who thought up the idea of paperless SOPs (and insist upon them) realised this; but then, they don't often work in laboratories.

RR1, I must admit that keeping the MHRA happy is very low on my list of things I want to do during my life; keeping the MHRA at bay is quite sufficient for me (another lot who have never worked in a Reference laboratory, but think they can improve things immensely after looking at a process for 5 minutes).

The people who are in charge of our Document Control say that, if we have a computer outing, it is unlikely to be national, and that they can always fax us the necessary SOP. I asked what we do during weekends and on-call hours (when, of course, they are not working). Oh, they said, then you can telephone to another RCI Centre within the NHSBT and get the peson on-call there to fax over the SOP. When we are on-call, we work from home, unless we are actually called in. If I was called by another on-call person at 3 o'clock in the morning, when I was tucked up in bed, sound asleep, to drive into my Centre, find the SOP on the computer, print it and then fax it to my colleague elsewhere, the reply I would give would not be allowed on this (or any other) website. Mind you, as there would be a patient at the end of it all, I would probably do just that anyway, and that is what the powers that be rely on.

Edited June 4, 2009 by Malcolm Needs
I got disturbed whilst I was ranting - I had to do some (sorry about using a 4 letter word) WORK!

[Marilyn Plett]

Every day I see our staff using paper sops even though they are sitting in front of computers that can access the controlled document. That tells me there is a need for hard copies. Any document system has to balance two issues: control and ease of use. A controlled document that no one uses has little value.

[Malcolm Needs ☆]

Thank you, that is exactly the point I have been trying, very clumsily, to put across Marilyn.

If the documents on the computer are difficult to get to (and, believe it or not, only my deputy and I have access on our computer system, because the rest of the staff have not been trained on the system, and so have not got a password), then the documents do not exist. If another of my staff are working alone on-call, and have to perform a little used technique, despite the fact that they have task-based training records, they will not remember the minutei of the SOP (such as, is it 0.1mL , 1mL or 0.01mL) will be working blind and will make a mistake.

There are patients on the end of this madness.

[RR1]

If your Quality system was working, these sorts of things wouldn't happen. Were you asked for an opinion before the paper sops were removed?- if not, so much for 'change control' procedures.

A formal complaint lodged with your quality department, made on a daily/weekly basis, would mean they would have to sort the problem out.

Computerised systems are not the answer to everything. Sometimes commonsense is needed.

[Geri Bollman]

Most of our SOP's are online. We have 4 hospital transfusion services using the same SOP's, so by having them on the intranet, I know that an older version isn't in use at one of them.

It helps that we have a document control wizard in charge of maintaining all the lab SOP's. When we revise or review, she posts the dates and revisions on the cover sheet of each SOP online. Monthly, she gives each lab department at each hospital an updated CD with the SOP's in case of downtime.

Techs can print out copies for immediate use, but do not keep the copies. They can also click on a procedure and search for a word or phrase to find the mls or incubation time, etc. They can downsize the procedure so that they can use the computer for entering results, etc.

[RR1]

Most of our SOP's are online. We have 4 hospital transfusion services using the same SOP's, so by having them on the intranet, I know that an older version isn't in use at one of them.

It helps that we have a document control wizard in charge of maintaining all the lab SOP's. When we revise or review, she posts the dates and revisions on the cover sheet of each SOP online. Monthly, she gives each lab department at each hospital an updated CD with the SOP's in case of downtime.

Techs can print out copies for immediate use, but do not keep the copies. They can also click on a procedure and search for a word or phrase to find the mls or incubation time, etc. They can downsize the procedure so that they can use the computer for entering results, etc.

How does your doc control wizard ensure no one has copied the CD files and are using the old version of the sops? Also, does she retrieve the previous CD ?

thanks.

[Malcolm Needs ☆]

Hi Geri,

But if the computers are out (not just the Document Control programme), how do they read the CD?

[Malcolm Needs ☆]

If your Quality system was working, these sorts of things wouldn't happen. Were you asked for an opinion before the paper sops were removed?- if not, so much for 'change control' procedures.

A formal complaint lodged with your quality department, made on a daily/weekly basis, would mean they would have to sort the problem out.

Computerised systems are not the answer to everything. Sometimes commonsense is needed.

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

I'll say no more, but I think you get my meaning:rolleyes:.

[eric1980]

I've been pushing to electronise my lab's SOPs since months ago.

The current SOPs in my lab are in paper format, and there are tonnes of them, covering every aspect of working in the lab. And as you would have expected, we got to take quite some time to dig out a SOP that was little used, just to find out some numbers to perform the process.

Electronised versions should have search functions which should show us what we need almost immediately, doing away with time spent on search.

A terminal could be appointed to have a small backup power system in case of power outage to address the power outage concern...

[clmergen]

If the power is completely out and I can't read my online SOP's then I probably can't do any testing either. My computers and all of my equipment are on the same emergency generators. The bigger concern of online documents is if the server goes down containing the doucments. Then the CD or Thumbdrive or whatever you have in place should suffice.

I do have the same concerns of getting people to read the SOP's but these are probably the same people not reading the paper copies now and trying to do everything from memory. At least with the online program we are using, we can hyperlink to other prcedures or to job aids as necessary.

[RR1]

Some good point clmergen, if the power is completely out I suppose it would be a little difficult to do the work (unless we all start performing tile groups). The problem is usually with the hospital computer systems being down. In London recently a number of hospitals were computer-less for upto 3 days, due to I think, computer virus/ software corruption.

[Mabel Adams]

Now, a year after this thread was last active, has anyone found a successful way to use online documents and efficiently capture annual medical director review?

At my prior workplace the techs liked the online versions and would keep them open in a narrow window across the bottom of the computer, scrolling so the part they were using was visible below the BBIS screen. It really worked pretty well. We did keep paper copies for the folks that hadn't adjusted yet, but maintaining up-to-date paper copies is a time-consuming nightmare and kills a lot of trees. Key points made here about downtime need to be addressed, of course.

[tricore]

There are several commercial document control systems that can be used. Wouldn't recommend the one we have.

PS our medical director review online

Edited September 15, 2010 by tricore
addition

[Mabel Adams]

We have Document Management software too. It doesn't seem to quite fit how labs and BBs do things. For instance, it has no system for annual review--only review of revisions. The review of revisions is designed to go to all the stakeholders for approval, which would be overly cumbersome for annual review. I was hoping someone with such a system had a workaround that worked well. The only thing I can think of is to create a document for annual revision and maybe attach it to a master list of documents and have that signed off each year to signify annual review of all sops.

[Marilyn Plett]

Our online document control software works fine for revision review but not annual review. We use a paper form. Document titles and numbers can be downloaded (that's what they tell me). Next to each document, there are three check boxes: acceptable; needs revision; archive. At the end are signature spaces for the responsible parties.

[mdcbk]

We have been using a commercial document management system across the entire lab (see Lucidoc.com) for almost two years. It manages revisions, annual review, and documentation of review quite well. We've been inspected since implementing and the inspection team was impressed. The learning curve was steep for both implementing and daily use, but now both staff and management are comfortable with it. We do have a copy printed out for use only in an emergency. There is also an internal backup file available if internet access is out. The techs sometimes print out a copy to use at the time of testing, but our policy is that these copies should be discarded after using. As time goes on, more techs are simply reading them off the computer.

[L106]

(I hope I'm on the right track with my response to your post, Mabel.)

After every procedure (both online versions and paper copies), we have a "document control" page where we record all the pertainent info about that procedure. (ie: author, validator, medical director review, date implemented, date of annual review and ID of the reviewer, changes to the procedure and the date changed, date the procedure was removed from service, etc.) So as long as you or your Medical Director can edit the document control page, you can record the review on that sheet.

Donna