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spavlis

Electronic Quality Control

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Has anyone tried to tackle electronic documentation in their department.

I have actually started a project where ALL our quality control is documented electronically.

As of now it consists of some excel spreadsheets and some forms.

It sounds wonderful and I'm hoping it works out.

I'm looking for some creative ways on how to deal with the completed electronic documentation.

  1. Do you print the completed forms for a regulatory binder.
  2. Do you put all the forms and spreadsheets in one BIG pdf file

I just want it to look clean and but searchable too.

Any suggestion??

Stephanie

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Just remember if at any point when doing QC, results are put on paper and later entered into the spreadsheet, you MUST also retain those.  Other than that, make sure you have everything backed up!  I am not sure why you would have to have printouts of everything.  

However you set it up on the computer, consider how your workers will access and use it, and include something somewhere that indicates that QC has been reviewed per policy.  (You also need to think how the inspectors will be looking at all of it.)

Scott

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31 minutes ago, SMILLER said:

I am not sure why you would have to have printouts of everything.  

I've had inspectors (usually older ones) that are still not trusting of computers.  Which I find very hard to believe in this day and age but...there are certain things I still print and keep just for them.  I have fought citations and won, but sometimes you just want them to look at the stuff and keep moving.  Much less drama.

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Our previous computer system allowed us to put in the antigen typing QC when testing patients and donor units. It was horribly cumbersome. Our rule here is that we only do QC on antisera once in a 24 hour period, starting at midnight. We could never tell if QC had been done by an earlier shift on a particular antisera so we would do it again. My boss finally relented and went back to paper forms due to cost savings and we also saved tech time and frustration by using a paper form.

Are you using a shared excel sheet that all techs use to enter QC? If I was inspecting, I would want to know how you could protect the info already entered, e.g. could someone change the entered information whether intentionally or by accident. In order for things to be added daily, you would need to prove that previously entered info is secure. If it is not secure, how would you know if something was changed on a excel sheet? Could you see a print out of the changes and who made them? I have had files disappear. Yes, our stuff is backed up but you have to tell the IT people when you thought it was deleted so they can look thru the dumped files of the whole system. I have lost files myself by moving them accidently to another file. I freaked out for a period of time. How would you document review within 30 days? You would need to add your electronic signature and date and it couldn't be changed or altered.

If there is something wonderful out there, I am interested. Otherwise I will stick with the old fashioned paper forms. They don't take up much room in a file and I don't have to worry about them disappearing into nothing. I think I'll let the next supervisor do something wonderful when I'm gone. There are just too many questions surrounding electronic QC. (I sound like an old fuddy duddy. LOL)

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I had all of the same questions as DebbieL regarding spreadsheets.  We keep our Automation QC electronically, but the manual reagents are all still on paper.

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It would be possible, though time consuming, to set-up everything electronically using Microsoft Access. You create Excel based spread sheets to store and manipulate data (e.g. expiry dates), forms to enter the data and reports that display/print out the data. So like LIS systems you assign different levels of user, some can only view reports (results), some can also enter data via forms and administrators can change forms/reports but nobody can change the actual data. Forms used to enter data can include dropdown only options, numbers only, text only etc.

I have used one described above but I did not set it up. It was set up for equipment QC and maintenance but I can see the potential with what spavlis is asking. However to do it well you would need someone who is good with Access, time, and have a good idea with what you need it to do. As long as the essential data is entered the forms and reports can evolve, the only thing changing would be how (forms), not what was entered and how the results were displayed (reports).

If going to this level it probably makes sense to only enter data electronically (no paper forms). You can however create reports that can be geared towards inspectors, bench techs, managers, down time and disaster box etc., this can also include the reports expiry date. For example a report listing the reagents QCed so far today or for a specific date.

I hope this gives the idea that I believe it is possible to have total electronic documentation in the BB including providing the downtime and disaster forms (printed before needed!!). There will however be many obstacles to overcome, inertia probably the biggest. But as most labs already have a LIS is this not only an extension of that?!

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We have been using Cerner Millennium Pathnet since 2005 and our amazing Lab Informatics team has set up QC entry for each test in Pathnet with parameters that we defined. Each test group has an established relationship with a QC group. When opening the result entry worksheet, an appropriate QC group for the tests being resulted must be chosen.  If the QC has not been satisfactorily resulted in the established time period, a warning displays and result/interpretation verification can not proceed until QC has been satisfied. This way we are always confident that QC is current for tests being resulted. If computer downtime is expected, we print copies of QC so we know when it has been performed and when it will expire. If unexpected downtime, we perform and record QC as indicated per procedures and enter it into Pathnet during downtime recovery. This process has served us well for the past 12 years and always satisfies AABB, CAP, FDA,  and internal auditors.

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I have all of our QC and temperatures set up in Meditech  esp BB and Micro for yrs now.  Later I built some Chemistry.  Hematology QC is on the analyzer. We can print them out for an inspection whenever needed.

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Great idea! It helps us in keeping a record on long term basis. Secondly, its would be very easy for us to share that document electronically. For that, I am already using Google drive to keep all my educational document Pdf and jpeg for a quick review. 

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On ‎5‎/‎5‎/‎2017 at 1:09 PM, macarton said:

I have all of our QC and temperatures set up in Meditech  esp BB and Micro for yrs now.  Later I built some Chemistry.  Hematology QC is on the analyzer. We can print them out for an inspection whenever needed.

What Meditech version do you have?  I am interested in setting up my QC in Meditech. Is it possible that you can email your protocol and screen shots?

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Has anyone had success with Adobe Pro? I have heard the information can be saved into a folder daily by the techs from a desktop master form. I really want something other than paper as we are loosing our current computer entry QC.  Going to Sun Quest in the spring.

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