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Has anyone started working on an IQCP plan?  I'm starting to look over the information to write one for the HIV test kit we use in Blood Bank.  Lots of IQCP's will have to be written in my lab.

 

I cannot find an example of one that's already written to compare mine with....does anyone have one they are willing to share?  Or does anyone have an IQCP development policy

 

Any help/comments appreciated!

Natalie

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  • 2 weeks later...
  • 2 months later...

I have been reading about this too...and very little seems to apply to strictly BB/TS testing. We do not use any 'kits' that we do NOT do QC on day of use. Nor do have any instruments with internal QC.

Is anyone doing anything differently as a result of this initiative?

Thanks.

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Our rapid HIV kit is non-waived for plasma/serum and waived for whole blood.  We just went through a Joint Commission inspection and the inspector, when giving us the heads-up about IQCP, suggested we only perform the rapid HIV testing on whole blood.  It seems like a simple solution.  Does anyone see a problem with it?

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  • 2 months later...

 

Our rapid HIV kit is non-waived for plasma/serum and waived for whole blood.  We just went through a Joint Commission inspection and the inspector, when giving us the heads-up about IQCP, suggested we only perform the rapid HIV testing on whole blood.  It seems like a simple solution.  Does anyone see a problem with it?

 

Our rapid HIV kit is only waived for fingerstick whole blood! So that's out. Waiting for our pathologist's decision on plan of action.

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I am still trying to wrap my brain around IQCP but the way I understand it, you don't have to do IQCP as long as you follow the manufacturer's instructions. I think as long as you do QC on the day of use following manufacturer's instructions, you are good to go. So I think BB will be OK, for the most part, with daily QC on our regular reagents as long as we do a negative and a positive for all reagents. (I beefed up my daily QC to add negatives for this part.)  Rare antisera will need QC on day of use but we already do that. If you have automation, as long as you follow their plan, you are OK. We have an Echo and it won't work if QC is not done when it is supposed to be done. I'm glad it shuts down because my people would try to stretch it for a few more hours.

 

I think the things that will need IQCP are the possible odd things such as Lui-Freeze or auto absorption. These are procedures from a book, not a kit with instructions,  so these sorts of tests will need IQCP. If you have a lab created test or something you do that doesn't follow the manufacturer's insert, you will have to do IQCP.

 

I went thru my procedure book and got rid of things that we never do anymore (auto absorption) and came up with a very small list. Lui Freeze is the only thing I can up up with that might need one and we are doing a study to possibly go to acid elution when a physician requests more work on a cord DAT.

 

Just so you know, I listened in on a long webinar from CMS about IQCP on July 15. At the question and answer portion where you write in a question and they answer after a few minutes, I asked specifically if we must do an IQCP for for panels for antibody identification. They had a very short answer. NO. (Whew!) The write up for that webinar should be on the CMS site somewhere. The title was IQCP for CLIA Laboratory Non waived Testing: Workbook Tool. There were workbooks to work thru the process that might be helpful.

 

I really think BB will come off easy on this IQCP process. The department that will be hit hard would be Micro. Evidently, micro tests media once per batch or once per week or something.  So to keep from doing QC everyday of use, they will have to write IQCPs for a ton of procedures.

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COLA has a software product that helps to develop IQCP's.  It has an annual license fee of around $400/CLIA.  Our labs purchased to use for all the need plans. 

The CAP website has lots of info on this topic.

 

Notification to CAP-Accredited Laboratories:
Individualized Quality Control Plan (IQCP)

To College of American Pathologists (CAP) Accredited Laboratories:

As a service to CAP-accredited laboratories, the CAP is providing the following information to help maintain continuous compliance. This is in response to changes in the Centers for Medicare & Medicaid Services (CMS) interpretive guidelines, effective January 1, 2016, that will remove the Equivalent Quality Control (EQC) option and replace it with the Individualized Quality Control Plan (IQCP) option. All laboratories performing nonwaived testing will be required to follow the default CLIA QC requirements, as written (two levels of external QC each day of testing or other specified frequency) or implement an IQCP to reduce the frequency of external quality control. IQCP is not applicable to waived testing.

To address these changes, the CAP will publish a new checklist edition in summer 2015 that will introduce new checklist requirements for nonwaived testing (CAP IQCP), and remove provisions for EQC (eg, the use of an internal electronic, procedural, or built-in control system on a daily basis in lieu of running traditional external control materials).

Effective January 1, 2016, all CAP-accredited laboratories must discontinue the use of EQC to meet daily QC requirements and implement an IQCP or utilize the default CLIA and CAP requirements, as written.

All CAP inspections occurring after January 1, 2016, will be evaluated for compliance with the revised QC requirements as published in the 2015 Checklist edition, regardless of the checklist edition being used for the inspection.

If a laboratory is located in a state that does not accept IQCP as an option for reducing the frequency of external QC, the laboratory must follow the state regulations and perform external QC each day of testing, following the frequency defined in the state regulations and yet to be published CAP 2015 checklists (whichever is more stringent).

The CAP’s IQCP checklist requirements will meet or exceed the CLIA and CMS regulations for nonwaived QC performance. As with the CMS requirements, a laboratory may NOT implement an IQCP that allows QC to be performed less frequently than indicated in the manufacturer’s instructions. The CAP will limit the eligibility for use of an IQCP to testing meeting both of the following criteria:

  • Nonwaived tests that employ an internal (electronic/procedural/built-in) QC system
    • Exception: Microbiology media and reagents used for microbial identification and susceptibility testing may implement an IQCP as defined in the checklist.
  • Tests performed in specialties other than Anatomic Pathology and Cytopathology
  • Exception: If an Anatomic Pathology or Cytopathology test can be assigned to a different CMS subspecialty, it may qualify (eg, FISH testing may be classified as either histopathology or cytogenetics).

The CAP checklist requirements will not require a specific IQCP format, but will allow laboratories to develop their own model or use other resources, such as the Clinical and Laboratory Standards Institute (CLSI) Guideline EP23-A, the CMS guidance, manufacturer protocols, or other commercially available products. The CAP will require laboratories to complete CAP forms that list and summarize their IQCP plans for inspector use during an onsite inspection. Additionally, the CAP is working collaboratively to produce templates for developing IQCP for microbiology. These will be available to participants on the CAP website, when available.

Resources
The CAP will provide information on IQCP requirements, including educational materials and training for laboratories and inspectors, on cap.org as they become available.

A complimentary IQCP webinar will be presented in August 2015, which will be available for download on the CAP website after the event. Registration for the webinar will open in June.

For now please review the following:

Questions? Contact us at 800-323-4040 or accred@cap.org.

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I am having trouble locating the actual transcript to the CMS webinar that DebbieL has referenced.  Can anyone shed more light on the reason that CMS said "NO" in short, when asked specifically if an IQCP was required for antibody ID panels?  Our primary method for antibody ID panels is on an Echo, which incorporates a positive and negative control with each test.  It is our back-up method of tube panels with Panocell-10 and PeG that concerns me.

THANKS IN ADVANCE FOR EVERYONE'S KNOWLEDGE AND FEEDBACK!

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I received an email that the written transcript was available on the CMS MLN (Medicare Learning Network). I went to the transcript and was pretty disappointed that my question was not included in the  written transcript. I asked my question late in the 2nd hour and there were many questions that didn't make it to the final transcript. I wanted to see it in writing.

 

Not sure if this link will work for you but I followed this link and typed in IQCP July 15. But since the answer to my question is not written there, the July 15 write up won't help you. You can search using just IQCP in the search box and find work books and flow charts that might help.

 

Medicare Learning Network®

 

We also have an Echo and I had the same concerns about gel and tube panels.

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  • 3 weeks later...

Just saw this from AABB:

The AABB has decided not to accept IQCP. You must follow the manufacturer's written instructions or follow the CFR regulations for quality control, whichever is more stringent

 

Where did you see this? What exactly does that mean? My facility is just starting bi-weekly IQCP meetings to start developing our game plan. I am a new supervisor so this is all a little overwhelming to me.

 

As far as panel cells go: I did get both my panocell 20 and panel A/B package inserts off their respective websites. According to the package inserts you should "periodically" check the panels with weak antibodies, and immucor suggests testing with antibodies that are "likely to deteriorate" like LeA -- Does anyone do this kind of testing at their facility? The hospital I work per diem at said they used to that a long time ago but it wasn't required so they stopped.

 

Danielle Correll

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Last week I called CAP with several specific questions about QC on panels.

 

And while I had her on the phone I specifically asked if we needed to do IQCP on panels. Her answer was no. She said BB would get off very easy for IQCP for the most part. She said IQCP will mostly affect kits with internal controls such as POCT and rapid strep kits where QC is not performed each day.  The only kit I can think of in my BB that has internal QC would be the Fetal Screen. The manufacturer says to run QC each day and we have always done that so no IQCP would be needed. I also asked her about Lui Freeze since I really thought I had to do one on that specific procedure but she also said IQCP would not be needed because all the reagents that would be used had been QC'd that day.

 

If you have questions, call CAP. I was very happy with the answers I got to my questions, this time.

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  • 3 weeks later...

DebbieL -

 

we are not inspected by CAP, and actually our NYS Inspector is pushing the IQCP - so it is pretty much QC two levels every day of use or develop IQCP. And when I talked to my Immucor Sales rep he stated that inspectors could and may interpret "may QC" with "must qc"... so we will be QCing our panels, I just haven't decided at what interval. Its the only IQCP plan I have to do.

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Where did you see this? What exactly does that mean? My facility is just starting bi-weekly IQCP meetings to start developing our game plan. I am a new supervisor so this is all a little overwhelming to me.

 

As far as panel cells go: I did get both my panocell 20 and panel A/B package inserts off their respective websites. According to the package inserts you should "periodically" check the panels with weak antibodies, and immucor suggests testing with antibodies that are "likely to deteriorate" like LeA -- Does anyone do this kind of testing at their facility? The hospital I work per diem at said they used to that a long time ago but it wasn't required so they stopped.

 

Danielle Correll

I have included in my antibody identification procedure, verbiage almost identical to what is listed in the Immucor package insert for panel cells. It's somewhat vague. Our JC inspectors suggested that the reason for doing QC on panel cells was to be in compliance with the manufacturer's instructions; they did NOT say it was a JC standard. I personally, think QC'ing panel cells is rubbish. I've been working in BB/TS for 25 years and this has never come up before. One argument I've heard is that it is impossible to verify the potency of the cell based on 1 antigen. If you were truly testing the quality of the cell, you'd have to test for every antigen.

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  • 2 weeks later...

Does anyone use Trinity-Biotech's Uni-Gold Recombigen HIV 1/2?  We currently have this kit in the Blood Bank and use it as a moderately complex test kit.  With IQCP, I'm wondering if it would easier to switch to the waived testing using WB venipunctures.  Anyone have any feed back they can share?

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  • 1 month later...

I just went to the CAP site and logged in. I typed in IQCP in the search box and selected IQCP Webinar and found a current Q&A.  I just copied the part that is relevant to BB below.

 

This is basically the answer I got when I called CAP with several questions about QC on panels and expired panels used for rule-out/rule-in. You must follow what the manufacturer insert says is required for QC but also a visual inspection of the panel at receipt and BEFORE use. I added some columns on my antigen typing form for the panel lot # and a visual check prior to use. We have always looked at our red cells before use but have never documented that they were OK.

Hope this helps.

 

 

 Topic: Individualized Quality Control Plan (IQCP) Frequently Asked Questions

Date: May 5, 2015 (last updated October 20, 2015)

 

 

37. Do I need to implement an IQCP for my blood bank antibody identification panels? (NEW 10/20/2015)

No, IQCP is not applicable to antibody panels used in the transfusion service laboratory. An antibody panel is considered a critical material and is subject to TRM.31241 for inspection and testing, as applicable, of new lots before use. This involves visual inspection of new lots and shipments for appropriate physical characteristics (e.g. no hemolysis) and quality control following manufacturer's instructions described in the product insert. If the manufacturer does not provide specific instructions for QC, the laboratory must define its own mechanisms to detect errors and monitor test performance. Because antibody panels are not used alone for identification of an antibody, laboratories typically have a variety of other control processes that are being used as part of the work-up, such as having specific rules for ruling in or ruling out antibodies based on panel reactions, correlating the results of the antibody screen to the antibody panel, and performing antigen typing on the patient to confirm the absence of the corresponding antigen. The control criteria used must be defined in the procedure

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