Alere Logo IQCP: Frequently Asked Questions 
Learning at your convenience. On your schedule.
  Alere's October 6, 2015 webinar entitled, 'Creating your IQCP for Microbiology: Real-Life Examples' delivered a wealth of information to microbiologists, point of care coordinators and laboratorians in general. Dr. Susan Sharp gave a maginficent presentation and generated so many questions that time did not permit her to answer them all. Thanks to Dr. Sharp's continuing effort and that of Alere's own subject experts, the following questions and answers from this session are provided here to assist as you prepare your own IQCP's. You can also review the recorded webinar in its entirety and view Dr. Sharp's slides just below. All of us at Alere hope this will be helpful as you complete your IQCP's.
Creating Your IQCP for Microbiology: Real-Life Examples 
Live Event: Tuesday, October 6, 2015  |  1:00 - 2:00 PM EDT
PACE® credit available until April 6, 2016  |  Florida Laboratory CE Credit available
View recordingView slides
Webinar summary:

With just a few short months left to complete your IQCP’s, it is likely that you’ve either begun the process or you’re just about to start. You may have attended webinars and seminars, or used tutorials and templates to help you get going. But IQCP affects so many lab specialties, it is difficult to cover them all in any depth in one session. This webinar will focus on IQCP for microbiology; a specialty that presents unique challenges because with such a high volume of laboratory testing you cannot always reasonably use CLIA default QC. With antimicrobial susceptibility testing, microbial identification systems, multiplex molecular assays, culture media, etc., IQCP can be overwhelming.

Dr. Susan Sharp, the renowned expert in the field of microbiology, will focus on helping you create your IQCP for antimicrobial susceptibility testing, microbial identification systems, multiplex molecular assays, and exempt culture media. Dr. Sharp will begin with a basic understanding of what must be included in an IQCP, and then cover the IQCP examples in detail, using actual tests for which IQCP's will be created.

This webinar will be presented in a a clear and practical manner that will allow you to become familiar with creating an IQCP and evaluating its impact on your laboratory.
Susan E. Sharp, Ph.D., ABMM, FAAM
Kaiser Permanente
Susan Sharp PhD
Dr. Sharp has been a clinical microbiologist and a very active member of The American Society for Microbiology (ASM) for 30 years serving on various boards and committees. Dr. Sharp is also the current President-Elect of ASM.  

Questions and Answers
Note: Many of the answers below are the opinion of the presenter and
Alere subject experts, and have not all been endorsed by CMS or CAP
Do the preanalytical, analytical, and postanalytical phases for the risk assessment have to include those 5 categories for each of the phases?

The five components of the testing process only need to be listed if there is a failure or error that may occur during the pre-analytical, analytical, and post-analytical phases of testing.

Is it a requirement that all IQCP's include the "Frequency of occurrence" and "Severity of harm to patient" in the risk assessment? I believe another webinar from CDC did not include these fields in their example of an IQCP.

Neither CMS nor the accrediting organizations require an evaluation of frequency or severity of harm in the risk assessment. It is only a suggested tool to help you evaluate if the risk is acceptable for the laboratory test system.

We use several antigen kits with internal QC, such as Clostridium Difficile, Campy Ag, Shiga toxin and Chlamydia. What is the required QC frequency for these? Can all of these tests be lumped together into one IQCP plan?

The required QC frequency at minimum is what is stated in the package insert. You must also follow all state, local, CMS, and the accrediting organization quality control requirements. It is not acceptable to combine Clostridium Difficile, Campy Ag, Shiga toxin and Chlamydia as one IQCP. You will need to do an IQCP for each assay.

What if you are installing a new AST instrument and do not have historical data?

If you are installing a new test system, the data from your new instrument verification can be used. You can use your precision, accuracy, and method correlations data to evaluate your device’s internal quality control features during your new instrument evaluation.

How do you answer to those sites that state there should be no "Not Acceptable" in a Risk Assessment? My understanding is that it would be expected to have some Not Acceptable risk factors.

There will be circumstances where there will be some “Not Acceptable” risk factors. The best example is if emergency release blood is given with appropriate screening, and the physician signs an emergency release because the patient will die if not given blood transfusion. The Laboratory Director will need to document why a Not Acceptable risk provides a risk benefit for the patient.

How do you deal with sites that fall under state regulations that are stricter than CAP recommendations? For the state of MD, our state requires: "The State of MD requires that the laboratory perform weekly quality control or follow the manufacturer’s instructions, whichever is more stringent." In the case of Cepheid quality control testing, weekly quality control, as recommended by our state, would still be too costly. I guess in a sense my question is, who trumps whom?

If the state requirement (weekly) is less stringent than CMS (2 levels daily), I think they would have to do an IQCP in order to go with the state weekly requirement.

Will IQCP be mandated by CMS or CAP or is it still voluntary?

IQCP is voluntary for laboratories. Starting January 1, 2016, laboratory directors have two options for complying with CLIA’s daily QC requirements for non-waived test systems under Section 493.1256 of the regulations:

A. Meet the default requirement set out in the regulations in one of two ways:

i. Run two levels of liquid external controls daily before patient testing OR

ii. Laboratories may develop and implement an IQCP for each non-waived test system.

How often does IQCP have to be reviewed/revised?

IQCPs need to be reviewed at minimum once a year. The Risk Assessment will also need to be reviewed during any failure investigation to determine if any new risks have developed. If a new risk or quality control procedure is identified in that investigation, the Quality Control Pl and Quality Assessment will need to be updated too.

For those of us who follow EQC and switched to weekly QC for all of our rapid kits, can we now go back to QC for each new lot number or shipment if that’s what the manufacturer requires, or do weekly QC since that is what our state department recommends?

MD state regulations will trump the other groups because it is a more stringent regulation than CMS and the accrediting organizations.

We were under the assumption that 30 day QC was not required if we determined in our RA it was not necessary.

A 30 day QC is not a requirement for determining the frequency for Quality Control. Your Risk Assessment can help you determine your Quality Control Plan study evaluation requirements.

What are the requirements for keeping the historical data used to arrive at the frequencies cited in the IQCP? Should it be kept separate for inspectors? If so how long?

Historical data needs to be available for inspectors. Dr. Sharp recommended a Historical Data Summary Sheet as a convenience for the inspectors. I would keep the historical data available for the lifetime of the test system, and keep the data with your system verification documentation.

What are the required vs recommended frequency to re-evaluate the IQCP? Monthly, 6 month or annually? Do you recommend creating a spreadsheet to facilitate this process?

IQCPs need to be reviewed at minimum once a year. The Risk Assessment will also need to be reviewed during any failure investigation to determine if any new risks have developed. If a new risk or quality control procedure is identified in that investigation, the Quality Control Pl and Quality Assessment will need to be updated too. If you have more than 1-2 IQCPs, I would recommend you use a spreadsheet to help keep records of the review of the IQCPs.

Is it a good idea to include a fishbone diagram in your IQCP?

It is up to you to decide if you want to use a fishbone diagram to map out the test process. You can also use flow diagrams or simply use your CLSI test system procedure to summarize the test procedure in sequential steps.

Can we run one IQCP for lateral flow kits that are very similar or do we have to do each kit separately?

You will need to do an IQCP for each kit separately. The nice thing is that, since the kits are very similar, subsequent IQCPs will be easier to write.

What about C diff complete and giardia/crypto complete tests - do these need IQCP?

Yes, C diff Complete and giardia/crypto need IQCP. Alere has an IQCP QUIK CHEK support document to be used for these tests. You can get this electronic document at

In the four months that I've been working on IQCPs, I've seen the procedures dissected e.g., add 100 ul of A to B, and then addressing what happens, and how to prevent it. Your examples look far more general, and focused on plugging in your current training and CA to a format. Is the focus on Risk Assessment details, or on the monitoring?

I believe the emphasis is going to be more on the Quality Control Plan than the “dissected details” of the Risk Assessment.

Do we have to verify the internal QC if we have an IQCP?

Yes. Fortunately, you can decide for yourself how to evaluate a device’s internal Quality Control. This is an important part of your Risk Analysis and Quality Control Plan where you describe how the internal QC works for the test system.

Is there a recommendation for IQCP with a brand new system where there is no historical QC data available?

When you install a new test system, the data from your new test system verification can be used. You can use your precision, accuracy, and method correlations data to evaluate your internal and external Quality Control during your new system verification.

CAP requires us to save QC reports for 2 years. Should we save the QC reports we use for our ICQP RA longer, such as filed as long as it still qualifies as a part of the IQCP?

I agree that the QC used for the IQCP RA should be on file as long as it is part of the IQCP.

Must the severity of harm to the patient be included in an IQCP?

The severity of harm does not have to be included in the IQCP.

If the risk is acceptable according to the CLSI EP23 document, do you still recommend noting measures to control risk or only for those with unacceptable risks per EP23. It looks from your example; you are addressing everything in the RA.

You need to address both acceptable and unacceptable risk in the Risk Assessment.

Does data (complaints, etc.) reviewed for constructing IQCP have to be included in the IQCP?

Data needs to be available for inspectors including complaints, etc. for constructing the IQCP.

Do we need to have the Quality Assessment done by January 1st or just ID what we will be assessing and start this at our defined intervals?

You will need to have your IQCP including your updated Quality Assessment plan completed by Jan. 1, 2016.

Given these examples, our lab is struggling with the items listed in the Testing Personnel area of the Risk Assessment. How is PT a Risk Factor for the test system? We're having a hard time wrapping our heads around this one.

Proficiency testing is not a risk factor for a test system, PT is used to evaluate the accuracy of a test and is actually a quality control procedure. It is important to review all PT, and do a PT Investigation failure if you have an analyte with unacceptable PT results. The unacceptable PT is submitted to Quality Assessment for a review and a new Risk Assessment for the PT failure will be evaluated and if changes need to be done for the IQCP.

Can IQCP approval be delegated from the CLIA director to a technical consultant or technical supervisor, or must the CLIA director sign?

CLIA Laboratory Director is the only person who can approve and sign IQCPs. The Laboratory Director may delegate the writing of an IQCP, but only to a Technical Consultant or Technical Supervisor. After the IQCP is written, the Laboratory Director can delegate who reviews the IQCPs.

We supply a smaller laboratory with Exempt Media for which we have already performed the QC in our Lab. Is it necessary for them to re-QC those media?

Guidance is not totally clear on this. We will propose that the smaller laboratory will need to do and document an abbreviated visual check to make sure the media was not damaged during transport. Time will tell if this is acceptable to CMS/CAP.

Is it necessary for us to do QC again even when the Commercial Media supplier send us a QC certificate?

You do not have to do media QC on CLSI-Exempt media IF you have an IQCP in place. The manufacturer Quality Certificates can be a part of your IQCP for CLSI Exempt media. QC must be performed, as we have always done, on CLSI Non-Exempt media.

We have a Vitek 2 that we use for both ID and AST. Can we do one IQCP since it is one system?

You could do one IQCP for your Vitek 2, but you need to make sure that you address all the mandated areas for the separate testing if they have separate risk factors. For example, you will have the same personnel performing both tests, the risk factors for ‘environment’ will be the same, etc. But if some risks may differ, then these need to be addressed separately. If you choose to use the CLSI Streamlined ID system, then you will need to be sure to include this in your IQCP for the ID part of the Vitek 2. We will be doing two separate IQCPs for ID and AST, but some areas will be the same.

Are QC results calculated as all drug/bug combinations or as an entire panel?

I would do your IQCP for the entire antibiotic panel.

In setting up IQCPs for ID panels such as RapID Anaerobe, Coryne, Non-Fermenter etc, can 1 IQCP be done to include all panel types? Perhaps columns can be provided in the RA for each panel type if there are differences in the panels?

I think these could be done together making sure that any risks that may be different between the testing systems are specifically addressed for that system.

Do you have to do an IQCP for Vitek ID panels if you do the complete ID as per manufacturer recommendations?

If you test a + and a – reactivity control for each substrate in the ID panel (do not use CLSI streamlined QC), then you are following Default CLIA QC and you do not need an IQCP.

Do Rapid Identification kits (RapID ANA, RapID CB, etc) require IQCP development? How about EIA kits (flu/rsv)?

These are testing systems and will need an IQCP.

I have started a Vitek Sensitivity QC & Biochemical ID IQCP. Do we have to write an IQCP for Oxidase test, Indol test, catalase test & things like this?

No, see the ASM website provided in the slides for tests that DO NOT need an IQCP. These tests are outlined in the CMS guidance and have acceptable QC already outlined.

Do you only have to have different IQCP for media if you have different manufacturers of the media and not individual IQCP for different types of media even if they are from the same manufacture?

For CLSI Exempt media you will need an IQCP in order to NOT have to do organism QC on those exempt media. It doesn’t matter the manufacturer. In your IQCP for CLSI Exempt media, you can state that you this media from X manufacturer and this media fro, Y manufacturer. As long as the manufacture does not require “end user” QC, you can develop an IQCP for your exempt media.

If we do not have an IQCP for exempt media, must we go back to QC'ing all media?


Does a BacTec blood culture analyzer require IQCP?

My impression is that BC bottles are media (exempt media) and that a blood culture instrument is not a ‘test system’ but an incubator/detection system. This is still a murky area with no direct answers from CMS.

Isn't the ID IQCP -such as Vitek--only required if you are doing the streamline QC?

Yes. If you are following CMS Default QC, and not doing CLSI Streamlined QC, you do not need an IQCP.

If we have been doing KB for 30 years with no record of 20 day , do you suggest performing that now?

No. Use your historical data to develop your IQCP. The 20-30 day QC prior to instituting weekly QC was a CLSI standard.

Does anyone know if an IQCP is needed for media or if it needed for only a select few media types?

An IQCP will be needed for CLSI Exempt media unless you want to perform organism QC on yoru exempt media as you do for your non-exempt media.

Do Rapid Identification kits (RapID ANA, RapID CB, etc) require IQCP development? How about EIA kits (flu/rsv)?

See previous answer above.

Have these example plans been presented to CAP or CLIA to deem that they are appropriate and have enough info to be accepted by inspectors?

See the ASM website for examples that have been approved by the CAP. CMS has not officially approved these examples (although CMS persons were involved in their develioment).

Our facility uses a Microscan Combo ID/MIC panel. Would we need an IQCP for the ID component and the MIC component or would we be able to combine them since they are the same panel?

See above answer regarding ID and AST on the same instrument.

Is it required to do a separate ICQP for E-testing?

Yes. Unless you perform QC each day you perform patient testing.

In reviewing procedures in Micro, I have found some ID kits that do not require an IQCP but appear to have more points of risk (failure) than does a serum hCG test kit. We were thinking of doing a RA on these. What are your thoughts?

IQCP is designed to help with laboratory quality. You may find the use of an IQCP for other than required tests may be beneficial.

Per the CAP checklist item COM.50500, external QC must be performed with each new lot/shipment and every 31 days. Does this apply to exempt media as well?

I sure hope not!

Does the CAP 31 day QC apply to all tests that have an IQCP, such as exempt media & Microscan identification?

I sure hope not!

Can we use this risk assessment for all media in one IQCP?

IQCP may only be used for CLSI Exempt media per CAP.

Do we need an IQCP plan for media requiring QC?

IQCP may only be used for CLSI Exempt media per CAP.

What is needed for oxidase, coagulase, catalase, gram stains?

See previous answer above.

For Microscan do we need ID and sensi panel written seperately?

See previous answer above.

CMS does not accept CLSI for nonexempt media, why was this included in the IQCP?

CMS and CAP will accept an IQCP for CLSI Exempt media.

If a lab that currently performs Vitek AST QC weekly decides to follow the QC protocol of running the QC daily instead of weekly, are they excempt from doing all the risk assessment study, etc?

Yes, if QC is tested each day of patient testing, then an IQCP would not be necessary as you would be following default CLIA QC.

Do you have to do an IQCP for each panel (e.g. gram negative, gram posituve, etc.)?

I assume you are referring to PG and GN ID panels. If so, and if you choose to use the CLSI Streamline QC for ID Systems, then you will need an IQCP – I think your GP and GN panels can be combined as long as any risks specific to each panel (if this exists) is included.

Does anyone have the latest status of ASM's questioning whether IQCP is appropriate for Microbiology?

Dr. Melissa Miller indicated earlier this week that no response has been forth coming from CMS.

If we are unable to complete an IQCP for non-exempt media prior to Jan 1st, will we have to perform QC daily?

Non-exempt media is not eligible for IQCP per CAP. Only Exempt media may have an IQCP.

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