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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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 www.alere.com/IQCP.

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

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.

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.

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

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

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

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

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

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.

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.

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.

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.

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.

I would do your IQCP for the entire antibiotic panel.

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.

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.

These are testing systems and will need an IQCP.

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.

Yes.

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.

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

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

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.

See previous answer above.

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).

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

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

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

I sure hope not!

I sure hope not!

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

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

See previous answer above.

See previous answer above.

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

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.

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.

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

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