IHC Validation. Oh boy. What's next?

[veo1]

Anyone see the e-mail from the CAP today? smh

I can somewhat understand the push for ER/PR/Her2 validation but to require validation for all IHC markers???? Stunning. See below:

IHC testing is an essential component of the pathologic evaluation of many specimens and increasingly provides key information that helps determine how patients are treated. As with any laboratory test, laboratories must validate all IHC assays before they are used to test patient specimens. Unfortunately, recent studies have found significant interlaboratory variation in validation practices and revealed that many laboratories do not follow consistent procedures.

The expert and advisory panels, chaired by Patrick L. Fitzgibbons, MD, FCAP, addressed the overarching question:

What is needed for initial analytic assay validation before placing any immunohistochemical test into clinical service and what are the revalidation requirements?

In addition, the panel is exploring the scope questions below:

When and how should validation assess analytic sensitivity, analytic specificity, accuracy (assay concordance) and precision (inter-run and inter-operator variability)?
What is the minimum number of positive and negative cases that need to be tested to analytically validate an immunohistochemical assay for its intended use(s)?
What parameters should be specified for the tissues used in the validation set?
How do certain pre-analytic variables influence analytic validation?
What conditions require assay revalidation?
The expert panel drafted recommendations following a systematic review of approximately 100 publications covering nearly 1,500 citations in the context of their own expert judgments.

The final recommendations after consideration of the public comments, further discussion, and analysis will be presented at the CAP ’13 course and later published in Archives of Pathology & Laboratory Medicine.

Share your voice during the open comment period, assuring our recommendations are clinically sound, practical, and implementable, thereby reducing risk to our patients and specialty.

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[Thrombus]

Anyone see the e-mail from the CAP today? smh

I can somewhat understand the push for ER/PR/Her2 validation but to require validation for all IHC markers???? Stunning. See below:

IHC testing is an essential component of the pathologic evaluation of many specimens and increasingly provides key information that helps determine how patients are treated. As with any laboratory test, laboratories must validate all IHC assays before they are used to test patient specimens. Unfortunately, recent studies have found significant interlaboratory variation in validation practices and revealed that many laboratories do not follow consistent procedures.

The expert and advisory panels, chaired by Patrick L. Fitzgibbons, MD, FCAP, addressed the overarching question:

What is needed for initial analytic assay validation before placing any immunohistochemical test into clinical service and what are the revalidation requirements?

In addition, the panel is exploring the scope questions below:

When and how should validation assess analytic sensitivity, analytic specificity, accuracy (assay concordance) and precision (inter-run and inter-operator variability)?
What is the minimum number of positive and negative cases that need to be tested to analytically validate an immunohistochemical assay for its intended use(s)?
What parameters should be specified for the tissues used in the validation set?
How do certain pre-analytic variables influence analytic validation?
What conditions require assay revalidation?
The expert panel drafted recommendations following a systematic review of approximately 100 publications covering nearly 1,500 citations in the context of their own expert judgments.

The final recommendations after consideration of the public comments, further discussion, and analysis will be presented at the CAP ’13 course and later published in Archives of Pathology & Laboratory Medicine.

Share your voice during the open comment period, assuring our recommendations are clinically sound, practical, and implementable, thereby reducing risk to our patients and specialty.

Unreal. Our leadership is completely out of touch with reality.

 

[pathstudent]

Absurd. Let ventana or cell marque or whoever validate it. If tjey validate and we are running it on their machines, then why the hell should it be revalidated. We have positive controls for every case. Moreover we are Mds and know when something smells fishy. This is further over reaching by administrative types who don't actually practice pathology, but they know what's best for us! Then why the **** don't they have us validate our trichromes, elastin stains, pas, and even the bloody h&e.

Anyone see the e-mail from the CAP today? smh

I can somewhat understand the push for ER/PR/Her2 validation but to require validation for all IHC markers???? Stunning. See below:

IHC testing is an essential component of the pathologic evaluation of many specimens and increasingly provides key information that helps determine how patients are treated. As with any laboratory test, laboratories must validate all IHC assays before they are used to test patient specimens. Unfortunately, recent studies have found significant interlaboratory variation in validation practices and revealed that many laboratories do not follow consistent procedures.

The expert and advisory panels, chaired by Patrick L. Fitzgibbons, MD, FCAP, addressed the overarching question:

What is needed for initial analytic assay validation before placing any immunohistochemical test into clinical service and what are the revalidation requirements?

In addition, the panel is exploring the scope questions below:

When and how should validation assess analytic sensitivity, analytic specificity, accuracy (assay concordance) and precision (inter-run and inter-operator variability)?
What is the minimum number of positive and negative cases that need to be tested to analytically validate an immunohistochemical assay for its intended use(s)?
What parameters should be specified for the tissues used in the validation set?
How do certain pre-analytic variables influence analytic validation?
What conditions require assay revalidation?
The expert panel drafted recommendations following a systematic review of approximately 100 publications covering nearly 1,500 citations in the context of their own expert judgments.

The final recommendations after consideration of the public comments, further discussion, and analysis will be presented at the CAP ’13 course and later published in Archives of Pathology & Laboratory Medicine.

Share your voice during the open comment period, assuring our recommendations are clinically sound, practical, and implementable, thereby reducing risk to our patients and specialty.

 

[Pingu]

Per CAP, we are already required to validate new antibodies. This has been since 2011. They recommend a minimum of 10 positive and 10 negative for a "well characterized antibody with a limited spectrum of antigenic targets. While they say the scope of the validation is at the discretion of the lab director, it pretty much insinuates that 10 and 10 is currently the bare minimum.

From the looks of the recommendations, they are looking to hike the numbers of cases to be validated sky high. Some of the literature was showing 40 or more positives and 40 or more negative cases for validation.

I also anticipate interlaboratory comparison of ALL IHCs to be a requirement...if not in this permutation, then eventually. Basically, I predict everything that is being done with ER/PR/HER2 will apply to all IHCs.

All of this seems to be part of the greater push to consolidate everything to larger labs.

Below is the current CAP requirement for Validation:

ANP.22750 Antibody Validation Phase II
The laboratory has documented validation of new antibodies, prior to use in patient diagnosis.

NOTE: The performance characteristics of each assay in the immunohistochemistry laboratory must be appropriately validated before being placed into clinical use. The initial goal is to establish the optimal antibody titration, detection system, and antigen retrieval protocol. Once optimized, a panel of tissues must be tested to determine the assay's sensitivity and specificity. The scope of the validation is at the discretion of the laboratory director and will vary with the antibody. For a well-characterized antibody with a limited spectrum of antigenic targets, like chromogranin or prostate specific antigen, the validation can be limited. A panel of 10 positive and 10 negative neoplasms
would be sufficient in this setting. For an antibody that is not well characterized and/or has a wide range of reported reactivity, a more extensive validation is necessary. The number of tissues tested should in this circumstance be large enough to determine whether the staining profile matches that previously described. An exception to the above requirements is that studies may not be feasible for antigens such as ALK that are only seen in rare tumors.

This checklist has additional validation requirements for HER2 and estrogen/progesterone receptor testing in breast carcinoma. Please refer to the subsection "Predictive Markers," below.

 

[WEBB PINKERTON]

Per CAP, we are already required to validate new antibodies. This has been since 2011. They recommend a minimum of 10 positive and 10 negative for a "well characterized antibody with a limited spectrum of antigenic targets. While they say the scope of the validation is at the discretion of the lab director, it pretty much insinuates that 10 and 10 is currently the bare minimum.

From the looks of the recommendations, they are looking to hike the numbers of cases to be validated sky high. Some of the literature was showing 40 or more positives and 40 or more negative cases for validation.

I also anticipate interlaboratory comparison of ALL IHCs to be a requirement...if not in this permutation, then eventually. Basically, I predict everything that is being done with ER/PR/HER2 will apply to all IHCs.

All of this seems to be part of the greater push to consolidate everything to larger labs.

Below is the current CAP requirement for Validation:

ANP.22750 Antibody Validation Phase II
The laboratory has documented validation of new antibodies, prior to use in patient diagnosis.

NOTE: The performance characteristics of each assay in the immunohistochemistry laboratory must be appropriately validated before being placed into clinical use. The initial goal is to establish the optimal antibody titration, detection system, and antigen retrieval protocol. Once optimized, a panel of tissues must be tested to determine the assay's sensitivity and specificity. The scope of the validation is at the discretion of the laboratory director and will vary with the antibody. For a well-characterized antibody with a limited spectrum of antigenic targets, like chromogranin or prostate specific antigen, the validation can be limited. A panel of 10 positive and 10 negative neoplasms
would be sufficient in this setting. For an antibody that is not well characterized and/or has a wide range of reported reactivity, a more extensive validation is necessary. The number of tissues tested should in this circumstance be large enough to determine whether the staining profile matches that previously described. An exception to the above requirements is that studies may not be feasible for antigens such as ALK that are only seen in rare tumors.

This checklist has additional validation requirements for HER2 and estrogen/progesterone receptor testing in breast carcinoma. Please refer to the subsection "Predictive Markers," below.

Seems like their agenda is to consolidate to larger ACADEMIC labs. How they handled the breast DCIS situation a few years ago was an eye opener. I hate them.

 

[veo1]

Unreal. Our leadership is completely out of touch with reality.

Can you imagine doing the CD markers alone? CD1a, CD2, CD3, CD4, CD5...............!!!

 

[path24]

What a joke! I put my comments in. The CAP is all about more rules/regulations. They just want more control. Get the CAP out of your lab. I have never had a patient/clinician care if the lab was CAP accreditated.

 

[Path or bust]

What a joke! I put my comments in. The CAP is all about more rules/regulations. They just want more control. Get the CAP out of your lab. I have never had a patient/clinician care if the lab was CAP accreditated.

Bingo, I am in talks with administration...we are considering moving our 3 hospitals to The Joint Commission laboratory accreditation.

 

[Thrombus]

What a joke! I put my comments in. The CAP is all about more rules/regulations. They just want more control. Get the CAP out of your lab. I have never had a patient/clinician care if the lab was CAP accreditated.

I wonder if it was Quest or LabCorpsE that snuck this idea into their head. These excessive regulations always hurt the little guy, just like the bank regulations.

Sickening.