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Exp. Date xx/xx/20xx
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Survey of Immunohistochemistry (IHC) Validation
Practices and Procedures
The College of American Pathologists (CAP) Pathology Laboratory Quality Center: Cooperative Agreement with Centers for Disease Control and Prevention (CDC)
Post Survey from CAP Proficiency Testing Mailing HER2B-2010 and "Principles of Analytic Validation of Immunohistochemical Assays" Evidence-Based Guideline
2014
Introduction
The CAP is collaborating with the CDC on a cooperative agreement, "Improving the Impact of Laboratory Practice Guidelines: A New Paradigm
for Metrics." We invite your laboratory to assist our goal of examining the current state of IHC validation practices and procedures by completing
this important follow-up survey to the original one sent in the 2010 HER2-B mailing. Your participation is completely voluntary and we appreciate
your time which is estimated to take 20 minutes for completion. We recommend that you have your current laboratory procedures available. Your
responses will remain anonymous. All information collected in this survey will be kept in a secure manner. No individual answers will be shared
with the CDC. Your CAP number will connect your survey answers to demographic data on file and will ensure that only one response per
laboratory is received. The CAP and the CDC will publish the post-survey overall results as part of the cooperative agreement. If you have any
questions, please email [email protected].
Validation of nonwaived test systems is mandated by Clinical Laboratory Improvement Amendments of 1988 (CLIA 88). Since the introduction of
immunohistochemistry, this test has been used as an adjunct to morphologic diagnosis and has not been subject to rigorous quality control and
quality assurance measures.
Recently, with the introduction of prognostic and therapeutic Food and Drug Administration (FDA)-approved IHC tests (eg, HER2) and the 2013
publication, "Principles of Analytic Validation of IHC Assays,"1 the field is being provided with more precise and consistent test procedures in
validation.
Please note that this survey does not apply to HER2 or the ER and PgR assays as separate guidelines for those markers have already been
established. A list of terms and definitions are included below:
TERM
DEFINITION
Analytic Validity
A test's ability to accurately measure the analyte of interest.
Clinical Validity
A test's ability to detect or predict a disorder, a prognostic risk, or likelihood of treatment response.
Predictive Marker
A stand-alone test that provides information on likely response to a given therapy and may directly determine
therapy (eg, CD20, CD117).
Non-Predictive Marker
A test usually done as part of a panel and interpreted only in the context of other morphologic and clinical data.
Laboratory developed test
(LDT)
A test developed within a clinical laboratory that is performed by the laboratory in which the test was developed
and is neither FDA-cleared nor approved.
Laboratory modified test
(LMT)
An FDA-cleared or approved test that is modified by a clinical laboratory.
Modified means any change to the assay that could affect its performance specifications for sensitivity,
specificity, accuracy, or precision, etc. Such modifications include but are not limited to:
Changes in specimen handling;
Changes in incubation times or temperatures;
Changes in specimen or reagent dilution;
Change in antibody;
Change or elimination of a procedural step;
Change in antigen detection system;
Change in scoring for semi-quantitative assays.
Validation
A defined process by which a laboratory confirms that a laboratory-developed or modified test performs as
intended or claimed.
Verification
The process by which a laboratory determines that a FDA-cleared or approved assay performs according to the
recommendations set forth by the manufacturer.
1 Fitzgibbons
PL, Bradley LA, Fatheree LA, et al. Principles of analytic validation of immunohistochemical assays: Guideline from the College of American Pathologists
Pathology and Laboratory Quality Center. Arch Pathol Lab Med. 2014;138(11):1432-1443.
Customer Contact Center 800-323-4040 option 1 (domestic)
or 001-847-832-7000 option 1 (international)
APN1
Results must be received at the CAP no later than
midnight, Central Time by the due date below:
Section I: IHC Validation Procedures
The following questions pertain to all IHC assays other than HER2, ER and PgR.
1.
Does your laboratory perform IHC staining?
010
2.
Does your laboratory have separate written procedures for validation of IHC predictive and non-predictive markers?
020
3.
129 Yes
130 No
503 Unsure
Does your laboratory have a written procedure that outlines the steps needed for analytic validation of new IHC assays?
030
4.
129 Yes
130 No, we only do interpretation (STOP HERE. Thank you for your response.)
657
Yes, for predictive markers only (other than HER2, ER, and PgR)
658
Yes, for non-predictive markers only
659
Yes, for both predictive and non-predictive markers
130
No (Skip to question 10.)
503
Unsure (Skip to question 10.)
Does the written procedure include specification for verifying unmodified FDA-approved assays?
040
129 Yes
130 No
259
503
5.
Does the written procedure include specification for validation of LDT or LMT assays?
050
6.
Not applicable; we don’t have FDA-approved or cleared IHC assays
Unsure
660
661
Yes, for predictive LDTs or LMTs only (other than HER2, ER and PgR)
Yes, for non-predictive LDTs or LMTs only
662
130
Yes, for both predictive and non-predictive LDTs or LMTs
No
259
Not applicable; we do not create LDTs or LMTs
503
Unsure
Does the written procedure include any specifications for validating IHC tests performed on cytologic specimens
(eg, alcohol fixed cell blocks, smears, cytospins)?
060
657
Yes, for predictive markers only
658
659
Yes, for non-predictive markers only
Yes, for both predictive and non-predictive markers
130
259
No
Not applicable; we do not perform IHC tests on cytology specimens
503
Unsure
Customer Contact Center 800-323-4040 option 1 (domestic)
or 001-847-832-7000 option 1 (international)
APN2
Results must be received at the CAP no later than
midnight, Central Time by the due date below:
Section I: IHC Validation Procedures, cont'd
7.
Does the written procedure include any specifications for validating IHC tests performed on decalcified specimens?
010
657
658
659
130
259
503
Yes, for predictive markers only
Yes, for non-predictive markers only
Yes, for both predictive and non-predictive markers
No
Not applicable; we do not perform IHC tests on decalcifed specimens
Unsure
Section II: Documentation Procedures
8.
Please answer the following in regards to validation of new IHC antibody assays in your laboratory.
If your laboratory does not have separate procedures, please complete Table A only.
Table A
When validating a new non-FDA approved, non-predictive IHC assay (eg, cytokeratin, S100, CD45), does your laboratory…
OR complete if there is only one procedure in your laboratory for both non-predictive and predictive IHC assays.
Yes
020
No
129
Test a specified minimum number of cases?
030
130
663
130
663
130
663
130
663
.
Total number:
040
Unsure/Not applicable
129
050
Include specified numbers of positive and negative
cases in the validation set?
.
Positive number:
060
.
Negative number:
070
129
080
Require minimum positive and negative concordance
rates?
Positive rate:
.
%
.
%
090
Negative rate:
100
Require a minimum overall concordance rate?
129
110
Overall rate:
Customer Contact Center 800-323-4040 option 1 (domestic)
or 001-847-832-7000 option 1 (international)
.
%
APN3
Results must be received at the CAP no later than
midnight, Central Time by the due date below:
Section II: Documentation Procedures, cont'd
8.
Continued from previous page.
Table B
When validating a new non-FDA approved predictive marker
IHC assay other than HER2, ER/PgR (eg, CD20), does your laboratory…
Yes
010
No
129
Test a specified minimum number of cases?
020
130
663
130
663
130
663
130
663
.
Total number:
030
Unsure/Not applicable
129
040
Include specified numbers of positive and negative
cases in the validation set?
.
Positive number:
050
.
Negative number:
060
129
070
Require minimum positive and negative concordance
rates?
Positive rate:
.
%
.
%
080
Negative rate:
090
Require a minimum overall concordance rate?
100
Overall rate:
9.
129
.
%
Does your laboratory document validations and verifications of IHC assays?
110
664
Yes, always
665
Yes, sometimes
130
No
503
Unsure
Customer Contact Center 800-323-4040 option 1 (domestic)
or 001-847-832-7000 option 1 (international)
APN4
Results must be received at the CAP no later than
midnight, Central Time by the due date below:
Section III: Re-Validation Procedures
10. For an existing validated IHC assay, does your laboratory have a written procedure that specifies when to reassess
an assay when there are changes in the conditions of testing to ensure it performs as expected?
010
657
658
659
Yes, for predictive markers only (other than HER2, ER and PgR)
Yes, for non-predictive markers only
Yes, for both predictive and non-predictive markers
130
503
No (Skip to question 12.)
Unsure (Skip to question 12.)
11. Please answer the following in regards to re-validation of existing IHC antibody assays in your laboratory.
If your laboratory does not have separate procedures, please complete Table A only.
Table A
Are the following changes explicitly specified when re-validating non-FDA approved, non-predictive IHC assays (eg, cytokeratin, S100, CD45)?
OR complete if there is only one procedure in your laboratory for non-predictive and predictive assays.
*If yes, please provide case information.
Yes*
No
Unsure
No.** of cases
specified
No.** of cases
variable and set by
Laboratory Director
No.** of cases
not specified
030
Introduction of a new lot of antibody
020
129
130
503
Change in antibody dilution
050
129
130
503
Change in antibody vendor (same clone)
080
129
130
503
Change in antibody clone
110
129
130
503
Introduction or change in antigen
retrieval method
140
129
130
503
Change in incubation or retrieval times
(same method)
170
129
130
503
Change in antigen detection system
200
129
130
503
Change in fixative type
230
129
130
503
Change in tissue processing equipment
260
129
130
503
Change in testing equipment
290
129
130
503
Change in environmental conditions
(eg, laboratory relocation)
320
129
130
503
Change in water supply
350
129
130
503
.
040
666
667
.
070
666
667
.
100
666
667
.
130
666
667
.
160
666
667
.
190
666
667
.
220
666
667
.
250
666
667
.
280
666
667
.
310
666
667
.
340
666
667
.
370
666
667
060
090
120
150
180
210
240
270
300
330
360
**No. of cases refers to typical minimum number cases required to test in validation set.
Customer Contact Center 800-323-4040 option 1 (domestic)
or 001-847-832-7000 option 1 (international)
APN5
Results must be received at the CAP no later than
midnight, Central Time by the due date below:
Section III: Re-Validation Procedures, cont'd
11. Continued from previous page.
Table B
Are the following changes explicitly specified when re-validating non-FDA approved predictive marker IHC assays
other than HER2, ER/PgR (eg, CD20)?
*If yes, please provide case information.
Yes*
No
Unsure
No.** of cases
specified
No.** of cases
variable and set by
Laboratory Director
No.** of cases
not specified
020
Introduction of a new lot of antibody
010
129
130
503
Change in antibody dilution
040
129
130
503
Change in antibody vendor (same clone)
070
129
130
503
Change in antibody clone
100
129
130
503
Introduction or change in antigen
retrieval method
130
129
130
503
160
129
130
503
Change in antigen detection system
190
129
130
503
Change in fixative type
220
129
130
503
Change in tissue processing equipment
250
129
130
503
Change in testing equipment
280
129
130
503
Change in environmental conditions
(eg, laboratory relocation)
310
129
130
503
Change in water supply
340
129
130
503
.
030
666
667
050
.
060
666
667
.
090
666
667
.
120
666
667
.
150
666
667
.
180
666
667
.
210
666
667
.
240
666
667
.
270
666
667
.
300
666
667
.
330
666
667
.
360
666
667
080
110
Change in incubation or retrieval times
(same method)
140
170
200
230
260
290
320
350
**No. of cases refers to typical minimum number cases required to test in validation set.
Customer Contact Center 800-323-4040 option 1 (domestic)
or 001-847-832-7000 option 1 (international)
APN6
Results must be received at the CAP no later than
midnight, Central Time by the due date below:
Section IV: General IHC Laboratory Data
Please answer the following questions with respect to ALL IHC assays currently in use.
12. What is the total number of antibodies in use in your IHC laboratory?
010
.
13. What was the total number of new antibodies introduced into your laboratory during 2014?
020
.
14. What was the total number of surgical pathology accessions in your laboratory during 2014?
030
.
15. Please provide the following information on the most recent IHC assay that your laboratory newly placed into
clinical service.
040
.
Year introduced
050
503 Unsure
070
503 Unsure
060
Name of antibody
Was a validation study performed for this
antibody assay?
080
129 Yes
130 No
503 Unsure
*If yes, please provide the following information.
090
Total number of cases included in the
validation set
.
100
503 Unsure
.
120
503 Unsure
140
503 Unsure
160
503 Unsure
.
180
503 Unsure
.
200
503 Unsure
110
Number of known positives cases tested
130
.
Positive concordance rate
150
.
Number of known negative cases tested
170
Negative concordance rate
190
Overall concordance rate
Customer Contact Center 800-323-4040 option 1 (domestic)
or 001-847-832-7000 option 1 (international)
APN7
Results must be received at the CAP no later than
midnight, Central Time by the due date below:
Section IV: General IHC Laboratory Data, cont'd
16. For your most recent IHC antibody assay, what primary method of validation did your laboratory use?
010
668
Correlated the new test’s results with the morphology and expected results
669
Compared the new test's results with the results of prior testing of the same tissues with
a validated assay in the same laboratory
670
Compared the new test's results with the results of testing the same tissue validation set
in another laboratory using a validated assay
671
Compared the new test’s results with previously validated non-immunohistochemical tests
672
Tested previously graded tissue challenges from a formal proficiency testing program
(if available) and compared the results with the graded responses
010
Other, specify:
020
503 Unsure
Section V: Awareness and Adoption
17. Prior to this survey, were you aware and/or familiar with the CAP "Principles of Analytic Validation of IHC Assays" 1
guideline published in 2014?
030
129 Yes
673 No, however plan to review the guideline within next 6 months (Skip to question 21.)
674
No, and do not plan to review the guideline (Skip to question 21.)
18. What is your current status with adopting the CAP "Principles of Analytic Validation of IHC Assays" 1 guideline
recommendations that apply to your laboratory practice?
040
675
676
Currently adopted all recommendations
Adopted some, but not all, recommendations
677
678
Plan to adopt all or some within the next 6 months
Plan to adopt all or some within the next 7-12 months
679
Do not plan to adopt unless they become requirement from accreditation agency
19. How do you currently use (or plan to use) the CAP "Principles of Analytic Validation of IHC Assays" 1 guideline
recommendations? (Fill all that apply.)
050
680
Prospectively for newly acquired antibodies for predictive markers
681
682
Prospectively for newly acquired antibodies for non-predictive markers
Prospectively for revalidation situations
683
684
Retrospectively to revalidate antibodies currently in use
Do not plan to use
1 Fitzgibbons
PL, Bradley LA, Fatheree LA, et al. Principles of analytic validation of immunohistochemical assays: Guideline from
the College of American Pathologists Pathology and Laboratory Quality Center. Arch Pathol Lab Med. 2014;138(11):1432-1443.
Customer Contact Center 800-323-4040 option 1 (domestic)
or 001-847-832-7000 option 1 (international)
APN8
Results must be received at the CAP no later than
midnight, Central Time by the due date below:
Section V: Awareness and Adoption, cont'd
20. Please indicate the most difficult aspect(s) about adopting the guideline recommendations into your validation process.
(Choose up to three responses.)
010
685
Number of cases recommended for predictive assays
686
Number of cases recommended for non-predictive assays
687
Number of cases available for routine antigens
688
Number of cases available for rare antigens
689
Achieving 90% concordance
690
Incorporating high-low expressors
691
Assessing cytology specimens
692
Assessing decalcified specimens
100
693
Changes in testing conditions (revalidation requirements); specify:
694
Documentation
695
Sufficient time/staff to run validations
696
Additional cost/expense
010
Other, specify:
650
Not applicable; do not plan to use
150
Section VI: Additional Information
21. What is your primary role/job title?
170
697
698
IHC Laboratory Director – MD/DO
IHC Laboratory Director – PhD
699
700
701
702
IHC Laboratory Director – Other medical credential(s), specify:
Department Chair/Laboratory Medical Director
Staff pathologist
IHC section/Histotechnology Supervisor/Manager
703
180
Quality Assurance Manager
190
704
Other role/title, specify:
22. Please provide any other additional information or comments on IHC validation practices in your laboratory.
200
Thank you for responding to this 2015 IHC Validation Practices and Procedures Survey. Your laboratory may be invited to
participate in a focus group.
Customer Contact Center 800-323-4040 option 1 (domestic)
or 001-847-832-7000 option 1 (international)
APN9
| File Type | application/pdf |
| Author | NT009999 |
| File Modified | 2015-02-04 |
| File Created | 2015-01-22 |