Fixation on Histology

CAP Changes to Predictive Markers: Tips for Compliance

  

One of the biggest challenges in any lab is compliance, and with the amount of regulations and rules we have to follow to ensure safe patient testing and keep our lab open,  it can be overwhelming. One of the biggest hurdles is proficiency testing (PT). In the world of histology, these proficiency tests are directed mainly at immunohistochemistry (IHC) and in-situ hybridization (ISH) assays. Knowing which assays require PT and which don’t depends on the tech  knowing, not just the analyte itself, but the manner in which the clinicians and pathologists will use the results generated by these tests. There are three ways test results are utilized by pathologists. Research Use Only (RUO) or Investigational Use Only (IUO) assays are utilized in research settings to help prepare them for future use and utility in patient care. Diagnostic assays are used by pathologists to either rule out or confirm a particular diagnosis, primary tumor, or disease state. Most of our IHC or ISH assays fall into this category. A smaller class of assays are considered predictive assays, which are used to guide a patient to a therapeutic treatment  proven to work best for them based on expressed characteristics of their individual disease state. These predictive assays are sometimes referred to as Companion Diagnostics, and have been in use for breast carcinoma many years. Recently, there have been a large proliferation in these predictive markers, including PD-L1, HER2-low, and Folate Receptor assays. Traditionally, the College of American Pathologists (CAP – the primary regulatory body for pathology labs in the US) have had very exacting compliance requirements for PT for predictive markers. These requirements can be a significant driver of cost in the lab, with some labs spending thousands of dollars annually for these programs. 

 

Over the last 10-15 years, there has been a drive towards consolidation in labs and operations, often times having laboratories looking to gain economies of scale to offset continuing cuts in reimbursements by payers. This led to a growth in the number of centralized labs, an arrangement in a hub-and-spoke model with a central processing lab and interpretation sites across a system of affiliated hospitals or clinics. In such a model, the specimens are processed, cut, and stained at the central lab while pathologists are dispersed across the system reviewing and interpreting histological slides. Subsequent diagnostic or predictive tests are also performed at the central lab and read at the off-site locations, the central lab, or both. One of the unintended consequences of such an arrangement has been that both the off-site location and the central lab have both had to purchase a full set of proficiency testing to be compliant with regulations. This has led to many different challenges, including increased costs and concerns surrounding PT referral. To address these challenges, the CAP updated requirements for compliance for predictive marker PT in 2023.

 

The biggest change this year is that CAP will only require PT for predictive assays if the lab performs both staining and interpretation on-site.

“For laboratories that perform only the staining or only the interpretation, but not both on site, alternative performance assessment will be required at least semiannually. Previously, staining-only laboratories were not required to perform proficiency testing or alternative assessment. For interpretation-only laboratories, it is a move away from proficiency testing to alternative performance assessment.”1

This means we will have to develop a program to perform an alternative assessment twice per year which will have a profound impact on how we manage this process moving forward. This can be daunting, and not just from a practical standpoint (you have to write a new SOP). You have to start from scratch and develop an entirely new process! 

 

To ensure compliance at your laboratory, use the following best practices:

  • Perform a thorough review of your test menu while comparing it to to the CAP Master Activity Menu. This can be accessed by your lab’s CAP administrator via their website. Once you examine all of the items on the activity menu, you may find you have a question or two about the manner your assays are being interpreted. Some markers can be diagnostic in one setting and predictive in another. Knowing which markers are used in which manner is important in deciding if any form of PT is required.2 You will need to involve your Medical Director and/or oversight pathologist to determine if your assays are being utilized in a predictive manner. If they are, you will be required to update your activity menu and enroll in the required PT or alternative assessment.

  • Once you know whether your assay is a predictive marker or not, you need to understand the nature of your staining and interpretation. If both are performed at the same site, then you must enroll in CAP-required PT. If your facility only does one or the other—but not both—then you are not required to enroll in a formal PT. However, you will need to perform an alternative assessment twice per year. Luckily, CAP has some fantastic resources for helping you establish such a program.

  • There are a few options for alternative performance assessments (APAs). Choosing a program that is right for your facility will take some time and collaboration with your pathologists. CAP suggests a few options for compliance with an APA program. These include: 
    • Enroll in a formal PT program. While this is an expensive option and may be redundant, it takes a significant burden off the table and puts it in the hands of the PT provider. It also compares your testing to a larger external peer group and is a more standardized approach. This is worth considering if your lab does not have the expertise or availability of resources to create an in-house APA program.
    • Split Sample Analysis. This is a technique where you send the same sample (or serial sections) to a reference lab with the same validated assay. If you choose a split-sample analysis, you will need to ensure your SOP delineates what would be considered acceptable performance and by what method it would be compared against, and how this will be documented.3

 

No matter what method you choose, an alternative performance assessment is a real challenge for starting or managing any lab  with the assurance of compliance. Though only a few months into 2023, it is not too late to take the necessary steps now to ensure you are compliant for the future. 

References:
1. Newitt, V. (2022). What’s Required in’23 for Predictive Marker Tests. CAP Today (Sept. 2022). Accessed from https://www.captodayonline.com/whats-required-in-23-for-predictive-marker-tests/
2. College of American Pathologists. (2022). Frequently Asked Questions form Immunohistochemistry Laboratories. Accessed from https://documents.cap.org/documents/Immunohistochemistry-IHC-FAQs.pdf
 
3. College of American Pathologists. (2022). Predictive Marker Activity Menu and PT Requirement Changes. Accessed from https://www.cap.org/laboratory-improvement/news-and-updates/predictive-marker-activity-menu-and-pt-requirement-changes

Written By: Jason Molnar, BS, HT(ASCP), QIHC(ASCP)

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#LaboratoryOperations
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