CAP Cancer Protocols - Frequently Asked Questions

Laboratories across the country and around the world rely on the CAP to help them stay current with the latest evidence-based practices and maintain quality and proficiency among the entire pathology team.

Since 1986 the CAP Cancer Protocols provide guidelines for collecting the essential data elements for complete reporting of malignant tumors and optimal patient care. These protocols incorporate the latest standards to help pathologists and laboratories keep abreast of the advances and updates in cancer reporting, including:

• The World Health Organization Classification of Tumors (Blue Books)
• The American Joint Committee on Cancer Staging Manual

Synoptic reporting using the CAP electronic Cancer Protocols (eCP) also helps laboratories and hospitals comply with requirements for organizations like the American College of Surgeons Commission on Cancer, the CAP Laboratory Accreditation Program, and more.

The CAP Biomarker Reporting Protocols are intended to provide reporting guidance for commonly ordered biomarkers and are not required for accreditation purposes.

The cancer protocols are created by a multidisciplinary team of expert medical professionals, led by the members of the CAP Cancer and PERT Committees, to facilitate comprehensive pathology reporting of a cancer specimen. Protocols can be utilized for a variety of procedures and tumor types for clinical care purposes. For accreditation purposes, only the definitive primary cancer resection specimen is required to have the core and conditional data elements reported in a synoptic format.

Each cancer protocol is composed of two parts:

1. Case Summary (i.e. the 'synoptic report' data elements) contains:
   • Core data elements must be reported whether applicable or not. Conditional data elements only need to be reported if applicable; for instance, the total number of lymph nodes examined must be reported, but only if nodes are present in the specimen.
   • Optional data elements are identified with “+” and although not required for CAP accreditation purposes, may be considered for reporting as determined by local practice standards.
2. Explanatory Notes provide brief educational material to facilitate accurate completion of the Case Summary

Cancer protocols should be used to report the definitive primary cancer resection specimen. The cancer protocols include tables that outline the tumor types that should be reported using the cancer protocol. The tables also include a small list of tumor types that should not be reported used the protocol and indicated alternate protocols when applicable.

For accreditation purposes, the cancer protocols are NOT required for use in:

• Cancer for which no CAP Cancer Protocol is available
• Additional surgical procedures performed after definitive surgical resection such as excision for positive margins or lymph node sampling
• Definitive resection specimens that do not contain cancer (eg, following neoadjuvant chemotherapy)
• Diagnostic biopsy, cytology specimens, or other diagnostic procedures done prior to definitive surgical therapy
• Metastatic tumors or resections for recurrent tumors
• Special studies, including biomarker testing performed in another laboratory

Many organizations use the cancer protocols to provide a composite report; e.g. reporting the definitive resection with information from the biopsy and prior procedures. Adding information from the biopsy to the case summary of the definitive resection is allowable for accreditation purposes, as long as the case summary contains all of the required elements and is in the appropriate synoptic format.

In cases where multiple tumors need to be staged separately, the report should include separate synoptic case summaries for each tumor. For sites where multiple tumors are staged together (i.e. using the ‘m’ modifier for T classification), the required elements for the multiple tumors may be reported together in one synoptic case summary.

Many of the cancer protocols address reporting of multiple tumors. Additionally, the AJCC Cancer Staging Manual 8th Edition covers the topic in detail in Chapter 1 and in many of the site-specific chapters and may be a valuable reference in these cases.

There is no requirement that case summaries be used for tumors that recur; however, hospitals and pathology groups may find the templates useful in reporting such tumors.

No. According to the AJCC 8th edition (chapter 1) "Only the managing physician can assign the patients stage, because only (s)he routinely has access to all the pertinent information from physical examination, imaging studies, biopsies, diagnostic procedures, surgical finding and pathology reports." In breast this also includes the results of genomic testing.

The data element should be represented in the report as it is listed in the case summary. Laboratories are allowed to alter the exact wording as long as it still conveys the meaning of the data element. The response for any data element may be modified from those listed in the case summary, including “Cannot be determined” if appropriate.

The CAP requires that all required data elements in applicable CAP Cancer Protocols are included with appropriate responses using a synoptic format in at least 90% of the surgical pathology reports from definitive resection specimens for primary invasive malignancies, as well as cases of ductal carcinoma in situ of the breast (DCIS). A self-audit is performed annually to ensure that all required elements are included.

Additionally, The Joint Commission requires the use of cancer protocols as a part of their Laboratory Accreditation Program. Pathologists reporting breast specimens in a program accredited by the National Accreditation for Breast Centers (NAPBC) are required to use CAP synoptic reporting and to include ER, PR and HER2 results in the report. Please refer to each organization’s website for details.

The Commission on Cancer does have requirements for use of the CAP Cancer Protocols for CoC-accredited organizations. The most current information regarding CoC accreditation requirements is available on the CoC website.

The CAP has established a guidance document and definition for 'synoptic reporting' within a surgical pathology report on cancer specimens. Synoptic reporting minimizes the variability between institutions and is presented in such a way that clinicians can easily and quickly find the pertinent information in the surgical pathology report, and ensures that the appropriate data needed for patient care is provided.

The synoptic component of the cancer reports meets the following four key criteria:

1. All core elements must be reported whether applicable or not. Elements identified in the Cancer Protocols as 'core-conditional' or “conditional” only need to be reported if applicable.
2. All data elements and responses must be reported in an element response pair format, ie, defined as data element followed by its response (eg, Histologic type: Invasive lobular carcinoma).
3. Each element response pair must be listed on a separate line or in a tabular format to achieve visual separation. Two or more data elements may NOT be listed together on one line with the following exceptions:
   • Anatomic site or specimen, laterality, and procedure
   • Pathologic Staging Tumor Node Metastasis (pTNM) staging elements
   • Negative margins, as long as all negative margins are specifically enumerated where applicable
4. All required data elements must be listed together in one location in the pathology report and may be listed in any order. Additional items may be added within the synoptic report as needed.

Additional information and examples of synoptic reports can be found at the Cancer Protocol Resources Page.

The cancer protocols are tools used to assist the pathologists in providing clinically useful and relevant information when reporting surgical specimen examinations of surgical specimens. The "Surgical Pathology Cancer Case Summary" portion of the protocols lists the reporting elements that CAP considers essential in the surgical pathology report. How an institution implements this is at the discretion of that institution, as long as it meets the requirements identified above for synoptic reporting. We recommend that format development for the surgical pathology report for cancer specimens at individual institutions or healthcare systems occurs as a multidisciplinary or organizational process.

There are various ways to incorporate the checklist portion of the cancer protocols into your surgical pathology reports. Some institutions have templated the entire checklist for each specimen and are using that in their diagnostic field. Other institutions still report out their diagnosis using a traditional format but have incorporated the synoptic reporting piece either elsewhere in the diagnostic field or in the comment field or even in the microscopic description field. Whatever format that an institution chooses to use, the synoptic reporting piece should be easily identifiable and distinct from other data included in the report, and must contain the required elements as identified in the cancer protocols. Additionally, the entire synoptic reporting portion of the surgical pathology report must be reported in a single place in the report, i.e., you cannot break up this portion and put it in various areas of the surgical pathology report.

The CAP's Cancer Committee and Cancer Protocol Review Panels are charged with developing new protocols and revising the existing CAP cancer protocols on a routine basis. Revisions to the protocols are initiated by updates in clinical standards, such as the AJCC and WHO, and by user submitted issues evaluated by the Committee. Updates of the CAP electronic Cancer Checklists (CAP eCC), which are available from CAP to license for your institution, are coordinated with cancer protocol releases.

The CAP Laboratory Accreditation Program allows a period of 8 months from the posting dates of new and revised protocols before laboratories are at risk of an accreditation deficiency.

The most up-to-date protocols and background documentation may be downloaded from the Cancer Protocol Templates page and integrated into your practice. The release date and version appears near the top of the title page of current protocols.

The CAP offers the CAP electronic Cancer Checklists (eCC) and the CAP eFRM software to help pathologists and laboratories incorporate the protocols directly into their workflow and AP-LIS vendor software. The CAP eCC is supported by all major AP-LIS systems and provides automatic updates of protocol content through your vendor. Please refer to the eCP page or email us at cancerprotocols@cap.org for more information.

Additionally, the CAP offers a summary of required elements containing concise lists of the required cancer reporting elements.

Please contact us at cancerprotocols@cap.org or visit our CAP electronic Cancer Protocols page for further information about using the CAP eCP’s to help you with cancer reporting at your institution.

The cancer biomarker reporting templates are produced to establish reporting guidance for commonly ordered biomarkers, create stand-alone reporting templates, and improve consistency and completeness of results reporting to assist tumor registrars and others involved in data collection, exchange, and surveillance. These reporting templates are intended to encompass all important data elements for routinely assessed tumor markers and are designed to be incorporated into electronic reporting systems. Completion of the template is the responsibility of the laboratory performing the biomarker testing and/or providing the interpretation.

Use of the cancer biomarker reporting templates is entirely optional and is currently not a requirement for laboratory accreditation. At this time, only the breast template includes required elements (in accordance with CAP/ASCO reporting guidelines), the results of which need be present somewhere in your pathology report. All elements found in the other biomarker reporting templates are currently optional, although this may change in future versions as new evidence emerges.

The CAP does not require labs to re-report the markers in resection specimens if they were performed on a previous biopsy specimen. It is at the laboratories discretion whether to include these results in the resection report. The National Accreditation Program for Breast Centers (NAPBC) now requires the results of ER/PgR and HER2 testing be included in the synoptic report of the definitive cancer resection specimen, even if the testing was done on an earlier needle biopsy or at an outside institution, but this requirement only applies to facilities that are accredited by NAPBC.

The cancer protocols and biomarker reporting templates are available free of charge and can be downloaded from the Cancer Protocol Templates page.

The free download authorization does not extend to reproduction or other use of any substantial portion of these protocols for commercial purposes. The cancer protocols and biomarker reporting templates are protected by copyright and cannot be used in an information system without a license. Please read the copyright, disclaimer, and authorized use licensing model for terms and conditions. This information is printed on the second or third page of every cancer protocol and biomarker reporting template. For commercial use of the protocols, contact cancerprotocols@cap.org or 847-832-7700.

Feedback from cancer protocol and biomarker reporting template users is invited and encouraged. You may provide feedback via cancerprotocols@cap.org.

To submit feedback, please go to the CAP electronic Cancer Protocols (CAP eCP) page to download the feedback form in the upper right side of the webpage.