Cancer Protocol Frequently Asked Questions

 

Since 1986, the CAP Cancer Protocols have served as a resource and reference for complete reporting of malignant tumors, including American Joint Committee on Cancer (AJCC) staging and the World Health Organization (WHO) histologic type standard elements. The production and maintenance of these important reference resources and cancer reporting tools is performed by the expert pathologists on the CAP Cancer Committee. The protocols have grown in number and scope over the past several years, and have influenced important global efforts such as the International Collaboration on Cancer Reporting (ICCR) datasets.

The move to integrate the Cancer Protocols into the pathologist AP-LIS workflow came in 2007 with the release of the CAP electronic Cancer Checklists (eCC), and the Pathology Electronic Reporting Committee (PERT) was created to manage this product and process. Uptake and use of the CAP eCC has grown significantly since its inception, with over 325 licensed laboratories in the US and Canada, and incorporation into all of the major AP-LIS vendor systems.

The Cancer Biomarker Reporting Committee (CBRC) was formed in 2013 to standardize cancer biomarker reporting, with a charge to produce the Cancer Biomarker Reporting Templates to complement the Cancer Protocols. Like the protocols, these templates are produced in both paper (Word/PDF) and electronic (eCC) format.

What is a cancer protocol?

The Cancer Protocols were created by a multidisciplinary team of expert medical professionals, led by the members of the College of American Pathologists Cancer Committee, to facilitate comprehensive pathology reporting of a cancer specimen. There are currently 66 protocols available covering most major organ systems.

A cancer protocol is composed of two parts:

  • a case summary (i.e. the 'synoptic report' format) Included in each case summary are "required data elements" for optimal patient care as well as "optional" elements that may be clinically important but are not yet evidence-based or regularly used in patient management. In some instances, a data element will be noted as conditionally required if present in the specimen (ie, lymph nodes in invasive carcinoma of the breast).
  • explanatory notes that provide brief educational material to facilitate accurate completion of the case summary

What are the Cancer Biomarker Reporting Templates?

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.

Are Cancer Protocols required to be used for accreditation purposes?

Yes, CAP accredited laboratories and hospitals that are Commission on Cancer (CoC) accredited have requirements for use of the Cancer Protocols for reporting. Additionally, the Joint Commission has recently added the use of Cancer Protocols as a part of their Laboratory Accreditation Program. Please refer to their website for details.

Is use of the Cancer Biomarker Reporting Templates required by accreditation?

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). All elements found in the other biomarker reporting templates are currently optional, although this may change in future versions as new evidence emerges.

How can I get copies of the cancer protocols and biomarker reporting templates?

The cancer protocols and biomarker reporting templates are now available without charge and can be downloaded from the CAP website.

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 capecc@cap.org or 847-832-7700.

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How can I get more information on the CAP electronic Cancer Checklists (CAP eCC)?

Please contact us at capecc@cap.org or visit us online at www.cap.org/capecc for further information about using the CAP eCC or the CAP eFRM software to help you with cancer reporting at your institution.

When should a cancer protocol be used?

For accreditation purposes, the Cancer Protocols are required to be used for reporting of the definitive resection specimen in which there is invasive malignancy. For patients that require multiple operative procedures to accomplish definitive resection, only the primary operative procedure requires use of the Cancer Protocol format.

Ductal Carcinoma in situ (DCIS) is the only in situ malignancy that requires use of a Cancer Protocol.

The Cancer Protocols are not required for use in:

  • Biopsy specimens
  • Resection after neoadjuvant therapy in which no tumor is present
  • Resection for recurrent disease
  • Resection for in situ disease, dysplasia without malignancy, or non-invasive tumors, with the exception of DCIS.

When are the protocols revised?

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. 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.

When new or revised cancer protocols are released, how soon should they be adopted?

Pathologists can and should begin using the updated protocols as soon as possible following their web posting. Vendors should also undertake immediate implementation of the new protocols into their products.

The CAP recognizes that full implementation by some institutions and laboratory informatics software vendors may require a period of months and recognizes an 8-month period of overlap for LAP accredited laboratories in which either the previous or new version of the protocol may be used.

How can I know that I am using the most current version of the protocols

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

What cancer protocol should be used for instances where there are multiple primary tumors?

In a case with multiple primary tumors, the required elements for each tumor should be evaluated and reported separately. Ideally, each required data element should be reported for each tumor in a separate report. Using multiple reports for a case with multiple primaries will ensure that all relevant information for each tumor is accurately reported. If there are extensions/metastases of a primary lesion that are not actually separate primaries, these can be covered in the same report.

An exception can be found in the invasive breast protocol in which a single report would only be required for reporting the largest carcinoma. If there are smaller carcinomas of a different type, this information should be included under "Additional Pathologic Findings".

If a cancer is excised and then recurs locally and is re-excised, should a template and pathologic stage be provided with the pathology report of the re-excision?

No. While in some cases the cancer protocols may be useful for re-excision specimens, the cancer protocols are primarily designed for the definitive initial pathology reporting of cancer specimens.

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Are there circumstances where a cancer protocol is recommended for diagnostic needle biopsies?

Although most cancer protocols are designed for resection specimens, some exist for biopsy specimens. There are some specific anatomic sites for which definitive non-surgical treatment of cancer is undertaken following a biopsy diagnosis of malignancy, and use of the checklist is recommended for such cases. Use of the cancer protocols are not required for biopsy specimens.

Should a cancer protocol be used for non-invasive carcinomas, i.e. carcinoma-in-situ, in the absence of a primary malignancy?

No, with the exception of breast ductal carcinoma in situ (DCIS), which has a separate cancer protocol.

Are there cancer protocols for benign tumors?

With the exception of the brain/spinal cord protocol, not at this time.

What are the CAP accreditation requirements for the cancer protocols?

The CAP requires that all accredited laboratories include the required data elements from the applicable cancer protocols in their surgical reports to achieve laboratory accreditation as part of their laboratory accreditation program.

Effective July 2015, the CAP Anatomic Pathology Checklist will not only require that accredited laboratories ensure that all required data elements are in reports, but that they also use the synoptic format and that they have an audit process in place to ensure compliance.

What does the American College of Surgeons Commission on Cancer (CoC) program require?

The most current information regarding CoC accreditation requirements is available on the CoC website.

CoC Standard 2.1 (2017 phase-in)
Each calendar year, 95 percent of the eligible cancer pathology contain all required data elements of the College of American Pathologists (CAP) protocols and are structured using the synoptic reporting format as defined by the CAP Cancer Committee.

Definition and Requirements:
The CoC requires that 95 percent of eligible pathology reports that include a cancer diagnosis are formatted using synoptic reporting and incorporate the required data elements outlined in the current applicable surgical case protocols and summary checklists of the College of American Pathologists (CAP) publication, Reporting on Cancer Specimens. Synoptic pathology reporting uses discrete data field format (i.e., each required data element has a specific place and format in the report).

For CoC-accredited programs, the CAP protocols apply to the following:

  • Pathology reports created by the program from resected specimens with a diagnosis of invasive cancer.
  • Pathology reports created by the program from resected specimens with a diagnosis of ductal carcinoma in situ (DCIS). Diagnostic biopsy specimens, cytology specimens, special studies, and reports of carcinoma in situ (except for ductal carcinoma in situ) are excluded.

At a minimum, a random sample of 10 percent of pathology reports eligible for the CAP protocols or a maximum of 300 cases are reviewed each year to document compliance with this standard. The cancer committee may delegate this quality control activity to the pathologists who report the quality control activity and a summary of findings regularly to the cancer committee or to other physicians on the cancer committee.

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What is a synoptic report?

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

Additional information and examples of synoptic reports can be found at the Cancer Protocol Resources page at www.cap.org.

How can I implement the cancer protocols into my pathology reports?

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 really 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 together as a group i.e. you cannot break up this portion and put it in various areas of the surgical pathology report.

Can I include multiple required data elements on one line?

Two data element names may not be listed on the same line, with the following exceptions:

  • Anatomic site and/or specimen, laterality, and procedure
  • Negative margins. Example: for colorectal carcinoma resection specimens, negative proximal, distal, and radial margins may be listed on one line
  • Pathologic staging: pT, pN, and pM categories may be listed on one line. It is not necessary to include definitions of the pT, pN, and pM categories in the report.

Otherwise, only multiple values pertaining to the same data element may be listed on the same line.

If an element is required but I don't have information, do I need to respond "NA" or can I just not include in the synoptic reporting portion of the report?

If it is a required element, it must remain in the synoptic portion of the report even if you don't have information. Using "not available" or "not applicable" or similar wording is appropriate. The exception is for conditional data elements indicated as required only if present in the specimen.

If an element in a cancer protocol is not identified as 'required', do I need to include it in the report if the clinicians at my hospital don't use the information?

Only the required data elements have to be included in the surgical pathology report (and in the synoptic reporting format described above). It is up to the pathologist, in discussion with their clinical colleagues, to decide what additional elements should be a part of the report. Also, data elements from the cancer protocols that are indicated as not required do not have to be included in the synoptic reporting portion of the surgical pathology report. If included, they may appear elsewhere in the report. Once again, this should be a decision made in close consultation with your clinical colleagues.

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Are tools available to ensure compliance?

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 in their 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 www.cap.org/capecc or email us at capecc@cap.org for more information.

Additionally, the CAP offers a summary of required elements containing concise lists of the required cancer reporting elements, which can be found at www.cap.org/cancerprotocols.

How can I comment on the Cancer Protocols and Biomarker Reporting Templates?

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

For feedback on the CAP electronic Cancer Checklists (eCC), please go to www.cap.org/capecc and complete and return the feedback form in the upper right side of the webpage.

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