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General information about laboratory reporting standards, not medical advice. Facts below are as described on the College of American Pathologists (CAP) Cancer Protocol Templates page and Cancer Protocols FAQ, read on 2026-11-07.
Who this is for: pathology laboratory directors, quality managers and accreditation leads who need to know which parts of the CAP cancer protocols are mandatory for accreditation, which specimens they apply to, and how to handle new releases.
What the CAP cancer protocols are and who runs them
The CAP cancer protocols are guidelines for collecting the data elements needed for complete reporting of malignant tumors. CAP says they incorporate the WHO Classification of Tumors (the Blue Books) and the AJCC Staging Manual. Each protocol is published as a PDF and a Word document, and the electronic Cancer Protocols (eCP) support synoptic reporting, in which each data element is followed by its response and all required elements sit together in one location, in any order. CAP states that the protocols help laboratories meet the requirements of organizations such as the American College of Surgeons Commission on Cancer. Questions go to [email protected], and CAP links its Cancer Protocol Revision Process and New Cancer Protocol Development Procedure from the same page.
Who must use them
As described in the CAP FAQ:
- CAP laboratory accreditation requires the synoptic format described below.
- The Joint Commission requires cancer protocols as part of its Laboratory Accreditation Program (see Joint Commission accreditation).
- NAPBC-accredited breast programs must use CAP synoptic reporting and include ER, PR and HER2 results.
- Commission on Cancer requirements are published on the CoC website, not in the CAP protocols.
What the protocols require: element types
| Element type | When to report | Accreditation effect (per CAP) |
|---|---|---|
| Core | Whether applicable or not | Required in synoptic format for in-scope specimens |
| Core-conditional / conditional | Only when applicable (CAP’s example: total lymph node count is reported only if nodes are present) | Required when they apply, for in-scope specimens |
| Optional, marked “+” | May be reported based on local practice | Not required for CAP accreditation |
CAP publishes a summary of required elements as a spreadsheet on its site, which is the quickest way to see the required set per protocol.
Which specimens are in scope
For accreditation, the definitive primary cancer resection specimen must carry the core and conditional elements in synoptic format. Laboratories must include the required elements in at least 90% of reports from definitive resections of primary invasive malignancies and breast DCIS. CAP lists what is not required: cancers with no CAP protocol, additional procedures after definitive resection, resections without residual cancer after neoadjuvant therapy, diagnostic biopsies or cytology, resections of metastatic or recurrent tumor, and special studies performed elsewhere.
Biomarker templates
Biomarker protocols are not required for accreditation purposes. Their use is optional; only the breast biomarker template has required elements, which must appear somewhere in the report. Some individual protocols can still become accreditation requirements: CAP notes that the phyllodes protocol is now required for accreditation of malignant phyllodes tumors.
Compliance steps for a laboratory
- Download the current version of each protocol you use from the Cancer Protocol Templates page; the release date and version appear near the top of the title page.
- Build or update the synoptic template in your anatomic pathology LIS. CAP’s electronic Cancer Checklists (eCC) are licensed for institutional use, supported by major AP-LIS systems and updated through the vendor alongside protocol releases; CAP also offers eFRM software.
- Read the Summary of Revisions published with each release and record the change in your document-control process (see change control for the general discipline).
- Map each protocol to the specimen types in scope above so that out-of-scope work, such as diagnostic biopsies, is not audited against it.
- Monitor the 90% completeness measure for definitive resections and review misses.
Release and update timeline
CAP says revisions are driven by AJCC and WHO updates and by issues that users submit to the committee. The accreditation program allows 8 months from the posting date before a deficiency risk applies to a new version. The Cancer Protocol Templates page lists several releases per year; on 2026-11-07 it showed releases ranging from December 2024 through September 2026, and each protocol lists its current version plus previous versions, with some marked “Protocol Retired”. Treat the page, not this guide, as the source for the current version of any protocol.
Common mistakes
- Applying protocols to diagnostic biopsies or metastatic resections that CAP lists as out of scope.
- Treating optional “+” elements as accreditation requirements, or omitting core elements because they seem not applicable. Core elements are reported whether applicable or not.
- Assuming biomarker templates are mandatory in general; only the breast template carries required elements.
- Using a superseded version after the 8-month allowance has passed.
Related programs and tools
| Item | Relationship (per CAP) |
|---|---|
| Electronic Cancer Protocols (eCP) | Support synoptic reporting |
| Electronic Cancer Checklists (eCC) | Licensed LIS implementation, updated with protocol releases |
| ACS Commission on Cancer | Its requirements are listed on the CoC website; CAP protocols help laboratories comply |
| NAPBC | Accredited breast programs must use CAP synoptic reporting with ER, PR and HER2 |
| Joint Commission Laboratory Accreditation Program | Requires cancer protocols |
For specimen-handling context see histopathology, what is pathology, and the CAP Biorepository Accreditation Program.
FAQ
Where do I find the CAP cancer protocol template or PDF?
On the CAP Cancer Protocol Templates page, each protocol is offered as a PDF and a Word file, with previous versions listed.
Are CAP protocols for breast, colon, thyroid, ovary or kidney all mandatory?
Each organ site has its own protocol. What is mandatory for accreditation is the synoptic reporting of core and conditional elements for definitive primary resections of cancers that have a CAP protocol, not every protocol in every situation.
Is there a 2026 version?
CAP’s page listed releases dated through September 2026 on 2026-11-07, and individual protocols show their own version and release month. Check the protocol you use on that page.
Are optional elements required?
No. Elements marked “+” are not required for CAP accreditation.
Sources
- CAP, Cancer Protocol Templates, read 2026-11-07.
- CAP, Cancer Protocols FAQ, read 2026-11-07.
